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Product Description, Features and Intended

Use

Product Description

The Radius PCG™ (model: EMMA Bluetooth) is a quantitative mainstream carbon dioxide monitor comprised of a

Sensor Body that fits on top of a disposable EMMA Airway Adapter.
The Radius PCG™ includes Bluetooth wireless technology so that data can be transferred to a paired device.

Intended Use

Radius PCG™ measures, displays and monitors carbon dioxide partial pressure and respiratory rate during anesthesia,

recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic,

emergency medicine and emergency transport settings for adult, pediatric and infant patients.

Содержание Radius PCG

Страница 1: ...Operator s Manual Radius PCG Mainstream Capnograph ...

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Страница 3: ...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 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 re...

Страница 4: ...1 A1 2012 C1 2009 R 2012 and A2 2010 R 2012 CSA CAN CSA C22 2 NO 60601 1 14 Patents www masimo com patents htm Masimo Radius and Root are federally registered trademarks of Masimo Corporation Radius PCG and XTP are trademarks of Masimo Corporation All other trademarks and registered trademarks are property of their respective owners 2021 Masimo Corporation ...

Страница 5: ...Chapter 1 Technology Overview 15 Chapter 2 Description 19 Chapter 3 Basic Setup and Use 21 Chapter 4 Operation 27 Chapter 5 Alarms and Messages 37 Chapter 6 Troubleshooting 41 Chapter 7 Specifications 43 Chapter 8 Service and Maintenance 57 Appendix A Operation with Root 67 Appendix B Concepts of Alarm Response Delay 91 ...

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Страница 7: ...tions and notes A warning is given when actions may result in a serious outcome for example injury serious adverse effect death to the patient or user WARNING This is an example of a warning statement A caution is given when any special care is to be exercised by the patient or user to avoid injury to the patient damage to this device or damage to other property CAUTION This is an example of a cau...

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Страница 9: ...Airway Adapter The Radius PCG includes Bluetooth wireless technology so that data can be transferred to a paired device Intended Use Radius PCG measures displays and monitors carbon dioxide partial pressure and respiratory rate during anesthesia recovery and respiratory care It may be used in the operating suite intensive care unit patient room clinic emergency medicine and emergency transport set...

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Страница 11: ...form a pre use tightness check of the patient circuit WARNING EMMA Airway Adapters shall not be reused Reuse of single use Adapters can cause cross infection WARNING Do not use the EMMA Adult Pediatric Airway Adapter with infants as the Adapter adds 6 ml dead space to the patient circuit WARNING Do not use the EMMA Infant Airway Adapter with adults pediatrics as this may cause excessive flow resis...

Страница 12: ...NG Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the Radius PCG Otherwise degradation of the performance of the Radius PCG could result WARNING When used in environments with known sources of RF interference e g diathermy electrocautery RFID avoid close proximity to such devices t...

Страница 13: ...ly Keep away from children WARNING Use only Alkaline batteries or Energizer Ultimate Lithium L92 batteries Use of other Lithium batteries may present a risk of fire or explosion WARNING Replace batteries immediately when the Battery Status Indicator starts blinking Remaining battery time depends on battery type and other circumstances and cannot be reliably predicted CAUTION Remove alkaline batter...

Страница 14: ...attached correctly Note The presence of ambient air 0 CO2 in the EMMA Airway Adapter is of crucial importance for a successful Zeroing Special care should be taken to avoid breathing near the Airway Adapter before or during the Zeroing procedure Compliance Warnings and Cautions WARNING Any changes or modifications not expressly approved by Masimo shall void the warranty for this equipment and coul...

Страница 15: ... from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help Note This equipment has been tested and found to comply with the Class B limits for medical devices according to the EN 60601 1 2 2015 Medical Device Directive 93 42 EEC These limits are designed to provide reasonable protection against harmful interference in all establishments includin...

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Страница 17: ...orbed light is measured by a miniaturized two channel spectrometer positioned to receive the infrared light beam The spectrometer incorporates a filter wheel fitted with two different optical color filters The wavelength ranges of these filters are chosen such that one filters out colors where carbon dioxide has very strong absorption and the other filters out colors where carbon dioxide has no ab...

Страница 18: ...www masimo com 16 Masimo 1 Spectrometer with optical filter wheel and infrared detector 2 Infrared light beam 3 Infrared light source 4 Respiratory gas ...

Страница 19: ...ediatric and Infant Radius PCG operates to specification with either Airway Adapter model when used with its appropriate patient population The Airway Adapters are intended for single patient use They are disposable and shall not be re used Reuse of single patient use Adapters can cause cross infection Airway Adapters shall be disposed of in accordance with local regulations for bio hazardous wast...

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Страница 21: ...chapter contains the description of the Radius PCG physical features General System Description The Radius PCG system includes the following Radius PCG Device Two 2 AAA Batteries For a complete list of compatible EMMA Airway Adapters visit www masimo com ...

Страница 22: ...attery Cover release button 3 Lanyard attachment 4 Alarm Silence button 5 EtCO2 Value 6 Capnogram 7 Power On button 8 EMMA Airway Adapter 9 Alarm Status 10 Respiratory Rate Value 11 Battery Status Indicator 12 Bluetooth Indicator 13 Radius PCG Sensor Body ...

Страница 23: ...rmation about setting up Radius PCG before use Installing Batteries Unpack and inspect the Radius PCG for external damage Please contact your local distributor in case of damage 1 Press the Battery Cover release button into the Radius PCG Sensor Body until the Battery Cover pops off ...

Страница 24: ...com 22 Masimo 2 Open the battery compartment and insert two 2 AAA batteries Make sure the batteries are fitted according to the indicated polarity After battery installation snap the Battery Cover back into place ...

Страница 25: ...www masimo com 23 Masimo Attaching Airway Adapter Snap the EMMA Airway Adapter into the Radius PCG Capnograph It will click into place when properly inserted ...

Страница 26: ... com 24 Masimo Connecting to a Tube or Mask The Radius PCG can be connected to a patient using an endotracheal tube or mask The following pictures illustrate these two methods of connection Endotracheal tube Mask ...

Страница 27: ...www masimo com 25 Masimo Power On 1 To power on Radius PCG press the Power On button 2 When the Radius PCG is ready the EtCO2 Value displays 0 and the Respiratory Rate Value displays dashes ...

Страница 28: ...dure perform a Zeroing procedure See Zeroing Procedure on page 60 Power Off The Radius PCG switches off automatically during following conditions If no breath is detected within 2 minutes from power up If no breath is detected for 2 minutes and the alarm has been silenced 15 seconds after the Airway Adapter is removed Note The device will not automatically power off if there is an alarm condition ...

Страница 29: ...D display that displays End Tidal Carbon Dioxide EtCO2 and Respiratory Rate RR parameters as well as the CO2 waveform Capnogram 1 EtCO2 Parameter Value 2 Capnogram 3 RR Parameter Value EtCO2 The Radius PCG is available in versions displaying End Tidal Carbon Dioxide EtCO2 either in mmHg 0 99 mmHg or kPa 0 0 9 9 kPa EtCO2 values are displayed after one breath and the averaged value is updated every...

Страница 30: ...ds 53 mmHg 7 kPa a horizontal dashed line 1 will be displayed to indicate that the Capnogram is saturated Auto Brightness To extend battery life time the Radius PCG display has an automatic brightness control which will be activated during stable conditions Any change in displayed vital parameters alarm or pressing any button will return the Radius PCG display to normal brightness ...

Страница 31: ...tus Indicator is normally lit with a steady green light in the upper right corner of the display Battery OK or Weak When batteries are low the Battery Status Indicator starts blinking Battery Status Battery Voltage Battery Status Indicator OK 2 4V 8 Weak 2 2V to 2 4V ...

Страница 32: ...period after power on Nearly depleted batteries may still be able to provide a voltage above the threshold for battery low indication even if the internal battery resistance is too high to provide sufficient current to start up the device next time the power on button is activated To extend battery life time the Radius PCG display has an automatic brightness control which will be activated during ...

Страница 33: ... Controls The Radius PCG has one Power On and one Alarm Silence button These buttons are also be used for adjusting the high and low EtCO2 alarm limits up and down 1 Power On Adjust Down button 2 Alarm Silence Adjust Up button ...

Страница 34: ... Lower range Upper range EtCO2 mmHg OFF 1 89 mmHg 11 99 mmHg OFF EtCO2 kPa OFF 0 1 8 9 kPa 1 1 9 9 kPa OFF Note The alarm limits will be reset to default values after Radius PCG powers off If the high EtCO2 limit is decreased close to the low EtCO2 limit the low limit will be automatically adjusted in order to maintain a minimum difference of 10 mmHg 1 0 kPa between the high and low alarm limit Si...

Страница 35: ... current low EtCO2 alarm limit See Controls on page 31 2 Release the Power On button 3 To adjust the alarm limit press the Alarm Silence button to increase or the Power On button to decrease the value It is possible to switch off the low EtCO2 alarm by adjusting the limit down to 0 The Radius PCG will indicate this setting by showing on the EtCO2 display during the adjustment routine If no button ...

Страница 36: ...ilence button 3 To adjust the alarm limit press the Alarm Silence button to increase or the Power On button to decrease the value It is possible to switch off the high EtCO2 alarm by adjusting the limit above 99 mmHg 9 9 kPa The Radius PCG will indicate this setting by showing on the EtCO2 display during the adjustment routine If no button has been activated for a short period the Radius PCG will ...

Страница 37: ...red device When the Bluetooth is enabled the Bluetooth indicator will appear on the screen to allow confirmation that the Bluetooth is active Disable the Bluetooth to stop or prevent authorized communication of data Once Bluetooth is enabled on Radius PCG refer to the User Manual for the device for pairing instructions To pair Radius PCG to Root follow the procedure in Pairing Radius PCG to Root o...

Страница 38: ...ain to enable Bluetooth When Bluetooth is enabled the Bluetooth symbol A and the serial number B for the Radius PCG display on the screen as shown Note If Radius PCG is off it must be turned on before Bluetooth can be enabled To disable Bluetooth operation 1 Press the On button two 2 times to enter Bluetooth mode 2 Press the On button once 1 again to disable Bluetooth ...

Страница 39: ... display i e the Alarm Status Silence Indicator will be lit Pressing the Alarm Silence button again during the 2 minutes mute period will reactivate the audible alarm If a No Breath alarm is muted by pressing the Alarm Silence button the Radius PCG will automatically switch off after 2 minutes provided that no new breaths are detected If the alarm situation passes while the audible alarm is silenc...

Страница 40: ...www masimo com 38 Masimo Alarm Signals Alarm at t 0 Alarm Priority Low at t 20 Alarm Priority Low t 40 60 80 Alarm Priority Medium No Breath Low EtCO2 n a High EtCO2 n a Clogged Adapter 1 n a n a ...

Страница 41: ...1 See Chapter 6 Troubleshooting on page 41 Note t 0 is defined as the time when the alarm condition first is indicated t 40 60 80 shall be interpreted as 40 sec later than t 0 60 sec later than t 0 80 sec later than t 0 etc For Low EtCO2 and Hi EtCO2 there is a 20 sec delay before t 0 when the alarm condition is indicated i e the Alarm Signal Generation Delay is 20 sec ...

Страница 42: ...O2 NORMAL value flashing value steady High EtCO2 NORMAL value flashing value steady Clogged Adapter ADAPTER n a n a No Adapter ADAPTER n a n a Zero point adjustment 3 NORMAL value steady value steady Note 1 EtCO2 value displays momentary CO2 during No Breath Note 2 RR value displays steady if no breath at all detected from power on Note 3 Perform Zeroing procedure See Zeroing Procedure on page 60 ...

Страница 43: ... replaced with a new one Replace the EMMA Airway Adapter with a new one Zero point adjustment alarm is displayed A zero point adjustment is required Perform a Zeroing procedure See Zeroing Procedure on page 60 The unit does not complete the turn on sequence Low battery Replace the batteries The unit does not turn on No battery Low battery Replace the batteries The measured values of EtCO2 are out ...

Страница 44: ...t does not display on the connected device using optional Bluetooth Bluetooth is not connected Connected device or Radius PCG out of range Connected device damaged Radius PCG damaged Confirm Bluetooth is on for the Radius PCG and the connected device See Bluetooth Operation on page 35 Move the Radius PCG and connected device closer to each other Check that Radius PCG is paired to the correct conne...

Страница 45: ... RR Respiration Rate 3 BPM to 150 BPM ETCO2 will be within specification for respiration rates up to 150 bpm 3 Accuracy ARMS Carbon Dioxide CO2 4 Range 0 mmHg to 99 mmHg 0 40 mmHg 2 mmHg 41 99 mmHg 6 of reading during standard conditions Range 0 kPa to 9 9 kPa 0 5 3 kPa 0 3 kPa 5 4 9 9 kPa 6 of reading during standard conditions Respiration Rate RR Range 3 to 150 bpm 1 bpm ...

Страница 46: ... to 50 C 23 to 122 F Transient Operating Temperature at least 20 minutes 20 to 5 C 4 to 23 F 6 Storage Transport Temperature 40 to 70 C 40 to 158 F Operating Humidity 50 hPa H2O non condensing 41 RH at 50 C Storage Humidity 10 to 95 RH condensing at a water vapor partial pressure not exceeding 50 hPa 95 RH at 32 C Operating Atmospheric Pressure 60 to 120kPa 1 i e Altitude up to 4000 m Storage Atmo...

Страница 47: ...x 1 8 x 1 6 Weight Approx 65 g 2 1 oz with batteries Display Type 96 x 96 pixel RGB OLED display Expected Service Life 5 Years Alarms Audio Alarm Description Alarm Characteristic Description No Breath Low ETCO2 High ETCO2 Clogged Adapter No Adapter Zero point adjustment Low Battery Alarm Volume v 57 dB A 67 dB A ...

Страница 48: ...5223 1 2016 Equipment Classification per IEC 60601 1 Type of Protection Internally powered Battery power Degree of Protection of Electrical Shock Defibrillation proof BF Applied Part Protection against harm from solid and liquid ingress IP44 Protection from tools and small wires greater than 1mm in diameter and from water spray from any direction Mode of Operation Continuous operation Sterility No...

Страница 49: ...Power 1 dBm Antenna Peak Gain 7 dBi Recommended Range 10 feet 3 meters line of sight Radio Compliance Radio Modes Bluetooth LE v4 0 USA FCC ID VKF EMMABT FCC parts 15 207 and 15 247 Canada IC 7362A EMMABT RSS 247 Europe RED 2014 53 EU ETSI EN 300 328 ETSI EN 301 489 1 ETSI EN 301 489 17 Japan Japanese Radio Law Item 19 of Article 2 1 ...

Страница 50: ...easured based on a 2 channel NDIR type gas analyzer at 4 5 μm with data acquisition rate at 10 kHz sample rate 20 Hz channel Models CO2 displayed in kPa or mmHg Drift of measurement Accuracy No drift Recovery Time After Defibrillator Test Unaffected Highest Surface Temperature At Ambient Temperature Surface Temperature 23 C 73 F 30 C 86 F 50 C 122 F 57 C 135 F Data Output Specifications Breath Det...

Страница 51: ...peration and full accuracy within 15 seconds Warm up time after storage at 40 C A warm up period of 15 minutes is required before Radius PCG is ready for use after being stored with batteries mounted at 40 C when the ambient temperature is 20 C Cool down time after storage at 70 C In operation and full accuracy within 15 seconds Calibration No routine calibration is required Total System Response ...

Страница 52: ...resonance imaging MRI systems Guidance and Manufacturer s Declarations Electromagnetic Emissions Emission Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 Radius PCG 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 B Radius P...

Страница 53: ... kV contact 15 kV air 8 kV contact 15 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 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of typical location in a typical hospital environment Radiated RF IEC 61000 4 3 10 ...

Страница 54: ...mmended separation distances calculated from the equation Otherwise degradation of the performance of this equipment could results 100 MHz to 400 MHz 400 MHz to 4 GHza 4 GHz to 8 GHz where P is the maximum output power rating of the transmitter and d is the recommended separation distance in meters m a In the presence of higher electromagnetic fields above 100V m at 4 GHz to 8 GHz i e exposure to ...

Страница 55: ...the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 80 MHz to 2 7 GHz 100 MHz to 400 MHz 400 MHz to 4 GHz 4 GHz to 8 GHz 0 01 0 06 0 03 0 004 0 006 0 1 0 19 0 095 0 013 0 019 1 0 6 0 3 0 04 0 06 10 1 9 0 95 0 13 0 19 100 6 3 0 4 0 6 For transmitters rated at a maximum output power not listed above the recommended sepa...

Страница 56: ...low Symbols Definition Symbols Definition Follow Instructions for use Defibrillation Proof Type BF Catalog number model number Serial number Lot Code Manufacturer Use by Date YYYY MM DD Date of Manufacture YYYY MM DD Storage humidity limitation Storage temperature range Atmospheric pressure limitation Do not Reuse ...

Страница 57: ...small wires greater than 1mm in diameter and from water spray from any direction Caution Federal law restricts this device to sale by or on the order of a licensed physician Identifies unit has been registered as a radio device Non ionizing electromagnetic radiation Federal Communications Commission FCC licensing Instructions Directions for Use Manuals are available in electronic format http www M...

Страница 58: ...piration rates up to 150 bpm 4 To include quantitative effect on gas reading from variations in environment conditions outside STP electromagnetic disturbances and presence of Halothane Ethanol Isopropyl alcohol He Acetone and Methane the CO2 accuracy range should be increased to 4 mmHg 0 5 kPa or 10 of reading whichever is the greater In addition the following interference effects on CO2 readings...

Страница 59: ...e the batteries and make sure the battery cover is re attached correctly To clean Radius PCG follow the instructions below 1 Remove the Airway Adapter 2 Wipe each of the outer surfaces twice or until the surfaces are free of any visible residue using one of the following solutions A cloth moistened with 70 Isopropyl Alcohol A quaternary ammonium chloride solution wipe for example CaviWipes Note Pa...

Страница 60: ... Sodium hypochlorite 1 10 Bleach to water solution Accelerated hydrogen peroxide Always wipe off residues of disinfection solutions with a wet cloth after exposure CAUTION Never saturate Radius PCG completely with any disinfection solution Airway Adapter Cleaning The EMMA Airway Adapters are not intended to be cleaned The Airway Adapters are intended for single patient use They are disposable and ...

Страница 61: ...tteries Use of other Lithium batteries may present a risk of fire or explosion To replace the batteries 1 Open the battery compartment by pressing the release button See Installing Batteries on page 21 2 Gently remove the depleted batteries 3 Insert two new AAA type batteries into the battery compartment Make sure that the batteries are fitted according to the polarity marking 4 When the batteries...

Страница 62: ...PCG by pressing the Power On button See Controls on page 31 2 Make sure that a new Airway Adapter is properly fitted See Attaching Airway Adapter on page 23 3 Press and hold down simultaneously the Power On and Alarm Silence button until the Service Screen display the Service code C0 and the Service value 10 Keep both buttons depressed while the Service value starts counting down i e displaying 9 ...

Страница 63: ... the Radius PCG 2 Turn on the Radius PCG and ensure that the EtCO2 reading is zero Otherwise conduct a Zeroing procedure according to chapter 7 4 above before proceeding 3 Insert the 15M connector into one end of the Airway Adapter and connect a second Airway Adapter to the other end see picture 4 Turn on the regulator flow 5 After 30 seconds record the EtCO2 reading 6 Turn off the flow 7 Determin...

Страница 64: ...79 36 41 4 8 5 5 780 799 37 42 4 9 5 6 If the unit is reading within the above range then your Radius PCG has been successfully verified If the unit is not reading within the above range disconnect the Airway Adapter from the gas cylinder and perform a Zeroing procedure and then repeat the Gas span check procedure See Zeroing Procedure on page 60 If verification still fails contact your local dist...

Страница 65: ...lude the RMA form provided or a letter describing in detail any difficulties experienced with Radius PCG 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 device is not under warranty or for tracking purposes if it is Ship to and bill to information Person name telephone Te...

Страница 66: ...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 supplies devices or systems external to the Product d disassembled reassembled or repaired by anyone other than a person authorized by Masimo e used with other products like new sensors reprocessed sensors or other...

Страница 67: ...y 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 including all accessories in their original packages with your sales receipt to Masimo for a full refund Restrictions 1 Copyright Restriction...

Страница 68: ...re is included Any attempt to assign any rights duties or obligations arising hereunder other than as set forth in this paragraph shall be void 4 U S Government Rights If Purchaser is acquiring Software including the related documentation on behalf of any part of the United State Government the following provisions apply the Software and documentation are deemed to be commercial software and comme...

Страница 69: ...raph display on both devices On Root the data is displayed in the Capnography window on the Main Screen of Root See Capnography Window on page 71 Note Bluetooth functionality is implemented differently by the various connected device manufacturers and incompatibility between the Radius PCG and your external device may occur Note Radius PCG can be paired to Root while an ISA Sidestream Gas Analyzer...

Страница 70: ... disabling the Bluetooth see Bluetooth Operation on page 35 7 Press the On button once 1 again to enable Bluetooth When Bluetooth is enabled the Bluetooth symbol A and the serial number B for the Radius PCG display on the screen Note If Radius PCG is off it must be turned on before Bluetooth can be enabled 8 Place Radius PCG close to Root Radius PCG should appear under the Devices Found list on th...

Страница 71: ...nd list and then press select the Pair button 10 After pressing selecting the Pair button Root returns to the Bluetooth screen The MAC address for Radius PCG displays on the screen The Info screen icon displays next to the MAC address See Accessing the Radius PCG Info Screen on page 84 ...

Страница 72: ...tion with Root Radius PCG may become disconnected from the Masimo device for a number of reasons which may include Moving out of Bluetooth range Powering off from non use Bluetooth connection is turned off on the Masimo device To reestablish communication with the Masimo device cycle the Radius PCG Bluetooth Off and back On 1 Press the Radius PCG On button two 2 times to enter Bluetooth mode 2 Pre...

Страница 73: ...rameters display by default as numeric values and as a graphical representation When multiple technologies are connected to the Masimo device each technology s parameters are displayed in an individual window On Root the relative size of each window can be configured using the Layout feature which is accessible though the Layout icon in the Main Menu For additional information see the Operator s M...

Страница 74: ...Operation in the Operator s Manual Root or Operator s Manual Root with noninvasive blood pressure and temperature 4 EtCO2 Display See Parameter Settings on page 74 5 FiCO2 Display See Parameter Settings on page 74 6 RR Display See Parameter Settings on page 74 7 Toggle Waveform On Off See Capnograph Display on page 73 FiCO2 does not display on the Radius PCG device FiCO2 only displays on Root as a...

Страница 75: ...iew Hide Waveform To toggle the waveform on or off touch the capnograph icon at the right end of the individual parameter display Accessing Main Menu Options To access the Main Menu options At the bottom right corner of the touchscreen press select the Main Menu icon With Radius PCG connected to the Masimo device the Main Menu options change and are reflected below Layout See Chapter 3 Operation o...

Страница 76: ...gs for the Radius PCG device The following Capnography settings options are available Parameter Settings See Capnography Settings on page 74 Additional Settings See Additional Settings on page 82 Parameter Settings From the Capnography screen touch Parameter Settings and then change individual parameter settings alarms by selecting one of the following parameters End tidal Carbon Dioxide See End t...

Страница 77: ...me time as the Radius PCG device See Chapter 4 Operation on page 27 for information on adjusting alarm limits on the Radius PCG device Options Description Alarm Priority Factory Default Settings User Configurable Settings High Limit High Limit is the upper threshold that triggers an alarm Medium 7 9 vol 7 9 kPa 60 mmHg 0 2 to 24 9 vol in steps of 0 1 or Off 0 2 to 29 9 kPa in steps of 0 1 or Off 2...

Страница 78: ... 2 5 vol in steps of 0 1 Off or 0 1 to 3 2 kPa in steps of 0 1 Off or 1 to 24 mmHg in steps of 1 Silence Duration Sets the amount of time that the alarm is silenced NA 2 minutes 30 seconds 1 2 or 5 minutes Alarm Delay When an alarm condition is met this feature delays the audible part of an alarm NA 30 seconds 0 5 10 15 20 30 or 60 seconds Capnography setting changes made on the Masimo device are ...

Страница 79: ...ice may not alarm at the same time as the Radius PCG device See Chapter 4 Operation on page 27 for information on adjusting alarm limits on the Radius PCG device Note At this time FiCO2 is not displayed on Radius PCG or the Masimo device The following information only discusses the settings on the Masimo device however FiCO2 parameters DO NOT display Options Description Alarm Priority Factory Defa...

Страница 80: ...of 1 Low Caution Range Lower area of the display range that provides a caution indicator NA Off Off or 0 1 to 2 5 vol in steps of 0 1 Off or 0 1 to 3 2 kPa in steps of 0 1 Off or 1 to 24 mmHg in steps of 1 Silence Duration Sets the amount of time that the alarm is silenced NA 2 minutes 30 seconds 1 2 or 5 minutes Alarm Delay When an alarm condition is met this feature delays the audible part of an...

Страница 81: ...alarm at the same time as the Radius PCG device See Chapter 4 Operation on page 27 for information on adjusting alarm limits on the Radius PCG device Options Description Alarm Priority Factory Default Settings User Configurable Settings High Limit High Limit is the upper threshold that triggers an alarm High 50 2 149 in steps of 1 or Off When set to Off alarm is disabled Low Limit Low Limit is the...

Страница 82: ...alarm NA 30 seconds 0 5 10 15 20 30 or 60 seconds Capnography setting changes made on the Masimo device are not transferred to the Radius PCG device Changes to Capnography settings for the Radius PCG device are made on the device itself See Chapter 4 Operation on page 27 for information about settings for the Radius PCG device About Parameter Information Additional information about each parameter...

Страница 83: ...xis Max EtCO2 FiCO2 The Trend Max is the highest value displayed 8 0 vol 8 0 kPa 60 mmHg 0 1 to 25 0 vol in steps of 0 1 0 1 to 30 0 kPa in steps of 0 1 1 to 225 mmHg in steps of 1 RR 35 1 to 150 in steps of 1 Y Axis Min EtCO2 FiCO2 The Trend Max is the highest value displayed 0 0 vol 0 0 kPa 0 mmHg 0 0 to 24 9 vol in steps of 0 1 0 0 to 29 9 kPa in steps of 0 1 0 to 224 mmHg in steps of 1 RR 0 0 ...

Страница 84: ...Displays the set N2O Range 0 30 vol NA CO2 Unit of Measure Sets the CO2 display unit mmHg mmHg kPa or vol Capnography setting changes made on the Masimo device are not transferred to the Radius PCG device Changes to Capnography settings for the Radius PCG device are made on the device itself See Chapter 4 Operation on page 27 for information about settings for the Radius PCG device These fields ar...

Страница 85: ... Masimo device using a Bluetooth connection or view connected device information For complete information on the Masimo device Bluetooth menu see the Operator s Manual for the Masimo device Option Description Factory Default Setting Configurable Settings Bluetooth Enables or disables Bluetooth connectivity Off On or Off EMMA Pairs Radius PCG to Root NA Pair Info After paring the Radius PCG Info sc...

Страница 86: ...G Bluetooth received signal strength indicator RSSI These fields are read only and cannot be configured by the user Displays when Radius PCG is turned on and connected to the Masimo device Accessing the Radius PCG Info Screen The following information is for viewing the Radius PCG Info screen Radius PCG information as well as disconnecting un pairing from the Masimo device are available on this sc...

Страница 87: ...onnection between Radius PCG and the Masimo device See Disconnecting Radius PCG from the Masimo Device on page 85 These fields are read only and cannot be configured by the user Displays when Radius PCG is turned on and connected to the Masimo device Disconnecting Radius PCG from the Masimo Device To disconnect Radius PCG from the Masimo device perform the following 1 Access the Radius PCG Info Sc...

Страница 88: ...s PCG Replace the adapter or sampling line Replace Adapter Indicates that an adapter is clogged or blocked not allowing flow Indicates that the adapter should be replaced High Check for a blockage and replace the adapter if necessary No Adapter Adapter disconnected not detected High Connect an adapter to Radius PCG Low EtCO2 SIQ Low FiCO2 SIQ Indicates low signal confidence in the measurement disp...

Страница 89: ...graphy devices Unable to handle Capnography channel on MOC 9 port X 1 3 A capnography device is connected to Root through the MOC 9 connection and Radius PCG is paired to Root The Capnography window is populated from the Radius PCG High Only one 1 capnography device can be connected to Root at one time Disconnect one of the capnography devices Radius PCG does not reconnect automatically after disc...

Страница 90: ...th on the Masimo device is turned on Ensure Radius PCG is within range of the Masimo device when pairing Radius PCG requires service See Service and Return Procedure on page 63 Root Specifications Display Range Measurement Display Range EtCO2 End Tidal CO2 0 to 25 0 kPa to 32 5 kPa 0 mmHg to 244 mmHg FiCO2 Fractional Concentration of Inspired CO2 0 to 25 0 kPa to 32 5 kPa 0 mmHg to 244 mmHg RR Res...

Страница 91: ...s for Radius PCG For Radius PCG specifications see Radius PCG Specifications on page 43 FiCO2 does not display on the Radius PCG device FiCO2 only displays on Root Parameter values are not displayed Resolution Parameter Resolution EtCO2 0 1 0 1 kPa 1 mmHg FiCO2 0 1 0 1 kPa 1 mmHg RR 1 BPM This parameter does not display on Radius PCG ...

Страница 92: ... display ranges Measurement Waveform Scale EtCO2 0 to 8 vol 0 to 8 kPa 0 to 60 mmHg Bluetooth Operational Range Bluetooth Operational Range Maximum distance from Masimo Device Approx 32 feet 10 meters Minimum Root Software Version Device Specifications Root Software greater than v2 0 9 6 ...

Страница 93: ...n Delay and Alarm Signal Generation Delay Alarm Condition Delay is the time from the occurrence of the triggering event to when the alarm system determines the alarm condition exists While Alarm Signal Generation Delay is the time from the onset of an alarm condition to the generation of its alarm signal The graphic below is a simplified illustration of the concept of alarm response delay and does...

Страница 94: ...ration The Alarm Condition Delay is graphically represented as t2 t1 in the figure above to show the delay due to processing and averaging The Alarm Signal Generation Delay is graphically represented as t3 t2 in the figure above to show the delay due to alarm system strategy and communication time The overall alarm system delay time is graphically represented as t3 t1 ...

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Страница 96: ...www masimo com 300617 LAB 10347G 0621 ...

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