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Rad-67

Chapter 8: Specifications

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The below Bland-Altman plot represents the correlation of the (SpHb - HiCN tHb) versus

(SpHb + HiCN tHb)/2 with an upper 95% and lower 95% limits of agreement.

Figure 2: Bland-Altman plot of SpHb vs. HiCN tHb

Resolution

Parameter Resolution

SpO

1 BPM

SpHb

0.1 g/dL
0.1 mmol/L

1 g/L

Содержание Rad-67 Pulse CO-Oximeter

Страница 1: ...Operator s Manual Rad 67 Pulse CO Oximeter Spot Check...

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Страница 3: ...s 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 Wire...

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Страница 5: ...5 Chapter 1 Technology Overview 19 Signal Extraction Technology SET 19 rainbow Pulse CO Oximetry Technology 21 Chapter 2 Description 25 General System Description 25 Features 26 Chapter 3 Setting Up 2...

Страница 6: ...tions 75 Display Range 75 Accuracy ARMS 75 SpO2 Performance Specifications 76 SpHb Accuracy Data 77 Resolution 78 Electrical 79 Environmental 79 Physical Characteristics 79 Display Indicators 80 Compl...

Страница 7: ...Rad 67 Contents www masimo com 5 Masimo Maintenance 94 Repair Policy 95 Return Procedure 95 Contacting Masimo 95 Index 99...

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Страница 9: ...cautions and notes A warning is given when actions may result in a serious outcome for example injury serious adverse effect death to the patient or user WARNING This is an example of a warning state...

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Страница 11: ...dio for transfer of parameter data Indications for Use The Masimo Rad 67 Pulse CO Oximeter and Accessories are intended for use in clinical and non clinical settings The Masimo Rad 67 Pulse CO Oximete...

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Страница 13: ...tibility of the device cable and sensor before use otherwise degraded performance and or patient injury can result WARNING Do not use the Rad 67 in the presence of flammable anesthetics or other flamm...

Страница 14: ...body positioning as well as other physiological conditions Any results exhibiting inconsistency with the patient s clinical status should be repeated and or supplemented with additional data Blood sa...

Страница 15: ...cal conditions that can significantly shift the oxygen disassociation curve A physiological condition that may effect vasomotor tone or changes in vasomotor tone WARNING Inaccurate SpO2 readings may b...

Страница 16: ...hat may affect the device preventing it from working properly CAUTION Failure to charge Rad 67 promptly after a Low Battery alarm may result in the device shutting down CAUTION Do not connect the AC p...

Страница 17: ...in the sensor s directions for use DFU Cleaning and Service Warnings and Cautions WARNING Do not attempt to remanufacture recondition or recycle the Rad 67 as these processes may damage the electrica...

Страница 18: ...on against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may...

Страница 19: ...s device complies with Industry Canada license exempt RSS standard s Operation is subject to the following two conditions 1 this device may not cause interference and 2 this device must accept any int...

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Страница 21: ...use they cannot distinguish between the arterial and venous blood movement sometimes referred to as noise Masimo SET pulse oximetry utilizes parallel engines and adaptive filtering Adaptive filters ar...

Страница 22: ...rm experience will provide a good feeling for changes that are artifactual or physiological and the speed timing and behavior of each The stability of the readings over time is affected by the averagi...

Страница 23: ...nal IQ identifies the timing that the algorithms have determined for the arterial pulsation The pulse tone when enabled coincides with the vertical line of the SpO2 SIQ The height of the vertical line...

Страница 24: ...diant power of the strongest light is rated at 25 mW The detector receives the light converts it into an electronic signal and sends it to the Rad 67 for calculation 1 Light Emitting Diodes LEDs 7 wav...

Страница 25: ...adings As blood samples are usually taken over a period of 20 seconds the time it takes to draw the blood a meaningful comparison can only be achieved if the oxygen saturation SaO2 levels of carboxyhe...

Страница 26: ...and methemoglobin levels the functional saturation SpO2 as measured by a pulse oximeter is given by SpO2 1 02 x HbO2 Martin Laurence All You Really Need to Know to Interpret Arterial Blood Gases Seco...

Страница 27: ...ontains the description of the Rad 67 physical features General System Description The Rad 67 system includes the following Rad 67 Device Rad 67 AC Power Supply Patient Cable Sensor For a complete lis...

Страница 28: ...home screen as well as turning the device on and off 3 Patient Cable Port Provides a connection to a patient cable 4 Masimo Proprietary Port Provides a connection to AC power supply for battery charg...

Страница 29: ...lowing steps 1 Confirm that you have all system components Rad 67 Device Rad 67 AC Power Supply Patient Cable Sensor 2 Read the Safety Information Warnings and Cautions on page 11 3 Setup the Rad 67 a...

Страница 30: ...ng the Rad 67 ON and OFF To turn ON the Rad 67 1 Press and hold the Home Button for more than two 2 seconds until two 2 audible tones sound 2 The Home Button will illuminate Green and the Rad 67 will...

Страница 31: ...tanding these instructions Using the Touchscreen and Home Button 1 Main Screen To access settings and other screens touch a value or icon on the Display View See About the Main Screen on page 33 2 Hom...

Страница 32: ...tion is reached A notification is displayed Swipe Touch and Move Touch move left right up or down and release Moves an object across the display Flick Touch and quickly swipe left right up or down and...

Страница 33: ...pses spinner Slider Touch and slide knob Moves knob Press anywhere along slider path Quickly moves knob to tap position Slider Spinner Touch and slide knob Moves knob Touch anywhere along slider path...

Страница 34: ...measurement Opens parameter or measurement menu Touch and hold Enables parameter and measurement drag and drop Well Touch parameter or measurement Opens parameter or measurement menu Touch and hold E...

Страница 35: ...Bar See About the Status Bar on page 34 2 Action Menu See About the Action Menu on page 36 3 Waveform View See Signal IQ Indicators on page 44 4 Parameter Display See Understanding Windows on page 37...

Страница 36: ...vity has been enabled See Bluetooth on page 51 3 Wi Fi Provides access to the Wi Fi screen If this icon is visible then Wi Fi connectivity has been enabled The icon itself also indicates the strength...

Страница 37: ...enever Rad 67 is connected to an AC power source and ON the AC Power Indicator icon will appear on the display as follows Icon Status Battery is currently charging Battery is fully charged Touch the A...

Страница 38: ...settings directly from the Main Screen Sensitivity Selecting this option cycles through the available sensitivity modes APOD NORM and MAX See Sensitivity Modes Overview on page 36 Note After approxima...

Страница 39: ...may be weak due to decreased perfusion When a sensor becomes detached from a patient it will have compromised protection against erroneous pulse rate and arterial saturation readings Understanding Wi...

Страница 40: ...e Numeric Value to the Well Step 3 Release the Numeric Value Accessing Main Menu Options To access the Main Menu options press the Main Menu icon at the bottom right corner of the touchscreen The Main...

Страница 41: ...page 54 Navigating the Main Menu Once the Main Menu screen is displayed users can access additional screens information and settings Swipe the screen left or right to pan through the menu icons Touch...

Страница 42: ...ttings 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 Dis...

Страница 43: ...User Configurable Settings Averaging Time The length of time over which the system calculates the average of all data points 8 seconds 2 4 4 6 8 10 12 14 or 16 seconds FastSat See FastSat Overview on...

Страница 44: ...f time over which the system calculates the average of all data points Medium Short Medium or Long Arterial Venous Mode Provides an arterial or venous value that displays on the main screen Arterial A...

Страница 45: ...on Additional information about each parameter is available To access additional information about parameters 1 From the Parameter Settings screen touch the About icon The following is an example for...

Страница 46: ...l bars for each individual pulsation The height of the bar provides an assessment of the confidence in the SpO2 measurement displayed Spot Check Settings Use the Spot Check Settings screen to configur...

Страница 47: ...are the spot check labels entered before the spot check Spots checks that do not require a label or are performed using the skip feature are listed by date and time of the spot check See Spot Check S...

Страница 48: ...sult Touching any of the SpHb criteria gauges displays an informational window for that specific item The window can be closed by touching the OK button or closes automatically after one minute Signal...

Страница 49: ...Highest volume Slide towards the left to decrease volume and to silence Pulse Tone Volume Sets the pulse tone volume level Highest volume Slide towards the left to decrease volume and to silence Smart...

Страница 50: ...on the Status Bar See About the Status Bar on page 34 Option Description Factory Default Settings User Configurable Settings Language Select the language display for Rad 67 English Choose from availa...

Страница 51: ...r Off Selected Network Displays the currently connected wireless network NA See Selected Network on page 49 Status Displays currently connected wireless network status NA See Status on page 50 Change...

Страница 52: ...the wireless network NA Alphanumeric Security Allows the wireless network security to be set WPA2 WPA WPA2 WPA Enterprise or WPA2 Enterprise Password Password for the wireless network NA Alphanumeric...

Страница 53: ...elect the search icon next to Manual Setup to display the Select a Network screen A network search is automatically performed and a list of available wireless networks displays 2 Select a wireless net...

Страница 54: ...screen to view the specific percentage of charge remaining in Rad 67 s battery The user can also access the Battery screen by pressing the Battery icon on the Status Bar See About the Status Bar on pa...

Страница 55: ...To enter Access Control 1 Press the key 2 When the screen displays enter the following 6 2 7 4 Asterisks will be displayed To undo an entry press Backspace 3 Press Enter to access the password protect...

Страница 56: ...hese fields are read only and cannot be configured by the user Screenshot Capture The user is able to take screenshots of Rad 67 displays and download them as png files onto a USB drive To download sc...

Страница 57: ...able to the Masimo Proprietary port of Rad 67 See Front Top and Bottom Views on page 26 Note Before connecting the USB drive in the next step there must be a folder titled screen_shot in the USB drive...

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Страница 59: ...red ON A previous spot check is completed and reviewed If at any time during a spot check a sensor and cable are not connected a message displays to connect a cable to the Rad 67 If a sensor is not co...

Страница 60: ...eyboard appears to enter the desired identification Note If Require Label is off in Spot Check Settings the label field does not display See Spot Check Settings on page 44 An age and gender selection...

Страница 61: ...t check begins The spot check requires user input if SpHb is to be included and measured Select the Measure SpHb button to include SpHb in the spot check After the sensor initializes a pleth is displa...

Страница 62: ...Rad 67 instructs the user to select a new location to place the sensor Complete the Spot Check After a spot check is performed the values display Note The spot check measurement displays for five 5 m...

Страница 63: ...riod whichever occurs first the screen displays spot check measurement information with SpHb as the most prominent value When SpHb is not included in the spot check the SpHb value displays as dashes T...

Страница 64: ...e between the SpHb value and a gold standard reference analyzer lie within this range In the example shown SpHb displayed is within the accuracy range and the LoA gauge is displayed This example shows...

Страница 65: ...can be used to acknowledge alerts Icon Appearance Description Visual Alerts There are currently no active alerts and no alerts have been acknowledged Note If an alert has been acknowledged this icon a...

Страница 66: ...O Ox Replace Cable or Please replace cable Incompatible cable Unrecognized cable Defective cable Cable life expired Replace the patient cable Pulse CO Ox Cable Near Expiration Cable life near expirati...

Страница 67: ...e Troubleshooting Measurements on page 67 Low Signal Stability Motion during SpHb measurement Keep measurement site stable See Troubleshooting Measurements on page 67 Demo Mode Device is in demo mode...

Страница 68: ...Replace sensor Minimize or eliminate motion at the monitoring site Submit blood sample for laboratory CO Oximetry test for comparison Check patient conditions indicated to affect SpHb accuracy Dashes...

Страница 69: ...Q message displayed Low signal quality Sensor is damaged or not functioning Improper sensor type or application Excessive motion Low perfusion Verify Sensor type and size and re apply sensor See Direc...

Страница 70: ...ifferent site Replace sensor Verify the device and sensor are configured with the parameter Verify proper sensor and sensor size for the patient Shield the sensor from excessive or strobing light Mini...

Страница 71: ...easure SpHb button was not selected during spot check Entered patient age is 17 or younger Low SIQ Value Ensure Measure SpHb button is selected during spot check SpHb is not measured on patients 17 ye...

Страница 72: ...ngs Low SIQ or Pi values Inappropriate sensor size or sensor measurement location Excessive motion Reposition sensor to site with strong SIQ and Pi Average readings taken from three different sites to...

Страница 73: ...n See Powering the Rad 67 ON and OFF on page 28 Contact Masimo service See Contacting Masimo on page 95 Speaker does not work Device audible settings may be incorrect Internal failure Turn Rad 67 Off...

Страница 74: ...Interference Internal failure Turn Rad 67 Off and On See Powering the Rad 67 ON and OFF on page 28 Relocate the device from other devices that may cause electromagnetic interference Contact Masimo se...

Страница 75: ...On See Powering the Rad 67 ON and OFF on page 28 Contact Masimo service See Contacting Masimo on page 95 Device does not communicate to other external devices through wireless connection External devi...

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Страница 77: ...mol L to 15 5 mmol L See Chapter 7 Troubleshooting on page 67 for assistance when measurement ranges are outside of the accuracy range Accuracy ARMS Oxygen Saturation SpO2 No Motion 1 SpO2 from 70 to...

Страница 78: ...pO2 Performance Specifications Accuracy testing for SpO2 was performed on healthy adult subjects The tables below provides ARMS Accuracy Root Mean Square values measured using the Masimo Rainbow SET T...

Страница 79: ...its of Agreement LOA based upon the clinical validation of the SpHb performance The 95 LOA was determined by the comparison of SpHb measurements against the tHb values determined by a HiCN reference m...

Страница 80: ...Bland Altman plot represents the correlation of the SpHb HiCN tHb versus SpHb HiCN tHb 2 with an upper 95 and lower 95 limits of agreement Figure 2 Bland Altman plot of SpHb vs HiCN tHb Resolution Pa...

Страница 81: ...e 6 hours 7 Environmental Environmental Conditions Operating Temperature 0 C to 35 C 32 F to 95 F Storage Transport Temperature 20 C to 60 C 8 4 F to 140 F Operating Humidity 10 to 95 non condensing S...

Страница 82: ...ate 1 Second Type Backlit Active Matrix TFT LCD Pixels 720 dots x 1280 dots Compliance EMC Compliance IEC 60601 1 2 2007 Class B Safety Standards Compliance ANSI AAMI ES 60601 1 2005 CAN CSA C22 2 No...

Страница 83: ...f Operation Continuous operation Output Interface Masimo Proprietary Port Wireless Specifications Communication Wi Fi Type WLAN Radio IEEE 802 11 a b g Channels 802 11a USA 36 40 44 48 52 56 60 64 100...

Страница 84: ...11b 1 2 5 5 11 Mbps 802 11g 6 9 12 18 24 36 48 54 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...

Страница 85: ...st 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 t...

Страница 86: ...terial the relative humidity should be at least 30 8 kV air 8 kV air Electrical fast transient burst IEC 61000 4 4 2 kV for power lines 2 kV for power lines Mains power quality should be that of a typ...

Страница 87: ...should be at levels characteristic of typical location in a typical hospital environment Portable and mobile RF communications equipment should be used no closer to any part of the ME Equipment includ...

Страница 88: ...ctromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephone...

Страница 89: ...d maximum output power of transmitter W Separation Distance According to Frequency of Transmitter m 150 K Hz to 80 MHz d 1 17 Sqrt P 80 MHz to 800 MHz d 0 18 Sqrt P 800 MHz to 2 5GHz d 0 35 Sqrt P 0 0...

Страница 90: ...n from ingress of particulates than 12 mm and water spray from any direction Class II Equipment Non Sterile Defibrillation proof Type BF applied part Separate collection for electrical and electronic...

Страница 91: ...anufacturer Catalog number model number Date of manufacture YYYY MM DD Masimo reference number Storage temperature range Serial number Keep dry Fragile handle with care Storage humidity limitation Do...

Страница 92: ...blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing rubbing and touching motions at 2 to 4 Hz at an amplitude of...

Страница 93: ...ime at operating temperature of 25 C 8 If the batteries are to be stored for extended periods of time it is recommended that they be stored between 20 C to 30 C and at a relative humidity less than 85...

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Страница 95: ...ad 67 to dry thoroughly before using again CAUTION To avoid permanent damage to the Rad 67 do not use excessive amounts of liquids to clean the device The surfaces of the Rad 67 may be cleaned with th...

Страница 96: ...Before using the Rad 67 without the AC power connected check the battery status indicator and ensure that the battery is fully charged See Battery Charge Status Indicator on page 35 To charge the Rad...

Страница 97: ...upport 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...

Страница 98: ...in the operator s manual or as otherwise provided in its labeling g reprocessed reconditioned or recycled and h damaged by accident abuse misuse liquid contact fire earthquake or other external cause...

Страница 99: ...le or create derivative works based on the Software or the written materials 3 Transfer Restrictions In no event may Purchaser transfer assign rent lease sell or otherwise dispose of the Product or th...

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Страница 101: ...2 Bluetooth 32 49 Brightness 46 50 69 92 C Capturing Screenshots 53 Change Network 47 48 Chapter 1 Technology Overview 17 Chapter 2 Description 23 Chapter 3 Setting Up 25 Chapter 4 Operation 27 Chapte...

Страница 102: ...93 Limits of Agreement LoA Gauge 60 Localization 33 45 46 66 Low Power Mode 34 M Maintenance 92 Masimo rainbow SET Parallel Engines 17 Masimo SET DST 18 Messages 62 N Navigating the Main Menu 37 O Ou...

Страница 103: ...a 60 75 SpHb Measurements During Patient Motion 22 SpHb Settings 39 40 SpO2 Performance Specifications 74 SpO2 Settings 39 Spot Check Results 43 58 59 Spot Check Sessions 37 42 Spot Check Settings 33...

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Страница 106: ...www masimo com 300362 LAB 10262A 0419...

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