Masimo Rad-67 Pulse CO-Oximeter Operator's Manual
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Masimo Rad-67 Pulse CO-Oximeter Operator's Manual

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Summary of Contents for Masimo Rad-67 Pulse CO-Oximeter

  • Page 1 Operator's Manual ® Rad-67™ Pulse CO-Oximeter Spot-Check...
  • Page 3 ®, Adaptive Probe Off Detection®, APOD®, Masimo®, Pulse CO-Oximeter®, rainbow®, SET®, Signal Extraction Technology®, Signal IQ®, SpHb®, and X-Cal™ are federally registered trademarks of Masimo Corporation. Rad-67™ is a trademark of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners. © 2019 Masimo Corporation www.masimo.com...

  • Page 5: Table Of Contents

    Using the Touchscreen and Home Button --------------------------------------------------------- 29 About the Main Screen ------------------------------------------------------------------------------- 33 Accessing Main Menu Options ---------------------------------------------------------------------- 38 Parameter Settings ----------------------------------------------------------------------------------- 40 Additional Settings ------------------------------------------------------------------------------------ 43 Spot-Check Settings ----------------------------------------------------------------------------------- 44 Spot-Check Sessions ----------------------------------------------------------------------------------- 44 Sounds --------------------------------------------------------------------------------------------------- 47 www.masimo.com Masimo...
  • Page 6 Guidance and Manufacturer's Declaration-Electromagnetic Emissions ---------------------- 83 Guidance and Manufacturer's Declaration-Electromagnetic Immunity ---------------------- 84 Recommended Separation Distances -------------------------------------------------------------- 87 Symbols-------------------------------------------------------------------------------------------------- 88 Citations ------------------------------------------------------------------------------------------------ 90 Chapter 9: Service and Maintenance ------------------------------------------------------------------ 93 Cleaning ------------------------------------------------------------------------------------------------- 93 Performance Verification ----------------------------------------------------------------------------- 93 www.masimo.com Masimo...
  • Page 7 Rad-67 Contents Maintenance -------------------------------------------------------------------------------------------- 94 Repair Policy ------------------------------------------------------------------------------------------- 95 Return Procedure -------------------------------------------------------------------------------------- 95 Contacting Masimo ----------------------------------------------------------------------------------- 95 Index -------------------------------------------------------------------------------------------------------- 99 www.masimo.com Masimo...

  • Page 9: About This Manual

    CAUTION: This is an example of a caution statement. A note is given when additional general information is applicable. Note: This is an example of a note. www.masimo.com Masimo...

  • Page 11: Product Description, Features And Indications For Use

     Wireless radio 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-Oximeter® and Accessories are indicated for non-invasive spot-check monitoring of functional oxygen saturation of arterial hemoglobin (SpO...

  • Page 13: Safety Information, Warnings And Cautions

    WARNING: Do not place the Rad-67 or accessories in any position that might cause it to fall on the patient. WARNING: Only use Masimo authorized devices with Rad-67. Using unauthorized devices with Rad-67 may result in damage to the device and/or patient injury.

  • Page 14: Performance Warnings And Cautions

    WARNING: Displayed parameter(s) may not be accurate when a low SIQ message is provided. Clinicians should consider additional information to supplement values to completely understand the patient’s condition. WARNING: If SpO values indicate hypoxemia, a laboratory blood sample should be taken to confirm the patient’s condition. www.masimo.com Masimo...
  • Page 15 CAUTION: If using Rad-67 during full body irradiation, keep the sensor out of the radiation field. If the sensor is exposed to the radiation, the reading might be inaccurate or the device might read zero for the duration of the active irradiation period. www.masimo.com Masimo...
  • Page 16 Wi-Fi signal strength. CAUTION: Replace the cable or sensor when a replace sensor or when a low SIQ message is consistently displayed while monitoring consecutive patients after completing the low SIQ troubleshooting steps listed in the troubleshooting section. www.masimo.com Masimo...

  • Page 17: Cleaning And Service Warnings And Cautions

    CAUTION: To prevent damage, do not soak or immerse Rad-67 in any liquid solution. Compliance Warnings and Cautions WARNING: Any changes or modifications not expressly approved by Masimo shall void the warranty for this equipment and could void the user’s authority to operate the equipment.
  • Page 18 Note: To satisfy RF exposure requirements, this device and its antenna must not be co- located or operating in conjunction with any other antenna or transmitter. Note: This Class B digital apparatus complies with Canadian ICES-003. www.masimo.com Masimo...
  • Page 19 Note: This 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 interference, including interference that may cause undesired operation of the device. www.masimo.com Masimo...

  • Page 21: Chapter 1: Technology Overview

    Masimo products. Signal Extraction Technology® (SET®) Masimo Signal Extraction Technology's signal processing differs from that of conventional pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only blood moving (pulsating) in the measurement site. During patient motion, however, the venous...
  • Page 22 Rad-67 Chapter 1: Technology Overview Masimo SET® DST This figure is for conceptual purposes only. General Description for Oxygen Saturation (SpO2) Pulse oximetry is governed by the following principles: Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry).

  • Page 23: Rainbow Pulse Co-Oximetry Technology

    (blood with oxidized hemoglobin) and blood plasma constituents differ in their absorption of visible and infrared light (using spectrophotometry). The amount of arterial blood in tissue changes with pulse (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well. www.masimo.com Masimo...
  • Page 24 Maximum skin- sensor interface temperature was tested to be less than 41º C (106º F) in a minimum ambient temperature of 35º C (95º F). The tests were conducted with sensors operating at reasonable worst case power. www.masimo.com Masimo...
  • Page 25 General Description for Total Arterial Oxygen Content (CaO2) Oxygen (O ) is carried in the blood in two forms, either dissolved in plasma or combined with hemoglobin. The amount of oxygen in the arterial blood is termed the oxygen content www.masimo.com Masimo...
  • Page 26 In this case, the measurement value for SpHb displays as dashes (---) and a message (Low SpHb SIQ) displays to alert the clinician that the device does not have confidence in the value due to poor signal quality caused by excessive motion or other signal interference. www.masimo.com Masimo...

  • Page 27: Chapter 2: Description

    This chapter contains 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 list of compatible sensors and cables, visit http://www.masimo.com. www.masimo.com Masimo...

  • Page 28: Features

    Provides data transfer and upgrade ability using a Masimo proprietary cable. Note: Always connect the Rad-67 to the mains power for continuous operation and/ or battery recharging. Note: Unplug the Masimo Proprietary cable to disconnect the AC power supply. www.masimo.com Masimo...

  • Page 29: Chapter 3: Setting Up

    Check all materials against the packing list. Save all packing materials, invoice and bill of lading. These may be required to process a claim with the carrier. If anything is missing or damaged, contact the Masimo Technical Service Department. See Return Procedure on page 95.

  • Page 30: Powering The Rad-67 On And Off

    To turn OFF the Rad-67 Press and hold the Home Button for more than 2 seconds, until two (2) audible tones sound. The Home Button will flash Orange. The Rad-67 will power down and turn off. www.masimo.com Masimo...

  • Page 31: Chapter 4: Operation

    The Home button is also used to power the device ON and OFF. See Powering the Rad-67 ON and OFF on page 28. The Home Button changes color depending on the on the charge status when the device is off. www.masimo.com Masimo...
  • Page 32 Applicable Actions Description  Switches between toggle states Toggle Touch and slide knob  Quickly moves knob left or right Touch and slide left or right of toggle  Switches between toggle states Labeled Toggle Touch and slide knob www.masimo.com Masimo...
  • Page 33 When open, collapses spinner Touch anywhere outside spinner  Performs action (as defined by the Button Touch button description)  Opens menu specified by tile Icon Menu Touch tile  Scrolls icons left or right Swipe left or right (anywhere) www.masimo.com Masimo...
  • Page 34  Enables parameter and measurement Touch and hold drag and drop  Silences all audible alerts Alert Silence Touch icon  Opens relevant menu Other Status Touch Bar icons  Exits menu, abandons any changes Back Arrow Touch www.masimo.com Masimo...

  • Page 35: About The Main Screen

    See Signal IQ Indicators on page 44. Parameter Display See Understanding Windows on page 37. Well See Understanding Windows on page 37. Main Menu See Accessing Main Menu Options on page 38. Alert Acknowledgment See About Alerts on page 63. www.masimo.com Masimo...
  • Page 36 Status Indicator on page 35. Provides access to the Sounds screen to adjust alert and pulse tone volume. This icon does not indicate the actual Sounds volume level of the alarm and pulse tone. See Sounds on page 47. www.masimo.com Masimo...
  • Page 37 When the battery charge reaches a low level:  The Battery Charge Status Indicator icon will change color (Red).  A “Low Battery” message appears and a medium priority alert tone will sound with a Yellow border on the display. www.masimo.com Masimo...
  • Page 38 APOD® (Adaptive Probe Off Detection® Sensitivity) APOD is the recommended sensitivity mode for situations which there is a high probability of the sensor becoming detached. It is also the suggested mode for care areas where patients are not visually monitored continuously. This mode www.masimo.com Masimo...
  • Page 39 Parameter Label. When a parameter is expanded, it will be shown in the Parameter display. To expand a parameter or measurement Order Instruction Step 1 Touch and hold the Numeric Value until it dims. Step 2 Drag the Numeric Value over the Parameter Display. Step 3 Release the Numeric Value. www.masimo.com Masimo...

  • Page 40: 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 Menu options are: Parameter Settings See Parameter Settings on page 40. Additional Settings See Additional Settings on page 43. Spot-Check Settings See Spot-Check Settings on page 44. www.masimo.com Masimo...
  • Page 41 Swipe the screen left or right to pan through the menu icons. Touch the arrow icon to return to the Main Screen. Icons at the bottom edge of the displayed menu screen correspond to the settings. Touch an icon to jump to the setting on the displayed menu screen. www.masimo.com Masimo...

  • Page 42: Parameter Settings

    To navigate to the previous screen, press the arrow in the top left corner of the touchscreen. To return to the Main Screen, press the Home Button at any time. Parameter Settings The following is an example of the Rad-67 Parameter Settings screen. www.masimo.com Masimo...
  • Page 43 When Rad-67 is set to FastSat On, the averaging algorithm evaluates all saturation values, providing an averaged saturation value that is a better representation of the patient’s current oxygenation status. With FastSat set to On, the averaging time is dependent on the input signal. www.masimo.com Masimo...
  • Page 44 SpHb value. Note: When unit is g/L, Precision is always 1 (whole numbers) Pi Settings From the Pi Settings screen, the following options are available: Additional Settings for Pi on page 43 About Parameter Information on page 43 www.masimo.com Masimo...

  • Page 45: Additional Settings

    An About screen appears for the selected parameter and displays information about the parameter. Additional Settings Use the Additional Settings screen to configure the following: Options Description Factory Default User Configurable Settings Settings Sensitivity Change Sensitivity Mode. MAX, APOD, NORM Mode See Sensitivity Modes Overview on page 36. www.masimo.com Masimo...

  • Page 46: Spot-Check Settings

    Use the Spot-Check Settings screen to configure the following: Option Description Factory Default User Configurable Settings Settings Require Require or not require a label when Off or On Label performing a spot-check Spot-Check Sessions Sessions allows the ability to review or clear previous spot-check sessions. www.masimo.com Masimo...
  • Page 47 Note: If multiple spot-check sessions are performed using the same label, all sessions are listed under that label. Touch the spot-check date and time to view the results screen for the spot-check session. See Spot-Check Results on page 61. www.masimo.com Masimo...
  • Page 48 Signal Stability is shown in the example. Sessions Settings From the Sessions Settings screen, change the following option: Option Description Factory Default User Configurable Settings Settings Clear Clears all previous spot-check Press Clear Sessions sessions from Rad-67. www.masimo.com Masimo...

  • Page 49: Sounds

    The Device Settings menu allows the user to view and customize settings for Rad-67. The Device Settings options are: Localization See Localization on page 48. Wi-Fi See Wi-Fi on page 49. Rad-67 Battery See Rad-67 Battery on page 52. www.masimo.com Masimo...
  • Page 50 Line Set to match regional power 60 Hz 50 Hz or 60 Hz Frequency line frequency. Date Set the current date. month, date, and year hour and minutes Time Set the current time. AM or PM www.masimo.com Masimo...
  • Page 51 Scroll to the bottom of the screen and press/select the Forget button. CAUTION: There are no prompts to confirm the Forget network request. Once selected, the network is disconnected and removed from Rad-67. www.masimo.com Masimo...
  • Page 52 Note: When a different network is connected, the currently connected wireless network settings are not saved. Manual Setup Press/select the Manual Setup option to display the Manual Setup screen. Option Description Factory Default User Configurable Settings Setting Network SSID for the wireless Alphanumeric Name network. www.masimo.com Masimo...
  • Page 53 Use the Bluetooth screen to enable or disable Bluetooth connectivity. When Bluetooth connectivity is enabled, the Bluetooth icon will appear in the Status Bar. The user can also access the Bluetooth screen by pressing the Bluetooth icon on the Status Bar. See About the Status Bar on page 34. www.masimo.com Masimo...
  • Page 54 Additional fields in the Bluetooth screen display read-only settings about the Bluetooth connection that cannot be configured by the user. Your Masimo sales representative can provide necessary information regarding an initial Bluetooth connection. Rad-67 Battery Use the Battery screen to view the specific percentage of charge remaining in Rad-67's battery.
  • Page 55 Note: The password will have to be entered every time this screen is accessed. Option Description Factory User Configurable Settings Default Setting USB Port Sets the USB port 9600, 19200, 38400, 57600, 921600 Baudrate communication speed. 115200, 230400, or 921600 Factory Options are restored to Press Restore. Defaults factory values. www.masimo.com Masimo...

  • Page 56: About

    Note: The USB drive must be formatted to FAT or FAT32 system file to enable the download of the screenshots. There must also be a folder titled “screen_shot” at the root level on the USB drive as Rad-67 looks for this folder to download the screenshots to. www.masimo.com Masimo...
  • Page 57 Remove any sensors connected to the patient to stop monitoring, and acknowledge any alarms triggered on Rad-67. Connect the Rad-67 Data Transfer Download Cable to the Masimo Proprietary port of Rad-67. See Front, Top, and Bottom Views on page 26.

  • Page 59: Chapter 5: Spot-Check

    Rad-67. If a sensor is not connected to the cable or non-spot- check sensor (and the cable is connected to the device), a message displays to connect a sensor to the cable. www.masimo.com Masimo...

  • Page 60: Performing A Spot-Check

    If gender is not visible, label and age are required to continue with the spot-check session. After entering a label and/or selecting an age and gender, touch Start to begin the spot-check session. www.masimo.com Masimo...
  • Page 61 When skip is selected instead of entering a patient label (when required), age and gender.  When the entered patient age is 17 or less. SpHb measurement can only be performed on patients 18 years of age or older. www.masimo.com Masimo...
  • Page 62 Note: The spot-check measurement displays for five (5) minutes or until the sensor is removed, whichever occurs first. To complete the spot-check session, remove the sensor from the patient and the spot-check results screen displays. See Spot-Check Results on page 61. www.masimo.com Masimo...

  • Page 63: Spot-Check Results

    When SpHb is not included in the spot-check, the SpHb value displays as dashes "--". Touch the Done button to complete the spot-check session. Spot-check sessions are stored on the device for review at a later time. See Sessions List on page 45. www.masimo.com Masimo...
  • Page 64 The LoA gauge is disabled. See Troubleshooting Measurements on page If low SIQ is encountered while attempting to read SpHb, SpHb is displayed as dashes "--", the LoA gauge is disabled and low SpHb SIQ displays. See Troubleshooting Measurements on page www.masimo.com Masimo...

  • Page 65: Chapter 6: Alerts And Messages

    Alert Interface Alert Source/Example Explanation The example shown here is a "Low Battery" alert. Note that the border of the entire Rad-67 display is illuminated, and the explanation of the alert is shown in the Status Bar (Low Battery). www.masimo.com Masimo...

  • Page 66: Messages

    Please replace sensor   Device is initializing the Allow time for parameter reading (Pulse CO-Ox) sensor. to stabilize. Sensor Initializing   Device is searching for Allow time for parameter reading (Pulse CO-Ox) pulse. to stabilize. Pulse Search www.masimo.com Masimo...
  • Page 67 See the Directions for Use Only unsuccessful SpHb sensor provided with your sensor. Mode initialization/pulse search  Use a Masimo light shield to routine or during cover the sensor and adjust the measurement. sensor.  Ensure proper sensor application. ...
  • Page 68  Battery charge is low. Connect device to the AC power Low Battery supply to charge the battery.   Device requires service. Contact Masimo Tech Support. Speaker See Chapter 9: Service and Failure Maintenance on page 93. www.masimo.com Masimo...

  • Page 69: Chapter 7: Troubleshooting

    Check the placement of the  Low perfusion. sensor. Re-apply sensor or move to a different site.  Replace sensor/cable.  Minimize or eliminate motion at the measurement site.  Set to Maximum Sensitivity. See Sensitivity Modes Overview on page 36. www.masimo.com Masimo...
  • Page 70 Check if blood flow to the sensor site is restricted.  Check the placement of the sensor. Re-apply sensor or move to a different site.  Replace sensor.  Verify proper sensor and sensor size for the patient. www.masimo.com Masimo...
  • Page 71 Check the placement of the sensor. Re-apply sensor or move to a different site.  Replace sensor.  Minimize or eliminate motion at the measurement site.  Set to MAX Sensitivity. See Sensitivity Modes Overview on page 36. www.masimo.com Masimo...
  • Page 72 Cable is not fully seated Verify proper connection in device. between cable and device.   Baud rate does not Verify baud rate settings. See match between device Access Control on page 53. and data download application. See settings. www.masimo.com Masimo...

  • Page 73: Troubleshooting Rad-67

    Device does not turn on   Depleted Battery. Check AC power supply.   Internal failure. Contact Masimo Service. See Contacting Masimo on page   Internal failure. Turn Rad-67 Off and On. See System failure Powering the Rad-67 ON and technical alarm active OFF on page 28.
  • Page 74  Battery may be Check AC power connection depleted. and recharge.   Internal failure. Contact Masimo service. See Contacting Masimo on page   EMI (Electro Turn Rad-67 Off and On. See Touchscreen/Buttons Magnetic Powering the Rad-67 ON and do not respond when Interference).
  • Page 75  Replace sensor.  Turn Rad-67 Off and On. See Powering the Rad-67 ON and OFF on page 28.  Contact Masimo service. See Contacting Masimo on page   External device is Check external device Device does not not compatible.

  • Page 77: Chapter 8: Specifications

    Low perfusion [3] from 70% to 100%) Adults, Pediatrics, Infants (SpO Pulse Rate (PR) Range 25 to 240 bpm No motion Adults, Pediatrics, Infants 3 bpm Motion [4] Adults, Pediatrics, Infants 5 bpm Low Perfusion Adults, Pediatrics, Infants 3 bpm www.masimo.com Masimo...

  • Page 78: Spo2 Performance Specifications

    A (Accuracy Root Mean Square) values measured using the Masimo Rainbow SET Technology with Masimo rainbow DCI-mini sensors in clinical studies under no motion conditions. The Bland-Altman plots provided in the operator’s manual are for the sensors identified in the respective plots. Bland-Altman plots for sensors not listed in the tables below are available in the Directions for Use (DFU) for those sensors.

  • Page 79: Sphb Accuracy Data

    1.96 standard deviation. Group Bias Precision Samples Upper LOA* Lower LOA* Overall 0.1 2.07 -1.82 * See Bland and Altman. Agreement between methods of measurement with multiple observations per individual. Journal of Biopharmaceutical Statistics (2007) vol. 17 pp. 571- 582. www.masimo.com Masimo...

  • Page 80: Resolution

    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 1 BPM SpHb 0.1 g/dL 0.1 mmol/L 1 g/L www.masimo.com Masimo...

  • Page 81: Electrical

    10% to 95%, non-condensing Storage/Transport Humidity 10% to 95%, non-condensing Operating Atmospheric Pressure 540 mbar to 1,060 mbar (540 hPa to 1060 hPa) Physical Characteristics Physical Characteristics Dimensions 19.4 cm x 8.2 cm x 2.4 cm (7.6” x 3.2” x 0.9”) www.masimo.com Masimo...

  • Page 82: Display Indicators

    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. 60601-1 IEC 60601-1:2005 EN/ISO 80601-2-61:2011 Equipment Classification per IEC 60601-1 Type of Protection Class II (AC power) Internally powered (battery power) www.masimo.com Masimo...

  • Page 83: Output Interface

    IP24 (Protection from ingress of particulates > than 12 solid and liquid ingress mm and water spray from any direction.) Mode of Operation Continuous operation Output Interface Masimo Proprietary Port Wireless Specifications Communication (Wi-Fi) Type WLAN Radio: IEEE 802.11 a/b/g 802.11a: ...
  • Page 84 Authentication Open System, Shared Key, Pre-Shared Key (PSK), 802.1X: LEAP, PEAP< TTLS, TLS, EAP-FAST Radio Compliance FCC Title 47, Part 15 FCC ID: VFK MWM1 Model - RAD-67 Canada IC:7362A-MWM1 IC Model: MWM1 RSS-210 Europe EN 301 489-1 EN 301 489-17 R & TTE Directive Japan TELEC www.masimo.com Masimo...

  • Page 85: Guidance And Manufacturer's Declaration-Electromagnetic Emissions

    Suitable for use in all establishments, including Class B domestic environments and those directly connected to CISPR 11 the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic Emissions Class A IEC 61000-3-2 Voltage fluctuations/ Complies Flicker emissions IEC 61000-3-3 www.masimo.com Masimo...

  • Page 86: Guidance And Manufacturer's Declaration-Electromagnetic Immunity

    0.5 cycle environment. on power supply for 0.5 input lines cycle IEC 61000-4-11 60% dip 60% dip in in mains mains voltage voltage for 5 cycle for 5 cycle www.masimo.com Masimo...
  • Page 87 Recommended separation distance Conducted RF IEC 3 Vrms 3 Vrms 61000-4-6 Radiated RF IEC 3 V/m 20 V/m 61000-4-3 80 MHZ to 2.5 80 MHz to 800 MHz 800 MHz to 2.5 GHz www.masimo.com Masimo...
  • Page 88 If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ME Equipment. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m. www.masimo.com Masimo...

  • Page 89: Recommended Separation Distances

    (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. www.masimo.com Masimo...

  • Page 90: Symbols

    Authorized representative in by or on the order of a the European community physician Federal Communications Identifies unit has been Commission (FCC) registered as a radio device Licensing Non-ionizing Industry Canada Identification electromagnetic radiation Warning, electricity Biohazardous Waste www.masimo.com Masimo...
  • Page 91 (polyvinyl chloride) material Not made with natural rubber Caution latex Catalog number (model Manufacturer number) Date of manufacture Masimo reference number YYYY-MM-DD Storage temperature range Serial number Keep dry Fragile, handle with care Storage humidity Do not use if package is...

  • Page 92: Citations

    Note: eIFU is not available in all countries. Citations [1] The Masimo rainbow SET technology with Masimo sensors has been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70%-100% SpO against a laboratory CO-Oximeter and ECG monitor.
  • Page 93 -20°C to +30°C, and at a relative humidity less than 85%. If stored for a prolonged period at environmental conditions beyond these limits, overall battery capacity may be diminished, and lifetime of the batteries may be shortened. *Registered trademark of Fluke Biomedical Corporation, Everett, Washington. www.masimo.com Masimo...

  • Page 95: Chapter 9: Service And Maintenance

    Before performing the following tests, do the following:  Connect the Rad-67 to AC power and fully charge the battery.  Disconnect any patient cables or pulse oximetry probes from the front of the Rad- www.masimo.com Masimo...

  • Page 96: Maintenance

    To conduct a Power-On Self-Test Power on the device by pressing the home button. Upon powering on, the device should emit a tone and the Masimo logo should display. Note: If the Rad-67 does not pass the Power-On Self-Test, a system failure technical alarm will be activated.

  • Page 97: Repair Policy

    Return Procedure Clean contaminated/dirty equipment before returning, following instructions in Cleaning on page 93. Make sure the equipment is fully dry before packing. Call Masimo at 800-326- 4890 and ask for Technical Support. Ask for an RMA number. Package the equipment...
  • Page 98 Products or Software. In no event shall Masimo’s liability arising from any Product or Software (under contract, warranty, tort, strict liability, or otherwise) exceed the amount paid by purchaser for the Product or Software.
  • Page 99 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 Copyright Restrictions: The Software and the accompanying written materials are copyrighted.

  • Page 101: Index

    Additional Settings • 36, 41 Compliance Warnings and Cautions • 15 Additional Settings for Pi • 40, 41 Contacting Masimo • 69, 70, 71, 93 Additional Settings for SpHb • 40 Contraindications • 9 Additional Settings for SpO2 • 39 Customizing Windows •...
  • Page 102 Low Power Mode • 34 Resolution • 76 Restrictions • 95 Return Procedure • 25, 93 Maintenance • 92 Run Time for Rad-67 • 92 Masimo rainbow SET® Parallel Engines • Masimo SET® DST • 18 Messages • 62 www.masimo.com Masimo...
  • Page 103 Status • 47, 48 Successful Monitoring for SpHb • 21 Successful Monitoring for SpO2, PR and Pi • 18 Symbols • 86 Touchscreen Function Test • 92 Troubleshooting Measurements • 21, 60, 63, 65 Troubleshooting Rad-67 • 68, 69 www.masimo.com Masimo...
  • Page 106 300362/LAB-10262A-0419...

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