Masimo SafetyNet Alert User Manual
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Masimo SafetyNet Alert User Manual

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  • Page 3 Patents: www.masimo.com/patents.htm Masimo® and ® are federally registered trademarks of Masimo Corporation. Masimo SafetyNet™ and Masimo SafetyNet Alert™ are trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners. © 2022 Masimo Corporation...

  • Page 5: Table Of Contents

    Cleaning and Service Warnings ..................10 Compliance Warnings ..................... 10 Risks and Benefits ........................12 Your Body and Oxygen ....................12 Risks of Masimo SafetyNet Alert ..................13 Benefits of Masimo SafetyNet Alert ................14 Description ..........................15 Masimo SafetyNet Alert System ..................15...
  • Page 6 Basic Setup and Use ......................19 Getting Started ......................... 19 Step 1: Smart Phone Setup ..................... 19 Step 2: Masimo SafetyNet Alert System Setup .............. 21 Home Medical Hub Setup ..................21 Masimo Sensor Setup ....................22 Add Emergency Contacts ..................28 Step 3: View Live Data .....................

  • Page 7: About This Manual

    The system includes the following pieces: Masimo SafetyNet Alert App - software application installed on a smart phone that provides the graphical user interface to display your data and alarm condition status.

  • Page 8: Who The Device Is Intended To Be Used On (Indications For Use)

    The Masimo SafetyNet Alert is also indicated for the monitoring of adults and pediatrics for substance induced oxygen desaturations (e.g. OIRD caused by oral or injectable opioids) in hospital and home environments.

  • Page 9: Safety Information

    CAUTION: Place the Home Medical Hub where you can easily disconnect it from AC power in case of an emergency. CAUTION: Only use the AC power supply included with your Home Medical Hub to prevent damage to the device. Note: Do not monitor more than one person at a time with Masimo SafetyNet Alert.

  • Page 10: Masimo Sensor

    WARNING: Do not self-diagnose or self-medicate on the basis of the measurements. Always consult your physician. WARNING: Do not use Masimo SafetyNet Alert as an apnea monitor. Masimo SafetyNet Alert is not designed to detect apnea. WARNING: Only use Masimo-approved parts with Masimo SafetyNet Alert to make sure the device works correctly.
  • Page 11 CAUTION: Avoid using Masimo SafetyNet Alert under bright light sources and direct sunlight to maintain the performance of the device. CAUTION: Check that the Masimo SafetyNet Alert alarm can be heard from other rooms in your home, especially when noisy appliances such as vacuum cleaners, dishwashers, clothes dryers, televisions, or radios are operating.

  • Page 12: Masimo Sensor

    CAUTION: Check your system setup by viewing the display on the smartphone Masimo SafetyNet Alert Application. The Masimo SafetyNet Alert App will provide an indication if there is a problem with the internet connection. CAUTION: Avoid placing Masimo SafetyNet Alert near other wireless devices to prevent loss of performance.
  • Page 13 Radio interference may result in no or inaccurate readings. Note: Masimo SafetyNet Alert complies with the limits for a Class B digital device, per Part 15 of the FCC Rules. These limits were designed to provide reasonable protection against harmful interference in a residential installation.

  • Page 14: Risks And Benefits

    5250-5350 MHz and 5650-5850 MHz and that these radars could cause interference and/or damage to LE-LAN devices. Note: When using Masimo SafetyNet Alert consideration should be taken to local government frequency allocations and technical parameters to minimize the possibility of interference to/from other wireless devices.

  • Page 15: Risks Of Masimo Safetynet Alert

    The Masimo SafetyNet Alert allows you to see your oxygen level so that you can understand how your body and oxygen are connected. If you have a medical condition that effects your breathing (e.g., asthma, COPD), your normal blood oxygen level may be lower. For these conditions, it is important that you seek the advice of your physician.

  • Page 16: Benefits Of Masimo Safetynet Alert

    • Masimo SafetyNet Alert allows for the storage and review of your blood oxygen level as you go about your normal activities, including exercise or sleep. Barker S.J. Anesth Analg. 2002 Oct;95(4):967-72.

  • Page 17: Description

    Description Masimo SafetyNet Alert System The Masimo SafetyNet Alert system consists of the following: Item Description Home Medical Hub Smart phone with Masimo SafetyNet Alert App Installed* Masimo Sensor Masimo Chip * Smart phone not included.

  • Page 18: Features

    Home Medical Hub Overview The Home Medical Hub is a device that transfers measured data from the wireless Masimo Sensor to the Masimo Cloud. It transfers data from the wireless Masimo Sensor to the Masimo Cloud and provides audible and visible alarms.
  • Page 19 Home Medical Hub is on and needs to be set up. Solid Green Home Medical Hub is paired with the sensor, connected to the Wi-Fi and communicating with the Masimo Cloud. Alarms and Notifications Flashing Orange Active Level 1 Alert. See on page 30.

  • Page 20: Masimo Sensor And Masimo Chip Overview

    Tape 2. Masimo Chip a. Light Indicator Sensor Lights When inserted in the sensor, the light indicator on the Masimo Chip shows the status of the sensor. Light Indicator Color What does it mean? Flashing Blue Sensor is paired with the Home Medical Hub.

  • Page 21: Basic Setup And Use

    To use your smart phone with the Masimo SafetyNet Alert App check the following: • Compatibility Note: For a list of smart phones and operating systems that work with the Masimo SafetyNet Alert App, check www.masimo.ca/support before upgrading the smart phone or its operating system. •...
  • Page 22 For more on how to install an app, see the smart phone's manual. Note: If the Masimo SafetyNet Alert App requests for the smart phone to share its location, select OK or Allow. The smart phone location is required for Bluetooth connection.

  • Page 23: Step 2: Masimo Safetynet Alert System Setup

    Step 2: Masimo SafetyNet Alert System Setup After the Masimo SafetyNet Alert App is installed and setup, follow the app instructions to set up your Masimo SafetyNet Alert System: • Pair the App to the Home Medical Hub. • Connect the Home Medical Hub to the Wi-Fi.

  • Page 24: Masimo Sensor Setup

    Troubleshooting screen instructions to verify the network and try again or view page 39. Next, you will need to attach the Masimo Sensor and connect it with the Home Masimo Sensor Setup Medical Hub. See on page 22 for additional instructions.
  • Page 25 Remove the sensor from the pouch. Peel off the yellow label to activate the battery. Place the sensor on the wrist as shown and carefully thread the tip of the strap through the open red c loop.
  • Page 26 Wrap the loose attachment strap around the wrist and press to secure. Remove part of the plastic film and place the star on top of the fingernail of your ring finger. Wrap the tape around your finger so the square marking on the sensor tape is on the finger pad directly across from the star.
  • Page 27 Squeeze top and bottom of finger to secure tape. Remove plastic film and continue to wrap remaining tape around your finger. Pairing the Masimo Sensor 10. Adjust the sensor cable to a comfortable length. Go to on page 26 for additional instructions.
  • Page 28 16. Insert the Masimo Chip into open compartment on the sensor. Press down on the Masimo Chip to secure. Listen for a click and look for a green light on the chip to confirm successful chip connection to sensor.
  • Page 29 Home Medical Hub: • Bluetooth Status LED - turns off • Status LED - turns green Masimo Chip: • Light Indicator - turns blue Troubleshooting • If the sensor and Home Medical Hub cannot pair, see page 39.

  • Page 30: Add Emergency Contacts

    Follow the on-screen prompts to select your Emergency Contacts from your smart phone. This allows the Masimo SafetyNet Alert App to contact them in case of an emergency. An emergency contact is someone who will be alerted if you experience an Alert event.

  • Page 31: Step 3: View Live Data

    Step 3: View Live Data After setting up the Masimo SafetyNet Alert system, the app displays data from the Masimo Sensor. The Live screen is also the Masimo SafetyNet Alert App Main Screen, with access to other App functions. 1. Data Display * Displays the data from the sensor.

  • Page 32: Alarms And Notifications

    Masimo SafetyNet Alert provides visual and audible alarms when your oxygen level becomes low. Masimo SafetyNet Alert will also contact your emergency contacts and notify if your oxygen level drops too low and you are unaware or unable to respond.
  • Page 33 When Level 1 is triggered, an alarm sounds on your Home Medical Hub and the App. The App displays a yellow CAUTION banner at the top of screen. Touch the Oxygen Level (1) or the yellow banner (2) to learn what the Level 1 notification means. LEVEL 1 CAUTION Alert Event Information Information about the low oxygen level event is shown along with steps on how to help your oxygen level...
  • Page 34 Levels 2 and 3 Notification Level Visual Alarm Audible Alarm Emergency Contact Level 2 WARNING (Red) Message sent to Emergency Contact Level 3 EMERGENCY (Flashing Red) When Level 2 or 3 alarms are triggered, an alarm will sound on your Home Medical Hub and the App. The App will display your Oxygen Level in the red zone and a red banner at the top of screen.
  • Page 35 LEVEL 2 WARNING/LEVEL 3 EMERGENCY Alert Event Information Information about the low oxygen level event is given along with steps on how to help your oxygen level recovery. Designated emergency contacts are notified to assist you. You have the option to: 1.
  • Page 36 Silencing Alarms From the Home Medical Hub Press and release the Home Medical Hub button to silence the Home Medical Hub alarm.

  • Page 37: Advanced Use

    Live Data screen can be turned On or Off from this screen. Change Option When setting up the Masimo SafetyNet Alert App, you were asked to select an Option that best applied to you. The selected Option helps to identify the most relevant Alert Events for you at the time you selected it.

  • Page 38: Oxygen Level

    Oxygen Level The Oxygen Level screen shows the Oxygen Level (SpO ) Low Limit and the time below the Low Limit (Time Delay) for triggering the different Alert Events. The triggers are different depending on the Option selected. Selecting the "?" icon next to the Option displays additional information about the Option. Low Oxygen Level and Alert Time Delay Default and Available Settings For COVID-19 or Other, you have the option to change the default Oxygen Level Low Limits and Alert Time Delays.
  • Page 39 Alert Event Defaults (Other) Alert Type Low SpO Limit % Low SpO Limit % User Time Delay Time Delay User Default Settings Default Settings Level 1 - Max: 95 30 seconds to 5 minutes 5 minutes Caution Min: Warning Limit +1% in 30 second increments Level 2 - Max: Caution Limit –1%...

  • Page 41: Troubleshooting

    • Obstructed battery • Low battery • Depleted battery "Allow Masimo SafetyNet Access to contacts on smart Allow smart phone permissions to share Alert to access your contacts" phone has not been granted. contacts with the Masimo SafetyNet Alert App.
  • Page 42 For more information on emergency member or caregiver that will emergency contact. contacts go to be alerted in the event you www.masimo.com/support. need immediate assistance regarding your Oxygen levels. SafetyNet gives you the option to Add an Emergency Contact now or later."...
  • Page 43 Displayed Messages Potential Causes Next Steps "Request Sent" Displayed after successfully For information only, no action is required. sending an emergency "A request has been sent to contact invitation your Emergency Contact. Follow up with your Emergency Contact to make sure they accept."...
  • Page 44 "Home Medical Hub Error" Home Medical Hub internal The Home Medical Hub requires replacement, hardware fault. please contact Masimo Customer Support. See Customer Support. "Unable to connect to Wi-Fi" Wi-Fi connection failure due Enter the correct password. to timeout or invalid password.
  • Page 45 Location services permissions Allow the smart phone permission to share its Alert to access this device's have not yet been granted location with the Masimo SafetyNet Alert App. location" when attempting to search for a Bluetooth device. "Please Enable App...
  • Page 46 "This account has already When attempting to resend Continue with Masimo SafetyNet Alert App been verified." an email Verification link to setup, as email has already been verified. an already verified account.

  • Page 47: Troubleshooting Masimo Safetynet Alert

    Operator's Manual or Directions needs to be updated. turn on For Use. • Incompatible smart phone. • Check for Masimo SafetyNet Alert App updates. • Check smart phone compatibility. See Specifications on page 51. • Contact Masimo Customer Support. See Customer Support.
  • Page 48 Update the smart phone software. Refer to Bluetooth Low Energy (BLE). the smart phone's Operator's Manual or Directions For Use. • Contact Masimo Customer Support. See Customer Support. • Home Medical Hub is not • Ensure Home Medical Hub is plugged in.
  • Page 49 5 seconds until an audible tone Home Medical Hub Setup is heard. See • Incorrect user logged into the on page 21. Masimo SafetyNet Alert App. • Ensure correct user is logged into the • Home Medical Hub has been Masimo SafetyNet Alert App.
  • Page 50 Masimo SafetyNet Alert App. is displayed App. • Log out the incorrect user and log into the correct account. • Restart Masimo SafetyNet Alert App and login to the system. • Contact Masimo Customer Support. See Customer Support. • •...
  • Page 51 Operator's Manual or Directions For Use. • Check network settings and availability. You may need to call network provider for further assistance. • Restart Masimo SafetyNet Alert App and login to the system. See • Contact Masimo Customer Support. See Customer Support. •...

  • Page 52: Troubleshooting Measurements

    Shield the sensor from excessive or strobing light. • Low battery/SafetyNet • Home Medical Hub not Replace sensor. plugged into AC power • Contact Masimo Customer Support. See Customer supply. Support. • Measurement may still • Allow time for the parameter measurement to Measurement be in progress.

  • Page 53: Appendix

    Perfusion Index (Pi) 0 to 20 Smart Phone Compatibility Item Specification* Operating System Android 6.0 (Marshmallow) (minimum) iOS 12.0 (minimum) * For complete specifications, refer to www.masimo.ca/support. Masimo Sensor Weight Range and Measurement Site Population Weight Measurement Site Adult and Pediatric > 40 kg (> 88.2 lbs) Finger Neonate <...
  • Page 54 Oxygen Level (SpO2) ARMS Performance Specifications The tables below provides A (Accuracy Root Mean Square) values measured using the Masimo Sensor (Radius PPG) under no motion, with Masimo Technology in a clinical study. Measurement Values for Radius PPG Sensors Accuracy Range (%)
  • Page 55 )/2 versus (SpO ) under no motion with an upper 95% and lower 95% limits of agreement. Figure 1: Radius PPG Sensors (ARMS 70-100%) Electrical Battery - Masimo Sensor Run Time 96 hours in typical continuous usage Environmental Masimo Sensor Environmental Conditions...

  • Page 56: Masimo Chip

    Masimo Sensor Environmental Conditions Storage Temperature 32°F to 122°F (0°C to 50°C) Operating Humidity 5% to 95%, non-condensing Storage Humidity 5% to 95%, non-condensing Masimo Chip Environmental Masimo Chip Environmental Conditions Operating Temperature 32°F to 104°F (0°C to 40°C) Storage Temperature -40°F to 158°F...
  • Page 57 Home Medical Hub Weight 0.12 lbs. (56g) Environmental Environmental Conditions - Home Medical Hub Operating Temperature 41°F to 104°F (5°C to 40°C) Storage Temperature -13°F to 158°F (-25°C to 70°C) Operating Humidity 10% to 95%, non-condensing Storage Humidity 10% to 95%, non-condensing Compliance EMC Compliance IEC 60601-1-2:2014, Class B...
  • Page 58 Equipment Classification per IEC 60601-1 Mode of Operation Continuous Wireless Specifications Communication (Bluetooth) Type Bluetooth Frequency 2402-2480 MHz Max Peak Output Power 8.45 dBm Classification of Output Power Rating Conducted Output Power Type Fixed at the Factory Modulation Types GFSK Modulation Signals Analog and Digital Available Data Rates...
  • Page 59 Communication (Wi-Fi) Modulation Signals Analog and Digital Available Data Rates 802.11b - 1, 2, 5.5, 11 Mbps. 802.11g - 6, 9, 12, 18, 24, 36, 48, 54 Mbps 802.11n- MCS0 – MCS7 Security and Authentication Encryption 64/128-bit WEP, Dynamic WEP, WPA-TKIP, WPA2-AES Authentication Open System, Shared Key, Pre-Shared Key (PSK), 802.1X: LEAP, PEAP, TTLS, TLS, EAP-FAST Radio Compliance Contains FCC ID: 2AC7Z-ESP32SOLO1...
  • Page 60 Guidance and Manufacturer's Declarations - Electromagnetic Compliance Electromagnetic Emissions Electromagnetic Emissions The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment. Emission Test Compliance Electromagnetic Environment - Guidance RF Emissions...
  • Page 61 Electromagnetic Immunity Electromagnetic Immunity The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment. Immunity Test IEC 60601 Test Compliance Level Electromagnetic Environment - Level...
  • Page 62 Electromagnetic Immunity Power frequency 30 A/m 30 A/m Power frequency magnetic fields should (50 / 60 Hz) be at levels characteristic of typical magnetic field location in a typical hospital environment. IEC 61000-4-8 Voltage dips on 0% U , 0.5 cycle, 0% U , 0.5 cycle, at 0°, Mains power quality should be that of a...
  • Page 63 Test Specifications for ENCLOSURE PORT IMMUNITY to RF Wireless Communication Equipment Test Band Service (a) Modulation Maximum Distance Immunity Frequency Power Test Level (MHz) (MHz) (V/m) Pulse 380- TETRA 400 modulation (b) 18 Hz FM (c) 430- +/- 5 kHz GMRS 460, FRS 460 deviation 1 kHz sine...
  • Page 64 Test Band Service (a) Modulation Maximum Distance Immunity Frequency Power Test Level (MHz) (MHz) (V/m) Note: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4- (a) For some services, only the uplink frequencies are included.

  • Page 65: Symbols

    Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the ME Equipment 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.

  • Page 66: Citations

    Note: eIFU is not available in all countries. Citations [1] The Masimo SET Technology has been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark pigmented skin in induced hypoxia studies in the range of 70%-100% SpO against a laboratory co-oximeter.

  • Page 67: Service And Maintenance

    5% for saturations ranging from 70% to 100%. [4] The Masimo SET Technology has been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator and Masimo’s simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70% to 100%.

  • Page 68: Customer Support

    Do not immerse the chip and wireless receiver in any liquid solution. • Do not sterilize by irradiation, steam, autoclave or ethylene oxide. Customer Support For answers to frequently asked questions (FAQ's) and product support, along with troubleshooting for your Masimo SafetyNet Alert product, please go to www.masimo.ca/support or email customercare@masimo.com.

  • Page 69: Concepts Of Alarm Response Delay

    Concepts of Alarm Response Delay As with any pulse oximeter equipment, the audible and visual alarms are subject to alarm response delay, which is composed of Alarm Condition 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.

  • Page 71: Index

    Home Medical Hub • 54 Basic Setup and Use • 19 Home Medical Hub Cleaning • 65 Benefits of Masimo SafetyNet Alert • 14 Home Medical Hub Lights • 16, 17 Home Medical Hub Overview • 16, 26 Home Medical Hub Setup • 21, 41, 46, 47, Change Option •...
  • Page 72 Specifications • 52 IMMUNITY to RF Wireless Communication Equipment • 61 Troubleshooting • 22, 27, 39 Pairing the Masimo Sensor • 25, 26, 39, 49 Troubleshooting Masimo SafetyNet Alert • Performance Warnings • 8 Troubleshooting Measurements • 50 Physical Characteristics • 54 Product Description •...
  • Page 74 303429/LAB-11534A-0222...

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