Masimo Stork User Manual
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Masimo Stork User Manual

Masimo Stork User Manual

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Masimo Stork™

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Summary of Contents for Masimo Stork

  • Page 1 User's Manual Masimo Stork™...
  • Page 3 There may be information provided in this manual that is not relevant for your system. Do not operate Masimo Stork without completely reading and understanding these instructions. If you encounter any serious incident with product, please notify the competent authority in your country and the manufacturer.

  • Page 5: Table Of Contents

    Masimo Stork System ............................... 13 Features ....................................13 Basic Setup and Use ................................17 Getting Started ..................................17 Step 1: Smart Phone Setup ............................. 17 Step 2: Masimo Stork System Setup ..........................18 Step 3: View Live Data ..............................25 Advanced Use ................................... 31...

  • Page 6: About This Manual

    Connecting your Masimo Stork System to WiFi. • Product Description and Intended Use Product Description Masimo Stork - a system that provides spot-checking and continuous monitoring of physiological data by wireless communication to medical technologies. The system includes the following pieces:...

  • Page 7: Who The Device Is Intended To Be Used On (Indications For Use)

    Masimo Stork App - software application installed on a smart phone that provides the graphical user interface to display your data and alarm condition status. Masimo Sensor - wireless, wearable sensor that provides the physiological data. Masimo Chip - attaches to the wireless Masimo Sensor and connects wirelessly to the Masimo Stork Hub.

  • Page 8: Performance Warnings

    WARNING: Carefully position any cables to avoid possible strangulation or entanglement. WARNING: Do not place the Masimo Stork Hub in areas where there are a lot of flammable gases such as anesthetics, oxygen, or nitrous oxide present to prevent risk of fire.
  • Page 9 WARNING: Avoid placing liquids on or near the Masimo Stork Hub Liquids spilled on Masimo Stork may affect how it works. WARNING: Do not place anything on top of the Masimo Stork Hub to avoid damaging or blocking the wireless signal or muffling the audible alarms.

  • Page 10: Cleaning And Service Warnings

    Unauthorized changes should not be made to the Masimo Stork system. • CAUTION: Check your setup by viewing the display on the App and the Masimo Stork Hub. The App and Masimo Stork Hub will provide an indication if there is a problem with the internet connection.

  • Page 11: Compliance Warnings

    Radio interference may result in no or inaccurate readings. Note: Masimo Stork 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 12 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 Stork consideration should be taken to local government frequency allocations and technical parameters to minimize the possibility of interference to/from other wireless...

  • Page 13: Risks And Benefits

    If your oxygen level stays too low for too long, the lack of oxygen to your brain, organs, and tissue or hypoxia can have serious long-term effects to your health including death. The Masimo Stork allows you to see your oxygen level so that you can understand how your body and oxygen are connected.

  • Page 14: Benefits Of Masimo Stork

    Masimo Stork uses the same proven pulse oximetry used in hospitals shown to have fewer • false alarms compared to other brand technology. Masimo Stork 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 15: Description

    Description Masimo Stork System The Masimo Stork system consists of the following: IMAGE TBD Item Description Masimo Stork Hub Smart phone with Masimo Stork App Installed* Masimo Sensor Masimo Stork Boot * Smart phone not included. Features The following describes the Masimo Stork system parts.
  • Page 16 Masimo Stork Hub Overview The Masimo Stork Hub is a device that transfers measured data from the wireless Masimo Sensor to the Masimo Cloud and provides audible and visible alarms. NEED NEW IMAGE NEED TO KNOW WHAT INDICATORS THE HUB WILL HAVE 1.
  • Page 17 Flashing White Hub is searching for or connecting to the Wi-Fi network. Solid Orange Hub is connected to the Wi-Fi and the Sensor is no longer connected. Masimo Sensor Overview The Masimo Sensor is for use with the Masimo Stork system.
  • Page 18 2. Masimo Chip a. Light Indicator ALL TBD NEED SENSOR AND SPECS Sensor Lights The light indicator on the Masimo Sensor shows the status of the sensor connection and battery. Indicator/LED Color What does it mean? Bluetooth Status Flashing Blue Sensor is paired with the Hub.

  • Page 19: Basic Setup And Use

    Attach the Masimo Stork Boot to the baby. • View Live Data – After the Boot with Sensor is attached to the baby, open the Masimo Stork App to start monitoring and view live data on the Vitals Dashboard. Step 1: Smart Phone Setup Prepare the Smart Phone for Use: A compatible smart phone is required to install and operate the Masimo Stork App.

  • Page 20: Step 2: Masimo Stork System Setup

    For more on how to install an app, see the smart phone's manual. NEED NEW Note: If the Masimo Stork App requests for the smart phone to share its location, select OK or Allow. The smart phone location is required for Bluetooth connection.
  • Page 21 Note: Make sure your smartphone Wi-Fi and Bluetooth connections are turned on. Refer to the smart phone's instructions to change its settings. WARNING: Place the Masimo Stork Hub in a safe location so as not to fall on anyone and where the alarm sounds can be heard.
  • Page 22 Charging the Masimo Sensor To charge the Masimo Sensor, remove it from the Masimo Stork Boot. Connect the Masimo Stork Sensor to a power outlet using the AC power cord and adapter and connect the charging cable to the Sensor charging port.
  • Page 23 Light Indicator - turns blue TBD • NEED NEW TBD If the sensor and Masimo Stork Hub cannot pair, see Troubleshooting on page 33. • After connecting the Sensor, the Your System is Connected screen displays indicating the <prod_name_ short> App setup is completed. Select Continue.
  • Page 24 Step 3 TBD Attaching the Masimo Stork Boot to the Baby Follow the instructions to attach the Masimo Sensor and Masimo Stork Boot to the foot. ALL TBD - DO NOT HAVE INSTRUCTIONS Place the sensor on the leg or wrist (not shown) and carefully thread the tip of the strap through the open red c loop.
  • Page 25 Route the sensor cable so that it runs along the top of the foot. Peel off the plastic backing and place the square detector mark on the fleshy pad of the great toe. The toe next to the great toe, or the thumb can be used (not shown). Wrap the adhesive tape around the toe so the emitter star is positioned on the nail bed of the great toe.
  • Page 26 Adjust the sensor cable to a comfortable length. Go to Pairing the Masimo Sensor on page 20 for additional instructions.

  • Page 27: Step 3: View Live Data

    Step 3: View Live Data After setting up the Masimo Stork App, connecting the Hub and Sensor and attaching the Boot to the baby, select Open Stork from the App screen. The Vitals Dashboard screen displays data from the Masimo Sensor. The Live screen is also the Masimo Stork App Home Screen, with access to other App functions.
  • Page 28 ALL TBD - I HAVE NOTHING ABOUT ALARMS Masimo Stork provides visual and audible alarms when your oxygen level becomes low. Masimo Stork will also contact your emergency contacts and notify if your oxygen level drops too low and you are unaware or unable to respond.
  • Page 29 When Level 1 is triggered, an alarm sounds on your Masimo Stork 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.
  • Page 30 Red) When Level 2 or 3 alarms are triggered, an alarm will sound on your Masimo Stork 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 31 On the App: Tap the alarm icon on the top left corner of the pop-up (1) Masimo Stork Hub: Press the button once. See Silence Alarms for additional information. To exit the screen, select the "X" (2) or select the Close button.
  • Page 32 Touch the Speaker icon shown on the banner to silence the App alarm. NEED NEW SCREEN SHOT Silencing Alarms From the Masimo Stork Hub Press and release the Masimo Stork Hub button to silence the Masimo Stork Hub alarm. NEED NEW IMAGE...

  • Page 33: Advanced Use

    Advanced Use Health Settings The Health Settings menu is located within the App Menu. See Step 3: View Live Data on page 24. Options available include: Body Temp - Information about the Body Temp and available settings. • Room Temp - Displays information about the Room Temp and available settings. •...

  • Page 35: Troubleshooting

    "Replace your sensor" • Press the alarm silence button on the Sensor became disconnected during "Wireless sensor Masimo Stork Hub. Follow the instructions audible alerts for including: disconnected during an alert" and attempt to pair the sensor again. See • Physiology alert or technical alert Pairing the Masimo Sensor on page 20.
  • Page 36 When an attempt was made to to End the monitoring session before attempting "Device in use" modify or delete the Masimo Stork Hub to modify the device. "Cannot modify a device that during active monitoring. is actively monitoring. Please end your monitoring session and try again."...
  • Page 37 The Masimo Stork Hub has paired For information only, no action is required. successfully. paired" "No Masimo Stork Hub Masimo Stork Hub is not connected to Follow instruction on the app or this manual to the app. complete set up. See Masimo Stork Hub added"...
  • Page 38 Bluetooth device. Notifications are not enabled on the Enable notifications on the smart phone for "Please Enable App smart phone for the Masimo Stork App. the Masimo Stork App. Notifications" Low diskspace during active monitoring Clear diskspace on the smart phone. A "Low Disc Space Warning!"...
  • Page 39 Displayed Messages Potential Causes Next Steps another user. When attempting to resend an email Continue with Masimo Stork App setup, as "This account has already Verification link to an already verified email has already been verified. been verified." account. Error when connecting to the server.

  • Page 40: Troubleshooting Masimo Stork

    • Check for Masimo Stork App updates. • Contact Masimo Customer Support. See Customer Support on page 57. • Masimo Stork Hub is not powered • Check that Masimo Stork Hub is plugged into the AC Masimo Stork power supply. App does not •...
  • Page 41 • Check that the device speaker is not being muffled. Hub speaker appliances). does not work • Check that the Masimo Stork Hub is on a flat surface with • Internal components may not be (no sound or minimal objects surrounding it.
  • Page 42 Operator's Manual or Directions For Use. • Contact Masimo Customer Support. See Customer Support on page 57. • Incorrect user currently logged into • Ensure the correct user is logged into the Masimo Stork Incorrect user the Masimo Stork App. App.

  • Page 43: Troubleshooting Measurements

    Next Steps • Sensor not properly placed on user. • Reapply the sensor. Masimo Stork • Pair the sensor with Masimo Stork Hub. See Pairing the • Sensor not properly paired to App does not Masimo Sensor on page 20.
  • Page 44 • Low signal quality. • Move the sensor to a location on the user's body with stronger measurement blood flow. Warm the hand where the sensor is placed. values • Contact Masimo Customer Support. See Customer Support on page 57.

  • Page 45: Appendix

    Appendix Specifications Masimo Stork App Measurement Range Measurement Display Range Unit of Measure Oxygen Level (SpO ) 0 to 100 Pulse Rate (PR) 0 to 240 Perfusion Index (Pi) 0 to 20 Smart Phone Compatibility Item Specification* Operating System Android 6.0 (Marshmallow) (minimum) iOS 12.0 (minimum)
  • Page 46 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 A Values for Radius PPG Sensors...
  • Page 47 - SaO 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 Operating Temperature 32°F to 104°F (0°C to 40°C)
  • Page 48 Masimo Stork Hub Electrical AC Power Requirements AC Power Input (External Power Supply) 100 to 240 VAC, 50 to 60 Hz, 1.2 A DC Power Input (Masimo Stork Hub) 5 VDC, 750 mA Physical Characteristics Masimo Stork Hub Dimensions 3.45” x 2.48” x 0.78”...
  • Page 49 Safety Standards Compliance IEC 62304 IEC 60601-1-11 Equipment Classification per IEC 60601-1 Type of Protection Class II (AC Power) Degree of Protection against Type BF-Applied Part Electrical Shock Protection against harm from IP22 (Protection from solid foreign objects ≥12.5 mm diameter and Water and Particulate Matter against ingress from vertically falling water drops when enclose tilted up to 15°)
  • Page 50 Communication (Wi-Fi) Type WLAN Radio: IEEE 802.11 b/g/n Frequency 802.11b/g/n(HT20): 2412-2462 MHz 802.11n(HT40): 2422-2452 MHz Max Peak Output Power WLAN 27.12 dBm Classification of Output Power Rating Conducted Output Power Type Fixed at the Factory Modulation Types 802.11b: DSSS 802.11g/n(HT20/HT40): OFDM Modulation Signals Analog and Digital Available Data Rates...
  • Page 51 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 52 Electromagnetic Immunity Electrical fast +/- 2 kV for +/- 2 kV for Mains power quality should be that of a typical transient/ burst power lines power lines commercial or hospital environment. IEC 61000-4-4 +/- 1 kV for +/- 1 kV for input/ output input/ output lines...
  • Page 53 Electromagnetic Immunity Voltage dips 0% U , 0.5 0% U , 0.5 Mains power quality should be that of a typical on power cycle, at 0°, cycle, at 0°, 45°, commercial or hospital environment. supply input 45°, 90°, 90°, 135°, 180°, lines 135°, 180°, 225°, 270°, and...
  • Page 54 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- modulation TETRA 400 18 Hz FM (c) 430- +/- 5 kHz GMRS 460, FRS 460 deviation 1 kHz sine Pulse...
  • Page 55 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 61000-4-3.
  • Page 56 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 57 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 58: 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 59 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 Stork product, please go to www.mymasimo.co.uk/safetynet-alert or email customercare@masimo.com.

  • Page 60: 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 61: Index

    Appendix • 43 Electromagnetic Compliance • 49 Attaching the Masimo Stork Boot to the Baby • 22 Attaching the Sensor to the Masimo Stork Boot • 22, 39 Health Settings • 25, 31 Basic Setup and Use • 17 In-App Videos • 4 Benefits of Masimo Stork •...
  • Page 62 Specifications • 44 IMMUNITY to RF Wireless Communication Equipment • 52 Troubleshooting • 19, 20, 21, 33 Pairing the Masimo Sensor • 20, 24, 33, 41 Troubleshooting Masimo Stork • 38 Performance Warnings • 6 Troubleshooting Measurements • 41 Physical Characteristics • 46 Product Description •...
  • Page 64 SUB-1449A-1122...

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