User's Manual Stork Camera Smart Home Baby Monitoring There may be information provided in this manual that is not relevant for your system. Do not operate 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. Wireless Radio:
Masimo Stork Camera:
- FCC ID:VKF-STORKC
- IC: 7362A-STORKC Manufacturer:
Masimo Corporation 52 Discovery Irvine, CA 92618, USA www.masimostork.com Patents: www.masimo.com/patents.htm Masimo and are federally registered trademarks of Masimo Corporation. Stork is a trademark of Masimo Corporation. Google Play and the Google Play logo are trademarks of Google LLC. App Store and App Store logo are registered trademarks of Apple Inc. The Bluetooth word mark and logo are registered trademarks owned by Bluetooth SIG, Inc. All other trademarks and registered trademarks are property of their respective owners. 2023 Masimo Corporation Masimo Corporation 1 www.masimo.com Contents About This Manual .......................................................................................... 4 Getting Started Guides ................................................................................... 4 In-App Videos ............................................................................................... 4 Product Description ........................................................................................ 5 Meet the Stork System ..................................................................................... 6 Stork System ................................................................................................ 6 Components of Stork ...................................................................................... 7 Basic Setup and Use of Stork ............................................................................. 8 Getting Started ............................................................................................. 8 Step 1: Smart Phone Setup ............................................................................... 8 Step 2: Setting up the Stork System .................................................................... 9 Step 3: View Live Data ................................................................................... 14 Advanced Use .............................................................................................. 15 Notifications ............................................................................................... 15 Live Controls ............................................................................................... 16 Side Menu .................................................................................................. 17 Bottom Menu .............................................................................................. 19 How to Turn Stork On and Off .......................................................................... 21 Troubleshooting ........................................................................................... 21 Appendix .................................................................................................... 22 Risks and Benefits ........................................................................................ 22 Safety Information ........................................................................................ 23 Specifications .............................................................................................. 28 Service and Maintenance ................................................................................ 32 Masimo Corporation 3 www.masimo.com Stork Camera About This Manual About This Manual Not intended for use as a medical device or to replace a medical device. Do not use it to diagnose, cure, treat, alleviate, or prevent any disease or health condition. This Manual provides an overview of the Stork System and how to set up and use the Stork System. You must read and understand the warnings and precautions to help ensure safe and effective use of the Stork System. See Safety Information on page 23. Please make sure to read the entire manual and notes. A warning is given when there is reasonable evidence of an association of a serious hazard with use of this device that may result in a serious injury, adverse effect, or death to the user. WARNING: This is an example of a warning statement. A caution is given when special care is to be exercised by the user to avoid injury to the user, damage to this device, or damage to other property. CAUTION: This is an example of a caution statement. A note is given when additional information applies. Note: This is an example of a note. Getting Started Guides Use the quick reference guide included for the following:
Basic Setup and starting your first monitoring session. In-App Videos Watch the videos in your app to find out more about:
Setting up your Stork System. Connecting your Stork Camera to Bluetooth and Wi-Fi. Masimo Corporation 4 www.masimo.com Product Description Masimo Masimo Stork Camera is designed for parents to monitor a healthy baby at home. The camera, cloud, and app combine to allow parents to stay connected with their baby via video and 2-way audio on the app. The camera consists of the following:
Stork App: A smart phone application that provides high-resolution video, room conditions, baby health, and audio controls. Stork Camera: Capable of providing 2K QHD video resolution so that you can see baby in the app regardless of time of day or room lighting. Additionally, the Stork Camera provides 2-way audio, room condition monitoring, and serves as a path to the cloud so that you can get the data on your phone no matter where you are. Masimo Cloud: A server accessed over the internet that gathers and stores the health data, video and audio communicated wirelessly from the Stork Sensor and the Stork Camera. Masimo Corporation 5 www.masimo.com Stork Camera Meet the Stork System Meet the Stork System Stork System Stork Camera kit consists of the following:
1 Stork Camera 2 Smart phone with Stork app Installed*
* Smart phone not included. Also included in the package but not pictured:
Stork Quick Start Guide Stork Camera AC power adapter Stork Camera power cable and cable covers Stork Camera wall mounting bracket (and hardware) Masimo Corporation 6 www.masimo.com Stork Camera Meet the Stork System Components of Stork Stork Camera Overview The Stork Camera supports the communication between the Stork System parts, captures audio and video, provides room ambient temperature and humidity, supports 2-way audio communication, and provides lullaby playback. 1 Speaker Used for 2-way communication and to play lullabies. 2 Status Light Shows notifications, camera operation and connection status. See Stork Camera Notifications on page 15 and Camera Status Light on page 28. 3 Ambient Light Sensor Measures ambient light in the room. 4 Microphone For listening to the baby. 5 Temperature and Humidity Sensors 6 Power Connector Measures ambient temperature and humidity of the room. Located on the bottom of the camera. Power is provided by the AC adapter and the power cable. The cable is routed through the opening in camera base. Note: A hole to access the factory reset button is located on the bottom of the camera. Masimo Corporation 7 www.masimo.com Stork Camera Meet the Stork System Basic Setup and Use of Stork Getting Started You can get the Stork Camera up and running by following these steps and the in-app instructions and tutorials:
1. Set up your smart phone with the Stork app. Download the app on your smart phone and follow the app instructions to create an account and a baby profile. 2. Set up the Stork System through the app and complete the following:
Connect the Stork Camera to the app using local Wi-Fi. Install the camera. 3. Confirm the correct setup Open the app and confirm live data on the Live Dashboard. Step 1: Smart Phone Setup Prepare the Smart Phone for Use:
A compatible smart phone is required to install and operate the Stork app. To use your smart phone with the Stork app, check the following:
Compatibility Note: For a list of smart phones and operating systems that work with the Stork app, check www.masimostork.com before upgrading the smart phone or its operating system. Smart phone battery is charged Bluetooth is ON Wi-Fi is ON and the smart phone in connected to the internet Time is set to the current local time Download and install the Stork app on your smart phone:
Download and install the Stork app. Follow the app instructions to install. For more on how to install an app, see the smart phone's manual. Note: If the Stork app requests the smart phone to share its location, select OK or Allow. The smart phone location is required for Bluetooth connection on some smart phones. Masimo Corporation 8 www.masimo.com Stork Camera Meet the Stork System Create a User Account After installation, open the app and follow the app instructions to create a new user account. If you have an existing user account, log in using the account credentials. Note: If you need to make changes to the account, see Side Menu on page 17. Create a Baby Profile Follow the app instructions to and set up a Baby Profile. Enter the requested information about the baby when prompted. Note: If you need to make changes to the baby profile or create a baby profile, see Side Menu on page 17. Add Stork Devices After creating an account and baby profile, select Add Device to continue. On the next screen, select a device that came with Stork to connect with the Stork system. If additional devices need to be connected to Stork, see Device Management on page 18. Step 2: Setting up the Stork System After the Stork app is installed and a user account and baby profile are created, follow the app instructions to set up your Stork System:
Connect the Stork Camera to the app and local Wi-Fi network, and set up the camera viewing location. Stork Camera Setup See Device Management on page 18 to connect the Stork Camera and follow the app instructions to:
Pair the camera to the Stork app using Bluetooth. Connect the camera to the wireless network (Wi-Fi). Install the camera. The camera can be set on a flat surface (such as a dresser) or mounted to the wall (preferred). Masimo Corporation 9 www.masimo.com Stork Camera Meet the Stork System Connecting the Stork Camera The Stork Camera is connected in two (2) steps. Step 1: Pair the Stork app to the camera using Bluetooth. Step 2: Connect the camera to the wireless network (Wi-Fi). 1. Plug the power cable into the camera (A), the power cable into the 12W AC power adapter (B) and plug the power adapter into a wall socket (C). Note: The camera Indicator is white when powered on. See Camera Status Light on page 28. A B C 2. Follow the app instructions to pair the camera. Hold your smart phone near the camera during setup. When pairing is complete, the Bluetooth Pairing is Successful screen appears. Note: If multiple devices are found, follow the app instructions to select the correct camera from a list. Note: If the Bluetooth connection fails, hold the smart phone closer to the camera and try to reconnect. If the camera cannot connect, see Troubleshooting on page 21. 3. Next, connect to your Wi-Fi by selecting Setup Wi-Fi and follow the app instructions. Note: If requested to Share Wi-Fi Settings, select Allow. 4. Select the wireless Network and enter the Password. Select Continue. Note: To view available Wi-Fi networks within range of the camera, click the Network field and select from the displayed list 5. Once the Wi-Fi connection is made, the Success! screen appears. Note: If the camera cannot connect, follow the app instructions to verify the network and try again or view Troubleshooting on page 21. Masimo Corporation 10 www.masimo.com Stork Camera Meet the Stork System Choosing a Location for the Stork Camera The Stork Camera can be set on a flat surface (for example: a dresser or a nightstand) or mounted to the wall (preferred). When set on a flat surface, place the camera in a safe location near the crib that is 4 to 5 feet above the mattress and so as not to fall on anyone, get damaged, or where communication is not muffled and notification sounds can be heard. For wall mounting, pick a spot on the wall near the crib that is 4 to 5 feet above the mattress. Ideally, the camera should be located somewhere near the middle of the crib (A). At this height, the camera will be able to monitor the whole crib. The camera needs to be located within reach of a wall outlet using the included power cable. WARNING: Do not place or mount the camera inside or on the edge of the crib to prevent the camera from falling on the baby or the baby pulling on the power cable. No matter the camera location, the camera can be adjusted for the perfect view of the baby. Masimo Corporation 11 www.masimo.com Stork Camera Meet the Stork System Installing the Stork Camera on a Wall Note: Ensure the power adapter is unplugged from the wall socket before installing the camera to the wall. 1. Plug the power cable into the bottom of the camera (A). Press the cable down to secure it in the built-in channel (B). 2. Place the camera on wall with the center of the mount (A) 4-5 feet above the crib mattress, near the center of the crib. Make sure it is level and the 4 hooks are facing up, then mark the locations of the screw holes. 3. Drill the 2 marked locations using a 1/4" (6.35 mm) drill bit. 4. Gently tap the two wall anchors into the holes until they are flush with the wall. 5. Hold the mounting plate against the wall. Secure the mounting plate onto the wall with the included screws. 6. Align the 4 holes on the camera base with the hooks on the mounting plate, and then slide the camera down to snap it in place. Masimo Corporation 12 www.masimo.com Stork Camera Meet the Stork System 7. Peel off the sticky pad liners on the back of the cable cover(s) to apply, starting at the camera. Add more covers as needed to fully protect the cable from being pulled on by the baby while in the crib. 8. Ensure the wall socket being used is within reach of the camera power cable. Plug the power cable into the 12W AC adapter. Plug the power adapter into the wall socket to power on the camera. The camera will automatically connect to the Stork app when powered on if previously connected. Adjust the camera angle as necessary for the best view. Masimo Corporation 13 www.masimo.com Stork Camera Meet the Stork System Step 3: View Live Data After setting everything up, open the Stork app to view the Live Dashboard. The Live Dashboard is also the Stork app home screen, with access to other app functions. Disclaimer: The app screens shown in this document might differ from the actual ones displayed in the app due to periodical app updates. 1 Side Menu - Displays the Side Menu with links to app functions and features. See Side Menu on page 17. 2 Notifications - Provides device, account, and environmental notifications. Notifications are available when an orange dot appears on the icon. Touch the icon to open the Notifications screen. See App Notifications - Vitals+. 3 Room Conditions - Displays the in-room temperature and humidity. 4 Camera Display - Displays the camera live view. Adjust the camera angle to get the best view of the baby. 5 Live Controls - Touch the screen and the Live Controls appear. See Live Controls on page 16. 6 Vitals Dashboard - When the Stork Sensor and Stork Boot are connected to the Stork System and attached to the baby's foot, the Vitals Dashboard displays the baby's health data. 7 Bottom Menu - Shortcuts to additional app functions and features. See Bottom Menu on page 19.
* For additional information about the Stork Sensor and Stork Boot and how to be able to track health data, go to www.MasimoStork.com. Masimo Corporation 14 www.masimo.com Stork Camera Advanced Use Advanced Use Notifications App Notifications Pop-Up Notifications Notifications appear on the Stork app screen for notifications related to the Stork Camera. In many cases, an notification also appears on the Stork Camera. Notifications Center Screen The Notification Center screen is accessed by touching the notifications icon on the app main screen. A dot on the icon the Notification Center screen. Touch a notification to view additional information and acknowledge. Any "next steps" to address the notification are also shown (when available). means there are notifications available. Touch the icon to open Ambient Temperature Notification - Room temperature levels high or low and when it returns to normal. Account Notification - Such as an incomplete baby profile or a shared user action item. Device Notification - If software updates are available for a device, a device goes off line, or the sensor battery is low. Acknowledge and Clear Notifications Pop-Up Notifications Touch the either button at the bottom of the screen to acknowledge the notification. Notifications Screen Individual Notifications - Touch the notification to acknowledge or swipe left on the notification and select the remove icon. All notifications - Select More in the upper right corner of the screen. Select Mark all as read to acknowledge all notifications or select Delete all to delete all notifications. Stork Camera Notifications Notifications are also communicated through the camera status light and speaker. Medium and high priority notifications are available. See Camera Status Light on page 28. When a low or medium priority notification is present, the camera status light flashes Yellow, and in some cases, an audible notification sounds. When a high priority notification is present, the camera status light flashes Red and an audible notification sounds. The app also shows pop-up notifications and some notifications appear on the Notifications screen. Masimo Corporation 15 www.masimo.com Stork Camera Advanced Use Examples of low/medium priority notifications:
The Stork Sensor battery is low (low priority notification) or depleted (medium priority notification). The Masimo Cloud server is disconnected from the Stork System. The ambient room temperature is too low. The ambient room humidity is too low. Examples of high priority notifications:
The Stork Sensor has come off or has been removed from the baby while measuring the baby's vitals. The Stork Sensor has disconnected from the system while measuring the baby's vitals. The ambient room temperature is too high. The ambient room humidity is too high. How to Silence and Acknowledge Notifications Touch the Dismiss button in the pop-up message on the app to acknowledge and silence the notification. Live Controls 1 Background Audio - Touch to toggle the sound from Stork between off to
"on with app open" or "on with another app displayed or phone locked". 2 Two Way Talk - Touch to toggle the Stork app microphone on or off
(shown as off). Microphone volume controls display on the screen above the Vitals Dashboard when on. 3 Lullaby - Touch to display the lullaby player. See Lullaby Player on page 17. 4 Snapshot - When selected, a photo button appears at the bottom of the live feed to take a picture. The picture is saved to the smart phone. Masimo Corporation 16 www.masimo.com Stork Camera Lullaby Player Lullaby music can be played over the Stork Camera speaker. 1 Volume Controls - Adjust the volume of the music playing on the camera speaker. 2 Play/Pause Button - Play or pause the music. Advanced Use Side Menu The Side Menu provides access to functions and features of Stork. Account - View and make changes to the account. Touching the name for the account (1) also opens the account. See Account Management on page 17. Baby Profile - View and make changes to the baby profile. Touching the baby's name (2) also opens the baby profile. See Baby Profile Management on page 18. Caregivers - Invite trusted people to view Stork health data. See Caregivers on page 18. Devices - View device status and info, add new devices or remove current devices. If an orange dot displays on the Devices icon, this indicates software updates are available for a device. See Device Management on page 18. Settings - Select the units of measurement. Help & Support - View information and tutorials about the app along with ways to contact customer service. Sign Out - Select to sign out of the Stork app. Masimo Corporation 17 www.masimo.com Stork Camera Advanced Use Account Management From the Account screen, the first and last name can be updated, a picture can be added, the password can be changed, or the account can be deleted. Baby Profile Management From the Baby Profile screen, the first and last name, biological sex, birthday, weight and length can be updated. Device Management The Devices screen displays all connected Stork devices and their current connection status. From this screen you can also view detailed connected device information, remove connected devices or add additional Stork devices from this screen. View information about the device - Select a device tile to view the following:
Device information Wireless information (Wi-Fi network can be changed from this screen) Tutorials for setting up and using the device. Remove the device. Update device firmware (when available). For the Stork Camera, make changes to the notifications for the ambient measurements (Room Settings). Add a Stork device - Select the add device "+" button at the bottom of the screen and select the Stork device to add. Follow the in-app instructions to add the device. Make sure you have the device you want to add with you for ease of adding to Stork. Remove a Stork device - Swipe left on the device and select the remove icon. Follow the in-
app instructions to remove the device. The device can also be removed from the Device Info screen. Caregivers Your baby's live health data as well as history health data can be shared with people you trust. From the Caregivers screen, select Add Caregiver and enter the email for who you want to be a caregiver. The caregiver can accept or reject the the email invitation. When the invitation is accepted, they will download the Stork app, and create an account to view the shared health data. Once complete, the shared data is viewed using the Sharing link in the Bottom Menu. See Bottom Menu on page 19. Masimo Corporation 18 www.masimo.com Stork Camera Advanced Use Remove caregiver access - Swipe left on the caregiver and select the remove icon. Cancel or resend an invitation - Swipe left on the invitation and select to cancel or resend the invitation. Private Mode can be enabled to stop sharing health data with caregivers at anytime, without revoking a caregivers access. See Live Controls on page 16. Bottom Menu The Bottom Menu provides access to the following functions and features of Stork:
1 Live - Displays the current data, room conditions and vitals. See Step 3: View Live Data on page 13. 2 History - Review history data recorded by Stork. See History on page 19. 3 Sharing - Access to view other Stork Systems that have been shared with you. See Sharing on page 20. Masimo Corporation 19 www.masimo.com Stork Camera History Advanced Use When History is selected, vitals history data displays. Up to 7 days (168 hours) of history can be recorded by Stork. 1 Camera View - Displays the recorded camera view and room temperature and humidity levels. 2 Refresh History Data - Touch to refresh to the latest recorded data. 3 Vitals Data History - Drag left or right to scrub through video recording. A play/pause button displays on the video when scrubbing through recording to play or pause the recording playback. Sharing When you have accepted to be a caregiver, downloaded the app and created a profile, the baby you have been granted access to appears when on the Sharing screen. Select the baby's name to see live health data as well as access history data. Reject invitation - Select Deny on the invitation from the Sharing screen. More than one baby - If you have been invited to be, or are the caregiver for more than one baby, invitations and other babies are shown on the Sharing screen. Stop being a Caregiver - Swipe left on the baby and select the remove icon. Note: Private Mode can be enabled by the person who invited you to be a caregiver to stop sharing health data at anytime, without revoking your caregiver access. Masimo Corporation 20 www.masimo.com Stork Camera Advanced Use How to Turn Stork On and Off Once the Stork System is connected to power during setup, and the sensor is charged, the system is on. The Stork Camera does not have an On/Off switch or controls to turn On or Off. To turn the system Off:
1. Unplug the camera power adapter from the wall socket. 2. Close the Stork app. Troubleshooting Stork Messages The following section lists possible messages, the potential cause, and next steps. Displayed Messages Potential Causes Next Steps
"No Internet Connection"
"Something unexpected happened. Please try again later."
The smart phone is not connected to a Wi-Fi network. The smart phone is not connected to a cellular network. System error. Ensure the smart phone is connected to a Wi-Fi or cellular network. Try again. If you still experience issues, please contact Masimo Customer Support. See Customer Support on page 32. Troubleshooting Stork The following section lists possible symptoms, the potential cause, and next steps. Symptom Potential Causes Next Steps Stork app does not communicate with Stork Camera Stork Camera is not powered Check that Stork Camera is plugged into the on. AC power supply. Smart phone is not in close proximity to Stork Camera. Bluetooth on the smart phone is not turned on and/or not correctly configured. Smart phone does not support Bluetooth Low Energy (BLE). Ensure the smart phone is in close proximity with Stork Camera. Ensure Bluetooth on the smart phone is turned on. Check smart phone compatibility. See Specifications on page 27. Update the smart phone software. Refer to the smart phone's Operator's Manual or Directions For Use. Contact Masimo Customer Support. See Customer Support on page 32. Masimo Corporation 21 www.masimo.com Stork Camera Appendix Symptom Potential Causes Next Steps Stork Camera does not connect to Wi-Fi or Masimo Cloud Stork Camera is not plugged Ensure Stork Camera is plugged in. in. Incorrect Wi-Fi network selected. Incorrect Wi-Fi password in entered. Wi-Fi network is not correctly configured. Masimo Cloud may be down. Ensure smart phone is connected to correct Wi-Fi network. See Stork Camera Setup on page 9. Ensure correct Wi-Fi network is selected. See Stork Camera Setup on page 9. Ensure correct Wi-Fi password is entered. See Stork Camera Setup on page 9. Check that the wireless features are correctly configured. Refer to the smart phone's Operator's Manual or Directions For Use. Check network settings and availability. You may need to call network provider for further assistance. Contact Masimo Customer Support. See Customer Support on page 32. Appendix Risks and Benefits The following information is provided to help you understand the risks and benefits of using Stork. Risks of Stork Because there are skin-contacting components, there is a risk of skin irritation, pressure injury, and general discomfort while a sensor is applied to a user. Periodically check the areas where the users skin contacts with the sensor to prevent potential issues. Benefits of Stork Stork is equipped with audible and visual physiological notifications that can notify you to changes in the users condition while monitoring within a home environment. Use of Pulse Oximeters and their Limitations Pulse oximeters provide blood oxygen, SpO2, based on how light shines through the foot. Accuracy of your SpO2 depends on how well the light through the foot is measured. Masimo Corporation 22 www.masimo.com Stork Camera Limitations Appendix Things that interfere with the light can affect your SpO2 accuracy. Some things can be controlled, while others need awareness. Controllable things:
Not wearing nail polish. Keeping feet dry and free of foreign objects. Not blocking the light through your foot. Avoiding direct exposure to bright lights, including direct sunlight. Keeping the foot still. Warming the baby's foot to improve circulation. Avoid use on same leg with blood pressure cuff inflated. Keep away from other electrical equipment that may cause readings to be affected
(e.g., microwaves, strong radio transmitters). Other things that require awareness:
Skin pigment or color. Skin or foot thickness. Foot deformities (e.g, severe club foot) Health conditions affecting how oxygen is carried in your blood (e.g., sickle cell, severe anemia). Poor blood circulation. Presence of blood components not able to carry oxygen (e.g., elevated carbon monoxide levels in your blood, recent tobacco use). Age and medical history. Safety Information Before using Stork, read the following safety information carefully. Always consult a physician if you have concerns about your baby's well-being. Call emergency services if you believe your baby is having a medical emergency. Do not rely on Stork for a clinical assessment. Stork is not intended to be used as a medical device or to replace a physician or health care professional. A clinical assessment of your baby should be done by a physician. Masimo Corporation 23 www.masimo.com Stork Camera Appendix Safety Use Information WARNING: For safe use, do not use any component of the Stork System if it appears damaged. WARNING: Do not adjust, repair, open, disassemble, or modify Stork. Such changes may lead to injury and/or incorrect readings. WARNING: Keep small parts away from small children and pets. Small items can be a choking hazard. WARNING: Carefully position the power cable to avoid possible strangulation or entanglement. WARNING: Secure the Stork Camera where it will not fall on anyone. WARNING: Do not place the Stork Camera in areas where there are a lot of flammable gases such as anesthetics, oxygen, or nitrous oxide present to prevent risk of fire. WARNING: In clinical settings, do not use Stork during magnetic resonance imaging (MRI) or in an MRI environment. WARNING: Remove the Stork Sensor before bathing to prevent damage. WARNING: During defibrillation, avoid contact with any devices applied to the person to prevent electric shock. WARNING: Avoid strapping the boot too tightly around the foot to avoid injury. WARNING: To avoid skin injury, consider alternating feet after it has been used for more than 12 hrs. CAUTION: Only use the AC power supply and cable included with your Stork Sensor to prevent damage to the device. CAUTION: Place the Stork Camera where you can easily disconnect it from AC power in case of an emergency. CAUTION: Only use the AC power supply and cable included with your Stork Camera to prevent damage to the device. Note: Do not monitor more than one person at a time with Stork. Performance Warnings General WARNING: Do not use the device as an apnea or as a sudden infant death syndrome
(SIDS) monitor. Oxygen changes may be delayed from when breathing actually stops. WARNING: Do not self-diagnose or self-medicate based on the measurements. Always consult your doctor. Masimo Corporation 24 www.masimo.com Stork Camera Appendix WARNING: Stork may be used during defibrillation. This may affect the accuracy or availability of the parameters and readings. WARNING: Stork is not intended for use during electrocautery. WARNING: Properly apply the Stork Sensor according to the instructions in this manual. Applying the Sensor incorrectly could result in incorrect or no readings. 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 patients condition. WARNING: Only use Masimo-approved parts with Stork to make sure the device works correctly. CAUTION: Avoid using Stork Sensor under bright light sources and direct sunlight to maintain the performance of the device. CAUTION: Keep the Stork Camera plugged in while in use. Loss of power may limit the notifications available. CAUTION: Do not connect the Stork Camera to an electrical outlet controlled by a wall switch or dimmer. Wireless WARNING: Only use Masimo authorized devices with Stork. Using unauthorized devices with Stork may result in damage to the device and/or patient injury. WARNING: When using with a smart phone, keep both devices within the recommended range of each other. See Specifications on page 27 for details. Moving outside of this range may cause a loss in connection. WARNING: Do not place anything on top of the Stork Camera to avoid damaging or blocking the wireless signal or muffling the audible notifications. WARNING: To ensure proper notification function, occasionally check for the following:
Notification features are turned on in the app and your smart phone (i.e., sounds, vibrations, etc.). Smart phone battery is fully charged or plugged in. Oxygen values are displayed on the app live view. WARNING: Move the devices away from sources that may interfere with Bluetooth connection. The presence of other devices that may create radio frequency interference (RFI). This may result in loss of Quality of Service. Devices that may cause RFI include but are not limited to the following: cell phones, laptops and tablets, pagers, Bluetooth devices, devices with remote controls, electrocautery equipment, diathermy equipment, and other baby monitors. Masimo Corporation 25 www.masimo.com Stork Camera Appendix CAUTION: Check that the Stork notifications 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. CAUTION: Check your system setup by viewing the display on the smartphone Stork application. The Stork app will provide an indication if there is a problem with the internet connection. CAUTION: To maintain Bluetooth connectivity with the Stork Sensor, ensure that the Stork Camera is within the specified distance and in line-of-sight of the Stork Sensor. See Specifications on page 27. CAUTION: Failure to charge Stork Sensor promptly after a Low Battery notification may result in the Sensor shutting down. Cybersecurity WARNING: If you expect your password or smart phone is compromised, reset your password to prevent unauthorized access to your data. CAUTION: To ensure security and prevent tampering of your smart phone, while using Stork:
Smart phone should be located with the responsible users. Unauthorized changes should not be made to the Stork system. Smart phone should not be left unattended. Security features on smart phone should be activated. Cleaning and Service WARNING: Do not attempt to remanufacture, recondition or recycle the Stork Camera to prevent harm or damage to the system. WARNING: Always turn off and unplug the Stork Camera before cleaning to prevent harm or damage to the device. CAUTION: Do not clean the Stork Camera with undiluted bleach, petroleum-based products, acetone, or other harsh solvents. Clean only with the solutions specified in this manual to prevent damage to the device. See Cleaning on page 32. CAUTION: Do not submerge Stork Camera in liquid or attempt to sterilize by any method to prevent damage to the device. Masimo Corporation 26 www.masimo.com Stork Camera Appendix Radio Compliance WARNING: Changes or modifications not approved by Masimo can void the users authority to operate the equipment. WARNING: The frequency bands of this device (2.4 GHz and 5.15 to 5.25 GHz) are only for indoor use in accordance with international telecommunication requirements. WARNING: 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 Stork, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. CAUTION: Disposal of product: Comply with local laws when disposing the device and/or its accessories. CAUTION: Do not place the Stork near electrical equipment that may affect the device, preventing it from working properly. CAUTION: Keep the Stork away from other electrical equipment that emit radio frequencies to minimize radio interference. Radio interference may result in no or inaccurate readings. Note: 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. Stork generates, uses, and can radiate radio frequency energy and may cause interference with radio communications. To determine if Stork interferes with radio or television reception, turn it off and see if the interference stops. To correct the interference, try the following:
Adjust or move the receivers antenna. Move the receiver farther away from Stork. Consult the dealer or a radio/TV technician for help. Plug the receiver and Stork into outlets on different circuits. Note: This device complies with part 15 of the FCC Rules and Industry Canadas license- exempt RSS standards. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. FCC Caution:
To assure continued compliance, any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate this equipment. Note: To satisfy RF exposure requirements, the Stork Camera and its antenna must operate with a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter. Note: Users are advised that high-power radars are allocated as primary users (i.e., priority users) of the bands 5250-5350 MHz and 5650-5850 MHz and that these radars could cause interference and/or damage to LE-LAN devices. Note: When using Stork consideration should be taken to local government frequency allocations and technical parameters to minimize the possibility of interference to/from other wireless devices. Note: Stork Camera has been tested to FCC 15 Subpart B. Masimo Corporation 27 www.masimo.com Stork Camera Appendix Specifications Stork App Measurement Display Range Measurement Display Range Unit of Measure Oxygen Level (SpO2) 0 to 100 Pulse Rate (PR) 25 to 240
bpm Temperature 77.0 to 109.4 (25.0 to 43.0) F (C) Ambient Temperature 59 to 113 (15 to 45) F (C) Ambient Humidity 10 to 100
Smart Phone Compatibility Item Specification*
Operating System Android 8.0 (Marshmallow) (minimum) iOS 15.0 (minimum)
* For complete specifications, refer to www.masimostork.com. Stork Camera Camera Status Light The indicator on the Stork Camera shows the connection and operational status. Color/Behavior What does it mean?
Slowly Blinking White The sensor is not actively monitoring. Solid White Blinking Green Slowly Blinking Blue Solid Blue Solid Yellow Blinking Yellow*
Solid Red Blinking Red*
Blinking Red in a pattern to indicate a numbered code The sensor is actively monitoring with a successful connection to the Masimo Cloud. The camera is ready for pairing to the smart phone/Stork app or to be connected to the wireless network. The camera software is currently updating. Readings from the sensor may be unavailable at this time. A Stork app user is actively listening through the hub. A low priority notification is active. A low or medium priority notification has been acknowledged. A medium priority notification is active. A high priority notification has been acknowledged and silenced. A high priority notification is active. A fault has been detected. Customer Support on page 32 Masimo Corporation 28 www.masimo.com Stork Camera Appendix
* An audible notification may also sound. Electrical Stork Camera AC Power Requirements 100 to 240 VAC, 50 to 60 Hz, 2.4A Power Consumption 12W Environmental Environmental Conditions Operating Temperature 41F to 95F (5C to 35C) Storage Temperature
-4F to 140F (-20C to 60C) Operating Humidity 10% to 95%, non-condensing Storage Humidity 10% to 95%, non-condensing Atmospheric Pressure 540 to 1060 mBar Physical Characteristics Stork Camera Dimensions 3.13 (L) x 3.13 (W) x 4.81 (H) (7.95 cm x 7.95 cm x 12.21 cm) Weight 0.70 lbs. (318g) Resolution 5 Megapixels Viewing Angle 130 degrees Rotation adjustment 254 degrees Tilt Adjustment 71 degrees Expected Service (Useful) Life Item Description Expected Service Life for Stork System Components 3 Years Masimo Corporation 29 www.masimo.com Stork Camera Appendix Compliance EMC Compliance FCC 15B, Class B (Emissions) Safety Standards Compliance IEC 62368-1 Equipment Classification per IEC 60601-1 Type of Protection Class II (AC Power) Mode of Operation Continuous Wireless Specifications Communication (Bluetooth) - Stork Camera Type Frequency Bluetooth LE 5.0 2402-2480 MHz Classification of Output Power Rating Conducted Max. Peak Output Power 4.28 dBm Output Power Type Modulation Types Modulation Signals Fixed at the Factory DH5, 2DH5, 3DH5 Analog and Digital Available Data Rates 1 Mbps Recommended Max. Range 100 ft (~30 meters) line-of-sight Communication (Wi-Fi) - Stork Camera Type Frequency WLAN Radio: IEEE 802.11 ac/a/b/g/n 802.11b/g/n(HT20): 2412-2462 MHz 802.11n(HT40): 2422-2452 MHz Classification of Output Power Rating Conducted Output Power Type Modulation Types Modulation Signals Available Data Rates Fixed at the Factory 802.11b: DSSS 802.11g: OFDM 802.11gn: OFDM 802.11a: OFDM 802.11an: OFDM 802.11ac: OFDM Analog and Digital 802.11b - 1, 2, 5.5, 11 Mbps. 802.11g - 6, 9, 12, 18, 24, 36, 48, 54 Mbps 802.11n- MCS0 MCS7 Masimo Corporation 30 www.masimo.com Stork Camera Appendix Security and Authentication - Stork Camera 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 - Stork Camera USA FCC ID: VKF-STORKC Canada IC: 7362A-STORKC Symbols The following symbols may appear on the product or product labeling:
Symbol Description Symbol Description Follow instructions for use Consult instructions for use Innovation, Science and Economic Development Canada (ISED) Separate collection for electrical and electronic equipment (WEEE) Federal Communications Commission
(FCC) Licensing ETL Intertek certification Identifies unit has been registered as a radio device MR Unsafe. Not appropriate for use in MR environment (i.e.: inside the MR magnet room) Non-Sterile Recyclable Product contains no PVC (polyvinyl chloride) material Not made with natural rubber latex Warning Caution Manufacturer Serial number Date of manufacture YYYY-MM-DD Catalog number (model number) Storage temperature range Masimo reference number Keep dry AC current Storage humidity limitation Do not use if package is damaged Atmospheric pressure limitation Wireless Symbol level Masimo Corporation 31 www.masimo.com Stork Camera Appendix 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% SpO2 against a laboratory co-oximeter.
[2] The Masimo SET Technology has been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark pigmented skin in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70%-100%
SpO2 against a laboratory co-oximeter.
[3] The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator with signal strengths as low as 0.02% for the simulated saturation range of 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 Masimos simulator with signal strengths of greater than 0.02%.
[5] The battery recharge time shall be no longer than 2 hours to reach 80% charge capacity at operating temperature of 25C (77F) ambient temperature and might not charge completely under elevated ambient temperature.
*Registered trademark of Fluke Biomedical Corporation, Everett, Washington. Service and Maintenance Cleaning The Stork Camera does not require cleaning with the exception of wiping the surface with a damp cloth. Customer Support For product support, along with troubleshooting for your Stork product, please go to the Stork Support page www.masimostork.com/en-us/support/contact-us.html. Masimo Corporation 32 www.masimo.com www.masimo.com 304200/LAB-11984A-0623