Owlet Dream Sock User Manual
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Owlet Dream Sock User Manual

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Owlet
Dream Sock
®
User Manual
Owlet Baby Care, Inc.
Toll Free: + 1 (844) 334-5330
Available Monday-Friday 10am-8pm EST
Email:
contact@owletcare.com
Owlet will respond within 1-2 business days
Chat: owletcare.com/chat
Available Monday-Friday 10am-12am EST

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  • Page 1 Owlet Dream Sock ® User Manual Owlet Baby Care, Inc. Toll Free: + 1 (844) 334-5330 Available Monday-Friday 10am-8pm EST Email: contact@owletcare.com Owlet will respond within 1-2 business days Chat: owletcare.com/chat Available Monday-Friday 10am-12am EST...
  • Page 2 5.1 Finding a Home for the Base Station 5.2 Set Up the Owlet Dream App 5.3 Health Notifications Function 5.4 Using the Owlet Dream App and Dream Sock with Multiples 6. How to Use Dream Sock 6.1 Sock Size, Fit & Placement...
  • Page 3 6.4.1 Excessive motion 6.4.2 How to turn off Dream Sock 6.5 Charging the Sensor 6.6 When to Discontinue Use of Dream Sock 7. Using the Owlet Dream App 7.1 Monitoring Sleep with Dream Sock 7.2 Display of Live Pulse Rate and Oxygen Saturation Levels 7.2.1 Pulse Rate...
  • Page 4 8.2 When to Replace the Sock or Sensor 8.3 Cleaning the Base Station 9. Maintenance 9.1 Sensor Battery Maintenance 9.2 Base Station Battery Maintenance 9.3 Testing Notification Signal Generation 9.4 Turning the Sensor Off and On 9.5 Unpairing your Sensor 9.6 Pairing your Sensor 10.
  • Page 5 16.6 In-Home Performance Study Report Summary 17. Cybersecurity Information 17.1 Ensuring Secure Access 17.2 Service Unavailability 17.3 Detecting Cybersecurity Events 17.4 Keeping Your Device Up To Date 17.4.1 Owlet Dream App Updates 17.4.2 Firmware Updates 18. Biocompatibility 19. Symbols Glossary...

  • Page 6: General Information

    The Owlet Dream Sock is intended to assist caregivers in tracking their child’s well-being by monitoring sleep patterns, quality and duration of sleep. When enabled (in-home use on healthy infants only), the Owlet Dream Sock displays pulse rate (PR) and oxygen...
  • Page 7 ©Owlet Baby Care, Inc. 2023 Dream Sock®, Owlet™, and the Owlet logo are trademarks/service marks of Owlet Baby Care, Inc. iPhone® and the Apple logo are trademarks/service marks of Apple Inc. Google Play™, Android™, and the Google logo are trademarks/service marks of Google LLC.
  • Page 8 FDA (Food and Drug Administration) Base Station capillaries. The Food and Drug Administration is a US The part of Dream Sock that is the primary government agency that regulates certain food, alarming device and audible and visual Pulse Oximeter drug, cosmetic, and medical device products.

  • Page 9: Safety Information

    Alert of potentially hazardous situations which, if not avoided, may result in minor or moderate injury to the baby or the Caregiver, or damage to the equipment or other property. Provides important information about Dream Sock or a specific topic.
  • Page 10 WARNING: USE DREAM SOCK AS INDICATED AND REGULATED FOR USE. Components of this product may or may not be a regulated medical device, as determined by the FDA or other regulatory agencies. Dream Sock is not intended to diagnose, cure, treat, alleviate or prevent any disease or health condition.The display and notification of Oxygen Saturation and Pulse Rate is regulated by the FDA.
  • Page 11 TO PROPERLY USE OUR PRODUCTS AND FOR CARE OF THE CHILD: RESPOND PROMPTLY WHENEVER A NOTIFICATION IS PROVIDED. DREAM SOCK IS NOT A SUBSTITUTE FOR ADULT SUPERVISION OR SAFE SLEEP PRACTICES . Do not rely solely on the notifications to determine if your baby is safe.
  • Page 12 CAUTION. Keep the Sensor out of direct sunlight when in use to minimize interference that may affect performance. CAUTION. If there is more than one baby in the house using different Dream Sock systems, write the name of each baby on each Sock, Sensor and Base Station to avoid confusion.
  • Page 13 CAUTION. Even if the baby meets the Dream Sock age and weight requirements, discontinue use of Dream Sock if all Sock sizes are either too small or too large. CAUTION. Alternate Sock between the baby’s feet every 8 hours of use and also after recharging the Sensor. Check the child’s foot often for any signs of irritated skin.
  • Page 14 CAUTION. Improper Sock fit or care can lead to injury to the baby’s skin. CAUTION. If you log out of the Owlet Dream App, you will no longer receive push notifications on your mobile device. CAUTION. Do NOT use caustic or abrasive cleaning agents such as ammonia, bleach or alcohol. Harsh chemicals could damage the Sock or Sensor.

  • Page 15: Before First Use

    ● in-home monitoring. ● healthy babies 1-18 months of age and 6-30 lbs. ● use during baby’s sleep. Dream Sock is an over-the-counter medical device and is not intended to diagnose, cure, treat, alleviate or prevent any disease or health condition.

  • Page 16: Network Requirements

    3.5 Network Requirements A Wi-Fi network is required to use Dream Sock with the Owlet Dream App, as it allows the hardware to communicate information such as Sleep States, notifications, and battery status with the app and with cloud servers. The Owlet Dream App will not function properly if the Base Station is not able to connect to a reliable Wi-Fi network.
  • Page 17 The Sensor captures readings from the child’s foot to track Pulse Rate, Oxygen Saturation, movement and sleep. The Sensor connects and sends data to the Base Station, and the Base Station sends data to your mobile device via the Owlet Dream App. The App also provides tips and developmental insights.

  • Page 18: Unpacking The Box

    How the Owlet Dream App Works Connect to Wi-Fi: The Base Station sends information to the Owlet cloud via Wi-Fi, and displays this data in the Owlet DreamApp. This enables real-time readings and notifications in the App from anywhere. The Base Station will indicate whether or not the Sensor is connected to Wi-Fi.

  • Page 19: Base Station Overview

    4.3 Base Station Overview The Base Station is a central component of Dream Sock. It communicates with the Sensor to obtain data. The Base Station logs and monitors the baby’s data and determines when to send notifications. The Base Station also relays baby’s information to the Owlet...
  • Page 20 Base Station Features Sock/Sensor Light Indicates that the Base Station is communicating properly with the Sensor. Wi-Fi Light Indicates that the Base Station is connected to Wi-Fi. Base Station Button: Turn on/off Base Station (Long press top of Base Station) Silence/Resume audible notifications (Short, single press)
  • Page 21 Base Station Notification Indicators The Base Station notifies you with lights and sound to inform you of the baby’s status (See Section 6.3.2 for details on Notifications). WARNING! The Base Station is the main source of notifications. DO NOT rely on the mobile device for notifications. Always keep the Base Station in audible range.
  • Page 22 Sensor Features The Sensor has a dome-shaped body with the Owlet logo on it. Attached to the Sensor is a flexible fabric strip with the light emitters and detector. This flexible fabric portion curves around the baby’s foot, placing the light emitters opposite the detector.
  • Page 23 8-hour charge in just 20 minutes, and full 16-hour charge in only 90-minutes. It is recommended to charge the Sensor at least once a day when Dream Sock is being used ( see Section 6.5 Turning off the Sensor See Section 9.4...
  • Page 24 CAUTION. Always ensure that the Sock with Sensor is placed correctly on the baby’s foot. Poor Sock placement may affect performance. 5. How to Set Up Dream Sock 5.1 Finding a Home for the Base Station WARNING! The Base Station is the main source of notifications. DO NOT rely on the mobile device for notifications.
  • Page 25 The Base Station must be within range of your home Wi-Fi network. Once Dream Sock is set up, verify Base Station connection using the Wi-Fi light on the bottom of the Base Station or the Owlet Dream App. If the connection is unstable, move the Base Station until the connection is stable.
  • Page 26 ● See and modify the baby’s sleep history ● Track baby’s sleep quality *Requirements: Dream Sock requires access to a device with iOS 13.0 or later or Android™ 7.0 or later with the Owlet Dream App downloaded; minimum OS versions apply, see app stores for details.
  • Page 27 A 2.4 GHz wireless internet connection is required for live readings in the Owlet Dream App, remote access to the App, and some App features. Connect to Wi-Fi: The Base Station sends information to the Owlet cloud via Wi-Fi, and displays this data in the Owlet Dream App.
  • Page 28 WARNING: USE DREAM SOCK AS INDICATED AND REGULATED FOR USE. Components of this product may or may not be a regulated medical device, as determined by the FDA or other regulatory agencies. Dream Sock is not intended to diagnose, cure, treat, alleviate or prevent any disease or health condition.The display and notification of Oxygen Saturation and Pulse Rate is regulated by the FDA.
  • Page 29 ● Not for substituting safe sleep practices. When the Health Notifications function is enabled, Dream Sock allows Caregivers to view live health readings such as Pulse Rate and Oxygen Saturation values during a monitoring session, and notifies Caregivers via a high-priority notification if the baby’s Oxygen Saturation or Pulse Rate leave preset ranges.
  • Page 30 Notifications function disabled by default and it must be manually enabled. Dream Sock Health Notifications function can be enabled via the Sock settings in the Owlet Dream App. If the App detects the Health Notifications function is disabled, a banner is displayed on the Home Page confirming Health Notifications are disabled. Once in Sock settings, you can begin the process to enable the Health Notifications function by tapping the toggle button [to the “on”...
  • Page 31 5.4 Using the Owlet Dream App and Dream Sock with Multiples Owlet Dream App supports multiple child profiles and Owlet devices to allow you to monitor multiple children. Be sure to keep your Socks with Sensors and their assigned Base Stations separated by child to ensure there is no confusion in the event of a notification.
  • Page 32 Step 2: Choose a Starting Size Each Dream Sock Monitoring System includes 4 socks - 2 sizes for both left and right feet. Use the guide below to choose a starting Sock size based on the baby’s weight. If the starting Sock doesn’t fit properly, try different sizes based on actual fit.
  • Page 33 CAUTION. Regularly verify Sock fit. The baby’s actual foot size may differ from the guidelines above and babies grow quickly. Stop using Dream Sock when the baby reaches 30 lbs or outgrows the largest Sock. CAUTION. Even if the baby meets the age and weight requirements, if all Sock sizes are either too small or too large,...
  • Page 34 CAUTION. Dream Sock performance may be affected by foot deformities. Because foot deformities vary widely in nature and severity, we recommend that you consult your pediatrician before use on babies with foot deformities.
  • Page 35 Secure the fastener from the toe strap around the foot above the toes and then wrap the ankle strap around the back of the ankle and secure it to the top of the foot.. Do NOT stretch when fastening. Let the straps connect naturally without stretching. The Sock should lay flat against the skin without gaps between the Sock and the foot.
  • Page 36 CAUTION. Do NOT stretch the straps when fastening. Stretching straps will lead to over tightening and increased risk for skin irritation. CAUTION. Do NOT fasten the Sensor to the baby’s foot using anything other than the Sock. Injury to the baby’s foot may result.
  • Page 37 Protect Sensitive Parts ● Make sure the abrasive part of the straps is not touching the baby’s skin. ● The Sock should not extend over the toes. Check Sock Size Sock too small If either Sock strap fails to naturally reach the fastener, try a larger Sock size. Do NOT stretch the straps and cinch the Sock too tightly, or it might be uncomfortable for the baby and could result in injury to the baby’s skin.
  • Page 38 Check Straps Verify the straps are adjusted correctly. Do NOT overtighten. ● Straps should lay flat against the skin but not press into the skin. ● Do NOT stretch the straps when fastening - this leads to overtightening. CAUTION. Do NOT apply the Sock and Sensor too tightly. Too much pressure for long periods can cause a pressure injury. CAUTION.
  • Page 39 ● Discontinue use on the affected foot and apply the Sock only to the unaffected foot until irritation resolves completely. ● Contact Owlet customer support for one-on-one help with avoiding red marks. ● Inspect the skin under the Sock on the unaffected foot every 4 hours to ensure irritation does not recur.
  • Page 40 6.2 Base Station Status & Control...
  • Page 41 Base Station will indicate the highest priority active notification. Note: High Priority Notifications are for Pulse Rate and Oxygen Saturation and require separate activation of the Health Notifications function within the Owlet Dream App.
  • Page 42 6.3.1 Notification Color Reference Chart...
  • Page 43 220 bpm. The Oxygen notification will occur when the measured Oxygen Saturation goes below 80%. Note that if multiple conditions occur at the same time that would cause a High Priority Notification to occur, the Owlet Dream App will display all of the conditions triggering the notifications.
  • Page 44 During a Lavender Notification, the Base Station will flash lavender and play a tone, and you will receive a push notification in the Owlet Dream App. A Lavender Notification indicates the child has been moving excessively and for an extended period of time. They may need your help going back to sleep.

  • Page 45: Charging The Sensor

    We recommend that you charge the Sensor whenever you are not monitoring. Charge the Sensor by placing Sensor onto the Base Station. The Base Station pulses white when the Sensor is fully charged. Dream Sock uses convenient drop-and-go Sensor charging...
  • Page 46 Base Station. The most important information is shown at the top of the Home screen on the Owlet Dream App. Live Status will let you know if the child is asleep or awake, or if they need you. Sleep Session on the App home screen will show the total amount of sleep and number...
  • Page 47 Pulse Rates that require attention. These are High Priority Notifications. The Owlet Dream App will also display Oxygen Saturation and Pulse Rate readings so that Caregivers can check on the status of their child while the Sock and Sensor are worn and monitoring is on. This section is intended to help a Caregiver understand the information on Pulse Rate and Oxygen Saturation they see on the Owlet Dream App when the Health Notifications function is enabled.
  • Page 48 7.2.1 Pulse Rate Infant Pulse Rates are much faster than those of adults. There are ranges of Pulse Rates which are generally seen when infants are awake and relaxed, seen in the table below. Pulse Rates in Healthy Infants By Age* Typical Pulse Rate range - Awake Infant 0 to 3 months 123-164...
  • Page 49 After you set up Dream Sock and connect the App, it is good to get to know how the baby’s Pulse Rate normally behaves during routine activities. This will help you recognize anything that is significantly different from the baby’s normal range in the future.
  • Page 50 90%. Readings from Dream Sock should only be used as an estimate of blood Oxygen Saturation. After you set up Dream Sock and connect the Owlet Dream App, it is good to get to know the baby’s typical Oxygen Saturation levels.
  • Page 51 7.3 Sleep Status Indicators The sleep status on the Owlet Dream App home screen updates every minute to inform you of the status of the child during their sleep session. A sleep session graph will display data after 10 minutes of monitoring and real-time sleep session information is shown below.
  • Page 52 Under the History tab, tapping on any previously recorded sleep sessions will take you to the sleep details page for that session. A sleep session is defined as the start of the start of the monitoring session to the end. You will see data from Dream Sock for various metrics recorded during that session for the past 30 days.
  • Page 53 Measurements should be interpreted thoughtfully considering other signs, symptoms and health history, otherwise the measurement may be misleading. The Owlet Dream App has tooltips that can be used as a quick reference by tapping the help question mark. The History page...
  • Page 54 7.5.1.1 Oxygen Trends Once the Dream Sock Health Notification function has been activated, a graph is available showing a trend of 10-minute averages of Oxygen Saturation readings. The graph will also be presented with an average of the Oxygen Saturation levels measured through the session.
  • Page 55 If you observe a change in the child’s Oxygen Saturation patterns, it is recommended that you also check the child for any signs of illness, and any safety issues in the child’s sleep environment. You can also look at a live Oxygen Saturation reading in the Owlet Dream App to determine if there is still a change in Oxygen Saturation from the child’s typical levels.
  • Page 56 When the Base Station light is pulsing white, the Sensor is charging; when the Base Station light is static white, the Sensoris fully charged. Low Sensor Battery Notification...
  • Page 57 If your Sensor battery has less than 50 minutes of operation time you will be notified in the Owlet Dream App with a blue notification, and the Base Station will play a sound and light up blue. You can also view Sensor battery status at any time in the Sock status screen.
  • Page 58 8. Cleaning 8.1 Cleaning the Sock and Sensor Caring for your fabric Sock and Sensor will make it last longer and be more comfortable for the baby. We recommend washing the Sock and Sensor at least every week or more often when visibly soiled. 1.

  • Page 59: Maintenance

    CAUTION. Use cleaning solutions sparingly to avoid getting any liquid in the Base Station enclosure. 9. Maintenance Dream Sock contains no user-serviceable components, and no calibration is required. Routine maintenance includes: ● Inspecting the device for damage and cleanliness NOT use if the device appears damaged.
  • Page 60 Discontinue use and contact Customer Support if notifications do not function as intended. To test a Low Priority, Medium Priority, or Lavender Notification, go to the guide tab in the Owlet Dream App and tap on the “Health Notifications” article. There will be previews for each notification.
  • Page 61 9.4 Turning the Sensor Off and On Owlet recommends placing the Sensor on the Base Station when not in use to charge the Sensor and to keep it safe. The Sensor should only be turned off for cleaning and short-term or long-term storage.

  • Page 62: Storage And Disposal

    10. Storage and Disposal 10.1 Storage Care should be taken when placing Dream Sock into long-term storage to ensure Dream Sock continues to work properly. Follow the steps below when storing Dream Sock. See Section 16 for more information. Storage Instructions 1.

  • Page 63: Clear Personal Data

    10.2 Clear Personal Data You can delete your baby’s data or delete Dream Sock from your Owlet Dream App account. Deleting Dream Sock from your App account will not remove the baby profile and the baby profile will be able to be paired with a different Owlet device.
  • Page 64 1. Open the Owlet Dream App. 2. From the Home Screen click “Account.” 3. Under the My Owlet Devices section choose the device you would like to delete. 4. Scroll to the bottom of the device information screen and select “Remove Device.”...
  • Page 65 NOTE: If you do not hear beeps, wait 5 seconds and try from step 1 again. Factory Reset A factory reset is a complete software reset of Dream Sock hardware to its original settings by erasing all information stored on the device.

  • Page 66: Troubleshooting

    Already connected to Wi-Fi network. Check if the Wi-Fi light on the bottom of the Base Station is on. If so, you can skip this step and continue setting up your account in the Owlet Dream App. Cannot see your home Your home router is 5.0 GHz (Owlet only...
  • Page 67 Log out of the Dream App and login with the correct account. If you are unable to resolve the issue or to report unexpected operations or events, contact Owlet Customer Support. Refer to Section 18 of this manual for contact information.

  • Page 68: Electromagnetic Compatibility

    12.1 Electro-Magnetic Compatibility Dream Sock is intended for use in the electromagnetic environment of typical homes. The user of Dream Sock should assure that it is used in such an environment. Dream Sock contains BLE and Wi-Fi modules which intentionally transmit and receive RF electromagnetic energy in the 2.4 GHz frequency band.
  • Page 69 12.3 Immunity During the following testing Dream Sock continued to operate within specifications (including accuracy and alarm functionality) or show an error. It will alarm if the Base Station cannot communicate with the Sensor due to electromagnetic interference. Immunity Test...
  • Page 70 Conducted RF 3 Vrms 3 Vrms Dream Sock is suitable for the IEC 61000-4-6 6 Vrms in ISM and 6 Vrms in ISM and electromagnetic environment Amateur Radio Bands Amateur Radio Bands of typical homes, or commercial settings.

  • Page 71: Limited Warranty

    13. Warranty & Guarantee Information 13.1 Limited Warranty LIMITED WARRANTY We warrant that if you use our products as they are intended, our products will be free from defects in materials and workmanship for a period of 1 year from the date of set up for new products and 6 months for refurbished products. We do not warrant our products against general wear and tear or damage as a result of misuse, modifications or improper maintenance.

  • Page 72: Satisfaction Guarantee

    Chat: owletcare.com/chat Available Monday-Saturday 7 AM- 9 PM MST www.owletcare.com In the Owlet Dream App, go to Account > Help and Support to contact our Customer Support team via in-app chat, email and phone, or go to http://support.owletcare.com/ . For more tips view the Guide tab in the App.

  • Page 73: Technical Information

    15. Technical Information 15.1 Peak Wavelengths and Maximum Optical Output of Power The peak infrared LED wavelength shall fall within 924nm to 937nm at time of manufacture. The peak red LED wavelength shall remain within 649nm to 657nm at time of manufacture. This information may be useful to clinicians. The below are the maximum optical output of power of the Sensor emitters: Blue emitter: 20mW Green emitter: 11mW...
  • Page 74 Alarm Alarm Condition Alarm Condition Delay High Priority Oxygen has dropped below the Low Oxygen Threshold (80% SpO2) 10 seconds Pulse Rate has fallen below the Low Pulse Rate Threshold (50 bpm) 10 seconds Pulse Rate has exceeded the High Pulse Rate Threshold (220 bpm) 10 seconds Medium Priority Sensor is disconnected from the base station for 60 seconds...

  • Page 75: Equipment Classification

    ● Powders, creams, or lotions applied to the baby’s foot may cause skin irritation and trouble getting data. ● Electrical equipment that emits radio frequencies may interfere with the performance and accuracy of Dream Sock. Refer to Section 12 for further details.
  • Page 76 Degree of protection against electric Type BF Applied Part (Sensor) shock IP22 Liquid Ingress Protection Rating of Base Indicates the device is protected against: Station 1) solid foreign objects of 12.5 mm and greater, and 2) water ingress of vertically falling water drops when the device is tilted up to 15°...

  • Page 77: Theory Of Operation

    16. Theory of Operation 16.1 Pulse Oximeter Theory Dream Sock measures functional Oxygen Saturation of arterial Hemoglobin (SpO2) and Pulse Rate. Pulse oximetry measurements are based on two physiological principles: ● The differences in optical absorbance properties between oxyhemoglobin (HbO2, oxygenated blood) and deoxyhemoglobin (Hb, non-oxygenated blood) ●...
  • Page 78 As described above, the light absorption properties of Hemoglobin vary with wavelength. The Pulse Oximeter technology used in Dream Sock requires no ongoing calibration because the specified wavelengths used in the LED light sources have been selected to be within the calibration range required for the measurement.
  • Page 79 16.5 Clinical SpO2 Accuracy Study Report Summary Dream Sock has been clinically evaluated for SpO2 accuracy in 18 healthy adult volunteers providing informed consent within an institutionally approved clinical study protocol per the method of ISO 80601-2-61:2011 Part 201.12.1.101.2. The demographics of subjects included 9 males and 9 females (age: 22-37 yrs., weight: 106-194 lbs., height:59-73”, BMI: 19-28).
  • Page 80 ± 2.22 % Arms 90% to 100% ± 2.46 % Arms ± 2.63 % Arms Results of the clinical study demonstrate Dream Sock meets established criteria for SpO2 accuracy (in non-motion conditions) for the range 70% to 100% SaO2 per the referenced standards.
  • Page 81 Pooled results from eighteen subjects showing error between Dream Sock readings and Co-Oximeter blood gas measurements, under no motion conditions. Upper and lower 95% limits of agreement (LOA) are shown.

  • Page 82: Cybersecurity Information

    16.6 In-Home Performance Study Report Summary Owlet conducted a prospective study in 35 infants between 1 and 18 months of age wherein the accuracy of Dream Sock was evaluated relative to an FDA-cleared pulse oximetry device. 71.4% of the study subjects were male. The mean weight of subjects was 17.2 lbs with a range of 9.5 to 26 lbs.

  • Page 83: Keeping Your Device Up To Date

    17.3 Detecting Cybersecurity Events Cybersecurity is a priority at Owlet. We have a team that is dedicated to ensuring the continued security of our products and services. Our products have logging enabled so that we can investigate suspected issues. If you suspect an issue, please contact us: https://support.owletcare.com/hc/en-us/categories/360003108872...
  • Page 84 17.4.2 Firmware Updates Owlet will periodically release updated firmware for your Dream Sock. When a new version of firmware is released by Owlet, your Base Station and/or Sensor will automatically be updated with the new firmware. When your firmware is updating, the status in the Owlet Dream App will indicate ‘Update in Progress’.

  • Page 85: Symbols Glossary

    The materials that come into contact with the infant/child have undergone extensive biocompatibility testing and comply with ISO 10993-1, ISO 10993-5, ISO 10993-10 and ISO 10993-23. Dream Sock is not made with natural latex rubber or DEHP plasticizers. No additional precautionary measures for infants, children, pregnant or nursing mothers are required for contact with the materials of Sock 4.
  • Page 86 Lot Reference – Indicates the manufacturer’s batch or lot code. Do not use if the package is damaged or opened. Keep Dry - Indicates a medical device that needs to be protected from moisture. Temperature Limit - Indicates the temperature limits to which the medical device can be safely exposed.
  • Page 87 Mandatory action: Follow instructions for use. Single Patient – multiple use Indicates the device is protected against: IP22 1) solid foreign objects of 12 mm and greater, and 2) water ingress of vertically falling water drops when the device is tilted up to 15° IP35 Indicates the device is protected against: 1) solid foreign objects of 2.5 mm and greater, and...
  • Page 88 Caution - Precautions alert of potentially hazardous situations which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property. Note - Provides important information about the product or on a specific topic. UDI (Unique Device Identifier) (01) GTIN (11) Expiration Date...
  • Page 89 Strangulation Warning - Always keep the base station at least 1 meter away from your baby’s crib because the cord can pose a strangulation hazard. Recycle Polyethylene terephthalate, also called PET, is the name of a type of clear, strong, lightweight and 100% recyclable plastic.
  • Page 90 Unique Device Identifier - a numeric or alphanumeric code unique to the device. IFU-SSV3OTC Rev. 13.0...

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