Masimo SafetyNet Opioid™
IMPORTANT – PLEASE READ CAREFULLY
When you click the “I ACCEPT” button below or when you download, install, or use the Masimo SafetyNet Opioid mobile application (the “App”), or when you use the System, or any part of the System or service, you are agreeing to be legally bound by these terms and conditions. You will also be legally bound to any third party terms and conditions that apply to your use of the System, including any applicable third party licenses.
How the System Works
The System can detect if your oxygen saturation (“O2”) levels drop below certain limits. Low O2 levels for too long a period are a serious risk for anyone taking opioids. They may reflect a more serious condition of opioid-induced respiratory depression. The System can be set up to notify you and people that you designate when your levels drop below these limits (“Emergency Contacts”). Emergency Contacts might include your family members, friends, or caregivers. The System can also be set up to contact emergency medical services first responders, such as police, ambulances and paramedics (“EMS”) to come to your aid in more extreme cases when your O2 levels drop below certain limits.
The System consists of a wrist-strapped Bluetooth® chip (“Chip”) , a fingertip sensor (“Sensor”), and a base station that captures O2 levels from the sensor (the “Bedside Station”) (the Chip, the Sensor and the Bedside Station, collectively the “Device”) and the App which displays O2 levels . The System is used in conjunction with your supported mobile device to communicate with a network of servers that stores and analyzes your data, and triggers notifications based on how you set up the System. Please read all the information that comes with the Device packaging and inside the App. This includes the user manual and all product inserts. These materials contain instructions on how to use the System, its limitations, and important safety information.
The System is a medical device and monitoring system. It is meant to be used in addition to, and not as a replacement for, other steps and safety measures to consider while taking opioids. These include following the directions of your health care professional. Not using the System correctly could result in the System not providing an accurate O2 measurement or any measurement at all. It could also mean you, your Emergency Contacts, and EMS may not be notified as to your condition. This could result in severe bodily injury or death.
Masimo does not guarantee that 1) the System will operate error-free; 2) you are able to use it properly; (3) Wi-Fi and Internet connections are always available and working; or (4) the System is fail-safe or foolproof. It is important to understand there are limitations with using any medical device. You must take reasonable precautions in addition to using the System.
Before using the System, you must read and agree to all of the following:
Risk of System Failure. The System requires the Sensor and Chip to be connected wirelessly to the Bedside Station using Bluetooth®. The Bedside Station needs to be connected to a power outlet and be actively connected to Wi-Fi with working Internet access. If there is a loss of power to the Bedside Station, or if the wireless connection between the Sensor/Chip to the Bedside Station or Bedside Station to the Internet is lost, the System will not operate properly. These possible failures (among others) are why you should not rely solely on the System and have other ways of monitoring and reacting to changes in your O2 levels. As further detailed in Section 6 below (Disclaimer of Warranties), you agree not to rely solely on the System. You also assume the risk that the System may fail.
Emergency Contact Permission and Failure to Designate Emergency Contacts and Set Up EMS Notifications. You have the option in the App to provide contact information for Emergency Contacts to be sent notifications if your O2 levels fall too low for too long. As further detailed in Section 2 below (User Requirements), you agree that, (i) you have permission from the Emergency Contact to use this information, (ii) the Emergency Contact has agreed to receive the notifications and to respond to them, (iii) the contact information for the Emergency Contact is accurate and up to date, and (iv) you trust the Emergency Contact with the information contained in the notifications. Masimo does not assume responsibility for any action or failure to act by any Emergency Contact you choose to notify. Masimo expressly disclaims this responsibility. Further, the System features that send notifications to your Emergency Contacts and/or EMS require you to actively opt in to these features and take steps to set them up in the App. If you do not opt in to these features and take these steps, no one will be contacted to come to your aid if your O2 levels drop too low for too long and only you will be responsible for seeking help.
Emergency Response Costs. If you set up the System to send an notification to EMS, you are solely responsible for any costs involved with their aid. These costs may be significant and may not be covered by your health insurance plan (if any). You assume these costs even if the emergency situation has been resolved by the time they arrive or if the notification is a false alarm.
Responder Mistakes. The System only contacts your Emergency Contacts and/or EMS based on how you set up the System. Masimo cannot control and is not responsible for their actions or failures to act. Masimo cannot and does not guarantee that they will respond in a timely manner or at all.
No Medical Advice. As further detailed in Section 6 below (Disclaimer of Warranties), Masimo does not offer any medical, clinical or diagnostic information, advice, or opinions as part of the System. The System will not remind you to take any medication, and it is not a substitute for medical care from a health care professional. Before using the System, you should consult with your health care professional. Make sure you understand how the System works, its limitations, and what other procedures and precautions you should take in addition to the System.
Geographic Limitations. The System will only work in the United States.