label version: 1.3
effective: 2023.05.25
last updated: 2023.06.07
The following digital labels are provided in lieu of printed labels attached to a physical product.
***
all.health Algo SaMD™ oximeter
Product Description
The all.health Algo SaMD™ oximeter is a pulse oximeter configured to operate in Software as a Medical Device (“SaMD”). The software device is intended to run remotely for use as an optional service component of a complete all.health ICM™ system, a non-medical-device (exempt) clinical decision support system.
The software device:
• collects input from compatible remote hardware sensor bands or other sensors;
• filters, analyzes, and validates the collected data; and,
• produces a clinical-grade pulse measurement of heart rate (HRp), respiration rate (RRp), and blood oxygen (SpO2%) for output, including outlier rejection, averages, trends, and ranges over time for the purpose of remote patient monitoring.
Medical Device Information
• This oximeter is a Class II (enforcement discretion) medical device.
• Rx Only. Federal law (USA) restricts this product to sale by or on the order of a licensed practitioner.
• UDI: [00860010157008](https://accessgudid.nlm.nih.gov/devices/00860010157008).
Name, Model, Version, and Type
• Short Name: Algo SaMD™ oximeter
• Long Name: all.health Algo SaMD™ oximeter
• Model: 1000
• Version: see Settings/About section of the patient app or provider portal.
• Type: Oximeter, wellness.
Warnings
• This device is NOT INTENDED FOR EMERGENCY RESPONSE, critical care, or urgent care use.
• This device is not real-time, Displayed measurements are typically delayed at least five minutes, and trended measurements and notifications can be delayed by hours.
• This device is for remote use. Data must be transmitted prior to collection and analysis.
• There are no alarms generated by this product.
• There are no alerts generated by this product.
• It is the patient’s responsibility to contact a qualified healthcare provider or to call 911 or the appropriate emergency response number for health emergencies or urgent concerns.
Cautions
• Patients and providers should verify unexpected readings with another device.
• Clinical correlation between a patient’s condition and displayed results is recommended.
• Review the factors that can degrade any pulse oximeter’s accuracy in the IFU.
Notes |
• This device is an optional component of a complete all.health ICM™ system. This device is not sold separately.
• This device collects data from compatible sensors, including the optional Band 01™sensor.
• This device collects sensor data sent to the cloud from the all.health app.
• Patients should wear or use any optional sensors or sensor bands as directed by their provider, including regular charging, cleaning, and updates.
• Patients can view their own results on the all.health app.
• Providers can view a patient’s results using the all.health portal.
• For more information, see below.
For more Information
• See Instructions for Use (IFU) in the Setting/About section of the patient app or provider portal.
• See FAQ / Troubleshooting in the Settings/About section of the patient app or provider portal.
• Visit us on the web at [www.all.health](https://www.all.health).
Product Support or Contact Us
• Connect directly to a customer support agent in the patient app or provider portal.
• Email us at <info@all.health>
• Visit us on the web at [www.all.health]
• Call us at 1.415.689.3018
• all.health, Inc.
• 200 Kansas St, Suite 205, San Francisco CA 94103
• w: [www.all.health]
• e: <info@all.health>
• t: 1.415.689.3018
• all.health, Inc.
• 200 Kansas St, Suite 205, San Francisco CA 94103
• w: [www.all.health](https://www.all.health)
• e: <info@all.health>
• t: 1.415.689.3018
[END OF SUBSTITUTE LABELING]