User Manual
LBL-xxxx Page 3
Proteus Two-part Patch Technical description Effective: xxXXX2016
The pod measures heart rate, activity, body angle relative to gravity (body position) and the time of
ingestible sensor detection. The pod is connected with a mobile device via Bluetooth®, using a mobile
application (app), such as Proteus Discover.
Your app will prompt you when it is time to change your patch strip. Always refer to your app when
changing your strip to ensure your patch is put together correctly and connected with your mobile
device.
The patch can be worn at anytime and during all your regular activities, including showering,
exercising and on airplanes. However, after putting on a new patch avoid showering or exercising
vigorously for a few hours to allow the patch to stick properly. How long it takes for a patch to stick
varies from person to person. If your patch doesn’t stick well wait a few hours longer when applying a
new patch. Before placing, ensure the area of the skin is free of hair, dry, and healthy. Do not apply
lotion before applying a new patch.
The patch can also measure ambient temperature. It is not intended to be used as a thermometer to
measure human body temperature, and should not be used to diagnose medical conditions.
5. Cautions And Warnings
Caution: Federal (U.S.A) law restricts this device to sale by or on the order of a physician.
General
Take the ingestible sensor pill with a sufficient amount of water.
Check the component expiration dates before use.
Keep components out of reach of children.
Do not store components in extremely hot, cold, humid or bright conditions.
Do not use as sole basis for medication treatment decisions. Detection accuracy is less than
100%. Patients instructed by a physician to take an Ingestible Sensor with medication may
selectively adhere to one or the other. Therefore, Ingestible Sensor data should be interpreted
with caution. Physicians should discuss medication-taking history with patients prior to making
medication changes.
Proteus Digital Health makes no warranty for any data or information that is collected
erroneously by the ingestible sensor and/or patch, or misuse or malfunction as a result of
abuse, accidents, alteration, misuse, neglect, or failure to maintain the products as instructed.
Users of the ingestible sensor and/or patch who experience clinical worsening or new clinical
symptoms should seek medical attention. Healthcare providers should exercise their clinical
judgment in interpreting and using any data from ingestible sensor and/or patch for clinical
decision-making.
Heart rate data may not be accurate for patients with pacemakers
Ingestible sensor pill
Do not chew.
Do not tamper with or place in water before ingestion.
Do not exceed 30 ingestions per day.
Two-part patch