Proteus Digital Health Inc. 01913 Manuale Utente

Customer support

Phone:   +1 855.255.5858 
Email:   helpdesk@proteus-support.com

CAUTION 
Federal (USA) law restricts this device to sale by or on 
the order of a physician.

Cautions

General
•  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
•  Take the ingestible sensor pill with a sufficient 

amount of water.

•  DO NOT chew.
•  DO NOT tamper with or place in water before 

ingestion.

•  DO NOT exceed 30 ingestions per day.

Patch
•  DO NOT continue use until further instructed by a 

physician if your skin is irritated, inflamed, or red 
around the disposable adhesive strip.

•   DO NOT place in locations where your skin is 

scraped, cracked, inflamed or irritated.

•  DO NOT place in a location that overlaps the area of 

the most recently removed strip.

•  DO NOT use if you are allergic to adhesive tape.
•  DO NOT drop or bump with excessive force.
•  DO NOT use to diagnose heart-related conditions.
•  DO NOT wear during magnetic resonance imaging 

(MRI), cautery and external defibrillation procedures.

•  DO NOT dispose of strips with household waste
•  DO NOT throw out the pod: keep it for use with your 

next strip

•  Pod may pose a choking hazard to children under 3 

years of age.

•  Patch does not contain medication.
•  The device contains no serviceable parts or 

components

•  Replace the strip about once per week or as 

prompted by mobile app.

•  Warning: No modification of this equipment is 

allowed. Modifying the Proteus Patch may cause a 
safety hazard for the user.

Additional information

For more detailed technical information, please visit:  
www.proteus.com/instructions

Problem 

The green light does 
not appear when the 
pod is placed in the 
strip.

Confirm that the pod and strip 
are put together correctly. If 
the green light still does not 
appear, replace the strip. If the 
green light still does not appear, 
contact Customer Support.

You have misplaced  
your pod.

If you cannot find your pod, 
contact Customer Support.

Problem 

You have visible skin 
changes, e.g. rash 
or blistering, around 
the strip.

Remove your patch from your 
torso, remove the pod from the 
strip, and set pod aside. Seek 
medical attention. Do not use 
another patch until told to do so 
by your healthcare provider.

Problem 

Your patch is itchy or 
uncomfortable  
(no visible skin 
changes).

Solution 

Remove your patch from your 
torso, remove the pod from the 
strip, place the pod into a new 
strip, and attach the new patch to 
your torso in a new location.

Problem 

Your patch no 
longer sticks to 
your skin.

Solution 

Remove the pod from the strip, 
place the pod into a new strip, 
and place the new patch on your 
body. The “Patch” section on the 
left-hand side of this document 
contains further information.

Problem 

The pill gets wet or 
damaged.

Do not take. Swallow a 
replacement pill if provided

Patch specifications

Coin Cell

Approximately 7 days

Original package under 

normal room temperature 

and humidity.

IP27 (Water resistant to 

3.3 feet or 1 meter)

Internally powered 

medical equipment

Type BF Applied Part

Continuous

•  This product complies with ISO 10993-1-2009,  

ISO 10993-5-2009, and ISO 01993-10-2010

•  This product complies with IEC 60601-1-2005,  

IEC 60601-1-2-2014, IEC 60601-1-11-2010

•  This device has no essential performance

•  This product complies with RoHS

•  The pod and strip do not contain natural latex rubber

Ingestible sensor pill

The ingestible sensor pill contains a tiny ingestible 
sensor made out of ingredients found in dietary 
supplements. The ingestible sensor sends a signal to 
the patch after it reaches your stomach.

Indications for use 

The Proteus® Digital Health Feedback Device consists 
of a miniaturized, wearable sensor (Proteus Patch) for 
ambulatory recording of physiological and behavioral 
metrics such as heart rate, activity, body angle relative 
to gravity (body position), and time-stamped patient 
logged events, including events signaled by the co-
incidence with, or co-ingestion with, the ingestible 
sensor accessory. When the ingestible sensor is 
ingested, the Proteus Digital Health Feedback Device 
is intended to log, track and trend intake times. When 
co-ingested with medication, the tracking and trending 
of intake times may be used as an aid to measure 
medication adherence. The Proteus Digital Health 
Feedback Device may be used in any instance where 
quantifiable analysis of event associated physiological 
and behavioral metrics is desirable, and enables 
unattended data collection for clinical and research 
applications.

Safety and performance 

The ingestible sensor was extensively tested in clinical 
studies. Overall, 492 volunteers (Age range 21–85, 
Mean: 44.6) participated in the wearable sensor 
studies representing 6,407 wearable sensor-use days. 
During these studies, 412 of these volunteers also 
took ingestible sensors representing 5,656 ingestion 
days (total of 20,993 ingestible sensor ingestions). 
No serious adverse events were observed in these 
clinical studies. Adverse events that occurred in ≥ 1% 
of study subjects are detailed as follows. Sixty-one 
(12.4%) of the study subjects experienced self-limited 
skin rashes localized at the site of wearable sensor 
placement. In the ingestion studies, four subjects 
(1.0%) reported nausea/vomiting which were possibly 
related to the ingestible sensor. In comparison with 
direct observation, the ingestible sensor was detected 
in 97.3% of ingestions, with 100% correct identification. 
In other words, one out of every 37 sensors may not be 
detected due to reasons other than non-adherence.

Troubleshooting 

If you experience difficulties in operating your patches or 
sample ingestible sensors, refer to the troubleshooting 
tables below or contact customer support.

Your patch is made up of a pod and disposable strip. 
The pod can be used for weeks or months at a time. 
It captures and sends information to your mobile 
application (app). The disposable strip is changed 
weekly. It sticks to the skin on your torso and contains a 
small battery that powers the pod.

Your patch measures heart rate, activity, body position, 
and when an ingestible sensor is detected. When taken 
with an ingestible sensor, you can see the pattern and 
regularity of how you take your medications. You can 
also see your sleep patterns by analyzing activity and 
body position over time. You can use your app to view 
your data and keep track of how you are doing.

Your patch can also measure ambient temperature. 
It is not intended to be used to measure human body 
temperature, and should not be used to diagnose 
medical conditions.

The data collected are securely transferred and then 
stored in Proteus’ databases. 

Your patch can be worn during most activities, including 
showering, exercising and on airplanes. However, after 
putting on a new strip avoid showering or exercising 
vigorously for a few hours to allow the strip to stick 
properly. How long it takes for a strip to stick varies 
from person to person. If your strip doesn’t stick well 
the first time wait a few hours longer when applying 
your next one. Before placing a strip on your body, 
ensure the area of the skin is free of hair, dry, and 
healthy. Do not apply lotion before applying a new strip. 
Clean your pod using household soap and water. You 
can rinse your pod under running water.

Strip disposal

Your strip contains the batteries that power the patch.
Dispose of your used strip in a sanitary fashion, and 
in the same way as you would household batteries or 
electronics (please check local electronic waste  
disposal standards). Do not throw out the pod. Keep the 
pod for reuse.

 Proteus Digital Health, Inc.  

2600 Bridge Parkway  
Redwood City, CA 94065, USA 
T +1-650-632-4031

 MedPass International Ltd. 

Windsor House 
Bretforton, Evesham 
Worcestershire, WR11 7JJ, UK

 
 

 

  
LBL-0XXX, Rev X, DDMMMYYYY

Instructions for Use

0086

Patch

Equipment symbols

 

Batch code

 

Serial number

 

Catalog number

 

European Authorized Representative

 Manufacturer
 

Read instructions before use

 

Type BF applied part

 

Emits radio waves

 

Single use only

 

Temperature range

 

Humidity range

 

Atmospheric Pressure range

 

Use by YYYY-MM-DD

 

Do not dispose with household waste

 

Ingress Protection rating of IP27

   

General warning

The patch needs special precautions regarding EMC 
and needs to be installed and put into service according 
to the EMC information provided in this document.

WARNING: Portable and mobile RF communications 
equipment can affect the Patch. Portable and mobile F 
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 
Patch. Otherwise, degradation of the performance of 
the Patch could result.