MC10 BioStamp nPoint - Important Safety Information; Indications for Use; Contraindications; Warnings

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BioStamp nPoint User Manual
Important Safety Information
Indications for Use
The BioStamp nPoint system is a wireless remote monitoring system intended
for use by researchers and healthcare professionals for continuous collection
of physiological data in home and healthcare settings. These physiological
data include heart rate, heart rate variability, respiration rate, activity
(including step count and activity classication), and posture (body position
relative to gravity). The system is also intended for measurement of surface
electromyography and to monitor limb or body movements during daily
living and sleep. Data is transmitted wirelessly from the Sensors for storage
and analysis.
The device is intended for use on general care patients who are 18 years of
age or older as a general patient monitor to provide physiological
information. The data from the BioStamp nPoint system is intended for use
by researchers and healthcare professionals for research applications or, at
the discretion of a qualied healthcare professional, as an aid to diagnosis and
treatment. The device is not intended for use on critical care patients.
Contraindications
The device is not intended for use on:
• patients who have implanted pacemakers or debrillators
• patients with known allergies or hypersensitivities to adhesives or
hydrogel
Warnings
• The wearable sensor may cause mild discomfort, skin irritation, redness,
itching, rash or contact dermatitis in some individuals. The device should
be removed if any pain or discomfort occurs.
• Histories of skin irritations should be considered prior to placing the
wearable sensor on a patient
• The wearable sensor should not be applied to broken, damaged, or
• irritated skin.
• The wearable sensor should be removed prior to external debrillation or
an MRI scan and should not be used in the presence of strong
• electromagnetic elds.
• Keep Link Hub components, tablet, and mobile devices away from water
and other liquids.
• No modication of this equipment is allowed.
• Clinical validation has not been performed on children or on patients
who are pregnant or breastfeeding.