vi
DL-00035 Rev. 4
The VitalPoint Home Monitor is intended to be used as a clinical tool for remotely
monitoring a patient’s health status at home or in another healthcare facility.
The system is intended to guide patients through a set of scheduled activities
whereby medical data (vital signs, symptoms, and medication compliance) is
collected. The system is intended to transfer the collected data to a remote
site where it is stored and reviewed by a clinician. The system is also intended
to allow the clinician to modify the patient’s scheduled activities in response
to the collected medical data or other information available to the clinician.
The intent is to provide clinicians caring for patients outside the hospital with
a means for keeping track of how the patients are doing without the patients
having to come in for a checkup or requiring the clinician to go to the patients. It
provides periodic remote monitoring of the patients self-reported symptoms or
vital signs, including:
• Non-invasive blood pressure
• Oxygen saturation
• Pulse rate
• Temperature
• Weight
Intended Use
WARNING:
THE VITALPOINT HOME MONITOR IS NOT AN EMERGENCY RESPONSE
SYSTEM. THE DEVICE LABELING ADVISES PATIENTS TO CONTACT THEIR
CAREGIVER, NURSE, OR DOCTOR; CALL LOCAL EMERGENCY NUMBER
AS APPROPRIATE; OR GO TO THE EMERGENCY ROOM WHENEVER THEY
FEEL THE NEED TO DO SO. THE VITALPOINT HOME MONITOR DOES NOT
ANALYZE PATIENT INFORMATION, NOR DOES IT OFFER MEDICAL ADVICE.
• Blood glucose level
• Fluid status
• Prothrombin time
• Electrocardiogram (ECG) and heart
rate monitors
CONTRAINDICATION:
• USE OF THIS DEVICE IS CONTRAINDICATED IN APPLICATIONS REQUIRING
AUTOMATED ARRHYTHMIA DETECTION.
• THIS DEVICE IS NOT TO BE USED AS AN APNEA MONITOR.
• THIS DEVICE IS NOT TO BE USED IN AN MRI ENVIRONMENT.
• THIS DEVICE IS NOT TO BE USED IN AN OPERATING ROOM OR SURGICAL
ENVIRONMENT.
CONTRAINDICATIONS OVERVIEW
