Delphi II DL-00035 manual Intended Use, Contraindications Overview

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Intended Use

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

•Blood glucose level

•Fluid status

•Prothrombin time

•Electrocardiogram (ECG) and heart rate monitors

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.

CONTRAINDICATIONS OVERVIEW

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.

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Contents Delphi Medical Systems VitalPoint Home Monitor Patient Guide Manufactured by DL-00035 Rev Classification Explanation of Packaging and Labeling Symbols Intended Use Contraindications OverviewVersion Precaution General InformationDL-00035 Rev DL-00035 Rev Precautions Overview Xii DL-00035 Rev Precaution Contents Introduction Monitor Features and Controls DL-00035 Rev Before YOU GET Started Dimming FeaturePower Supply Choosing a Location for the MonitorMonitor Setup Phone ConnectionImportant Reminders For Help Operating the VitalPoint Home Monitor Selecting OptionsMain Menu Screen 10 DL-00035 Rev Reporting Symptoms 12 DL-00035 Rev Taking Measurements ECGMeasuring Blood Pressure Measuring Temperature Measuring Pulse OximetryMeasuring Blood Glucose Measuring Prothrombin TimeMeasuring Fluid Status Measuring Weight Do not step onto the scale yetMeasuring ECG Medication Reminder Viewing NURSE’S Instructions Viewing Setup Options 22 DL-00035 Rev Concluding Activities 24 DL-00035 Rev Trademarks DisclaimerDelphi Medical Systems
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