Delphi Medical Systems VitalPoint Home Monitor Patient Guide
Manufactured by: Delphi Medical Systems 5725 Delphi Drive Troy, Michigan 48098-2815 U.S.A. CE0086 The information in this document is subject to change without notice. This document contains proprietary information that is protected by copyright. No part of this document may be reproduced in any manner, in whole or in part (except for brief excerpts in reviews and scientific papers), without the prior written consent of Delphi Medical Systems.
The ringer equivalence number (REN) is used to determine the number of devices that may be connected to a telephone line. Excessive RENs on a telephone line may result in the devices not ringing in response to an incoming call. In most, but not all, areas the sum of RENs should not exceed five (5). To be certain of the number of devices that may be connected to a line, as determined by the total RENs, contact the local telephone company.
Classification This equipment is ETL listed. This equipment is classified as: • Class II • Type CF • IPX0 • Continuous operation iv DL-00035 Rev.
Explanation of Packaging and Labeling Symbols For indoor use only Caution, consult accompanying documents (month/year) Manufacture date (mm/yyyy) Do not use if package damaged Direct current power input, 15 V, 600 milliamperes Serial number Catalog number only U.S. federal law restricts this device to sale by or on the order of a physician On Off Class II device This end up Fragile/breakable Atmospheric pressure limitation 0.3 bar to 1.
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 VitalPoint Home Monitor can also be configured to remind the patient to take medications at certain times of the day as well as to take requested vital signs measurements. The VitalPoint Home Monitor is set up for a specific patient’s needs by a clinician. While the VitalPoint Home Monitor is intended for use in adult and pediatric patients, the user interface is tailored for an adult operator. The VitalPoint Home Monitor is not intended for use on neonatal patients.
General Information This user manual provides information for users of the VitalPoint Home Monitor. For the sake of brevity, the terms “VitalPoint,” “monitor,” or “device” are sometimes used in this document to refer to the VitalPoint Home Monitor. IMPORTANT Users should read this entire patient guide before operating the VitalPoint Home Monitor. Failure to do so could result in personal injury and/or death.
Warnings and Precautions WARNINGS OVERVIEW CRITICAL! EXPLOSION HAZARD. DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS. DO NOT INCINERATE UNIT. WARNING: 1. PACEMAKER PATIENTS: RATE METERS MAY CONTINUE TO COUNT THE PACEMAKER RATE DURING OCCURRENCES OF CARDIAC ARREST OR SOME ARRHYTHMIAS. DO NOT RELY ENTIRELY UPON RATE METER ALARMS. 2. THE VITALPOINT HOME MONITOR IS NOT AN EMERGENCY RESPONSE SYSTEM.
WARNING: • IN SOME CASES, FREQUENT AND PROLONGED MEASUREMENTS CAN RESULT IN PETECHIA, ISCHEMIA, PURPURA, OR NEUROPATHY. CHECK THE CUFF SITE REGULARLY WHEN TAKING FREQUENT MEASUREMENTS OVER AN EXTENDED TIME PERIOD. ALSO CHECK FOR ANY SIGNS OF RESTRICTED CIRCULATION IN THE EXTREMITIES OF THE LIMB WHERE THE NBP CUFF IS WRAPPED. • BE SURE THE NON-INVASIVE BLOOD PRESSURE HOSE IS NOT BLOCKED OR KINKED DURING A MEASUREMENT.
PRECAUTIONS OVERVIEW PRECAUTION: 1. .S. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE U ORDER OF A PHYSICIAN. 2. THE VITALPOINT HOME MONITOR IS NOT INTENDED TO BE A PRIMARY SOURCE OF MEDICAL INFORMATION. CONTACT CLINICIAN WITH QUESTIONS. 3. FOR CONTINUED OPERATION, ALWAYS CONNECT THE MONITOR TO A WALL OUTLET. FAILURE TO DO THIS CAN LEAD TO AN INTERRUPTION OF MONITORING. 4. THERE ARE NO USER-SERVICEABLE PARTS IN THIS DEVICE. 5.
PRECAUTION: • TO OBTAIN ACCURATE BLOOD PRESSURE READINGS, KEEP THE LIMB AND THE CUFF AS STILL AS POSSIBLE. • NON-INVASIVE BLOOD PRESSURE MEASUREMENTS MAY NOT BE ACCURATE IF THE PATIENT IS CONVULSIVE, EXPERIENCING TREMORS, OR IS DEFIBRILLATED DURING THE MEASUREMENT. 10. PULSE OXIMETRY PRECAUTIONS: • READ INSTRUCTIONS PROVIDED WITH THE PULSE OXIMETRY SENSOR TO UNDERSTAND THE BEST APPLICATION TECHNIQUE AND ALL RELEVANT SAFETY INFORMATION.
PRECAUTION: 13. ECG/RESPIRATION PRECAUTIONS: • LINE ISOLATION MONITOR TRANSIENTS MAY RESEMBLE ACTUAL CARDIAC WAVEFORMS AND THUS INHIBIT HEART RATE ALARMS. TO AVOID THE RISK OF THIS HAPPENING, FOLLOW THE DIRECTIONS FOR PROPER ELECTRODE PLACEMENTS, AND KEEP THE ECG LEAD WIRES AWAY FROM SOURCES OF LINE NOISE. • TO AVOID LARGE OFFSET POTENTIALS DUE TO POLARIZATION OF ELECTRODES, BE SURE TO USE ONLY ELECTRODE TYPES SPECIFIED FOR THIS DEVICE, AND BE SURE THAT ALL ELECTRODES USED ARE OF THE SAME TYPE. 14.
Contents Classification Explanation of Packaging and Labeling Symbols Intended Use Contraindications Overview General Information Warnings and Precautions Warnings Overview Precautions Overview Introduction Monitor Features and Controls Before You Get Started Choosing a Location for the Monitor Turning the Monitor On Dimming Feature Power Supply Phone Connection Monitor Setup Important Reminders For Help Operating the VitalPoint Home Monitor Selecting Options Main Menu Screen Reporti
Introduction Thank you for using the VitalPoint Home Monitor. The monitor allows your clinician to monitor your status while you are at home or in another healthcare facility. The monitor collects vital signs and other information from you and sends it to your clinician over a phone line.
Monitor Features and Controls Power on indicator LED; “on” when lit Main screen (dims after 5 minutes) Power switch Battery charging indicator LED; power connected and battery charging when lit Serial number Catalog number Service access CAUTION: Do not remove; for qualified service personnel only Phone jack receptacle Reserved for future use 2 DL-00035 Rev.
Pulse oximeter receptacle (SpO2) Blood pressure receptacle (NBP) Electrocardiogram receptacle (ECG) Temperature probe receptacle (TEMP) Fluid status monitor receptacle (1) Glucose meter receptacle (2) Weight scale receptacle (3) Power receptacle USB port for Delphi approved accessories only Reserved for future use Phone jack receptacle DL-00035 Rev.
BEFORE YOU GET STARTED Some important things to note before using the VitalPoint Home Monitor: Choosing a Location for the Monitor Work with your clinician to identify a convenient location for the monitor. The VitalPoint Home Monitor should be placed in a location that is: • Near a power outlet and a phone jack. • Flat and stable. A tabletop is a good choice. • Away from common areas.
Phone Connection The monitor should remain connected to a phone line at all times. Connect the phone line by plugging one end into the receptacle on the right-hand side of the monitor and the other into a wall phone jack. The monitor will need to use the phone line for brief periods during the day to send any reported data to your clinician. While dialing, the following message will appear on the monitor: “Sending Data Now. This may take a few minutes.
IMPORTANT REMINDERS: • Do not use a monitor or any accessory that shows any sign of damage. • Use only approved accessories with the monitor. • The monitor is intended for indoor use only. The monitor should not be exposed to liquids. • Contact your clinician immediately if the device stops working or you can no longer hear sounds when activities are due. • The monitor should be left on at all times. You should always be able to see the screen. If not, contact your clinician right away.
FOR HELP Your clinician should have gone over the basic use of the monitor with you. Also refer to any printed or written information you received from your home health nurse, pharmacist, or physician with respect to your ongoing care. This patient guide will assist you with basic operation of the VitalPoint Home Monitor. Your clinician can make other necessary adjustments, such as volume control, if necessary. WARNING: THE VITALPOINT HOME MONITOR IS NOT AN EMERGENCY RESPONSE SYSTEM.
Operating the VitalPoint Home Monitor IMPORTANT: The monitor should remain on at all times. Please work with your clinician to set the volume at a comfortable level for the voice and alert prompts. SELECTING OPTIONS The VitalPoint Home Monitor operates by displaying options on the screen. A voice prompt also reads each option. To select an option, simply press the button on the screen with your finger. Some screens allow for only one response (for example, yes or no questions).
In other cases, you may select more than one answer. Each button you press will be highlighted. Press all answers that apply, and press “Continue” to move on. Note: At any time, you may press “Go Back” to review the previous menu screen, or “Main Menu” to return to the Main Menu screen. MAIN MENU SCREEN The Main Menu displays a personal greeting and lets you know if there are activities to do right away: To begin activities, press “Begin Activities” and follow the instructions on the screen.
Or if activities are scheduled for later: These activities are programmed by your clinician for your care. These activities can include: • Taking measurements • Medication reminders • Nurse’s instructions (may include nurse’s questions and predefined answers) It is very important that you complete all activities when requested.
REPORTING SYMPTOMS When you press “Report Symptoms,” the monitor will remind you this is not an emergency response system: Press “Continue” to report symptoms. The monitor allows you to report symptoms related to: • Breathing • Swelling • Heart • Stomach/bowel • Urine • Wound • Pain • General For each problem you choose to report, the monitor will display a series of questions. Answer each to move on to the next screen. DL-00035 Rev.
Sub-problems in only one problem category can be reported at a time, but you will be able to report additional problems when the current problem category is complete. At that time, the monitor will ask you if there are more problems to report: • If you have more, answer “Yes”; you will be returned to the “Choose a Problem to Report” screen. • If you are finished, answer “No”; you will be taken to the “Confirm Problems” screen.
TAKING MEASUREMENTS When “Take Measurements” is pressed from the Main Menu, the monitor will allow you to measure: • Blood pressure • Pulse oximetry • Temperature • Prothrombin time • Fluid status • Blood glucose • Weight • ECG For each selection, the monitor will display detailed instructions on how to take each measurement. You should be familiar with the operation and use of the vital signs accessories attached to your monitor.
Measuring Blood Pressure The monitor will display the following instructions to apply the cuff and take a blood pressure measurement: 1. Sit down in a chair next to the monitor. 2. Roll up the sleeve on your arm or remove any tight clothing. (Use left arm if able.) 3. Slide the cuff onto your arm. 4. Make sure that the bottom edge of the cuff is 1” (2.5 cm) above the crease of your elbow. 5. Make sure that the tubing is on the inside of your elbow. 6.
Measuring Pulse Oximetry The monitor will display the following instructions to apply the pulse oximetry sensor and take a pulse oximetry measurement: 1. Place the finger sensor on your middle or index finger. If the blood pressure cuff is also in use, do not apply the finger sensor and blood pressure cuff to the same arm. 2. Fit the sensor as shown on the screen. When ready, press “Take Measurement” and remain still until the measurement is complete.
Measuring Blood Glucose PRECAUTION: FOLLOW THE MANUFACTURER’S INSTRUCTIONS FOR USE WHEN USING A GLUCOSE METER AND STRIPS. The monitor will ask you if you wish to use the LifeScan OneTouch® Ultra® Blood Glucose Meter that came with the monitor, or if you want to enter your blood glucose level manually. To use the OneTouch® Ultra® meter, connect the meter to the appropriate cable on the monitor and follow the instructions on the screen.
Measuring Fluid Status PRECAUTION: FOLLOW THE MANUFACTURER’S INSTRUCTIONS FOR USE WHEN USING A FLUID STATUS MONITOR. To use the fluid status monitor, connect the monitor to receptacle 1 on the back of the VitalPoint monitorand follow the instructions on the screen. The VitalPoint monitor will display the following instructions to take a fluid status measurement: 1. Snap the new electrodes to the cable. 2.
Measuring Weight Position the scale close to the monitor. The monitor will display the following instructions to take a weight measurement: 1. Make sure you are wearing no clothing or similar light clothing and your shoes are removed. 2. Make sure your bladder is empty. 3. Do not step onto the scale yet. It is very important that there is no weight on the scale when the weight sequence is started. This allows the scale to re-zero itself and become prepared to take your weight.
MEDICATION REMINDER PRECAUTION: YOU SHOULD NOT RELY SOLELY ON THE MONITOR REGARDING WHEN TO TAKE YOUR MEDICATIONS. YOU SHOULD CONSULT YOUR PHYSICIAN BEFORE TAKING ANY PRESCRIPTION OR NONPRESCRIPTION MEDICATION OR CHANGING ANY MEDICATION REGIMENS. VITALPOINT IS INTENDED AS A REMINDER SYSTEM ONLY. Information about medication, dose, frequency, and any instructions for taking the medication will be displayed on the monitor. You will be asked if you took your medication.
The monitor will alert you that your clinician will be informed of the problem. Press “Continue” to advance to the next activity, if one is scheduled. The monitor will return to the Main Menu if no additional activities are scheduled. VIEWING NURSE’S INSTRUCTIONS Nurse’s instructions are available through the Main Menu. Nurse’s instructions may also be displayed after all other activities are completed. Press “Main Menu” to return to the Main Menu. 20 DL-00035 Rev.
VIEWING SETUP OPTIONS To change the speaker volume or initiate a connection with the Central Server, press “Setup” on the Main Menu. To adjust the speaker volume, press “Setup.” When the next screen is displayed, press “Set Speaker Volume.” DL-00035 Rev.
Press the appropriate button, depending on whether you want to increase or decrease the current volume (which is highlighted in yellow) of the voice prompt. Press “Go Back” if you would like to return to the Main Menu. Press “Continue” if you would like to adjust the alarm volume. To initiate a connection with the Central Server from the setup menu, press “Dial Central Server Now.” This allows you to test the connection or upload data immediately. 22 DL-00035 Rev.
Concluding Activities When all activities for a session are complete, or you have completed taking measurements or have reported symptoms, the monitor will send the data to your clinician. While doing so, it displays: Do not use your phone until the monitor indicates: “Confirmation. Monitor successfully communicated with the Central Server!” IMPORTANT: If you attempt to use your phone while the monitor is uploading data, you will not hear a dial tone. If you need to use your phone immediately (e.g.
If the phone line is in use, or there is an issue with the phone connection, the monitor will display: The monitor will continue to try to dial the Central Server until communication is successful. If communication is not successful, you will receive a final message: “Monitor has not been able to communicate with the Central Server for a long time. Please contact your clinician for help.” Contact your clinician right away. 24 DL-00035 Rev.
Trademarks VitalPoint is a trademark of Delphi Corporation. All other trademarks are the property of their respective owners. Disclaimer The information in this document has been carefully examined and is believed to be reliable. Furthermore, Delphi Medical Systems reserves the right to make changes to any products herein to improve readability, function, or design.
VITALPOINT MONITOR DE SINAIS VITAIS Importado por: Delphi Automotive Systems do Brasil Ltda CNPJ: 00.857.758/0001-40 Av. Goiás, 1820/1860 – Santa Paula – São Caetano do Sul - SP Fone: +55(11)4234 9500 e-mail: delphi@delphi.com.br website: www.delphi.com.br Fabricado por: Delphi Medical Systems 5725 Delphi Drive Troy, Michigan 48098-2815 U.S.A. Fone: +1(888)526 1426 e-mail: medical@delphi.com www.delphi.
