Delphi DL-00035 User's Manual

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.
Delphi Medical Systems makes no warranty of any kind on this material, including but not limited to, the implied warranties of merchantability and fitness for
a
particular purpose. Delphi Medical Systems shall not be liable for errors contained herein or for incidental or consequential damages concerning the furnishing,
performance, or use of this material.
Before using any Delphi Medical Systems product, be sure to read carefully and
understand all manuals provided with the product.
Delphi Medical Systems Remote Device Connectivity complies with the U.S.
Health Insurance Portability and Accountability Act (HIPAA) protecting the security
and privacy of health data. It is recommended that the healthcare facility ensures
that patients complete all necessary paperwork so that the facility complies with
the HIPAA requirements.
This equipment complies with Part 68 of the U.S. Federal Communications
Commission (FCC) rules and the requirements adopted by the American Council
for Terminal Attachments (ACTA). On the back of the Delphi Medical Systems
VitalPoint™ Home Monitor is a label that contains, among other information, a
product identifier in the format US:AAAEQ##TXXXX. If requested, this number
must be provided to the telephone company.
The Universal Services Ordering Code (USOC) jack used to connect the VitalPoint
Home Monitor to the premises’ wiring and telephone network must comply with
the applicable FCC Part 68 rules and requirements adopted by the ACTA.
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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. For products approved after July 23, 2002,
the REN is part of the product identifier that has the format US:AAAEQ##TXXXX.
The digits represented by ## are the REN without a decimal point (i.e., 03 is a REN
of 0.3). For earlier products, the REN is separately shown on the label.
If this VitalPoint Home Monitor causes harm to the telephone network, the
telephone company will notify you in advance that temporary discontinuance of
service may be required. But if advance notice isn’t practical, the telephone company will notify the customer as soon as possible. Also, you will be advised of your
right to file a complaint with the FCC if you believe it’s necessary.
The telephone company may make changes in its facilities, equipment, operations,
or procedures that could affect the operation of the VitalPoint Home Monitor. If this
happens, the telephone company will provide advance notice in order for you to
make necessary modifications to maintain uninterrupted service.
Connection to party line service is subject to state tariffs (U.S.). Contact the state
public utility commission, public service commission, or corporation commission
for information.
If installed in a home with specially wired alarm equipment connected to the
telephone line, ensure the installation of the VitalPoint Home Monitor does not
disable the alarm equipment. If you have questions about what will disable alarm
equipment, consult the telephone company or qualified installer.
Electrical safety advisory: Parties responsible for equipment requiring AC power
should consider including an advisory notice in their customer information suggesting the customer use a surge arrestor. Telephone companies report that electrical
surges, typically lightning transients, are very destructive to customer terminal
equipment connected to AC power sources. This has been identified as a major
nationwide problem.
DL-00035 Rev. 4
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Classification
This equipment is ETL listed.
This equipment is classified as:
• Class II
• Type CF
• IPX0
• Continuous operation
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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 1.0 bar
Storage temperature limitation -4°F to 122°F (-20°C to 50°C)
Humidity limitation 10% to 95%
IPX0
Ordinary protection
Type CF
DL-00035 Rev. 4
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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
• Blood glucose level
• Oxygen saturation
• Fluid status
• Pulse rate
• Prothrombin time
• Temperature
• Electrocardiogram (ECG) and heart rate monitors
• Weight
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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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.
Version
Please refer to this patient guide for instructions on warnings, precautions, and
additional information. Printed in U.S.A.
DL-00035 Rev. 4
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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.
If you have questions about the information in this patient guide or about the
safe operation of this system, contact your clinician.
TYPOGRAPHICAL CONVENTIONS IN THIS USER MANUAL
This guide contains warnings, precautions, and notes to help call your attention to the most important safety and operational aspects of the system. To
help identify these items when they occur in the text, they are shown using
the following typographical conventions:
WARNING:
STATEMENTS THAT DESCRIBE SERIOUS ADVERSE REACTIONS AND
POTENTIAL SAFETY HAZARDS.
PRECAUTION:
STATEMENTS THAT CALL ATTENTION TO INFORMATION REGARDING
ANY SPECIAL CARE TO BE EXERCISED BY THE PRACTITIONER AND/OR
PATIENT FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE.
IMPORTANT:
Statements that call attention to additional significant information about the
device or a procedure.
Note: Statements that provide supplemental information.
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DL-00035 Rev. 4
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. 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.
3. DO NOT USE THE MONITOR NEAR SOURCES OF LIQUIDS SUCH AS
SINKS, SHOWERS, OR BATHTUBS.
4. UNPLUG THE MONITOR BEFORE CLEANING. DO NOT SPRAY CLEANERS
INTO THE RECEPTACLES.
5. DO NOT USE A MONITOR OR ANY ACCESSORY THAT SHOWS ANY
SIGN OF DAMAGE.
6. DO NOT USE THE MONITOR IF THE MAIN MENU SCREEN IS NOT
DISPLAYED PROPERLY WHILE CONNECTED TO AC POWER.
7. DEVICE INTERCONNECTIONS: THROUGH ITS OMD (OTHER MEDICAL
DEVICE) PORT, THE VITALPOINT HOME MONITOR CAN BE CONNECTED
TO EXTERNAL DEVICES. THE MONITOR SHOULD NOT BE CONNECTED
TO DEVICES THAT ARE NOT DESCRIBED IN THIS MANUAL.
8. THE VITALPOINT HOME MONITOR CONTAINS A LITHIUM-ION
BATTERY. ONLY TRAINED SERVICE PERSONNEL SHOULD REMOVE OR
CHANGE THE BATTERY.
9. NON-INVASIVE BLOOD PRESSURE WARNINGS:
• THE NON-INVASIVE BLOOD PRESSURE (NBP) CUFF SHOULD BE AT
THE SAME LEVEL AS THE PATIENT’S HEART. IF THE NBP CUFF
CANNOT BE PLACED AT THIS LEVEL, ADD TO MEASURED
PRESSURE VALUES 1.4 mmHg FOR EACH 2 cm ABOVE HEART LEVEL,
OR SUBTRACT 1.4 mmHg FOR EACH 2 cm BELOW HEART LEVEL.
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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. A BLOCKED
OR KINKED HOSE COULD LEAD TO EXCESSIVE PRESSURE IN
THE BLOOD PRESSURE CUFF, WHICH COULD CAUSE LIMB DAMAGE.
IN THE EVENT THE CUFF NEEDS TO BE STOPPED DURING OPERATION
DUE TO AN ERROR CREATED BY A BLOCKED OR KINKED HOSE,
THE CUFF SHOULD BE REMOVED FROM THE ARM BY RELEASING
THE VELCRO® STRAP OR PULLING/CUTTING THE HOSE OFF OF THE
CONNECTOR.
10. PULSE OXIMETRY WARNINGS:
• REPOSITION THE PULSE OXIMETRY SENSOR AT LEAST EVERY 4
HOURS (2 HOURS FOR POORLY PERFUSED PATIENTS). MOVE THE
SENSOR IF YOU SEE ANY SIGNS OF SKIN IRRITATION OR IMPAIRED
CIRCULATION.
• ELEVATED LEVELS OF CARBOXYHEMOGLOBIN OR METHEMOGLOBIN
IN MONITORED PATIENTS CAN RESULT IN INACCURATE PULSE
OXIMETRY READINGS.
• A PULSE OXIMETER SHOULD BE CONSIDERED AS AN
EARLY WARNING DEVICE. AS A TREND TOWARD PATIENT
DEOXYGENATION IS INDICATED, BLOOD SAMPLES SHOULD BE
ANALYZED BY A LABORATORY CO-OXIMETER.
11. PROBES AND CABLES ARE DESIGNED FOR USE WITH SPECIFIC MONITORS. VERIFY COMPATIBILITY AND USE ONLY APPROVED ACCESSORIES WITH VITALPOINT. USING NON-APPROVED ACCESSORIES MAY RESULT IN DEGRADED PERFORMANCE, DAMAGE TO THE MONITORING EQUIPMENT, OR IN HARM TO THE PATIENT, AND MAY VOID WARRANTY COVERAGE.
12. TO AVOID AN ELECTRICAL SHOCK HAZARD, THE CONDUCTIVE
PART OF THE ELECTRODES SHOULD NOT BE ALLOWED TO COME IN
CONTACT WITH OTHER CONDUCTIVE OBJECTS, INCLUDING EARTH.
13. DO NOT INTRODUCE ANY ADDITIONAL PATIENT CONNECTION
THAT MAY PRODUCE ELECTRICAL CURRENT. VITALPOINT APPLIES
APPROXIMATELY 2 MICROAMPERES (2 µA).
14.ACCESSORIES SHOULD BE DISPOSED OF ACCORDING TO THE MANUFACTURER’S INSTRUCTIONS ON PACKAGING.
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PRECAUTIONS OVERVIEW
PRECAUTION:
1. U
.S. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE
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. PORTABLE AND MOBILE RADIO-FREQUENCY (RF) COMMUNICATIONS
EQUIPMENT CAN AFFECT THE VITALPOINT HOME MONITOR. IF
THE VITALPOINT HOME MONITOR DOES NOT APPEAR TO BE
WORKING NORMALLY, TRY TO RELOCATE OR REORIENT THE
VITALPOINT HOME MONITOR.
6. USE OF ACCESSORIES NOT APPROVED FOR USE WITH THE VITALPOINT HOME MONITOR MAY RESULT IN INCREASED EMISSIONS OR DECREASED IMMUNITY OF THE VITALPOINT HOME MONITOR. REFER TO THE APPROVED ACCESSORIES LIST FOR THE VITALPOINT HOME MONITOR.
7. THE VITALPOINT HOME MONITOR SHOULD NOT BE USED ADJACENT
TO OR STACKED WITH OTHER EQUIPMENT; AND THAT IF ADJACENT
OR STACKED USE IS NECESSARY, THE VITALPOINT HOME MONITOR
SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION.
8. THESE CHEMICALS MAY DAMAGE THE MONITOR’S FRONT PANEL:
ACETALDEHYDE, ACETONE, AMMONIA, BENZENE, HYDROXYTOLUENE,
METHYLENE CHLORIDE, OR OZONE. DO NOT USE THOSE CHEMICALS
OR CLEANSERS CONTAINING N-ALKYLDIMETHYLBENZYLAMMONIUM
CHLORIDE.
9. NON-INVASIVE BLOOD PRESSURE PRECAUTIONS:
• DO NOT APPLY THE NON-INVASIVE BLOOD PRESSURE CUFF ON
THE SAME LIMB AS THE SpO2 SENSOR. DURING BLOOD PRESSURE
MEASUREMENTS, THE PERFUSION IS TEMPORARILY REDUCED,
WHICH CAN RESULT IN INACCURATE PULSE OXIMETRY READINGS.
• DO NOT ALLOW THE NON-INVASIVE BLOOD PRESSURE CUFF OR
HOSE TO COME IN CONTACT WITH FLUIDS. IF THIS OCCURS,
ALLOW TO DRY THOROUGHLY BEFORE USE. CHECK THE HOSE
AND CUFF FREQUENTLY FOR SIGNS OF DAMAGE OR DEBRIS. AN
OBSTRUCTION IN THE HOSE MAY INTERFERE WITH INFLATION AND
DEFLATION, RESULTING IN INACCURATE NON-INVASIVE BLOOD
PRESSURE READINGS.
DL-00035 Rev. 4
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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.
• DO NOT APPLY THE PULSE OXIMETRY SENSOR ON THE SAME LIMB
AS THE NON-INVASIVE BLOOD PRESSURE CUFF. DURING BLOOD
PRESSURE MEASUREMENTS, THE PERFUSION IS TEMPORARILY
REDUCED, WHICH CAN RESULT IN INACCURATE PULSE OXIMETRY
READINGS.
• BRIGHT LIGHT CAN CREATE PROBLEMS WITH THE PULSE OXIMETRY
MEASUREMENTS, RESULTING IN INACCURATE PULSE OXIMETRY
READINGS. IF THE SENSOR IS IN A PLACE WHERE IT MAY BE
EXPOSED TO BRIGHT LIGHT, COVER THE SENSOR WITH SOME
OPAQUE MATERIAL TO BLOCK THE LIGHT.
• PULSE OXIMETRY READINGS MAY BE INACCURATE IN THE PRESENCE
OF TOO MUCH MOTION OR IF THE PATIENT HAS TREMORS. IF
QUESTIONABLE READINGS ARE OBTAINED, RE-CHECK THE VITAL
SIGNS BY ALTERNATE MEANS BEFORE TAKING MEDICATION.
11. SHOULD THE AC ADAPTER’S GREEN LIGHT NOT REMAIN ON WHILE
PLUGGED INTO AN AC OUTLET, REPORT THE PROBLEM TO YOUR
CLINICIAN AND DISCONTINUE MONITOR USE UNTIL THE PROBLEM
CAN BE IDENTIFIED AND CORRECTED.
12. YOU SHOULD NOT RELY SOLELY ON THE MONITOR REGARDING
WHEN TO TAKE 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.
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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. FOLLOW THE MANUFACTURER’S INSTRUCTIONS FOR USE WHEN
USING A GLUCOSE METER AND STRIPS.
15. FOLLOW THE MANUFACTURER’S INSTRUCTIONS FOR USE WHEN
USING A FLUID STATUS MONITOR.
16. FOLLOW THE MANUFACTURER’S INSTRUCTIONS FOR USE WHEN
USING A PROTHROMBIN TIME METER.
DL-00035 Rev. 4
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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 Reporting Symptoms Taking Measurements Measuring Blood Pressure Measuring Pulse Oximetry Measuring Temperature Measuring Blood Glucose Measuring Prothrombin Time Measuring Fluid Status Measuring Weight Measuring ECG Medication Reminder Viewing Nurse’s Instructions Viewing Setup Options Concluding Activities Trademarks Disclaimer xiv
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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. It can check your blood pressure, oxygen
saturation, pulse rate, respiration rate, ECG, and temperature, and can be
connected to devices such as a digital weight scale, prothrombin time meter,
fluid status monitor, and a blood glucose meter. Your clinician can also use
the monitor to send you messages reminding you to conduct certain tests or take
your medication.
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.
DL-00035 Rev. 4
1
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
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DL-00035 Rev. 4
Fluid status monitor receptacle (1)
Glucose meter receptacle (2)
Weight scale receptacle (3)
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. 4
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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. Avoid areas with a lot of foot traffic to help
prevent injury from tripping on cords and to help prevent the cords from
being disconnected.
• Away from a water source. Avoid areas near sinks, showers, and bathtubs.
Turning the Monitor On
Turn the monitor on by flipping the switch located on the back of the monitor.
A green light on the front is lit when the monitor is powered on. The monitor
should be left on at all times while in your home.
Dimming Feature
The monitor’s main screen will automatically dim after 5 minutes so that the
brightness will not disturb a patient who wishes to sleep. A simple tap on the
screen or any monitor activity will return the screen to its original brightness.
Power Supply
The monitor should be kept plugged into an AC power outlet at all times while in
your home. Connect the AC adapter to the monitor by plugging the round
connector into the receptacle on the right side of the monitor. Plug the other
end of the AC adapter into an AC power outlet. The green light on the plug indicates proper connection of the adapter. Use only the power supply cord that
came with the monitor.
The monitor contains a lithium-ion rechargeable battery. In the event of a power
outage, the monitor can function on this battery for up to 5 hours. If power is
out for a longer period of time, contact your clinician.
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DL-00035 Rev. 4­­
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.
Please do not use your telephone while the data is sent.” Do not use the phone
while the monitor is communicating. Once the confirmation message is displayed,
it is OK to use your phone again.
If the phone line is busy while the monitor is trying to send data, or telephone
connection to the server is interrupted for some reason, the following message
will appear on the monitor: “The Monitor could not communicate with the Central
Server. You will be returned to the Main Menu. Monitor will keep trying to dial
the Central Server every five minutes.” Data will be stored until successful
communication is complete.
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., to
call local emergency number in an emergency), turn off the monitor, and try
your phone again. No data will be lost.
Monitor Setup
The monitor will be programmed by your clinician for your care. Confirm that
your name appears on the monitor when it is installed in your home and that you
fully understand its use. If you have any questions regarding the monitor, contact
your clinician.
Alert chimes will sound when it is time to perform a scheduled activity. The chime
will continue to sound every 5 minutes until the activity is completed. If you do
not complete the activity, the monitor will send a message to your clinician that
the activity has been missed.­­
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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.
• It is important to enter the correct information at all times to ensure your vital signs are being accurately reported to your clinician.
• The monitor is here to record your data. DO NOT allow anyone else to use the monitor to avoid mistakes in your medical record.
• Discuss all medications with your physician.
• If any of the following occurs, contact your clinician immediately:
- Activities do not appear or patient name is no longer on the main screen
- Data is no longer displayed (screen is not functioning)
- Data on the screen is no longer heard (speaker is not functioning)
- Data cannot be input (touch screen not functioning)
- Device does not start up or does not function
• Never attempt to repair a malfunctioning monitor. All repairs should be
conducted by trained service personnel. Contact your clinician immediately
if the monitor needs service.
• Accessories such as glucose meter and strips, blood pressure cuffs,
temperature probes, ECG cables, and SpO2 sensors should be disposed of
according to manufacturer’s instructions on packaging.
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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. 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.
If you have questions about this information or about the safe operation of the
monitor, or do not understand any of the instructions on the screen, call your
clinician right away.
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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).
As soon as you select your answer, the monitor moves on to the next screen.
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DL-00035 Rev. 4
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.
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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.
The Main Menu screen includes options to:
• Report symptoms
• Take measurements
• See nurse’s instructions
• Adjust speaker volume or dial Central Server
To report symptoms, press “Report Symptoms” and follow the instructions on
the screen.
To take measurements, press “Take Measurements” and follow the instructions on
the screen.
To check the nurse’s instructions, press “See Nurse’s Instructions” and follow
the instructions on the screen.
Note: This option will not exist if nurse’s instructions have not been entered.
To adjust speaker volume or dial Central Server now, press “Setup” on the Main Menu.
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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.
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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.
At the “Confirm Problems” screen, the monitor will display all the problems you
have reported (for example, “Breathing”).
• If the reported problems are correct, press “Yes, send the problems to my clinician now” to send the report to your clinician.
• If the reported problems are correct, but you have additional measurements to take, press “Yes, but I would like to record measurement(s)” to go to the Take Measurements screen. All data will be sent when sending
measurements.
• If the reported problems are incorrect, press “No, I would like to report more problems” to return to the “Choose a Problem to Report” screen.
If you select a problem that has already been reported, the monitor will warn you:
• If you press “Yes,” any problems you reported in this category before will be deleted and replaced with your new answers.
• If you press “No,” the monitor will first ask if you have more problems to report before returning to the “Confirm Problems” screen.
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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. If you have difficulty, or if the monitor
displays an error message, call your clinician.
When all instructions have been read, press “Take Measurement.” A voice
prompt will alert you to: “Please remain still, measurement may take some time.”
After the measurement is complete, the measurement results will be displayed on
the screen.
After each measurement, you will be asked if you have more measurements to
do. Answer “Yes” or “No.”
If you answer “Yes,” the monitor will continue to store measurements in memory
and send them to your clinician all at once when you are finished. Press “No” if
you are finished; the data will be sent to your clinician. If you accidentally press
“No,” the monitor will immediately send this information to your clinician. Once it
is finished sending the data, you can continue taking more measurements using
the “Take Measurements” button on the Main Menu.
When measurements appear as an activity, after completion of the measurements,
the screen will advance to the next scheduled activity.
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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. Secure the cuff by using the Velcro® strap to make the cuff snug,
but not too tight.
7. Place your arm, raised to the level of your heart, on a table. Remain still and do not talk while your blood pressure is being taken.
When ready, press “Take Measurement” and remain still until the measurement
is complete. When finished, the measurement will be displayed on the screen.
If you receive any error codes while taking measurements, follow the instructions
on the screen and contact your clinician.
WARNING:
BE SURE THE NON-INVASIVE BLOOD PRESSURE HOSE IS NOT
BLOCKED OR KINKED DURING A MEASUREMENT. A BLOCKED
OR KINKED HOSE COULD LEAD TO EXCESSIVE PRESSURE IN THE
BLOOD PRESSURE CUFF, WHICH COULD CAUSE LIMB DAMAGE. IN
THE EVENT THE CUFF NEEDS TO BE STOPPED DURING OPERATION
DUE TO AN ERROR CREATED BY A BLOCKED OR KINKED HOSE,
THE CUFF SHOULD BE REMOVED FROM THE ARM BY RELEASING
THE VELCRO® STRAP OR PULLING/CUTTING THE HOSE OFF OF
THE CONNECTOR.
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­­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. When finished, the measurement will be displayed on the screen.
If you receive any error codes while taking measurements, follow the instructions
on the screen and contact your clinician.
Measuring Temperature
The monitor will display the following instructions to use the temperature probe
and take a temperature reading:
1. Put the tip into a new disposable plastic cover, if one is available.
If you do not have a plastic cover, clean the pointed end (probe)
with soap and warm water or rubbing alcohol. Rinse it with cool water.
2. With your mouth open, put the covered tip under your tongue.
3. Close your lips gently around the temperature probe.
When ready, press “Take Measurement” and remain still until the measurement
is complete. When finished, the measurement will be displayed on the screen.
If you receive any error codes while taking measurements, follow the instructions
on the screen and contact your clinician.
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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.
For manually entered information, the monitor will ask you to verify that the
number you entered is correct. (Blood glucose level can be entered in either
mg/dL or mmol/L, depending on personal preference or meter type.)
If you receive any error codes while taking measurements, follow the instructions
on the screen and contact your clinician.
Measuring Prothrombin Time
PRECAUTION:
FOLLOW THE MANUFACTURER’S INSTRUCTIONS FOR USE WHEN
USING A PROTHROMBIN TIME METER.
1. Press “Take Measurements.”
2. Press “Protime.”
The monitor will display the following instructions:
1. Enter your protime reading (as displayed on your meter) per manufacturer’s instructions.
2. Is this PT (prothrombin time) or INR (internationalized normalized ratio)?
3. Press “Complete” when data is entered.
If you receive any error codes while taking measurements, follow the instructions
on the monitor’s screen and contact your clinician.
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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. Place the first electrode just above the top of your breastbone, with the arrow pointing down.
3. Place the second electrode just below the bottom of your breastbone, with the arrow pointing up.
4. Press the Start button on the fluid status machine.
5. Remain still and do not talk while your fluid status is taken. The measurement may take some time.
The VitalPoint monitor will record and display the data displayed on the fluid
status monitor.
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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.
Press “Continue.”
4. Step on the platform and remain as still as possible without leaning
on anything.
When ready, press “Take Measurement.” When finished, the measurement will
be displayed on the screen in both pounds and kilograms.
If you receive any error codes while taking measurements, follow the instructions
on the screen and contact your clinician.
Measuring ECG
Only a clinician or a patient authorized by their clinician is authorized to perform an
ECG measurement. The measurement will report automatically on the monitor.
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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.
• If you answer “Yes,” the monitor will advance to the next activity,
if there is one. The monitor will return to the Main Menu if no additional
activities are scheduled.
• If you answer “No,” the monitor will ask you why you did not take
your medication.
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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.
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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.”
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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.
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DL-00035 Rev. 4
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., to
call local emergency number in an emergency), turn off the monitor, and try
your phone again. No data will be lost.
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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.
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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. Delphi
Medical Systems does not assume any liability arising out of the application or
use of any product or circuit described herein; neither does it cover any license
under its patent rights nor the rights of others.
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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.com/medical
Responsável Técnico: Ricardo Augusto Martins – CREA nº
5060652270
Nº do Registro na ANVISA: 80455010001
Delphi Medical Systems
5725 Delphi Drive
Troy, Michigan 48098-2815 U.S.A.
www.delphi.com/medical
VitalPoint is a trademark of Delphi Corporation.
All other trademarks are the property of their respective owners.
© 2009 Delphi Corporation. All rights reserved.
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