Biomedical Systems BRHA01 Handheld Mobile Telemetry Device User Manual Patient Instruction Manual pub

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Document ID	1299878
Application ID	BCU4BxRXUAV1sVjTeEAGsA==
Document Description	Patient Instruction Manual
Short Term Confidential	No
Permanent Confidential	No
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Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	46.26kB (578253 bits)
Date Submitted	2010-06-22 00:00:00
Date Available	2010-08-06 00:00:00
Creation Date	2010-06-03 16:16:18
Producing Software	Acrobat Distiller 9.0.0 (Windows)
Document Lastmod	2010-06-03 16:16:18
Document Title	Patient Instruction Manual.pub
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Document Author:	eb

TruVue Mobile Telemetry
Patient Instruction Manual
BIOMEDICAL SYSTEMS
WIRELESS AMBULATORY ECG
Biomedical Systems
77 Progress Parkway
St. Louis, MO 63043
www.biomedsys.com
● 24-hour continuous ECG
monitoring
● Patient friendly handheld unit
that is easy to use
● Around the clock patient support
and monitoring
Page 2
Page 23
CALL BIOMEDICAL SYSTEMS WITHIN
24-HOURS OF RECEIVING HEART MONITOR AND
BEFORE REMOVING MONITOR FROM THE BOX.
DISCLAIMER
1-800-000-0000
If you have questions regarding your monitor or about billing after your heart monitoring service begins, please call
our Customer Service Department at 1-800-877-6334.
When your physician decides the heart monitor can be removed, please return both units and any additional supplies
to Biomedical Systems within 24-hours to avoid being
billed.
Disclaimer:
UPON COMPLETION OF MONITORING PERIOD
RETURN UNIT IN PREPAID BOX TO:
Biomedical Systems
77 Progress Parkway
St. Louis, MO 63043
Customer Service 1-800-877-6334
(Monday -Friday 8:00am –5:00pm CST)
Mobile Telemetry Lab 1-800-000-0000
(24 hours/day, 7 days/week)
Copyright Declaration:
Page 22
Summary of Cautionary
Statements
CAUTION: The TruVue Handheld device contains a cellular phone. If you have an implantable device follow
your device manufacturers recommendations on the use
of cellular phones with your device.
CAUTION: Take care not to get the sensor or handheld
wet. Remove the sensor prior to bathing.
CAUTION: Do not drop the devices or dangle the sensor
from the leadwires
CAUTION: When on an airplane, follow the instructions
on the use of wireless devices. You can turn of the all
wireless radios through the handheld user interface, the
sensor will continue to monitor you.
CAUTION: There are no user serviceable parts in the
TruVue device. Do not attempt to remove the cover from
either the sensor or the handheld.
CAUTION: Use only AAA Alkaline batteries in the TruVue Sensor. Do not use rechargeable batteries in the sensor.
CAUTION: Use only the supplied wall charger to charge
the handheld.
CAUTION: Always use the carrying case when carrying
the handheld on your body.
Page 3
Federal Law restricts this device to sale by or on the
order of a physician
Note for patients with implantable devices such as a
pacemaker or ICD:
CAUTION: The TruVue Handheld device contains a cellular phone. If you have an implantable device follow
your device manufacturers recommendations on the use
of cellular phones with your device.
CAUTION: The TruVue system is not an emergency
response device. If you feel you are having a medical
emergency call 911 and/or your local emergency medical service.
Page 21
Page 4
Regulatory Statements
Table of Contents
Mobile Telemetry …………………………………………..4
What is Mobile Telemetry (MT)
Indications for Use
How MT Works
Method of Payments ……………………………………….5
Contents of Box
Patient Instructions ……………………..………………….6
Electrode (patch) Placement
Showering or Bathing Instructions..………………………..8
Handheld Unit Instructions ………………………………...9
Important Device Information………………………….….13
Cleaning the Unit
Frequently Asked Questions ……………………………...14
How to Return Monitoring Units …………………………18
NOTE: This equipment has been tested and found to comply with the
limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference
to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does
cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged
to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna.

Increase the separation between the equipment and receiver.

Connect the equipment into an outlet on a circuit different from
that to which the receiver is connected.

Consult the dealer or an experienced radio/TV technician for help.
Radiofrequency radiation exposure Information:
For body worn operation, this phone has been tested and meets the FCC
RF exposure guidelines when used with the Biomedical Systems accessories supplied or designated for this product. Use of other accessories
may not ensure compliance with FCC RF exposure guidelines.
Page 20
Regulatory Statements
Federal Law restricts this device to sale by or on the
order of a physician
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device
must accept any interference received, including interference
that may cause undesired operation.
Sensor FCC ID: YCVBRSA01
Handheld FCC ID: YCVBRHA01
NOTICE:
Changes or modifications made to this equipment not expressly approved by Biomedical System may void the FCC
authorization to operate this equipment.
Page 5
Mobile Telemetry
What is Mobile Telemetry?
Mobile Telemetry (MT) is a way for your physician to
monitor your cardiac (heart) activity for an extended period
of time. This is done by wearing a small sensor that includes
wires and electrodes (patches) attached to your chest, that
records your heart rhythm (activity) 24 hours a day while
you continue with normal daily activities.
Why did my Doctor Prescribe Mobile Telemetry?
MT is often prescribed for patients who may have infrequent
complaints of symptoms, such as dizziness, light headedness,
feeling faint, or palpitations. It may also be worn by patients
who have recently had cardiac (heart) surgery or other cardiac procedures. MT is useful for patients undergoing antiarrhythmic medication changes or who may be starting antiarrhythmic therapy. MT is also frequently prescribed to
identify asymptomatic (without symptoms) cardiac (heart)
arrhythmias (abnormal heart patterns).
How Does Mobile Telemetry Work?
Real-time MT automatically records and transmits (sends)
cardiac rhythm data to an attended central data monitoring
center. Therefore, it requires minimal (if any) patient interaction. Cardiac monitoring is occurring continuously
whether the patient is experiencing symptoms or not, and
this data is constantly being sent to the monitoring center.
The data is analyzed by Certified Cardiac Monitor Technicians (CMT’s) and sent to your physician for review. Your
physician will receive a daily report of your cardiac activity,
and will be notified immediately of any abnormal cardiac
(heart) rhythm activity.
Page 19
Page 6
Methods of Payment
Biomedical Systems will verify and obtain authorization for
payment from Medicare and/or your insurance provider. Depending on your coverage, you may be responsible for a copayment and/or deductible amount.
In the event your insurance provider does not cover this procedure, Biomedical Systems will work with you to develop a
payment plan and help you to understand your payment options.
Contents of Box
How to Return the Device
When your doctor decides your heart no longer needs to be
monitored, promptly return the monitoring units and contents
of the box to avoid being billed.
1. Place all items (handheld and sensor units, DVD, and any
left over supplies) into the prepaid box provided.
2. Ensure that box is securely closed and place in mailbox
for US postal service pick-up.
If you are unable to return the device for any reason, please
call our Customer Service Department immediately so that
we can make arrangements to have the units picked up via
UPS.
Customer Service
(Monday – Friday 8:00am – 5:00pm)
1-800-877-6334
Mobile Telemetry Monitoring Lab
(24 hours/day, 7 days/week)








Handheld unit (1) with carrying case
Sensor unit with cable wires (1)
Electrodes
AAA Alkaline Batteries
Patient manual (1)
DVD (1)
Charger
Prep Pads
1-800-000-0000
Return Address:
Biomedical Systems
Attn: Mobile Telemetry
77 Progress Parkway
St. Louis, MO 63043
Non-returned MT units will be billed to patient.
Page 7
Page 18
Patient Instructions
Frequently Asked Questions
Figure 1
How do I return the Mobile Telemetry Sensor and Handheld units, and other contents in the box?
Return the complete system to Biomedical Systems within
24 hours of being discharged from monitoring to avoid being
billed for the units. Use the prepaid box sent to you with
your initial shipment. In the event you are unable to return
the MT units for any reason, please contact our Customer
Service Department at 1-800-877-6334 so that we can make
arrangements to have it picked up via UPS.
Black Electrodes
White Electrode
Red Electrode
ELECTRODE (PATCH) PLACEMENT:
What should I do if I faint or if I experience symptoms
that are more frequent than usual or don’t seem to go
away?
Precaution: Shave any hair that is in the area the electrodes
(sticky patches) are placed. If hair is not shaved, the recorded activity of your heart is difficult to read.
If you experience any new symptoms or your symptoms
have worsened, you should contact your physician as soon as
possible. If you feel that your symptoms are life threatening
or require immediate attention, you should call 911 or go to
the nearest emergency room immediately.
1. Shave area where electrodes (sticky patches) will be
placed (if applicable). Wipe each area with alcohol in a
circular motion and let dry. (See Figure 1 for electrode
placement).
I have additional questions or concerns.
Please call the Customer Service Department at 1-800-8776334.
2. Remove the sensor (See Figure 3) from the box. Snap
each lead wire onto an electrode.
(See Figure 2)
3. Remove backing from the
electrode attached to the black
snap and place it on the left
side of your upper chest just
below your clavicle as shown in
Figure 1.
Figure 2
Sensor unit Lead wires
Electrodes
(patches)
Handheld unit
Page 17
Page 8
Electrode (Patch) Placement
Frequently Asked Questions
I’ve already worn a Holter or Event monitor, so why did
my doctor order Mobile Telemetry for me?
Figure 3
4. Remove backing from the electrode attached to the
red snap and place it on the lower left portion of your
chest as shown in Figure 1.
5. Remove backing from the electrode attached to the
white snap and place it on the right side of your upper
chest just below your clavicle as shown in Figure 1.
The holter monitor only captures 1-2 days of your heart’s
electrical activity. Often times this is not long enough to rule
out cardiac arrhythmias that may occur less frequently than
24 to 48 hours. Event monitor’s are typically only used for
patient’s who experience symptom’s, and do not pick up on
abnormal cardiac (heart) activity that may occur asymptomatically (when you are not experiencing symptoms).
How will I be billed?
We will bill your insurance carrier, whether you have Medicare Part B, private insurance, or belong to an HMO. You
will only be billed for the co-pay and/or deductible, if any.
The patches are irritating my skin, what should I do?
Precaution: Press firmly all around electrode patches to secure them firmly to skin. If they are not secured firmly to
skin the heart activity will not record well.
We have alternate electrodes (patches) with a skin prep
available upon request. Please call Biomedical Systems Customer Service at 1-800-877-6334.
6. On the back side of the Sensor, remove the battery cover
as shown in Figure 4 and put
(1) AAA Alkaline battery in
place if not already done. Replace battery
cover.
Figure 4
I am having difficulty using the Handheld unit and/or
have questions about the unit?
The Cardiac Monitoring Technician’s are available 24 hours
a day, 7 days a week to answer any questions you may have
and to monitor your heart’s activity. Please call at any time
of the day so that we can answer your questions.
Page 16
Page 9
Lanyard Connection
Frequently Asked Questions
What should I do when I shower or take a bath?
Simply remove the device and patches. Throw away the old
patches, and apply new ones to a clean area of skin. Be sure
not to use lotions or creams on chest area, as this will prevent
them from sticking securely to your skin. Shave hair in area
of electrode.
I have used all of my supplies and need additional
patches, etc.?
Contact our Customer Service Department at 1-800-8776334.
What should I do if I forget my Handheld unit at home
or somewhere else?
The Handheld and Sensor units are continuously communicating with one another. If it is not possible to return home
to get the Handheld unit, the Sensor will continue to store
your hearts activity until you find the Handheld. However,
your hearts activity will not be sent to monitoring center for
evaluation until a connection between the Sensor and Handheld units is re-established or made. Once you are able to
retrieve the handheld, there is nothing that you need to do to
reestablish this connection. Please call the monitoring center
at 1-800-000-0000 as soon as possible if you have left your
Handheld at home or another location. The monitoring center also has the capability to send a text message to the Handheld unit should you lose the device and someone else picks
it up.
7. If sensor is not already
attached to the lanyard (neck
strap), then snap sensor onto
lanyard as shown in Figure 5.
Once lanyard (neck strap) is in
place, put lanyard around your
neck and wear as shown in
Figure 5.
Figure 5
Important Notes:
Every 24 hours you will need to change the AAA Alkaline battery in the sensor.
 Electrode patches should be changed every 24 hours or if
they become loose or are not sticking well.
 Always wipe with alcohol before applying new patches,
and shave hair if necessary.







When Showering or Bathing
Remove lead wires attached to sensor from the electrodes (patches).
Place sensor (attached to lanyard) in a dry secure
place. Do not allow sensor to get wet. It may cause
sensor to stop working properly.
Remove electrodes (patches) from skin even if they
have already been changed in past 24 hours.
After showering or bathing, dry skin thoroughly. Do
not apply powder or lotion of any kind to chest
area.
Wipe skin with alcohol in area where electrodes
(patches) will be placed. Replace electrodes (patches)
as previously instructed in Steps 3 - 5 on pages 6 and
7.
Page 15
Page 10
Handheld Unit Instructions
Figure 6
Why did my doctor order a Mobile Telemetry test for
me?
Figure 7
Power Button
1. Remove Handheld unit from box. (Handheld unit shown
in Figure 6 above).
2. Press and hold the Power button for five (5) seconds.
(Power button is located on right side of unit)
See Figure 7.
Note: A green light will appear and will begin to
blink after about 10 seconds. You may hear a
‘beeping’ sound.
3. After unit is ‘Powered on’, the following screens shown
in Figure 8 on page 10 will appear as you scroll through
each screen on the Handheld unit screens. See Figure 7
to view the buttons on the Handheld unit.
Soft Keys
Up/Down Arrow Keys
Frequently Asked Questions
Mobile Telemetry (MT) will assist your doctor in determining if the symptoms you are having are related to your heart.
If a problem with your heart is detected, the heart monitor
will assist your doctor in determining the nature and severity
of the problem. Doctors also prescribe MT for medication
changes or post surgical procedures related to your heart.
How long will I have to wear the heart monitor?
The monitor must be worn at all times during the test period
which can be up to 30 days. However, your doctor may discharge you from MT at any time upon making a diagnosis,
or if he/she feels the cardiac (heart) monitoring is no longer
necessary.
What if a patch is loose or comes off?
It is critical that the patches (electrodes) are securely attached at all times to your skin. If a patch is loose, remove
the patch completely, ensure the area is free of hair, rub the
area with alcohol, and then apply a new patch. Be sure to
press firmly on the patch to ensure that it is secured to the
skin.
Patches should be changed every day and when you bathe or
shower. Remove the patches and device prior to bathing,
and then reapply before dressing. (Refer to page 6 and 7 for
electrode (patch) placement.
Page 14
Page 11
Things you
should know
Cleaning the Unit:
Both the Handheld and Sensor units may be cleaned with a
small amount of alcohol; however, do not submerse the units
in the alcohol, water, or any other liquid. If either unit gets
wet, it may damage them and prevent them from working properly.
IMPORTANT DEVICE INFORMATION:
SENSOR
Sensor is attached to a lanyard which should be worn by
patient around the neck
 Sensor is responsible for collecting the ECG data (heart
activity) via lead wires and electrodes (patches)
 Sensor is powered by a 1.5V AAA Alkaline battery that
should be changed every 24 hours

Handheld Unit Instructions
4. After turning Handheld unit ‘Power On’, you will see the
following screens (Figure 8), as you scroll through the
instructions on each screen. The first screen instructs
you to press ‘Start’ to begin monitoring. The second
screen has the word ‘Important” at the top, and so on.
Select the ‘Next’ button after viewing each screen in
order to move through the screens. The display screen
will guide you through the process step by step.
Important Note: Handheld unit should be charged every
night while you sleep. Plug in to charger in same room that
you sleep. This will allow Sensor unit and Handheld unit to
continue to communicate, and your cardiac (heart) activity
will continue to be sent to the data center.
HANDHELD
Handheld is powered by a rechargeable battery
Handheld incorporates a speaker and microphone to enable communication between monitoring center and patient
 Handheld should be recharged EVERY evening while
you sleep in order to provide up to 24-hours of battery
life.


Figure 8
(Will need to make pictures much bigger and if possible, include
picture of handheld with arrow to correct soft key to push).
Important Note: The third screen will display a number for
you to call. If not already on the phone with the monitoring
department, call the number listed. (1-800-000-0000).
Page 13
Page 12
Handheld Unit Instructions
Handheld Unit Instructions
5. The fourth (4th) screen you will see is the ‘Code Entry’
screen (Figure 9). If not done so already, call the number
listed on the previous screen to obtain your code (Mobile
Telemetry Lab at 1-800-000-0000.
6. Once you have successfully entered your Code, the
display screen will take you to the main monitoring mode
screen (Figure 10).
Precaution: Device will not work properly unless correct
code is entered. You must call Biomedical Systems Mobile
Telemetry Lab immediately.
NOTE: In the ’Code Entry’ screen, the right and left arrows
move between the four numbers. The up and down arrows
scroll through the numerals 0 to 9.
Place clear pictures of each
of these screens in this section to include the status
bar, and each of the 6
screens depicted here.
When the code has been entered the right soft-key (refer to
Figure 7 on page 9) will take you to monitoring mode if the
code is correct.
Figure 10
Figure 9
NOTE: The main monitoring mode screen allows you to:






View battery levels
Adjust volume
Record symptoms
View messages sent from monitoring center technicians
View device information screen
Change wireless settings
These screens will be reviewed with you by the Cardiac
Monitoring Technician during the instruction process.

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