Braemar Fusion MCT User manual

Braemar, Inc.
Fusion MCT
Wireless Recorder
Indications for Use:
The device is intended for diagnostic evaluation of patients who
experience transient symptoms that may suggest cardiac
arrhythmia. The device continuously monitors, automatically
generates an alarm triggered by an arrhythmia detection algorithm
or manually by the patient, and automatically transmits the
recorded cardiac activity associated with these symptoms for
review by a licensed physician.
Contraindications:
1. Patients with potentially life-threatening arrhythmia who
require inpatient monitoring.
2. Patients who the attending physician thinks should be
hospitalized.

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Braemar Limited Warranty
Braemar products are warranted to be free from manufacturing and
material defects for a period of one (1) year from the date of shipment
from Braemar to the original purchaser.
Excluded from this warranty are expendable supply items including, but
not limited to, electrodes, lead wires, patient cables and batteries. This
warranty does not apply to any product which Braemar determines has
been modified or damaged by the customer.
Except for the express warranties stated above, Braemar disclaims
all warranties including implied warranties of merchantability and
fitness. The stated express warranties are in lieu of all obligations
of liabilities on the part of Braemar for damages, including but not
limited to, special indirect or consequential, arising out of or in
connection with the use or performance of Braemar products.
Device is to be serviced by Factory Authorized Technicians only.
Do not attempt to repair, modify, service Braemar Fusion wireless
monitor. Opening case will void recorder warranty.
Any action for breach of warranty shall be commenced within one (1)
year of said breach or be forever barred. Any repairs made to the
product which are not covered by the warranty shall be billed to the
customer.
Document Number: 600-0645-00
Revision: A
Date: February 2011
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Table of Contents
Indications for Use:...................................................................................2
Contraindications:.....................................................................................2
Overview...................................................................................................3
Precautions...............................................................................................3
Disclaimer.................................................................................................4
Recorder Components..............................................................................5
Set up Steps.............................................................................................6
3 Lead 2 Channel Electrode Placement .................................................10
Start the Recording and Check Connection to Server............................13
Patient Operating Instructions ................................................................14
Establishing the Home Link ....................................................................14
Troubleshooting......................................................................................20
Service and Maintenance.......................................................................21
Service Items and Accessories...............................................................21
Equipment Symbols................................................................................22
Specifications .........................................................................................23
Electromagnetic Emissions.....................................................................24
Electromagnetic Immunity ......................................................................24
Recommended Separation Distances ....................................................27
FCC / IC Statements...............................................................................28

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Overview
The Fusion MCT Wireless recorder is a battery operated, solid state
recorder designed to record symptomatic as well as asymptomatic heart
arrhythmias.
The Fusion recorder provides up to 30 days of total recording time for 2
channels. The Fusion recorder is enhanced with Arrhythmia Detection
firmware which will capture and automatically record asymptomatic,
infrequent, or elusive heart arrhythmia events such as Bradycardia,
Tachycardia, Pause, and Atrial Fibrillation.
Once an event is recorded, the event ECG is automatically transferred
via a digital cellular link. If a digital cellular link is not available, the
event ECG can be transferred by Bluetooth to a phone line via a Home
Link Bluetooth modem.
Precautions
A. Patient leads must be removed from electrodes before defibrillation.
B. Observe local laws for disposal of batteries.
C. Do not leave the batteries in the recorder when it is not in use.
Damage from corrosion could result.
D. Patient should be instructed to avoid close proximity to heavy
electrical equipment or other sources of electromagnetic
interference.
E. Use only the provided battery pack. Observe polarity when
inserting.
F. Recorder is not for infant use.
G. No automatic analysis algorithm can replace data review by a
qualified physician. Review and confirmation of analysis results is
required.
H. Patients should seek immediate medical attention if they experience
symptoms that concern them.
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Disclaimer
Operation of the Fusion recorder may be subject to governmental and
business restrictions, including but not limited to air travel and hospital
visitations.
This device is approved for use only in the United States of America.
Additional equipment classification information as required in EN 60601-1
A. EQUIPMENT not suitable for use in the presence of a
FLAMMABLE ANAESTHETIC MIXTURE WITH AIR OR
WITH OXYGEN OR NITROUS OXIDE
B. IPX0 Ordinary Equipment (enclosed equipment without protection
against ingress of water)
C. Internally Powered Equipment
D. Mode of Operation - Continuous Operation

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Recorder Components
Batteries 3.6V AA Lithium battery pack. Insert into battery
compartment observing polarity symbols.
Patient Cable To adjust, move plastic slip rings up or down to keep
leads together. To lengthen, pull leads apart.
Caution: U.S. Federal law restricts this device to sale by or on the
order of a physician.
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Set up Steps
DO NOT ENROLL PATIENT IN SOFTWARE UNTIL INSTRUCTED
TO DO SO.
This manual is designed to allow a technician to follow the instructions
page by page to set up the Fusion recorder. Here is the general layout:
The Fusion recorder is preprogrammed from the factory for default
settings. The device is fully programmable through the Fusion Wireless
Monitoring System Software. Please refer to the Fusion Wireless
Monitoring System Software for programming capabilities and options.
1. If the recorder contains batteries, and/or a cable remove them and
insure the screen is blank before proceeding.
2. Install fresh batteries into recorder. Install only AA Lithium battery
packs provided by Braemar. Observe proper battery polarity when
installing. The battery indicator resets to indicate a full capacity
battery each time the batteries are inserted. For an accurate
indication you must install fresh unused batteries.
3. Inspect LCD Screen. There are several screens that may be viewed
when powering on a recorder. This section covers each of those
screens.
“No cable” screen: The recorder does not have any previous
patient data and you can proceed to step 4.

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“Recording…” screen: The recorder is still recording data, you
must stop the recording and erase all the data before setting up
the recorder for the next patient.
Press the left and right buttons together and it will
prompt you if you want to stop the recording.
Press the Enter button to stop recording the data and
the “Recording Complete” screen will appear.
Continue to erase the data by following the
“Recording Complete” screen steps.
“Recording Complete” screen: The recorder still has data in it,
you must erase all the data before setting up for the next
patient.
Press the left and right buttons together and it will
prompt you to “Erase Data”.
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Press the Enter button to erase the data. The display
will have the message “Recorder Empty”.
Continue setting up the recorder by following the
“Recorder Empty” screen steps.
“Recorder Empty” screen: The recorder is ready to be reset.
Remove the batteries
Return to step 2
4. Apply electrodes to patient.
a. Snap the electrode onto the lead wire.
b. Remove the protective backing from the adhesive side of
the electrode
c. Apply the electrode to the patient’s skin per Electrode
Placement diagram in this manual or as instructed by the
physician.
Notes:
i. It is recommended that trained medical personnel
instruct the patient in the proper application of
electrodes.
ii. Use good quality long term electrodes. Braemar
recommends the use of low impedance Holter
electrodes. Instruct patient to apply fresh
electrodes regularly. (Usually on a daily basis.)
iii. Proper preparation of the patient's skin is
absolutely essential for obtaining a quality ECG
recording. The skin surface where the electrodes
will be placed should be cleaned with alcohol,
allowed to dry, and abraded.
iv. Any loose electrode needs to be replaced.

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5. Connect snaps to electrodes.
6. Plug the Patient Cable into recorder.
7. Observe LCD main menu screen.
8. Verify lead status to be OK as described below.
9. Verify ECG signal is OK as described below.
10. Remove Batteries.
11. Enroll patient on software via Enrollment Tab using the Fusion
Wireless Monitoring System Software.
12. Verify Enrollment by looking for yellow dot in the Patients Tab
using the Fusion Wireless Monitoring System Software.
13. Insert Batteries into the Fusion recorder.
14. Verify the recording starts automatically by inspecting the LCD for
the Recording…. Screen.
15. Verify yellow dot has been changed to two green dots in the
Patients tab using the Fusion Wireless Monitoring System Software.
16. Set up is complete and the recoding has been successfully started.
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3 Lead 2 Channel Electrode Placement
This is a typical electrode placement for a 3 lead 2 channel patient cable.
Channel 1 = Red (1+), White (1-, 2-)
Channel 2 = Black (2+), White (1-, 2-)

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1. Patient cable connection
At this time, the patient leads should be connected to the electrodes,
the electrodes should be connected to the patient, and the patient
cable should be inserted into the recorder.
Setup Menu Overview
2. Checking lead connections:
Using the left and right arrow buttons, select Lead Status
(or icons) and press the Enter button. Check the status of the
lead to make sure each of them has a good connection.
Leads with good connections display
Leads with poor connections display
“Lead Error” will also display at the bottom of the screen
At least two leads must be connected to see the Lead Status. If
there are less than two leads present, a “No Cable” message is
displayed. Press the Enter button to return to the Setup Menu.
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3. Checking ECG signals:
Using the left and right arrow buttons, select View ECG ( icon)
and press the Enter button.
You can change to another channel by pressing the left or right
buttons. If any channel is not available due to an error detecting a
lead, a “Lead Error” message will be displayed for only that
affected channel. If the cable becomes disconnected, all channels
will display “No Cable”.
To enter or exit zoom mode, press the left and right buttons
simultaneously for one second. A magnifying glass ( ) will
appear next to the channel number in the upper right corner.
Pressing the right button will increase the amplitude of the signal,
while pressing left will decrease the amplitude of the signal. Pacer
pulse marks are displayed with a paced signal below the trace to
indicate each detection of a pacer pulse.
Note that the gain setting only changes the display and not
the gain of the ECG signal stored in the recorder.
.5x gain 1x gain (default) 2x gain
Grid background indicates the display gain.
Press the Enter button to return to the Setup Menu.
General notes:
A. All button presses should beep to provide feedback for the
user.
B. The backlight for the display is on while accessing the menus,
after recording a manual event, or after receiving a text
message.
C. The backlight will remain off during normal recording
D. Lead loss and Pacer detection is on all the time.
E. The number of channels a patient cable contains will determine
the number of channels the recorder will record.

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F. Although the device detection algorithms are very
sophisticated, there is no guarantee that the device will catch
all episodes of arrhythmia.
Start the Recording and Check Connection to Server
The Recording screen should now be displayed. An icon in the
upper right corner indicates the type of connection that is being
used to transfer the information to the Fusion Server.
(not transmitting) Cellular
Bluetooth modem USB cable
A majority of the time the recorder will not be transmitting and so
there will only be the battery icon in the upper right corner. The
battery icon will diminish the amount of displayed dark region as
battery capacity is reduced.
Call the service center and verify the SN of the recorder has
contacted the Fusion Server. It is now the job of the service center
to complete enrollment of the patient with the recorder.
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Patient Operating Instructions
Establishing the Home Link
In accordance with FDA directive, Fusion Wireless Monitoring with
patient alarm conditions requires the establishment of a Home Link
alternative to cellular data communications. The Fusion recorder kit
contains Bluetooth wireless hardware that must be connected to a
normal RJ-11C telephone jack. The jack used should typically be
located on the nightstand or near where the patient will spend most of
their time during the procedure. Patients inside the home location
should be in Home Link wireless contact if they are within
approximately 75 feet of the system. Note: This modem has an actual
line of site range of 328 feet but due to walls and other structural
impedance the modem should be placed within 100 feet.
The Fusion recorder and Home Link modem connections are preset at
the factory and do not need any user configuration.

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Home Link hardware overview:
Bluetooth modem (top view) Bluetooth modem (back view)
Telephone cord Bluetooth modem power adapter
Male phone splitter Female phone splitter
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Installation of the Home Link modem:
After installation of the Home Link, the patient must call the monitoring
center to verify that the redundant data transfer system is able to
communicate with the Fusion Server.
1. The PWR light should turn on when the modem has power.
2. The LINK light will turn on when the Fusion recorder connects to
the modem.
3. The OH light will turn on when the telephone line is “Off Hook”
meaning the modem has started a connection over the telephone
line.
4. The ACT, TX, and RX lights will blink while the Fusion recorder is
transmitting data.

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Recorder information:
The recorder should be ready when you receive it from the technician.
If there are any problems, refer to the Troubleshooting section.
Display overview:
To Hookup:
1. Snap lead wires onto electrodes first, and then apply electrodes
according to physician instructions.
2. Reapply fresh electrodes daily.
3. Insert the patient cable into the recorder.
4. The recorder is now recording data as seen in the above screenshot.
5. Insert the recorder into the holster and clip holster to belt or similar
clothing.
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Record ECG: ECG to be marked will be described by the physician.
1. Press the RECORD/ENTER button until an audible tone is heard,
then release.
2. Hold as still as possible during recording but continue breathing.
The recording should only last a few seconds.
Automatic Recording:
If an event is detected, the recorder will silently record and transmit the
event to the monitoring center for further review.
Note about TEXT Messaging:
The Fusion Wireless Monitoring System Software can provide text
messaging back the Fusion recorder. Messages up to 3 lines with 32
characters per line can be displayed on the LCD of the Fusion recorder
to allow communications back to the patient. A TEXT message
received by a recorder will initiate an audible alert of three beeps in
rapid succession. The alert will repeat every 10 minutes until the patient
presses one of the arrow keys or it is silenced by the monitoring center.
The message shall be displayed continuously until cleared by the
monitoring center. The patient is not able to clear the message unless
the batteries are removed.
To Send:
In most cases, events are automatically downloaded to the receiving
center via digital cellular link. If an appropriate cellular signal is not
present for the transmission to start, the recorder will automatically
connect to the Home Link Bluetooth modem. There isn’t any patient
interaction required for this transmission to occur. Under the rare
circumstance when neither a cellular link nor Home Link Bluetooth is
available, the recorder will automatically retry establishing a connection
according to the following schedule; 1) retry in 5 minutes, if
unsuccessful, 2) retry in 5 minutes, if unsuccessful 3) retry in 50
minutes, if unsuccessful return to 1).