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.

Fusion MCT Wireless Recorder
1
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
Fusion MCT Wireless Recorder
2
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

Fusion MCT Wireless Recorder
3
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.
Fusion MCT Wireless Recorder
4
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

Fusion MCT Wireless Recorder
5
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.
Fusion MCT Wireless Recorder
6
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.

Fusion MCT Wireless Recorder
7
“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”.
Fusion MCT Wireless Recorder
8
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.

Fusion MCT Wireless Recorder
9
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.
Fusion MCT Wireless Recorder
10
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-)

Fusion MCT Wireless Recorder
11
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.
Fusion MCT Wireless Recorder
12
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.

Fusion MCT Wireless Recorder
13
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.
Fusion MCT Wireless Recorder
14
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.

Fusion MCT Wireless Recorder
15
Home Link hardware overview:
Bluetooth modem (top view) Bluetooth modem (back view)
Telephone cord Bluetooth modem power adapter
Male phone splitter Female phone splitter
Fusion MCT Wireless Recorder
16
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.

Fusion MCT Wireless Recorder
17
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.
Fusion MCT Wireless Recorder
18
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).

Fusion MCT Wireless Recorder
19
Battery Change:
1. Remove cable.
2. Open door.
3. Pull ribbon.
4. Check for blank screen.
5. Insert new battery watching for correct polarity.
6. Close door.
Fusion MCT Wireless Recorder
20
Troubleshooting
Symptom Recommended Solution
No display Ensure batteries are inserted with correct polarity.
Ensure RECORD button has been pressed.
Will not record Ensure Patient Cable is inserted completely.
Recorder stops recording
Enter button pushed but a
recording does not start Patient cable must be inserted with a good connection to
patient before an event recording starts.
Recorder will not turn off
after removing batteries The recorder will remain on for a few seconds after the
battery is removed. Wait at least 5 seconds after removing
the batteries to completely turn off the recorder. Verify
screen is blank before replacing batteries.
Bluetooth connection does
not allow dial out Check the BT -> RS232 switch on the back of the Bluetooth
modem. It should be set to “BT”
Noise artifact on recorded
ECG at patient location Electrodes must be securely attached to patient.
Patient should remain still while recording.
Replace patient cable. Pulling on lead wires may damage
cable.
Verify the recording did not take place near a source of
electromagnetic interference (fluorescent lights, computer
monitors, or household appliances).
Move electrodes slightly to the right or left of the original
location.
Rising tone Ready to record

Fusion MCT Wireless Recorder
21
Service and Maintenance
Cleaning
Cleaning should occur before each patient use and more frequently if
needed.
Remove the batteries before cleaning the recorder. Clean the battery
terminals with a soft dry cloth. Dampen a soft cloth with mild detergent
and water to clean the recorder, lead wires and holster.
Do not use alcohol or acetone on the lead wires since they could stiffen
and the insulating plastic could crack.
Service
If there is a problem with the recorder, review the problem descriptions
and solutions listed in the Troubleshooting Section. If additional
assistance is required contact customer support via phone, Fax or E-mail
listed below. Call customer support before returning a recorder to make
shipping arrangements.
A. Note there isn’t any preventative inspection or maintenance
that can be performed by the end user.
Service Items and Accessories
Note: Only authorized accessories are permitted.
Description Part Number
Patient Cable, 2 channel, 3 lead 350-0302-04
Recorder belt clip / Holster 100-1910-001
Operator manual 600-0645-00
AA Lithium Battery Pack 350-0294-00
USB 2.0 Data Cable 200-2792-001
Phone splitter-Male 200-2899-001
Phone splitter-Female 200-2900-001
Phone cord, 6ft, RJ-11 200-2893-001
Bluetooth modem 350-0308-00
Fusion MCT Wireless Recorder
22
Equipment Symbols
Symbol Description
Type B Applied Part
Consult manual
Serial Number is numerically printed and bar coded
Waste Electrical and Electronic Equipment (WEEE)
It is the responsibility of the end user to dispose of
this equipment at a designated collection point for
recycling.
Bluetooth trademark indicating conformity to
specifications
Manufacturer:
Braemar, Inc.
1285 Corporate Center Drive, Suite 150
Eagan, MN 55121 USA
Phone: [phone]
651.286.8620
Fax: [phone]
E-mail: [e-mail]
Web: http://www.braemarinc.com
Contact Braemar for further technical information.

Fusion MCT Wireless Recorder
23
Specifications
Functional
Fusion 2 channel
Sample rate 256 samples per second
User interface LCD display and sound
Memory
Max total record time
Two channel 30 days
Type Flash
Data retention Non-volatile
Physical
Dimensions 4.1"x 2.25"x .75"
Weight with batteries 5.5 oz.
Enclosure Molded plastic
Operating position Any orientation
Electrical
Input impedance 10M min.
CMR ratio 60dB
AC signal range +/- 5mV
DC signal range +/- 300mV
Resolution 12 bits
Frequency response .05Hz to 40Hz, (or 80Hz with right leg cable)
FCC ID HHMFUSIONMCT or HHMFUSION
check S/N label on the device
IC ID 9158A-FUSION
Environmental
Operating temperature 0C to +45C
Non-operating temperature -20C to +65C
Operating humidity 10% to 95% without condensation
Non-Operating humidity 5% to 95% without condensation
Battery
Type (2) AA Lithium Thionyl
Life Battery life varies greatly due to local wireless
coverage, distance to the wireless towers, Bluetooth
usage, number of arrhythmia detections and other
factors. Typical life is approximately 8-10 days.
Remove batteries during storage
For optimum shelf life store batteries at ambient
room temperature and 30% to 50% relative humidity
Warranty 12 months from shipment
Fusion MCT Wireless Recorder
24
Electromagnetic Emissions
Emissions test Compliance Electromagnetic
environment - guidance
RF emissions
CISPR 11 Class B Fusion is suitable for use in all establishments, including domestic
establishments and those directly
connected to the public low-
voltage power supply network that
supplies buildings used for
domestic purposes.
Electromagnetic Immunity
Immunity test IEC 60601
test level Compliance level Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the relative
humidity should be at least
30% without condensation.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.

Fusion MCT Wireless Recorder
25
Fusion MCT Wireless Recorder
26

Fusion MCT Wireless Recorder
27
Recommended Separation Distances
Refer to the following table for recommended separation distances
between Fusion and portable and mobile RF communications
equipment.
Fusion is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The user of Fusion can help
prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment
(transmitters) and Fusion as recommended below, according to the
maximum output power of the communications equipment.
Separation distance according to
frequency of transmitter
Rated maximum
output power of
transmitter
W
150 kHz
to 80 MHz
d= 1.2 P
80 MHz
to 800 MHz
d= 1.2 P
800 MHz
to 2,5 GHz
d= 2.3 P
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitters rated at a maximum output power not listed above,
the recommended separation distance din meters (m) can be
estimated using the equation applicable to the frequency of the
transmitter, where Pis the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE1: At 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
Fusion MCT Wireless Recorder
28
FCC / IC Statements
NOTICE: This device complies with Part 15 of the FCC 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.
NOTICE:
Changes or modifications made to this equipment not expressly
approved by Braemar, Inc. may void the FCC authorization to
operate this equipment.
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.

Fusion MCT Wireless Recorder
29
The internal wireless radio operates within guidelines found in
radio frequency safety standards and recommendations, which
reflect the consensus of the scientific community. Braemar Inc.
therefore believes the internal wireless radio is safe for use by
consumers.
However, the use of wireless radios may be subject to
governmental and business restrictions, including but not
limited to air travel and hospital visitations. If you are unsure
of restrictions, you are encouraged to ask for authorization before
turning on the wireless radio.
Radio Frequency radiation exposure Information
For body worn operation, this device has been tested and meets
the FCC RF exposure guidelines when worn in the belt clip /
holster and used with the Braemar accessories supplied or
designated for this product.
Use of other accessories may not ensure compliance with FCC
RF exposure guidelines.
NOTICE: This device complies with part 15 of the FCC rules and
with RSS-210 of Industry Canada. Operation of this device is
subject to the following two conditions: (1) This device may not
cause harmful interference; (2) This device must accept
interference received including interference that may cause
undesired operation. Changes or modifications made to this
equipment not expressly approved by Braemar may void the FCC
authorization to operate this equipment.
Fusion MCT Wireless Recorder
Braemar Inc. Phone: [phone]
1285 Corporate Center Drive, Suite 150 Fax: [phone]
Eagan, MN 55121 USA E-Mail: [e-mail]
Copyright 2011, Braemar Inc. All rights reserved