Braemar FUSIONMCT User Manual

Braemar, Inc.

Fusion

Wireless

Recorder

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.

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: 21 Date: June 2010

Fusion Wireless Recorder

Table of Contents

Overview...................................................................................................2

Precautions...............................................................................................2

Disclaimer.................................................................................................3

Recorder Components..............................................................................4

Setup Steps ..............................................................................................5

Electrode Application and Placement .......................................................7

1/2/3 Channel Electrode Placement .........................................................8

3 Channel (5 lead) Electrode Placement (1st option)………………9

3 Channel (5 lead) Electrode Placement (2nd option)………………10

Recorder Preparation ............................... Error! Bookmark not defined.

Establishing the Home Link ....................................................................14

Troubleshooting (page 1 of 2).................................................................19

Service and Maintenance .......................................................................21

Service Items and Accessories...............................................................21

Equipment Symbols................................................................................22

Overview

The Fusion Wireless recorder is a battery operated, solid state recorder designed to record symptomatic heart arrhythmias.

The Fusion recorder provides up to xx days of total recording time for 3 channels, xx days of total recording time for 1 or 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.

Specifications .........................................................................................23

Electromagnetic Emissions.....................................................................24

Electromagnetic Immunity ......................................................................24

Recommended Separation Distances ....................................................27

Fusion Wireless Recorder

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

Recorder Components

Batteries

Patient Cable

Caution: U.S. Federal law restricts this device to sale by or on the

order of a physician.

3.6V AA Lithium battery pack. Insert into battery compartment observing polarity symbols.

To adjust, move plastic slip rings up or down to keep leads together. To lengthen, pull leads apart.

Fusion Wireless Recorder

Setup Steps

DO NOT ENROLL PATIENT IN SOFTWARE UNTIL INSTRUCED TO DO SO

This manual is designed to allow a technician to follow the instructions page by page to setup 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 you may be

greeted with 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.

“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”.

Press the Enter button to erase the data. The display will have the message “Recorder Empty”.

Continue setting up the recorder by following to 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

5. Connect snaps to electrodes

6. Plug 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 Wireless Recorder

Electrode Application and Placement

For each electrode lead wire:

1. Snap the electrode onto the lead wire.

2. Remove the protective backing from the adhesive side of the

electrode.

3. Apply the electrode to the patient’s skin per Electrode Placement

diagram in this manual or as instructed by the physician.

Notes:

A. It is recommended that trained medical personnel instruct the

patient in the proper application of electrodes.

B. 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.)

C. 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 abraeded.

D. Any loose electrode needs to be replaced.

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-),

Channel 2 = Black (2+), White (1-)

+ 11 hidden pages

Braemar FUSIONMCT User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual