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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:
Patients with potentially life-threatening arrhythmia who
1.
require inpatient monitoring.
Patients who the attending physician thinks should be
2.
hospitalized.
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Summary of Contents for Braemar Fusion MCT
- Page 1 Braemar, Inc. Indications for Use: Fusion MCT The device is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac Wireless Recorder arrhythmia. The device continuously monitors, automatically generates an alarm triggered by an arrhythmia detection algorithm...
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Page 2: Table Of Contents
The stated express warranties are in lieu of all obligations Establishing the Home Link ..............14 of liabilities on the part of Braemar for damages, including but not limited to, special indirect or consequential, arising out of or in Troubleshooting ..................20 connection with the use or performance of Braemar products. -
Page 3: Overview
Fusion MCT Wireless Recorder Fusion MCT Wireless Recorder Overview The Fusion MCT Wireless recorder is a battery operated, solid state Disclaimer recorder designed to record symptomatic as well as asymptomatic heart Operation of the Fusion recorder may be subject to governmental and arrhythmias. -
Page 4: Recorder Components
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. - Page 5 “Recording Complete” screen: The recorder still has data in it, Use good quality long term electrodes. Braemar you must erase all the data before setting up for the next recommends the use of low impedance Holter patient.
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Page 6: Lead 2 Channel Electrode Placement
Fusion MCT Wireless Recorder Fusion MCT Wireless Recorder 5. Connect snaps to electrodes. 3 Lead 2 Channel Electrode Placement 6. Plug the Patient Cable into recorder. 7. Observe LCD main menu screen. This is a typical electrode placement for a 3 lead 2 channel patient cable. - Page 7 Fusion MCT Wireless Recorder Fusion MCT Wireless Recorder Patient cable connection 3. Checking ECG signals: At this time, the patient leads should be connected to the electrodes, Using the left and right arrow buttons, select View ECG ( icon) the electrodes should be connected to the patient, and the patient and press the Enter button.
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Page 8: Start The Recording And Check Connection To Server
Fusion MCT Wireless Recorder Fusion MCT Wireless Recorder F. Although the device detection algorithms are very Patient Operating Instructions sophisticated, there is no guarantee that the device will catch all episodes of arrhythmia. Establishing the Home Link Start the Recording and Check Connection to Server... - Page 9 Fusion MCT Wireless Recorder Fusion MCT Wireless Recorder Home Link hardware overview: Installation of the Home Link modem: Bluetooth modem (top view) Bluetooth modem (back view) After installation of the Home Link, the patient must call the monitoring center to verify that the redundant data transfer system is able to...
- Page 10 Fusion MCT Wireless Recorder Fusion MCT Wireless Recorder Record ECG: ECG to be marked will be described by the physician. Recorder information: 1. Press the RECORD/ENTER button until an audible tone is heard, then release. The recorder should be ready when you receive it from the technician.
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Page 11: Troubleshooting
Fusion MCT Wireless Recorder Fusion MCT Wireless Recorder Troubleshooting Battery Change: Symptom Recommended Solution 1. Remove cable. No display Ensure batteries are inserted with correct polarity. 2. Open door. Will not record Ensure RECORD button has been pressed. 3. Pull ribbon. -
Page 12: Service And Maintenance
Recorder belt clip / Holster 100-1910-001 E-mail: service@braemarinc.com Operator manual 600-0645-00 Web: http://www.braemarinc.com AA Lithium Battery Pack 350-0294-00 USB 2.0 Data Cable 200-2792-001 Contact Braemar for further technical information. 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... -
Page 13: Electromagnetic Emissions
Fusion MCT Wireless Recorder Fusion MCT Wireless Recorder Specifications Electromagnetic Emissions Functional Fusion 2 channel Electromagnetic Sample rate 256 samples per second Emissions test Compliance User interface LCD display and sound environment - guidance Memory RF emissions Class B Fusion is suitable for use in all... - Page 14 Fusion MCT Wireless Recorder Fusion MCT Wireless Recorder...
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Page 15: Recommended Separation Distances
(transmitters) and Fusion as recommended below, according to the Changes or modifications made to this equipment not expressly maximum output power of the communications equipment. approved by Braemar, Inc. may void the FCC authorization to operate this equipment. Separation distance according to... - Page 16 (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. Braemar Inc.
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