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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: 

 

 

1.

 

Patients with potentially life-threatening arrhythmia who 
require inpatient monitoring.

  

 

 

2.

 

Patients who the attending physician thinks should be 
hospitalized.

  

 

 

Содержание Fusion MCT

Страница 1: ... 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...

Страница 2: ...se 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...

Страница 3: ... 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 ...

Страница 4: ...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...

Страница 5: ...ue 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 o...

Страница 6: ...e 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 start...

Страница 7: ...tecting 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 whil...

Страница 8: ...f 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 hardw...

Страница 9: ...me 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 tel...

Страница 10: ... 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 s...

Страница 11: ...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 a...

Страница 12: ... 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 B...

Страница 13: ...rhythmia 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 i...

Страница 14: ...Fusion MCT Wireless Recorder 25 Fusion MCT Wireless Recorder 26 ...

Страница 15: ...lection 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...

Страница 16: ...F 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 no...

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