Braemar FUSION Ambulatory Arrhythmia Monitoring Device User Manual Rev 09 Fusion Recorder Manual

Braemar Inc. Ambulatory Arrhythmia Monitoring Device Rev 09 Fusion Recorder Manual

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: 05 Date: February 2009
Fusion Wireless Recorder 1 Table of Contents Overview...................................................................................................2 Precautions...............................................................................................2 Disclaimer.................................................................................................3 Recorder Components..............................................................................4 Setup Steps ..............................................................................................5 Electrode Application and Placement .......................................................5 1/2/3 Channel Electrode Placement .........................................................6 3 Channel (5 lead) Electrode Placement (1st option)………………7 3 Channel (5 lead) Electrode Placement (2nd option)………………8 Recorder Preparation ...............................................................................9 Establishing the Home Link ....................................................................13 Troubleshooting (page 1 of 2).................................................................16 Service and Maintenance .......................................................................18 Service Items and Accessories...............................................................18 Equipment Symbols................................................................................19 Specifications .........................................................................................20 Electromagnetic Emissions.....................................................................21 Electromagnetic Immunity ......................................................................21 Recommended Separation Distances ....................................................24 Fusion Wireless Recorder 2 Overview The Fusion Wireless Recorder is a battery operated, solid state recorder designed to record symptomatic heart arrhythmias. The Fusion Recorder provides up to 20 days of total recording time for 3 channels, 30 days of total recording time for 1 or 2 channels with the AA Lithium battery pack. 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 Wireless Recorder 3 Disclaimer Operation of the Fusion Recorder may be subject to governmental and business restrictions, including but not limited to air travel and hospital visitations. 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 Wireless Recorder 4 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 Wireless Recorder 5 Setup Steps 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: 1. Connect leads and electrodes to patient. 2. Prepare Recorder for recording. A. Choose/Setup program options you want to use. B. Erase all previous data. 3. Connect Patient Cable to 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. Fusion Wireless Recorder 6 1/2/3 Channel Electrode Placement This is a typical electrode placement. Refer to Analysis System software and the physician for recommended positioning. 1, 2, and 3 Channel Electrode Placement Channel 1 = Red (1+), White (1-), Green (ground (RL)) Channel 2 = Red (1+), White (1-/2-), Black (2+), Green (ground (RL)) Channel 3 = Brown (1+), Red (1-/2-), Black (2+,3+), White (3-), Green (ground (RL))
Fusion Wireless Recorder 7 3 Channel (5 lead) Electrode Placement (1st option) Five color-coded leadwires are used to create a 3-channel ECG recording. This is a typical electrode placement. Refer to your Analysis System software and the physician for a recommended position. 5 Lead Electrode Placement # Channel Color Location 1 3- White Next to the right Manubrium border on the Clavicle 2 1-, 2- Red Centered on the Manubrium 3 2+, 3+ Black Lower left rib margin over bone. 4 1+ Brown Left Anterior Auxiliary line on the 6th rib 5 Green Lower right rib margin over bone. Fusion Wireless Recorder 8 3 Channel (5 lead) Electrode Placement (2nd option) Five color-coded leadwires are used to create a 3-channel ECG recording. This is a typical electrode placement. Refer to your Analysis System software and the physician for a recommended position. Figure 4 - 5 Lead Electrode Placement # Channel Color Placement 1 3- White Right side below the V1 position, at the bottom of the rib cage 2 1-, 2- Red Center on the Manubrium, the top of the sternum 3 2+, 3+ Black Left side at the V5 position, on a rib 4 1+ Brown Left side at the V3 position, on a rib 5 Green Right side opposite V5 position.
Fusion Wireless Recorder 9 Recorder Preparation 1. General setup: Remove the Patient Cable if it is connected to the Recorder. Open the battery compartment by sliding battery door upward. Install the AA Lithium battery pack. Observe proper battery polarity. The Recorder will sound rising tones after completion of power up. After a few seconds, the splash screen will appear. If a patient cable is not connected, a message indicating that a cable is not connected will be displayed. Please insert a patient cable to exit the splash screen and enter the Setup (New Recording) Menu with the battery level in the upper right corner. The battery level should be near 100%. All button presses should beep to provide feedback for the user. The backlight for the display is on while accessing the Menus, after recording a manual event, or after receiving a text message. The backlight will remain off during normal recording. 2. Erase Data: If the Recorder still has data and the Recording is Complete, you must erase all the data before setting up the Recorder for the next patient. A. Remove the Patient Cable. B. Press the Left and Right buttons together and it will prompt you to Erase Data. C. Press the Enter button to erase the data. The display will have the message “Recorder Empty”. D. Insert the patient cable, press the Left and Right buttons together, and the Setup (New Recording) Menu will appear with the battery level in the upper right corner. The battery level should be near 100%. Fusion Wireless Recorder 10 If 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. A. Remove the Patient Cable. B. Press the Left and Right buttons together and it will prompt you if you want to Stop Recording. C. Press the Enter button to stop recording the data and the Recording Complete screen will appear. D. Continue to erase the data by following the steps above. 3. Preliminary Setup: At this time, the patient leads should be connected to the electrodes and the electrodes should be connected to the patient. Using the left and right arrow buttons, select the “ ” to check the lead status then press the “ ” button, also called Enter, to select the menu option. Any leads are disconnected will have a caution symbol (“ ”) next to it and a “Lead Error” will be displayed. Also, the “ ” changes to “ ” when there is lead loss in the Current Menu icon and in the Setup (New Recording) Menu. 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 (New Recording) Menu. Lastly, use the left and right buttons to select the View ECG option, “ ”, and press Enter to check the ECG measurements. You can
Fusion Wireless Recorder 11 look through all the available channels by pressing the Left and Right buttons. If any channel is not available due to an error detecting a lead, a “Lead Error” message will be displayed for only those affected channels. If the cable becomes disconnected, all channels will display “No Cable”. To enter or exit zoom mode, press the Left and Right buttons together 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. If the data looks good, press the Enter button to return to the Setup (New Recording) Menu. If necessary, use the right and left arrow buttons to select the “?” and press Enter for the About Screen. This screen displays the Model, Serial Number, Recorder Firmware version, the current Time, and the current Date. General notes: A. Lead loss and Pacer detection is on all the time. B. The number of channels a Patient Cable contains will determine the number of channels the Recorder will record. C. Although the device detection algorithms are very sophisticated, there is no guarantee that the device will catch all episodes of arrhythmia. Fusion Wireless Recorder 12 4. Programming the Fusion Recorder: 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. 5. The Recorder is ready to record data. Once all setup is complete, start the recording. The Recording screen should now be displayed. Depending on the connection status to the server, the Recording screen could be displayed in the following way:
Fusion Wireless Recorder 13 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, typically located on the nightstand or 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 100 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. After installation of the Home Link, the patient will contact the monitoring center to verify that the redundant data transfer system is functioning. The Fusion Recorder and Home Link modem wireless connection are already preset by the Braemar factory. Follow the directions provided with the Home Link hardware to connect the modem to the patient’s telephone line. After installation of the Home Link, the patient will contact the monitoring center to verify that the redundant data transfer system is functioning. Fusion Wireless Recorder 14 Patient Operating Instructions 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.
Fusion Wireless Recorder 15 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, which should only last a few seconds, but continue breathing. 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 the arrow keys or 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. To Download via USB: Once the recording is finished, remove the patient cable from the recorder. Connect the recorder to a PC running at the service center. Software on the PC will download the ECG as needed. There is no patient interaction with USB and USB cables cannot be connected while a patient cable is connected. Fusion Wireless Recorder 16 Troubleshooting (page 1 of 2) 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
Fusion Wireless Recorder 17 Troubleshooting (page 2 of 2) 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). Noise artifact on recorded ECG at patient location Move electrodes slightly to the right or left of the original location. Rising tone Ready to record Fusion Wireless Recorder 18 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 belt clip. Remove any adhesives from the patient lead wires with an adhesive tape remover solution or swab. Use a mild disinfectant. 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 on the next page. 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, 3 channel, 5 lead 350-0302-00 Patient Cable, 2 channel, 4 lead 350-0302-01 Patient Cable, 1 channel, 3 lead 350-0302-02 Patient Cable, 1 channel, 2 lead 350-0302-03 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
Fusion Wireless Recorder 19 Equipment Symbols Symbol Description Type B Applied Part Consult manual SN Serial Number 0086 Complies with the Medical Device Directive of the European Union. 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. Date of Manufacture Bluetooth trademark indicating conformity to specifications Manufacturer: Braemar, Inc. 1285 Corporate Center Drive, Suite 150 Eagan, MN 55121 USA Phone: 800.328.2719 651.286.8620 Fax: 651.286.8630 E-mail: service@braemarinc.com Web: http://www.braemarinc.com Contact Braemar for further technical information. Authorized European Rep: QNET BV Hommerterweg 286 6436 AM Amstenrade The Netherlands Fusion Wireless Recorder 20 Specifications Functional Fusion 1, 2, or 3 channel Sample rate 256 samples per second User interface LCD display and sound Memory Max total record time One channel 30 days Two channel 30 days Three channel 20 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 80Hz 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 500 transmissions Remove batteries during storage Warranty 12 months from shipment
Fusion Wireless Recorder 21 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 Wireless Recorder 22
Fusion Wireless Recorder 23 Fusion Wireless Recorder 24 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 d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is 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 Wireless Recorder 25 FCC 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 (manufacturer name) 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. 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. The level of energy emitted is far less than the electromagnetic energy emitted by wireless devices such as mobile phones SAR value of 0.522W/kg max. 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 pouch 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 (manufacturer name) may void the FCC authorization to operate this equipment.
Braemar Inc. Phone: 800.328.2719 1285 Corporate Center Drive, Suite 150 Fax: 651.286.8630 Eagan, MN 55121 USA E-Mail: Service@BraemarInc.com Copyright 2008, Braemar Inc. All rights reserved

Navigation menu