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 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 ............................... 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Establishing the Home Link ....................................................................14 Troubleshooting (page 1 of 2).................................................................19 Service and Maintenance .......................................................................21 Service Items and Accessories...............................................................21 Equipment Symbols................................................................................22 Specifications .........................................................................................23 Electromagnetic Emissions.....................................................................24 Electromagnetic Immunity ......................................................................24 Recommended Separation Distances ....................................................27 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. 1 2 Fusion Wireless Recorder Fusion Wireless Recorder Recorder Components 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 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. 4 3 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. 2. 3. If the recorder contains batteries, and/or a cable remove them and insure the screen is blank before proceeding 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. 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. 5 Fusion Wireless Recorder 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 6 Fusion Wireless Recorder 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 patients 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-) 7 8 Fusion Wireless Recorder Fusion Wireless Recorder 3 Channel (5 lead) Electrode Placement (1st option) 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. 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
1 2 3 4 5 Channel Color 3-
White 1-, 2-
2+, 3+
1+
Red Black Brown Green Location Next to the right Manubrium border on the Clavicle Centered on the Manubrium Lower left rib margin over bone. Left Anterior Auxiliary line on the 6th rib Lower right rib margin over bone. 9 Figure 4 - 5 Lead Electrode Placement Channel Color 3-
White 1-, 2-
Red 2+, 3+
1+
Black Brown Green Placement Right side below the V1 position, at the bottom of the rib cage Center on the Manubrium, the top of the sternum Left side at the V5 position, on a rib Left side at the V3 position, on a rib Right side opposite V5 position. 10
1 2 3 4 5 Fusion Wireless Recorder Fusion Wireless Recorder 1. Patient cable connection 3. Checking ECG signals:
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. 2. Checking lead connections:
Setup Menu Overview Using the left and right arrow buttons, select Lead Status
lead so make sure each of them has a good connection. icons) and press the Enter button. Check the status of the or 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. Using the left and right arrow buttons, select View ECG (
and press the Enter button. icon) 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 channels. 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 (
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.
) will 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. 11 12 Fusion Wireless Recorder Fusion Wireless Recorder 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 an so there will only be the battery icon in the upper right corner. 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 complete enrollment of the patient with the recorder. 13 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. 14 Fusion Wireless Recorder Fusion Wireless Recorder Home Link hardware overview:
Installation of the Home Link modem:
Bluetooth modem (top view) Bluetooth modem (back view) Telephone cord Bluetooth modem power adapter Male phone splitter Female phone splitter 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. 15 16 Fusion Wireless Recorder Fusion Wireless Recorder 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. Insert the recorder into the holster and clip holster to belt or similar clothing. 5. 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 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 isnt any patient interaction required for this transmission to occur. Battery Change:
Remove cable Open door Pull ribbon Check for blank screen Insert new battery watching for correct polarity 17 18 Fusion Wireless Recorder Fusion Wireless Recorder Troubleshooting (page 2 of 2) Noise artifact on recorded ECG at patient location Rising tone 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. Ready to record Close door. Troubleshooting (page 1 of 2) Symptom No display Will not record recorder stops recording Enter button pushed but a recording does not start Recorder will not turn off after removing batteries Bluetooth connection does not allow dial out Recommended Solution Ensure batteries are inserted with correct polarity. Ensure RECORD button has been pressed. Ensure Patient Cable is inserted completely. Patient cable must be inserted with a good connection to patient before an event recording starts. 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. Check the BT -> RS232 switch on the back of the Bluetooth modem. It should be set to BT 19 20 Fusion Wireless Recorder Fusion Wireless Recorder 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 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 isnt any preventative inspection or maintenance that can be performed by the end user. Service Items and Accessories Note: Only authorized accessories are permitted. Description Patient Cable, 3 channel, 5 lead Patient Cable, 2 channel, 4 lead Patient Cable, 1 channel, 3 lead Patient Cable, 1 channel, 2 lead Patient Cable, 2 channel, 3 lead Recorder belt clip / Holster Operator manual AA Lithium Battery Pack USB 2.0 Data Cable Phone splitter-Male Phone splitter-Female Phone cord, 6ft, RJ-11 Bluetooth modem Part Number 350-0302-00 350-0302-01 350-0302-02 350-0302-03 350-0302-04 100-1910-001 600-0645-00 350-0294-00 200-2792-001 200-2899-001 200-2900-001 200-2893-001 350-0308-00 21 Equipment Symbols Symbol Description SN 0086 Type B Applied Part Consult manual Serial Number 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 800.328.2719 Phone:
651.286.8620 651.286.8630 Fax:
E-mail:
service@braemarinc.com http://www.braemarinc.com Web:
Contact Braemar for further technical information. Authorized European Rep:
QNET BV Hommerterweg 286 6436 AM Amstenrade The Netherlands 22 Fusion Wireless Recorder Fusion Wireless Recorder Specifications Functional Fusion Sample rate User interface Memory Max total record time Type Data retention Physical Dimensions One channel Two channel Three channel Weight with batteries Enclosure Operating position Electrical Input impedance CMR ratio AC signal range DC signal range Resolution Frequency response FCC ID IC ID Environmental Operating temperature Non-operating temperature Operating humidity Non-Operating humidity Battery Type Life Warranty 1, 2, or 3 channel 256 samples per second LCD display and sound 30 days 30 days 20 days Flash Non-volatile 4.1"x 2.25"x .75"
5.5 oz. Molded plastic Any orientation 10M min. 60dB
+/- 5mV
+/- 300mV 12 bits
.05Hz to 80Hz HHMFUSIONMCT 9158A-FUSION 0C to +45C
-20C to +65C 10% to 95% without condensation 5% to 95% without condensation
(2) AA Lithium Thionyl 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 12 months from shipment 23 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 Electrostatic discharge (ESD) IEC 61000-4-2 Power frequency
(50/60 Hz) magnetic field IEC 61000-4-8 IEC 60601 Compliance Electromagnetic test level level environment - guidance 6 kV contact 6 kV contact 8 kV air 8 kV air 3 A/m 3 A/m 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 magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 24 Fusion Wireless Recorder Fusion Wireless Recorder 25 26 Fusion Wireless Recorder Fusion Wireless Recorder 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. Rated maximum output power of transmitter W 0,01 0,1 1 10 100 Separation distance according to frequency of transmitter 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 0,12 0,38 1,2 3,8 12 0,12 0,38 1,2 3,8 12 0,23 0,73 2,3 7,3 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. 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 (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. 27 28 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 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 (manufacturer name) may void the FCC authorization to operate this equipment. Braemar Inc. 1285 Corporate Center Drive, Suite 150 Eagan, MN 55121 USA Copyright 2010, Braemar Inc. All rights reserved Phone: 800.328.2719 Fax: 651.286.8630 E-Mail: Service@BraemarInc.com