Lohman Technologies AfibAlert Instruction Manual Download Page 22

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8. SPECIFICATIONS

Device Classification

Type 3 per ANSI/AAMI EC38:1998

Physical & Environmental

Size

5.88” X 2.75” X 1.11”

Weight (without batteries)

5 ounces

Weight (with batteries)

6.5 ounces

Cable connector

4-position, in-line safety

Operational temperature

0ºCt o+ 45ºC( +32ºFt o+ 113ºF)

Storage and transport

-120ºC to +60ºC (-4ºF to +140ºF)

General Electrical

Battery type

Two AAA 1.5V Eveready® X-92, Titanium Alkaline or equivalent

Battery life (used once daily)

27 days nominal

Memory Specifications

Maximum number of stored events

Maximum number of stored events
available for phone transmissions

Event length

45 seconds

Transmission System

Transmission media

Voice grade telephone line

Coupling

Acoustic

Modulation type

Center Frequency

1900 Hz – 100 Hz/mV sensitivity

Transmission speeds

1x (Times real Time)

Functional Features

User programmable

Low battery detection

Yes

Baseline Centering

Yes - automatic

Heart rate accuracy

±1 BPM - (Average for data collected, updated every three seconds)

Summary of Contents for AfibAlert

Page 2: ...ND IT IS POSSIBLE THAT OTHER CARDIAC ARRHYTHMIAS MAY BE PRESENT EVEN IF THE GREEN LIGHT ILLUMINATES AGAIN ITS ONLY PURPOSE IS TO DETECT THE PRESENCE OF ATRIAL FIBRILLATION Although the AfibAlert is highly accurate in the detection of Atrial Fibrillation certain cardiac rhythms and electrode contact failure can reduce the accuracy If you feel you are in Atrial Fibrillation or are unsure of your sym...

Page 3: ...SE 9 What the Lights Mean 9 Taking a Reading 10 Thumb Electrodes 10 Installing the Patient Cable 11 Wrist Electrodes 11 4 DATA TRANSMISSION 13 Uploading to the AfibAlert Web Site Using a USB Connection 13 Transmitting Using a Standard Analog Telephone 15 5 SOFTWARE UPDATES 16 Internet Software Updates 16 Mail In Updates 16 Resetting the ECG Data 17 6 MAINTENANCE AND SERVICE 18 Handling Precautions...

Page 4: ...re the test was complete 3 GREEN Light Circle with Checkmark Icon When lit at end of test it means that data has been successfully stored for later transmission If you are experiencing symptoms see page 7 you should transmit your data see page 13 If there is any question about the seriousness of the symptoms call 911 Also lights at end of successful data transmission or web upload 4 Side Mounted B...

Page 5: ...rpose The AfibAlert is a cardiac event recorder capable of storing 34 45 second events in solid state non volatile memory The AfibAlert allows patients who have been diagnosed with or are susceptible to developing Atrial Fibrillation to take periodic readings with a computerized heart rhythm monitor The system was developed for the patient who has been previously diagnosed with Atrial Fibrillation...

Page 6: ...ors 1 3 A normal heart rhythm 1 4 A heart rhythm experiencing Atrial Fibrillation A normal heart beat starts as a tiny impulse that originates in the sino atrial node S A node and as this pulse spreads throughout the heart it causes first the upper chambers atria to contract and then the lower ventricles forcing blood to flow to the lungs and throughout the body This process becomes unreliable whe...

Page 7: ...nd algorithm confusion Therefore regardless of whether or not the Red Light illuminates if you are symptomatic it is best to transmit or upload your ECG data for professional review How the AfibAlert Works The AfibAlert allows daily or even hourly checks of your heart rhythm Your physician needs to be contacted when the Red Light illuminates and or when you are experiencing concerning symptoms see...

Page 8: ... or designated service will be able to or your own review them For either a physician or receiving center to have direct data access you must authorize them to view your uploaded ECG data To request a physician or receiving center be provided access to your account submit a support request with their information from the AfibAlert application under the Support tab The AfibAlert will have periodic ...

Page 9: ...e page 13 Your physician may contact you and provide further instructions A GREEN Light will illuminate at the end of a test It means that data has been successfully stored for later transmission and the algorithm did not detect the likelihood of Atrial Fibrillation being present However if you are experiencing symptoms see page 7 contact your physician or receiving service and upload or transmit ...

Page 10: ...g the test Do not take the test during or immediately following exercise If subsequent readings are taken during the day it is best to relax for 5 10 minutes before taking the test Watch TV read a book or just sit and relax This provides the best opportunity for a high quality reading Using the Thumb Pad Electrodes Relax for 10 minutes before taking the reading Sit down or get in a comfortable pos...

Page 11: ...cket on the bottom of the AfibAlert The connector can only be inserted one direction Push the connector straight into the socket To remove the cable squeeze the connector and pull straight out Note The cable can remain connected to the recorder if the wrist electrodes will always be used Do not twist the cable connector when installing or removing 3 3 The cable can only be inserted in one directio...

Page 12: ...it a high low beep and all five lights will flash once The BLUE Light will illuminate while the recorder is taking the reading Three 3 dashes will flash on the LCD display until your heart rate reading is calculated and displayed Your heart rate will continue to appear in the display during the analysis process Continue with the test until a RED GREEN or YELLOW indicator light appears This will ta...

Page 13: ...ither a hard copy or an electronic form at time of purchase or can be downloaded as needed from the AfibAlert website It is recommended that you check to confirm you have the most recent version of the Installation Guidelines prior to installing or reinstalling the software The current version will always be available online Computer Minimum Requirements Windows 98SE Me 2000 XP Vista Windows 7 Win...

Page 14: ...ware update is indicated or if you want to upload your Recordings This will upload your Recordings to the Internet for your physician to review A progress bar will appear while this process takes place After the Recordings have been uploaded the progress bar will close When the word Disconnected appears next to the Device Status you may disconnect the USB cable from the recorder The recorder is no...

Page 15: ...transmitting only the most recent recording 1 When directed hold the recorder s speaker see image 4 1 next to the mouthpiece of the telephone Press and hold the Black Power button for three 3 seconds or until a single beep is heard Release the button After releasing the button you will hear a long tone and the BLUE icon will light 2 Be certain you are holding the recorder s speaker to the mouthpie...

Page 16: ... Device button if a software update is required 5 1 Screen shot of when your AfibAlert recorder indicates a software update is available for the device Note If the USB cable is unplugged or loss of power occurs while doing a software update your device will not function until you reconnect your AfibAlert and reopened your application You can follow the same process as above to complete the install...

Page 17: ...that allows the ECG data to be erased from device memory This will erase all saved ECG data stored in the memory It is not necessary to reset the device after each test New tests automatically replace the oldest data 1 Press and release the Black Power button The AfibAlert will emit a high low beep 2 As shown in the picture below immediately insert a paper clip ball point pen or similar item into ...

Page 18: ...the AfibAlert or allow liquid to enter through the openings Never use abrasive materials or chemicals to clean the AfibAlert Avoid dropping the AfibAlert Never expose the AfibAlert to dirt dust or extreme conditions Store the AfibAlert in its protective case whenever it is not being used Never leave the wrist straps or any other metal object in contact with the Thumb Electrodes for long periods of...

Page 19: ...th Remove batteries from devices that will be stored for extended periods Replace batteries with the size and type specified Remove all used batteries from the device at the same time and then replace them with new batteries of the same size and type Store batteries in a cool dry place at normal room temperature Never dispose of batteries in a fire they may rupture or leak Never carry loose batter...

Page 20: ...warranty This limited written warranty is provided in place of any other warranty express or implied TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW LOHMAN TECHNOLOGIES LLC DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE This LIMITED WRITTEN WARRANTY is your EXCLUSIVE REMEDY for product defe...

Page 21: ...ss Reset Button Arrow points to access hole Speaker TUV certification mark Date of manufacture B type body protected symbol This means that the applied part s so marked are suitable for connection to humans and animals provided there is no direct electrical connection to the heart and gives a basic level of protection against electric shock This applied part is not electrically isolated from mains...

Page 22: ...y type Two AAA 1 5V Eveready X 92 Titanium Alkaline or equivalent Battery life used once daily 27 days nominal Memory Specifications Maximum number of stored events 34 Maximum number of stored events available for phone transmissions 5 Event length 45 seconds Transmission System Transmission media Voice grade telephone line Coupling Acoustic Modulation type FM Center Frequency 1900 Hz 100 Hz mV se...

Page 23: ...d below The customer or the user of the AfibAlert should assure that it is used in such an environment Immunity Test IEC 60601 Compliance Electromagnetic Test level level environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air full compliance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative ...

Page 24: ...LC All Rights Reserved Page 24 of 24 9 CONTACT INFORMATION Lohman Technologies LLC N27 W23953 Paul Rd Ste 204 Pewaukee WI 53072 Phone 262 672 6232 Toll Free 866 321 AFIB 2342 Fax 888 494 8950 Email websupport lohmantech com SPEC 50006 Ver2 0 ...

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