Eko Devices E5 EKG and digital stethoscope device(BLE) User Manual

Eko Devices, Inc. EKG and digital stethoscope device(BLE) Users Manual

UserManual.wiki >

Users Manual

User Manual, Model E5

P.2The Eko Model E5 System is designed to support healthcare professionals in analyzing cardiac and other internal organ sounds. The Eko Model E5 System includes a device capturing heart sounds and ECG readings (herein referred to as DUO), a smartphone application (App), and a web application (Dashboard).DUO features audio and ECG data transmission via Bluetooth that allows the user to open and playback sounds and visualize phonocardiograms (PCG) and electrocardiograms (ECG) in a mobile application on compatible iOS smartphones and tablets. The App provides the ability to save audio recordings and waveforms (PCG and ECG) within Electronic Health Record (EHR) systems, share patient recordings with other practitioners, and annotate notes on recorded audio. Eko is intended for use on pediatric and adult patients. The device is not intended for infants weighing less than 10 kg.CAUTION: Federal (USA) law restricts this device to sale to or on the order of a clinician.For general and product related comments, questions, or concerns, please contact Eko Devices, Inc. directlyPlease report any injury or adverse event to Eko using any of the contact methods below.Eko Devices, Inc.2600 10th St. Suite 260Berkeley, CA 94710USAGeneral Assistance and FAQsekodevices.com/getstartedDirect Contactsupport@ekodevices.comPhone Support1.844.356.3384Product Reference and Informationwww.ekodevices.com1.1Introduction, Warnings, and Safety1.2For Help and AssistanceConsult instructions for use.This product contains electrical and electronic components and must not be disposed of using standard refuse collection. Please consult local directives for disposal of electrical and electronic equipment.This product and packaging does not contain natural rubber latex.This product contains an intentional RF radiator certied by the FCC.Catalog NumberLot NumberSerial NumberHumidity Limit (Operational)Temperature Limit (Operational)This product is provided non-sterile. Do not attempt to re-sterilize the device.This product uses wireless Bluetooth communicationBF Applied PartContents (Quantity)Protection against dust and water jets when earpieces are attached. The earpieces are not IP protected.MR Unsafe1.3Safety Related Labels & SymbolsLATEX10%95%45° C113° F10° C50° FNONSTERILESNLOTREFIP55

P.3CAUTION•To reduce the risk of device interference, keepDUO at least 2 meters away from all RF emittersincluding Wi routers and radios when operatingor charging.•To reduce the risks associated with infectionfollow all cleaning and disinfecting instructionsincluded in this manual. Establish and follow acleaning and disinfecting schedule after each use.•To reduce the risks associated with inaccuratedata acquisition store and operate this device onlyas instructed in this manual. It is recommendedthat the battery be recharged within thirty minutesof the LED indicator turning red. Recharge thebattery using only the wireless charging padprovided with the device.•DO NOT immerse the device in a liquid or subjectit to any sterilization processes other than thosedescribed in this manual. The device is non-sterile.•To reduce the risks associated with very strongelectromagnetic elds avoid using the devicenear strong radio frequency (RF) signals orportable and/or mobile RF devices. If suddenor unexpected sounds are heard, move awayfrom any radio transmitting antennas. Usingaccessories, transducers, and cables notproduced by Eko may result in increased RFemissions or decreased immunity of DUO.•Please read, understand, and follow all safetyinformation contained in these instructions priorto using DUO. It is recommended that theseinstructions be retained for future reference.•DUO contains a Bluetooth Class 2 wirelessdata link. The maximum radio frequency eldstrength generated by the device is below threevolts per meter, a level that is considered safe touse with other medical devices. However, audio,video, and other similar equipment may causeelectromagnetic interference. If such devices areencountered and cause interference, immediatelymove DUO away from that device and/or turn theBluetooth feature OFF.•To reduce the risks associated withenvironmental contamination follow applicableregulations when disposing of this device. DUOcontains a rechargeable battery; please properlydispose of the device as mandated by localdirectives.•No modication of this equipment is allowed.There are no repairable parts inside DUO.•Disperse any static electricity before using theunit.•Warning: MR-unsafe! Do not expose the deviceto a magnetic resonance (MR) environment. Thedevice may present a risk of projectile injury dueto the presence of ferromagnetic materials thatcan be attracted by the MR magnet core. Thermalinjury and burns may occur due to the metalcomponents of the device that can heat duringMR scanning. The device may generate artifactsin the MR image. The device may not functionproperly due to the strong magnetic and radiofrequency elds generated by the MR scanner.•This device does not detect or measure all heartrate, heart rhythm and heart waveform changes.•The device has not been tested for use on infantsweighing less than 10kgs.•Conductive parts of electrodes and associatedconnectors for Type BF Applied Parts, includingthe neutral electrode, should not contact otherconductive parts including earth.•Do not use DUO while it is charging.•Do not use on patients with cardiac pacemakersor other electronic implanted devices.•Do not use the DUO on a portion of the body withtoo much body fat, body hair or very dry skin, asuccessful recording may not be possible.•Do not use DUO while charging your mobiledevice, this will cause electrical interference withthe ECG signal.•Do not store the DUO in extremely hot, cold,humid, or wet conditions.•Do not expose to strong electromagnetic elds.•Do not use as sole basis for medication ortreatment decisions.•Do not take a recording if the electrodes are dirty.Clean them rst.•Do not use the DUO over broken skin or woundareas.1.4Caution

P.41.5Skin PreparationExcessive hair, dirty skin, dry skin, or oily skin can impact the quality of the ECG tracing. Clean the patient's skin with water and soap and remove excess hair as needed to achieve the highest quality tracing. Do not use the DUO over wound areas or areas of broken skin. Do not use an alcohol based skin cleaner as this dries out the patient's skin and increases resistance. Dry the skin vigorously to increase capillary blood ow to the tissues.ECG gels or saline solutions can be used on the electrodes to improve signal quality.FCC Intentional Radiator Certi icationFCC ID: 2ANB3-E5 IC:23063-E5 This equipment contains an intentional radiator approved by the FCC under the FCC ID numbers shown above. This device complies with Part 15 of the FCC rules. 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 undesirable operation.NO MODIFICATION: Modications to this device shall not be made without the written consent of Eko Devices, Inc. Unauthorized modications may void the authority granted under Federal Communications Commission rules permitting the operation of this device.EMC Compliance EuropeThis equipment complies with the EMC requirements of the IEC 60601-1-2.1.6EMC ComplianceTo ensure a proper ECG and PCG recording, clean the electrodes with an alcohol-based cleaning solution prior to use.Cleaning and Disinfecting ProcedureThe device and earpieces should be cleaned between each patient use. All cleaning instructions pertaining to stethoscopes and ECG units in general apply. Under normal conditions it is unnecessary to separate the device from the earpieces for cleaning. All external parts of the hardware can be cleaned with 70% isopropyl alcohol wipes. NOTE: DO NOT immerse the device in any liquid or subject it to any high-pressure/autoclave sterilization processes.1.7CleaningRSS-GEN, Sec. 7.1.3This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.Le pr sent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils radio exempts de licence. L’exploitation est autoris e aux deux conditions suivantes : (1) l’appareil ne doit pas produire de brouillage, et (2) l’utilisateur de l’appareil doit accepter tout brouillage radio lectrique subi, m me si le brouillage est susceptible d’en compromettre le fonctionnement. Caution: Any changes or modifications to this device not explicitly approved by manufacturer could void your authority to operate thisequipment.Attention: Les changements ou modifications de cet appareil non express ment approuv par le fabricant peuvent annuler votre droit utiliser cet quipement.

P.5The device is intended to be prescribed by licensed medical professionals. The device may be used on patients during a physical assessment in a clinical setting or by patients with a prescription and under the supervision of a clinician. The system provides one source of data that is signicant only when used in conjunction with clinician oversight and consideration of other relevant patient information.DUO should be used only by qualied clinicians or prescribed to patients with an adequate understanding of the device. DUO is intended for use on patients that can be auscultated on normally with an acoustic stethoscope. This manual provides instructions for the use of DUO and the Eko App. It is assumed that the user is familiar with basic mobile application use on iOS™ and Android™ devices.Standard procedures for auscultation should be followed including background noise reduction and optimal patient positioning. The quality of the ECG is dependent on proper preparation practices including, but not limited to, patient body temperature and clean contact area.The device uses a Bluetooth Class 2 wireless data link. The Bluetooth range will be reduced when objects (walls, furniture, people, etc) are between DUO and a paired mobile device. To improve Bluetooth connection, reduce the distance and/or allow a line of sight between DUO and the mobile device.In order to transmit sounds and record electrical activity to the Eko App, DUO and the mobile device must be connected via Bluetooth, and in order to fully use certain functions, the mobile device must be connected to the internet.It is highly recommended that users of the mobile App and web Dashboard use device and networking security features to protect patient data created and stored using this software, in addition to security features embedded in the system. NOTICE: Some of the features of the Eko App require a minimum internet connection speed. The minimum recommended upload speed for the mobile app is 4000 Kbps. 4G cellular data service or similar is recommended for the App.The app can be used to visualize waveforms and tracings without an internet connection, however an internet connection is necessary to save the data.1.8Precautions

P.6The Eko Model E5 System is intended to be used by healthcare professionals to electronically amplify, lter, and transfer body sounds and single-channel electrocardiogram (ECG) waveforms. The Eko Model E5 System also displays ECG waveforms and phonocardiogram waveforms on the accompanying mobile application for storage and sharing (when prescribed or used under the care of a physician). It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds, and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary, or abdominal organ systems. The device can be used on adults and pediatrics.The data offered by the device is only signicant when used in conjunction with physician over read as well as consideration of other relevant patient data.The device should not be used on infants weighing less than 10kg.1.9Indications for UseThe privacy of patient health information may be protected by state, federal, or international/foreign laws that regulate how such information can be used, stored, transmitted, and disclosed. The Eko system employs security features that are compliant with HIPAA policies. Third party access may be prohibited to such information without obtaining written authorization from the patient.The user is fully responsible for understanding and following all laws that regulate storage, transmission, and disclosure of any electronic patient data through the use of software. If the user becomes unable to comply with a law or restriction that applies to use and disclosure of such data, the user should not proceed to collect or save such information. This application may require entry of individually identiable health information in order to function. Records are stored and recalled through the use of patient name, date of birth, and/or patient ID number. By entering this information, the user assumes any and all risks of and liabilities incurred with using or transmitting such information. This package includes(1) Eko DUO(1) Wireless Touch Charging Pad(1) 5W / 2A USB Power Adapter(1) Micro USB to USB Cable(1) Eko EARPIECE(6) Silicone Rubber Eartips(1) Getting Started Instruction CardFor full functionality, the system requires users to connect their DUO with an internet-enabled smart mobile device using the Eko App (not included). The App supports many Apple® and Android™ mobile devices.NOTE: DUO can be used with other audio equipment or headphones through the 3.5mm audio jack. However, no performance guarantees are claimed using other audio products.System RequirementsThe mobile app software can be used with iPhone® 4S, 5, 5C, 5S, 6, 6 Plus, 6s, 6SE, 6S Plus, iPad Mini™ 2, 3, iPad Air®/Air 2, and iPad® 3rd/4th generations with iOS 7.0+ and at least 25MB of free memory. DUO uses Bluetooth® Smart; mobile devices used must be compatible with Bluetooth® Smart.Apple®, iPhone®, iPad®, iPad Air®, and iPad Mini™ are registered trademarks of Apple, Inc.Bluetooth® is a registered trademark of Bluetooth SIG, Inc.1.10Patient Privacy1.11Contents and Operation

P.7Install included EARPIECE by plugging the audio jack into the 3.5mm audio port at the base of DUO and tightening the threads.To charge DUO, place the device on the Wireless Touch Charging Pad. Connect the charging pad to a power source using the included USB charging cable and power adapter. The LED light ring on DUO will begin to ash to signal the charging status. All of the LEDs in the ring will light up when the device is fully charged. DUO should be periodically recharged even when in storage. Lithium ion batteries slowly lose charge when in storage and may fall to an unacceptably low level, damaging the battery. NOTE: DUO will not operate or connect to the Eko App while charging.2.1Setup2.2ChargingMicro USBWireless Touch Charging PadEARPIECE

P.8To Do This LED Ring ResponsePower On / Off Press and hold the action button for two seconds.The active LED turns on/offChange audio lters Press the action button once. The active LED rotates to a new position corresponding to the lter type.3.1DUO Use2sDUO is controlled using the action button located on the top face. An LED ring illuminates when the device is powered on.Power Save ModeDUO will automatically power off after 5 minutes of continuous inactivity. To resume DUO, press and hold the action button for two seconds.Volume ControlThe device’s sound level can be amplied in 12 increments. Change the volume level by pressing the top (+) and bottom (-) of the volume button on the side of the device. Increasing the volume by one level can be conrmed by the increasing number of LEDs lit in the LED ring.+–

P.9The device is OFF. All functions of the device are disabled. The device is ON but not paired. Active LED blnks every 1.5 seconds. The device is discoverable and ready to connect via Bluetooth.The device is ON and paired with a phone/tablet. Active LED is lit and solid. The device is streaming live audio and ECG to the paired device.The device is ON and playing back sounds and waveforms from a paired phone/tablet. LEDs in LED ring light up based on volume level. The device is ON. The lter change is indicated by the active LED in the LED ring rotating to a new position. The device is ON and has low battery. The red warning LED turns on. Device functions normally. The device is ON and its battery level is below 10%. The LED ashes rapidly for 4 seconds, then turns off. The device will no longer stream or playback audio or ECG. The device is OFF and is charging. The percent of charge completed is indicated by the fullness of the LED ring. The device is OFF and fully charged. This is indicated by an LED ring with all 12 of the LEDs lit and solid. 3.2DUO Use

P.103.3DUO UseDUO can be used on various locations and orientations of the chest. Each position will produce a unique heart sound and ECG tracing.PCGCapture sounds by placing DUO anywhere on the body. For best audio, press the device rmly against the skin to ensure good contact.ECGCapture ECG by placing and orienting DUO on the chest. The optimal position to capture ECG data is at an inward-facing 45° angle at the upper left pectoral below the clavicle. If the patient has particularly dry skin, body fat or hair, conductive gel used with other ECG systems may be used to improve the quality of the data.Electrodes Diaphragm

P.11EnvironmentalThe operating range of the Core is 10° to 40°C (50 to 113°F), and 10% to 95% relative humidity. The storage and transport range is -10° to 60° and 10% to 95% relative humidity. Acceptable pressure is 1 atm.It is recommended to avoid exposure to extreme heat, cold, solvents and oils. Extreme heats and colds will negatively affect the lithium ion battery in the device, and may affect battery life.Operating WarningsFailure to follow care and maintenance recommendations could result in damage to the internal components of the device. Internal damage to the product could cause malfunction of the product, possibly leading to complete loss of function. If problems are encountered with the device, do not attempt to repair it. Please notify our support team for assistance. Eko provides a limited warranty for DUO.Please visit ekodevices.com/warranty for a full description of the warranty.5.1Operating Conditions6.1Warranty

P.12Installation for iPhone® Open the App Store® using a supported mobile device. Ensure that the device is connected to the internet and search for the Eko Stethoscope App. Follow the instructions to download the App and wait until it has nished installing.Installation for iPad®Open the App Store® using a supported iPad model. Ensure that the device is connected to the internet. When searching the app store for the Eko Stethoscope App, make sure to select “iPhone Only” from the search options. Follow the instructions to download the App and wait until it has nished installing.For more information, visit http://ekodevices.desk.com/customer/en/portal/articles/1992653-how-do-i-download-the-eko-app-Log In with Username and PasswordOpen the Eko App on the mobile device. When prompted, create a new account, or enter your existing username and password.Log in with PINNew users are encouraged to set up a 4-digit login PIN to simplify the login process on the Eko mobile app.To create or edit a login PIN manually, select the Menu icon on the top left of the home screen. Select Account Settings > PIN and follow the onscreen instructions. To modify your PIN, you need to enter the number twice for verication purposes.Bluetooth PairingBluetooth must be enabled in the smartphone or tablet’s Bluetooth settings in order to use the device with the Eko App. First, enable Bluetooth on the selected mobile device. On the iOS device go to Settings > Bluetooth > and tap the slider to turn Bluetooth ON. Open the Eko App and login to your account. Press "Connect Device" and follow the onscreen instructions to pair with your DUO.The mobile device is now ready to record sounds and display waveforms from DUO. If Bluetooth pairing is unsuccessful, an error message will appear in the App and no sounds will be recorded. If Blueooth pairing is successful a waveform will be displayed on the app.7.1Eko App Use9W X Y Z8T U V7P Q R S6M N O5J K L4G H I3D E F2A B C10DeleteEmailtap in your code89%AT&T1:45 PM

P.13Capture & Save Recordings using the Mobile App Open the Eko Mobile App and log in. Ensure that DUO is paired to the mobile device (See Bluetooth Pairing). To associate the recording with a body position, select the target icon on the top center of the screen. Use the gure and icons to select the most appropriate position.Press the circular button to begin recording. Press the square button (in the same location as start button) to stop and save the recording.Adding Notes to Recordings on Mobile AppTo create notes on any patient recordings, log into the mobile application. Access the list of patients by selecting the patients tab on the top right of the home screen. Select the desired patient and select a recording to add notes to. Scroll to the bottom of the recording screen. Select “Add Comment” and begin typing your note. Select the the check mark to save.Sharing from the Eko Mobile AppPatients and recordings can be shared to other clinicians and collaborators within the Eko App. Navigate to the patient list by selecting the top right tab and selecting the patient to be shared. Select the sharing icon on the top right of screen and select the preferred method of sharing. Press the checkmark to complete the process. NOTE: Only the original creator of a patient account is granted access to share patient prole with a collaborator.7.2Eko App Use89%AT&T1:45 PMHill, ThomasCrouch, Tyler89%AT&T1:45 PMHeart - AorticAdd Note…June 6, 2016 - AorticCrouch, Tyler00:0000:00

P.14The Main Recording Screen allows users to view audio data captured by the device, begin the recording process, retrieve patient-specic data, or adjust settings. Audio data is represented in real-time as a phonocardiogram and the ECG waveform. The grid behind the waveform denotes 25mm/s and 10mm/mV.7.3Main Recording Screen89%AT&T1:45 PMHill, ThomasSettingsModify BluetoothAdjust VolumeChange Audio Source iPhone speakers or DUOEarpiecesAdjust Account Details Name Username Password/PIN Contact InformationAudio WaveformRetrieved from deviceTap to RecordECG WaveformRetrieved from devicePatient SelectionCreate a patient-specic recordingsReview patient recordsImport patients from select EHR systemsRecording SetupSelect Position

P.15The Settings icon on the Main Recording Screen allows the user to access Bluetooth pairing to the device, remaining battery charge level of a connected device, playback volume, view mode, grid settings, and audio lter modes. The Settings screen also allows users to change email and password information or set a login PIN. The PIN allows for quicker access to the Eko App. Setting a PIN is recommended so that users do not have to enter full login information each time the App is opened. Finally, users may log out of the App from this screen. 7.4Settings ScreenMy DevicesAudio SettingsLive StreamHelpAccountV 2.12.1.34.1ConnectAudio SettingsAdjust VolumeChange Audio Source iPhone speakers or DUOLive StreamTurn Livestream ON/OFFShare Livestream LinkSupportHelp (Link to www.ekodevices.com/support)AccountModify NameModify UsernameModify Password and PINUpdate Contact InformationLog OutReturn to Previous ScreenMy DevicesConnect to DUO or CORE

P.16Selecting the Patient Search icon on the main screen brings up the patient list and search bar. Patients appear in alphabetical order by default. The search bar narrows the list to entries containing the alphanumerical digits entered. Selecting a patient displays a list of all recordings associated with the patient. Patients may be added to the list individually through manual input or syncing with compatible EHR services.7.5Patients ScreenAaberg, MarkAnonymousPS01CEP90784Aortic stenosis pilot programAdamente, IsabellaPS01CEP90784Accala, ManuelPS01CEP90784Tag or description to add context to the pati… Abril, GabriellaPS01CEP90784Abdelhamid, SahithiPS01CEP90784SearchAll Patients89%AT&T1:45 PMAdd New PatientGroupsSearch Patient ListPatient ListHospital IDDescription Tag

P.17This screen displays a waveform of each recording, options to playback the sound, or add notes. Notes may be added by any user with access to the patient’s prole. 7.6Review ScreenCan someone take a closer look at 01:57 for me?Martin Stemper 4:59pmRRR Murmur heard and Indicated.Martin Stemper 4:59pmThis is one of the more complicated ab cardiology characteristics. Will address tomorrow.You 4:59pmNOTESAdd Note…Crouch, Tyler89%AT&T1:45 PMHeart - AorticThanksMartin Stemper 5:05pmJune 6, 2016 - AorticCrouch, Tyler00:0000:00CommentsPatient InformationRecording DataJune 6, 2016 - AorticCrouch, Tyler 00:0000:00

P.18Warning: The use of accessories other than those specied, with the exception of accessories sold by Eko as replacement parts, may result in increased emissions or decreased immunity of DUO.Warning: DUO should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, DUO should be observed to verify normal operation in the conguration in which it will be used.Guidance and Manufacturer’s Declaration - Electromagnetic EmissionDUO is intended for use in the electromagnetic environment specied below. The user of DUO should assure that it is used in such an environment.Applicable Emissions Test Compliance Electromagnetic Environment- GuidanceRF emissions CISPR 11 Group 1 DUO uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.8.1Electrical Safety

P.19Guidance and Manufacturer’s Declaration - Electromagnetic ImmunityDUO is intended for use in the electromagnetic environment specied below. The user of the Eko DUO should assure that it is used in such an environment.Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment-GuidanceElectrostatic Discharge (ESD) IEC 61000-4-2+/- 8 kV contact+/- 15 kV air+/- 8 kV contact+/- 15 kV airFloors should be wood, concrete, or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at least 30%Electrical Fast Transient/Burst IEC 61000-4-4+/- 2 kV for supply lines+/- 1kV for input/output lines+/- 2 kV for supply lines+/- 1kV for input/output linesMains power quality should be that of a typical commercial or hospital environmentSurge IEC 61000-4-5+/- 1 kV line to line+/- 2 kV line to earth+/- 1 kV line to line+/- 2 kV line to earthMains power quality should be that of a typical commercial or hospital environmentVoltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-115% UT (95% dip in UT) for 0.5 cycles40% UT (60% dip in UT) for 5 cycles70% UT (30% dip in UT) for 25 cycle<5% UT (>95% dip in UT) for 5 sec5% UT (95% dip in UT) for 0.5 cycles40% UT (60% dip in UT) for 5 cycles70% UT (30% dip in UT) for 25 cycle<5% UT (>95% dip in UT) for 5 secMains power quality should be that of a typical commercial or hospital environment.Power frequency (50/60 Hz) magnetic eld IEC 61000-4-830 A/m 30 A/m Power frequency magnetic elds should be at levels characteristic of a typical location in a typical commercial magnetic eld or hospital environment.Conducted RFIEC 61000-4-63 Vrms150kHz - 80 Mhz3 Vrms150kHz - 80 MhzPortable and mobile RF communications equipment should be used no closer to any part of DUO, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distance:d = [ 3.5 / V1] √Pd = [ 3.5 / E1] √P 90 MHz to 800 MHzd = [ 7 / E1] √P 800 Mhz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from xed RF transmitters, as determxined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol:Radiated RFIEC 61000-4-33 V/m80 MHz to 2.5 GHz3 V/m80 Mhz to 2.5 GhzNOTE 1 - At 80 MHz and 800 MHz, the higher frequency range appliesNOTE 2 - These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and is affected by absorption and reection from structures, objects and people.a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To address the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which DUO is used exceeds the applicable RF compliance level above, DUO should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating DUO.b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.8.1Electrical Safety

P.20Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Eko Electronic Stethoscope SystemDUO is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The user of DUO can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and DUO as recommended below, according to the maximum output power of the communications equipment.Rated Maximum OutputPower of Transmitter (W)Separation Distance According to Frequency of Transmitter (m)150 kHz to 80 MHzd = 1.2 √P80 MHz to 800 MHzd = 1.2 √P800 MHz to 2.5 GHzd = 2.3 √P0.01 0.12 0.12 0.230.1 0.37 0.37 0.741 1.2 1.2 2.310 3.7 3.7 7.4100 12 12 23For transmitters rated at a maximum output power not listed above, the recommended separation distance d is meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum power rating of the transmitter in watts (W) according to the transmitter manufacturer.NOTE 1: 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 reection from structures, objects and people.8.1Electrical Safety

Navigation menu