VALES and HILLS BIOMEDICAL TECH ICV200BLE ECG Acquisition System User Manual SELLER

VALES & HILLS BIOMEDICAL TECH. LTD. ECG Acquisition System SELLER

user manual

®CardioView®FamilyiCV200(BLE) User Manual1VH-JS-08(60F) Version A/0VALES & HILLS BIOMEDICA TECH. LTD.Tel: 0086-010-51665548Fax: 0086-010-67856343E-mail: sales@vhmedical.comWebsite: http://www.vhECG.comAddress: Bldg 46-1, No2 North Street Jingyuan, Beijing Economic-technological DevelopmentArea, 100176 Beijing, ChinaCARDIO SYSTEMES 6 rue Descartes 78370 PLAISIR France
®CardioView®FamilyiCV200(BLE) User Manual2Table of ContentsPreface..................................................................................................................................................................................31 iCV200BLE......................................................................................................................................................71.1About the iCV200(BLE).........................................................................................................................71.2List of packing ........................................................................................................................................81.3Accessories ..............................................................................................................................................82.Installation........................................................................................................................................................ 92.1 iCV200(BLE)ECG Acquisition Recorder............................................................................................92.2 Down Load vhECG HD from Apple App Store...............................................................................103.Electrodes Hookup.........................................................................................................................................113.1Hoopup...................................................................................................................................................114.Getting Start................................................................................................................................................... 124.1Recorder Setting....................................................................................................................................124.2Communication Between the Recorder and iPad............................................................................... 135.vhECG Resting ECG System........................................................................................................................145.1System Setting....................................................................................................................................... 155.2Patient Records Archive....................................................................................................................... 165.3Monitoring and Recording....................................................................................................................165.4Records Review.....................................................................................................................................175.4.1 Records State...................................................................................................................................175.4.2 ECG Review....................................................................................................................................185.4.3 Average ECG...................................................................................................................................195.5 VHCloud..................................................................................................................................................... 206.Cleaning and Maintenance............................................................................................................................217.Guidance and Manufacture’s Declarations..................................................................................................23Annex I : iCV200(BLE) ECG Recorder Technical Specifications........................................................ 26Annex II : Definitions and Rules For ECG Measurements.....................................................................27
®CardioView®FamilyiCV200(BLE) User Manual3PrefaceCopyrightCopyright 2014, Vales and Hills (V&H). All rights reserved. No one is permitted to translate, reproduceor duplicate this manual or any part thereof, in any form, without prior written permission from V&H,V&H assumes no responsibility for any injury to anyone, or for any illegal or improper use of theproduct, that may result from failure to use this product in accordance with the instructions, cautions,warnings, or statement of intended use published in this manual. Unauthorized copying of thispublication may not only infringe copyright but also reduce the ability of V&H to provide accurate andup-to-date information to users and operators alike.The information contained in this manual is subject to change without notice. All changes will be incompliance with regulations governing manufacture of medical equipment.General Description and Intended UseiCV200(BLE) is a portable ECG system with CardioView family. It includes a data acquisition recorderand iPad with vhECG App. The system is designed and manufactured by V&H for patient ECGrecording with automatic measurements and interpretations.This product is not intended for use as sustain or support life devices.This product is not intended for introcardiac use.This product is not intended for use in operating room or ICUThis product is not intended for infant.The device is intended to provide reference for medical diagnosis, not intended for a replacement ofdiagnosis clinicians.PrecautionsRadio Frequency (RF) interference between the iCV200BLE recorder or electrocardiograph and anyexisting RF transmitting or receiving equipment at the installation site, including electrosurgicalequipment, in close proximity to the electrocardiograph should be evaluated before the equipment isoperated as they may seriously degrade performance.The iCV200BLE is susceptible to interference from RF energy sources (lowered RF immunity) whichexceed the IEC 60601-1-2 limits, such as power line bursts, other medical equipment, cellular products,information technology equipment and radio/television transmission.To reduce EMC interference the cardiograph shall be separated from the emitting sources as much aspossible. If assistance is needed, call V&H service.Artifact on the ECG caused by electromagnetic interference should be evaluated by a physician orphysician authorized personnel to determine if it will negatively impact diagnosis or treatment.Like all electronic devices, this electrocardiograph is susceptible to electrostatic discharge (ESD). ESDtypically occurs when electrostatic energy is transferred to the patient, the electrodes, or theelectrocardiograph. ESD may result in ECG artifact that may appear as narrow spikes on the cardiographdisplay or on the printed report. When ESD occurs, the electrocardiograph’s interpretation may beinconsistent with the physician’s interpretation.
®CardioView®FamilyiCV200(BLE) User Manual4V&H assumes no liability for failures resulting from RF or ESD interference between V&H CardioViewseries and any RF or ESD generating equipment when these levels exceed those established byapplicable standard.WarningsThe electrocardiograph has not been designed for use with high frequency (HF) surgical equipment anddose not protect against hazards to the patient.Ensure the location of the electrode and associated cables provides maximum separation away from allsources of HF energy. The best way to ensure patient safety is to completely remove all electrodes andcables from the patient when exposed to HF energy.Other medical equipment, including but no limited to defibrillators, ultrasound machines, pacemakers,and other simulators, may be used simultaneously with the electrocardiograph. However, such devicesmay disturb the electrocardiograph signal.Can not touch the patient during Defibrillation.This equipment has been tested and found to comply with the limits for a Class B digital device,pursuantto part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmfulinterference in a residential installation. This equipment generates uses and can radiate radio frequencyenergy and, if not installed and used in accordance with the instructions, may cause harmful interferenceto radio communications. However, there is no guarantee that interference will not occur in a particularinstallation. If this equipment does cause harmful interference to radio or television reception, which canbe determined by turning the equipment off and on, the user is encouraged to try to correct theinterference 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 isconnected.- Consult the dealer or an experienced radio/TV technician for helpChanges or modifications not expressly approved by the party responsible for compliance could voidthe user's authority to operate the equipment. 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 interferencereceived, including interference that may cause undesired operation.Warranty and ServiceV&H provides a one-year warranty and life-time service to all CadioView series products. Repairs onproducts under warranty must be performed or approved by V&H. Unauthorized repairs will void thewarranty. In addition, whether or not covered under warranty, any product repair shall exclusively beperformed by V&H certified service personnel.Limited warranty statementThe warranty will not cover the damages caused by:1) Use or maintenance contrary to labeled instructions2) Alteration or repair by anyone not authorized by V&H3) Accidents.Troubleshooting
®CardioView®FamilyiCV200(BLE) User Manual5Most of the problem can be solved by contacting V&H service department support@vhmedical.com. Toget the prompt and efficient response you will provide:Product name and its serial number.A complete problem descriptionThe complete name, address and phone number of your facilityFor out-of-warranty repairs or spare parts order, a purchase orderFor parts order, the required spare or replacement part numberProduct returnIf the product has to be returned for service, V&H recommends these parking instructions:Wherever possible, use the original shipping carton and packing materials.Including a packing list.Including a problem description report.It is recommended that all returned goods be insured. Claim for loss or damage to the product must beinitialed by the sender.Unit disposal InstructionsDisposal of battery and the unit after the end of device life in municipally approved recycling area. Thelife of device is 4 years.ClassificationDegree of protection against electrical shockType CF, defibrillation-proofThe power supply of ECG Acquisition box2XAA BatteryDegree of protection against harmful ingressof waterEnclosed equipment withoutprotection against ingress ofwaterDegree of safety of application in the presenceof a flammable anesthetic mixture with air orwith oxygen or nitrous oxideNot suitable for use in thepresence of a flammableanesthetic mixture with air orwith oxygen or nitrous oxide.Method(s) of sterilization or disinfectionrecommended by the manufacturerSterilization: not applicabledisinfection: see user manualMode of operationContinuous operationThe defibrillation-proof recovery time10sList of Symbols
®CardioView®FamilyiCV200(BLE) User Manual6----------------------------------------------------------------------------------------------------------------------------Warning: Warning statements describe conditions or actions that can result in personal injury or lost of life.-----------------------------------------------------------------------------------------------------------------------------Caution: Warning statements describe conditions or actions that can result in damage to the equipment of software.-----------------------------------------------------------------------------------------------------------------------------Note: Notes contain additional information on iCV200(BLE) usage.SymbolsMeaningCaution, consult accompanying documents.SNSerial Number(xxxxxxxxxxxxxxx)ManufacturerDate of manufactureAuthorized representative in the European communityThe CE marking with the Registration Number of the Notified Body. This denotesthe compliance of European Medical Device Directive 93/42/EECWaste Electrical and Electronic Equipment (WEEE) It is the responsibility of the enduser to dispose of this equipment at a designated collection point for recycling.DEFIBRILLATION-PROOF TYPE CF APPLIED PARTBluetoothFunction switch buttonKeep drytemperature limitsIndicates the range of humidity to which the medical device can besafely exposed.IPX0Against ingress of water with harmful effects : non-protected
®CardioView®FamilyiCV200(BLE) User Manual71. iCV200(BLE)iCV200(BLE) Rest ECG for iOS (iPad, iPad-mini and iPhone)Thank you for your purchase of iCV200(BLE) Resting ECG System and we hope that you will enjoyworking with it. If you have any comments or suggestions, we would appreciate hearing from you.Please contact support@vhmedical.com1.1 About iCV200(BLE)iCV200(BLE) is a portable ECG system. It includes a data acquisition recorder and patient cable. Thesystem is designed and manufactured by V&H, The ECG Acquisition System is capable of sampling,recording and analyzing patients resting ECG. This system is applicable to the heart disease analysis forthe medical treatment institution.Fig1.1 iCV200(BLE) Rest ECG Composition
®CardioView®FamilyiCV200(BLE) User Manual81.2 List of packingThe ECG Acquisition Systems consists of the following items:Part No.DescriptionQTYCV060F-010ECG Acquisition Box1iCV200(BLE) software(Note1)1M0201120ECG cable1CV060F-060User manual1Note1: About the software download please see 2.2 Download vhECG HD from Apple App Store.1.3 AccessoriesItem No.DescriptionIntended UseCV-022010-M0201120ICV200(BLE) patient cableCables allow connection to theelectrode leads, which adhere tothe patient for detection of ECGsignalsCV-021010-M0201044Standard Patient CableCV-040002BatteryPower for ECG acquisition boxNote：1. If any lead wire of lead part is failure, the user is unable to replace the lead wire, please contact withV&H.2. If any lead wire of lead part is failure, the user can replace the standard 6511ECG cable, the ECGcable safety requirements tested for compliance with 93/42/EEC, should have the CE certificate. Vales& Hills recommends Qingdao Bright medical, the model is M0201020.If use the manufacturer approvalattachment may reduce the safety of the products.3.iCV200(BLE) is powered by two AA LR06 batteries.Insufficient of power may affect thecommunication between the recorder and iPad.Check the batteries with adequacy of power before using.If the power is low,the user can replace the new battery, Vales & Hills recommends the battery model isAA LR06.4.For the sake of environmental protection, please recycle disposal of the battery.5.For products and accessories that are no longer used, it will be the cause of environmental pollution, itshould be properly treated.6.Do not include standard Patient cable and battery when we sale.7.If you find anything above is not included in the packing, please contact us by the following address:Technical Support Dept. of Vales & Hills Biomedical Tech. Ltd.Tel:0086-010-51665548E-mail:service@vhmedical.comWebsite: http://www.vhecg.comFax:0086-010-67856343
®CardioView®FamilyiCV200(BLE) User Manual92. InstallationA complete iCV200(BLE) system consists of iCV200(BLE) data acquisition recorder and iPad or iPad-mini with Apple App – vhECG HD. This section will guide you iCV200(BLE) recorder compositionand vhECG HD installation.2.1Hardware ConnectioniCV200(BLE) ECG Acquisition RecorderFig 2.1 iCV200(BLE) Recorder
®CardioView®FamilyiCV200(BLE) User Manual10iCV200(BLE) Connecting further accessoriesThe illustration on the Fig2.2 show further accessories and the interface where they areconnected.patientpatient cable (F-TYPE APPLIED PART)Bluetoothipad/iphone iCV200(BLE) ECG acquisition boxFig 2.22.2. Download vhECG HD from Apple App StoreiCV200(BLE) Resting ECG System has its software running on iPad or iPad-mini named vhECG HDapproved by Apple.PurchaseFind vhECG HD in App Store and download it wth your Apple ID and registered credit card.Free DownloadIf you have got a promotion code from V&H, you can use it to download vhECG HD to your iPad oriPad-mini free as following steps:Step 1. Login with your Apple ID (Settings → Store). If you do not have an Apple ID, you can createone with your e-mail address.Step 2. In AppStore, scroll to the bottom and find <Redeem> button.Step 3. Click <Redeem>, and then enter your promotion code in the popup dialog.Step 4. After step 3, you will be asked to enter your Apple ID password again.Step 5. Download in process and you get vhECG HDNote: The promotion code is valid within four weeks.You should download vhECG HD within thisperiod.
®CardioView®FamilyiCV200(BLE) User Manual11If you have any questions about vhECG HD download, please contact support@vhmedical.com.3. Electrodes Hookup3.1 Hookup
®CardioView®FamilyiCV200(BLE) User Manual124. Getting StartThe communication between iPad and iCV200(BLE) Recorder is through Bluetooth.iCV200(BLE) Resting ECG System for iPad is vhECG. It currently runs with the following languages:The running language of vhECG depends on your iPad language setting. The default language is English,that means if your iPad sets the language not belong to above selections, vhECG will run in English.vhECG will support more languages in progress. V&H appreciates your participations in vhECGdevelopment.4.1 Recorder SettingReferring to 2.1 to get the <terms> explaining.The communication between iCV200(BLE) recorder and iPad is through Bluetooth.Battery: Set two AA batteries into the recorder.<Button> Control:Turn on: Click <button> to turn on the recorder.Turn off: Keep press (two seconds) <button> to turn off the recorder.<LED(Green)> State:Off: The recorder is off.On: The recorder is on.Slow Flash (once four seconds): Power insufficient -- change the batteries.
®CardioView®FamilyiCV200(BLE) User Manual134.2 Communication between Recorder and iPadStep 1: Turn on the recorder.Step 2: Click “” on iPad to enter settings.Step 3: Click “ ” on iPad. To enable bluetooth function of the iPad device.Step 4: Open the vhECG software . Click to enter vhECG settings, then click “ ecg DeviceConnectivity” and select Bluetooth method. Such as.Step 5: Come back to the home page ,click on the top-right corner of your iPad.When the connection is successed, you will see “Device Connected” at the bottom of your iPad.Click the round icon with numbers to start work.Note: the last five digits of the device will show on the bottom of your iPad, you need to select the samedevice number on the iPad with your recorder.
®CardioView®FamilyiCV200(BLE) User Manual145. vhECG Rest ECG SystemvhECG is designed as an easy using application program which offers professional ECG tools andfantastic user experience. Most of its usages follow to iOS operating style. If you are familiar with anyApple App and have a general knowledge of ECG, you will have no problem and be happy workingwith vhECG.Click iPad App icon to enter vhECG Resting ECG System.
®CardioView®FamilyiCV200(BLE) User Manual155. 1 System SettingsYou can customize your vhECG to your own preference. Click Fig 5.2 to enter vhECG Settings whichconsist of four parts:1. GeneralHospiomtal Name - Input your hospital or organization name, etc.①Doctor Name - vhECG user’s name2. Live MonitorUse Demo Data - ON/OFF: Use DEMO data in monitoringNew Born Baby Mode – Select a set of chest leads for newbornsRecording Time – Time of recording: 10-30 secondsLowpass – Cutoff frequency of low-pass filter: 30-250Hz, default: 70HzAC Notch – OFF/50/60(Hz): to eliminate power-line interferenceBaseline Wander Erase – ON/OFF: to keep the baseline stable②EMG Filter –ON/OFF: to remove muscle noise from ECG signal③Patients Queue Mode –ON/OFF: ON for patients collected recording④3. CommunicationECG Device Connectivity – BLEDevice SN Last Digit – the last digit of your iCV200(BLE) recorder’s serial numberECG Cloud / FTP Address – ECG Network (e.g. www.vhcloud.net)4. ReportTo custom the printing form:Report Title – Title on the print reportReport Format – PDF or JPEGLead Layout –1×12 or 2×6Paper Orientation – A4 or B5, Portrait or LandscapePrint Grid – ON / OFF: with or without grid in printing report①If you have registered in an ECG Network (e.g. vhCloud) group, the group name has its priority. Torestore the input name you should exit from the group.②This function can efficiently remove baseline wandering due to respiration or body movementwithout impacting ECG frequency response, such as ST segment. The function works only to ECGsignal with QRS complex exist, that means it is not applicable to signals like square or sine waves, etc.③Patented by V&H. Muscle noise can be removed by setting LPF with low cutoff frequency but it willseverely affect ECG high frequency component such us QRS complex. vhECG EMG filter caneffectively remove muscle noise with little affection to ECG signal.④With Patient Queue Mode, vhECG asks you to pre-collect a queue of patients, from HIS or manual input,before recording. It is for a convenient using when thereis a set of patients’ ECGs to be recorded and sent toECG Network for diagnosing. When you click, you will
®CardioView®FamilyiCV200(BLE) User Manual16get fig5.2 to set up your patient list.5.2 Patient Records ArchiveThis section shows how to create a new patient record or assign the recording ECG data to an existingpatient. You can do it either in ECG “Recording” or “Reviewing” at any time by click or infig5.1.Create a new patient record:5.3 Monitoring and RecordingThis section shows how to record ECGs.1. Place the electrodes on the patient2. Turn on the recorder and make sure it is connected to iPad with BLE.3. Click to start recording
®CardioView®FamilyiCV200(BLE) User Manual17Display Layout: 12×1, 6×2 and 3×4 display formats switch. In 3×4 format there is a rhythm strip(default: lead-II) at the bottom. You can switch to any other lead as rhythm strip by click the leadwindow.Display Gain: You can change the ECG gain (5mm/mV, 10mm/mV and 20mm/mV) by two fingerssliding.Recording and Save: Click to start recording while the ECG signal displayed stably. When therecording finished, you get a window pop-up with three selections:* Record Next: Record the next ECG while #numerical order plus one* Review Now: Enter “5.4.2 ECG Reviewing” page to review the current ECG recorded* Return: Return to the main menuNote: The duration of the record for 8s.Restart Recording: Double click the screen to restart recording when you find the ECG signal not good.Leadoff: iCV200(BLE) has the function to detect electrode disconnect. When there is any electrodedisconnected, the color of the lead name in its related window(s) will turn in red with a mark [×] andthe trace shows zero-line.5.4 Records Review5.4.1 Patient Records StateClick to select a record to review when at “Select Mode”, or select records to delete when at“Cancel” (Top-Right corner button)Fig5.5 Recorder List
®CardioView®FamilyiCV200(BLE) User Manual185.4.2 ECG ReviewingvhECG offers various views on an ECG with automatic parameter measurements and diagnosticinterpretations. vhECG also offers effective tools for you to measure parameters and edit interpretations.①Interpretations list:You can select the diagnostic terms from the list when you edit your ECGdiagnosis（See Fig.5.7）.②Doctor confirm: Sign your name to confirm the diagnosis. The signature is keeped for printing andemail(See Fig.5.8).Tips:1.) Zoom: With two fingers sliding to zoom in and zoom out ECG display.2.) Gain: Double click the screen with one finger to change the ECG gain.3.) Speed: Double click the screen with two fingers to change the ECG speed.
®CardioView®FamilyiCV200(BLE) User Manual195.4.3 Average ECGAverage ECG is calculated the dominant beats of the recorded ECG based on QRS complexmorphology. vhECG offers two forms of average ECG, single lead average ECG and superimpositionaverage ECG of 12 leads for your convenient using.Marks positioning:There are three sets of marks: P(onset, offset), QRS(onset, offset) and T(offset). You can adjust the markby moving your finger. To delete a set of marks: move it to the rightmost of the screen. To add a set ofmarks: move your finger from the rightmost to left. The related parameters will be correctedsimultaneously while the mark position(s) in changing.Measurements:You can measure the distance (in ms) and the gain (in mV) of the two points either on average ECG orECG strip conveniently by sliding your two fingers (V&H patented). See Fig. 5.9
®CardioView®FamilyiCV200(BLE) User Manual205.5 vhCloudvhECG is a full functional ECG network designed on group permissions by V&H. Depends on yourauthority in the group you are belonging, you can store, achieve, diagnose and share the ECGs in thegroup. For more information, please contact support@vhmedical.com
®CardioView®FamilyiCV200(BLE) User Manual216. Cleaning and MaintenanceIt is recommended to check your iCV200(BLE) regularly to keep it in perfect condition.Note: Only the qualified personnel authorized by V&H may service iCV200(BLE).CleaningUse a moist cloth to wipe the recorder surface and patient cable cleaning. Do not allowliquids to enter the recorder. All cleaning agents and disinfectants without alcoholcommonly used in hospitals are suitable. If liquids have entered the recorder, notifyService to have the system inspected for damage before it is used again.DO NOT use disinfectants with a phenol base or peroxide compounds to disinfect theexternal surfaces.Note: When pull off the cable from the recorder, be sure to hold the plug, not the cable.Battery CareIf a longer period of time without using ECG acquisition box, remove the battery to avoid batteryleakage risk.Important: For environment protection, please disposal the used batty to the recycling bin.Operating EnvironmentTemperature: 5℃～35℃Humidity: 25%～95%Pressure :860hPa～1060hPaTransport and StorageTemperature: -20℃～55℃Humidity: <93%Pressure :860hPa～1060hPa
®CardioView®FamilyiCV200(BLE) User Manual22TroubleshootingThe following table contains a list of iCV200(BLE) recorder troublesome scenarios accompanied bysuggestions for problem solving.TroubleResponses to the troubleCannot StartCheck the batteries to have sufficient power.Cannot connet toiPadCheck your iPad setting statues at the correct mode.Keep your iPad and Recorder in a reasonable distance,recommend visual distance: five meters, but it is some extentdependent on the environment around.Check the router if the recorder at Net-work mode.With a fixedECG signalYour vhECG is in DEMO mode. Enter your iPad vhECG’s setting partand set “Use Demo Data” OFF.Without ECGsignal or with toomuch noiseCheck the connection between the recorder and patient cableCheck the connection between the patient cable and electrodesCheck the connection between the electrodes and patient skinSkin treatment if necessaryCheck if there are forceful electrical power or strong magneticfield around
®CardioView®FamilyiCV200(BLE) User Manual237. Guidance and Manufacture’s DeclarationsDeclarations:iCV200(BLE) needs special precautions regarding EMC and needs to be installed and put intoservice according to the EMC information provided in the User Manual;Portable and mobile RF communication equipment can affect iCV200(BLE).Electromagnetic emissionsiCV200(BLE) is intended for use in the electromagnetic environment specified below. The customer orthe user of iCV200(BLE) should assure that it is used in such an environment.Emissions testComplianceElectromagnetic environment –guidanceRF emissionsCISPR 11Group 1iCV200(BLE) uses RF energy only for its internal function.Therefore, its RF emissions are very low and are not likely tocause any interference in nearby electronic equipment.RF emissionsCISPR 11Class BiCV200(BLE) is suitable for use in all establishments, includingdomestic establishments and those directly connected to the publiclow-voltage power supply network that supplies buildings used fordomestic purposes.
®CardioView®FamilyiCV200(BLE) User Manual24Electromagnetic immunityiCV200(BLE) is intended for use in the electromagnetic environment specified below. The customer orthe user of the ECG Acquisition Systems should assure that it is used in such an environment.Immunity testIEC 60601test levelCompliancelevelElectromagnetic environment –guidanceElectrostaticdischarge (ESD)IEC 61000-4-2±6 kV contact±8 kV air±6 kV contact±8 kV airFloors should be wood, concrete or ceramic tile.If floors are covered with synthetic material, therelative humidity should be at least 30 %.Radiated RFIEC 61000-4-33 V/m80 MHz to 2,5GHz3 V/m3,5[ ]3d p80 MHz to 800 MHz7[ ]3d p800 MHz to 2,5 GHzwhere Pis the maximum output power rating of thetransmitter in watts (W) according to the transmittermanufacturer and dis the recommended separationdistance in meters (m). Field strengths from fixed RFtransmitters, as determined by an electromagnetic sitesurvey, ashould be less than the compliance level ineach frequency range.bInterference may occur in thevicinity of equipment marked with the followingsymbol:aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephonesand land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot bepredicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RFtransmitters, an electromagnetic site survey should be considered. If the measured field strength in thelocation in which the iCV200(BLE) is used exceeds the applicable RF compliance level above,iCV200(BLE) should be observed to verify normal operation. If abnormal performance is observed,additional measures may be necessary, such as reorienting or relocating the ECG Acquisition Systems.bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
®CardioView®FamilyiCV200(BLE) User Manual25Recommended separation distances between portable and mobile RFcommunication equipment and iCV200(BLE)iCV200(BLE) is intended for use in an electromagnetic environment in which radiated RF disturbancesare controlled. The customer or the user of iCV200(BLE) can help prevent electromagnetic interferenceby maintaining a minimum distance between portable and mobile RF communications equipment(transmitters) and iCV200(BLE) as recommended below, according to the maximum output power ofthe communications equipment.Rated maximumoutput powerof transmitter(W)Separation distance according to frequency of transmitter (m)150Hz to 80MHz80 MHz to 800 MHz800 MHz to 2,5 GHz0.010.1170.1170.23330.10.369990.369990.7368111.171.172.33103.699863.699867.3681110011.666711.666723.3For transmitters rated at a maximum output power not listed above, the recommended separationdistance din meters (m) can be estimated using the equation applicable to the frequency of thetransmitter, where Pis the maximum output power rating of the transmitter in watts (W) according tothe transmitter manufacturer.
®CardioView®FamilyiCV200(BLE) User Manual26Annex I: iCV200(BLE) ECG Recorder Technical SpecificationsSampling Rate:A/D: 24K/SPS/ChRecording: 1K/SPS/ChQuantization Precision:A/D: 24BitsRecording: 16BitsResolution: 0.4μVCommon Mode Rejection: >90dBInput Impedance: >20MΩFrequency Response: 0.05-150HzTime Constant: ≥3.2 Sec.Maximum Electrode Potential: ±300mVDynamic Range: ±15mVDefibrillation Protect: Build-inData Communication: BLEPower: 2×AA( LR06)Recovery time after defibrillation：≤10S
®CardioView®FamilyiCV200(BLE) User Manual27Annex II: Definitions and Rules for ECG Measurements1. ECG Waveform and Contour ClassificationThe ECG waveform consists of P-QRS-T complex which measured as:P-onset, P-offset：Pb, PeQRS- onset, QRS- offset：Qb, Se(J)T- offset：TeNote: Globally, i.e. for all LEADS valid, Durations or intervals of P-QRS-T are defined, based onphysiological reasons, by the earliest onset (for ST interval, the latest offset) of any LEAD to the latestoffset (for PR interval, the earliest onset) of any other LEAD.All parameters used in the diagnostic criteria of the contour classification are measured in therepresentative P-QRS-T complex. The lead-independent, overall parameters are presented in the tablebellowing:Name DescriptionsHeart Rate Ventricular rate (in beats per minute, bpm)P duration From P-onset to P-offset (in ms)PR interval From P-onset to QRS-onset (in ms)QRS duration From QRS-onset to QRS-offset (in ms)QT interval From QRS-onset to T-offset (in ms)Corrected QT interval QT interval correct for heart rate: QTc=QT*√(HR/60) (in ms)P/QRS/T axis Axis of P, QRS or T wave (in degree, from -180°to 180°)2. Duration and Amplitude Measurements
®CardioView®FamilyiCV200(BLE) User Manual28Normal electrocardiogramIsoelectric segment: value of midpoint between P-offset and QRS-onset3. ECG AxisP/QRS/T axis is calculated based on Einthoven Triangl
®CardioView®FamilyiCV200(BLE) User Manual294. Acceptance of minimum wavesThe labeling of the QRS complex depends by definition on the first wave detected. A tiny positive waveat beginning is called r or R following Q and may mask a true. The acceptance criteria of initialwaveforms should be clearly defined and standardized. The rule for acceptance of minimum waves is:the signal with amplitudes smaller than 20uV cannot be accepted.

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