VALES and HILLS BIOMEDICAL TECH ICV200S ECG Acquisition Systems User Manual SELLER

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

User manual

® CardioView® Family iCV200S User Manual VH-JS-08(63F) Version A/0 VALES & HILLS BIOMEDICA TECH. LTD. Tel: 0086-010-51665548 Fax: 0086-010-67856343 E-mail: sales@vhmedical.com Website: http://www.vhECG.com Address: Bldg 46-1, No2 North Street Jingyuan, Beijing Economic-technological Development Area, 100176 Beijing, China CARDIO SYSTEMES 6 rue Descartes 78370 PLAISIR France 1
® CardioView® Family iCV200S User Manual Table of Contents Preface ................................................................................................................................................................ 3 1 iCV200S.............................................................................................................................................. 7 1.1About the iCV200S...................................................................................................................... 7 1.2List of packing ............................................................................................................................ 8 1.3Accessories ................................................................................................................................. 8 2.Installation........................................................................................................................................... 9 2.1 iCV200SECG Acquisition Recorder ........................................................................................... 9 2.2 Down Load vhECG HD from Apple App Store ....................................................................... 10 3.Electrodes Hookup ............................................................................................................................ 11 3.1Hoopup ...................................................................................................................................... 11 4.Getting Start ...................................................................................................................................... 12 4.1Recorder Setting ........................................................................................................................ 12 4.2Communication Between the Recorder and iPad ........................................................................ 13 5.vhECG Resting ECG System ............................................................................................................. 14 5.1System Setting ........................................................................................................................... 15 5.2Patient Records Archive............................................................................................................. 16 5.3Monitoring and Recording ......................................................................................................... 16 5.4Records Review ......................................................................................................................... 17 5.4.1 Records State ....................................................................................................................... 17 5.4.2 ECG Review ........................................................................................................................ 18 5.4.3 Average ECG ....................................................................................................................... 19 5.5 VHCloud ........................................................................................................................................ 20 6.Cleaning and Maintenance ................................................................................................................. 21 7.Guidance and Manufacture’s Declarations ......................................................................................... 23 Annex I : iCV200S ECG Recorder Technical Specifications........................................................... 26 Annex II : Definitions and Rules For ECG Measurements .............................................................. 27 2
® CardioView® Family iCV200S User Manual Preface Copyright Copyright 2014, Vales and Hills (V&H). All rights reserved. No one is permitted to translate, reproduce or 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 the product, 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 this publication may not only infringe copyright but also reduce the ability of V&H to provide accurate and up-to-date information to users and operators alike. The information contained in this manual is subject to change without notice. All changes will be in compliance with regulations governing manufacture of medical equipment. General Description and Intended Use iCV200S is a portable ECG system with CardioView family. It includes a data acquisition recorder and iPad with vhECG App. The system is designed and manufactured by V&H for patient ECG recording 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 of diagnosis clinicians. Precautions Radio Frequency (RF) interference between the iCV200S recorder or electrocardiograph and any existing RF transmitting or receiving equipment at the installation site, including electrosurgical equipment, in close proximity to the electrocardiograph should be evaluated before the equipment is operated as they may seriously degrade performance. The iCV200S is susceptible to interference from RF energy sources (lowered RF immunity) which exceed 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 as possible. If assistance is needed, call V&H service. Artifact on the ECG caused by electromagnetic interference should be evaluated by a physician or physician authorized personnel to determine if it will negatively impact diagnosis or treatment. Like all electronic devices, this electrocardiograph is susceptible to electrostatic discharge (ESD). ESD typically occurs when electrostatic energy is transferred to the patient, the electrodes, or the electrocardiograph. ESD may result in ECG artifact that may appear as narrow spikes on the cardiograph display or on the printed report. When ESD occurs, the electrocardiograph’s interpretation may be inconsistent with the physician’s interpretation. 3
® CardioView® Family iCV200S User Manual V&H assumes no liability for failures resulting from RF or ESD interference between V&H CardioView series and any RF or ESD generating equipment when these levels exceed those established by applicable standard. Warnings The electrocardiograph has not been designed for use with high frequency (HF) surgical equipment and does not protect against hazards to the patient. Ensure the location of the electrode and associated cables provides maximum separation away from all sources of HF energy. The best way to ensure patient safety is to completely remove all electrodes and cables from the patient when exposed to HF energy. Other medical equipment, including but not limited to defibrillators, ultrasound machines, pacemakers, and other simulators, may be used simultaneously with the electrocardiograph. However, such devices may disturb the electrocardiograph signal. Cannot touch the patient during Defibrillation. 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 Changes or modifications not expressly approved by the party responsible for compliance could void the 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 interference received, including interference that may cause undesired operation. Warranty and Service V&H provides a one-year warranty and life-time service to all CardioView series products. Repairs on products under warranty must be performed or approved by V&H. Unauthorized repairs will void the warranty. In addition, whether or not covered under warranty, any product repair shall exclusively be performed by V&H certified service personnel. Limited warranty statement The warranty will not cover the damages caused by: 1) Use or maintenance contrary to labeled instructions 2) Alteration or repair by anyone not authorized by V&H 3) Accidents. Troubleshooting 4
® CardioView® Family iCV200S User Manual Most of the problem can be solved by contacting V&H service department support@vhmedical.com. To get 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 number Product return If 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 be initialed by the sender. Unit disposal Instructions Disposal of battery and the unit after the end of device life in municipally approved recycling area. The life of device is 4 years. Classification Degree of protection against electrical shock Type CF, defibrillation-proof The power supply of ECG Acquisition box 2XAAABattery Degree of protection against harmful ingress of water Enclosed equipment without protection against ingress of water Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Method(s) of sterilization or disinfection recommended by the manufacturer Sterilization: not applicable disinfection: see user manual Mode of operation Continuous operation The defibrillation-proof recovery time 10s List of Symbols 5
® CardioView® Family iCV200S User Manual ---------------------------------------------------------------------------------------------------------------------------- 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 iCV200S usage. Symbols Meaning Caution, consult accompanying documents. SN Serial Number(xxxxxxxxxxxxxxx) Manufacturer Date of manufacture Authorized representative in the European community The CE marking with the Registration Number of the Notified Body. This denotes the compliance of European Medical Device Directive 93/42/EEC 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. DEFIBRILLATION-PROOF TYPE CF APPLIED PART Bluetooth Function switch button Keep dry temperature limits Indicates the range of humidity to which the medical device can be safely exposed. IPX0 Against ingress of water with harmful effects : non-protected 6
® CardioView® Family iCV200S User Manual 1. iCV200S  iCV200S Rest ECG for iOS (iPad, iPad-mini and iPhone) Thank you for your purchase of iCV200S Resting ECG System and we hope that you will enjoy working with it. If you have any comments or suggestions, we would appreciate hearing from you. Please contact support@vhmedical.com 1.1 About iCV200S iCV200S is a portable ECG system. It includes a data acquisition recorder and patient cable. The system 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 for the medical treatment institution. Fig1.1 iCV200S Rest ECG Composition 7
® CardioView® Family iCV200S User Manual 1.2 List of packing The ECG Acquisition Systems consists of the following items: Part No. Description QTY CV060F-010 ECG Acquisition Box 1 iCV200Ssoftware (Note1) 1 M0201120 ECG cable 1 CV060F-060 User manual 1 Note1: About the software download please see 2.2 Download vhECG HD from Apple App Store. 1.3 Accessories Item No. Description Intended Use CV-022010-M0201120 ICV200S patient cable Cables allow connection to the electrode leads, which adhere to the patient for detection of ECG signals CV-021010-M0201044 Standard Patient Cable CV-040002 Battery Power for ECG acquisition box Note： 1. If any lead wire of lead part is failure, the user is unable to replace the lead wire, please contact with V&H. 2. If any lead wire of lead part is failure, the user can replace the standard 6511ECG cable, the ECG cable 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 approval attachment may reduce the safety of the products. 3.iCV200Sis powered by two AAA LR03 batteries.Insufficient of power may affect the communication 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 is AAA LR03. 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, it should 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:0086-010-51665548 E-mail:service@vhmedical.com Website: http://www.vhecg.com Fax:0086-010-67856343 8
® CardioView® Family iCV200S User Manual 2. Installation A complete iCV200S system consists of iCV200S data acquisition recorder and iPad or iPad-mini with Apple App – vhECG HD. This section will guide you iCV200S recorder composition and vhECG HD installation. 2.1Hardware Connection iCV200S ECG Acquisition Recorder Button LED 15-Pin-Share-Socket iCV200S Patient Cable Connector iCV200S Recorder Frontside Battery Compartment Cover iCV200S Recorder Backside Fig 2.1 iCV200S Recorder 9
® CardioView® Family iCV200S User Manual iCV200S Connecting further accessories The illustration on the Fig2.2 show further accessories and the interface where they are connected. Patient Patient cable (F-TYPE APPLIED PART) Bluetooth iPad/iPhone iCV200S ECG acquisition box Fig 2.2 2.2. Download vhECG HD from Apple App Store iCV200S Resting ECG System has its software running on iPad or iPad-mini named vhECG HD approved by Apple. Purchase Find vhECG HD in App Store and download it wth your Apple ID and registered credit card. Free Download If you have got a promotion code from V&H, you can use it to download vhECG HD to your iPad or iPad-mini free as following steps: Step 1. Login with your Apple ID (Settings → Store). If you do not have an Apple ID, you can create one 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 HD Note: The promotion code is valid within four weeks.You should download vhECG HD within this period. If you have any questions about vhECG HD download, please contact support@vhmedical.com. 10
® CardioView® Family iCV200S User Manual 3. Electrodes Hookup 3.1 Hookup 11
® CardioView® Family iCV200S User Manual 4. Getting Start The communication between iPad and iCV200S Recorder is through Bluetooth. iCV200S 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 vhECG development. 4.1 Recorder Setting Referring to 2.1 to get the <terms> explaining. The communication between iCV200S recorder and iPad is through Bluetooth. Battery: Set two AAA 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. 12
® CardioView® Family iCV200S User Manual 4.2 Communication between Recorder and iPad Step 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 Device Connectivity” 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 same device number on the iPad with your recorder. 13
® CardioView® Family iCV200S User Manual 5. vhECG Rest ECG System vhECG is designed as an easy using application program which offers professional ECG tools and fantastic user experience. Most of its usages follow to iOS operating style. If you are familiar with any Apple App and have a general knowledge of ECG, you will have no problem and be happy working with vhECG. Click iPad App icon to enter vhECG Resting ECG System. 14
® CardioView® Family iCV200S User Manual 5. 1 System Settings You can customize your vhECG to your own preference. Click Fig 5.2 to enter vhECG Settings which consist of four parts: 1. General Hospiomtal Name - Input your hospital or organization name, etc.① Doctor Name - vhECG user’s name 2. Live Monitor Use Demo Data - ON/OFF: Use DEMO data in monitoring New Born Baby Mode – Select a set of chest leads for newborns Recording Time – Time of recording: 10-30 seconds Lowpass – Cutoff frequency of low-pass filter: 30-250Hz, default: 70Hz AC Notch – OFF/50/60(Hz): to eliminate power-line interference Baseline Wander Erase – ON/OFF: to keep the baseline stable② EMG Filter –ON/OFF: to remove muscle noise from ECG signal③ Patients Queue Mode –ON/OFF: ON for patients collected recording④ 3. Communication ECG Device Connectivity – BLE Device SN Last Digit – the last digit of your iCV200S recorder’s serial number ECG Cloud / FTP Address – ECG Network (e.g. www.vhcloud.net) 4. Report To custom the printing form: Report Title – Title on the print report Report Format – PDF or JPEG Lead Layout – 1×12 or 2×6 Paper Orientation – A4 or B5, Portrait or Landscape Print Grid – ON / OFF: with or without grid in printing report ① If you have registered in an ECG Network (e.g. vhCloud) group, the group name has its priority. To restore the input name you should exit from the group. ② This function can efficiently remove baseline wandering due to respiration or body movement without impacting ECG frequency response, such as ST segment. The function works only to ECG signal with QRS complex exist, that means it is not applicable to signals like square or sine waves, etc. ③ Patented by V&H. Muscle noise can be removed by setting LPF with low cutoff frequency but it will severely affect ECG high frequency component such us QRS complex. vhECG EMG filter can effectively remove muscle noise with little affection to ECG signal. ④ With 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 there is a set of patients’ ECGs to be recorded and sent to ECG Network for diagnosing. When you click, you will get fig5.2 to set up your patient list. 15
® CardioView® Family iCV200S User Manual 5.2 Patient Records Archive This section shows how to create a new patient record or assign the recording ECG data to an existing patient. You can do it either in ECG “Recording” or “Reviewing” at any time by click or in fig5.1. Create a new patient record: 5.3 Monitoring and Recording This section shows how to record ECGs. 1. Place the electrodes on the patient 2. Turn on the recorder and make sure it is connected to iPad with BLE. 3. Click to start recording 16
® CardioView® Family iCV200S User Manual Display 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 lead window. Display Gain: You can change the ECG gain (5mm/mV, 10mm/mV and 20mm/mV) by two fingers sliding. Recording and Save: Click to start recording while the ECG signal displayed stably. When the recording 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 menu Note: 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: iCV200S has the function to detect electrode disconnect. When there is any electrode disconnected, the color of the lead name in its related window(s) will turn in red with a mark [×] and the trace shows zero-line. 5.4 Records Review 5.4.1 Patient Records State Click 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 17
® CardioView® Family iCV200S User Manual 5.4.2 ECG Reviewing vhECG offers various views on an ECG with automatic parameter measurements and diagnostic interpretations. 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 ECG diagnosis（See Fig.5.7）. ②Doctor confirm: Sign your name to confirm the diagnosis. The signature is keeped for printing and email(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. 18
® CardioView® Family iCV200S User Manual 5.4.3 Average ECG Average ECG is calculated the dominant beats of the recorded ECG based on QRS complex morphology. vhECG offers two forms of average ECG, single lead average ECG and superimposition average 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 mark by moving your finger. To delete a set of marks: move it to the rightmost of the screen. To add a set of marks: move your finger from the rightmost to left. The related parameters will be corrected simultaneously 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 or ECG strip conveniently by sliding your two fingers (V&H patented). See Fig. 5.9 19
® CardioView® Family iCV200S User Manual 5.5 vhCloud vhECG is a full functional ECG network designed on group permissions by V&H. Depends on your authority in the group you are belonging, you can store, achieve, diagnose and share the ECGs in the group. For more information, please contact support@vhmedical.com 20
® CardioView® Family iCV200S User Manual 6. Cleaning and Maintenance It is recommended to check your iCV200S regularly to keep it in perfect condition. Note: Only the qualified personnel authorized by V&H may service iCV200S. Cleaning  Use a moist cloth to wipe the recorder surface and patient cable cleaning. Do not allow liquids to enter the recorder. All cleaning agents and disinfectants without alcohol commonly used in hospitals are suitable. If liquids have entered the recorder, notify Service 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 the external surfaces. Note: When pull off the cable from the recorder, be sure to hold the plug, not the cable. Battery Care If a longer period of time without using ECG acquisition box, remove the battery to avoid battery leakage risk. Important: For environment protection, please disposal the used batty to the recycling bin. Operating Environment Temperature: 5℃～35℃ Humidity: 25%～95% Pressure :860hPa～1060hPa Transport and Storage Temperature: -20℃～55℃ Humidity: <93% Pressure :860hPa～1060hPa 21
® CardioView® Family iCV200S User Manual Troubleshooting The following table contains a list of iCV200S recorder troublesome scenarios accompanied by suggestions for problem solving. Trouble Responses to the trouble Cannot Start Check the batteries to have sufficient power. Cannot connet to iPad  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 extent dependent on the environment around.  Check the router if the recorder at Net-work mode. With a fixed ECG signal Your vhECG is in DEMO mode. Enter your iPad vhECG’s setting part and set “Use Demo Data” OFF. Without ECG signal or with too much 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 magnetic field around 22
® CardioView® Family iCV200S User Manual 7. Guidance and Manufacture’s Declarations Declarations:  iCV200Sneeds special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the User Manual;  Portable and mobile RF communication equipment can affect iCV200S. Electromagnetic emissions iCV200S is intended for use in the electromagnetic environment specified below. The customer or the user of iCV200S should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 iCV200Suses 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. RF emissions CISPR 11 Class B iCV200Sis 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. 23
® CardioView® Family iCV200S User Manual Electromagnetic immunity iCV200S is intended for use in the electromagnetic environment specified below. The customer or the user of the ECG Acquisition Systems should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment –guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air ±6 kV contact ±8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2,5 GHz 3 V/m 3,5[]3dp= 80 MHz to 800 MHz 7[]3dp= 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 fixed RF transmitters, as determined 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: a Field strengths from fixed 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 assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the iCV200S is used exceeds the applicable RF compliance level above, iCV200S 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. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m. 24
® CardioView® Family iCV200S User Manual Recommended separation distances between portable and mobile RF communication equipment and iCV200S iCV200S is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of iCV200S can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and iCV200S as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 150Hz to 80MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz 0.01 0.117 0.117 0.2333 0.1 0.36999 0.36999 0.73681 1 1.17 1.17 2.33 10 3.69986 3.69986 7.36811 100 11.6667 11.6667 23.3 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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. 25
® CardioView® Family iCV200S User Manual Annex I: iCV200S ECG Recorder Technical Specifications  Sampling Rate: A/D: 24K/SPS/Ch Recording: 1K/SPS/Ch  Quantization Precision: A/D: 24Bits Recording: 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×AAA( LR03)  Recovery time after defibrillation：≤10S 26
® CardioView® Family iCV200S User Manual Annex II: Definitions and Rules for ECG Measurements 1. ECG Waveform and Contour Classification The ECG waveform consists of P-QRS-T complex which measured as: P-onset, P-offset： Pb, Pe QRS- onset, QRS- offset： Qb, Se(J) T- offset： Te Note: Globally, i.e. for all LEADS valid, Durations or intervals of P-QRS-T are defined, based on physiological reasons, by the earliest onset (for ST interval, the latest offset) of any LEAD to the latest offset (for PR interval, the earliest onset) of any other LEAD. All parameters used in the diagnostic criteria of the contour classification are measured in the representative P-QRS-T complex. The lead-independent, overall parameters are presented in the table bellowing: Name Descriptions Heart 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 27
® CardioView® Family iCV200S User Manual Normal electrocardiogram Isoelectric segment: value of midpoint between P-offset and QRS-onset 3. ECG Axis P/QRS/T axis is calculated based on Einthoven Triangl 28
®CardioView® Family iCV200S User Manual 4. Acceptance of minimum wavesThe labeling of the QRS complex depends by definition on the first wave detected. A tiny positive wave at beginning is called r or R following Q and may mask a true. The acceptance criteria of initial waveforms should be clearly defined and standardized. The rule for acceptance of minimum waves is: the signal with amplitudes smaller than 20uV cannot be accepted. 29 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 undesired operation.Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

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