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Lepu Medical LeECG Series Operator's Manual

Electrocardiograph
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Electrocardiograph
Operator's Manual

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  • Page 1 LeECG & NeoECG Series Electrocardiograph Operator’s Manual...
  • Page 3 Preface Declaration Shenzhen Carewell Electronics Co., Ltd. (hereinafter referred to as "Carewell") makes no warranties of any kind, including (but not limited to) implied warranties of merchantability and fitness for a particular purpose. Carewell assumes no responsibility for any errors that may appear in this document, or for incidental or consequential damage in connection with the furnishing, performance or use of this material.
  • Page 4 referenced chapters or sections. [XX] is used to indicate the character string in the software.  → is used to indicate operational procedures.  All illustrations in this manual serve as examples only and may  differ from what is actually seen. Special Notes The warnings, cautions and tips in this manual are used to remind readers of some specific information.
  • Page 5 Manufacturer's Liability and Warranty Manufacturer's Liability Carewell is responsible for the safety, reliability and performance of the device, only if: Assembly operations, expansions, re-adjustments,  improvements and repairs of this device are performed by personnel authorized by Carewell; The electrical installation of the relevant room complies with the ...
  • Page 6 Warranty The warranty period is subject to the terms in the sales contract. The warranty covers all device failures caused by material, firmware or production process. Any faulty parts can be repaired and replaced free of charge during the warranty period. Manufacturing Process and Raw Materials Carewell warrants that there is no defect in raw material and manufacturing process.
  • Page 7 Address: Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District 518108, Shenzhen, P.R. China Zip code: 518108 EC-Representative Lepu Medical (Europe) Coöperatief U.A. Abe Lenstra Boulevard 36, 8448 JB, Heerenveen, The Netherlands Tel: +31-515-573399 Fax: +31-515-760020...
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  • Page 9: Table Of Contents

    Table of Contents Chapter 1 Safety Guidance ..............1-1 1.1 Safety Warnings ..............1-1 1.1.1 Device Warnings ............1-1 1.1.2 Defibrillator and Pacemaker Warnings ....... 1-5 1.1.3 Battery Warnings ............1-6 1.2 Cautions ................. 1-8 1.2.1 General Cautions ............1-8 1.2.2 Cleaning &...
  • Page 10 3.1 Unpacking and Checking ............3-1 3.2 Selecting an Installation Location .......... 3-1 3.3 Preparing the Device ............. 3-2 3.3.1 Using the Battery ............3-3 3.3.2 Installing the Battery of Recorder Base ...... 3-4 3.3.3 Loading the Recording Paper ........3-5 3.3.4 Connecting the Device to the Base ......
  • Page 11 Chapter 6 Acquisition, Analysis and Printing ........6-1 6.1 Selecting the Working Mode ..........6-1 6.2 Selecting the Lead Mode ............6-1 6.3 Setting ECG Waveform and Report ........6-2 6.4 Acquisition and Analysis ............6-2 6.4.1 Auto Diagnosis ............6-2 6.4.2 AI Diagnosis ..............
  • Page 12 8.6.2 Date & Time ..............8-8 8.6.3 Other Setup ..............8-9 8.7 System Maintenance ............8-10 8.8 Factory Maintenance ............8-10 Chapter 9 Prompt Messages and Troubleshooting ......9-1 Chapter 10 Cleaning, Disinfection and Maintenance ......10-1 10.1 Recommended Cleaning Agents ........10-1 10.2 Cleaning ................
  • Page 13 B.1 EMC Compliance ..............B-1 B.2 Radio Regulatory Compliance..........B-6 Appendix C Sensitivity Test and ECG Waveform Distortion TestC-1 C.1 Sensitivity Test ..............C-1 C.2 ECG Waveform Distortion Test ..........C-2...

  • Page 14: Chapter 1 Safety Guidance

    Chapter 1 Safety Guidance This chapter provides important safety information related to the use of the device. In other chapters, it also contains relevant safety information for specific operations. In order to use the device safely and effectively, please read and strictly observe all of the safety information described in this manual before use.
  • Page 15 Warning Only service engineers authorized by the manufacturer can open the device housings. Warning Replacement of components by unauthorized personnel may lead to unacceptable risks. Warning Do not open the device housings while the power is connected. Warning EXPLOSION HAZARD - Do not use the device in the presence of flammable anesthetic mixture with oxygen or other flammable agents.
  • Page 16 configurations shall comply with the valid version of IEC 60601-1. If in doubt, consult our technical service department or your local distributor. Warning The summation of leakage current should never exceed leakage current limits while several other devices are used at the same time. Warning Only the patient cable and other accessories supplied by Carewell can be used.
  • Page 17 Warning Do not touch the patient and live parts simultaneously. Otherwise patient injury may result. Warning To avoid risk of electric shock, do not touch the patient cable connector when acquiring an ECG. Warning Do not carry out maintenance and repair of the device in use. Warning The frequency setting of AC filter should be consistent with the frequency of local mains supply, otherwise, the anti-interference performance of the...

  • Page 18: Defibrillator And Pacemaker Warnings

    Warning To avoid the risk of electric shock, when the device is used together with the recorder base, be sure that the recorder base must only be connected to a supply mains with protective earth. 1.1.2 Defibrillator and Pacemaker Warnings Warning When used with a defibrillator or pacemaker, all electrodes connected and not connected to the patient and the patient should not be grounded.

  • Page 19: Battery Warnings

    Warning During defibrillation, use disposable electrodes and ECG adapter wires specified by the manufacturer and use them in accordance with their instructions for use. Warning After defibrillation, the ADS filter is set at 0.67Hz, and the cardiogram is displayed and maintained within 10 seconds. Warning Use only the patient cable and electrodes supplied by the manufacturer while defibrillating.
  • Page 20 Warning Danger of explosion - Do not reverse the anode and the cathode when installing the battery. Warning Do not use the battery near a fire source or in the place where the temperature exceeds 60℃. Do not heat the battery or throw it into fire. Do not expose the battery to liquid.

  • Page 21: Cautions

    Warning Remove or install the battery only when the device is powered off. Warning Remove the battery from the device when the device is not used for a long time. Warning If the battery is stored alone and not used for a long time, we recommend that the battery should be charged at least once every 6 months to prevent over discharge.
  • Page 22 equipment, radiological equipment and magnetic resonance imaging equipment etc. is likely to bring electromagnetic interference. Caution Do not detach the electrodes from the patient during ECG analysis. Caution Disposable electrodes can not be reused. Caution When installing the thermal recording paper, put the side with grids toward the thermal print head.

  • Page 23: Cleaning & Disinfection Cautions

    Caution Clinical interpretation of the ECG report may be affected by the filter settings. Caution The results given by the device should be examined based on the overall clinical condition of the patient, and they can not substitute for regular checking.

  • Page 24: Device Symbols

    Caution The device shall be disinfected if it is touched by infected patient or suspected patient. Caution Do not use high temperature, high pressure steam and ionizing radiation for disinfection. Caution Carewell is not responsible for the effectiveness of the disinfectant or disinfection method used as a means of infection control.
  • Page 25 Symbol Description Symbol Description Date of Manufacturer manufacture The symbol indicates that the device complies with Authorised the European Council representative in Directive 93/42/EEC the European concerning medical Community devices. Non-ionizing Serial number electromagnetic radiation Dispose of in Caution! Consult accordance to your accompanying documents country’s...
  • Page 26  Note This manual is printed in Black and White. 1-13...
  • Page 27 This page intentionally left blank. 1-14...

  • Page 28: Chapter 2 Product Introduction

    Chapter 2 Product Introduction The NeoECG S120 / LeECG OS12 / NeoECG T120 / NeoECG T180 / LeECG OT12 electrocardiograph (hereinafter referred to as the “device”) is a portable ECG analysis device, with convinent and flexible product configuration. There are two screen sizes: 7 inches (7") and 10.1 inches (10.1").

  • Page 29: Structure And Composition

    2.3 Structure and Composition Standard Configuration: The electrocardiograph (including multi-channel electrocardiograph software (V1) and CWECG-SLA ECG analysis program (V1)), power adapter, patient cable (model: ECG-FD10X4 or ECG-FD18X4 (CE) and ECG-FD08X4 (US)) and ECG electrodes (chest electrode model: ECG-FQX41, limb electrode model: ECG-FJX42). Optional Configuration: Glasgow ECG analysis program (V30), recorder base (for 10.1"...

  • Page 30: Model Difference

    2.4 Model Difference Screen 9-lead 12-lead 15-lead 18-lead Size & Model Synchronous Synchronous Synchronous Synchronous Remarks Device Acquisition Acquisition Acquisition Acquisition Color NeoECG ● ● 7" white S120 LeECG ● ● 7" black OS12 NeoECG ● ● Electrical structural T120 10.1"...

  • Page 31: Product View

    2.5 Product View 2.5.1 7”Device Front View 2 3 4 Name Description Press this key to turn on the device. Press and hold this key for about 5 seconds to turn off the device. Power On/Off Press and hold this key for no less than 10 seconds to forcibly shut down the device if it could not be shut down normally.
  • Page 32 Name Description Green: the device is on Power-on indicator Off: the device is off Green: DC power connected DC power indicator Off: DC power disconnected Green: the battery is fully charged. Battery Yellow: the battery is being charged. indicator Off: The battery is not charged. Rear View Name Description...
  • Page 33 Name Description Scan the code type supported to input patient Camera information Battery compartment Lock/unlock battery compartment cover cover lock Battery Built-in rechargeable lithium-ion battery compartment Speaker holes Give notification tone, heartbeat tone, etc. Left and Right View Name Description Microphone Reserved function...
  • Page 34 Top View Name Description Patient cable Connects the patient cable for ECG acquisition connector Bottom View Name Description DC power Connect the DC power adapter to power the device supply and charge the built-in lithium battery. connector Used to connect a U disk for data transfer and system upgrades;...

  • Page 35: Device

    2.5.2 10.1”Device Front View Name Description Press this key to turn on the device. Press and hold this key for about 5 seconds to turn off the device. Power On/Off Press and hold this key for no less than 10 seconds to forcibly shut down the device if it could not be shut down normally.

  • Page 36: Recorder Base

    Rear View Name Description Contact-type, matched with the device connector Recorder base on the recorder base, connecting with the connector recorder base for data transmission and powering the device Handle Carry the device Battery compartment Lock/unlock battery compartment cover cover lock Battery Built-in rechargeable lithium-ion battery compartment...
  • Page 37 Left View Name Description A standard RJ45 connector for LAN, connects the Network device to the network for data connector transmission Used to connect a U disk for data transfer and system upgrades; and to connect an external connector printer. Microphone Reserved function Right View...
  • Page 38 Top View Name Description DC power Connect the DC power adapter to power the device supply and charge the built-in lithium battery connector Bottom View Name Description Microphone Reserved function Scan the code type supported to input patient Camera information Speaker holes Give notification tone, heartbeat tone, etc.
  • Page 39 2.5.3 Recorder Base Front View Name Description Green: the recorder base is on Power-on indicator Off: the recorder base is off Green: AC power connected AC power indicator Off: AC power disconnected Green: the battery is fully charged Battery Yellow: the battery is being charged indicator Off: The battery is not charged Green: recorder ready (recording paper installed,...
  • Page 40 Name Description Device lock Lock / unlock device Device Used to connect with the device, for data connector transmission, powering and charging the device Rear View Name Description Battery Built-in rechargeable lithium-ion battery compartment 2-13...
  • Page 41 Left View Name Description Recorder Turn on / off the recorder switch Ventilation Heat dissipation holes Right View Name Description Paper compartment Press this button to open the paper compartment cover open cover button Ventilation Heat dissipation holes 2-14...
  • Page 42 Top View Name Description AC power input Connect the AC power cable Equipotential Connect the grounding cable, for protective grounding purposes and complying with the requirements of terminal IEC 60601-1 Bottom View 2-15...

  • Page 43: Function Features

    2.6 Function Features Portable design, compact in size with low weight, easy for carry.  Color touch screen, easy to operate.  Can be powered by an external DC power supply or a built-in  rechargeable lithium battery, or a recorder base. Support synchronous acquisition and display of 9/12/15/18-lead ...

  • Page 44: Operating Modes

    Freeze the ECG waveform on the screen.  Output files in multiple formats, such as Carewell ECG, PDF,  BMP, HL7, DICOM, SCP. Auto-saving function: save the ECG data when the report is  printed. Store, preview, review, edit, export, upload, print and search ...

  • Page 45: Emergency Use

    mode, which is most frequently used clinical mode. In this mode, you can perform ECG measurement, record waveforms, measured values and analysis results, set up the system, print ECG reports and export ECG data. In the auto diagnosis mode, click the exit icon in the upper right corner of the screen to exit the current mode and return to the login screen.

  • Page 46: Demo Mode

    inactive for a predefined time limit. To set the time to automatically enter the standby mode, follow the steps below: Click [ ] button in the lower right corner of the main screen to open the menu screen. Click the [Setup] button to enter the setting screen. Click [System Setup] →...
  • Page 47 To enter the demo mode, follow the steps below: Click [ ] button in the lower right corner of the main screen to open the menu screen. Click the [Setup] button to enter the setting screen. Click [System Setup] → [Demo]. Select [Normal ECG] or [Abnormal ECG].

  • Page 48: Chapter 3 Operation Preparations

    Chapter 3 Operation Preparations 3.1 Unpacking and Checking Before unpacking, examine the packaging carefully for signs of damage. If any damage is found, please contact the carrier immediately. If the packaging is intact, perform unpacking inspection according to the following steps: Open the package and take out the device and accessories carefully.

  • Page 49: Preparing The Device

    Caution Do not locate the device in a place where the power plug is difficult to plug in and out. 3.3 Preparing the Device If you purchased a thermal recorder base, the device preparation includes the following steps, and each step is described in detail in the following sections: 错误!未找到引用源。...

  • Page 50: Using The Battery

    If you have not purchased a thermal recorder base, device preparation includes the following steps: 错误!未找到引用源。 Using the DC Power Source 错误!未找到引用源。 错误!未找到引用源。 Login and Account Management Connecting the Printer 错误!未找到引用源。 3.3.1 Using the Battery The device can be powered by a rechargeable lithium battery. When a battery is installed, the device will automatically run from battery power in case of power failure of the DC power supply or the recorder base.

  • Page 51: Installing The Battery Of Recorder Base

    Reinstall the battery compartment cover and slide the latch to the lock position. Charging the Battery  Because of the power consumption during the storage and transportation, the battery capacity may not be full, so it is necessary to charge the battery before using it for the first time. The battery is charged whenever the device is connected to the recorder base or an DC power source regardless of whether or not the device is currently turned on.

  • Page 52: Loading The Recording Paper

    and insert the battery into the battery compartment. Close the battery compartment cover and tighten the fixing screws. For charge time and run time of the battery, refer to A.3 Physical and Hardware Specifications. 3.3.3 Loading the Recording Paper The thermal recorder supports 210mm and 216mm width roll thermal sensitive paper.

  • Page 53: Connecting The Device To The Base

    To install the recording paper, follow the steps below: As shown in the figure above, push the open button on the right side of the base and press forward slightly to open the paper compartment cover. Take out the paper roller, insert it into the new roll paper and put the paper with roller back into the paper compartment.

  • Page 54: Connecting Ac Power To The Base

    3.3.5 Connecting AC Power to the Base To connect the AC power to the base, follow the steps below: Insert the three-wire plug of the power cable into an AC receptacle. Insert the other end of the power cable into the AC power input on the base.

  • Page 55: Connecting The Patient Cable And Electrodes (Applied Part)

    3.3.8 Connecting the Patient Cable and Electrodes (Applied Part) Connecting the Patient Cable  Connect the patient cable to the patient cable connector of the device, and then tighten the knobs on both sides of the patient cable plug to secure it. Connecting the Electrodes ...

  • Page 56: Inspections Before Power-On

    European Standard American Standard Identifier Color Code Identifier Color Code White/Black Brown/Orange White/Violet Brown/Violet White/Pink Brown/Yellow White/Grey Brown/Red White/Green Brown/Green White/Orange Brown/Black White/Blue Brown/Blue White/Yellow Brown/Yellow 3.3.9 Inspections Before Power-On To ensure the safe and effective operation of the device, perform the following inspections before power-on and operation.

  • Page 57: Login And Account Management

    powered by DC power supply. Check that the power cord is securely connected if the recorder is powered by AC power supply. Use only power socket that is properly grounded. Patient Cable:  Make sure that the patient cable is connected to the device firmly. Electrodes: ...

  • Page 58: Connecting The Printer

    enter the main screen of the device. AI diagnosis mode  Before the first use, you need to connect to the network, set the IP address and port number of the server, and input an authorized account and password to log into the device after establishing a connection with the server.

  • Page 59: Setting Up The Device

    When selecting [Network Printer], you need to set the IP  address and port number of the network printer, and use it after the connection is successful. When selecting [USB Printer], plug the USB cable supplied with  the printer into an appropriate USB adapter which has been inserted ino the device.

  • Page 60: Turning Off The Device

    3.3.13 Turning off the device Follow the steps below to turn off the device: Confirm that the patient's ECG examination has been completed. Remove the electrodes from the patient. Press and hold the power button for about 5 seconds, the screen displays the prompt message "Shutting down...", and then the device shuts down.

  • Page 61: Attaching Electrodes To The Patient

    Shave hair from electrode sites, if necessary. Excessive hair prevents a good connection. 3.4.2 Attaching Electrodes to the Patient The quality of ECG waveform will be affected by the contact resistance between the patient and the electrode. In order to get a high-quality ECG, the skin-electrode resistance must be minimized when you attach electrodes to patients.
  • Page 62 C1: on the fourth intercostal space at right border of sternum. C2: on the fourth intercostal space at left border of sternum. C3: midway between the C2 and C4 electrode positions. C4: on the fifth intercostal space at the left midclavicular line. C5: on the left anterior axillary line, horizontal with the C4 electrode position.
  • Page 63 C3R: on the right side of chest, opposite to the C3 electrode position. C4R: on the right side of chest, opposite to the C4 electrode position. C5R: on the right side of chest, opposite to the C5 electrode position. V7+V8+ Posterior Chest Leads ...
  • Page 64 paste evenly to the electrode area on the limb. Daub a thin layer of conductive paste on the metal part of the limb electrode clamp. Connect the electrode to the limb, and make sure that the metal part is placed on the electrode area above the ankle or the wrist. Attach all limb electrodes in the same way.
  • Page 65 3-18...

  • Page 66: Chapter 4 Screen Introduction

    Chapter 4 Screen Introduction 4.1 Main Screen After logging into the device, the normal ECG acquisition screen is displayed, as shown in the figure below: Barcode scanning button Click the [ ] button to enter the patient ID by scanning the patient's barcode with the built-in camera.
  • Page 67 Click the patient information area to enter the Patient Info  screen to view and edit the detailed patient information. Heart rate (HR) area Display the heartbeat symbol and real-time HR value and unit.  The refreshing speed of the dynamic icon is the same as the heart beating speed.
  • Page 68 Prompt information area Display prompt information such as "All leads off", "HR overrange". Status display area Display the current network, internal battery, external power, external USB device connection status of the device. Wired network  : indicates that the device is connected to a wired ...
  • Page 69 : indicates that the device is powered by a  battery. : indicates that the device is powered by a battery  and the battery power is low. : indicates that the battery is almost depleted and  needs to be charged immediately. Otherwise, the device will automatically shut down soon.

  • Page 70: System Buttons

    Waveform area Displays the ECG waveform.  The waveform layout is the same as the waveform display  format set in different working modes. System button area Displays the commonly used system buttons. For more information, see 4.2 System Buttons. 4.2 System Buttons At the bottom of the main screen, there are the following buttons: working mode, low-pass filter, display format, waveform freezing,...
  • Page 71 130 seconds, the waveform of the actual duration from the beginning of waveform refresh to the time when the button is clicked is displayed. You can switch the speed, sensitivity and lead format of the frozen waveform, as well as store and print ECG reports. You can manually add or modify diagnosis results.
  • Page 72 Copy  Click the [Copy] button to directly print the most recently stored report. Setup  Click the [Setup] button to set the device comprehensively. For more information, see Chapter 8 System Settings. STAT  Click this button, the symbol " "...
  • Page 73  During a manual measurement, click this button to place a 1mV calibration square wave on each waveform on the acquisition screen and ECG report. Lead Switch  During a manual measurement, click this button to switch the leads to be recorded. Start / Stop button ...

  • Page 74: Chapter 5 Entering Patient Information

    Chapter 5 Entering Patient Information 5.1 Setting Patient Information Certain patient information directly affects ECG analysis, correct and complete patient information is helpful to the accuracy of analysis and treatment of the patient. Patient information is classified as required information and detailed information. The required information must be entered.

  • Page 75: Entering Patient Information

    screen. Select the required information items, ID mode, etc. For specific setting information, see 8.2 Patient Info Setup. 5.2 Entering Patient Information Use any of the following methods to enter patient information before taking an ECG examination. Enter patient information manually ...
  • Page 76 information.  Note You can save patient information only when all the required patient information is entered. Reading Patient ID with the Device’s Camera To read the patient ID with the built-in camera of the device, follow the steps below: Click the [ ] button to start scanning.
  • Page 77 Selecting a Patient from the Order List To select a patient from the order list, follow the steps below: In the main screen, click [File] → [Order List] to enter the order list screen. Select a patient and edit the patient information as necessary. The patient information in the order list is automatically downloaded from the AI server.

  • Page 78: Chapter 6 Acquisition, Analysis And Printing

    Chapter 6 Acquisition, Analysis and Printing 6.1 Selecting the Working Mode The device supports manual and automatic measurement (pre-sampling, real-time sampling, periodic sampling, trigger sampling), and R-R analysis. To select the working mode, follow the steps below: In the main screen, click [ ] →...

  • Page 79: Setting Ecg Waveform And Report

    To select the lead mode, follow the steps below: In the main screen, click [ ] → [Setup] to enter the setting screen. Click [ECG Setup] → [Lead Mode] to set the required lead mode. Return to the main screen after setting. 6.3 Setting ECG Waveform and Report Set the ECG waveform and report before starting an ECG measurement.
  • Page 80  Note In the Manual mode, the device continuously prints the waveforms of selected leads in real time. The manual measurement provides only printed report without measurement and analysis results. You cannot save the report or send it to the external device. In the auto measurement mode, ECG analysis provides: Measurement parameters, including: ...

  • Page 81: Ai Diagnosis

    Measurement parameters, including:  Sampling Time (s), Total QRS, Heart Rate (bpm), Average RR Interval (ms), Max RR Interval (ms), Min RR Interval (ms),Max/Min (Ratio of Maximum RR Interval to Minimum RR Interval) Time-domain analysis index: SDNN (Standard Deviation of Normal to Normal Intervals) (ms) RMSSD (The Root Mean Square Successive Difference) (ms) Frequency-domain analysis indexes: Total Power (ms*ms), VLF (extremely low frequency, ms*ms), LF...

  • Page 82: Printing Reports

    view the diagnosis result and print the report. If the auto upload function is not enabled or the upload fails, ECG data will be automatically stored in the device, and they can be manually uploaded to the server in the file management menu. 6.5 Printing Reports You can print ECG reports through an external printer.

  • Page 83: Copying Reports

    6.6 Copying Reports The device can print another copy of the latest ECG report. Operation procedure: In the main screen, click [ ] → [Copy] button: When the archived data is not empty, the most recently stored  report will be printed directly. When there is no report, a “No data!”...

  • Page 84: Report Examples

    6.8 Report Examples 6.8.1 Auto mode Take a 6x2+1R real-time sampling ECG report under the 12-lead auto measurement mode as an example to illustrate the elements in the report. A report usually includes waveform area, patient information area, measurement parameter area, diagnosis result area. You can also select to print the average template and measurement matrix information.
  • Page 85 2. Measurement parameters 1. Patient information area area 3. Diagnosis result area 4. Waveform area 5. Speed 6. Sensitivity 7. AC filter 8. Lowpass filter 9. ADS filter 10. System software version 11. Algorithm software version 12. Examination date and time 13.

  • Page 86: Rr Analysis

    Page 3 - Measurement matrix 6.8.2 RR analysis...
  • Page 87 Page 1 - 1min rhythm waveform of lead II Page 2 - RR measurement and analysis result 6-10...

  • Page 88: Chapter 7 File Management

    Chapter 7 File Management In the waveform acquisition screen, click the [File] button to enter the patient file management screen, as shown in the figure below. In this screen, all files are listed in chronological order, and the latest files are displayed on the top. You can re-acquire, upload, preview, edit, export, print, query and delete the stored historical records.
  • Page 89 Button Description Click to perform the following operations on the selected patient data: View waveform data, change waveform display  format, sensitivity and speed. Edit the patient information (the unique ID cannot be  modified). After the current patient information is Edit edited, the corresponding patient information in the patient information list will be updated.

  • Page 91: Chapter 8 System Settings

    Chapter 8 System Settings In the main screen, click [ ] → [Setup] to enter the setting screen.  Note The underlined options in the following table are the system default settings. 8.1 ECG Setup Menu Items Description Sampling Manual, Real-time, Pre-sampling, Periodic, Trigger, R-R Mode Lead Setup 9-lead, 12-lead, 15-lead (Standard + right), 15-lead...
  • Page 92 Menu Items Description Rhythm Lead I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V3R, V4R, V5R, V7, V8, V9 Rhythm Lead I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V3R, V4R, V5R, V7, V8, V9 Rhythm Lead I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V3R, V4R, V5R, V7, V8, V9...

  • Page 93: Patient Info Setup

    Menu Items Description bradycardia value. If the entered value of tachycardia is less than that of bradycardia, a prompt "The tachycardia value cannot be less than the bradycardia value" will pop Other Setup Auto Upload On, Off Auto Save On, Off Preview On, Off 8.2 Patient Info Setup...

  • Page 94: Sampling Setup

    Menu Items Description Unique ID Patient ID, Inpatient ID, Outpatient ID, Accession No. Patient ID Auto Accumulation, Manual Input 8.3 Sampling Setup Menu Items Description Sampling Time Setup Real-time 10 Sec, 20 Sec, 30 Sec, 60 Sec Sampling Manually enter an integer number in minutes into the text Periodic Sampling The input range is 1-60 Min, and the default value is 60...

  • Page 95: Record Setup

    8.4 Record Setup Menu Items Description Print Setup Print Sequence Synchronous, Sequential Save Paper, Quick Mode  Note Print Mode Save paper mode and quick mode are only suitable for printing ECG report in auto mode. Print Device Network Printer, USB Printer Print Preview On, Off Printout...

  • Page 96: Communication Setup

    Menu Items Description Template ECG report generated by auto measurement. Unchecked by default. Select whether Diagnosis Result is included in the ECG report generated by auto measurement. Diagnosis Result Checked by default. Select whether Minnesota Code is included in the ECG report generated by auto measurement.

  • Page 97: Mobile Network

    You can choose to automatically obtain IP address for network connection, or set IP address, gateway and subnet mask according to the actual situation. After successful connection, ECG data can be transmitted through wired network. 8.5.2 Mobile Network The device can be equipped with mobile network module. Insert the mobile network card and enable the [Mobile Network] function to transmit ECG data through mobile network.

  • Page 98: System Setup

    the [Test] button to test the connection to AI server. Port Local IP Enter your local IP. 8.6 System Setup 8.6.1 Display & Sound Menu Items Description Drag the slider to adjust the brightness of the display Brightness screen Volume Drag the slider to adjust the volume of the device.

  • Page 99: Other Setup

     Note In AI server login mode, after connecting to the AI server, the time of the device is synchronized with that of the server. 8.6.3 Other Setup Menu Items Description Select the UI language. Language Simplified Chinese, English, Spanish, Portuguese, French, Russian, Italian are optional Demo Options: Off, Normal ECG, Abnormal ECG...

  • Page 100: System Maintenance

    8.7 System Maintenance In the setting screen, click [System Setup] → [System Maintenance] to enter the system maintenance screen. Menu Items Description Set the frequency of AC filter. AC Frequency Options: 50Hz, 60Hz It can only be used after authorization, and "Authorized" will be displayed after authorization.
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  • Page 102: Chapter 9 Prompt Messages And Troubleshooting

    Chapter 9 Prompt Messages and Troubleshooting Messages or Troubles Solutions Recorder out of paper Load the paper properly. Recorder door not closed Close the recorder door. 1. Check the corresponding electrodes and lead wires. Re-apply the electrodes or reconnect the lead wires if necessary.
  • Page 103 Messages or Troubles Solutions change the storage device / location. If you acquire the ECG data immediately after the leadwires are applied to the patient, the ECG traces may not display because the Some Lead without Waveform ADS is not stable yet. Normally it is Printout necessary to wait for the waveform of each lead to be stable if all leads...
  • Page 104 Messages or Troubles Solutions Nobody is touching the  patient. There is no powerful electrical  equipment operating nearby, such as X-ray machines or ultrasonic instruments. The patient is not wearing  glass or diamond ornaments. AC filter frequency is properly ...
  • Page 105 Messages or Troubles Solutions recorded waveform is slightly attenuated. It is caused by the great fluctuation of the waveform. The printed ECG waveform is Set the sensitivity to "Auto". The out of the grid area of the device will automatically adjust the printing paper.
  • Page 106 Messages or Troubles Solutions use an ADS filter.
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  • Page 108: Chapter 10 Cleaning, Disinfection And Maintenance

    Chapter 10 Cleaning, Disinfection and Maintenance Sterilization is not recommended for this device and its accessories, but they should be kept clean. If the device has become contaminated, clean it before disinfection. 10.1 Recommended Cleaning Agents Supported cleaning agents: water, neutral soap solution, ethanol solution (volume ratio: 70% to 80%).

  • Page 109: Cleaning Patient Cable And Electrodes

    10.2.2 Cleaning Patient Cable and Electrodes Before cleaning the patient cable and electrodes, remove the patient cable from the device. For the cleaning of the patient cable and electrodes, refer to their instructions for use delivered with the accessories. 10.2.3 Cleaning the Thermal Print Head Dirty print head deteriorates the printing quality.

  • Page 110: Care And Maintenance

    10.4 Care and Maintenance To ensure the performance and safety of the device and its accessories, routine care and maintenance should be carried out. 10.4.1 Device and Recorder Base Follow the below guidelines to maintain the device and recorder base: Avoid excessive temperature, sunshine, humidity and dirt.

  • Page 111: Reusable Electrodes

    Once damage or aging of the patient cable is found, replace it  with a new one immediately. For the replacement cycle of the patient cable, refer to its  instructions for use. 10.4.3 Reusable Electrodes Follow the below guidelines to maintain the reusable electrodes: Clean the electrodes after each use and make sure there is no ...

  • Page 112: Regular Maintenance

    10.5 Regular Maintenance The device shall be calibrated and measured at least once a year according to local regulations. 10.6 Viewing System Information When performing maintenance for the device, you may need to check the system information. In the main screen, click [ ] →...
  • Page 113 This page intentionally left blank. 10-6...

  • Page 114: Chapter 11 Accessories

    Chapter 11 Accessories The recommended standard and optional accessories are listed in the table below: Accessory Model/Type Quantity Power cable (recorder base) 10A/250V DC power adapter PH30-12 ECG-FD10X4 (IEC) Patient cable (12-lead) 1 set ECG-FD08X4 (AHA) Patient cable (18-lead) ECG-FD18X4 (IEC) 1 set Chest electrodes ECG-FQX41...
  • Page 115 Accessory Model/Type Quantity (device) Rechargeable lithium battery KMD-18650-14.4-4400B (recorder base) For the replacement cycle and replacement method of the patient cable and electrodes, refer to the instructions for use provided with the accessory. Warning Use accessories specified in this chapter. Using other accessories may cause damage to the device or not meet the claimed specifications in this manual.

  • Page 116: Appendix A Technical Specifications

    Appendix A Technical Specifications A.1 Safety Specifications MDD 93/42/EEC Medical Device Directive Medical electrical equipment - Part 1: IEC 60601-1: General requirements for basic safety 2005+A1:2012 and essential performance Medical electrical equipment - Part IEC 60601-2-25: 2-25: Particular requirements for the Standards 2011 safety of electrocardiographs...

  • Page 117: Environment Specifications

    Installation and Portable, not permanent installation use: device Working mode: Continuous operation EMC: Group Ⅰ, Class B Degree of safety of application in Equipment not suitable for use in the the presence of presence of flammable gas flammable gas: A.2 Environment Specifications Relative Humidity Atmospheric Environment...

  • Page 118: Physical And Hardware Specifications

    A.3 Physical and Hardware Specifications 7” device: 197mm×112mm×26mm (Width×Depth×Height) Dimensions 10.1” device: 273mm×182mm×40mm (Width×Depth×Height) 7” device: 0.8kg, including the main unit and battery, excluding accessories Weight 10.1” device: Main unit 1.2kg, including the main unit and battery, excluding accessories 7” device: 7 inches, color LCD touch screen Resolution: 1024 ×...
  • Page 119 charged, the device can work normally for more than 12 hours (acquiring ECG every 5 minutes); and if putting the device into standby mode, the battery can last for at least 72 hours. Charge time: Charge the battery for at least 5 hours before using it for the first time.
  • Page 120 Charge Time: Charge the battery for at least 5 hours before using it for the first time. For a depleted battery: less than 4 hours to 90% when the device is off. less than 5 hours to 100% when the device is off.

  • Page 121: Ecg Specifications

    A.4 ECG Specifications Method Peak-peak detection Measurement 30bpm~300bpm Measurement range Accuracy ± 1bpm 9-lead, 12-lead, 15-lead and 18-lead Leads synchronous acquisition and analysis A / D 24 bits conversion Sampling rate 32000 points / sec Skew between No skew channels Amplitude 0.95 μV/LSB quantisation...
  • Page 122 Frequency ＋０．４ｄＢ 0.01 Hz～350 Hz －３．０ｄＢ , 10Hz response Auto, 2.5mm/mV, 5 mm/mV, 10 mm/mV, 20 mm/mV, 40 mm/mV Sensitivity Accuracy: ± 5% AC filter: 50Hz, 60Hz, Off EMG filter: 25Hz, 35Hz, 45Hz, Off ADS filter: 0.01Hz, 0.05Hz, 0.32Hz, Filter 0.67Hz Lowpass filter: 75Hz, 100Hz, 150Hz, 300Hz, Off...
  • Page 123 defibrillation discharge Pacing pulse with amplitude of ± 2mV~± 700mV, duration of Pacing pulse 0.1ms~2.0ms, rise time of less than display 100µs, and frequency of 100/min can be displayed on the ECG recording. Minimum detectable 20μVp-p signal Analysis Glasgow Resting ECG Analysis Program algorithm...

  • Page 124: Appendix B Emc And Radio Regulatory Compliance

    Appendix B EMC and Radio Regulatory Compliance B.1 EMC Compliance Basic performance: The device can acquire ECG data normally. Warning Don’t use near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
  • Page 125 Warning The device may still be interfered even if other devices meet the emission requirements of the corresponding national standards. Caution Users shall install and use the device according to the EMC information provided in the this manual. Caution Mobile or portable RF communication equipment may affect the performance of the device.
  • Page 126 The guidelines and manufacturer’s declaration are detailed in the following tables: Table 1 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Emissions test Compliance RF emissions Group 1 CISPR 11 RF emissions Class B CISPR 11 Harmonic emissions Class A IEC 61000-3-2 Voltage fluctuations/ flicker emissions Clause 5...
  • Page 127 Table 2 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electrostatic ± 8 kV contact ± 8 kV contact discharge (ESD) IEC ± 2 kV, ± 4kV, ± 8 kV, ± 15 kV ±...
  • Page 128 Table 3 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity Immunity IEC 60601 Test Level Compliance Level Test Conducted 0.15 MHz to 80 MHz 0.15 MHz to 80 MHz 6 V in ISM bands between 0.15 6 V in ISM bands between 0.15 61000-4-6 MHz and 80 MHz MHz and 80 MHz...
  • Page 129 810 MHz **Pulse 28 V/m 28 V/m Modulation: 870 MHz 18Hz 930 MHz 1720 MHz **Pulse 28 V/m 28 V/m Modulation: 1845 MHz 217Hz 1970 MHz 2450 MHz **Pulse 28 V/m 28 V/m Modulation: 217Hz 5240 MHz **Pulse 0.2 W 9 V/m 9 V/m Modulation:...
  • Page 130 when placed on the market in Belgium (BE), Bulgaria (BG), the Czech Republic (CZ), Denmark (DK), Germany (DE), Estonia (EE), Ireland (IE), Greece (EL), Spain (ES), France (FR), Croatia (HR), Italy (IT), Cyprus (CY), Latvia (LV), Lithuania (LT), Luxembourg (LU), Hungary (HU), Malta (MT), Netherlands (NL), Austria (AT), Poland (PL), Portugal (PT), Romania (RO), Slovenia (SI), Slovakia (SK), Finland (FI), Sweden (SE), the United Kingdom (UK), Turkey (TR),...
  • Page 131 Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
  • Page 132 Warning 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. Warning Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the...
  • Page 133 Appendix C Sensitivity Test and ECG Waveform Distortion Test C.1 Sensitivity Test Testing device: Calibration Device for Electric Cardiac Monitor Testing method: Connect the tested electrocardiograph with the calibrator through patient cable, and set the sensitivity of electrocardiograph at 10mm/mV. The calibrator outputs a sine wave signal with a peak value of 1mV and a frequency of 10Hz to the tested electrocardiograph.
  • Page 134 C.2 ECG Waveform Distortion Test The function of the electrocardiograph will not be affected by pacemaker, which can be verified by the following methods: Superimpose the pulse wave with peak value of 200mV, rise time of less than 100μs, pulse width of 1ms, repetition rate of 100 times / min and sine wave signal with peak valley value of 1mV and frequency of 40Hz, input them to the electrocardiograph, and the time taken for the recorded sine...
  • Page 135 The electrocardiograph can pass the following tests: Output triangular pulse, 120bpm, 2mV, pulse width 100ms to LA (L). Measure lead I and record the amplitude as B. Set the pacing pulse to 200mV, pacing interval 1ms, pacing rate 120bpm. When measuring lead I, the difference between the amplitude recorded by triangle wave signal and the amplitude B without pulse shall not exceed 20%.
  • Page 136 Shenzhen Carewell Electronics Co., Ltd. Manufacturer address: Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District 518108, Shenzhen, P.R. China Tel: +86-755-86170389 Fax: +86-755-86170478 Website: www.carewell.com.cn Email: market@carewell.com.cn P/N: SZ09.24300554-03 Version: V1.2...

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