LeECG & NeoECG Series Electrocardiograph Operator’s Manual
I 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.
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. Warning Indicates a potential hazard or unsafe practice, which, if not avoided, could result in death or serious injury.
II 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 applicable national and local requirements; The device is used in accordance with the instructions in this manual.
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.
carried out by Carewell service personnel or its authorized distributors. Otherwise, Carewell will not be responsible for the safety, reliability and performance of the device. Date of Manufacture and Service Life The service life of the device is 10 years. Please refer to the label on the back of the main unit for the date of manufacture. Service Contact Shenzhen Carewell Electronics Co., Ltd. Customer Service Center Tel: +86-755-86170389 Fax: +86-755-86170478 Email: service-intl@carewell.com.
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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 .....................................................
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.
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 ...........................................................
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 ........................
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 .............................................
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. 1.1 Safety Warnings 1.1.1 Device Warnings Warning This device is not designed for direct cardiac application. Warning This device is not intended for treatment.
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. Warning Do not use the device adjacent to or stacked with other device.
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. Otherwise, the performance, electric shock protection or defibrillator protection cannot be guaranteed.
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 device will be seriously affected.
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.
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.
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. Warning Do not gouge the battery with metal, hammer or drop the battery or destroy the battery by other means, otherwise it will cause the battery over-heated, smoking, distorted or burning, even in danger.
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. 1.2 Cautions 1.2.1 General Cautions Caution Avoid water splashing on the device.
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. Caution Use only thermal recording paper supplied by the manufacturer. Using other paper may shorten the service life of the thermal print head.
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. 1.2.2 Cleaning & Disinfection Cautions Caution Turn off the device, disconnect the DC adapter and remove the patient cable before cleaning and disinfection. Caution Prevent the detergent from seeping into the device when cleaning.
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. Please consult your hospital's infection control director or epidemiologist for advice. 1.
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.
Note This manual is printed in Black and White.
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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"). The 10.1" screen model device can be equipped with removable recorder base. This manual takes the 10.
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" screen model), chest electrode (ECG-EQD01), limb electrode (ECG-EJ01).
2.4 Model Difference Model NeoECG S120 LeECG OS12 NeoECG T120 NeoECG T180 LeECG OT12 9-lead 12-lead 15-lead 18-lead Synchronous Synchronous Synchronous Synchronous Acquisition Acquisition Acquisition Acquisition ● ● N/A N/A Screen Size & Device Remarks Color 7" white N/A ● ● N/A N/A ● ● N/A N/A ● ● ● ● ● ● N/A N/A Note ● indicates “default configuration”, and N/A indicates “not applicable”. 2-3 7" black 10.1" white 10.
2.5 Product View 2.5.1 7”Device Front View 2 3 4 1 No. Name Description Press this key to turn on the device. Press and hold this key for about 5 seconds to 1 Power On/Off turn off the device. 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.
No. 2 3 Name Description Power-on Green: the device is on indicator Off: the device is off DC power Green: DC power connected indicator Off: DC power disconnected Green: the battery is fully charged. 4 Battery indicator Yellow: the battery is being charged. Off: The battery is not charged. Rear View 1 2 3 4 No.
No. Name 1 Camera Description Scan the code type supported to input patient information Battery 2 compartment Lock/unlock battery compartment cover cover lock 3 4 Battery compartment Speaker holes Built-in rechargeable lithium-ion battery Give notification tone, heartbeat tone, etc. Left and Right View 1 No.
Top View 1 No. 1 Name Patient cable connector Description Connects the patient cable for ECG acquisition Bottom View 1 No. Name DC power 1 supply connector 2 USB connector 2 Description Connect the DC power adapter to power the device and charge the built-in lithium battery. Used to connect a U disk for data transfer and system upgrades; and to connect an external printer.
2.5.2 10.1”Device Front View 1 2 3 4 No. Name Description Press this key to turn on the device. Press and hold this key for about 5 seconds to 1 Power On/Off turn off the device. 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. 2 3 Power-on Green: the device is on indicator Off: the device is off DC indicator power Green: DC power connected Off: DC power disconnected Green: the battery is fully charged.
Rear View 1 2 3 4 No.
Left View 1 No. 1 2 3 Name Network connector USB connector Microphone 2 3 Description A standard RJ45 connector for LAN, connects the device to the network for data transmission Used to connect a U disk for data transfer and system upgrades; and to connect an external printer. Reserved function Right View 1 No.
Top View 1 No. Name DC power 1 supply connector Description Connect the DC power adapter to power the device and charge the built-in lithium battery Bottom View 2 1 3 No. Name Description 1 Microphone Reserved function 2 Camera 3 Speaker holes Scan the code type supported to input patient information Give notification tone, heartbeat tone, etc.
2.5.3 Recorder Base Front View 1 2 3 4 5 6 No.
No. Name Description 5 Device lock Lock / unlock device Device Used to connect with the device, for data connector transmission, powering and charging the device 6 Rear View 1 No.
Left View 1 2 No. 1 2 Name Recorder switch Ventilation holes Description Turn on / off the recorder Heat dissipation Right View 1 2 No.
Top View 1 2 No.
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 waveform, as well as heart rate detection. Provide ECG algorithm to automatically analyze the acquired ECG waveform, output measured values and diagnosis results.
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 patient data. Support wireless transmission of ECG data via WiFi and mobile networks. Print ECG reports through an external printer or an external thermal recorder. Export patient data to USB flash disk via USB connector.
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.
inactive for a predefined time limit. To set the time to automatically enter the standby mode, follow the steps below: 1. Click [ ] button in the lower right corner of the main screen to open the menu screen. 2. Click the [Setup] button to enter the setting screen. 3. Click [System Setup] → [Other Setup] → [Auto Standby]. 4. Set the time to automatically enter standby mode. In the standby mode, the display screen is black, and the device enters the power saving state.
To enter the demo mode, follow the steps below: 1. Click [ ] button in the lower right corner of the main screen to open the menu screen. 2. Click the [Setup] button to enter the setting screen. 3. Click [System Setup] → [Demo]. 4. Select [Normal ECG] or [Abnormal ECG]. When the demo mode is enabled, both the waveform area of the acquisition screen and the parameter information area at the bottom left of the printed report display the word "Demo”.
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: 1. Open the package and take out the device and accessories carefully. 2. Check all materials according to the packing list. 3. Check the device for any mechanical damage. 4.
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: 1. 错误!未找到引用源。 2. Installing the Battery of Recorder Base 3. Loading the Recording Paper 4. Connecting the Device to the Base 5. Connecting AC Power to the Base 6. Connecting the Grounding Cable 7. 错误!未找到引用源。 8.
If you have not purchased a thermal recorder base, device preparation includes the following steps: 1. 错误!未找到引用源。 2. Using the DC Power Source 3. 错误!未找到引用源。 4. 错误!未找到引用源。 5. Login and Account Management 6. Connecting the Printer 7. 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.
4. 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.
and insert the battery into the battery compartment. 3. 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.
To install the recording paper, follow the steps below: 1. 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. 2. Take out the paper roller, insert it into the new roll paper and put the paper with roller back into the paper compartment. Be sure to place the movable end of the paper roller close to the open button side, and make sure that the paper is installed with the paper’s grid side facing up. 3.
3.3.5 Connecting AC Power to the Base To connect the AC power to the base, follow the steps below: 1. Insert the three-wire plug of the power cable into an AC receptacle. 2. Insert the other end of the power cable into the AC power input on the base. 3. Check whether the AC power indicator is on to ensure that the AC power supply is connected well. 3.3.
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 Connect the electrode connectors with chest electrodes and limb electrodes respectively. The electrode identifiers and color codes of the internationally accepted European and American standards are shown in the table below.
European Standard American Standard Identifier Color Code Identifier Color Code C5 White/Black V5 Brown/Orange C6 White/Violet V6 Brown/Violet C3R White/Pink V3R Brown/Yellow C4R White/Grey V4R Brown/Red C5R White/Green V5R Brown/Green C7 White/Orange V7 Brown/Black C8 White/Blue V8 Brown/Blue C9 White/Yellow V9 Brown/Yellow 3.3.
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: Make sure that all electrodes are connected to lead wires of the patient cable correctly. Ensure that the electrodes, especially the chest electrodes do not contact with each other.
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. Note In an emergency situation, click the [Emergency] button to quickly perform ECG examination without logging in.
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. Make sure the USB printer is connected successfully. 3.3.12 Setting Up the Device Set up the device before using it for the first time. The operation steps are as follows: 1.
3.3.13 Turning off the device Follow the steps below to turn off the device: 1. Confirm that the patient's ECG examination has been completed. 2. Remove the electrodes from the patient. 3. Press and hold the power button for about 5 seconds, the screen displays the prompt message "Shutting down...", and then the device shuts down. Caution Press and hold the power button for no less than 10 seconds to forcibly shut down the device if it could not be shut down normally.
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. Before placing the electrode, make sure that the electrode is clean. Reusable electrodes should be cleaned immediately after each use.
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. C6: on the left midaxillary line, horizontal with the C4 electrode position.
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.
paste evenly to the electrode area on the limb. 3. Daub a thin layer of conductive paste on the metal part of the limb electrode clamp. 4. 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. 5. Attach all limb electrodes in the same way. Attaching Chest and Back Electrodes Suction bulb Metal cup Electrode To attach the chest and back electrodes, follow the steps below: 1.
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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: 1 2 3 4 5 6 7 8 9 1 Barcode scanning button Click the [ ] button to enter the patient ID by scanning the patient's barcode with the built-in camera. 2 Patient information area The patient information area displays the patient ID, name, gender, age and other required information.
Click the patient information area to enter the Patient Info screen to view and edit the detailed patient information. 3 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. When the HR exceeds the detectable HR range, the HR value area is displayed as "-". 0 means cardiac arrest, displayed as 0.
5 Prompt information area Display prompt information such as "All leads off", "HR overrange". 6 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 network successfully. Not displayed when not connected. Wireless networks : indicates that a WiFi wireless network is connected. The solid part indicates network signal strength.
: 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. : indicates that no battery is installed or battery charging fault. Power supply : indicates that a DC power supply is connected. Not displayed when not connected.
8 Waveform area Displays the ECG waveform. The waveform layout is the same as the waveform display format set in different working modes. 9 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, start / stop button, file, sensitivity, speed and menu.
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. You can quickly select the diagnosis results you want by entering keywords, because the device has loaded the diagnosis result template.
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 " " appears on the screen. You can click the [STAT] button before and during the acquisition process, and click the [Cancel STAT] button to cancel the STAT ECG. After taking an urgent/STAT ECG, the stored report in the file list is marked as " ".
Cal 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 Click the [Start] button to start the acquisition and printing operation immediately. During acquisition, the button displays "stop and sampling time (current sampling time / set sampling time)".
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. In the [Patient Info] screen, an asterisk (*) is placed behind the required information.
screen. 3. Select the required information items, ID mode, etc. 4. 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.
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: 1. Click the [ ] button to start scanning. 2. Use the device's camera to scan the linear barcode or QR code, and enter the decoded content into the patient ID text box. 3. Enter other patient information manually. 4.
Selecting a Patient from the Order List To select a patient from the order list, follow the steps below: 1. In the main screen, click [File] → [Order List] to enter the order list screen. 2. Select a patient and edit the patient information as necessary. The patient information in the order list is automatically downloaded from the AI server. You can also create patient information manually. The newly added information is synchronized to the AI server.
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: 1. In the main screen, click [ ] → [Setup] to enter the setting screen. 2. Click [ECG Setup] → [Sampling Mode] to configure the sampling mode as needed. 3. Return to the main screen after setting. 4.
To select the lead mode, follow the steps below: 1. ] → [Setup] to enter the setting In the main screen, click [ screen. 2. Click [ECG Setup] → [Lead Mode] to set the required lead mode. 3. 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. Operation procedures: 1. Click the quick keys at the bottom of the main screen to set the speed, sensitivity, display format and filter frequency respectively. 2.
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.
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 (low frequency, ms*ms), LFnorm (nu), HF (high freque
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. Refer to 3.3.11 Connecting the Printer for methods for connecting the printer to your device. Before printing a report, check that the paper is properly loaded.
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!” message appears. Acquire ECG data first. 6.7 Freezing Waveforms You can freeze the currently displayed waveforms on the screen for a careful observation or printing.
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.
1. Patient information area 2. Measurement parameters 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. Print data and time 14.
Page 3 - Measurement matrix 6.8.
Page 1 - 1min rhythm waveform of lead II Page 2 - RR measurement and analysis result 6-10
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. The device can store 10000 routine ECG reports. Button Description Refresh Click to refresh the data list.
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. Print Edit the diagnosis. Re-analysis. Save analysis results. Print the ECG report of the patient.
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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.
Menu Items Description Rhythm Lead I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V3R, V4R, 1 V5R, V7, V8, V9 Rhythm Lead I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V3R, V4R, 2 V5R, V7, V8, V9 Rhythm Lead I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V3R, V4R, 3 V5R, V7, V8, V9 Filter Setup ADS Filter 0.01Hz, 0.05Hz, 0.32Hz, 0.67Hz EMG Filter 25Hz, 35Hz, 45Hz, Off Lowpass Filter 75Hz, 100Hz, 150Hz, 300Hz, Off AC Filter On, Off Display Setup Speed Sensitivity 5mm/s, 6.
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 up. Other Setup Auto Upload On, Off Auto Save On, Off Preview On, Off 8.
Menu Items Description Unique ID Patient ID, Inpatient ID, Outpatient ID, Accession No. Patient ID Auto Accumulation, Manual Input 8.
8.4 Record Setup Menu Items Description Print Setup Print Sequence Synchronous, Sequential Save Paper, Quick Mode Print Mode Note 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 On, Off Network Printer Network IP When "Network Printer" is selected for "Print Device”, Port set the network IP and port.
Menu Items Description Template ECG report generated by auto measurement. Unchecked by default. Select whether Diagnosis Result is included in the ECG Diagnosis Result report generated by auto measurement. Checked by default. Select whether Minnesota Code is included in the ECG Minnesota Code report generated by auto measurement. Unchecked by default. Select whether Print Time is included in the report. Print Time Unchecked by default.
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.
Port the [Test] button to test the connection to AI server. Local IP Enter your local IP. 8.6 System Setup 8.6.1 Display & Sound Menu Items Brightness Description Drag the slider to adjust the brightness of the display screen Volume Drag the slider to adjust the volume of the device. Touch Tone On, Off QRS Beep On, Off Low Battery Beep On, Off Lead Off Beep On, Off Print End Beep On, Off 8.6.
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.
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" SCP will be displayed after authorization. It can only be used after authorization, and "Authorized" HL7 will be displayed after authorization.
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Chapter 9 Prompt Messages and Troubleshooting No. Messages or Troubles Solutions 1 Recorder out of paper Load the paper properly. 2 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. 2. Check that the patient cable is 3 XX lead off (All leads off) properly connected to the device. 3.
No. 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 8 Some Lead without Waveform Printout traces may not display because the ADS is not stable yet. Normally it is necessary to wait for the waveform of each lead to be stable if all leads are in good contact before ECG measurement. Check the following aspects of the device for solving problems: AC Interference grounded.
No. 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 set. If the interference cannot be cleared after the above measures, use an AC filter, and the recorded waveform is slightly attenuated.
No. Messages or Troubles Solutions recorded waveform is slightly attenuated. It is caused by the great fluctuation of the waveform. The printed ECG waveform is 11 Set the sensitivity to "Auto". The out of the grid area of the device will automatically adjust the printing paper. sensitivity according to the amplitude of the ECG signal.
No. Messages or Troubles Solutions use an ADS filter.
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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%). Supported cleaning tools: cotton ball, soft gauze, soft brush, soft cloth. 10.2 Cleaning 10.2.
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. Clean the print head at least once a month or as needed. To clean the thermal print head, follow the steps below: 1. Turn off the recorder base. 2.
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. Prevent shaking it violently when moving it to another place. Prevent any liquid from penetrating into the device, otherwise the safety and performance of the device can not be guaranteed.
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 remainder gel on them. Keep the rubber bulbs of chest electrodes away from direct sunshine and excessive temperature.
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 [ ] → [Setup] → [System Setup] → [My Device] to view the software version, algorithm version, unique device identifier (UDI) of the device, and perform system upgrades.
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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 1 DC power adapter PH30-12 1 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 6 pcs ECG-EQD01 6 pcs ECG-FJX42 4 pcs ECG-EJ01 4 pcs 915W50 50 pcs ECG adapter (optional) Banana connector (4.
Accessory Model/Type Quantity KMD-18650-14.4-4400B 1 (device) Rechargeable lithium battery (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.
Appendix A Technical Specifications A.
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.
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 Main 10.1” device: unit 1.2kg, including the main unit and battery, excluding accessories 7” device: 7 inches, color LCD touch screen Resolution: 1024 × 600 pixels Display 10.1” device: 10.
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. For a depleted battery with the device power off: ≤4h to 90% capacity ≤5h to 100% capacity Recorder base Physical Dimensions 295mm×288mm×111.2mm (Width×Depth×Height) Specifications Weight About 2.
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. Recorder type Thermal recorder Recording Rolled thermo-sensitive paper, paper paper width: 210mm, 216mm 5mm/s, 6.25mm/s, 10mm/s, 12.
A.4 ECG Specifications Method HR Measurement Measurement range Accuracy Leads A/D conversion Sampling rate Skew between channels Amplitude Main unit quantisation Peak-peak detection 30bpm~300bpm ±1bpm 9-lead, 12-lead, 15-lead and 18-lead synchronous acquisition and analysis 24 bits 32000 points / sec No skew 0.
Frequency response ＋０．４ｄＢ 0.01 Hz～350 Hz－３．０ｄＢ, 10Hz Auto, 2.5mm/mV, 5 mm/mV, 10 Sensitivity mm/mV, 20 mm/mV, 40 mm/mV Accuracy: ±5% AC filter: 50Hz, 60Hz, Off EMG filter: 25Hz, 35Hz, 45Hz, Off Filter ADS filter: 0.01Hz, 0.05Hz, 0.32Hz, 0.67Hz Lowpass filter: 75Hz, 100Hz, 150Hz, 300Hz, Off 5mm/s, 6.25mm/s, 10mm/s, 12.
defibrillation discharge Pacing pulse with amplitude of Pacing pulse display ±2mV~±700mV, duration of 0.1ms~2.0ms, rise time of less than 100µs, and frequency of 100/min can be displayed on the ECG recording.
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. Warning Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.
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. Avoid strong electromagnetic interference when in use, such as near mobile phones, microwave ovens, etc.
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 IEC 61000-3-3 B-3
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 ±2 kV, ±4kV, ±8 kV, ±15 61000-4-2 air kV air Electrical fast ±2 kV for power supply lines ±2 kV for power supply transient/burst IEC 61000-4-4 lines ±1 kV for input/output lines ±1 kV for input/output lines Surge IEC61000-4-5 ± 0.5kV, ± 1 kV line(s) to lines ± 0.
Table 3 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity Immunity IEC 60601 Test Level Compliance Level Conducted 3V 3V RF 0.15 MHz to 80 MHz 0.15 MHz to 80 MHz IEC 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 Radiated RF 10V/m 10V/m IEC 80 MHz to 2.
810 MHz **Pulse 870 MHz Modulation: 930 MHz **Pulse 1845 MHz Modulation: 2450 MHz 28 V/m 28 V/m 2W 28 V/m 28 V/m 2W 28 V/m 28 V/m 0.2 W 9 V/m 9 V/m 18Hz 1720 MHz 1970 MHz 2W 217Hz **Pulse Modulation: 217Hz 5240 MHz **Pulse 5500 MHz Modulation: 5785 MHz 217Hz Note* - As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.
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), Norway (NO), Switzerland (CH), Iceland (IS), and Liecht
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.
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 equipment.
Appendix C Sensitivity Test and ECG Waveform Distortion Test C.1 Sensitivity Test Testing device: Calibration Device for Electric Cardiac Monitor Testing method: 1. 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. 2.
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: 1.
The electrocardiograph can pass the following tests: 1. Output triangular pulse, 120bpm, 2mV, pulse width 100ms to LA (L). Measure lead I and record the amplitude as B. 2. Set the pacing pulse to 200mV, pacing interval 1ms, pacing rate 120bpm. 3. When measuring lead I, the difference between the amplitude recorded by triangle wave signal and the amplitude B without pulse shall not exceed 20%. And on the ECG record, the position of pacemaker pulse can be clearly identified.
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.
