Gima ECG1200G Manual

12 channel with monitor

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PROFESSIONAL MEDICAL PRODUC TS

1200G ECG

12 CHANNEL WITH MONITOR

ECG1200G (GIMA 33224)

CONTEC MEDICAL SYSTEMS CO., LTD

No. 112 Qinhuang West Street,

Economic & Technical Development Zone,

Qinhuangdao, Hebei Province,

PEOPLE'S REPUBLIC OF CHINA

Made in China

Prolinx GmbH, Brehmstr. 56, 40239

Duesseldorf Germany

Imported by:

Gima S.p.A.

Via Marconi, 1 - 20060 Gessate (MI) Italy

gima@gimaitaly.com - export@gimaitaly.com

www.gimaitaly.com

55˚C

-20˚C

500hPa

0123

95%

1060hPa

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Page 1 PROFESSIONAL MEDICAL PRODUC TS 1200G ECG 12 CHANNEL WITH MONITOR ECG1200G (GIMA 33224) 0123 CONTEC MEDICAL SYSTEMS CO., LTD No. 112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei Province, PEOPLE’S REPUBLIC OF CHINA Made in China Prolinx GmbH, Brehmstr. 56, 40239...
Page 2 Preface Please read the User Manual carefully before using this product. The operating procedures specified in this User Manual should be followed strictly.This manual describes in detail the operation steps which must be noted, the procedures which may result in abnormality, and possible damage to the product or users.
Page 3 Responsibility of the company The company supplies qualified products to user in accordance with enterprise standard.  The company installs and debugs the equipment and trains the physicians by contract.  The company performs device repair in warranty period (a year) and maintenance service ...
Page 4: Table Of Contents
Contents Chapter1 Overview ...................... 1 1.1 Overview ...................... 1 1.2 Intended use ....................1 1.3 Main technical specifications ............... 1 1.4 Main Characteristics ..................2 1.5 Software overview..................3 Chapter2 Safety Precautions ..................4 Chapter 3 Warranty ...................... 6 Chapter4 Working Principle and Structural Characteristics ......... 7 4.1 Working principle and its block diagram .............
Page 5 7.7 Sampling setup ................... 24 7.8 Print setup ....................25 7.9 Lead placement ..................26 7.10 About......................26 Chapter 8 Troubleshooting ..................28 8.1 Auto shutdown ................... 28 8.2 AC interference ..................28 8.3 EMG interference ..................28 8.4 Baseline drift ....................29 8.5 Troubleshooting list..................
Page 6 4. Data sources and data preprocessing ............47 4.5 Data coverage of verification for automated interpretation ......49 5. Process and Result of Verification ................. 51 5.1 Verification of measurement function ............51 Appendix II EMC Guidance and Manufacturer Declaration ........59...
Page 7: Chapter1 Overview
Chapter1 Overview 1.1 Overview This product is a kind of electrocardiograph, which is able to sample 12 leads ECG signals simultaneously and print out the ECG waveform with thermal printing system. Its functions are as follows: recording and displaying ECG waveform in auto/manual mode; measuring ECG waveform parameters automatically, and automatic analysis and diagnosis;...
Page 8: Main Characteristics
1.3.9 Filter: AC Filter(50Hz/60 Hz), EMG Filter(25 Hz/35 Hz (-3 dB)), DFT Filter 1.3.10 Recording way: Thermal printing system 1.3.11 Specification of recording paper: 210 mm(W)×20 m(L) high-speed thermal paper 1.3.12 Time base selection(paper speed): 12.5 mm/s, 25 mm/s, 50 mm/s, error: ±5% 1.3.13 Gain control(sensitivity): 5, 10, 20 mm/mV, accuracy is ±2%;...
Page 9: Software Overview
1.4.9 Multi-language (Chinese, English, Turkish, Portuguese, German, Russian, Kazakhstan, etc.) interface and report. 1.5 Software overview Name of software: ECG1200G embedded software Software specification: none Software version: V1.6.15 Version naming rules: V<major version number>.<minor version number>.<revision version number>...
Page 10: Chapter2 Safety Precautions
Chapter2 Safety Precautions 2.1 Ensure that the device is placed on a flat level worktable. Avoid strong vibration or impact when moving it. 2.2 When working with AC power, the power cord must be 3-core, the frequency and voltage value of the AC power source must match the identification on the manual and have sufficient capacity.
Page 11 2.14 If other equipment is connected with this ECG device, it must be a Class I device that complies with IEC60601-1. Because the total leakage current may hurt patient, the monitoring of leakage current is carried out and taken charge by the connected equipment. 2.15 Notes related to EMC The device complies with the safety standards for medical electrical equipment or system electromagnetic compatibility in IEC60601-1-2.
Page 12: Chapter 3 Warranty
2.16.6 Merging of versatile arrhythmia may result in unreliable measurement because of the difficulty in distinguishing P wave in such situation. 2.16.7 The device has an automatic analysis function that automatically analyzes the obtained ECG waveform without reflecting all the patient’s status. The results of the analysis may sometimes not comply with the doctor’s diagnosis.
Page 13: Chapter4 Working Principle And Structural Characteristics
Chapter4 Working Principle and Structural Characteristics 4.1 Working principle and its block diagram 4.1.1 The power supply unit （1）Principle of power supply The switching power supply provides +24V working voltage for the thermal print head, provides constant voltage current limiting charging for the rechargeable lithium battery in the device through the DC-DC circuit, and generates +5V and +12V voltage through the power conversion to supply power to the corresponding modules.
Page 14: Name Of Each Part And Its Function
4.1.3 Control unit （1）Principle of control unit The control system consists of printing system, button system, liquid crystal display system, and signal acquisition system. The ECG signal sent from the signal acquisition system through the high-speed optoelectronic coupler is received by the CPU system, after digital filtering, gain adjustment and motor drive, it is sent to the printing system to print the ECG waveform.
Page 15 1. Paper compartment cover Keep the paper compartment closed, hold the printing paper 2. Display screen Display patient’s ECG and related information 3. Button area Control the operations of the device, and enter information. Note Do not put heavy objects on the screen or hit against it, otherwise the screen will be ...
Page 16 Figure 4-5 Bottom view 10. Battery compartment Built-in rechargeable lithium battery. 11. Fuse Built-in fuse tube, T1.6A L250V. It can avoid the damage to human body caused by large voltage and large current generated by grid pollution. Note Lead cables must be disconnected from patient before connecting with a computer via the USB interface.
Page 17 4. Backspace Change entered information, long pressing it could clear the title. 5. ON/OFF When the device is turned on, short press this button, it will prompt whether to shut down the device, long press this button to turn off the device. 6.
Page 18 Manufacturer Date of manufacture Lot number Not made with natural rubber latex Atmospheric pressure limit Temperature limit Humidity limit For indoor use only Polarity of d.c. power connector WEEE disposal This side up Fragile, handle with care Keep in a cool, dry place Stacking limit by number Follow instructions for use Medical Device compliant with Directive 93/42/EEC...
Page 19: Chapter 5 Operation Precautions
Unique device identifier Chapter 5 Operation Precautions 5.1 Precautions before use 5.1.1 For safe and effective use, please read the user manual carefully before operation. 5.1.2 Check to ensure that the device is in good condition. 5.1.3 The device shall be placed on a flat surface, and moves gently to avoid strong vibration or shock.
Page 20: Chapter 6 Preparations Before Operation
Chapter 6 Preparations before Operation 6.1 Installation of recording paper 6.1.1 The device adopts high-speed recording paper, its specification is 210 mm(W)×20 m(L). 6.1.2 The installation method of recording paper is described as below: 1. As shown in Figure 6-1, use both hands to lift both sides of the paper compartment cover at the same time to open it.
Page 21: Lead Cable Connection
re-installed by user. Check the battery's power and status before use. Note: Connect one end of the potential equalization wire to the equipotential terminal of the device, and connect the other end to the ground to enhance the reliability of the grounding.
Page 22 electrodes should not touch each other to avoid short circuit. Note: Please use qualified conductive paste to avoid damaging the skin. 6.4.2 Limb electrodes The limb electrodes should be placed on the soft skin of both hands and feet. Before connecting, clean the skin of the electrode installation area with alcohol, and then apply a small amount of conductive paste on the cleaned skin.
Page 23 6.4.4 Lead method and system As shown in Figure 6-5: Figure 6-4 Lead system 6.4.5 Lead-off and overload indication The device can check the connection status of the lead at any time. If lead-off or overload is detected, the screen will display corresponding lead code on the top left corner, as shown in Figure 7-2.
Page 24: Chapter 7 Operation Instructions And Parameter Setting
Chapter 7 Operation Instructions and Parameter Setting 7.1 Main Interface Status bar 1. Time System time can be set in , so the detail time of ECG recording can be noted. 2. Memory usage It directly shows the capacity of memory space according to actual usage. The green part represents the memory usage, the white part represents the remaining memory space.
Page 25: Sampling Interface
Quick setup: Click the functional module on the screen to quickly set the corresponding function. 2.Friendly tips. 7.2 Sampling interface Click on the main interface or press the button to enter the sampling interface. Note: There is input time of cases in the system setting, therefore, in default, case information should be input before sampling.
Page 26: Case Information Input Interface
12.5 mm/s, 25 mm/s and 50 mm/s. 2. Gain (sensitivity): use the button to switch the gain between 2.5 mm/mV, 5 mm/mV, 10 mm/mV, 20 mm/mV ,40 mm/mV,10/5 mm/mV,20/10 mm/mV,1.25 mm/mV. The overall gain (sensitivity) can be checked by calibration function. 3.
Page 27: Case Management
or “EN” to switch between Chinese and English. Clicking “Caps” can switch between numbers, lowercase letters, capital letters and symbols. “Space” is the space key, press it to enter a space; “Backspace” is the backspace key, press it to delete the last character entered. Click “OK” to confirm the entry and exit the interface.
Page 28: Date And Time Setup
will clear all query conditions that entered. “Cond.And” and “Cond.Or” indicate the matching mode of the query conditions. You can choose one of the two. If you select “Cond.And”, the displayed query results will satisfy all the input conditions at the same time; if you select “Cond.Or”, the displayed query results only need to meet any of the conditions entered.
Page 29 Item Options Description If there is no operation after reaching the [30Seconds]/[1Minute]/ set time, screen backlight will turn off. If it Back-light [2Minutes]/[5Minutes]/ is set to “Always On”, the backlight will [10Minutes]/[Always On] always keep on. [10%degree]/[20% degree]/ [30%degree]/[40% degree]/ Light-degree [50%degree]/[60% degree]/ After setting light degree, the screen will...
Page 30: Sampling Setup
7.7 Sampling setup In the main interface, click to enter the sampling setup interface. The optional content of each setting item and its description are shown in the following table: Item Options Description AC Filter ON/OFF Turn on or off the AC filter. AC Filter [50Hz]/[60Hz] To set the parameters of AC filter.
Page 31: Print Setup
Reverse Set whether to prompt limb lead connection of ON/OFF reversal in the conclusion. limb leads 7.8 Print setup In the main interface, click to enter the print setup interface. The optional content of each setting item and its description are shown in the following table: Item Options Description...
Page 32: Lead Placement
Print [Inside]/[Outside A4] Choose to print out the ECG waveform by Device thermal printing system or USB external printer Print Depth [1]/[2]/[3]/[4] Set the waveform depth according to necessary. Timing Set to display the time mark on the print ON/OFF Marker paper or not.
Page 33 including the following content: 1. App Version: the version number of current software 2. Firm Info: click it see the firmware information of the device. 3. Return: click it to exit the interface.
Page 34: Chapter 8 Troubleshooting
Chapter 8 Troubleshooting 8.1 Auto shutdown The battery is almost running out, which causes overdischarge protection circuit action.  The voltage of AC power supply is too high, which causes overvoltage protection circuit  action. 8.2 AC interference Whether the device is grounded reliably? ...
Page 35: Baseline Drift
8.4 Baseline drift Whether the electrode installation is stable?  Whether the connection of lead cables or electrodes is reliable?  Whether the electrodes and patient skin are cleaned and are daubed with enough  conductive paste? Whether it is caused by patient's movement or breathing? ...
Page 36: Chapter 9 Maintenance
1. Low power. 1. Charge the battery. Baseline draft 2. Patient movement. 2. Keep patient still. 1. Charge the battery. 1. Low battery. 2. Cut off the power, clean the 2. The printer head surface is printer head with alcohol, air Unclear waveform dirty.
Page 37: Recording Paper
shorten due to operation condition and environment. 9.1.3 The battery should be recharged in time after discharged completely. If not used for long period, the battery should be recharged every 3 months, which can extend the life of the battery. 9.1.4 When the battery can not be recharged or works no more than 10 minutes after fully charged, please replace the battery.
Page 38: Maintenance After Use
meet the requirements may damage the thermal print head or silicone rubber roller. 9.3 Maintenance after use 9.3.1 Press button to shutdown the device. 9.3.2 Unplug the power cord and lead cables. Hold the header of plug to disconnect, and do not pull the cable with force directly.
Page 39: Fuse Replacement
once a month during normal use. 9.7 Fuse replacement Use a cross screwdriver to remove the fuse holder in the direction of the arrow (counterclockwise), and replace the damaged fuse with a primary fuse provided or approved by our company. Screw the fuse holder in the opposite direction to fasten it. The replacement method is shown in Figure 9-1: Figure 9-1 Replacing the fuse Note ：...
Page 40: Chapter 10 Packing List And Accessories
Chapter 10 Packing List and Accessories 10.1 Accompanying accessories When the device is shipped from the factory, the intact packaging should contain the following contents, as shown in Table 10-1: Table 10-1 Packing list and accessories Name Quantity Electrocardiograph 1 pc Chest electrodes (suction cup/electrode slice) 1 set (6 pcs) Limb electrodes (limb clip)
Page 41: Appendix I Ecg Automated Measurement&Interpretation Guide
Appendix I ECG Automated Measurement&Interpretation Guide 1. Preface The appendix describes the functions of ECG automated measurement and automated interpretation. It explains the specific implementation method, algorithm and formulas related to these two functions, as well as the content output by the automated measurement and automated interpretation.
Page 42 Completeness Right Bundle branch block Completeness Left Bundle branch block No Completeness Right Bundle branch block No Completeness Left Bundle branch block V1 shows RSR' type Left anterior fascicular block Left posterior fascicular block Left ventricular hypertrophy Right ventricular hypertrophy I atrioventricular block Early anteroseptal MI Possible acute forepart anteroseptal MI...
Page 43: Algorithm Description
ST depression, mild anterior myocardial ischemia ST depression, mild extensive anterior myocardial ischemia ST depression, mild apical myocardial ischemia ST depression, mild anterolateral myocardial ischemia ST depression, mild high lateral myocardial ischemia ST depression, mild inferior myocardial ischemia ST depression, mild inferolateral myocardial ischemia ST depression, anteroseptal myocardial ischemia ST depression, anterior myocardial ischemia ST depression, extensive anterior myocardial ischemia...
Page 44 The workflow is shown as below: Start ECG waveform sampling Recognize all R points by slope method Waveform superposition taking R point as center Determine the positions of each wave Calculate the amplitudes of each wave Get measurement parameter, interpretation item 3.1 Find the cardiac impulse location 1) Data preprocessing, obtain the absolute value trend of slope for each lead;...
Page 45 5) Dynamically threshold adjustment: after found the cardiac impulse location, use the value at the cardiac impulse location for the dynamically adaptive adjustment of the threshold value. Define the threshold value as 1/3 of the average of the nearest three cardiac impulses. 6) After found the cardiac impulse location, compute the RR-interval and accumulate it with the previous RR-intervals, then count the number of accumulated RR-intervals.
Page 46 6) If the found P-wave is still narrow, it means that P-wave doesn’t exist. 4. Find T-wave 1) Peak of T-wave: search the max value within 30ms-300ms after the end of QRS-complex, save it as the peak of T-wave. 2) Threshold value of the beginning of T-wave: search the minimal value within 0ms-100ms after the end of QRS-complex, the minimal value plus 1/10 of the peak value of T-wave is the threshold for finding the beginning of T-wave.
Page 47 is above the QRS baseline, it is R wave, if it is below the baseline, it is Q wave or S wave. Find the extreme value of this wave, and the difference between the extreme value and the baseline is the amplitude of Q/R/S wave.
Page 48 ⑦ - Qs   Electric axis formula: arctan(2.0 × × × ⑧ P electric axis: : voltage sum from the beginning point to the end point of P-wave on lead III : voltage sum from the beginning point to the end P/QRS/T electric point of P-wave on lead I axis...
Page 49: Interpretations Judgment Based On Parameters
3.5 Interpretations judgment based on parameters Item Rule of interpretation No any abnormal are detected No abnormal Sinus P-wave, PR-interval between Sinus mode Bradycardia 110ms-210ms, HR≤*/min, general *=50 Sinus P-wave, PR-interval between Sinus mode Tachycardia 110ms-210ms, HR≥ */min, general *=100 P-wave of leads I, II, aVL shall meet the conditions: width increase of P-wave≥110ms, Left atrium Hypertrophy...
Page 50 R amplitude of lead I >1.5mV, R amplitude of lead V5 >2.5mV, R amplitude of lead aVL >1.2mV, R amplitude of lead Left ventricular hypertrophy aVF >2mV, R amplitude of lead V5 minus S amplitude of lead V1 >4mV (male) or 3.5mV (female).
Page 51 Early myocardial infarction change of leads I, Early anterolateral MI aVL, V4, V5, V6 Acute myocardial infarction change of leads Possible acute anterolateral MI I, aVL, V4, V5, V6. Old myocardial infarction change of leads I, Old anterolateral MI aVL, V4, V5, V6 Early myocardial infarction change of leads I, aVL, no change of leads II, III, aVF, V4, V5, Early high lateral MI...
Page 52 Mild ST-segment depression of leads I, aVL, ST depression, mild high lateral and no change of leads II, III, aVF, V4, V5, myocardial ischemia Mild ST-segment depression of leads II, III, ST depression, mild inferior aVF, and no change of leads I, aVL. myocardial ischemia Mild ST-segment depression of leads I, II, ST depression, mild inferolateral...
Page 53: Data Sources And Data Preprocessing
at 20ms, voltage at 60ms point >= the one at 40ms, with change of ST elevation. 4. Data sources and data preprocessing 4.1 Data sources According to the requirement of IEC60601-2-51:2003 Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiograph, the CSE measurement database, CSE diagnostic database, CTS calibration database and customized data shall be used to evaluate the function of automated measurements and automated interpretations.
Page 54 recommended standard for general ECG measurements based on the investigation and study of the database, which has been widely recognized by the world. CSE database diagnostic items: Item Number Normal Left ventricular hypertrophy Right ventricular hypertrophy Biventricular hypertrophy Anterior myocardial infarction Inferior myocardial infarction Complex myocardial infraction Synthetical accuracy...
Page 55: Data Coverage Of Verification For Automated Interpretation
5)Conduction block Determined by the physician diagnostic results of cardiac catheterization. The standard of normal population in the customized database: physical examination is normal, no heart disease or other diseases that may affect cardiac functions or shape. 4.5 Data coverage of verification for automated interpretation Analyzing the content of CSE diagnostic database and customized data, the overall condition and coverage of statistical samples are shown as below:...
Page 56 Note: The heart abnormalities such as posterior myocardial ischemia, early posterior MI and old posterior MI are not included in the database. These abnormalities and other heart disorders not contained in above sheet won’t be regarded as the judgment object for the verification of automated interpretation accuracy.
Page 57: Process And Result Of Verification
of D_0001~D_1220 shall be used for the following verification of automated interpretation. 4.6.3 Customized data preprocessing The customized initial case files shall be processed for voltage conversion and frequency conversion for resampling as the applicable format in the system. Then cases will be imported to the device.
Page 58 5.1.2 Verification and Process for CSE measurement database Import the converted case files into the device, add appropriate database records, then waveform for all case files can be reviewed in the device, therefore the automated measurement parameters can be obtained. Eliminate the cases existing obvious error for the diagnostic parameters (P-wave location is wrong) from the CSE database.
Page 60 5.1.3 Verification results 5.1.3.1 Accuracy of amplitude measurements Calibration and analytical ECGs shall be used to measure the amplitude value, the summary as follows: Amplitude Mean difference (uV) Standard deviation (uV) P-wave -1.70 5.72 Q-wave 7.51 18.07 R-wave -18.05 21.70 S-wave 7.77 18.58...
Page 61 QT-interval High frequency -14.55 6.51 QT-interval Line frequency -8.55 20.73 QT-interval Base-line 36.20 64.47 The biological ECGs are fed into the device in form of digital signals, then the measurement value can be obtained by calculation. Test condition: a) without NOISE b)with 25uV high frequency c) with 50uV peak to valley 50Hz/60Hz sinusoidal line frequency NOISE d) with 1mV peak to valley 0.3Hz sinusoidal base-line NOISE...
Page 62 5.2.1.2 Customized database...
Page 63 5.2.2 Verification results Positive ECGs Sensiti Specific Item predictive number vity % ity % value % No abnormal 92.01 79.16 97.38 Sinus mode Bradycardia 96.68 99.73 98.64 Sinus mode Tachycardia 97.44 96.49 96.90 Left atrium Hypertrophy 51.09 99.89 81.82 Right atrium Hypertrophy 42.64 99.66 50.00...
Page 64 Possible acute inferior MI 76.00 99.60 61.11 Old inferior MI 96.07 99.24 93.44 Early inferolateral MI 98.77 96.82 75.94 Possible acute inferolateral MI 11.11 99.94 50.00 Old inferolateral MI 84.62 99.83 78.57 ST depression, mild anteroseptal 75.36 99.55 46.67 myocardial ischemia ST depression, mild anterior 81.24 99.94...
Page 65: Appendix Ii Emc Guidance And Manufacturer Declaration
Appendix II EMC Guidance and Manufacturer Declaration Table 1: Guidance and manufacturer’s declaration –electromagnetic emission The device is intended for use in the electromagnetic environment specified below. The purchaser or the user of the device should assure that it is used in such environment. Emission test Compliance RF emissions CISPR 11...
Page 66 The device is tended for use in the electromagnetic environment specified below. The purchaser or the user of the device should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Conducted RF 0,15 MHz –...
Page 67 LTE Band 5 GSM 1800; 1720 CDMA 1900; Pulse GSM 1900; 1845 1 700 – modulation DECT; 1 990 LTE Band 1, 217 Hz 1970 4, 25; UMTS Bluetooth, WLAN, Pulse 2 400 – 802.11 modulation 2450 2 570 b/g/n, RFID 2450, 217 Hz LTE Band 7...
Page 68 Disposal: The product must not be disposed of along with other domestic waste. The users must dispose of this equipment by bringing it to a specific recycling point for electric and electronic equipment. GIMA WARRANTY TERMS The Gima 12-month standard B2B warranty applies.

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33224