Page 1: ......
Page 2: ...anual shall not be reproduced photocopied in any form without prior written permission from ECGMAC ECGMAC reserve the right to change update revise the product design specification and function at any time without notice Responsibility of the Manufacturer ECGMAC only considers itself responsible for any effects on safety reliability and performance of the equipment if Assembly operations extension...
Page 3: ......
Page 4: ...4 Cleaning Disinfection Maintenance 11 2 5 Intended Use 12 2 6 Contraindication 12 3 Structure and principle 13 3 1 Product structure 13 3 2 Electrodes connection 18 3 3 Patient cable connection 20 3 4 Power connection 21 3 5 Principle and Schematic diagram 22 3 6 Features 23 4 Operation Preparations 23 4 1 Applicable fields 23 4 2 Environmental operating conditions 23 4 3 Inspection before operat...
Page 5: ... control panel not working 50 7 4 AC interference 50 7 5 EMG interference 50 7 6 Baseline Drift 51 8 Warranty and after sale service 52 8 1 Warranty 52 8 2 Customer service 52 Appendix A Packaging and Accessories 53 A 1 Packing 53 A 2 Caution 53 Appendix B Product Performance 54 B 1 External Output 54 B 2 External DC signal Input 54 Appendix C Specification 56 C 1 Technical Index 56 C 2 Dimension ...
Page 6: ... equipment z Make sure the integrity of the external protective earth conductor in the room 1 2 Before operation z Check if the equipment is in good condition z Check if the equipment is placed properly z Check if all the lead wires are well connected and the equipment is properly grounded z When the instrument is used with other instruments special attention should be paid to safety misdiagnosis ...
Page 7: ...quipment Once this equipment is used be sure to remind people to turn off mobile phones and small wireless devices 1 5 2 The influence of Impact and electromagnetic waves The high frequency noise made by other instruments may bring electromagnetic interference to the instruments via entering AC outlet Please identify the noise source and stop using the corresponding equipment If it can not be stop...
Page 8: ... state ECG and EEG metrological verification regulations 1 8 Discarding the equipment Discard electronic materials packing materials battery and other declared waste according to the local laws Support the sorting recycling work of the local administration 1 9 Symbols Symbols Function Symbols Function USB Alternating current Battery recharging indicator Product serial number Manufacturer Date of m...
Page 9: ...t head s life And the deteriorated print head may lead to illegible ECG record and block the advance of paper etc Please do pay attention to the following aspects 1 Never use wax coated recording paper Otherwise wax may stick to the heater of the print head and damage it 2 Record paper should be stored in dry and cool area avoiding excessive temperature humidity and sunshine 3 Avoid exposure to fl...
Page 10: ... the shell case Auxiliary equipments connected to the digital and analog interfaces must be certified according to IEC standards e g IEC950 for data processing equipment and IEC60601 1 for medical equipment Therefore anybody who connects additional equipment to the signal input or output connector to configure a medical system must make sure that it complies with the requirements of the valid vers...
Page 11: ...imit high frequency current density to an acceptable range The total leakage current should never exceed leakage current limits while several other instruments are used at the same time The operator should not touch patient patient bed table or instrument when it use simultaneous with the defibrillator or pacemaker Please use the patient cable and other accessories supplied by ECGMAC Otherwise it ...
Page 12: ...same model and specification provided by the manufacturer should be used When the shelf life of battery is due or foul smell and leakage has been found stop using it and contact the manufacturer or local distributor for disposal or dispose the battery according to local regulations Do not pull in or take out the battery when the equipment is powered on which will cause white screen crash etc Take ...
Page 13: ...st should be applied on the instrument regularly at least once every two years tests should include a Check if the instrument and accessories has mechanical and functional damage b Check if the safety ID is broken c Check the fuse whether it fulfills the requirement the rated current and short circuit characteristic d Check the function of the instrument according to its operation manual e Perform...
Page 14: ... disinfectant such as chloride and sodium hypochlorite etc Maintenance and repair should be applied on the main units and accessories regularly at least once every half year ECG machines are classified into Measuring Instrument so users should send it to Official Measurement Administrative to test and certify according to national metrological calibration regulation of electro cardiograph and elec...
Page 15: ...te pulmonary embolus or pulmonary infarction 8 Acute noncardiac disorder that may affect exercise performance or be aggravated by exercise eg infection renal failure thyrotoxicosis 9 Acute Myocarditis or Pericarditis 10 Serious Physical Disability which disable to make safe and effective test 11 Without acquiring patient s permission Relative contraindications 1 Left main coronary stenosis or its ...
Page 16: ...ecorder Load recording paper print ECG report B LCD screen Display operation interface and contents C Keyboard Function buttons input of numbers and letters The LCD screen can be damaged if place heavy object on it or hit it Please fold the screen to prevent accidental damage after use B A C ...
Page 17: ... Internal heat dissipation channel D Product label Product information label E Fuse label Fuse specification label F Fuse compartment AC fuse installation 1 Battery compartment The rated output voltage and capacity of built in rechargeable lithium batteries are as follow Rated output voltage 14 8V Rated capacity 4400mAh 3 1 3 Rear View B A C F E C A B D ...
Page 18: ...t D USB Slave Port Standard USB 2 0 port to connect external printer support PCL6 E USB Master Port Standard USB 2 0 port to connect PC F LAN socket Standard LAN port connect with network cable G Potential equalization When need to use potential equalization grounding cable to protect the security of electricity use grounding cable to connect this potential equalization terminal with the grounding...
Page 19: ...kspace Delete the character to the left of the cursor E Input method Choose the input methods English Numbers F Five way navigation buttons Up down left right and action G Copy button Copy the last ECG signals when the system works in automatic model H ON OFF Turn on or off the ECG I Reset Make lead input fast and stable and reset lead print output J Recording mode Select recording modes manual au...
Page 20: ...t of type CF with defibrillator proof Definition of corresponding pins Pin Signal Pin Signal Pin Signal 1 C2 input 6 SH 11 F input 2 C3 input 7 NC 12 NC 3 C4 input 8 NC 13 C1 input 4 C5 input 9 R input 14 NC 5 C6 input 10 L input 15 N or RF input 3 1 7 Patient cable Patient cable includes main cable and lead wires The lead wires include 6 chest lead wires Lead Wires Electrode Connectors Main Cable...
Page 21: ...s Please ensure electrodes are well connected Disposable electrodes cannot be used together with reusable electrodes old or new Different models cannot be used together otherwise it will seriously affect the accuracy of ECG record Electrodes or lead wire socket cannot touch other conductors such as metal beds All electrodes need to be replaced together during replacement 3 2 1 Limb electrodes conn...
Page 22: ...trodes attach them to C1 C6 The connection is shown in the following figure C1 V1 Fourth inter costal space at right border of the sternum C2 V2 Fourth inter costal space at left border of the sternum C3 V3 Midway between locations C2 and C4 C4 V4 Mid clavicular line in the fifth inter costal space C5 V5 Left anterior axillary line on the same horizontal level as V4 C6 V6 Left mid axillary line on...
Page 23: ... Grey Yellow Right foot RF Grey Black Left foot F Grey Green C1 White Red C2 White Yellow C3 White Green C4 White Brown C5 White Black Chest C6 White Purple 3 2 4 Lead method and system diagram 3 3 Patient cable connection Plug the patient cable connector into the socket on the right side of ECG machine as shown ...
Page 24: ...ibrillation protection cables 3 4 Power connection 3 4 1 AC power Plug one end of three core power cord to the power socket on the ECG and the other end to the socket on the wall as shown below 3 4 2 DC Battery The battery is not put into the battery compartment when it is dispatched with the machine it needs installation after receive it After receiving the ECG if built in rechargeable battery is...
Page 25: ... controller for the waveform printing When printing finished the measurement and analysis will be processed by the CPU system Besides the CPU system will receive the interrupt signal and button codes to finish the interrupt processing And CPU system will handle lead off signal no paper detection auto power off of batter voltage management sampling and print of CRO simulation output and EXT input K...
Page 26: ...r LCD 4 Operation Preparations 4 1 Applicable fields EM301 EM601 are applicable for hospitals clinics group checkup and other outdoor activities 4 2 Environmental operating conditions Please make sure the temperature and humidity meets the requirement for use Temperature 5 40 Relative humidity 25 95 4 3 Inspection before operation z Check if the instrument Socket and grounding cable are well conne...
Page 27: ...according to the prompt message and reconnect them 1 Electrodes fall off When the lead wires are not connected to the patient or the instrument stably ECG signals can not be transmitted correctly this message will be displayed for reminding When the polarization voltage exceeds the limit value the message will be displayed for reminding 2 If the electrodes off message is shown handle it according ...
Page 28: ... 2 Put out the battery from accessories box make sure the leads are all in order as Picture B C D 3 Tidy the leads and put the battery into the battery pack horizontally as Picture C 4 Close the battery cover and screw it tightly clockwise As picture D 4 6 Recording paper EM 301 80mm width 20M thermal rolled paper EM 601 110mm width 20M thermal rolled paper ...
Page 29: ... Insert the rollers into the rolled paper as shown below 3 As shown in the figure below put the paper with rollers back into the paper compartment After that pull about 2cm of the paper out and close the cover 5 Operation Instructions 5 1 Startup and shutdown 5 1 1 Startup with the mains supply When power cord and grounding cable are well connected and the AC supply indicator is lit Press ...
Page 30: ... in battery And the DC indicator is lit Then the same startup and shutdown operation with the mains supply 5 1 4 Battery charge If the built in rechargeable battery is weak when mains supply is used it will be recharged automatically at the same time Please exactly follow the above instruction Otherwise disordered messages will be displayed on the screen When the shutdown prompt message is display...
Page 31: ...te the current power supply mode AC or battery F Heart rate Current Heart rate value G Name Patient name no more than 20 characters H ID Patient ID no more than 10 digits I Leads and waveform display Display the waveforms F1 Patient Press F1 enter patient information setup interface F2 Paper speed setup Press F2 choose paper speed within 6 25mm s 12 5mm s 25mm s 50 mm s F3 Sensitivity setup Press ...
Page 32: ... F5 Press F5 to return to the first page of the main interface 5 3 Operation mode This ECG has three operation modes Manual mode AUTO mode and Rhythm mode Users can press manual automatic or rhythm button to select Manual mode under manual mode users can select lead group need to be recorded When the users need to record another ECG lead group manual switch is required AUTO mode under auto mode th...
Page 33: ... simultaneously The users can record the ECG waveforms for three leads Manual six leads ECG is set to display six leads simultaneously The users can record the ECG waveforms for six leads Note Manual 6 is applicable for EM 601 Manual1 Select Manual 1 mode by pressing manual button Users can select one lead in 12 leads to display The display interface is shown as the below 1 Press F2 to set require...
Page 34: ...mode by pressing manual button Users can choose any one lead in12 leads and rhythm lead to display The display interface is shown as below For detailed operation please refer to Manual 1 mode Manual 3 Select Manual 3 mode by pressing manual button Users can choose any three leads in 12 leads to display The display screen is shown as the following figure For detailed operation please refer to Manua...
Page 35: ... Rhythm Mode This mode is rhythm lead record mode Under the mode the ECG can acquire users defined rhythm Press Start Stop for recording and the record length is 0 60 seconds the ECG rhythm lead waveform with rhythm analysis will printed out To select rhythm please refer to chapter 5 4 Select rhythm mode by pressing RYH button The ECG will connect data about the defined rhythm lead The display scr...
Page 36: ...se or stop the print just press START STOP button 5 3 3 Auto Mode Under Auto Mode select 6 automatic display formats through display setup screen 3CH 4 3 CH 4 1R 3 CH 4 3R 6 CH 2 6 CH 2 1R and 12 CH 1 z 3 CH 4 3rows 4 columns z 3 CH 4 1R 3rows 4 columns 1 rhythm lead z 3 CH 4 3R 3 rows 4 columns 3 rhythm leads z 6 CH 2 6 rows 2 columns z 6 CH 2 1R 6 rows 2 columns 1 rhythm lead z 12 CH 1 12 rows 1...
Page 37: ...on to start printing records record time is depend on Users control If needing to pause or stop the print just press START STOP button 3CH 4 1R format Detailed operation please refer to 3 4 format 3CH 4 3R format Detailed operation please refer to 3 4 format ...
Page 38: ...35 6CH 2 format Detailed operation please refer to 3 4 format 6CH 2 1R format Detailed operation please refer to 3 4 format 12CH 1 format Detailed operation please refer to 3 4 format ...
Page 39: ...aVL aVF V1 V2 V3 V7 V8 V9 3 Right chest lead system I II III aVR aVL aVF V1 V2 V3R V4R V5R V6R 4 left chest lead system I II III aVR aVL aVF V3R V4R V5R V7 V8 V9 5 Previous intercostal lead system I II III aVR aVL aVF V1 V2 V3 V4 V5 V6 6 Next intercostal lead system I II III aVR aVL aVF V1 V2 V3 V4 V5 V6 7 FRANK lead system I II III aVR aVL aVF V1 V2 V3 V4 V5 V6 8 CUBRERA lead system aVL I aVR II ...
Page 40: ...e figure below Under display setup interface select setting item between display format and display order through and button After selecting the setting item use and button to choose setting contents There are 6 display formats as following 3CH 4 3CH 4 1rhythm 3CH 4 3rhythm 6CH 2 6CH 2 1rhythm and 12CH 1 Display sequence sequential mode or simultaneous mode In sequential mode the waveforms will be...
Page 41: ... Press F1 button to save system setting and return press F3 button to cancel setting and return or press F2 button to return to the default setup Press button 1 9 to enter different items settings menu 1 Print setup 2 Auto analysis setup 3 Communication setup 4 Information setup 5 Administrator setup 6 Filter 7 Time and date 8 Lead setup 9 Others ...
Page 42: ... items among Printer Record order and ECG grids print and then use and to set Printer Thermal Printer Laser Printer and Ink Printer Record order sequential and simultaneous ECG grid print enable and disable grid printing on the recording paper 1 When the record order is set to be sequential the leads will acquire data sequentially 2 When the record order is set to be simultaneous the leads will ac...
Page 43: ...etting items among ECG auto classification ECG auto analysis function ECG measurement Auto analysis results confirmation and Heart rate range use and to enable and disable Press F1 button to save auto analysis setup and return or press F2 button to cancel and return 5 6 4 Communication setup Press 3 to enter communication setup at the system setup interface The interface is shown as figure below A...
Page 44: ...use and button to select setting items and use number keys and letter keys to select and input Press F1 button to save information setup and return or press F2 button to cancel and return 5 6 6 Admin setup configuration Press button 5 to enter Admin setup configuration at the system setting interface Type in password 123456 and press F1 to enter The interface is shown as figure below Use and butto...
Page 45: ... interface use and button to select setting times among AC filter Baseline drift filter and EMG Filter use and to set Baseline Drift Filter 0 05Hz 0 15Hz 0 25Hz 0 5Hz ADS OFF EMG Filter 30Hz 40Hz OFF AC Filter 50Hz 60Hz OFF Press F1 button to save filter setup and return or press F2 button to cancel and return 5 6 8 Time and date setup Press button 7 to enter time and date setup at the system setu...
Page 46: ... and return or press F2 button to cancel and return 5 6 9 Lead selection setup Press button 8 to enter lead selection setup at the system setup interface For details please refer to chapter 5 4 5 6 10 Others Press button 9 to enter other setup at the system setup interface the interface is shown as below At the other function setup interface use and button to select setting items among keypad tone...
Page 47: ...Delete the patient data selected Print print the file selected Preview preview the patient file selected Press more to next page Edit Edit the patient information here it is able to edit the name ID etc Query query the patient data by ID Name Sex Age time ...
Page 48: ...gure showed above is the data freeze for 10 seconds ECG waveform is displayed from the 3rd second Pre Sec Display from previous second Next Sec Display from next second Pre Page Display from previous page Next Page Display from next page Play Play from the current displayed waveform Pause Pause in the play process Diagnosis make diagnosis for the 10 seconds ECG waveform current displayed ...
Page 49: ...abinet and take out recording paper when the ECG is power off Wipe the printing head gently with a clean soft cloth damped in 75 alcohol Do not use hard objects to scratch the printing head Otherwise the printing head will be damaged Load the recording paper and close the cover when all traces of alcohol are evaporated 4 Cleaning the silicon glue alloy Shaft Silicon glue alloy Shaft should be flat...
Page 50: ...t time Battery recharging should be suggested before first usage When connect with the mains supply the battery will be recharged automatically Then the battery recharge indicator light and mains supply indicator light on When the capacity of battery is full the battery recharge indicator light will be off 2 Battery capacity indicator When using the battery there is a sign representing the battery...
Page 51: ...eck the ECG instrument regularly 2 Patient Cable 1 Check the patient cable is well collected according to the following table The resistor between the electrode plug and plug pin of the patient cable plug should be less than 10Ω Note the resistance or of patient cable with the function of defibrillating protection is around 10KΩ Wire plug symbol R L F RF C1 C2 C3 C4 C5 C6 Plug pin location 9 10 11...
Page 52: ...ooting and solution 7 1 Some lead without waveform printout This phenomenon might be caused by following issues z When the patient cable is connected with patient if the instrument start record before ECG waveforms and data become stable it might leads to data value saturation or overflow in the baseline stable software Solution repeat operation z There is failure with patient cable Check the pati...
Page 53: ...l voltages with the mains frequency Phenomenon shown as below Solutions z Make sure the instrument is properly grounded z Electrode or patient cable is correctly connected z Applied electrode gel is enough z The metal bed is properly grounded z Keep the patient from physical contact with the surroundings z There is no powerful equipment operating nearby such as X ray or ultrasonic machine z The pa...
Page 54: ...vious effect for the weakening of R wave 7 6 Baseline Drift Phenomenon The baseline of the recorded ECG waveforms wandering as shown in the following ECG waveforms Solutions z Make sure the electrodes are well connected z The lead wire and electrodes are well connected z Check the cleaning of the electrode and patient skin z Electrode gel is applied on the electrodes and skin z Keep the patient fr...
Page 55: ...GMAC will not provide a substitute product for use when the defective product is being repaired The service claimer is responsible for freight insurance and customs duties for the returned products to ECGMAC ECGMAC responsible for the freight insurance and customs duties to service claimer within the warranty The service claimer is responsible for any freight insurance custom charges for the produ...
Page 56: ...x check the accessories and files according to the packing list and then check the instrument 3 If the package does not match the packaging list or the instrument does not work properly contact the sales department or customer service department 4 Please use the accessories supplied by ECGMAC Accessories from other suppliers may damage the instrument and affect its performance and safety Before us...
Page 57: ...rade 5 10 20mm mV Tolerance 5 by shifting 1 9 2 Anti polarization Voltage Applying 300mV DC polarization Voltage the tolerance of sensitivity is 5 1 9 3 Minimum testing signal Testing the energy of deviated sine signal of 10Hz 20μV summit 1 10 Noise Level By paralleling impedance of 0 047μF capacitor and 51kΩ resistance which is connected between input terminal and neutral electrode Within the fre...
Page 58: ...w Frequency Time Constant no less than 3 2s 1 15 Baseline stability 1 15 1 Stable Power baseline drifting should be no more than 1mm 1 15 2 Unstable Power baseline drifting should be no more than 1mm 1 15 3 Sensitivity no signal input baseline drifting should be no more than 2mm 1 15 4 Temperature Drift From 5 40 baseline drifting should be no more than 0 5mm 1 16 Paper Speed 6 25 mm s 12 5 mm s 2...
Page 59: ...1 2008 1 23 1 Measurement tolerance of time interval Should not excess the error range of table A 2 1 A 2 2 in Appendix JJG 1041 2008 Appendix C Specification C 1 Technical Index 1 Main Machine Lead Standard 12 Leads Sampling Method 12 leads simultaneously Measurement Parameter HR PR interval QRS duration QT QTC R QRS T electric axis RV5 SVI amplitude Input Method Floating Ground input with defibr...
Page 60: ... dots mm 25 mm s 16 dots m 50 mm s Horizontal Recording Paper EM 601 110mm width rolling paper EM 301 80mm width rolling paper 3 Display Display 7 inches color LCD screen display resolution 800 480 Display information Paper Out Lead Off Alarm Operation Manual Patient Information Battery Volume Date and Time Heart Rate Working Mode Paper Speed Gain Filter 4 Others Leads Standard 12 leads with defib...
Page 61: ...5 2009 Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity ISO 10993 5 2009 5 EN ISO 10993 10 2009 Biological evaluation of medical devices Part 10 Tests for irritation and delayed type hypersensitivity ISO 10993 10 2002 including Amd 1 2006 6 EN ISO 13485 2003 AC2007 Medical devices Quality management systems Requirements for regulatory purposes ISO 13485 2003 7 EN ISO...
Page 62: ...3 A1 2006 16 EN 60601 1 8 2007 Medical electrical equipment Part 1 8 General requirements for basic safety and essential performance Collateral Standard General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601 1 8 2006 17 EN 60601 2 25 1995 A1 1999 Medical electrical equipment Part 2 25 Particular requirements for the safety...
Page 63: ...er than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes EMC guidance and manufacturer s declarations Electromagnetic emissions For all the equipments and systems EMC guidance and manufacturer s declarations Electromagnetic immunity EM 301 EM 601 electrocardiograph is intended for use in the electromagnetic envi...
Page 64: ...nded that EM 301 electrocardiograph be powered from an uninterruptible power supply or battery Note U AC voltage before test voltage is applied EMC guidance and manufacturer s declarations Electromagnetic immunity For non life support equipment EMC guidance and manufacturer s declarations Electromagnetic immunity EM 301 EM 601 electrocardiograph is intended for use in the electromagnetic environme...
Page 65: ...ed field strength in the location in which EM 301 EM 601 electrocardiograph is used exceeds the applicable RF compliance level above the electrocardiograph should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the electrocardiograph B Over the frequency range 150 kHz to 80 MHz field strengths should ...
Page 66: ...rer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Appendix F Manufacturer information Manufacturer Shenzhen ECGMAC Medical Electronics Co Ltd Factory Address 2nd Floor of Block 2 Haoye Industria...
