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1.4 After Operation

Reset all the function setup to the initial state and shut down the power;

Gently remove the electrodes, and do not harshly drag the wires;

Clean the instrument and accessories for the later use.

1.5 EMC and Relevant Notes

This instrument complies with IEC60601-1-2 standard about the medical electronic equipment

safety standards on electromagnetic compatibility. But in an electromagnetic environment

exceeding the limitation of IEC60601-1-2 standard, the instrument might suffer from harmful

interference and will not provide expected function or get worse performance. If the

performance of the instrument is degraded while working, please check and eliminate possible

adverse effects before any further use. This manual provides the following preventive

procedures.

1.5.1 The Influence of Electromagnetic Radiation

Mobile phone may affect the operation of this equipment. 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 stopped then use de-noising equipment to reduce

the influence.

1.5.3 Electrostatic Affect

The static electricity in a dry room may affect the operation of this instrument, especially in

the winter. Before using this instrument, humidify the air in the room, or discharge the static

electricity from cables or the ECG patients.

1.5.4 Impact of Lightning

Nearby lightning may cause high-voltage surge. If worried about this issue, please disconnect

the AC power and use the battery power.

1.6 Device Classification

Protection against electric shock: Class I, Type CF internally powered

Protection against ingress of hazardous liquid : Normal equipment (no protection against

Содержание EM-1201

Страница 1: ...anual shall not be reproduced photocopied in any form without prior written permission from ECGMAC ECGMAC reserves the right to change update revise the product design specification or function at any...

Страница 2: ...2...

Страница 3: ...12 2 6 Contraindication 13 3 Structure and Principle 14 3 1 Product Structure 14 3 2 Electrodes Connection 19 3 3 Patient Cable Connection 21 3 4 Power Connection 22 3 5 Principle and Schematic Diagra...

Страница 4: ...orm 52 7 3 Buttons on the Control Panel not Working 52 7 4 AC Interference 52 7 5 EMG Interference 53 7 6 Baseline Drift 53 8 Warranty and After sale Service 54 8 1 Warranty 54 8 2 Customer Service 54...

Страница 5: ...quipment 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...

Страница 6: ...ion of this equipment 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 frequen...

Страница 7: ...please use the high speed thermal paper supplied or appointed by ECGMAC Other paper may shorten print head s life And the deteriorated print head may lead to illegible ECG record and block the advance...

Страница 8: ...t of type CF with defibrillator proof Battery indicator Note general warning the information you should know to avoid possible damage to patients or operators Note the information you should know to a...

Страница 9: ...edical 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...

Страница 10: ...s including neutral electrodes and patient to be contacted with any conducting parts or earth 2 2 Warnings for Rechargeable Lithium Battery Improper operation might cause the rechargeable lithium batt...

Страница 11: ...radio transmitter or mobile phone etc Attention large medical electrical equipment such as electrosurgical equipment radiological equipment and magnetic resonance imaging equipment etc are likely to...

Страница 12: ...atient cable or electrodes Disinfection if required can not be done with high temperature autoclaving or radiation Do not use chloric disinfectant such as chloride and sodium hypochlorite etc Maintena...

Страница 13: ...ncardiac 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 d...

Страница 14: ...14 3 Structure and Principle 3 1 Product Structure It mainly consists of main unit and patient cable 3 1 1Top View EM 1201 Top view EM 1202 1203 Top view...

Страница 15: ...ental damage after use 3 1 2 Bottom Panel Signal Name Function description A Battery compartment Lithium battery installed inside B Battery label Battery group label C Vents Internal heat dissipation...

Страница 16: ...c safety C Handle Portable to carry D Vents Internal cooling channels 3 1 4 Side View Sign Name Function description A Patient cable socket Connect patient cable B Test interface Testing by manufactur...

Страница 17: ...F Tab When using Z fold paper and enable Paper Marker press the tab key to advance the recording paper to next black marker it will stop advance paper once the black marker is detected automatically...

Страница 18: ...Reserved buttons for stress test function for EM 1202 EM 1203 only 3 1 6 Patient Cable Socket and Definition for Plug Pins Applied part of type CF with defibrillator proof Definition of corresponding...

Страница 19: ...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...

Страница 20: ...fth inter costal space C5 V5 Left anterior axillary line on the same horizontal level as V4 C6 V6 Left mid axillary line on the same horizontal level as V4 Electrode gel coating should to be separated...

Страница 21: ...e right side of ECG machine as shown below and lock the screw on both sides Only use the designated patient cables Do not use any other models Patient cables socket is designed for ECG signal input on...

Страница 22: ...Principle and Schematic Diagram 3 5 1 Principle Multi channel ECG is made up of amplifier circuit print controller keyboard controller LCD controller CPU system and other parts Lead signals from optic...

Страница 23: ...s in xml pdf jpg bmp every 10sec which can be transmitted to PC by connecting USB interface High resolution thermal matrix printing system recording frequency response is not more than 150Hz Big keybo...

Страница 24: ...des are well connected No contact with each other z Check if the patient is nervous or talking or moving or contacting the metal part of the bed z Check if the environment is comfortable and if the be...

Страница 25: ...is shown handle it according to the following method Press INST button to eliminate the influence of the polarization voltage to amplifier It will get the amplifier back to normal quickly If pressing...

Страница 26: ...t Loading Roll Paper The applied width for the recording paper is 216 mm load the paper according to following steps Press the Open Button to open the paper compartment cover according to the arrow sh...

Страница 27: ...5 Advance the recorder paper After folding paper is selected press to advance the paper to next black marker It will stop advance paper automatically once the next paper marker is detected by the ther...

Страница 28: ...n operation with the mains supply 5 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 th...

Страница 29: ...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 patient information input F2 Paper speed setup Press F2 ch...

Страница 30: ...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 Pau...

Страница 31: ...er file management interface F7 More Press F7 to return to the first page of the main interface File Press F2 to enter file management interface Identifier Name Description F1 Transmit Press F1 to tra...

Страница 32: ...s below Press F1 Confirm to save patient information and return to previous menu Press F2 Cancel to cancel current patient information input and return to previous menu Press F3 List to show all the p...

Страница 33: ...he waveforms from it Rhythm mode under rhythm mode users can select rhythm lead group and record its rhythm waveforms 5 6 1 Manual Mode Under manual mode Manual 1 Manual 2 Manual 3 and Manual 6 Manual...

Страница 34: ...available to select 3 Press F4 to freeze the ECG waveform displayed on main interface 4 Press F5 to see electrodes placement indication 5 Press F6 to enter system settings to set the system parameter...

Страница 35: ...rs 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 Manual 1 mode Manual 6 Select Manual 6 working mode by p...

Страница 36: ...t start print after the 60seconds acquisition duration Please refer to 5 7 for selected rhythm In the Rhythm mode press RHY to select single channel rhythm 3 channel rhythm The acquisition duration is...

Страница 37: ...ds of sensitivity are available for selection 2 5mm mV 5mm mV 10mm mV and 20mm mV 3 When waveforms become stable press Start Stop for recording and the printing duration is controlled by user press St...

Страница 38: ...tion interface for input the patient information 2 Press F2 to set paper speed 5mm s 6 25mm s 10mm s 12 5mm s 25mm s and 50 mm s available 3 Press F3 to set sensitivity 2 5mm mV 5mm mV 10mm mV and 20m...

Страница 39: ...39 Detailed operation please refer to 3CH 4 format 3CH 4 3R format Detailed operation please refer to 3CH 4 format 6CH 2 format...

Страница 40: ...e second page of main interface press F6 setup button to enter system setting press 8 Lead selection to enter leads setup interface There are 8 lead systems for selection For lead rhythm you can choos...

Страница 41: ...displayed is the lead set here Three lead rhythms Users can set any 3 leads as lead rhythms in the 12 leads Under auto mode if 3 4 3R is selected the lead rhythm recorded as the rhythm leads set here...

Страница 42: ...12 leads ECG waveform display with 12 rows 1 column Display sequence sequential mode or simultaneous mode In sequential mode the waveforms will be displayed one group after another group In simultaneo...

Страница 43: ...setup 4 Information setup 5 Administrator setup 6 Filter 7 Time and date 8 Lead setup 9 Others 5 9 1 Management Setup 5 9 2 Print Setup Press button 1 to enter print setup interface in the system setu...

Страница 44: ...s you pressing the START STOP button Trigger Mode After pressing the START STOP key if arrhythmia ECG data is detected during the learning course the printing will be triggered automatically Otherwise...

Страница 45: ...in the system setup interface The interface is shown as figure below At the communication setup interface use and button to select setting items and use and number keys and letter keys to set and inpu...

Страница 46: ...etting interface Type in password 123456 and press F1 to enter The interface is shown as figure below Use and button to select setting items of ID generated by Language Saved to etc use and to set Aft...

Страница 47: ...nterface use and button to select setting items of date format date time format and time and use and button and number key to set and input Date Time users can set current date and time Date and time...

Страница 48: ...Cleaning the Main Unit and Patient Cable Wipe the exterior of the main unit and patient cable with a damp cloth using mild non caustic neutral detergent diluted in water Then wipe it with a dry cloth...

Страница 49: ...on Do not use chlorine containing disinfectant for disinfection such as chlorinated lime and sodium hypochlorite etc 6 3 Care and Maintenance 6 3 1 Battery Capacity Charging and Replacement Inappropri...

Страница 50: ...manufacturer should be used Battery has to be disposed and recycled according to the local regulation 6 3 3 Maintenance of Main Unit Patient Cable Electrodes 1 Main Unit Make sure the instrument is p...

Страница 51: ...g gel on them z Keep the suction ball of chest electrodes from sunshine and excessive temperature z After long time use the surface of electrodes will be oxidized because of erosion and other causes I...

Страница 52: ...he heating unit of print head gets damaged Please contact with our service department or appointed maintenance center 7 3 Buttons on the Control Panel not Working Possible reason The control panel and...

Страница 53: ...ECG base line has irregular vibration as shown in the following ECG waveforms Solutions Move to a comfortable room if the room is uncomfortable Let the patient get relaxed Make sure the bed is not too...

Страница 54: ...terials components or workmanship and the warranty claim is made within the warranty period ECGMAC will at its discretion repair or replace the defective part s free of charge ECGMAC will not provide...

Страница 55: ...1 Open the box from the top 2 After opening the box 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 th...

Страница 56: ...Sensitivity control At least three grade 5 10 20mm mV Tolerance 5 by shifting 2 6 2 Anti polarization Voltage Applying 300mV DC polarization Voltage the tolerance of sensitivity is 5 2 6 3 Minimum te...

Страница 57: ...0 to 70Hz the tolerance of amplitude of frequency is 30 5 2 11 Features of Low Frequency Time Constant no less than 3 2s 2 12 Baseline stability 2 12 1 Stable Power baseline drifting should be no more...

Страница 58: ...value 1BPM 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 e...

Страница 59: ...r 216mm 295mm 100P 3 Display Display 12 inch color LCD screen display resolution 800 600 EM 1203 10 inch color LCD screen display resolution 800 480 EM 1201 EM 1202 Display information Paper Out Lead...

Страница 60: ...hine are intended for use in the electromagnetic environment specified below The customer or user of EM 1203 1202 electrocardiograph should assure that it is used in such an environment Emissions test...

Страница 61: ...put output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode...

Страница 62: ...sure that it is used in such and environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC61000 4 6 Radiated RF IEC61000 4 3 3Vrms 150kHz 80...

Страница 63: ...ce for transmitters in these frequency ranges c Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radi...

Страница 64: ...or the higher frequency range applies Note 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and...

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