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Содержание iSE-301

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Страница 2: ...d into other languages Materials protected by the copyright law including but not limited to confidential information such as technical information and patent information are contained in this manual...

Страница 3: ...in and repair some parts which EDAN may define as user serviceable Terms Used in this Manual This guide is designed to give key concepts on safety precautions WARNING A WARNING label advises against c...

Страница 4: ...hing Electrodes to the Patient 14 3 4 1 Reusable Electrodes 14 3 4 2 Disposable Electrodes 17 3 5 Inspection Before Power On 18 Chapter 4 Sampling and Printing ECG 20 4 1 Entering Patient Information...

Страница 5: ...Cleaning 41 9 2 1 Cleaning the Main Unit 42 9 2 2 Cleaning the Patient Cable 42 9 2 3 Cleaning the Reusable Electrodes 43 9 3 Disinfection 43 9 3 1 Disinfecting the Main Unit 43 9 3 2 Disinfecting the...

Страница 6: ...V A1 3 Physical Specifications 52 A1 4 Power Supply Specifications 52 A1 5 Performance Specifications 53 Appendix 2 EMC Information 55 Appendix 3 Abbreviation 59...

Страница 7: ...interpretive statements is offered to clinicians on an advisory basis only WARNING 1 This equipment is not designed for intracardiac use or direct cardiac application 2 This equipment is not intended...

Страница 8: ...apt the three prong plug to fit a two slot outlet 7 If the integrity of the external protective conductor is in doubt the equipment should be operated by using the built in rechargeable battery 8 Do n...

Страница 9: ...quipment and the patient simultaneously 21 The use of equipment that applies high frequency voltages to the patient including electrosurgical equipment and some respiration transducers is not supporte...

Страница 10: ...e respective IEC EN standards e g IEC EN 60950 for data processing equipment and IEC EN 60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the standard...

Страница 11: ...according to Appendix 2 EMC Information 38 The equipment should not be used adjacent to or stacked with other equipment refer to the recommended separation distances provided in Appendix 2 EMC Inform...

Страница 12: ...f can the battery be installed or removed 9 Remove the battery from the electrocardiograph when the electrocardiograph is not used for a long time 10 If the battery is stored alone and not used for a...

Страница 13: ...ives hand the batteries over to the applicable collection points for the recycling of waste batteries For more detailed information about recycling of this product or battery please contact your local...

Страница 14: ...NUMBER 11 Date of manufacture 12 MANUFACTURER 13 AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY 14 CE marking 15 Disposal method 16 SD card slot 17 USB socket 18 Net port 19 Power adapter port 2...

Страница 15: ...Black 23 FCC ID SMQSE301EDAN Federal Communications Commission FCC ID SMQSE301EDAN 24 Non ionizing electromagnetic radiation NOTE 1 Applicable to the Electrocardiograph configured with WIFI module 2 F...

Страница 16: ...SE 301 series can be powered by the mains supply or a built in rechargeable lithium battery Two models are available SE 301 with WIFI as an optional configuration and iSE301 with WIFI as a standard c...

Страница 17: ...3 Right Panel No Description A Patient cable socket B Power key Long press switch on off short press sleep mode Color when using the mains supply Green Color when using built in battery Blue Color whe...

Страница 18: ...NOTE 1 When the folded thermal paper is used the paper roller is unnecessary and must be taken out 2 The grid side of the paper should face the thermal print head and the black marker on the paper sho...

Страница 19: ...ductor of electricity and frequently creates artifact that distorts the ECG signal By performing methodical skin preparation you can greatly reduce the possibility of the noise caused by muscle tremor...

Страница 20: ...ires to the corresponding electrodes according to the colors and identifiers Firmly attach them 3 4 Attaching Electrodes to the Patient There are two types of electrode for you to choose one is the re...

Страница 21: ...ellow LA Black Right leg N or RF Black RL Green Left leg F Green LL Red Chest 1 C1 White red V1 Brown red Chest 2 C2 White yellow V2 Brown yellow Chest 3 C3 White green V3 Brown green Chest 4 C4 White...

Страница 22: ...uction bulb Unclench it and the electrode is adsorbed on the chest 7 Attach all chest electrodes in the same way NOTE Long time measurement with a strong negative pressure on the suction bulb may caus...

Страница 23: ...ace are as the following table and figures American label European label Electrode placement RA R Right deltoid LA L Left deltoid RL N or RF Above right ankle Alternate placement upper leg as close to...

Страница 24: ...ance 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 CAUTION The disposable electrodes c...

Страница 25: ...should be used When the battery capacity is low recharge the battery before use 3 Patient Cable Check whether the patient cable is connected to the unit firmly and keep it far away from the power cord...

Страница 26: ...the patient information or you can configure the patient information items in system setup first NOTE The patient information cannot be set or changed during the printing course Item Description Pace...

Страница 27: ...e main screen to open the patient information window and then click Order to open the Order screen 5 Click Load to download order records from the server 6 Select an order and click Examine to enter t...

Страница 28: ...he AUTO Mode b Figure 4 1 and Figure 4 2 show an ECG report in the AUTO mode Template is selected and Record Style is set to 3 4 The ECG report includes 3 4 ECG waves ID Current Date and time Patient...

Страница 29: ...of RV5 and SV1 RV6 SV2 optional The maximum of the amplitude of R or R wave of one selected dominant beat from lead V6 The maximum absolute value of the amplitude of S or S wave of one selected domin...

Страница 30: ...ograph User Manual Sampling and Printing ECG 24 25mm s Paper Speed 10mm mV Gain 60 Heart Rate Electrocardiograph Model V1 0 Software Version SEMIP V1 8 Algorithm Version Institution Name 4 3 2 PDF Rep...

Страница 31: ...e displayed 5 1 Transmitting ECG Records to the PC NOTE To transmit ECG records to the PC data management software DMS of EDAN must be installed in the PC You should log into the Smart ECG Viewer soft...

Страница 32: ...n 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 op...

Страница 33: ...rong happens the electrocardiograph will give the error information Then you should check whether the external memory is connected to the electrocardiograph well 4 If you want to import records from t...

Страница 34: ...patient record in the table and then click the delete symbol on the top 5 4 Printing a Patient Record in the File Manager screen 1 Open the File Manager screen 2 If you want to print the patient reco...

Страница 35: ...arrhythmia is detected in the AUTO mode a hint will pop up to ask you whether to print an extra rhythm report after the 12 lead ECG report 6 2 Filter Item Description AC Filter Choose from On or Off...

Страница 36: ...e AUTO or RHYT mode Speed Choose from 5mm s 6 25mm s 10mm s 12 5mm s 25mm s and 50mm s NOTE The speed is corresponding with the work mode Gain Choose from 1 25mm mV 2 5mm mV 5mm mV 10mm mV 20mm mV 10...

Страница 37: ...aper Marker Paper Marker is used to identify the start point of each page of the recorder paper Choose from Yes or No Select Yes if the paper with black markers on the bottom is used and the device ca...

Страница 38: ...the corresponding USB printer to the electrocardiograph before printing with the selected record device WARNING If the printer used is not the type listed above additional safety measures such as appl...

Страница 39: ...is set to On patient name will be divided into first name and last name ID Choose from Auto Time or Manual ID Hint Choose from On or Off In the AUTO or RHYT mode when ID is set to Manual and ID Hint...

Страница 40: ...eport is printed out in the AUTO or RHYT mode Transmission Mode Choose from Ethernet or Wireless FTP Information Enter data in the FTP Path FTP User Name textboxes IP Addresses Set Server IP Local IP...

Страница 41: ...mory 2 X in the directory of ECGDATA ECG X Store Examination Date can be set in the Device No textbox in the Transmission Setup window File Format Choose from DAT PDF SCP FDA XML and DICOM To select S...

Страница 42: ...tion is only available when the electrocardiograph is powered by using the mains supply LCD off time Set to 0 120 6 9 System Maintenance Import export the system settings backup the settings or load t...

Страница 43: ...enabled the electrocardiograph gives a short sound when you press keys Hint Volume When enabled the electrocardiograph gives a sound when a hint such as Lead Off Overload Battery Weak etc is displaye...

Страница 44: ...sn t detect any black signs while the paper style is set as Folded on the System Setup Screen BAT WEAK The built in battery is weak Demo The system is in the demonstration mode Sampling Analyzing Reco...

Страница 45: ...ar the pages with rumples and then put the paper in the paper tray again adjust the position of the paper carefully and close the casing Q3 The hint PaperErr is displayed on the screen what should I d...

Страница 46: ...smission course for example the connection between the ECG and the net cable may loosen In this case please restart the ECG If it doesn t work please restart the PC If the problem still exists please...

Страница 47: ...nded cleaning agents and disinfectants listed in this manual Others may cause damage not covered by warranty reduce product lifetime or cause safety hazards Always dilute according to the manufacturer...

Страница 48: ...ft cloth dampened with the cleaning solution until no visible contaminants remain 3 Wipe off the cleaning solution with a fresh cloth or towel dampened with tap water after cleaning until no visible c...

Страница 49: ...on is performed only when it is considered as necessary according to your hospital s regulations Clean the equipment and reusable accessories before they are disinfected The validated disinfectants fo...

Страница 50: ...lectrodes and the clamps of limb electrodes with a soft cloth dampened with the disinfectant solution 2 Wipe off the disinfectant solution with a dry cloth after disinfection 3 Leave the suction bulbs...

Страница 51: ...ery from the electrocardiograph when the electrocardiograph is not used for a long time 4 If the battery is stored alone and not used for a long time we recommend that the battery should be charged at...

Страница 52: ...IEC EN 60601 1 Limit NC 500 A SFC 1000 A g Test the enclosure leakage current according to IEC EN 60601 1 Limit NC 100 A SFC 500 A h Test the patient leakage current according to IEC EN 60601 1 Limit...

Страница 53: ...ting or disconnecting the patient cable Align the patient cable to avoid twisting knotting or crooking in a closed angle while using it Store the lead wires in a big wheel to prevent any people from s...

Страница 54: ...638 Power cord AHA 21 13 036384 Patient Cable IEC 01 57 107402 01 57 471500 Patient Cable AHA 01 57 110375 01 57 471499 Adult Chest electrodes 01 57 040163 Adult Limb electrodes 01 57 040162 Thermal R...

Страница 55: ...ble Resting electrodes 01 57 471031 Net Cable 01 13 20096 Thermal Recorder Paper 01 57 78079 Grounding Wire 01 13 114114 U Disk 01 18 052275 SE 301 and accessories are available by contacting the manu...

Страница 56: ...AN d damage caused by accidents e replacement or removal of serial number label and manufacture label If a product covered by this warranty is determined to be defective because of defective materials...

Страница 57: ...ctric shock degree Type CF Degree of protection against harmful ingress of water Ordinary equipment Sealed equipment without liquid proof Disinfection sterilization method Refer to the user manual for...

Страница 58: ...2 mm Weight 1kg Excluding recorder paper and battery Display 800 480 LCD Screen A1 4 Power Supply Specifications Mains Supply Operating voltage 100V 240V Operating frequency 50Hz 60Hz Power adapter o...

Страница 59: ...0mm 20m Effective Width 72mm Paper Speed 5mm s 6 25mm s 10mm s 12 5mm s 25mm s 50mm s 3 Accuracy of data 5 x axis 5 y axis HR Recognition Technique Peak Peak Detection HR Range 30 BPM 300 BPM Accuracy...

Страница 60: ...ampling Frequency 16000Hz Pacemaker Detection Amplitude 2mV to 700mV 2mV to 700mV Width 0 1ms 2 0ms Sampling Frequency 16 000 sec channel WIFI Optional Transmitting Frequency 2 4GHz Frequency Band 2 4...

Страница 61: ...ublic low voltage power supply network that supplies building used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Electrom...

Страница 62: ...40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 di...

Страница 63: ...61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m P d 2 1 80 MHz to 800 MHz P d 3 2 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manu...

Страница 64: ...stomer or the user of the electrocardiograph can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and th...

Страница 65: ...lectrocardiogram Electrocardiograph HR Heart Rate aVF Left Foot Augmented Lead aVL Left Arm Augmented Lead aVR Right Arm Augmented Lead LA Left Arm LL Left Leg RA Right Arm RL Right Leg ID Identificat...

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