EDAN SE-1515 User Manual Download Page 7

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Appendix 2 EMC Information .................................................................................................... 99

Appendix 3 Abbreviations ......................................................................................................... 103

Summary of Contents for SE-1515

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Page 2: ...mited to confidential information such as technical information and patent information are contained in this manual the user shall not disclose such information to any irrelevant third party The user...

Page 3: ...tions that could result in personal injury or death CAUTION A CAUTION label advises against actions or situations that could damage equipment produce inaccurate data or invalidate a procedure NOTE A N...

Page 4: ...embling Wireless System 17 2 2 3 ECG Sampling Box 19 2 3 Installing the Software 21 2 3 1 Requirements of the PC 21 2 3 2 About Installation Window 22 2 4 Features 22 Chapter 3 Preparations Before Ope...

Page 5: ...ut the Parameters 58 5 2 Exercise ECG 59 5 2 1 About the Summary Screen 59 5 2 2 About the All View Screen 61 5 2 3 About the ECG Strip Screen 62 5 2 4 ST Analysis 62 5 2 5 ST Trend 63 5 3 VCG 63 5 3...

Page 6: ...al Points 85 10 2 Cleaning 85 10 2 1 Cleaning the Sampling Box 86 10 2 2 Cleaning the Patient Cable 86 10 2 3 Cleaning the Reusable Electrodes for Resting ECG 86 10 3 Disinfection 87 10 3 1 Disinfecti...

Page 7: ...VI Appendix 2 EMC Information 99 Appendix 3 Abbreviations 103...

Page 8: ...use or direct cardiac application 2 This system is not intended for home use 3 This system is not intended for treatment or monitoring 4 This system is intended for use on adult and pediatric patient...

Page 9: ...Ensure that the conductive parts of electrodes and associated connectors including neutral electrodes do not come in contact with earth or any other conducting objects 9 Disposable electrodes must be...

Page 10: ...to the 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 sta...

Page 11: ...cations equipment can affect medical electrical equipment refer to the recommended separation distances provided in Appendix 2 EMC Information 34 The equipment should not be used adjacent to or stacke...

Page 12: ...1 2 3 Operation Warnings for Wireless System WARNING 1 Make sure that there is no intense electromagnetic interference source around the wireless system 2 Do not open the battery cover of the transmi...

Page 13: ...nnect the power cord from the wall outlet after using the system 5 Make sure that the power is turned off and the power cord is disconnected from the AC socket before defibrillation 6 Keep the four fe...

Page 14: ...monary embolus or pulmonary infarction 7 Acute myocarditis or pericarditis 8 Acute aortic dissection 9 The patient opposes the test Relative Contraindications 1 Left main coronary stenosis 2 Moderate...

Page 15: ...PPLIED PART 2 Caution 3 Operating instructions 4 General symbol for recovery recyclable 5 Part Number 6 SERIAL NUMBER 7 Date of manufacture 8 MANUFACTURER 9 CLASS II equipment 10 AUTHORISED REPRESENTA...

Page 16: ...a physician 17 Federal Communications Commission FCC ID SMQDX12TREDAN for DX12 Transmitter FCC ID SMQDX12REEDAN for DX12 Receiver 18 Refer to User Manual Background Blue Symbol White 19 Warning Backgr...

Page 17: ...d receiver PC ECG software Patient cable Disposable electrodes USB cable According to the configurations of different types of workstations the following purchased accessories can also be included tab...

Page 18: ...SE 1515 PC ECG User Manual Introduction 11 2 1 Wired SE 1515 System 2 1 1 Wired System Connection Diagram 1 Resting ECG of Wired SE 1515 System 2 Exercise ECG of Wired SE 1515 System...

Page 19: ...r Manual Introduction 12 2 1 2 Assembling the Wired System The DE15 ECG sampling box is used as an example here Patient Cable DE15 ECG sampling box Resting ECG Cable Exercise ECG Cable Assembly Drawin...

Page 20: ...2 1 3 ECG Sampling Box WARNING 1 When the computer connected to the USB cable is powered on do not connect the USB cable to the ECG sampling box when the system is powered on do not disconnect the US...

Page 21: ...art 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 freque...

Page 22: ...oid the user s authority to operate the equipment 2 2 1 Wireless System Connection Diagram The DX12 device which consists of transmitter and receiver has passed FCC certification This device complies...

Page 23: ...to the analog and digital interfaces must be certified according to the respective IEC EN standards e g IEC EN 60950 for data processing equipment and IEC EN 60601 1 for medical equipment Furthermore...

Page 24: ...nected to a patient the sum of the leakage currents may exceed the limits given in the IEC EN 60601 1 and may pose a safety hazard Consult your service personnel 4 DX12 transmitter of the wireless sys...

Page 25: ...the patient cable into socket 2 of DX12 transmitter 2 Insert DX12 transmitter into pocket 3 of DX12 belt and then wear the belt around the waist 3 Insert plug 8 of the cable into socket 6 of the DX12...

Page 26: ...9 Unlock burglar lock 11 and insert into the burglar lock keyhole of DX12 receiver and fix the wireless system via the other end of the burglar lock 10 Make sure that the above parts are properly con...

Page 27: ...k or unlock the keyboard When the main screen is displayed press the button to switch leads When the menu screen is displayed press the button to display one item in black Bluetooth Connection Icon If...

Page 28: ...ound Try again later will be displayed for 1 second if no matching DX12 receiver is found Device Information You can see the related information such as software version ID address of DX12 receiver ma...

Page 29: ...ormats including PDF Word JPG and BMP Supporting multi language Supporting auto measurement and diagnosis Editing the diagnosis templates The following features are only for the exercise test function...

Page 30: ...ring massive patient data in the computer which enables you to review and analyze the exercise ECG in any time Automatically controlling and adjusting the speed and the elevation of the treadmill Supp...

Page 31: ...d patient cable are connected inform the patients that 1 No talking 2 Breathe smoothly 3 Try to be calm 4 Not to chew or keep his teeth firmly The more relaxed the patient is the less will the ECG wav...

Page 32: ...t Cable Example The patient cable includes patient cable plugs and lead wires which can be connected to electrodes according to the colors and identifiers The lead wires have 10 chest leads and 4 limb...

Page 33: ...g to the colors and identifiers The lead wires have 10 chest leads and 4 limb leads Insert the patient cable plugs to the socket of DX12 transmitter Align all lead wires of the patient cable to avoid...

Page 34: ...electrodes The identifiers and color codes of electrodes used comply with IEC EN requirements In order to avoid incorrect connections the electrode identifiers and color codes are specified in Table...

Page 35: ...the Reusable Electrodes Only for the Disposable Electrodes IEC AHA Electrode Placement C1 V1 Fourth intercostal space at the right border of the sternum C2 V2 Fourth intercostal space at the left bor...

Page 36: ...right border of the sternum C2 V2 Fourth intercostal space at the left border of the sternum C3 V3 Fifth rib between C2 and C4 C4 V4 Fifth intercostal space on the left midclavicular line C5 V5 Left...

Page 37: ...ary line on the same horizontal level as C3 and C4 C2 Corresponding to E V2 Corresponding to E Sternum at the level of C3 and C4 C3 Corresponding to C V3 Corresponding to C Mid clavicular line in the...

Page 38: ...achment point of the second rib to the right sternal edge Nax C4R A2 V4R Fifth intercostal space on the left posterior axillary line Nap C4 V4 Left mid clavicular line in the fifth intercostal space V...

Page 39: ...e same horizontal level as C4 and C7 C9 V9 Left paraspinal border on the same horizontal level as C4 and C8 DE15 IEC AHA Electrode Placement C7 V7 Left posterior axillary line on the same horizontal l...

Page 40: ...ns on Body Surface IEC AHA Electrode Placement R L RA LA Below the right left clavicle N F RL LL Below the right left rib 3 4 3 Attaching the Reusable Electrodes 3 4 3 1 Attaching the Limb Electrodes...

Page 41: ...ctrode site and squeeze the suction bulb Unclench it and the electrode is adsorbed on the chest 6 Attach all chest electrodes in the same way NOTE Long time measurement with a strong negative pressure...

Page 42: ...odes to the electrode positions on the body surface 4 Connect Snap Banana Socket Adapters to the disposable electrodes WARNING 1 The disposable electrodes can only be used for one time 2 The clip elec...

Page 43: ...ent Cable Check whether the patient cable is connected to the ECG sampling box firmly and keep it far away from the power cord 5 Electrodes Check whether all electrodes are connected to lead wires of...

Page 44: ...ter installation an Initial Setting window will be displayed and you can configure parameters such as the hospital name lead mode and sequence NOTE If you need to reinstall the software reinstall it u...

Page 45: ...tion is complete these options won t be displayed in the New Patient window For details see section 8 1 1 and 8 2 Enter basic information You can fill out the basic information of a patient If Pacemak...

Page 46: ...ensional On the Archives screen scan the barcode and the New Patient window will be displayed with the patient information filled out automatically or place the cursor on the patient ID in the New Pat...

Page 47: ...e order select Start examination after order in the Display Setting of System Setting Figure 4 3 Resting ECG Sampling 4 4 1 1 Buttons NOTE 1 You can directly press F1 F4 and F5 on the keyboard to cont...

Page 48: ...clicked you can configure the parameters provided on the displayed window 4 4 1 2 Signal Strength Indication At the bottom right corner of the ECG sampling screen a signal strength indication model i...

Page 49: ...anged Contact the manufacturer if you want to make any modifications on it Sampling time You can configure the sampling time for resting ECG Lead mode Options provided are 9 lead 12 lead 15 lead 16 le...

Page 50: ...played group by group If simultaneously is selected all the leads will be displayed at the same time QRS Sound Options provided are ON and OFF AC Filter It is used to protect on the ECG signals from t...

Page 51: ...port to be printed The options provided are Normal ECG Report Detailed Report Template Report Rhythm Wave Report and VCG Report If Template Report is selected the Feature Point Location option will be...

Page 52: ...me line If it is set to Auto the system automatically adjusts the baseline for each lead group If it is set to OFF the system adjusts the baseline for each lead group to an average value If Auto Gain...

Page 53: ...on the DE15 DE18 sampling box functions as the Start button on the ECG sampling Screen When Forbidden is selected there will be no response when pressing the ECG key 4 4 1 7 Other Setup Click on Sett...

Page 54: ...on the main screen and you can enter the sampling screen for resting ECG directly The system automatically generates a patient ID NOTE The difference between the resting ECG sampling and STAT ECG sam...

Page 55: ...covery stage In the Recovery stage you can click Recovery to move into the next Recovery stage NOTE This function cannot be used when the test in the last Recovery stage Stop F4 Once Stop is clicked t...

Page 56: ...p the exercise test temporarily and click Start Tmill to continue the exercise test Keep Click Keep during the exercise test and the system will maintain the current speed and slope before you click K...

Page 57: ...s yellow it indicates that the current systolic or diastolic is abnormal Information display area If a treadmill is used the information display area displays the total time protocol stage time stage...

Page 58: ...lect the Accumulate Baseline and the baseline mean wave will be folded up to the average template of each lead This operation is only available during the Exercise stage Select the Accumulate All and...

Page 59: ...e default value BP monitor You can set BP monitor to the port that can be used on the computer BP Sampling Mode Options provided are Once per stage The system starts measuring the blood pressure immed...

Page 60: ...roup and the startpoint of the ST segment It is also the reference point used by the system to determine the place of the ST segment Please select the J point based on the actual ECG waveforms of the...

Page 61: ...e arrhythmia report ECG Report ST ECG Report Analysis Duk e Score FAI If ECG Report ST ECG Report Analysis Duke Score or FAI is selected corresponding information will be contained in the printed repo...

Page 62: ...e All List screen double click on a record to enter the analysis screen When Resting ECG is selected the ECG analysis screen contains the resting ECG rhythm ECG and pharma study ECG 5 1 Resting ECG 5...

Page 63: ...l includes measurement information feature description and diagnosis result Measurement information Parameter values can be input manually If the value is beyond range it will turn red automatically S...

Page 64: ...the gain of average templates You can drag marker lines of P1 P2 Q S and T on average templates P1 is the onset of P wave P2 is the offset of P wave Q marks the onset of the QRS wave S marks the offse...

Page 65: ...Status and Diagnosis Result Click on a record and you can view the related information on the analysis screen displayed 5 1 6 About the Parameters On the analysis screen for resting ECG if you made a...

Page 66: ...It indicates the sampling time in a certain stage 3 HR The last HR value before entering the next stage is regarded as the HR in that stage 4 BP 5 Max ST Min ST An ST value is calculated and saved ev...

Page 67: ...value must be a decimal fraction from 0 to 100 0 and only one decimal digit is allowed Max ST Min ST Max ST The value must be a decimal fraction from 0 to 0 80 and two decimal digits are allowed Min...

Page 68: ...ear covering the 10s waveform centered on where you clicked You can press the left or right direction key to shift the rectangle 2 Select print thumbnail ECG segment Click Seg Select and you can manua...

Page 69: ...cted simultaneously 5 2 3 2 12 Lead ECG Double click on a strip on the ECG Strip window you can open the corresponding original 12 lead ECG to obtain more detailed information about the waveforms and...

Page 70: ...form screen 5 3 VCG Vector ECG displays 3D image of ECG activity You can choose the plane and the vector loop on the VCG analysis screen Plane choices include Frontal Horizontal Sagittal and ALL Loop...

Page 71: ...and the loop of ALL A Vector ECG of Frontal B Vector ECG of Horizontal C Vector ECG of Sagittal D Average templates of X Y and Z leads Double click on this figure to display the magnified average temp...

Page 72: ...Angle The angle of the Max vector of QRS P T loop degree Direction Rotation direction of QRS P T loop CW Clockwise CCW Counter clockwise 8 8 font ring 0 01 amplitude The amplitude at 0 01s from QRS lo...

Page 73: ...width in T loop T R angle The degree between the Max vector of T loop and the Max vector of QRS loop degree F Click on 3D to display the 3D VCG graph G Diagnosis Field 1 Enter your own opinions in th...

Page 74: ...to display the 3D VCG graph 3D Three Dimensional Vector Loops This function allows you to observe the Vector ECG in three dimensions Select Rotate and then you can rotate the whole picture to view all...

Page 75: ...al Max Min Ratio of Maximum RR interval to Minimum RR interval SDNN Standard Deviation of Normal to Normal Intervals RMSSD Root Mean Square Successive Difference NN50 the total beat number The number...

Page 76: ...k Exit to close the print preview screen and return to its upper level screen 5 6 Report Printing Click Print on the ECG analysis screen or print preview screen and the default printer will print the...

Page 77: ...ta will be sent by Window Live Mail Windows 7 Vista when it is saved to the designated directory NOTE In Windows 7 Vista only if Window Live Mail is installed can the report be sent by Email WARNING T...

Page 78: ...t Information Select a patient record in the patient list and click Modify the New Patient window will be displayed In the displayed window you can modify the patient information In this case modifica...

Page 79: ...Records NOTE Data cannot be recovered after being deleted Be careful when deleting examination records Select one or multiple patient records in the patient list and click Delete to delete the selecte...

Page 80: ...File select the right directory and the patient data to be imported and click Import to import the patient data to the Archives screen NOTE Only ECG data in DAT format can be imported 6 1 8 Export On...

Page 81: ...rder Fill out the patient information based on the patient and click OK If the order is successful the patient record will be displayed in the Order List below 6 2 2 Inbox In the inbox the doctor can...

Page 82: ...date You can specify a time range by clicking Assign and choose a time Or you can choose the starting date and the ending date in the time selection region The default time is Last month On the Measu...

Page 83: ...orresponding items in the New Patient window will change into what is filled Memory Select Memory in Basic Information window the content of Customize_1 in the New Patient window will be saved If Memo...

Page 84: ...ient ID Physical Exam ID and None No When examination records are uploaded from the ECG machine the records will not be matched with the order information Request No Exam ID Patient ID Outpatient ID I...

Page 85: ...to the analysis screen after the data has been uploaded Deliver after diagnosis When this function is selected the status of a record diagnosed on the analysis screen will be changed into Delivered au...

Page 86: ...GDT file when sampling stops When selected the system automatically outputs a GDT file after the sampling is complete Output GDT file when making diagnosis When selected the system automatically outp...

Page 87: ...igure the Start Address End Address Male Code Female Code and Device Port for each sub item based on the actual situation NOTE Only the USB bar code reader recommended by the manufacturer can be used...

Page 88: ...code Setting window click Yes to restart the SE 1515 software 8 9 Other Setup Item Description System Maintenance Production Activation System Password Setting After the password has been changed succ...

Page 89: ...t and Device Name Click Save S to save the configuration You can modify the department name add or delete data entries 8 9 2 2 Examination Type and Item Management Click on Exam Type and Item Manageme...

Page 90: ...The name of the backup folder does not allow special characters or letters in languages other than English 8 9 2 5 Request Department Management Click on Request Dept Management you can modify the dep...

Page 91: ...ng box to the PC 2 Click on the Device tab in the System Setting window of the SE 1515 system and check whether the sampling device is set correctly 3 The USB cable falls off the PC during the samplin...

Page 92: ...age not covered by warranty reduce product lifetime or cause safety hazards Always dilute according to the manufacturer s instructions Unless otherwise specified do not immerse any part of the equipme...

Page 93: ...ith the cleaning solution until no visible contaminants remain 2 Wipe off the cleaning solution with a fresh cloth or towel dampened with tap water after cleaning until no visible cleaning agent remai...

Page 94: ...nt such as chloride sodium hypochlorite etc 3 Clean and disinfect reusable electrodes after each use 10 3 1 Disinfecting the Sampling Box WARNING When the DX12 transmitter is used turn off the power d...

Page 95: ...e Test the earth leakage current according to IEC EN 60601 1 Limit NC 500 A SFC 1000 A f Test the enclosure leakage current according to IEC EN 60601 1 Limit NC 100 A SFC 500 A g Test the patient leak...

Page 96: ...le IEC 01 57 471306 16 Lead Patient Cable AHA 01 57 471305 Adult Chest Electrodes 01 57 040163 Adult Limb Electrodes 01 57 040162 Resting ECG USB Cable 01 13 036134 Portable Bag 01 56 465623 DP12 ECG...

Page 97: ...ectrode 01 57 471046 Snap Electrode Adaptation Cable 01 13 107449 Multi Function Electrode Adapter 01 57 040172 Clip on Electrode Adapter 01 57 040173 Patient Cable for Exercise ECG 01 13 036135 DP12...

Page 98: ...med 4 0 mercury 4 0 Manufacturer h p cosmos sports medical gmbh Germany CE marking Model RUNNER RUN 2011 T Manufacturer Runner srl CE marking Model TMX428 Manufacturer Full Vision Inc CE marking Ergom...

Page 99: ...n medical electrical equipment of the SE 1515 system directly to the wall outlet because the non medical electrical equipment of the system is intended to be powered by using the electrical outlet and...

Page 100: ...aused by accidents 5 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 components o...

Page 101: ...equipment without liquid proof Disinfection sterilization method Refer to the user manual for details Please see Chapter 10 Cleaning Care and Maintenance Degree of safety of application in the presen...

Page 102: ...3mm L 107mm W 23mm H 2mm DX12 receiver 155mm L 100mm W 30mm H 2mm Weight DE15 DE18 ECG sampling box Approx 215g DP12 ECG sampling box Approx 210g DX12 transmitter Approx 113g not including battery DX1...

Page 103: ...leads DP12 DX12 12 leads Acquisition Mode DE18 simultaneously 18 leads DE15 simultaneously 16 leads DP12 DX12 simultaneously 12 leads Sample Frequency DE18 DE15 1kHz Analysis 16kHz Sampling DP12 1kHz...

Page 104: ...mV Input Impedance DE18 DE15 100M DP12 50M DX12 20M Input Circuit Current 10 nA Calibration Voltage 1mV 2 DC Offset Voltage DE18 DE15 DP12 600mV DX12 500mV Minimum Amplitude 20 Vp p Noise DE18 DE15 DP...

Page 105: ...ilter DX12 150Hz 100Hz 75Hz DE18 DE15 300Hz 270Hz 150Hz 100Hz 150Hz 100Hz 75Hz Pacemaker Detection DE18 DE15 750uV 700mV 50us 2 0ms DP12 2mV 700mV 0 1ms 2 0ms DX12 2mV 500mV 0 1ms 2 0ms DX12 Bluetooth...

Page 106: ...r use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61...

Page 107: ...hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in...

Page 108: ...in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surve...

Page 109: ...of SE 1515 PC ECG can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and SE 1515 PC ECG as recommended...

Page 110: ...breviations Abbreviation Full Description LCD Liquid Crystal Display BP Blood Pressure ECG Electrocardiogram Electrocardiograph HR Heart Rate AC Alternating Current USB Universal Serial Bus AGC Auto G...

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