EDAN EDA044 User Manual Download

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SE-1010 PC ECG User Manual Abbreviation

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Appendix 3 Abbreviation

Abbreviation Statement

ECG Electrocardiograph/Electrocardiogram

BP Blood

Pressure

HR Heart

Rate

P P-wave

Duration

PR P-R

Interval

QRS

QRS Complexes Duration

QT/QTc

Q-T Interval of the Current Lead / Normalized QT Interval

P/QRS/T

Dominant Direction of the Average Integrated ECG
Vectors

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 Identification

AC Alternating

Current

USB

Universal Serial Bus

NC Normal

Condition

SFC Single

Fault

Condition

Summary of Contents for EDA044

Page 1: ......

Page 2: ...and patent information are contained in this manual the user shall not disclose such information to any irrelevant third party The user shall understand that nothing in this manual grants him expressl...

Page 3: ...label advises against certain actions or situations that could result in personal injury or death CAUTION A CAUTION label advises against actions or situations that could damage equipment produce inac...

Page 4: ...the Software 15 2 2 1 System Running Environment 16 2 2 2 About Installation Window 16 2 2 3 Matching DX12 Transmitter with Tablet PC 17 2 3 Features 20 Chapter 3 Preparations Before Operation 21 3 1...

Page 5: ...37 Chapter 6 Processing Orders 39 6 1 Loading Orders 39 6 2 Creating and Editing Orders 40 6 3 Examining Orders 40 6 4 Deleting Orders 40 6 5 Setting Orders 41 Chapter 7 Processing Records 43 7 1 Sel...

Page 6: ...eaning the Reusable Electrodes 65 10 2 Disinfection 66 10 3 Care and Maintenance 66 Chapter 11 Accessories 68 Chapter 12 Warranty Service 69 12 1 Warranty 69 12 2 Contact information 69 Appendix 1 Tec...

Page 7: ...ac 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 patie...

Page 8: ...reusable electrodes with electrode gel are used during defibrillation the system recovery will take more than 10 seconds The manufacturer recommends the use of disposable electrodes at all times 9 El...

Page 9: ...he system 22 Accessory equipment connected 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...

Page 10: ...with the valid version of the standard IEC 60950 and be used outside the patient environment at least 2 meters away from the patient The tablet PC shall be charged outside the patient environment and...

Page 11: ...n or in the presence of corrosive 3 Make sure that there is no intense electromagnetic interference source around the equipment such as radio transmitters or mobile phones etc Attention large medical...

Page 12: ...urer Authorized Representative in the European Community The symbol indicates that the device complies with the European Council Directive 93 42 EEC concerning medical devices It indicates that the de...

Page 13: ...nd compact size SE 1010 PC ECG is suitable for doctors inspections and visits and can perform a reliable data recording anywhere at any time SE 1010 PC ECG includes the following equipment you can als...

Page 14: ...12 transmitter of the wireless system uses the Bluetooth technology which could make the patient with the pacemaker uncomfortable Keep DX12 transmitter far away from the pacemaker when using the wirel...

Page 15: ...nybody 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 version of the system...

Page 16: ...Signal Pin Signal 1 GND 6 GND 2 VCC 7 GND 3 QRS 8 GND 4 GND 9 D 5 GND 10 D WARNING 1 When the computer connected to the USB cable is powered on do not connect the USB cable to the DP12 ECG sampling bo...

Page 17: ...nt Cable Socket Definitions of corresponding pins Pin Signal Pin Signal Pin Signal 1 C2 V2 6 SH 11 F LL 2 C3 V3 7 NC 12 C1 V1 or NC 3 C4 V4 8 NC 13 C1 V1 4 C5 V5 9 R RA 14 RF N RL or NC 5 C6 V6 10 L L...

Page 18: ...SE 1010 PC ECG User Manual Introduction 12 Top Panel and Bottom Panel 2 1 3 DX12 ECG Sampling Box of the Wireless System DX12 Transmitter Appearance Decorative Chip Label Screw...

Page 19: ...aution Definitions of corresponding pins Pin Signal Pin Signal Pin Signal Pin Signal 1 NC 6 C5 V5 11 NC 16 L LA 2 F LL 7 NC 12 C2 V2 17 NC 3 NC 8 C4 V4 13 NC 18 R RA 4 C6 V6 9 NC 14 C1 V1 19 NC 5 NC 1...

Page 20: ...return to the previous screen When the Main or Menu screen is displayed press this key to enter the next menu Press this key and then press in 1 2 seconds to lock unlock the keypad When the Main scree...

Page 21: ...elect IEC or AHA Match Device Inquiring will be displayed for 10 seconds to search the device The address of the device will be displayed for 8 seconds if a matching device is found No device found Tr...

Page 22: ...in the installation folder to open the following installation window Click on the Install button to install PC ECG Click on the Next button continually during installation After installing PC ECG cli...

Page 23: ...he tablet PC 1 Press the icon for My Computer for a while choose Prosperities Change Settings Change C input PCECG in the Computer name textbox and then click on the OK button If more than one tablet...

Page 24: ...layed for 8s and then Initialization is completed the system will restart in 5s will be displayed on the screen of DX12 transmitter 4 After DX12 transmitter restarts choose Devices and Printers Add a...

Page 25: ...E 1010 PC ECG User Manual Introduction 19 5 Click on Enter the device s pairing code and then click on the Next button 6 Input the default password 12345678 and then click on the Next button to confir...

Page 26: ...multaneously ECG waves can be frozen and reviewed Supporting auto measurement and diagnosis Measurement point adjustment and re analysis manual measurement with an electronic ruler of high precision P...

Page 27: ...preparation you can greatly reduce the possibility of noise caused by muscle tremor and baseline drift ensuring high quality ECG waves There is natural resistance on the skin surface due to dry dead e...

Page 28: ...trodes and associated connectors including neutral electrodes do not come in contact with earth or any other conducting objects The identifiers and color codes of electrodes used comply with IEC EN re...

Page 29: ...eft arm L Yellow LA Black Right leg Right leg N or RF Black RL Green Left leg Left leg F Green LL Red Chest 1 I C1 White Red V1 Brown Red Chest 2 E C2 White Yellow V2 Brown Yellow Chest 3 C C3 White G...

Page 30: ...d F LL Right leg Upper leg as close to torso as possible N RL Left leg Upper leg as close to torso as possible 3 3 2 Attaching the Reusable Electrodes 3 3 2 1 Attaching the Limb Electrodes Limb Electr...

Page 31: ...adsorbed on the chest 6 Attach all chest electrodes in the same way NOTE Long time measurement with a strong negative pressure on the suction bulb may cause reddening of the skin When using the elect...

Page 32: ...ECG software for the first time the following window will be displayed Figure 4 2 Initial Window You can set the unit print frequency of AC and the saving path of source data based on your needs Click...

Page 33: ...ing Patient Information You can view the patient information in one of the following two ways 1 Click on an order in the Order Manager window and then click on the Examine button Or double click on an...

Page 34: ...nding textboxes in the Patient Information window and then click on the OK button to confirm Or 1 Click on the pull down list and then click on the Edit button Input the information of physician or de...

Page 35: ...s bar code with the bar code reader and then the patient information will appear in the corresponding boxes of the Patient Information window NOTE 1 Only bar code readers recommended by the manufactu...

Page 36: ...click on the Start button the system will save the sampled ECG data Stop Click on this button to stop sampling ECG data The system will stop sampling ECG data and display the ECG analysis screen autom...

Page 37: ...odes you select on the ECG sampling screen 3 1 and 6 1 display modes are displayed in 3 4 and 6 2 modes You can set the display mode the lowpass filter the gain and the speed from 4 5 Sampling STAT EC...

Page 38: ...op sampling after clicking on the Start button and the system will display the ECG analysis screen automatically Or double click on an examination record in the examination record list on the Data 5 1...

Page 39: ...e overlapped with the same central axis You can drag marker lines of P1 P2 Q S and T on average templates P1 is the start point of P wave P2 is the end point of P wave Q marks the position of Q point...

Page 40: ...ve and then drag the mouse to another point Then click on Print to print the selected wave field 5 2 Measuring ECG Click on in the Waveform or Average Template window Click on one point on the wave an...

Page 41: ...S wave of V1 lead RV6 SV2 mV The amplitude of R wave of V6 lead the amplitude of S wave of V2 lead Enter your own opinions in the Diagnosis textbox and then click on the Save button If the Integratio...

Page 42: ...SE 1010 PC ECG User Manual Analyzing ECG Data 36 Effect pictures of report title are as shown below Report Title in One Line Report Title in Two Lines...

Page 43: ...on the preview screen to print an ECG report NOTE You can set the printer type on the Printer and Faxes screen The report color is defined by setting the printer type and can be observed on the previe...

Page 44: ...e sampled data will be sent by Window Live Mail Windows 7 when it is saved to the designated directory During the saving and sending course the system will give the hint information NOTE In Windows 7...

Page 45: ...ndow Figure 6 1 Order Manager Window 6 1 Loading Orders Before loading orders please configure the Order Setup window For details please refer to Section 6 5 Operation procedures are as follows 1 Clic...

Page 46: ...ne after order in the Patient Information window after you click on the OK button to create an order the system will automatically examine this patient Select an order in the Order Manager window clic...

Page 47: ...m Select ID Order Date Request No or State orders will be displayed in sequence of the selected condition in the Order Manager window Sequence Choose from Ascending or Descending NOTE 1 When Condition...

Page 48: ...fter the order is examined Exam Room Filter Select this item and enter an exact exam room in the textbox such as Electrocardiograph Then all the orders which meet the requirements will be searched and...

Page 49: ...ecords examined by this physician will be displayed in the patient information list B Select this item all the patient records which are registered but not examined will be displayed in the patient in...

Page 50: ...the information of Examination ID Diagnosis Status Examination Type ExamTime and Physician 7 1 Selecting and Modifying Patient Records Click on a patient record in the patient information list and th...

Page 51: ...by one After selecting all the patient records to be deleted click on the Delete button to delete all the selected patient records The operation methods of deleting examination records are similar to...

Page 52: ...o points will be displayed 7 6 Importing ECG Data into the Data Manager Screen Click on the Import button on the Data Manager screen select the data to be imported and then click on the Select button...

Page 53: ...t Save window Assign the file name saving path and export file format SCP FDA XML DICOM dat pdf and then click on the OK button to export the data into the selected path At the same time the patient i...

Page 54: ...ing window 1 Click on the OK button to save these modifications and exit 2 Or click on the Cancel button to cancel these modifications and exit 8 1 Basic Information Setup Figure 8 1 Basic Information...

Page 55: ...ly Manually or Accumulatively Select Automatically the patient ID can be automatically generated according to the examination date Select Manually you should enter the patient ID manually in the Patie...

Page 56: ...input signals whose frequency is higher than the setting cutoff frequency will be attenuated Choose from 75Hz 100Hz or 150Hz AC Filter AC filter suppresses AC interference without attenuating or dist...

Page 57: ...ackground grid Select this item the ECG waveforms will be displayed with a background grid Anti aliasing Select this item the system will automatically make the waveform smooth QRS Voice Select this i...

Page 58: ...Setting input the correct password in the pop up textbox and then click on the OK button Click on the Access Network Setting tab to open the Access Network Setting window Figure 8 4 Access Network Se...

Page 59: ...b to open the Barcode Setting window Figure 8 5 Barcode Setup Window Item Description Barcode Setting Enter the start and end addresses the male and female codes and the device port and then click on...

Page 60: ...on the Computer Management screen and then click on Human Interface Devices to view port information 4 In the Barcode Setting window set Device to the port you view on the Computer Management screen a...

Page 61: ...me and Last Name textboxes Select D O B the D O B textbox appears in the Patient Information window and the Age textbox becomes unavailable NOTE 1 Pacemaker appears in the Patient Information window a...

Page 62: ...printed out Print Format Set Orient to landscape or portrait Set Sequence to sequential or synchronous Select sequential the lead group is printed one by one in a certain sequence The start time of a...

Page 63: ...Select Modify File Naming you can also modify the file name manually such as Name ID Exam Time NOTE Select at least one item as a file name when you select Modify File Naming SCP Setting Select Data C...

Page 64: ...ng finishes the system will automatically output FDA XML files when sampling finishes Select Output when making diagnosis the system will automatically output FDA XML files when making diagnoses DICOM...

Page 65: ...window Click on the button to assign the backup path Select Select Time to back up the data files during the set time range Deselect Select Time to back up all the data files Click on the OK button in...

Page 66: ...stem to transmit the result data to EDP ECG ID Enter information in this textbox to set GDT ID assigned to the system which will be entered in field 8315 or 8316 in the GDT protocol EDP ID Enter infor...

Page 67: ...sword Setting window and then click on the OK button to set the system password After a successful password setting you should have a correct password to enter the System Setting window Wave Width and...

Page 68: ...ubitem such as bb in the textbox and then click on the Add button The added subitem will be displayed under aa 3 Deleting an item Click on the item you wanted to delete from the Edit Diagnosis Templat...

Page 69: ...port is interrupted 1 Reconnect the ECG sampling box to the PC 2 Click on the Device tab in the System Setting window of the PC ECG system and check whether the sampling device is set correctly Commun...

Page 70: ...SE 1010 PC ECG User Manual Hint Information 64 Sorry Can not Connect to the Database MSDE 2000 or SQL Server 2005 Express is not started up Fail to create database The system fails to create database...

Page 71: ...ter 75 alcohol 10 1 2 Cleaning the Reusable Electrodes 1 Remove the remainder gel from the electrodes with a clean soft cloth first 2 Take suction bulbs and metal cups of chest electrodes apart and ta...

Page 72: ...ed person who has adequate training knowledge and practical experience to perform these tests a Inspect the equipment and accessories for mechanical and functional damage b Inspect the safety related...

Page 73: ...tor plug instead of the cable when connecting 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...

Page 74: ...01 57 040162 Chest Electrode 01 57 040163 Hasee Tablet PC 02 04 240844 Portable Bag 01 56 465280 10 Table 11 2 Standard Accessory List for Wireless System Accessory Part Number PC ECG Stress ECG DX12...

Page 75: ...aused 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 components o...

Page 76: ...ilization method Refer to the user manual for details Degree of safety of application in the presence of flammable gas Equipment not suitable for use in the presence of flammable gas Working mode Cont...

Page 77: ...2x1 5V Excell Alkaline AA IEC LR6 Operation life of battery 12 hours A1 5 Performance Specifications Display Display Content System name Patient ID Patient name Hear rate Display mode Printing mode S...

Page 78: ...sampling 500 Hz lead analysis DP12 ECG sampling box 24 bits A D Resolution DX12 transmitter 18 bits Time Constant 3 2 s Frequency Response 0 05 Hz 150 Hz 3 dB Gain 2 5 mm mV 5 mm mV 10 mm mV 20 mm mV...

Page 79: ...tude DX12 transmitter 2 to 500 mV Width 0 1 to 2 0 ms Sampling Frequency DP12 ECG sampling box 10 000 Hz rhythm lead DX12 transmitter 10 000 Hz lead NOTE Test the accuracy of input signal reproduction...

Page 80: ...ission test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 SE 1010 PC ECG uses RF energy only for its internal function Therefore its RF emissions are very low and are n...

Page 81: ...If floor are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines Not applicable Mains power quality s...

Page 82: ...pecified below The customer or the user of SE 1010 PC ECG should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance...

Page 83: ...from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically w...

Page 84: ...the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output power of transmitter W 150 kHz to 80 MHz P d 2 1 80 MHz to 80...

Page 85: ...QRS Complexes Duration QT QTc Q T Interval of the Current Lead Normalized QT Interval P QRS T Dominant Direction of the Average Integrated ECG Vectors aVF Left Foot Augmented Lead aVL Left Arm Augmen...

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