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SE-1201 Electrocardiograph User Manual Safety Guidance

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UP/DOWN Arrow key

REVIEW key

Gender key

Age Group key

Recycle

Part Number

Serial Number

Date of Manufacture

Manufacturer

Authorized Representative in the European Community

The symbol indicates that the device complies with the
European Council Directive 93/42/EEC concerning
medical devices.

Rx only (U.S.)

Federal (US) law restricts this device to sale by or on the
order of a physician.

It indicates that the device should be sent to the special
agencies according to local regulations for separate
collection after its useful life.

Summary of Contents for SE-1201

Page 1: ......

Page 2: ...n 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 expressly or implicitly any right or license to use any of the intellectual properties of EDAN EDAN holds the rights to modify update and ultimately explain this manual Responsibility of the Manufacturer ED...

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 inaccurate data or invalidate a procedure NOTE A NOTE provides useful information regarding a function or a procedure ...

Page 4: ...atient Cable to the Electrocardiograph 19 3 1 2 Connecting the Patient Cable to Electrodes 20 3 2 Preparing the Patient 20 3 2 1 Instructing the Patient 20 3 2 2 Preparing the Skin 21 3 3 Attaching Electrodes to the Patient 21 3 3 1 Electrode Placement 21 3 3 2 Attaching the Reusable Electrodes 23 3 3 2 1 Attaching the Limb Electrodes 23 3 3 2 2 Attaching the Chest Electrodes 24 3 3 3 Attaching th...

Page 5: ...ode 50 6 1 5 Review Printing 51 6 2 Copy Printing 51 6 3 Freezing ECG Waves 52 6 4 Printing a Stored ECG Report 53 6 4 1 Printing on the File Manager Screen1 2 53 6 4 2 Printing on the Preview Screen 53 6 5 Sample ECG Reports 54 6 5 1 ECG Reports in the Auto Mode 54 6 5 2 ECG Reports in the Rhythm Mode 58 6 5 3 ECG Reports in the Manual Mode 59 6 5 4 ECG Reports in the R R Analysis Mode 60 6 5 5 E...

Page 6: ... 80 Chapter 10 System Setup 82 10 1 Factory Defaults 82 10 2 Work Mode Setup 86 10 3 Filter Setup 88 10 4 Record Info Setup 89 10 4 1 Setup 1 89 10 4 2 Setup 2 94 10 5 Patient Information Setup 95 10 6 Transmission Setup 97 10 7 Lead Setup 98 10 8 Display Sound Setup 99 10 9 Date Time Setup 101 10 10 File Setup 102 10 11 System Maintenance Setup 104 10 12 Other Setup 105 Chapter 11 Hint Informatio...

Page 7: ...able 116 Chapter 14 Accessories 118 14 1 Standard Accessories 118 14 2 Optional Accessories 118 Chapter 15 Warranty Service 120 15 1 Warranty 120 15 2 Contact information 120 Appendix 1 Technical Specifications 121 A1 1 Safety Specifications 121 A1 2 Environment Specifications 121 A1 3 Physical Specifications 122 A1 4 Power Supply Specifications 122 A1 5 Performance Specifications 123 Appendix 2 E...

Page 8: ...s not designed for internal use or direct cardiac application 2 This equipment is not intended for home use 3 This equipment is not intended for treatment or monitoring 4 This equipment is intended for use on adult and pediatric patients only 5 The results given by the equipment should be examined based on the overall clinical condition of the patient and they can not substitute for regular checki...

Page 9: ...able and other accessories supplied by the manufacturer can be used Or else the performance and electric shock protection can not be guaranteed 9 Make sure that all electrodes are connected to the patient correctly before operation 10 Ensure that the conductive parts of electrodes and associated connectors including neutral electrodes do not come in contact with earth or any other conducting objec...

Page 10: ...t of the system to the multiple portable socket outlet supplying the system 22 Do not connect any equipment or accessories that are not approved by the manufacturer or that are not IEC EN 60601 1 1 approved to the electrocardiograph The operation or use of non approved equipment or accessories with the electrocardiograph is not tested or supported and electrocardiograph operation and safety are no...

Page 11: ...trical equipment complying with IEC EN 60601 1 and b Outside the patient environment the level of safety appropriate for non medical electrical equipment complying with other IEC or ISO safety standards 30 If multiple instruments are connected 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 3...

Page 12: ...e battery from the electrocardiograph when the electrocardiograph isn t used for a long time 10 If the battery is stored alone and not used for a long time we recommend that the battery be charged at least once every 6 months to prevent overdischarge 1 2 3 General Cautions CAUTION 1 Avoid liquid splash and excessive temperature The temperature must be kept between 5 ºC and 40 ºC during operation a...

Page 13: ...nd of their lives 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 Civic Office or the shop where you purchased the product 6 Federal U S law restricts this device to sale by or on the order of a physician 1 3 List of Symbols External output External in...

Page 14: ...ety Guidance 7 Mains supply Battery indicator Battery recharging indicator Enter key Delete key Esc key RESET key Shift key Fn key Power On Off key 1mV COPY key MODE key PRINT STOP key Tab key FEED Paper key Lead switch key LEFT RIGHT Arrow key ...

Page 15: ...presentative in the European Community The symbol indicates that the device complies with the European Council Directive 93 42 EEC concerning medical devices Rx only U S Federal US law restricts this device to sale by or on the order of a physician It indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life ...

Page 16: ... SE 1201 can be powered by the mains supply or the battery With a high resolution thermal recorder a 32 bit processor and a large capacity memorizer SE 1201 has advanced performance and high reliability The compact size makes it suitable for clinic and hospital uses SE 1201 adopts 800 480 multicolor LCD screen Configuration main unit power cord patient cable chest electrodes limb electrodes dispos...

Page 17: ... this indicator is lit B Battery indicator When the device is powered by the battery this indicator is lit C Battery recharging indicator When the device is powered on the indicator flashes for a few seconds When the battery is being recharged this indicator is lit 2 2 Keyboard and Keys Figure 2 2 SE 1201 Keyboard E A B C L K J I H F D Q O P N M G R ...

Page 18: ...AUTO mode NOTE The system will not respond to the REVIEW key unless 10s data has been collected on the main screen H PRINT STOP Press to start or stop printing reports I 1mV COPY In the manual mode pressing the 1mV COPY key can insert a 1mV calibration mark in the printing course In the auto or rhythm mode pressing the 1mV COPY key can print the ECG report which was printed out last time J RESET P...

Page 19: ... N Shift Press Shift and a numeric key to input the special character in the top left corner of the key If Caps Lock is set to Off pressing Shift P can type a capital P If Caps Lock is set to On pressing Shift P can type a lowercase p O Tab Press to move the cursor Pressing Tab can move the cursor forward and pressing Shift Tab can move the cursor backward P Fn Press Fn and a letter key to type sp...

Page 20: ...ole Path for internal heat emission E Fuse The specification is T3 15AH 250V Ø5 20 2 4 Right Panel Figure 2 4 SE 1201 Right Panel Name Explanation A Patient Cable Socket Connecting to the patient cable B SD Card Socket Connecting to SD card C USB Socket 1 2 Standard USB Host socket connecting to a U disk a bar code reader or a USB printer recommended by the manufacturer D USB Socket 3 Standard USB...

Page 21: ...Signal Pin Signal 1 C2 input V2 input 6 SH 11 F input LL input 2 C3 input V3 input 7 NC 12 C1 input V1 input or NC 3 C4 input V4 input 8 NC 13 C1 input V1 input 4 C5 input V5 input 9 R input RA input 14 RF N input RL input or NC 5 C6 input V6 input 10 L input LA input 15 RF N input RL input NOTE The left side of is European standard and the right side is American standard 2 SD Socket ...

Page 22: ...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 IEC EN 60601 1 1 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 v...

Page 23: ...Signal 1 GND 4 GND 2 GND 5 ECG Signal input 3 GND 6 ECG Signal output 2 5 Bottom Panel Figure 2 5 SE 1201 Bottom Panel Name Explanation A Speaker Hole Path for sound from speaker B Battery Compartment Compartment for the battery C Heat Emission Hole Path for internal heat emission D Label Position for product information label B D A C ...

Page 24: ...ery and batteries of the same model and specification must be used 4 Only when the device is off can the battery be installed or removed NOTE If the battery has not been used for two months or more you should recharge it before using it again 2 Fuse There are two fuses of the same specification installed on the bottom of the main unit The specification is T3 15AH 250V Ø5 20 WARNING Ruptured fuses ...

Page 25: ...and filter The auto manual rhythm R R analysis and off modes can be chosen freely Flexible printing formats Supporting ECG waves displaying with grid Automatic baseline adjustment for optimal printing Convenient operation of system setup and file management Multiple file formats DAT SCP optional FDA XML optional PDF Measurement function and interpretation function Supporting bar code reader ECG da...

Page 26: ...atient Cable to the Electrocardiograph and Electrodes WARNING The performance and electric shock protection can be guaranteed only if the original patient cable and electrodes of the manufacturer are used The patient cable includes the main cable and lead wires which can be connected to electrodes 3 1 1 Connecting the Patient Cable to the Electrocardiograph Connect the patient cable to the patient...

Page 27: ...ght deltoid R Red RA White Left arm Left deltoid L Yellow LA Black Right leg Upper leg as close to torso as possible N or RF Black RL Green Left leg Upper leg as close to torso as possible 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 Brown V4 Brown Blue Chest 5 C5 White Black V5 Brown Orange Chest 6 ...

Page 28: ...air prevents a good connection 2 Wash the area thoroughly with soap and water 3 Dry the skin with a gauze pad to increase capillary blood flow to the tissues and to remove the dead dry skin cells and oils 3 3 Attaching Electrodes to the Patient Two kinds of electrode can be used one is the reusable electrode including chest electrodes and limb electrodes and the other is the disposable electrode W...

Page 29: ...ostal 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 anterior axillary line at the horizontal level of C4 C6 V6 Left midaxillary line at the horizontal level of C4 L LA Right arm Right deltoid R RA Left arm Left deltoid F LL Right leg Upper leg as close to torso as possible N RL Left leg Upper leg as...

Page 30: ... second rib to the right sternal edge Nax A2 Fifth intercostal space on the left posterior axillary line Nap V4 Left mid clavicular line in the fifth intercostal space R RA Right arm L LA Left arm N or RF RL Right leg F LL Left leg 3 3 2 Attaching the Reusable Electrodes 3 3 2 1 Attaching the Limb Electrodes Limb Electrode Reed Connecting to a Lead Wire Clamp ...

Page 31: ...Chest Electrodes Chest Electrode Chest Electrode Connection 1 Ensure that the electrodes are clean 2 Clean the electrode area on the chest surface with 75 alcohol 3 Daub the round area of 25mm in diameter on each electrode site with gel evenly 4 Place a small amount of gel on the brim of the chest electrode s metal cup 5 Place the electrode on the chest electrode site and squeeze the suction bulb ...

Page 32: ...posable electrodes to the electrode positions on the body surface 4 Clip the disposable electrodes with the alligator clips The quality of ECG waveform will be affected by the contact resistance between the patient and the electrode In order to get a high quality ECG the skin electrode resistance must be minimized while connecting electrodes 3 4 Inspection Before Power On In order to avoid safety ...

Page 33: ...city is low recharge the battery before use 3 Patient Cable Make sure that the patient cable is connected to the unit firmly and keep it far away from the power cord 4 Electrodes Make sure that all electrodes are connected to lead wires of the patient cable correctly Ensure that the chest electrodes do not contact with each other 5 Patient The patient should not come into contact with conducting o...

Page 34: ...ress on the keyboard to turn on the unit and then the battery indicator will be lit and the battery symbol will be displayed The logo will be displayed on the LCD screen after self test Because of the consumption during the storage and transport course the battery capacity may not be full If the symbol and the hint information Battery Weak are displayed which means the battery capacity is low plea...

Page 35: ...ing down on the screen 3 6 Loading Replacing Recorder Paper Four kinds of folded thermal paper can be used For details on selecting the paper style please refer to Section 10 4 1 Setup 1 NOTE 1 When using the paper of 216mm in width the two movable parts should be removed For more detailed information about removing the two movable parts please contact the manufacturer or the local distributor 2 T...

Page 36: ... 3 Take off the wrapper of the new folded paper and then put it in the paper tray NOTE If the paper with black markers is used make sure that the markers are on the bottom 4 Pull the paper out with the grid side facing the thermal print head and close the recorder casing firmly 5 Make settings of Paper Marker and Paper Style in the Record Info Setup window For details please refer to Section 10 4 ...

Page 37: ...30 6 Advance the recorder paper If Paper Marker is set to Yes you can press FEED to advance the recorder paper to the next black marker if Paper Marker is set to No you can press FEED to advance the paper for 2 5cm Pressing FEED again can stop advancing the paper ...

Page 38: ...TION Do not touch the LCD screen with sharp things such as pencils or pens otherwise it will be damaged 4 1 Navigation Tips 4 1 1 Selecting Menu Functions Press F1 F2 F3 F4 F5 or F6 to select the corresponding menu function To select Patient press the function key F1 below Patient on the main screen1 To select Setup press the function key F1 below Setup on the main screen2 For details about the ma...

Page 39: ...n Caps Lock is set to Off in the Other Setup window pressing Shift and a letter key can input a capital letter For example pressing Shift P can type a capital P When Caps Lock is set to On in the Other Setup window pressing Shift and a letter key can input a lowercase letter For example pressing Shift P can type a lowercase p 3 Press Del on the keyboard to erase the typed information 4 Press Enter...

Page 40: ...rrow to highlight an option 3 In the Work Mode Setup window press Tab or Shift Tab to move the cursor to a textbox Enter data in the selected textbox 4 Press Enter to confirm or press Tab or Shift Tab to move the cursor to the OK button and then press Enter to confirm 5 Press Esc to cancel the operation or press Tab or Shift Tab to move the cursor to the Cancel button and then press Enter to cance...

Page 41: ... Operation Guidance 34 4 3 Screen Description 4 3 1 About the Main Screen After the electrocardiograph is turned on the main screen appears Figure 4 1 SE 1201 Main Screen1 Figure 4 2 SE 1201 Main Screen2 Q U T S R J D E F H I G A B P O N M L K C ...

Page 42: ...Gender Male Female Cleared E Hint Information 1 Including DEMO Module Error Overload Lead Name When the leads are off the lead names will be shown in black on a yellow background For details please refer to Chapter 11 Hint Information F Hint Information 2 Including No Paper Paper Error Battery Weak Sampling Analyzing Recording Testing Learning Transmitting Transmit Fail Detecting Memory Full U Dis...

Page 43: ...ain screen is only effective for the current patient O Freeze Freezing ECG waves For details please refer to Section 6 3 Freezing ECG Waves P Patient Press the function key F1 below Patient to open the Patient Information window For details please refer to Chapter 5 Entering Patient Information Q ECG waveform Display ECG waveform R Press to return to the main screen1 S Order Press to open the Orde...

Page 44: ... display the System Setup screen NOTE If you set the system password in the System Maintenance window you need enter the password before opening the System Setup screen For details refer to Section 10 11 System Maintenance Setup On the System Setup screen move the cursor on an item and then press Enter to open the setup window of the item ...

Page 45: ...in screen1 Figure 4 3 Order Manager Screen Name Explanation A Examine Press to return to main screen1 for starting examination of the selected order B Load Press to load orders to the electrocardiograph C Setup Press to make the related settings D Search Press to search for orders on the Order Manager screen E Delete Press to delete the selected order from the electrocardiograph F Del All Press to...

Page 46: ...ager screen Once the electrocardiograph is turned on you can open the Order Manager screen by pressing Patient if orders without examination exist on the Order Manager screen After you press Esc on the Order Manager screen to return to main screen1 you cannot open the Order Manager screen by pressing Patient until you complete an order examination next time 4 3 4 About the File Manager Screen Swit...

Page 47: ...SE 1201 Electrocardiograph User Manual Basic Operation Guidance 40 Figure 4 4 File Manager Screen1 Figure 4 5 File Manager Screen2 A B C D E F H G I J K L M N H G ...

Page 48: ...fo Setup window F Import Press to import files from the U disk or SD card to the electrocardiograph G File Count For example 1 200 200 is the total number of files that can be stored in the electrocardiograph 1 is the current number of files stored in the electrocardiograph I Edit Press to open the Patient Information window Then you can edit the patient information J Record Press to print the sel...

Page 49: ...ine the lead group to be displayed and printed Pressing the Left or Right arrow can switch among the lead groups RHYT In the rhythm mode the ECG data can be saved and transmitted You can print 60s rhythm lead ECG waveform of one lead in the Single Lead style or 20s rhythm lead ECG waveform of three leads in the Three Leads style R R In the R R analysis mode you can select a lead to print its R R h...

Page 50: ...ms Select the desired items in the Patient Information Setup window and then press Enter to confirm For details please refer to Section 10 5 Patient Information Setup 2 Select a mode from the ID list box For details please refer to Section 10 5 Patient Information Setup 3 Press Enter to confirm 2 Select Patient on the main screen1 to open the Patient Information window 3 Enter data in a desired te...

Page 51: ...ot input the patient ID before pressing the PRINT STOP key a hint will pop up to remind you to input the patient ID 2 The total number of supported characters may be fewer if either special Latin characters or Chinese characters are entered 3 If you select D O B in the Patient Information Setup window the D O B textbox appears and the Age textbox becomes unavailable in the Patient Information wind...

Page 52: ...software of the manufacturer must be installed in the PC Operation procedures are as follows 1 Connect the electrocardiograph to the PC with Ethernet cable recommended by the manufacturer 2 Log into the Smart ECG Viewer software 3 Set Remote IP Local IP Gateway and Subnet Mask in the Transmission Setup window For details please refer to Section 7 1 1 Transmitting ECG Data in DAT Format through Eth...

Page 53: ...s by using a bar code reader 1 Select On from the Order Acquired list box in the Patient Information Setup window 2 Connect the bar code reader to USB socket 2 on the right panel of the electrocardiograph 3 Select Patient to open the Patient Information window and then move the cursor to the ID textbox 4 Scan the patient s bar code with the bar code reader and then the related order will be loaded...

Page 54: ... again can stop advancing the paper If Paper Maker is set to No in the Setup1 window pressing the PRINT STOP key can stop printing an ECG report and advancing the paper immediately 6 1 Printing an ECG Report 6 1 1 Auto Mode Operation Method 1 To set Mode Options Auto DispStyle Sampling Mode Record Style Rhythm Lead1 2 3 or Lead Sequence Optional 1 Select AUTO from the Mode Option list in the Work ...

Page 55: ...t an ECG report It will stop automatically after printing a complete ECG report of 12 leads Or press the PRINT STOP key again to stop printing the report 6 1 2 Manual Mode Operation Method 1 To set Mode Options Manual Style or Lead Sequence Optional 1 Select MANU from the Mode Option list in the Work Mode Setup window 2 Select a style from the Manual Style list in the Work Mode Setup window 3 Sele...

Page 56: ...ted 4 Press the PRINT STOP key to print an ECG report Or press the PRINT STOP key to stop printing the ECG report 6 1 3 Rhythm Mode Operation Method 1 To set Mode Options Rhythm Style Rhythm Lead1 2 3 or Lead Sequence Optional 1 Select RHYT from the Mode Option list in the Work Mode Setup window 2 Select a style from the Rhythm Style list in the Work Mode Setup window 3 Select a lead from the Rhyt...

Page 57: ...on the main screen When the sampling time reaches 60s in the Single Lead style or 20s in the Three Leads style it begins to print an ECG report 4 It will stop automatically after printing a complete report of rhythm lead ECG waveforms Or press the PRINT STOP key again to stop printing the ECG report 6 1 4 R R Analysis Mode Operation Method 1 To set Mode Options or Rhythm Lead1 1 Select R R from th...

Page 58: ...INT STOP key to stop printing the ECG report NOTE In the R R analysis mode you can not set the speed The constant speed is 25mm s and the printing speed is 5mm s because in the R R analysis mode the ECG wave length is compressed to one fifth of the original wave length 6 1 5 Review Printing In the auto or off mode after you press the Review key 10s ECG data sampled before you press the key will be...

Page 59: ... filter on the main screen1 2 Select Freeze to display the freezing screen Figure 6 1 Freezing Screen NOTE Within ten seconds after returning to the main screen pressing F2 can not display the freezing screen 3 Select Pre Page or select Next Page to turn pages 4 Select Pre Sec or select Next Sec to view the ECG waves of the previous or next second 5 Select 10mm mV to set the gain of the ECG waves ...

Page 60: ...screen1 and then press Select to select the file and open the File Manager screen2 3 Press PRINT STOP or Record on the File Manager screen2 to print the selected file 4 Or press PRINT STOP again to stop printing the file 6 4 2 Printing on the Preview Screen Operation Method 1 Select File on the main screen to open the File Manager screen1 2 Select a file on the File Manager screen1 and then press ...

Page 61: ...SE 1201 Electrocardiograph User Manual Printing ECG Reports 54 6 5 Sample ECG Reports 6 5 1 ECG Reports in the Auto Mode Quick Mode a ...

Page 62: ...e Template is selected and Record Style is set to 6 2 1r The ECG report includes Patient Information Measure Information Diagnosis Information Report Confirmed by Current Date and Current Time 6 2 1r ECG waves 0 67 100Hz 0 67Hz DFT Filter 100Hz Lowpass Filter AC50 50Hz AC Filter 25mm s Paper Speed 10mm mV Gain 80 Heart Rate ...

Page 63: ...ed dominant beats Normalized QT interval RV5 SV1 amp Dominant direction of the average integrated ECG vectors P QRS T axis The maximum of the amplitude of R or R wave of one selected dominant beat from lead V5 The maximum absolute value of the amplitude of S or S wave of one selected dominant beat from lead V1 RV5 SV1 amp Sum of RV5 and SV1 RV6 SV2 amp The maximum of the amplitude of R or R wave o...

Page 64: ...SE 1201 Electrocardiograph User Manual Printing ECG Reports 57 Save Paper Mode The above figure shows an ECG report in the auto mode The style is 6 2 1R ...

Page 65: ...SE 1201 Electrocardiograph User Manual Printing ECG Reports 58 6 5 2 ECG Reports in the Rhythm Mode The above figure shows an ECG report in the rhythm mode and Rhythm Style is set to Three Leads ...

Page 66: ...SE 1201 Electrocardiograph User Manual Printing ECG Reports 59 6 5 3 ECG Reports in the Manual Mode The above figure shows an ECG report in the manual mode and Manual Style is set to 12 channels ...

Page 67: ...SE 1201 Electrocardiograph User Manual Printing ECG Reports 60 6 5 4 ECG Reports in the R R Analysis Mode a ...

Page 68: ...SE 1201 Electrocardiograph User Manual Printing ECG Reports 61 b ...

Page 69: ... Gain Speed Filter 1mV calibration mark II Lead name 180s compressed ECG wave of Lead II HR Heart Rate RR Avg Interval Average RR interval RR Max Interval Maximum RR interval RR Min Interval Minimum RR interval 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 RR Histogram RR Trend Figure b...

Page 70: ...SE 1201 Electrocardiograph User Manual Printing ECG Reports 63 6 5 5 ECG Reports Printed by the USB Printer ...

Page 71: ...SE 1201 Electrocardiograph User Manual Printing ECG Reports 64 6 5 6 ECG Report of Patient with Pacemaker The above figure shows the ECG report of a patient with a pacemaker ...

Page 72: ...SE 1201 Electrocardiograph User Manual Printing ECG Reports 65 6 5 7 ECG Report of Nehb Lead The above figure shows the ECG report of Nehb lead ...

Page 73: ...onnect the electrocardiograph to the network of the PC with an Ethernet cable recommended by the manufacturer NOTE 1 If the wireless AP transmission is used please refer to the user manual delivered with the wireless AP 2 There should be no shield in or around the room where the wireless AP is used or else the wireless transmission may fail 3 Configure the Transmission Setup window NOTE For more i...

Page 74: ... sections of the Gateway item to the first three sections of the IP of the electrocardiograph The last section of the Gateway item must be set to 1 5 Set the Subnet Mask item to 255 255 255 0 6 Press Enter to confirm and then press Esc to return to the main screen 4 Set Auto Transmission to On in the Transmission Setup window 5 In the auto or rhythm mode ECG data will be transmitted through the ne...

Page 75: ...the room where the wireless AP is used or else the wireless transmission may fail 3 Configure the Transmission Setup window 1 Set Auto Transmission to On 2 Set IP addresses For details please refer to Section 7 1 1 Transmitting ECG Data in DAT Format through Ethernet Cable 3 Set the FTP User Name FTP Password and FTP Path items a The user name and the password you input in the FTP User Name and FT...

Page 76: ... ECG report is printed out In the off mode 10s ECG data sampled after pressing the PRINT STOP key will be transmitted through the net cable automatically 7 2 Real time Transmission to PC ECG NOTE For the real time transmission the PC ECG software of the manufacturer must be installed in the PC 1 Run the PC ECG software and configure it for the real time transmission ...

Page 77: ...onnect USB socket 3 of the electrocardiograph to the USB socket of the PC by using the high speed USB cable For details please contact the manufacturer or the local distributor 3 Start the real time transmission The electrocardiograph transmits to the PC the ECG signals acquired from the patient Acquisition and transmission are simultaneous The ECG signals are displayed on the PC monitor and event...

Page 78: ...er to Section 8 5 Setting Orders Operation procedures are as follows 1 Connect the electrocardiograph to the PC installed with the Smart ECG Viewer software by using an Ethernet cable recommended by the manufacturer 2 Set Remote IP Local IP Gateway and Subnet Mask in the Transmission Setup window For details please refer to Section 7 1 1 Transmitting ECG Data in DAT Format through Net Cable 3 Sele...

Page 79: ... Load 8 2 Examining Orders Select an order on the Order Manager screen and then select Examine or press Enter to return to main screen1 for starting an examination NOTE If you select Delete After Examination on the Order Setup screen the order will be deleted from the Order Manager screen after you examine the selected order Otherwise the order will be marked by mark on the Order Manager screen af...

Page 80: ...r the search information and then press Enter to confirm All the orders which meet the requirements will be searched and displayed on the Order Manager screen NOTE The time mode in the SearchInfo Setup window is the mode you select in the Date Time Setup window 8 5 Setting Orders 8 5 1 Factory Defaults of Orders Items Default Condition Default Sequence Ascending Delete After Examination Deselect E...

Page 81: ...d in ascending sequence based on the option you select from the Condition list box Select Descending orders will be displayed in descending sequence based on the option you select from the Condition list box NOTE 1 When Condition is set to State and Sequence is set to Ascending orders without examination will be displayed on the top of the Order Manager screen 2 When Condition is set to State and ...

Page 82: ...m Filter You can enter an exact exam room in the textbox such as Electrocardiograph If the room you entered exists in the Smart ECG Viewer software all the related information will be searched and displayed on the Order Manager screen Deselect this item or enter nothing in the textbox all the loaded information will be searched and displayed on the Order Manager screen ...

Page 83: ...data in the electrocardiograph you should set Auto Save to to ECG in the File Setup window Then the ECG data in the auto off or rhythm mode will be saved on the File Manager screen automatically For details please refer to Section 10 10 File Setup Figure 9 1 File Manager Screen1 Figure 9 2 File Manager Screen2 ...

Page 84: ...t a file on the File Manager screen1 and then press Select to display the File Manager screen2 Select Trans on the File Manager screen2 and then press Enter to transmit the selected file from the electrocardiograph NOTE If you select Delete After Trans Or Export in the File Setup window the files will be deleted from the File Manager screen after they are transferred 9 2 Exporting Files 1 Connect ...

Page 85: ...r screen after they are exported 9 3 Deleting Files Pressing Del All on the File Manager screen1 can delete all the files from the electrocardiograph Or you select a file on the File Manager screen1 and then press Select to display the File Manager screen2 Select Delete on the File Manager screen2 and then press Enter to delete the selected file from the electrocardiograph 9 4 Searching Files Sele...

Page 86: ...the ECG files in DAT format produced by the electrocardiograph of the manufacturer can be imported 9 6 Editing Patient Information Press Select on the File Manager screen1 to display the File Manager screen2 and then select Edit to open the Patient Information window NOTE The Address item can be defined in the User defined text box in the Patient Information Setup window For details please refer t...

Page 87: ...ct Preview on the File Manager screen2 to open the file preview screen 2 Select Waveform to display the waveform screen You can press the Left or Right arrow to switch between the lead groups when previewing a file on the waveform screen 3 Select Template to display the template screen ...

Page 88: ... to display the measure screen which shows the measurement information 5 Press PRINT STOP or select Record on the preview screen to print the selected file Or press PRINT STOP again to stop printing the file 6 Select Diagnosis to show Minnesota Code and Diagnosis Information ...

Page 89: ...p screen Figure 10 1 System Setup Screen 10 1 Factory Defaults Table 10 1 Factory Defaults Work Mode Setup Items Default Mode Options Auto Manual Rhythm Manual Style 6 channels Auto Display Style 6 2 Rhythm Style Three Leads Sampling Mode Real time Sample Duration Periodic Sample 60 min Interval Periodic Sample 1 min Auto Extend Record Off ...

Page 90: ...Record Device Thermal Speed 25mm s Paper Marker Yes Paper Style 210 140mm Sample Time 10s Record Info Setup Setup2 Items Default Template Measure Analysis On Position Marker Minnesota Code Off Baseline Adjustment Horizontal RR Interval List Off Grid of Thermal Report Off Grid of USB Report On Patient Information Setup Items Default Gender Pacemaker On First Last Name BP Race Height Weight Medicati...

Page 91: ...rder Acquired Off User defined Cleared Transmission Setup Items Default Auto Transmission Off FTP User Name FTP Password FTP Path Cleared Lead Setup Items Default Lead Sequence Standard Nehb Off Rhythm Lead 1 II Rhythm Lead 2 V1 Rhythm Lead 3 V5 Display Sound Setup Items Default Brightness 16 Display Colors Option 1 Antialiasing Off Grid On QRS Volume Off Hint Volume Medium ...

Page 92: ... Time Mode 24 Hours Power Off LCD Off Cleared File Setup Items Default Auto Save To ECG File Format DAT Delete After Trans Or Export Off Replace When Memory Full Off SCP File Compression after being activated On Maintenance Setup Items Default System Password Cleared Other Setup Items Default External Input Off External Output Off Caps Lock Off ...

Page 93: ...ed Select AUTO the lead groups are switched automatically according to the lead sequence during the printing course After the ECG waves of one lead group are printed within a certain time the system switches to print ECG waves of another lead group automatically Select RHYT you can select rhythm leads to print 60s or 20s rhythm lead ECG waves Select R R you can select a lead to print its R R histo...

Page 94: ...e Lead c to print 60s ECG waves of the appointed single rhythm lead Select Three Leads to print 20s ECG waves of three appointed rhythm leads Sampling Mode Choose from Real time Sample Triggered Sample or Periodic Sample Select Real time Sample 10s ECG data sampled after pressing the PRINT STOP key will be printed out Select Triggered Sample after pressing the PRINT STOP key if Arrhythmia ECG data...

Page 95: ...s filter is to keep the ECG signals on the baseline of the printout Choose from 0 05Hz 0 15Hz 0 25Hz 0 32Hz 0 5Hz or 0 67Hz The set value is the low limit of the frequency range EMG Filter EMG Filter suppresses disturbance caused by strong muscle tremor Choose from 25Hz 35Hz 45Hz or Off The cutoff frequency can be set to 25Hz 35Hz or 45Hz Select Off to turn off the function Lowpass Filter Lowpass ...

Page 96: ...print ECG waves of 12 leads in 4 groups of 3 Select 3 4 1R to print ECG waves of 12 leads in 4 groups of 3 with the ECG wave of one rhythm lead on the bottom of the ECG reports Select 3 4 3R to print ECG waves of 12 leads in 4 groups of 3 with the ECG waves of three rhythm leads on the bottom of the ECG reports Select o 6 2 to print ECG waves of 12 leads in 2 groups of 6 Select 6 2 1R to print ECG...

Page 97: ...e in a certain sequence The start time of a lead group is just the end time of the previous lead group Select Synchronous the lead group is printed one by one in a certain sequence All leads are printed with the same start time Gain You can set the indicated height of 1mV ECG on the paper Choose from 10mm mV 20mm mV 10 5mm mV AGC 2 5mm mV or 5mm mV AGC means auto gain control When ECG signals vary...

Page 98: ...is mode 4 Make sure that paper is installed in the USB printer before printing Error may occur if no paper is loaded in the USB Printer CAUTION It is forbidden to connect or disconnect a U disk an SD card or a USB printer during the transmission course Speed Choose from 5mm s 6 25mm s 10mm s 12 5mm s 25mm s or 50mm s In the manual mode select 5mm s 6 25mm s 10mm s 12 5mm s 25mm s or 50mm s Only 25...

Page 99: ...e period is set from 11 to 24 seconds in the auto mode after pressing the PRINT STOP key the ECG waves of the set time period are printed NOTE If the time period is set from 11 to 24 seconds the ECG data sampled will not be analyzed or stored Paper Style Paper Style is used to identify the style of the recorder paper Choose from 210 140mm 216 140mm A4 210 295mm or Letter 215 280mm All the recorder...

Page 100: ...SE 1201 Electrocardiograph User Manual System Setup 93 210 295mm 215 280mm ...

Page 101: ...lead groups are adjusted simultaneously and the baselines of the leads in the same row are on the same line Auto Record Info NOTE 1 The items of Auto Record Info are available only in the auto mode and Template and Position Marker do not work in the Save Paper mode 2 To get more information about the above contents please refer to Section 6 5 1 ECG Reports in the Auto Mode RR Record Info Select RR...

Page 102: ...Pacemaker appears in the Patient Information window after it is selected in the Patient Information Setup window Set Pacemaker to Yes in the Patient Information window and the Pacemaker information will be displayed on the report printed out ID Choose from Auto Time or Manual Select Auto the patient ID can be automatically generated The patient ID range is 0 1999 999 999 Select Time the patient ID...

Page 103: ...r Age Group key can be available For details please refer to Section 2 2 Keyboard and Keys H W Unit Choose from cm kg or inch lb BP Unit Choose from mmHg or kPa Select kPa two extra edit boxes will be displayed in the Patient Information window for inputting decimal fraction Prompt Choose from Confirmed By or Unconfirmed Select Confirmed By the physician s name is printed in the ECG reports if it ...

Page 104: ... Transmission Setup window Figure 10 7 Transmission Setup Window Item Description Device No If you input 0 in the Device No textbox after you save data to the U disk or SD card the data will be in the directory of ECGDATA ECG 0 Store Examination Date of the U disk or SD card after you export files from the electrocardiograph to the U disk or SD card the files will be in the directory of ECGDATA EC...

Page 105: ...2 3 Choose from І П Ш aVR aVL aVF V1 V2 V3 V4 V5 or V6 In the auto mode When Record Style is set to 3 4 1R or 6 2 1R the rhythm lead selected in the Rhythm Lead1 list box will be printed in the ECG reports When Record Style is set to 3 4 3R 3 rhythm leads selected respectively in the Rhythm Lead1 2 3 list box will be printed in the ECG reports In the rhythm mode When Rhythm Style is set to Single ...

Page 106: ...ra Lead Sequence Lead group 1 Lead group 2 Lead group 3 Lead group 4 Standard І II Ш aVR aVL aVF V1 V2 V3 V4 V5 V6 Cabrera aVL І aVR II aVF Ш V1 V2 V3 V4 V5 V6 Nehb Lead Sequence I II III ND NA NI Choose from On or Off NOTE If you set Nehb to On the working mode is fixed to be manual 10 8 Display Sound Setup Select Display Sound on the System Setup screen and then press Enter to open the Display S...

Page 107: ...lect Off there is no hint sound QRS Volume Choose from Low Medium High or Off Select Low Medium or High the electrocardiograph gives a sound when an R wave is detected Select Off there is no sound when an R wave is detected Notify Volume Choose from Low Medium High or Off Select Low Medium or High the electrocardiograph gives a sound after ECG report is printed Select Off there is no sound after E...

Page 108: ... YYYY MM DD YYYY or YYYY MM DD NOTE Select OK in the Date Time Setup window or press Enter to confirm Then the new setup will become effective Time Mode Choose from 24 Hours or 12 Hours Power Off Time Input the power off time manually If you enter 0 Minutes or nothing this function will not be effective NOTE 1 Power off time is counted from the time when you last press the keys on the keyboard 2 O...

Page 109: ...card after an ECG report is printed out In the off mode 10s ECG data sampled after pressing the PRINT STOP key will be automatically saved to the directory of ECGDATA ECG X Store Examination Date of the U disk or SD card NOTE 1 Please insert the U disk or SD card recommended by the manufacturer Please set the format to FAT or FAT32 when formatting the U disk or SD card 2 X in the directory of ECGD...

Page 110: ... 200 the files will replace the earlies one automatically Select Off if the stored files reaches 200 the following hint will be displayed If you select Yes the current file will replace the earliest file stored in the electrocardiograph If you select No the current file will not be saved SCP File Compression Choose from On or Off Select On the SCP file will be compressed After the SCP function is ...

Page 111: ...k or SD card to the electrocardiograph Back up Settings Press to back up the system settings to the ECG Load Backup Settings Press to load the backup settings from the ECG Record System Settings Press to print the system settings Pressing this button again can stop printing system settings System Password Enter the password If you set the system password after you press F1 below Setup on the main ...

Page 112: ... fewer if either special Latin characters or Chinese characters are entered Language Select a language Caps Lock Choose from On or Off Select On the letters entered will be capital Pressing Shift and a letter key can input a lowercase letter Select Off the letters entered will be lowercase Pressing Shift and a letter key can input a capital letter External Input The external input socket is equipp...

Page 113: ...iggered If External Input is set to On and External Output is set to Standard or Triggered the electrocardiograph sends the signals which it receives If External Input is set to Off and External Output is set to Standard the electrocardiograph sends ECG signals of rhythm lead 1 If External Input is set to Off and External Output is set to Triggered the electrocardiograph sends pulses with the heig...

Page 114: ...mpled periodically Sampling Analyzing Recording ECG signals are being sampled analyzed recorded Learning The self study process of arrhythmia arithmetic in the Trigger Sample mode Detecting The examining process of arrhythmia data in the Trigger Sample mode Transmitting ECG data is being transmitted from the electrocardiograph to the PC through the net in the auto rhythm or off mode Transmit Fail ...

Page 115: ...aved without printing In the same way if the transmission settings are configured the ECG data could be transmitted to the PC without printing Q4 The screen of SE 1201 is too shiny Could it be possible to weaken the brightness of the screen A4 There is a setup item named brightness in the Display Sound Setup window you can press the Left or Right arrow to change the value which would lead to the c...

Page 116: ...case please open the recorder casing pull the paper out of the paper tray tear 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 If it happened several times it might have something to do with your configuration Please check the Paper Marker and Paper Style setting and make sure that the settings match the loaded p...

Page 117: ...er there is any error information displayed on the screen If the hint No Paper or Paper Error is shown on the screen please deal with it according to the above mentioned measures If the hint Transmitting is shown on the screen which means that the ECG is transmitting the data to the PC please wait a few seconds You can start the printing after the data is transmitted If the problem still exists pl...

Page 118: ... restarted the machine several times but there is no better change A1 The reason for this problem might be there is a key pressed down without springing up Find that key and make it spring up the problem should be solved Q2 I was doing the examination when the machine suddenly gave out a sound and displayed the hint Lead Off What should I do A2 The corresponding electrodes are not connected well P...

Page 119: ...xternal surfaces of the electrocardiograph with a soft cloth dampened in any of the approved cleaning solutions listed below To clean the patient cable 1 Dampen a soft cloth with one of the disinfectants or cleaning agents listed below 2 Wring excess moisture from the cloth before cleaning Recommended Cleaning Solutions Mild soap and water 75 alcohol 13 1 2 Cleaning the Reusable Electrodes 1 Remov...

Page 120: ...o the main unit while cleaning Do not immerse the unit or the patient cable into liquid under any circumstances 13 2 Disinfection Disinfection of the main unit is not necessary need in daily maintenance it is only necessary in operating room In that case please use hospital standard disinfectant NOTE Clean and disinfect the chest and limb electrodes after each use CAUTION 1 Do not use high tempera...

Page 121: ...ged the symbol stops flashing and the battery recharging indicator is black Because of the capacity consumption during the storage and transport course the battery capacity is not full when it is used for the first time Battery recharge should be considered before the first use NOTE The battery will automatically stop charging if you print an ECG report CAUTION Repeated undercharging of the batter...

Page 122: ...deteriorated print head may lead to illegible ECG reports and block the advance of the paper Storage Requirements Recorder paper should be stored in a dry dark and cool area avoiding excessive temperature humidity and sunshine Do not put the recorder paper under fluorescence for a long time Make sure that there is no polyvinyl chloride or other chemicals in the storage environment which will lead ...

Page 123: ...ng to IEC EN 60601 1 Limit 0 1 ohm f Test the earth leakage current according to IEC EN 60601 1 Limit NC 500μA SFC 1000μA g Test the enclosure leakage current according to IEC EN 60601 1 Limit NC 100μA SFC 500μA h Test the patient leakage current according to IEC EN 60601 1 Limit NC a c 10μA d c 10μA SFC a c 50μA d c 50μA i Test the patient auxiliary current according to IEC EN 60601 1 Limit NC a ...

Page 124: ...g 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 stumbling Once damage or aging of the patient cable is found replace it with a new one immediately 3 Reusable Electrodes Electrodes must be cleansed after use and make sure there is no remainder gel on th...

Page 125: ...01 57 471017 11 Patient Cable European 01 57 471016 Adult Chest electrodes 01 57 040163 Adult Limb electrodes 01 57 040162 12 Thermal Recorder Paper 01 57 471182 10 Fuse 01 21 064144 Rechargeable Li ion Battery 21 21 064149 14 2 Optional Accessories Table 14 2 Optional Accessory List Accessory Part Number 01 57 107581 Snap Style Patient Cable European 01 57 107583 Grabber Style 01 57 107582 Snap S...

Page 126: ...ounding Wire 11 13 114114 03 24 38952 Smart ECG Viewer 03 24 38953 11 18 47116 TINY SPRO Smart ECG Viewer Software Key 12 01 47194 USB Ethernet download cable 11 13 20096 High Speed USB Cable 11 13 36063 Wireless AP 11 17 047338 External Ink jet Printer HP Deskjet 1050 01 18 052250 External Ink jet Printer HP Deskjet 2010 01 18 052251 External Ink jet Printer HP Deskjet 2050 01 18 052256 SD Card R...

Page 127: ...amage 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 components or workmanship and the warranty claim is made within the warranty period EDAN will at its discretion repair or replace the defective part s free of charge EDAN will not provide a substitute prod...

Page 128: ...ed equipment without liquid proof Disinfection sterilization 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 Continuous operation EMC Group І Class A NC 10μA AC 10μA DC Patient Leakage Current SFC 50μA AC 50μA DC NC 10μA AC 10μA DC Patient Auxiliary Current SFC ...

Page 129: ...uency 50Hz 60Hz Mains Supply Input Current 0 9 0 4A Rated voltage 14 8V Rated capacity 2200mAh When the battery is fully charged SE 1201 can work normally about 4 hours and it can continually print about 1 5 hours in the MANU mode or print about 300 ECG reports of 3 4 1R in the auto mode Charge mode Constant current voltage Charge current standard 0 45 C5A 1000mA Charge voltage standard 16 8V Fina...

Page 130: ...tive Width 210mm 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 1 BPM ECG Unit Leads 12 standard leads Acquisition Mode simultaneously 12 leads A D Resolution 24 bits Time Constant 3 2s 0 20 Frequency Response 0 05Hz 150Hz 3dB Gain 2 5 5 10 20 10 5 AGC mm mV Input Impedance ...

Page 131: ...ernal Input Output Optional Input 100kΩ Sensitivity 10mm V 5 Single ended Output 100Ω Sensitivity 1V mV 5 Single ended NOTE 1 Test the accuracy of input signal reproduction according to the methods described in clause 4 2 7 2 in ANSI AAMI EC11 1991 R 2001 and the result complies with the clause 3 2 7 2 in ANSI AAMI EC11 1991 R 2001 2 Overall System Error is tested using the method described in AAM...

Page 132: ...ironment Emission test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The 12 channel electrocardiograph uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emission CISPR 11 Class A Harmonic emissions IEC EN 61000 3 2 Class A Voltage fluctuations flicker e...

Page 133: ...ines 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC EN 61000 4 5 1 kV line to line 2 kV line to ground 1 kV line to line 2 kV line to ground Mains power quality should be that of a typical commercial or hospital environment Power frequency 50Hz 60Hz magnetic field IEC EN 61000 4 8 3A m 3A m Power frequency magnetic fields sh...

Page 134: ...nnel electrocardiograph should assure that it is used in such an environment Immunity test IEC EN 60601 test level Complianc e level Electromagnetic environment guidance Conducted RF IEC EN 61000 4 6 Radiated RF IEC EN 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3Vrms 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the 12 channel electro...

Page 135: ...itters 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 with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the 12 channel electrocar...

Page 136: ...ocardiograph as recommended below according to 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 800 MHz P d 2 1 800 MHz to 2 5 GHz P d 3 2 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maxi...

Page 137: ...od Pressure ECG Electrocardiogram 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 Identification AC Alternating Current USB Universal Serial Bus AGC Auto Gain Control NC Normal Condition SFC Single Fault Condition ...

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