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SE-1200 Operators Manual

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2. next second 6 Press Play function key to display ECG wave continuously 7 Press Pause function key to stop playing ECG wave 8 Press Return function key to return to main screen 34 12 Channel Electrocardiograph User Manual 5 4 Auto Mode In the Auto mode the lead groups are switched automatically according to the lead sequence while recording When the ECG signal of one lead group has been recorded within a certain time it will be switched to another lead group automatically and begins to record the ECG signal of that lead group 1mV calibration mark will be recorded at the beginning of recording Operation Method 1 Input patient information before recording 2 Enter Work Mode Setup interface to select Auto mode and set Auto Display Style Sample Mode and Preview 3 Enter Record Information Setup interface to select Record Control page and set Record Style Record Sequence and Record Mode 4 Enter Lead Setup interface to set Lead Sequence 5 After finishing setting parameters exit the System Setup Window 6 If Preview is set as off press START STOP key to begin recording It will stop automatically after a full 12 lead ECG is recorded 7 If Preview 1s set as on press START STOP key to enter the Preview Window In Preview Window pressing Measure function key can enter the Measure Window pressing Diagnosis function key can enter the Diagnosis Window pressing Continue function key can begin recording an
3. RV5 SV1 amplitude RV6 SV2 amplitude The File Diagnosis Window shows Minnesota code and Diagnosis Information In the File Preview Window pressing Record function key can begin recording this case pressing Return function key can return to the File Manage Window 7 Search In the File Manager Window pressing Search function key the following Search Information Setup interface will pop up On the Search Info Setup interface selecting the Name or ID the corresponding case will be found on the File Manage interface selecting the Time all corresponding cases from starting time to ending time will be found on the File Manage interface search Type Name LTD Time Note Users can only select one of the Search Type on the Search Info Setup interface Note The Time Mode is year month and day on the Search Info Setup interface 8 Return In the File Manage Window pressing Return function key can return to the Main Screen Note To save ECG data to the File Manage Window please refer to 5 9 11 Save Option Settings A WARNINGS Do not cut off the mains supply directly when no battery is installed in the device or else the stored data may be lost XWARNINGA When patient cases are being recorded transmitted deleted or copied users can not turn off the electrocardiograph 63 12 Channel Electrocardiograph User Manual 5 11 AUTO Mode Record 5 11 1 Example of 6x2 1rhy 5 11 1 1 Save Mode
4. mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur Compliance level 6 kV contact 8 kV air 2V for power supply lines t kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur 93 Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floor are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Power frequency magnetic fields should be at characteristic of a levels typical location in a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the SE 1200 Electrocardiograph requires continued operation during power mains interruptions it 1s recommended that the 12 Channel Electrocardiograph User Manual for 25 cycles for 25 cycles SE 1200 Electrocardiograph lt 5 Ur lt 5 Ur be powered from an gt 95 dip in Ur gt 95 dip in Ur uninterruptible power for 5 sec for 5 sec supply or a battery NOTE Uris the a c mains voltage prior to application of the test level Guidance and manufacture s dec
5. period The warranty period begins on the date the products are shipped to distributors The warranty 1s void in cases of a damage caused by handling during shipping b subsequent damage caused by improper use or maintenance c damage caused by alteration or repair by anyone not authorized by EDAN d damage caused by accidents e replacement or removal of serial number label and manufacture label If a product covered by this warranty 1s 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 product for use when the defective product is being repaired 9 2 Service Policy All repairs on products must be performed or approved by EDAN Unauthorized repairs will void the warranty In addition whether or not covered under warranty any product repair shall be exclusively be performed by EDAN certified service personnel If the product fails to function properly or if you need assistance service or spare parts contact EDAN s service center A representative will assist you troubleshooting the problem and will make every effort to solve it over the phone or Email avoiding potential unnecessary returns In case a return can not be avoided the representative will record all necessary information and will provide a Re
6. 1rhy ECG wave 0 15 100Hz 0 15Hz DFT Filter 100Hz Lowpass Filter AC50 50Hz AC Filter 25mm s Paper Speed 10mm mV Gain 2 by 5s 1 rhythm 12 leads are recorded in 2 groups of 6 and every group is recorded 64 12 Channel Electrocardiograph User Manual about 5s with one rhythm lead at the bottom simultaneously SE 1200 Express Electrocardiograph Model V1 7 Version number 5 11 1 2 Quickly Mode a 65 12 Channel Electrocardiograph User Manual FI st Pes o eee A AS Er a m A BT iih m EL DTE isi 1 afam P LI F bano iR ru ET m HL ds acabas um ipn non ea arm E et a A a 12 A02 i iur ib iE nuts JE zm P b 66 12 Channel Electrocardiograph User Manual The above figure a and b show the ECG record in the Auto Mode The Template 1s set as on and Auto Style is 6x2 1rhy Figure a shows ID 2690 Patient ID 08 06 2005 08 34 07 Current Date amp Current Time IL ImV calibration mark I IL HI aVR aVL aVF V1 V2 V3 V4 V5 V6 12 standard Leads and ECG wave II on the bottom Rhythm Lead and rhythm wave 0 15 100Hz 0 15Hz DFT Filter 100Hz Lowpass Filter AC50 50Hz AC Filter 25mm s Paper Speed 10mm mV Gain 2 by 5s 1 rhythm 12 leads are recorded in 2 groups of 6 and every group is recorded about 5s with one rhythm lead at the bottom simultaneously SE 1200 Express Electrocardiograph Model V1 7 Version number
7. Software Key TINY SPRO Smart ECG viewer Software Key USB DeskJet HP2368 90 Part Number MSIR 107402 A0 MSIR 110265 A0 MSIR 110375 A0 MSIR 110266 A0 MISR 040168 M15R 040169 MS1 19907 MS1 20016 M15 40090 M15 40024 M15 40109 M59 38952 MS9 38953 M15R 040172 M50 78047 MS2 20117 MS2 20096 M17 47116 M17 47194 M18 52168 M50 78105 12 Channel Electrocardiograph User Manual ECG bag M50 78118 SD Card Reader M17 047324 MT 201 Trolley MS9 107058 MT 801 Trolley MS9 107625 12V Vehicle carried Inverter M21 64056 12 channel electrocardiograph and accessories are available by contacting the manufacturer or your local distributor Manufacturer EDAN INSTRUMENTS INC Address 3 F B Nanshan Medical Equipments Park Nanhai Rd 1019 shekou Nanshan Shenzhen 518067 P R China Zip code 518067 Tel 86 755 26882220 Fax 86 755 26882223 9 12 Channel Electrocardiograph User Manual 11 EMC Information Guidance and manufacture s declaration electromagnetic emissions for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic emission The SE 1200 Electrocardiograph is intended for use in the electromagnetic environment specified below The customer or the user of the SE 1200 Electrocardiograph should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance The S
8. ds F ra A A O AE AE OS A AO see fee MX eia iu Pe po ESS EIS Nake prd 3 B ITI HER Hocede 116566 05 ring Hi El Ami A d3T 5b0 1701000 213 600 256 428 i Css om ie EROS ED Rma d modii666 86 600 aue zno dem ipsus li 6a jl eR a Et SF RES ERARE SREB ERAS CARRE A d zh E btt edel i m af z Ed m up HER Bhs Pete c 1093 74 12 Channel Electrocardiograph User Manual The above figure a b and c show the ECG record in the R R Mode Figure a shows Current Date amp Current Time Patient Information Name ID Gender Age Height Weight BP Measure Time Total R Num Total R wave number 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 The Root Mean Square Successive Difference RR Histogram RR Trend Chart Figure b shows Current Date amp Current Time Patient Information Name ID Gender Age Height Weight BP Gain Speed Filter IL ImV calibration mark II Lead name 180s ECG wave of Lead II Figure c shows All the RR values within the measure time 75 A nan passum un uai gm ae Ww3 7a 12 8 06 2008 09 a er er ses peteht opp tree dell a a a weds wari r ma om a
9. e a u b 1 re e eee of 1 Cm m mw mo m ee ee ON NON m ms bars 1 5 1 IT dd 1 1 i a i D hu EE x po I I i prt y d 1 hos ess 1 y T a a 1 J ef T E radar 21 3242 EEEE b b 73 12 Channel Electrocardiograph User Manual E T ERG ST Caper eel je geom UE RACE aur NE SEPETI EH EEN HER EEH HES ME EN BTE HATET HEH EEH HEH EIH HEH HIT Eu A HE CER DHES 57M gu pps ERDE N etsium nobiliter pm zd E DELI LIE ELE ERES ie ad 2 ESI NN TRER Cnet ERA e 4 mb AER EA AA 3000 BGO 0 DE EA O 55 A A Pe We A BEA Era eae HEB e o Set FER A Pas MERI TERI LELET ILE a bid RE in HE rsa Hell units T eT et pp i it pep EEEXS 0000 HE isses d i nen 6 hose 21429 010 raa sen Toskana qe T RE A E doloso Bc 300 178 01990 20 428 2641429 LN Le z ul sent FE zs sal ae RE leise jefa Tio ds a 00 181 1006 204 425 2671429 1 Weise Jede E n LEE M SERT 1S des 5 lt H RIE era rra fama A TETETITI vinim evene A air pa cu Lota eri paa AND MAA rara Jr M n m o eee A A O AA PA 5 A PA A ee b e dla ET Eos e a do E eo us IT z E AS a gn AA ASA RA AA A AAA A AA Se eee e ee SO i a eae 7 e f a X e AE TA Bu PEF Em os EREE O eee BPBRPE A EA MA A BREE n LI INI O A gt ra A ee E rl nnn A t nnl a 5 d Les a aia rrr a meg A LA
10. on ncm om ew cm cm ce na o m ee mma mmn EE BLA ls be gt e oa men narra n Lh k Wap ss are tied Pa id mime m m a me nu EE Brian n oe ga p wd zur bl vara bd LNI bad as he as ia ARI ns Br pas mi m dial wm e em cs ed o 3 49 mma ll cb Ler n uu mo TUR 33 12 Channel Electrocardiograph User Manual T5cn m tal i 115 57d nV 52 m d ght uz mo mo iD 1 54 28 39 a 09570 M 193 on 0 g ET 1 D E E 8 8 1 E 3 De 1 1 tal nnig E dus thm ah 76 5 15 ECG Report Tom Ti T r BR Age Wei Race 204R 25 years ght amp 5 kg Hei F Dur dnt PR IC dnt q P QRS T RvS SV1 ST ZA RVS SVl amp AV S 2 amp Minnesota Code J i EInfnrmati WS 1 egnasis t rum Rhy ree EDO Si 300 tHo Report Keviened sy 12 Channel Electrocardiograph User Manual As figure above shows ECG Report printed by USB printer includes ID Paper speed Gain Date and time Name BP Age Gender Weight Height Race Medications Ward No Technician Heart Rate P duration PR interval QRS duration QT QTC interval P QRS T axis RV5 SV1 amplitude RV5 SV1 amplitude RV6 SV2 amplitude Minnesota code Diagnosis information Report Confirmed by DFT Filter Lowpass Filter AC Filter ECG waveform of 12 leads 5 16 Switch Off When built i
11. to select Rhythm mode and set Rhythm Style 3 Enter Lead Setup interface to select rhythm leads 4 After finishing setting parameters exit the System Setup Window 5 Press START STOP key and the sampling time will be counted When the sampling time reaches 60s in Single Lead Style or 20s in Three Lead Style it begins to record 6 It will stop automatically after a full rhythm lead ECG waveform is recorded Pressing START STOP again during the course of recording can stop sampling or recording 5 7 R R mode In the R R mode users can select a lead to record its R R Histogram R R Trend Chart 180s ECG waveform and all the R R values Operation Method 1 Input patient information before recording 2 Enter Work Mode Setup interface to select R R mode 3 Enter Lead Setup interface to select a lead in the field of Rhythm Lead 1 4 Enter Recording Information Setup interface to select the style of R R Analysis Report 5 6 NN After finish setting parameters exit the System Setup Window NN Press START STOP key to begin to count the sampling time When the Sampling Time reaches 180s 1t begins to record ia 12 Channel Electrocardiograph User Manual 7 It will stop automatically after a full R R analysis is recorded Pressing START STOP again during the course of recording can stop recording Note In the R R mode users can not set the speed The constant speed is 25mm s That s because when recording in t
12. users do not set Transmission Mode before transmitting dialog box a will pop up to remind users to select If users do not connect cable well or do not set the SMARTECG VIEWER software well before transmitting dialog box b c will pop up to remind users to connect or set again _58 12 Channel Electrocardiograph User Manual HINT Please select Transmission Mode first HINT Please Check Net Connection and Po Software HINT Please Check Cable Connection and FC Software HINT All cases have been transferred d To transmit all cases in the File Manage Window users can press Trans All function key to implement this operation After all cases are transmitted dialog box d will pop up If users do not set Transmission Mode or connect cable well or set the SMARTECG VIEWER software well before transmitting dialog box a b c will pop up to remind users to set or connect again A WARNING It is forbidden to insert or pull out U disk or USB printer in the course of transmitting 3 To USB AII to USB Firstly the user should insert the U disk recommended by EDAN to the USB Socket 2 of electrocardiograph Select a patient case and press To USB function key to copy this case into the ECGDATA folder of the U disk automatically If U disk is not connected well the information U disk is not ready will be displayed on the LCD screen of electrocardiograph then the user should connect
13. waves are recorded in the same paper When Record Mode is set as Quickly Mode pressing START STOP key on the Main Screen interface to begin recording the patient information and the ECG waves are recorded in two papers Note In the Auto Mode Quickly Mode is available when Sample Mode is set as Real time Sample Note When Record Style is set as 3x4 3x4 1rhy or 3x4 3rhy only Save Paper Mode is available When Record Style is set as 12x1 only Quickly Mode is available 44 12 Channel Electrocardiograph User Manual 4 Periodic Sample The Interval and Total Time can set for Periodic Sample in the AUTO mode Note please refer to Chapter 5 9 1 to see the Periodic Sample in Work Mode Setup 5 10 24s Sample Users can set the time of sampling printing from 10 to 24 seconds or disable this function When the Sample recording function is selected in the Auto Mode pressing START STOP key on the Main Screen interface the ECG waves are recorded according to the current setting Note Users should select the function on the Advanced Setup interface 5 9 3 3 Record Info Setup Record Into Setup Record CtrljRecord Info Auto RecIntfo Gi Template Position Marker Measure Analysis Minnesota Code K R Analyse I R R Histogram I R R Waveform MR Interval List Ck Press Fl or lt F2 gt to switch Page 1 Auto Record Info Auto Record Info includes Patient Info Position Marker Analysis Template Measure and M
14. 00 7 060 mmHg Medications digitalis Medical Technician i cl Wang Wu e Press Tab key to move the cursor to Name e Press Delete key to delete old information e Press the letter keys or number keys on the keyboard to input patient name and press Enter key to confirm In the File Manage Window the general operations of selecting ECG files setting parameters and inputting characters are the same as the content described above 32 12 Channel Electrocardiograph User Manual 5 3 Freeze Users can freeze the ECG wave displaying on the main screen Operation Method 1 Press the corresponding Function Key of Freeze on the keyboard hereinafter called Freeze function key to freeze ECG wave Sin a Aiuto m 60 15 52 55 E au E cm ina E a B G Y pe LIEN t PL ee XD IE i 2 On the Freeze interface Press 3x4 1rhy function key can set the style of recording 3 Press Review function key to review the ECG wave which has been frozen 333 12 Channel Electrocardiograph User Manual Rew lew ees EE l A Y h A A d LA ees Oe l mm ako l XR D Li o r A ee o A ee 6r v r gt HA A AR AAA AAA AA l I pere a hes ha i E ok i It L ped ia A i A exl Page 4 Press Pre Page Next Page function key to turn the pages 5 Press Pre Sec Next Sec function key to view the ECG wave of pre second
15. 01 06 2005 WHE SEE Th 435 Name Tani Hk oi TPM Dingnasis faformation a 3600 Pur os ona 200 Sins Rhythm Age Ae ES Gender Male PR int i ITI ro Normal EC Heighi 75 cwm Weight DOES Eg ORS Dur 835 ms L ir 12064 mante Kare Unke MATA ina gt 384 841 firi PAFRE T mula c SWS 7 Minnaala Une ibd iai y lak TAT mt wus ice m t ER REVESTI zd p TT PUES my Kcperi Mid ipu hy r i i bunn M E EE Es rt A Wied a ol Lem EEMS BARRYN TF i i ET d Fl i ue E 1 pps d i i mag EX BS GE E a P A NA E LEA HE E il Ala Ela lA Lon B F H 1 E io ur E i H Ll ER Ce bilidad RUN 4 Ae Ei EET NY Hale TET 3T oF Y fa HT HP Im RE fi ux 7 1 il pU e pe HA o E ls ies m e rt Be ger 1 i r i f j SEU AA A A bu NAME Fike Se ir j HA cal cal 4 al BAN a S Er al a A E A A Er FEE i PEM O PF E AAA BEER eed EA PEE PRE be ae m do i i Ay zo med Li A ee e d e s 159 lll 5s P Er Lm y E Les FT o Saw a pns HE Ed a AA rui iE Ed sl bL Haat ald ME AR UM al alice As HER A La eel Lar pta LL rt UIST ACTO nms mim Xhy5actdrhfhm SH EXPRESS V1 7 The above figure shows the ECG record in the Auto Mode The Auto Style is 6x24 Irhy The ECG record includes Patient Information Measure Information Diagnosis Information Minnesota Code Report Reviewed By Current Date and Current Time 6x2
16. 10 characters Including Demo Display Modu Error Overload Lead Off When the leads are off they will be shown in black words on yellow background in the SE 1200 Express while in the SE 1200 they will be shown in black words on white background Information Including No Paper Paper Error Battery Weak Hint Sampling Analyzing Recording Doing Information 2 Learning Transmitting Transmit Fail Detecting Memory Full U Disk USB Printer Lead Off Work Mode Manual Auto Rhythm or R R Actual Heart Rate Refer to Chapter 5 9 10 Battery Symbol Identify the current capacity of the rechargeable battery Enter File Manage Window Refer to Chapter 5 10 EMG Filter 25Hz 35Hz or 45 Hz Lowpass Filter 75Hz 100Hz or 150Hz Note This setup can t be saved if it is modified on the Main Screen Gain 2 5 mm mV 5 mm mV 10 mm mV 20 mm mV 10 5 mm mV or AGC 10mm mV M Note This setup can t be saved if it is modified on the Main Screen M Paper Speed 5 mm s 6 25 mm s 10 mm s 12 5 mm s 25 mm s or 50mm s 25mm s oh ed B Note This setup can t be saved if it is modified on the Main Screen Freeze ECG waveform Refer to Chapter 5 3 Enter Patient Information interface Refer to Chapter 5 9 6 ECG waveform Display ECG waveform ED 12 Channel Electrocardiograph User Manual 3 1 2 Keyboard and Keys 9 5 3
17. 3 69 DJ CJ CJ P5 3 G7 j 2 5 bI ES 653 ud GJ GO 0 E 67 A EJ E E EI OJ bd 9 A Le H jejD deee memi gu I J K L M N Figure 3 5 SE 1200 SE 1200 Express Keyboard 12 Channel Electrocardiograph User Manual ana o Dew tig in OO Moving cursor On the Main Screen interface pressing the Tab key to Tab feed the recording paper to the next paper marker when Paper Marker is set as Yes or get to 2 5cm when Paper Marker is set as No pressing the Tab key again to stop feeding Used for entering special characters G e Used for entering capital letters 1t Shift Tab BackTab H Canceling operation Esc Draw the baseline to zero quickly in the case of baseline drift Power On Off Power on Power off J Selecting Work mode Manual Auto Rhythm MODE Note Only in the Work Mode Setup interface can R R mode be selected K SLEEP Used for resting and wakening electrocardiograph WAKE UP COPY Reviewing the last ECG data recorded in the Auto mode START STOP Start Stop recording N Moving cursor Up Down Left Right Arrow Keys In the Manual Mode or Rhythm Mode press Up Down to switch the lead group 14 12 Channel Electrocardiograph User Manual 3 2 Front Panel Indicator Lamps From the top down 1s A B C Figure 3 6 SE 1200 Express Front Panel Indicator Lamps From the top down 1s A B C Figure 3 7 SE 1200 Front Panel 1 Indicator Lamp A x Mains supply When
18. 5 Filter EMG Filter 25Hz 35Hz 45Hz OFF LOWPASS Filter 150Hz 100Hz 75Hz CMRR gt 115dB Sampling Frequency 1000Hz Patient Leakage Current lt 1OHA 220V 240V Patient Auxiliary Current lt 0 IuUA DC Dielectric Strength 4000V rms External gt 100k Q Sensitivity 10mm V 5 I t Input Output M Optional Single ended lt 100 Q Sensitivity 1V mV 5 Output Single ended 81 12 Channel Electrocardiograph User Manual 8 Cleaning Care and Maintenance 8 1 Cleaning CAUTION D 8 1 8 1 8 1 Turn off the power before cleaning and disinfection Mains supply must be switch off if it is in use 1 Cleaning the Main Unit and Patient Cable The surfaces of the main unit and patient cable can be wiped with a clean soft cloth damped in soapy water or non caustic neutral detergent After that remove detergent remainder with a clean dry cloth 2 Clean the Electrodes Remove the remainder gel from the electrodes with a clean soft cloth first Take the suction bulb and the metal cup of chest electrodes apart and take the clamp and the metal part of the limb electrodes apart Clean them in warm water and be sure there is no remainder gel Dry the electrodes with a clean dry cloth or air dry naturally 3 Clean the Print Head Dirty and soiled thermal print head will deteriorate the record definition So it should be cleaned at least once a month regularly Open the recorder casing and re
19. COSSOTrlOS ooocccccnconcnncnncnnoncnncnncnncnno nono non a a me nennen 90 IV 11 EMC Information 12 Channel Electrocardiograph User Manual 1 Safety Guidance In order to use the electrocardiograph safely and effectively avoiding possible dangers caused by improper operations please read through the user manual and be sure to be familiar with all functions of the equipment and proper operation procedures before use Please pay more attention to the following warning and caution information 1 1 Safety Warnings NWARNINGA 1 The electrocardiograph is provided for the use of qualified physicians or personnel professionally trained and they should be familiar with the contents of this user manual before operation Only qualified service engineers can install this equipment and only service engineers authorized by EDAN can open the shell The results given by the equipment should be examined with respect to the overall clinical condition of the patient and it can not substitute for regular checking NWARNING 4 EXPLOSION HAZARD Do not use the electrocardiograph in the presence of flammable anesthetic mixture with oxygen or other flammable agents SHOCK HAZARD The power receptacle must be a hospital grade grounded outlet Never try to adapt the three prong plug to fit a two slot outlet If the integrity of external protective conductor in installation or arrangement is in doubt the equipment should b
20. CattonS Tec 4 1 4 Cleaning Disinfection Cautions oooccccccnccncnncncnncnnnncnnononacnonos 5 2 IntFodHUu cO oro 6 Zl FUNCION FEU Sida 7 2 2 EISUOPSSVInDOLS ritmos ltda 7 3 General Information seriada aaa 10 Be ls Cl cewek S LU ITEM 10 58 OD AAA E ee ee T eR 10 3 1 2 KOVOOard a a KOY Saa 13 312 PROMI ANON E 15 VO Ey ir eC ica saan ocean o TT 16 nn o II II 17 SA A A 20 4 Operation Preparations eere eee 22 4 1 POW ET AN GE artin esee co ak dn tenu E ed ERE S aci UE RUE 22 4 2 Loading Replacing Recording Paper sseeeeeseeseeeeeeeee 23 4 3 Patient Cable Connection eienn n a E E ORN 25 4 4 Electrode Conneccion oooccccccconcnconconconcnnonnonncnno non ncnncnncnro eese 25 4 5 Inspection before Power On sssssssssssssee III emnes 28 5 Operation InstructionS icouioresesa eua RETE KE ERU PEREMVER RES 30 S B ele Sae PIRE T T 30 52 General Operador das dolido 30 9 9 EZ uev D NIME M GA MEMMIUS R 33 BIO AIO Cae sates a sees T eae 35 So Manual MOJO ii UT T TM 36 A oe ee ncn DN ents Cen onan ere ere 37 S TAGE IMO OC RR waa arene ETE 37 D0 CODY ak 38 Deo CUO RIP ES 38 dl WOIK Node gt UD E 38 9 929 IO el AAA A LM SM ILU DE 4 III 5 9 3 Record Information Setup oocccccccconcnconccnoncnnoncnnoncononnnncnnanos 42 5 9 4 Patient Question Setup seseriai a S 46 9 95 Tratsmisslorn oetuD uses niu
21. E 200 Electrocardiograph uses RF RF emissions energy only for its internal function CISPR 11 Therefore its RF emissions are very low Group 1 l and are not likely to cause any interference in nearby electronic equipment The SE 1200 Electrocardiograph is CISPR 11 suitable for use in all establishments Harmonic other than domestic and those directly emissions Class A connected to the public low voltage IEC 61000 3 2 EX supply network that supplies Voltage buildings used for domestic purposes fluctuations e Complies flicker emissions IEC 61000 3 3 o9 92 12 Channel Electrocardiograph User Manual Guidance and manufacture s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity The SE 1200 Electrocardiograph is The environment specified below customer or intended for use in the electromagnetic the user of SE 1200 Electrocardiograph should assure that 1t 1s used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Power frequency 50Hz magnetic field IEC61000 4 8 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 IEC 60601 test level 6 kV contact 8 kV air 2 kV for power supply lines t kV differential mode 2 kV common
22. EDAN INSTRUMENTS INC C E 0123 YavisOIpsv90 1999 q sso1dx 3 007I AS 007I AS User Manual Manual Ver V1 2 Release Date Dec 2008 Part Number MS1R 106764 V1 2 P N MS1R 106764 V1 2 Copyright Copyright EDAN INSTRUMENTS INC 2007 2008 All rights reserved Statement Edan Instruments Inc hereinafter called EDAN makes no warranty of any kind with regard to this material including but not limited to the implied warranties of merchantability and fitness for a particular purpose EDAN assumes no responsibility for any error that may appear in this document or for incidental or consequential damage in connection with the furnishing performance or use of this material No part of this document may be photocopied reproduced or translated to another language without prior written consent of EDAN All information contained in this publication is believed to be correct EDAN shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing performance or use of this material This publication may refer to information and protected by copyrights or patents and does not convey any license under the patent rights of this company nor the rights of others This company does not assume any liability arising out of any infringements of patents or other rights of third parties The information contained in this document is subject to change without notice Respon
23. Lal cin I SH I U SERE F p remm ESE EE 0 15 100Hz ACE l5manis I manim SHALE KXPMESE VI The figure above shows the ECG record in the Rhythm Mode and the Rhythm Style is Three Lead ID 2690 Patient ID 08 06 2005 08 38 37 Current Date amp Current Time 00 00 00 10 Timer 60 Heart Rate JL 1mV calibration mark II V1 V5 Rhythm Lead name 20 seconds rhythm waveform of lead II V1 V5 0 15 100Hz 0 15Hz DFT Filter 100Hz Lowpass Filter AC50 50Hz AC Filter 25mm s Paper Speed 10mm mV Gain SE 1200 Express Electrocardiograph Model V1 7 Version number 70 12 Channel Electrocardiograph User Manual 5 13 MANUAL Mode Record A A 200 Age 25 venti I j i Eramaa ubt eL hen vf E EA epa 1 E aH Ella ede ens tee Hall AL P TE LACE I AL A ie mi Hiedra spe M Ali GL koc EE ol deL LA a A Baz i ise M sra AH ae io re oe EH oF aa se ii vn up op Fs ay n sate i i bint nal 541 EH SH iE Kee HB EBE 1 urb i E REB i i HI i 4 iB 3 i i AAA AAA PE MEA T moe aora r Hep oH ap Er T ru Tm iru FERRI E E ela zx dub de ium tA AL el j i E pa A ees ues iis a O BER EN La ry IEA JL AE id einn Ens E Es a dj A ML IE rl e I air T Ix Sd 1 Alect AB LEE BEBE EE a EL E EEE elas Ge i 016 145 ACEO J4mm time Ceo SIDE EXPEESNS V1 7 The figure above shows the ECG record in the Manual Mode and the Man
24. NING Potential equalization conductor of the unit should be connected to the potential equalization bus bar of the electrical installation when necessary 4 2 Loading Replacing Recording Paper Two kinds of paper can be used as ECG recording paper One is Rolled thermal paper another 1s folded thermal paper Note When using folded thermal paper the Paper Roller should be removed Note When using the paper of 216mm width the two movable parts should be removed Note The Exit Edge can help the user tear the recording paper CAUTION Be sure that recording paper especially rolled paper should be installed in the center of the recorder and the edge of paper should be parallel with the edge of casing in the direction of feeding paper in order to avoid paper deviation and the damage to the edge of paper When there 1s no paper loaded or it reaches the end of paper hint message Paper Empty will be given on the screen Under this circumstance recording paper 203 12 Channel Electrocardiograph User Manual should be loaded or replaced immediately CONE Movable Movable Part 1 Part 2 Paper Tray Exit Edge Edge for Casing Button tearing Paper Roller Exit Casing Loading Replacing Process for Rolled paper 1 Press the Casing Button downwards with one hand and pull the casing upwards with another hand to open the recorder 2 Take out the Paper Roller and remove remainder paper from the roller
25. Note The version number recorded on the paper is just an example The real version number can be found on the screen of electrocardiograph when you turn on the device 67 12 Channel Electrocardiograph User Manual Figure b shows Patient Information Measure Information Minnesota Code Diagnosis Information Average Template Technician Report Confirmed By Current Date and Current Time 0 15Hz DFT Filter 100Hz Lowpass Filter AC50 50Hz AC Filter 25mm s Paper Speed 10mm mV Gain SE 1200 Express Electrocardiograph Model V1 7 Version number Patient Information includes ID Name Age Gender Height Weight BP Race Ward No Measure Information includes HR Heart Rate P Dur P wave duration mean of duration of P wave from several of 12 selected dominant beats PR int P R interval mean of P R interval from several of 12 selected dominant beats QRS Dur QRS complex duration mean of duration of QRS complexes from several of 12 selected dominant beats QT QTC int Q T interval mean of Q T interval from several of 12 selected dominant beats Normalized QT interval P QRS T axis dominant direction of the average integrated ECG vectors RV5 SV amP The maximum of amplitude of R or R wave of one selected dominant beat from lead V5 The maximum of amplitude of S or S wave of one selected dominant beat from lead V1 RV5 5V1 amP Sum of RV5 and SV1 RV6 SV2 amP The maxim
26. R aes P nunmY di r E A BOw9PRESRS Vi T The above figure shows the ECG record in the Auto Mode The Auto Style is 3x4 1rhy The ECG record includes Patient Information Measure Information Diagnosis Information Minnesota Code Report Reviewed By 08 06 2005 08 30 56 Current Date and Current Time 3x4 1rhy ECG wave 0 15 100Hz 0 15Hz DFT Filter 100Hz Lowpass Filter AC50 50Hz AC Filter 25mm s Paper Speed 10mm mV Gain 4 by 2 5s 1 rhythm 12 leads are recorded in 4 groups of 3 and every group is recorded about 2 5s with one rhythm lead at the bottom simultaneously SE 1200 Express Electrocardiograph Model V1 7 Version number Note Please refer to Chapter 5 11 1 for the explanation of Patient Information Measure Information and Diagnosis Information 69 12 Channel Electrocardiograph User Manual 5 12 RHYTHM Mode Record 2S 03 35 57 49 Name Ton ID 2490 Age 12 Tears hoe See l ils BEI E SI EE AL ESSE ES e LLL LIEL LL E Sia Soa vi cH m rai ic gs Ie ete i tHE a ST a GE a e EE Y tl t i 1 H E Ee ad E I FH i if l Sa peg dl nae Pr Ey e 9 ag m AE UE EE esi ri assert bal ee esata ulus Zi It He C SRL TET EEUU aes set ae TE i a il i 3 ii AAA eines t sn E Spesa EE 1 l EM y rey ae ad ET mede eed namie e e Di ne RU e Me a E Ie B ua i ET ELSE o y 2j a MP E a E ene het tl am es Mr
27. TO o a NO Doctor Technician DTO TAR m Tren ode o m eise swa o Rime o G rmm o o aims NN NN hd Screen Colors Only for SE 1200 SUE CANICHE AEREAS 0 ion Mom COI o o CU 56 12 Channel Electrocardiograph User Manual 5 10 File File Manage LL File Manaze Hanc ID Tim Node Lu File Manage Window 51 12 Channel Electrocardiograph User Manual Press File function key on the keyboard to enter the File Manage Window In the File Manage Window patient cases can be recorded transmitted displayed searched or deleted SE 1200 can accommodate 100 patient cases SE 1200 Express can accommodate 200 patient cases If there is no patient case in the window the following dialog box will be displayed when pressing function keys HINT No Case 1s stored 1 Edit Select a patient case and press Edit function key to pop up Patient Information window Users can edit the information except patient ID and press OK to confirm Patient Information Name Zhang Sar Age 30 years Weight 170 kg BP 100 60 mmHg Medication Doctor Technician Li ol mang Wu 2 Transmission Before transmitting users should enter the Transmission Setup interface to set the Transmission Mode as Ethernet UART connect Ethernet cable UART cable and set the SMARTECG VIEWER software in PC Select a patient case and press Trans function key to begin transmitting If
28. ain of limb leads is set as l mm mV while the gain of chest leads is set as 5mm mV 6 Paper Marker The Paper Marker is used to identify the start point of each page of the paper When the paper with black markers on the bottom is used and Paper Marker is set as Yes the device can identify the start point of each page of the paper while recording When Paper Marker is set as No the device can not identify the start point of each page of the paper while recording 43 12 Channel Electrocardiograph User Manual 5 9 3 2 Record Control Setup Record Info Setup Record Ctrl Record Into Record style Record sge Periodic sample sequential Total Time leo Min pynchronous Interval lo1 Min eee Press Fl gt or lt F2 gt to switch Pase e 1 Record Style In the Auto Mode when Record Style of Recorder Ctrl is set as3x4 3x4 1rhy 3x4 3rhy 6x2 6x2 1rhy or 12x1 the ECG Report will be recorded In the Auto mode when Record Style of Recorder Ctrl is set as Off the ECG Report will not be recorded 2 Record Sequence When Record Sequence is set as Sequential the lead group is recorded one by one in a certain sequence When Record Sequence is set as Synchronous ALL leads are recorded synchronously 3 Record Mode When Record Mode is set as Save Paper Mode pressing START STOP key on the Main Screen interface to begin recording after the sampling time reaches 10s The patient information and the ECG
29. ains supply or built in rechargeable Lithium battery can be used as power With a high resolution thermal recorder a 32 bit processor and a huge capacity memorizer 12 channel electrocardiograph has advanced performance and high reliability and the compact size makes it suitable for clinic hospital and ambulance use 12 channel electrocardiograph has two models SE 1200 SE 1200 Express Configurations Main unit power cord patient cable chest electrodes limb electrodes thermal recording paper fuses and lithium battery Intended use The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with ECG electrodes The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only A WARNING This equipment is intended for use on adult and pediatric patients only ANWARNINGS This equipment is not designed for internal use or direct cardiac application A WARNINGA The results given by the equipment should be examined with respect to the overall clinical condition of the patient And it can not substitute for regular checking 12 Channel Electrocardiograph User Manual 2 1 Function Feat
30. and functional damage b Inspect the safety related labels for legibility c Inspect the fuse to verify compliance with rated current and breaking characteristics d Verify the device functions properly as described in the instructions for use e Test the protection earth resistance according to IEC EN 60601 1 Limit 0 lohm f Test the earth leakage current according to IEC EN 60601 1 Limit NC 500uA SFC 1000uA g Test the patient leakage current according to IEC EN 60601 1 Limit 10uA CF h Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC EN 60601 1 Limit 50uA CF The leakage current should never exceed the limit The data should be recorded in an equipment log If the device is not functioning properly or fails any of the above tests the device has to be repaired A WARNINGAS Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure 85 12 Channel Electrocardiograph User Manual and possible health hazards 1 Main Unit Avoid excessive temperature sunshine humidity and dirt Put on the dustproof coat after use and prevent from shaking violently when moving it to another place Prevent any liquid from seeping into the equipment for it will affect the safety and performance of electrocardiogr
31. aph 2 Patient Cable Integrity of patient cable including main cable and lead wires should be checked regularly And be sure that it is conductible Do not drag or twist the patient cable with excessive stress while using Hold the connector plugs instead of the cable when connecting or disconnecting the patient cable Align the patient cable to avoid twisting knotting or crooking in closed angle while using Store the lead wires in a bigger wheel to prevent any people from stumbling Once damage or aging of the cable patient has been found replace it with a new one immediately 3 Electrodes Electrodes must be cleansed after use and be sure there is no remainder gel on them Keep the suction bulb of chest electrode from sunshine and excessive temperature After long term use the surface of electrodes will be oxidized because of erosion and other causes By this time electrodes should be replaced to achieve high quality ECG YCAUTION The device and accessories are to be disposed of according to local regulations after their useful lives Alternatively they can be returned to the dealer or the manufacturer for recycling or proper disposal 86 12 Channel Electrocardiograph User Manual 9 Warranty and Service Policy 9 1 Warranty EDAN warrants that EDAN s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty
32. at the metal part be placed on the electrode area above the ankle or wrist Attach all limb electrodes in the same way 4 5 Inspection before Power On In order to avoid safety hazards and get good ECG records the following inspection procedure is recommended before power on and operation 1 Environment Check and make sure that there is no electromagnetic interference source around the equipment especially large medical electrical equipment such as electrosurgical equipment radiological equipment and magnetic resonance imaging equipment etc Switch off these devices when necessary Keep the examination room warm to avoid muscle action voltages in ECG signal caused by cold 2 Power Supply If mains power is used please check whether the power cord has been connected to the unit well and the grounded outlet should be used Recharge the battery first when the battery capacity is weak before use 3 Patient Cable 28 12 Channel Electrocardiograph User Manual Check whether the patient cable has been connected to the unit firmly and keep 1t far away from the power cord 4 Electrodes Check whether all electrodes have been connected to lead wires of patient cable correctly according to the identifier and color Ensure that the chest electrodes do not contacted with each other 5 Recording Paper Ensure that there is enough recording paper loaded correctly 6 Patient The pa
33. ccording to the direction of arrow on the plug and then secure it with two SCICWS 4 4 Electrode Connection Chest Electrode Suction Metal Cup Electrode 25 12 Channel Electrocardiograph User Manual Limb Electrode Electrode Reed Clamp The identifier and color code of electrodes used complies with IEC EN requirements In order to avoid incorrect connections the electrode identifier and color code are specified in Table 4 1 Moreover the equivalent code according to American requirements is given in Table 4 1 too Table 4 1 Electrodes and their identifiers and color codes Identifier Color code owes e os ows ow 8 C5 I 2 3 As the following figure shows the chest electrodes positions on body surface are Cl 2 C3 C4 ES C6 Fourth intercostals space at right border of sternum Fourth intercostals space at left border of sternum Fifth rib between C2 and C4 Fifth intercostals space on left midclavicular line Left anterior axillary line at the horizontal level of C4 Left midaxillary line at the horizontal level of C4 26 12 Channel Electrocardiograph User Manual Cl C4 C2 C6 C3 C5 The contacting resistance between the patient and the electrode will affect the quality of ECG greatly In order to get a high quality ECG the skin electrode resistance must be minimized while connecting electrodes NWARNING Be sure that all electrodes hav
34. cessory 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 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 connector or output connector to configure a medical system must make sure that it complies with the requirements of the valid version of the system 2 12 Channel Electrocardiograph User Manual standard IEC EN 60601 1 1 If in doubt consult our technical service department or your local distributor 18 The summation of leakage current should never exceed leakage current limits while several other units are used at the same time 19 The potential equalization conductor can be connected to that of other equipment when necessary to make sure that all these equipment are connected with the potential equalization bus bar of the electrical installation 1 2 Battery Care Warnings A WARNINGA 20 Improper operation may cause the battery to be hot ignited or exploded and it may lead to the declination of battery s capacity It is necessary to read the user manual carefully and pay more attention to warning messages 21 Only qualified service engineer authorized by EDAN can open the battery compartment and replace the battery and the battery of
35. d pressing Cancel function key can cancel recording 35 12 Channel Electrocardiograph User Manual harn fin EA Ene Preview Window Pressing START STOP again during the course of recording can stop recording Note Whether in the auto rhythm R R or manual mode Work Mode can not be changed during the course of recording Stop recording before choosing Work Mode 5 5 Manual Mode In the Manual mode users can determine which lead group needs to be recorded and set the parameters according to different lead group Operation Method 1 Input patient information before recording 2 Enter Work Mode Setup interface to select Manual mode and set Manual Style 3 Enter Lead Setup interface to set Lead Sequence 4 After finishing setting parameters exit the System Setup Window 5 Press UP or DOWN key to select the lead group to be recorded 6 Press START STOP key to begin recording 7 Press START STOP key to stop recording after ECG is recorded UP or DOWN key can be pressed to switch the lead group during the course of 36 12 Channel Electrocardiograph User Manual recording Pressing START STOP again during the course of recording can stop recording 5 6 Rhythm mode In the Rhythm mode users can record 60s rhythm lead ECG waveform in Single Lead Style or 20s rhythm lead ECG waveform in Three Lead Style Operation Method 1 Input patient information before recording 2 Enter Work Mode Setup interface
36. e 5 C Gnpu 10 L npu IS Nor RF Gnput 2 Serial port 1 A WARNINGA serial port 1 is 1500V AC isolated intensity and the maximum voltage applied should not exceed 15V DC Definition of corresponding pins Pin Signal Pin Signal Pin Signal 1 Nc fa NC 7 neo 2 RxD npu onp s DV 3 Dow 6 NC 9 nec 3 Serial port 2 6 8 2 7 1 5 3 4 18 12 Channel Electrocardiograph User Manual Definition of corresponding pins EN 7 a oo o owy 5 USB Socket 1 USB Socket 2 Optional ANWARNING Only the USB equipment recommended by EDAN can be connected to the USB interface 19 12 Channel Electrocardiograph User Manual NWARNINGA 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 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 valid version of the system standard IEC EN 60601 1 1 If in doubt consult our technical service department or your local distributor The summation of leakage current should never exceed leakage curr
37. e and five function keys Waveform Template Measure Diagnosis Record and Return In the File Preview Window pressing Record function key can begin recording this case pressing Return function key can return to the File Manage Window Note Rhythm data can not be previewed 60 12 Channel Electrocardiograph User Manual lado tend AES B E 1 I LC lcs A aua mt oc xr e A E I EI n Eo a aee mE I EI I EMT NEP MEN l ey ee MEN M PE File Preview Window If users need to view the average template of the selected case press Template function key to enter the File Template Window as the following figure shows Se LUITI File Template Window 61 12 Channel Electrocardiograph User Manual If users need to view the Measure information of the selected case press Measure function key to enter the File Measure Window as the following figure shows E O A ee eet clum File Measure Window If users need to view the Diagnosis information of the selected case press Diagnosis function key to enter the File Diagnosis Window as the following figure shows Naesnocia Iriormztior Suu Eine EEvtbrm f ormel Edip Ware room BESA aeui File Diagnosis Window 62 12 Channel Electrocardiograph User Manual The File Measure Window shows Patient Name Patient ID Heart Rate P Duration PR interval QRS Duration QT QTC interval P QRS T axis RV5 SV1 amplitude
38. e been connected to the patient correctly before operation WARNING Ensure that the conductive parts of electrodes and associated connectors including neutral electrode do not come in contact with earth or any other conducting objects Chest electrode connection 1 2 3 4 5 6 Ensure that the electrodes are clean Align all lead wires of patient cable to avoid twisting and connect the associated electrode connectors to corresponding electrodes according to the color and identifier Clean electrode area on chest surface with alcohol Daub the round area of 25mm in diameter on each electrode site with gel evenly Place a small mount of gel on the brim of chest electrode s metal cup Place the electrode on chest electrode site and squeeze the suction bulb Unclench it and then the electrode is adsorbed on chest Attach all chest electrodes in the same way Limb electrode connection 1 Ensure that the electrodes are clean 27 12 Channel Electrocardiograph User Manual 2 Align lead wires of patient cable to avoid twisting and connect the electrode connectors to corresponding electrodes according to the color and identifier 3 Clean electrode areas on a short distance above the ankle or wrist with alcohol 4 Daub the electrode areas on limbs with gel evenly 5 Place a small amount of gel on the metal part of limb electrode clamp 6 Connect the electrode to limb and be sure th
39. e operated by using a built in rechargeable battery Do not use this equipment in the presence of high static electricity or high voltage equipment which may generate sparks 12 Channel Electrocardiograph User Manual 8 This equipment is not designed for internal use and direct cardiac application ANWARNING 9 Only patient cable and other accessories supplied by EDAN can be used Or else the performance and electric shock protection can not be guaranteed 10 Be sure that all electrodes have been connected to the patient correctly before operation 11 Ensure that the conductive parts of electrodes and associated connectors including neutral electrode do not come in contact with earth or any other conducting objects 12 Electrodes with defibrillator protection should be used while defibrillating 13 Always use electrode gel with reusable electrodes during defibrillation as ECG recovery will take longer than 10 seconds EDAN recommends the use of disposable electrodes at all times 14 There is no danger for patients to use pacemaker However if a pacemaker is used the results given by the equipment may be invalid or lose the clinical significance 15 Do not touch the patient bed table or equipment while using the ECG together with a defibrillator or a pacemaker 16 In order to avoid being burnt please keep the electrode far away from the radio knife while using electrosurgical equipment simultaneously A WARNINGA 17 Ac
40. e user should connect the USB printer recommended by EDAN to the USB Socket 2 of electrocardiograph with specialized cable Note please refer to Chapter 5 15 to see the ECG Report printed by USB printer Note USB printing works only in AUTO Pre Sample mode AUTO Real time sample mode Copy Freeze Review and File Manage Window Note Make sure that paper has been installed in USB printer before printing Paper Empty may results in error Note The USB printer can not be cancelled by Start Stop key A WARNING It is forbidden to frequently insert and pull out U disk or USB printer 2 Paper Length Users can set the length of one page of folded paper 140mm or 295mm is available 42 12 Channel Electrocardiograph User Manual 3 Paper Width Users can set the width of paper 210mm or 216mm is available When the paper of 216mm width is used the two movable parts in the Paper Tray and Casing of the recorder should be removed 4 Speed Users can set the paper speed as 5 6 25 10 12 5 25 or 50mm s In the AUTO mode and Rhythm mode only 25mm s and 50mm s are available In the R R mode only 25mm s is available 5 Gain Users can set the indicated length of ImV ECG on the paper Users can set Gain as 10mm mV 20mm mV 10 5mm mV AGC 2 5mm mV or 5mm mV AGC means auto gain control When ECG signal varies greatly AGC can be selected to adjust the gain automatically according to actual signal 10 5mm mV means the g
41. ed while recording ECG In the Rhythm mode when Rhythm Style is set as Single Lead 60s waveform of the rhythm lead selected in Rhythm Lead 1 will be recorded while recording ECG when Rhythm Style is set as Three Lead 20s waveform of every rhythm lead selected in Rhythm Lead 1 and Rhythm Lead 2 and Rhythm Lead 3 will be recorded while recording ECG 2 Lead Sequence Standard Cabrera Lead Lead group 1 Lead group 2 Lead group 3 Lead group 4 Sequence Standard I II W aVR aVL aVF V1 V2 V3 V4 V5 V6 aVL I aVR II aVF Il V1 V2 V3 V4 V5 V6 5 9 8 Display Setup Display Setup 1 Brightness The brightness of LCD screen Users can set the brightness within 0 20 5 12 Channel Electrocardiograph User Manual 2 Screen Colors only for SE 1200 Express Screen The colors of LCD screen Users can set the screen colors as Monochrome Optionl or Option 2 3 Antialiasing When Antialiasing is set as On system will automatically make waveform smooth When Antialiasing is set as Off system will not make waveform smooth 5 9 9 Sound Setup pound Setup Key Volume 1 Key Volume When users press keys on the keyboard electrocardiograph gives a short beep sound which is called Key Beep Users can set the Key Volume as Small Medium Big or off When set as off there is no sound while pressing keys 2 QRS Volume During the course of ECG displaying in main screen or ECG recording e
42. ee pexu aio 48 9 9 5 Patient INFORMALION uode cr beoe e da eb dau VR ced 49 9 9 47 Legis elus pipe aem Ia te ders dote E ir 50 9 9 9 DISPLAYS UD E SUMENDA UI EU ud 51 8 99 SOWING gt DOS 52 5 9 10 Dates MMe Setra HIS EHE E NE CE ee RR E EE ENS 53 A A EE 54 A e En e rs Merete Ec 57 ST AUTO Mode RECO sanar didas 64 911 1 EXample or 5X2 HET aaa 64 STZ Example OF 9 4 TE DV eseoiiteteunt lala 69 5 12 AMY THM Mode Record adt id 70 5 135 MANUAL Mode Recortar si n 71 S414 HH MOde HeCOEQ eo eed A eos 72 es Gt RODO T E TT TM 76 su ees IS E EE 77 5 HINEIN OrMaliO Nissan ds 78 7 Technical SpeciTICatlOons ono 79 8 Cleaning Care and Maintenance 82 ome MM 82 8 1 1 Cleaning the Main Unit and Patient Cable 82 9 12 Clean the Electrodes e SEL ELO es 82 8 19 Clean the Prnt FIe3g uoc rer tT Reese ditas 82 A DISIDIOGLHOP A A O OPC Ri ras terce ducts A eue bI EE 83 8 9 Care and Malntehallee s eet erred tatt d ute tbt Reip Aere inest EA 83 8 3 1 Recharge and Replacement of Battery suususse 83 3 02 Recording apet minos idilio a ii 84 8 3 3 Maintenance of Main Unit Patient Cable amp Electrodes 85 9 Warranty and Service Policy 87 OM Eg ACY AN US 87 A A nse a eee ess eae eect 87 10 ACCOSSOTIGBS wsacetedeccicteiecacanctiewtastsatecteatstebewionnenenrs 89 10 1 Sta aara ACCeSSOfIG nada 89 10 2 Optional C
43. elected the system will not automatically turn into the Next patient interface 4 H W Unit BP Unit User Defined Not performed _47 12 Channel Electrocardiograph User Manual 5 ID Mode Users can set the ID Mode as Auto time or manual When ID Generate Mode is set as Auto patient ID can be automatically generated Patient ID range 0 1999 999 999 When ID Generate Mode is set as time patient ID can be automatically generated according to the system time When ID Generate Mode is set as manual patient ID can be manually inputted in patient information Only input ASCII code Note When the patient ID 1s generated by system time 1t can not be displayed on the Main Screen 6 Prompt When Prompt is set as Unconfirmed Unconfirmed Report is recorded in the ECG Report When Prompt is set as Reviewed by Report Reviewed by is recorded in the ECG Report 5 9 5 Transmission Setup Transmission setup Transmission Mode Remote IP Local IF oubnet Mask Gateway m Note To transfer ECG data to PC SMARTECG VIEWER software of EDAN must be installed in PC Receive ECG Data window in the software should be opened up and transfer type should be selected 48 12 Channel Electrocardiograph User Manual 1 Transmission Mode When Transmission Mode is set as off ECG data can not be transferred When Transmission Mode is set as Ethernet firstly connect the net port of electrocardiograph and the
44. ent limits while several other units are used at the same time 3 5 Bottom Panel D C 1 D e EES Au e aaa E C T E B A Figure 3 10 SE 1200 SE 1200 Express Bottom Panel Speaker Hole Path for sound from speaker OBO Battery Compartment Compartment for Lithium battery The specification is AC100V 240V TIA use 05x20 20 12 Channel Electrocardiograph User Manual EM Heat Emission Hole Path for internal heat emission Position for product information label 1 Battery Compartment The rated voltage and rated capacity of rechargeable Lithium battery pack are SE 1200 Express Rated Voltage 14 8V Rated Capacity 4000mAh 4400mAh SE 1200 Rated Voltage 14 8V Rated Capacity 2000mAh 2200mAh 2400mAh A WARNINGA Improper operation may cause the battery to be hot ignited or exploded and it may lead to the decrease of battery s capacity Therefore it is necessary to read the user manual carefully and pay more attention to warning messages A WARNINGA When leakage or foul smell found stop using the battery immediately If the leakage liquid gets to your skin or cloth cleanse it with clean water at once If the leakage liquid gets into your eyes do not wipe them Irrigate them with clean water first and go to see a doctor immediately A WARNINGA Only qualified service engineer authorized by EDAN can open the battery compartment and replace the battery And the battery of same m
45. he R R mode the ECG wave is compressed to one fifth of the original wave length and then 25mm s is equal to 5mm s 5 8 Copy Pressing COPY key can recall the ECG data that was recorded last time During the course of recording pressing START STOP again can stop recording Note After return to the main interface from any other interfaces the user should not immediately press START STOP key to record in the AUTO mode or MANUAL mode within three seconds Otherwise the recorder will not respond 5 9 Setup 5 9 1 Work Mode Setup On the Work Mode Setup interface users can set up Work Mode Manual Style Rhythm Style Auto Display Style Sampling Mode and Preview Work Mode Setup Work Mode Auto Dispst oampling Mode 1 Work Mode 38 12 Channel Electrocardiograph User Manual Manual In the Manual mode users can determine which lead group needs to be recorded and set the parameters according to different lead group Auto In the Auto mode the lead groups are switched automatically according to different lead sequence while recording When ECG signal of one lead group has been recorded within a certain time 1t will be switched to another lead group automatically and begins to record the ECG signal of that lead group Rhythm In the Rhythm mode users can select rhythm leads to record 60s or 20s rhythm wave R R In the R R mode users can select a lead to record its R R Histogram R R Trend Chart 180
46. he examining process of arrhythmia data in the Trigger Sample mode Memory Full The amount of patient cases in the File Manage Window of SE 1200 exceeds 100 The amount of patient cases in the File Manage Window of SE 1200 Express exceeds 200 There 1s something wrong with the signal sample module Demo Display The system is in demonstration mode The direct current offset voltage on an electrode is too high A U disk is connected to the USB interface USB Printer A USB printer is connected to the USB interface _78 12 Channel Electrocardiograph User Manual 7 Technical Specifications Safety Standards Classification Power Supply IEC 60601 1 1988 A1 A2 EN 60601 1 1990 A1 A2 IEC EN60601 1 2 2001 A1 IEC EN60601 2 25 ANSI AAMI EC 11 Class I with internal power Anti electric shock type supply Anti electric shock degree Ordinary equipment Sealed equipment without liquid proof Degree of protection against harmful ingress of water Disinfection sterilization method Refer to the user manual for details Equipment not suitable for use Degree of safety of application in in the presence of flammable the presence of flammable gas gas Working mode Continuous operation Group I type A E 420mmx330mm 120mm 5 0kg without recording paper and battery 320 X 240 dot single color LCD Screen 800 X 600 multicolor LCD Screen Relative 25 93 25 80 Humidity non condensing non conde
47. he time of LCD off When LCD is off pressing any key on the keyboard can wake up LCD again When the LCD Off is set as 000 Minutes this function will not be effective Note LCD Off is counted from the time of last pressing the keys on the keyboard 5 9 11 More Setup Pile Format DAT Institution Sheng nen Hospital Save Option Default Ort Yes 1 Language Users can set language as any one contained in the software 2 Save Option When Save Option is set as On ECG data recorded in the Auto mode or Rhythm mode will be saved into the flash memory of the device automatically When Save Option is set as Off ECG data recorded will not be saved into the flash memory of the device 3 Institution Users can input institution name Within 20 characters 54 12 Channel Electrocardiograph User Manual 4 Extern Input Extern output Extern input output socket is equipped in electrocardiograph through which electrocardiograph can receive signal from external equipment or send signal to other external equipment Set this item as On to turn on the function and Off to turn off Note When Extern Input is set as On the Touch Screen will become ineffective and then the user should operate the device with keys on the keyboard 5 File Format Not performed 6 Default OT o sw O CN 6 ome 0 ow O O a o NT OG CHE HN 55 12 Channel Electrocardiograph User Manual a a TI
48. higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths 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 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 S E 200 Electrocardiograph is used exceeds the applicable RF compliance level above the SE 200 Electrocardiograph should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the SE 1200 Electrocardiograph Over the frequency range 150 kHz to 80 MHz field strengths should be less than 1 V m 05 12 Channel Electrocardiograph User Manual Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT or SYSTEM that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the SE 1200 Electrocardiograph The SE 1200 Electrocardiograph is intended for use in an electromagnetic environment in which radiated RF distu
49. ian When Gender Height Weight BP Race Medication Ward NO Doctor or Technician is selected the item will display on patient information interface When Gender Height Weight BP Race Medication Ward NO Doctor or Technician is not selected the item will not display on patient information interface 2 ID Hint In the Auto mode and the rhythm mode when ID Generate Mode is set as manual 46 12 Channel Electrocardiograph User Manual press the START STOP key if users have not input patient ID before operating the Hint Information will pop up to remind users to input patient ID 3 Next Patient In the Auto mode when the Next Patient is selected Press START STOP key the system will automatically turn into the Next Patient interface after a full ECG wave 1s recorded On the Next Patient interface pressing Same Patient function key can return to the Main Screen all the patient information will keep the same pressing Next Patient function key can return to the Main Screen all the patient information will be cleared except for gender pressing F3 function key can switch the Auto Record Style pressing F4 function key can switch the paper speed and pressing the F5 can switch the Gain On the Next Patient interface users can print the current ECG Report again according to the Auto Style speed and Gain settings fae a Auto deb al y 1 35 eee ES Sampling M UU In the Auto mode when Next patient is not s
50. if necessary 3 Take off the wrapper of paper roll and then put through the roller with the paper s grid side facing downward 4 Place the paper and roller gently in the recorder with the roller pin facing to the groove 5 Pull about 2cm of paper out from the Exit and put down the recorder casing 6 Secure the casing by pressing it firmly Loading Replacing Process for Folded paper 1 Press the Casing Button downwards with one hand and pull the casing upwards with another hand to open the recorder 2 Remove remainder paper in the Paper Tray if necessary 3 Take off the wrapper of folded paper and then put it in the Paper Tray with the paper s grid side facing right while putting the free end of paper upright 24 12 Channel Electrocardiograph User Manual 4 Pull about 2cm of paper out from the Exit and put down the recorder casing 5 Secure the casing by pressing it firmly 4 3 Patient Cable Connection A WARNINGA The performance and electric shock protection can be guaranteed only if original EDAN patient cable and electrodes are used Patient cable includes two parts main cable and lead wires with associated connectors which can be distinguished from the color and identifier on the connectors Main Cable Lead Wire Screw i Electrode Connectors j Connector Connecting Main Cable Plug the connector of main cable into the patient cable socket on the right side of the unit a
51. ill be recorded while recording When Sampling Mode is set as Real time Sample 10s ECG data sampled from the time of pressing START STOP key will be recorded while recording When Sampling Mode is set as Trigger Sample after pressing START STOP key if Arrhythmia ECG data including Asystole Ventricular Fibrillation Ventricular Tachycardia 5 gt PVCS gt 3 Paired PVCS Bigeminy Trigeminy R ON T single PVC and Missed Beat are detected during the course of sampling recording will be triggered automatically When Sampling Mode is set as Periodic Sample first users should set Total Time and Interval on the Record Control Setup interface of the Record Info setup For example if Interval is set to 2 minutes the Total Time set to 24 minutes by Pressing START STOP key it will record every 2 minutes and totally 12 times Note No saving copying or transmitting in the Period Sample Mode Note Patient information will not be changed while carrying out the period recording Note Total Time must be greater than Interval or else the setting will not be effective 6 Preview When Preview is set as on users can preview the ECG wave to be recorded When Preview is set as off users can not preview the ECG wave to be recorded 40 12 Channel Electrocardiograph User Manual 5 9 2 Filter Setup PEE Setup AO Filter DFT Filter DI EMG Filter Off 1 AC Filter AC Filter suppresses AC interference without attenua
52. information can not be set or changed during the course of recording Name Patient Name SE 1200 Within 12 characters SE 1200 Express Within 20 characters ID Patient ID Within 10 characters Range 0 1999999999 For detail information please refer to Chapter 5 9 4 Age Patient Age Range 1 255 Gender Patient Gender Male Female Empty Weight kg Patient Weight Range 0 999 Height cm Patient Height Range 0 999 BP mmHg Patient Systolic Blood Pressure Diastolic Blood Pressure Race Patient Race unknown Oriental Caucasian Black Indian Mongolian Hispanic Asian Pacific other Medications The medication which patient took previously Within 20 characters Ward No Ward Number Within 10 characters Medical Medical Name Within 20 characters Technician Technician Name Within 20 characters Note Please refer to Chapter 5 2 for the method of inputting words on Patient Information interface 5 9 7 Lead Setup Rhythm Leads 50 12 Channel Electrocardiograph User Manual 1 Rhythm Lead 1 Rhythm Lead 2 Rhythm Lead 3 The rhythm lead can be one of 12 standard leads I II I a VR aVL aVF V1 V2 V3 V4 V5 or V6 In the Auto mode when Auto Style is set as 3x4 1rhy or 6x2 1rhy the rhythm lead selected in Rhythm Lead 1 will be recorded while recording ECG when Auto Style is set as 3x4 3rhy 3 rhythm leads selected in Rhythm Lead 1 and Rhythm Lead 2 and Rhythm Lead 3 will be record
53. ing as the original 32 The device and accessories are to be disposed of according to local regulations after their useful lives Alternatively they can be returned to the dealer or the manufacturer for recycling or proper disposal 33 his electrocardiograph can not be directly applied to the heart 34 Federal U S law restricts this device to sale by or on the order of a physician 1 4 Cleaning amp Disinfection Cautions CAUTION D 35 Turn off the power before cleaning and disinfection If mains supply used the power cord should be drugged out of the outlet also And prevent the detergent from seeping into the equipment 36 Do not immerse the unit or patient cable into liquid under any circumstances 3 Do not clean the unit and accessories with abrasive fabric and avoid scratching the electrodes 38 Any remainder of detergent should be removed from the unit and patient cable after cleaning 39 Do not use chloric disinfectant such as chloride and sodium hypochlorite etc 12 Channel Electrocardiograph User Manual 2 Introduction 12 channel electrocardiograph gathers 12 leads simultaneously and carries out visual display of operation menu ECG parameters as well as electrocardiogram 12 channel waves can be viewed on the LCD liquid crystal display screen simultaneously and 1t can be recorded by high quality thermal recorder Manual auto rhythm or R R work mode can be chosen conveniently Either m
54. innesota Code When Patient Info Position Marker Analysis Template Measure or Minnesota Code is selected it will be recorded while recording When Patient Info Position Marker Analysis Template Measure or Minnesota Code is not selected it will not be recorded while recording 2 R R Analysis R R Analysis includes R R Histogram R R Waveform and R R Interval List When R R Histogram R R Waveform or R R Interval List is selected it will be 45 12 Channel Electrocardiograph User Manual recorded while recording When R R Histogram R R Waveform or R R Interval List is not selected it will not be recorded while recording Note Users can press Space key to select or cancel on the Record Information Setup interface Note The items on the Record Info Setup interface are valid only in the Auto mode and Template and Position Marker do not work under the Auto Style of 3x4 3x4 1rhy and 3x4 3rhy and the Style of 6x2 and 6x2 1rhy in the Quickly Mode Note To get more information about the above contents please refer to Chapter 5 11 Auto Mode Record 5 9 4 Patient Question Setup Patient Question M Race Technician IV Height Medication User Defined M Weight Ward NO I ID Hint I BP Doctor I Next Patient H W Unit ID Mode Prompt om kg Auto C Unconfirmed C inch lb C Time Reviewed By BP Unit Manu mmHg User Defined C kPa 1 Gender Height Weight BP Race Medication Ward NO Doctor Technic
55. laration electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and manufacture s declaration electromagnetic immunity The SE 1200 Electrocardiograph is intended for use in the electromagnetic environment specified below The customer or the user of SE 1200 Electrocardiograph should assure that it is used in such an environment Immunity IEC 60601 test Compliance Electromagnetic environment test level e level guidance Portable and mobile RF communications equipment should be used no closer to any part of the SE 1200 Electrocardiograph including cables than the recommended separation distance Conducted aN RF 150 kHz to 80 IEC MHz 61000 4 6 calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3 V m Radiated RF 80 MHz to 2 5 IEC GHz 61000 4 3 80 MHz to 800 800 MHz to 2 5 Where P is the maximum output power rating of the transmitter in watts W according to the 94 12 Channel Electrocardiograph User Manual transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol qx NOTE 1 At 50 MHz and 800 MHz the
56. lectrocardiograph makes a short beep sound when an R wave has been detected Users can set the QRS Volume as Small Medium Big or off When set as off there is no sound while detecting R wave 3 Hint Volume Besides Key Beep and QRS Beep electrocardiograph can make other hint sound Users can set the Hint Volume as Small Medium Big or off When set as off there is no hint sound 52 12 Channel Electrocardiograph User Manual 5 9 10 Date8 Time Setup Date Time Setup Current Date Current Time Bs 11 20 99 fiz 39 46 Time Mode Power Off Minutes LCD Off Minutes 1 Current Date Current Time Users can set current date and current time on this interface and it will be displayed on the paper while recording 2 Date Mode Users can set Date Mode as dd mm yyyy mm dd yyyy or yyyy mm dd 3 Time Mode Users can set Time Mode as 24 hours or 12 hours Note When finishing setting on this interface users should click on OK to confirm and exit The new setup will become effective when entering this interface again 4 Power Off When the device is powered by the built in rechargeable lithium battery users can set the time of automatic power off When the Power Off is set as 000 Minutes this function will not be effective Note Power Off is counted from the time of last pressing the keys on the keyboard 53 12 Channel Electrocardiograph User Manual 5 LCD Off Users can set t
57. move the paper Wipe the print head gently with a clean soft cloth damped in 75 alcohol For stubborn stain soak it with a little alcohol first and wipe it off with a clean soft cloth After air dried load the recording paper and shut the casing of the recorder CAUTION D Prevent the detergent from seeping into the main unit while cleaning Do not immerse the unit or patient cable into liquid under any circumstances 82 12 Channel Electrocardiograph User Manual CAUTION D Do not clean the unit and accessories with abrasive fabric and avoid scratching the electrodes 8 2 Disinfection To avoid permanent damage to the equipment disinfection can be performed only when it has been considered as necessary according to your hospital s regulations Before disinfection clean the equipment first Then wipe the surfaces of the unit and patient cable with hospital standard disinfectant CAUTION D Do not use chloric disinfectant such as chloride and sodium hypochlorite etc 8 3 Care and Maintenance 8 3 1 Recharge and Replacement of Battery 1 Capacity Identification Current capacity of the rechargeable battery can be identified according to the battery symbol in the top right corner on LCD screen For SE 1200 Express Full capacity Capacity is limited and hint information Battery Weak will be displayed on LCD screen Recharge should be taken into account fini Battery is weak and hi
58. n battery used after finishing ECG record press Power ON OFF key 99 to display the information System is shutting down on the screen After a few seconds the device will be off When mains supply used after finishing ECG record press Power ON OFF key to 99 display the information System is shutting down on the screen After a few seconds the device will be off And then pull off the plug from the outlet Note When switching off the device please operate it according to the sequence above strictly or else there will be something wrong on the screen Note Do not keep on pressing the Power ON OFF key when the device displays the hint information System is shutting down on the screen aif Ja 12 Channel Electrocardiograph User Manual 6 Hint Information Hint information and corresponding cause provided by electrocardiograph is listed in Table 6 1 Table 6 1 Hint Information and Causes Lead off Electrodes fall off from patient or patient cables fall off from the unit Sampling Analyzi ECG signal is being sampled analyzed recorded ng Recording Learning The self study process of arrhythmia arithmetic in the Trigger Sample mode Transmitting ECG data is being transmitted from electrocardiograph to PC through Ethernet or serial port in the Auto mode Transmit Fail ECG data fails to be transmitted from electrocardiograph to PC through Ethernet or serial port in the Auto mode Detecting T
59. net port of PC through an Ethernet cable recommended by the manufacturer Secondly open the Receive ECG Data window of SMARTECG VIEWER software in PC select the transfer type Net Trans and press Connect button Then set the Remote IP and Local IP in electrocardiograph In the AUTO mode ECG data can be transferred through net automatically after ECG recording is finished When Transmission Mode is set as UART firstly connect the serial port 1 of electrocardiograph and the serial port of PC through a serial cable recommended by the manufacturer Then open the Receive ECG Data window of SMARTECG VIEWER software in PC select the transfer type Serial Trans set the right PortNum and press Connect button In the AUTO mode or the Rhythm mode ECG data can be transferred through serial port automatically after ECG recording is finished 2 Remote IP Users can set Remote IP on Transmission Setup interface 3 Local IP Users can set Local IP on Transmission Setup interface 4 Gateway Users can set Gateway on Transmission Setup interface 5 Subnet Mask Users can set Subnet Mask on Transmission Setup interface 5 9 6 Patient Information Patient Information Name ID Zhang Sar 1123 Age 30 years Gender fusus Weight 170 kg BP 100 s0 mmHg Race Medication Ward NO Digitailis 305 Doctor Technician Li ol mang Wu 49 12 Channel Electrocardiograph User Manual Note The patient
60. nput power TOVA Make sure the mains supply meets the above requirements before power on and then press Power ON OFF button on the keyboard to power on the unit Then the mains supply indicator lamp J will be lit If the built in rechargeable battery is weak when mains supply used it will be recharged automatically at the same time And both the mains supply indicator lamp gt and the battery recharging indicator lamp 2 3 will be lit Built in rechargeable battery While using the built in rechargeable lithium battery pack turn on the unit 2002 12 Channel Electrocardiograph User Manual by pressing Power ON OFF button on the keyboard and the battery indicator lamp iz will be lit The battery symbol will be displayed on the LCD screen Because of the consumption during storage and transport the capacity of battery may not be full If the symbol i or Bi and the hint information Battery Weak are displayed which means the battery capacity 1s weak please recharge the battery first When the capacity of battery 1s full SE 1200 can work normally for nearly 2 hours about 200 ECG of 3 x4 1r can be recorded in the Auto Mode SE 1200 Express can work normally for nearly 3 5 hours about 400 ECG of 3x4 1rhy can be recorded in the Auto Mode Please refer to the maintenance section for how to recharge the battery During recharging the battery electrocardiograph can be powered by mains supply A WAR
61. nsing Atmospheric S60hPa 700hPa 1060hPa Pressure 1060hPa Rated input voltage 100V 240V Mains Supply Rated frequency 50 60Hz Rated input power 70VA 79 12 Channel Electrocardiograph User Manual Rated voltage 14 8 V SE 1200 Express Rated capacity 4000mAh 4400mAh SE 1200 Rated capacity 2000mAh 2200mAh 2400mAh When the capacity of battery is full SE 1200 can work normally for nearly 2 hours about 200 ECG of 3x4 1r can be Built in Lithium recorded in the Auto Mode SE 1200 Battery Pack Express can work normally for nearly 3 5 hours about 400 ECG of 3x4 1rhy can be recorded in the Auto Mode Charge mode Constant current voltage Charge current standard 0 2C5A 320mA Recording Thermal dot matrix recorder Recording Paper Folded paper Rolled paper Paper Width 216mm 210mm Effective Width 200mm 195mm 5mm s 10mm s 12 5mm s 25mm s Paper Speed 50mm s 43 Accuracy of data 5 x axis 5 y axis T 80 12 Channel Electrocardiograph User Manual A D Resolution 24 bits Time Constant 23 2s Frequency Response 0 05Hz 150Hz Gain 2 5 5 10 20 10 5 AGC mm mV Input Impedance 50M Q 10Hz Input Circuit Current lt 10nA Input Voltage Range t5 mVpp Calibration Voltage 1mV 2 DC Offset Voltage 600mV Noise lt 12 5u Vp p Multichannel crosstalk lt 0 5mm AC Filter On Off DFT Filter 0 05 0 15 0 25 0
62. nt information Battery Weak will be displayed on LCD screen The battery should be recharged immediately For SE 1200 OR Full capacity m Capacity 1s limited and hint information Battery Weak will be displayed 83 12 Channel Electrocardiograph User Manual on LCD screen Recharge should be taken into account mm Battery is weak and hint information Battery Weak will be displayed on LCD screen The battery should be recharged immediately 2 Recharge 12 channel electrocardiograph is equipped with recharge control circuit together with built in rechargeable lithium battery When connect with the mains supply the battery will be recharged automatically And then the battery recharge indicator lamp 29 3 and the mains supply indicator lamp 2 will be lit at the same time During the course of recharging the symbol E or L will flash in the top right corner of LCD screen When the capacity of battery is full the symbol will stop flashing and the battery recharge indicator lamp gt will be black Because of the capacity consumption during storage and transport the capacity of battery is not full while using at the first time Battery recharge should be considered before first usage 3 Replacement When the useful life of battery is over or foul smell and leakage has been found please contact with manufacturer or local distributor for replacement of battery A WARNINGA Only qualified se
63. odel and specification provided by manufacturer must be used A WARNINGA Only when the device is off can the battery be installed or removed Note If the battery has not been used for two or three months or above recharge should be done before use the battery again 2 Fuse There are two same fuses installed on the bottom of the main unit The specification is ACIOOV 240V TIA 05x20 A WARNINGAS Ruptured fuse must only be replaced with that of the same type and rating as the original a2 12 Channel Electrocardiograph User Manual 4 Operation Preparations CAUTION D Before use the equipment patient cable and electrodes should be checked Replace it if there is any evident defectiveness or aging which may impair the safety or performance and be sure that the equipment is in proper working condition 4 1 Power and Earthing NWARNINGA If the integrity of external protective conductor in installation or arrangement is in doubt the equipment should be powered by the built in rechargeable battery Power Supply The electrocardiograph can be powered by either mains supply or the built in rechargeable lithium battery pack Mains supply The mains connection socket is on the rear panel of the unit If mains supply is used connect the power cord to the socket first and then connect the plug of the cord to the hospital grade outlet Rated input voltage lOOV 240V Rated frequency 50Hz 60Hz Rated i
64. pment etc are likely to bring electromagnetic interference CAUTION 29 Before use the equipment patient cable and electrodes etc should be checked Replacement should be taken if there is any evident defectiveness or aging symptom which may impair the safety or performance 30 The following safety checks should be performed at least every 24 months by a qualified person who has adequate training knowledge and practical experience to perform these tests Inspect the equipment and accessories for mechanical and functional damage Inspect the safety relevant labels for legibility Inspect the fuse to verify compliance with rated current and breaking characteristics Verify the device functions properly as described in the instructions for use Test the protection earth resistance according to IEC EN 60601 1 Limit 0 1 ohm f Test the earth leakage current according to IEC EN 60601 1 Limit g NC 500 uA SFC 1000uA Test the patient leakage current according to IEC EN 60601 1 12 Channel Electrocardiograph User Manual Limit 10 uA CF h Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC EN 60601 1 Limit 50uA CF The data should be recorded in an equipment log If the device is not functioning properly or fails any of the above tests the device has to be repaired 31 Ruptured fuse must only be replaced with the same type and rat
65. rbances are controlled The customer or the user of the SE 200 Electrocardiograph can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the SE 200 Electrocardiograph as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum 150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2 5 GHz output power MHz of transmitter 0 uer s mwm For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 96 A EDAN EDAN INSTRUMENTS INC 3 F B Nanshan Medical Equipments Park Nanhai Rd 1019 Shekou Nanshan Shenzhen 518067 P R CHINA TEL 86 755 26882220 FAX 86 755 26882223 EC REPRESENTATIVE Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 D 20537 Hamburg Germany TEL 49 40 2513175 FAX 49 40 255726
66. rvice engineer authorized by EDAN can open the battery compartment and replace the battery And the battery of same model and specification provided by manufacturer must be used Danger of explosion Do not reverse the anode and cathode when connecting the battery When the battery s useful life is over contact the manufacturer or local distributor for disposal or dispose the battery according to local regulations 8 3 2 Recording Paper Note Recording paper provided by manufacturer should be used Other paper may shorten thermal print head s life And the deteriorated print head 84 12 Channel Electrocardiograph User Manual may lead to illegible ECG record and block the advance of paper etc Storage requirements Recording paper should be stored in dry dark and cool area avoiding excessive temperature humidity and sunshine Do not put the paper under fluorescence for long time Be sure that there is no polyvinyl chloride or other chemicals in the storage environment which will lead to color change of the paper Do not overlap the recording paper long time or else the ECG record may trans print each other 8 3 3 Maintenance of Main Unit Patient Cable amp Electrodes The following safety checks should be performed at least every 24 months by a qualified person who has adequate training knowledge and practical experience to perform these tests a Inspect the equipment and accessories for mechanical
67. s ECG waveform and all the R R values 2 Manual Style When Manual Style is set as 3 channel users can record 3 leads ECG wave simultaneously When Manual Style is set as 6 channel users can record 6 leads ECG wave simultaneously When Manual Style is set as 12 channel users can record 12 leads ECG wave simultaneously 3 Auto Display Style When Auto Display Style is set as 3x4 12 leads are displayed in 4 columns and 3 rows When Auto Display Style is set as 3x4 1rhy 12 leads are displayed in 4 columns and 3 rows with one rhythm lead at the bottom When Auto Display Style is set as 3x4 3rhy 12 leads are displayed in 4 columns and 3 rows with three rhythm leads at the bottom When Auto Display Style is set as 6x2 12 leads are displayed in 2 columns and 6 rows When Auto Display Style is set as 6x2 1rhy 12 leads are displayed in 2 columns and 6 rows with one rhythm lead at the bottom 39 12 Channel Electrocardiograph User Manual When Auto Display Style is set as 12x1 12 leads are displayed in 12 channels 4 Rhythm Style When Rhythm Style is set as Single Lead in the Rhythm Work Mode 60s ECG wave of the appointed single rhythm lead will be recorded When Rhythm Style is set as Three Lead in the Rhythm Work Mode 20s ECG wave of every appointed rhythm lead will be recorded 5 Sampling Mode When Sampling Mode is set as Pre Sample 10s ECG data sampled before pressing START STOP key w
68. same model and specification provided by manufacturer should be used 22 Danger of explosion Do not reverse the anode and cathode when connecting the battery 23 Do not heat or splash the battery or throw it into fire or water 24 When leakage or foul smell is found stop using the battery immediately If your skin or cloth comes into contact with the leakage liquid cleanse it with clean water at once If the leakage liquid splashes into your eyes do not wipe them Irrigate them with clean water first and go to see a doctor immediately 25 When the battery s useful life is over contact the manufacturer or local distributor for disposal or dispose the battery according to local regulations 26 Only when the device is off can the battery be Installed or removed 12 Channel Electrocardiograph User Manual 1 3 General Cautions CAUTION 26 Avoid liquid splash and excessive temperature The temperature must be kept between 5 C and 40 C while working and it should be kept between 20 C and 55 C during transportation and storage 27 Do not use the equipment in dusty environment with bad ventilation or in the presence of corrosive 28 Be sure that there is no intense electromagnetic interference source around the equipment such as radio transmitter or mobile phone etc Attention large medical electrical equipment such as electrosurgical equipment radiological equipment and magnetic resonance imaging equi
69. sibility of the Manufacturer EDAN only considers itself responsible for any effect on safety reliability and performance of the equipment 1f Assembly operations extensions re adjustments modifications or repairs are carried out by persons authorized by EDAN and The electrical installation of the relevant room complies with national standards and The instrument is used in accordance with the instructions for use NOTE This device is not intended for home use NWARNING4 This device is not intended for treatment Upon request EDAN may provide with compensation necessary circuit diagrams and other information to help qualified technician to maintain and repair some parts which EDAN may define as user serviceable Using This Label Guide This guide is designed to give key concepts on safety precautions NWARNING A A WARNING label advises against certain actions or situations that could result in personal injury or death 4 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 Revision History 2008 08 ECO QR 8029 Amend battery specification 2008 12 ECO SE 8031 Uperade Sotware II Table of Contents 159atety Guidant e siria e 1 ki Saey W ablic Seesen ENER E EENAA 1 1 2 Battery Gare Warning Sismo nicole cnica 3 Lo General
70. tem Setup Window for example 1 Entering System Setup Window Press the corresponding Function Key of Setup on the keyboard to enter the System Setup Window 3 12 Channel Electrocardiograph User Manual System Setup System Setup Window Work Mode erie Record Info Sub item lt 2 Selecting sub items in the System Setup Window In the System Setup Window press Up Down Left Right Tab BackTab key to move the cursor to a certain sub item and then press Enter key to get into the setup interface of the sub item 3 Sub item Setup interface Take the Work Mode Setup interface for example Work Mode Setup Work Mode Setup eny sampling Mode Option Rhythm otvle Single Lead OK Cancel On the Work Mode Setup interface pressing Tab BackTab key can move the cursor between different Setup Menus pressing Up Down key can move the cursor between different options in a Setup Menu Move the cursor to a certain option and press Enter key to confirm or Esc key to cancel Users can also press Tab key to move the cursor to OK and press Enter key to confirm Aj 12 Channel Electrocardiograph User Manual move the cursor to Cancel and press Enter key to cancel operation 4 Inputting characters Take the Patient Information interface for example Patient Information Name ID Zhang San 0200611054 Age 030 years Gender EMS Weight 070 kg Height 170 cm BP 1
71. the U disk again If it fails to copy the information Copy file Error will pop up After finishing coping successfully the information Copy file success will be displayed To copy all cases in the File Manage Window to U disk the user can press All to USB 59 12 Channel Electrocardiograph User Manual function key to carry out this operation The hint information displayed during the course of All to USB is the same as the hint information displayed during the course of To USB Note Please use the U disk or insert the SD Card Reader that EDAN recommends Only FAT format should be selected when formatting the U disk 4 Delete Select a patient case and press Delete function key to pop up the following dialog box Press OK to delete the selected case or press Cancel to cancel deleting HINT You will delete this case Are you sure To delete all cases in the File Manage Window users can press Del All function key to pop up the following dialog box Press OK to delete all cases or press Cancel to cancel deleting HINT You will delete all the cases Are you sure 5 Record Select a patient case and press Record function key to begin recording During the course of recording pressing START STOP again can stop recording 6 Preview Select a patient case and press Preview function key to enter the File Preview Window The File Preview Window shows Patient Name Patient ID 12 channel ECG wav
72. the device is powered by mains supply indicator lamp the lamp will be lit o When the device is powered by the built in Battery indicator rechargeable Lithium battery the lamp will be lit Battery recharging When the battery is recharged this lamp will indicator lamp be lit 2 Cable bracket Optional Used for supporting patient cable 15 12 Channel Electrocardiograph User Manual 3 3 Rear Panel Explanation Mains supply N AC SOURCE alternating current supply socket Socket Potential Potential equalization conductor provides a Equalization connection between the unit and the potential Terminal m equalization bus bar of the electrical installation 16 12 Channel Electrocardiograph User Manual 3 4 Right Panel C A G ee A rr E MEN L A A A dg HE BH e Lo L1 Figure 3 9 SE 1200 SE 1200 Express Right Panel en D suroni comentare Standard USB socket connecting USB USB USB Socket 2 Optional printer recommended by EDAN E External Input Output Connecting external signal device Socket 1 Patient Cable Socket ul Applied part of type CF with defibrillator proof 17 12 Channel Electrocardiograph User Manual A Attention see accompanying document Definition of corresponding pins E POE NON C2 npu 6 SH H F inpu 3 cacinpuy 8 NC 13 Cl n L4 cSd 9 Rp 14 n
73. tient should not contact conducting objects such as earth metal part of bed etc Ensure the patient is warm and relaxed and breathes calmly A WARNINGAS The electrocardiograph is provided for the use of qualified physicians or personnel professionally trained and they should be familiar with the contents of this user manual before operation 29 12 Channel Electrocardiograph User Manual 5 Operation Instructions 5 1 Switching On While using mains supply firstly connect the power cord and the mains supply indicator lamp A is lit Then press Power ON OFF key on the keyboard to turn on the unit Equipment information such as manufacturer device name and version No will be displayed on LCD screen after self test Then electrocardiograph is ready for examination and recording While using built in rechargeable lithium battery press Power ON OFF key on the keyboard directly to turn on the unit and then the battery indicator ta is lit After self test electrocardiograph is ready for examination and recording 5 2 General operation All the operations including ECG recording parameter setting and file managing can be implemented by using the keyboard For SE 1200 Express users can also carry out the operations by using the Touch Screen ANWARNING Do not touch the LCD screen with such sharp things as pencil or pen otherwise it will be damaged Take these general operations needed when using Sys
74. ting or distorting the ECG signal Select On to turn on the function and select Off to turn off 2 DFT Filter DFT Filter greatly reduces the baseline fluctuations without affecting the ECG signal The purpose of this filter is to keep the ECG signals on the baseline of the printout The setting value is the low limit of the frequency range including 0 05Hz 0 15Hz 0 25Hz 0 5Hz 3 EMG Filter EMG Filter suppresses disturbances caused by strong muscle tremor The cutoff frequency is defined at 25Hz 35Hz or 45Hz Select Off to turn off the function 4 Lowpass Filter Lowpass Filter restricts the bandwidth of input signal The cutoff frequency is defined at 150Hz 100Hz or 75Hz All the input signals whose frequency is higher than the setting cutoff frequency will be attenuated A1 12 Channel Electrocardiograph User Manual 5 9 3 Record Information Setup There are three pages on the Record Info Setup interface Recorder Record Control and Record Info Users can Press F1 or F2 function key to switch them 5 9 3 1 Recorder Setup Record Info setup Recorder Record Device Paper Width Thermal r 140 210nm TE a Paper Marker __ 5mm s lo No Io 25mm s 1 Omm s Fa omm s bh Press CFI or P2 to Switch Page FEF 1 Recorder Device Users can set the Recorder Device as Thermal DeskJet or LaserJet The DeskJet and the LaserJet both belong to USB printer When DeskJet or LaserJet 1s selected th
75. turn Material Authorization RMA form that includes the appropriate return address and instructions An RMA form must be obtained prior to any return 87 12 Channel Electrocardiograph User Manual Freight policy Under warranty the service claimer is responsible for freight amp insurance charges when a return is shipped to EDAN for service including custom charges EDAN is responsible for freight insurance amp custom charges from EDAN to service claimer Out of warranty the service claimer is responsible for any freight insurance amp custom charges for product Contact information If you have any questions about maintenance technical specifications or malfunctions of devices please do not hesitate to contact us immediately Telephone 86 755 2689 9221 2689 9914 Fax 86 755 2689 8330 Email support edan com cn 88 12 Channel Electrocardiograph User Manual 10 Accessories 10 1 Standard Accessories A WARNINGAS Only patient cable and other accessories supplied by EDAN can be used Or else the performance and electric shock protection can not be guaranteed Table 10 1 Standard Accessories List ECG Cable American Thermal recording paper Rechargeable Lithium Battery 89 12 Channel Electrocar 10 2 Optional Accessories diograph User Manual Table 10 2 Optional Accessories List Accessory ECG Cable European ECG Cable American Smart ECG Viewer Smart ECG viewer
76. ual Style is 12 channel ID 2690 Patient ID 08 06 2005 08 41 56 Current Date amp Current Time IL ImV calibration mark I IL W aVR aVL aVF V1 V2 V3 V4 V5 V6 12 standard Leads ECG waveform of 12 standard leads 0 15 100Hz 0 15Hz DFT Filter 100Hz Lowpass Filter AC50 50Hz AC Filter 25mm s Paper Speed 10mm mV Gain 60 Heart Rate SE 1200 Express Electrocardiograph Model V1 7 Version number e 12 Channel Electrocardiograph User Manual 5 14 R R Mode Record ni 1 t El E AER Edo aoan E ii i re rt Ep 12 Channel Electrocardiograph User Manual bh t J I 1 f i 1 fP 4 cm o o meom m ds ass 1 zd a a 9 o ill 1 7 i 1 AA i H i i 4 4 4 H i 1 i i i i a a no Ammo uir Qe L a in 1 1 I i h i 4 i 1 i i aje a ENSE i E ou E ou I ou IE i TE E ii E 4 ex E me oes on E dm rr et m es m rm sdb nt Geo 5 F I mnes i E ER 3 tt Pre non as 3 EA i b i T 1 be Erran re 1 z EE O E m L m ome E pe ae ee gt prt n FL jo I os 1 H ms uu d i E i i au Cee i s en eee a T rl or rar r pn HE Sees ee maia E iind E L i J Eia ied kasas i MEER EESTI LEKEI LIRU CELS T 7 k L l anas er pnr i e i EE feat E Tr B LE 1 I fh pul hisses f gon be as
77. um of amplitude of R or R wave of one selected dominant beat from lead V6 The maximum of amplitude of S or S wave of one selected dominant beat from lead V2 Diagnosis Information Diagnosis Information shows the auto diagnosis result Average Template Average Template shows the average value of 10s sampled ECG signal of every lead The dashed on the template is Position Marker It respectively marks the start points and end points of P wave and QRS wave and the end point of T wave 68 12 Channel Electrocardiograph User Manual 5 11 2 Example of 3x4 1rhy Ss 084056 xU E ee A i AS BUM Ron armor e Re tt iua l 498 anne i Tom Hk BPM Diagnosis Information ID 24098 P Dur 9 mis il Sinus hy ihn Age 145 vears erder Sale PR in t iT mx A5 Ema ECG Heighri i 275 em Wain lgi 67 ke RES itur t W3J diis Ty 1205 mmHg Race ST nr i QTYFFEC ani SS nix PAESI ares gS a Tigre petu Codo HV EST i n TOA mv 2 4 Vd HVSISVI amp 1 044 mi RV Syz amp o 4777914 mv Report Reviewed by avi VT f F i I He i L ULM mr LEE LL pner is Li JUL E E e EL 1I um i 1 i 1 Y HEF 8 9 1 s a ida Gala Ld Pi i r H LAS ie Ad p Ad an d Es mr Pallet i 14 pU UE ET avi eS HMM aa wij T i JEn FF h dci i G yi i al A E mL oe ic al aes iH Bu RN E EU tes GH AU E Al i4 Ll dm A A is fe es De E Le ioci fee ee amps ABE K 15 01u45Hg ACE
78. ures Low weight and compact size Multi language support 12 lead gathered and amplified simultaneously 12 channel ECG are displayed and recorded simultaneously High resolution thermal recorder recording frequency response lt 150Hz Flexible recording formats Big keyboard design separate number and letter keys for easy operation For SE 1200 Express touch screen is available Auto mode manual mode rhythm mode R R mode optional Convenient system setup and file management operation Auto measurement and auto interpretation optional Hint information for lead off lack of paper and low battery capacity etc Built in rechargeable Lithium battery with high capacity Automatic adjustment of baseline for optimal recording 2 2 List of Symbols External output External input Equipment or part of CF type with defibrillator proof E tajo lt e d TI a 8 8 C GJ 9 OP 12 Channel Electrocardiograph User Manual Attention general warning see accompanying document Potential equalization Mains supply Battery indicator Battery recharging indicator Delete key Enter key Esc key Baseline Reset key Shift key Fn key Power On Off key COPY key MODE key SLEEP WAKE UP key JTOP eX LAY ed P N SN ual uil ITI El C 0123 ptm Rx only U S 12 Channel Electrocardiograph User Manual START STOP key Tab key Feed Paper ke
79. y UP DOWN LEFT RIGHT arrow 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 The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life and that this unit was put on the market after 13 August 2005 Federal U S Law restricts this device to sale by or on the order of a physician 9 12 Channel Electrocardiograph User Manual 3 General Information 3 1 Top Panel Indicator LCD Screen Recorder O DOOODODOUODODODOO Keyboar CJOJOD C O XO OO C CO CJ i Indicator LCD Screen Recorder ooooooooaoooo Keyboar OOCOC OC OOC OC Figure 3 2 SE 1200 3 1 1 LCD Screen SE 1200 320x240 dot single color LCD Screen SE 1200 Express 800x600 multicolor LCD Screen 10 12 Channel Electrocardiograph User Manual ON E o F AA ii as j K 7 4 d 4 L di i mi d FA ME 4 ru TIT f as Al AL O LIL E Lj i LJ Li OT NT M L K I I 006002311 2 Figure 3 4 SE 1200 Main Screen 12 Channel Electrocardiograph User Manual Explanation Patient Name Within 20 characters Patient ID Within

SE-1200 Operators Manual

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