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1. Figure 3 36 Language Set YM303i 3channel Resting ECG System Operator s Manual 49 Date format When the cursor moved on Date Format parameter and press the ENTER button it will be shown up the selection box Set the desired date format with number pad Hospital Name Physician Enter to edit Technician Enter to edit Location No 0 Cart No 0 Language English Date Format DD MM 1 Date Time Format Time hh mm 00 27 Figure 3 37 Data format setting Date Move the cursor on Date field and set the current date with number pad Example If today is 2010 08 26 and date format is yyyy mm dd Then type the flowing numbers using number pad Type 2 0 1 0 0 8 2 6 System Setup Hospital Name Physician Enter to edit Technician Enter to edit Location No 0 Cart No 0 Language English Date Format DD MM YYYY Date 01 01 2000 Time Format 12hr PM Time hh mm 00 27 Figure 3 38 Date setting Time format Move the cursor on Time Format field and set the desired time format with number pad Example1 gt If current time is 2 30pm and desired time format is 12h Then type the flowing numbers using number pad Type 1 4 Example2 gt If current time is 2 30pm and desired time format is 24h Then type the flowing numbers using number pad Type 2 System Setup Hospital Name Physician Enter to edit Technician Enter to edit Location No 0 Cart No 0 Language English Date Format DD MM
2. Enter to submenu of Patient Data edit G Auto Enter to submenu of File Management Oe d Gon B Enter to submenu of Maintenance Ge ge The title of selected menu Interpretation Yes st of a EECH ke The parameters list of submenu Print Detail Result No Muscle Filter Off No of Copy 1 Current setting value O Selectable options of current parameter Figure 3 4 The Menu Screen of YM303i Up main configuration menu Down submenu 3 3 1 Automatic mode Menu 1 Switch to Automatic operation mode This menu is dependent the operation mode It is necessary switch to Automatic mode If press the AUTO button it will be switched the operation mode to Automatic mode AUTO YM303i 3channel Resting ECG System Operator s Manual 33 2 Press the MENU button to enter the configuration menu If press the MENU button at Home Screen it will be shown the MENU di Configuration menu Move the cursor on Auto and press the ENTER button to enter the submenu of Auto configuration ENTER If other function is running such as Acquisition Analysis or RUN Printing could not enter the configuration menu Configuration Auto System Setup Patient Data File Management Mainternance Report Format Rhythm Lead Interpretation Print Median Beat Print Detail Result Muscle Filter No of Copy Figure 3 5 Autom 10mm mV 25mm s 3x4 Il Yes No No Off 4 atic mode configuration 3 The p
3. A EE TATA AT 73 gt 25mm axari 08 25 2010 Pmog 24 sp gr SD Card Insert Muscle Filter Enabled Lead Fail Detection C D E F G H Figure 3 3 The Home screen A Gain I Heart Rate B Paper Speed J ECG Wave C Print format K Low Pass Filter D Operation Status L High Pass Filter E Date M AC Filter F Time N Anti Floating System enabled G O H 30 YM303i 3channel Resting ECG System Operators Manual 3 2 ECG measurement 3 2 1 Automatic mode 1 Turn on the YM303i Press the Power button to turn on the YM3031 2 Switch to the automatic mode gr Press the AUTO button to Automatic mode Operation mode setting available only home screen 3 Connect the YM303i with a patient Put electrodes to a patient and connect with patient cable For more detail information refers to the Electrodes position and Leads connection 4 Press the Run button to begin ECG signal recording In automatic operation mode recording process has 3 states The state is shown on status cell a 2 Acquisition Getting ECG signal from the patient RUN b Analysis Analysis and interpretation the signal c Printing Printing the ECG waveform and result If you want stop the process press the STOP button YM303i 3channel Resting ECG System Operator s Manual 31 3 2 2 Manual mode 1 2 3 4 5 32 This operation mode provides continuous ECG record without interpretation Turn on YM303i Press the POWER bu
4. The YM3031 is to acquire multi channel ECG signals from adult patients from body surface ECG electrodes and to record display analyze and store these ECG signals for review by the user The YM303 is to be used in healthcare facilities by trained healthcare professionals Analysis of the ECG signals is accomplished with algorithms that provide measurements data presentations graphical presentations and interpretations for review by the user The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only It is to be used in conjunction with the clinicians knowledge of the patient the results of the physical examination the ECG tracings and other clinical findings A qualified physician is asked to overread and validate or change the computer generated ECG interpretation YM303i 3channel Resting ECG System Operator s Manual 17 2 2 YM303i Overview Top view LCD Power Status LED Thermal printer Power button Keypad Cover open button Side view SD card slot Patient cable connector Ventilation hole USB socket firmware upgrade only Rear view RS232 connector LAN connector AC socket Battery cover Equivalent GND Terminal Bottom view Tilt feet Rubber feet Product label Figure2 1 YM3031 Overview 18 YM303i 3channel Resting ECG System Operators Manual 2 2 1 Power switch The Y
5. lt Physician Normal Sinus Rhythm Technician 1 Medication No Medication No Comments 3 lt System Setting gt Sp d 25mm s Gain 10mm mV Filter 005 150Hz 60Hz AFS Off Time 2010 04 30 52 Version MEDIANA YM303i Ver 0 1 0 06 ii Figure 3 10 Format 3x4 2 R 12 Lead ECG waveform prints in 2x6 and a rhythm lead added Figure 3 11 Format 2 R YM303i 3channel Resting ECG System Operator s Manual 38 3 R 12 Lead ECG waveform prints in 3x4 and a rhythm lead added MEDIGATE HOSPITAL f ID Sex Male Ag a R i i y i i il Il EZ MN TAL MC AA ele i ii ji ser i TA LA PA EE EY AE A AS ANCLAS CLA EN E LI E mm ma tm Fly Katie eth AN tet ee TA HA eA Auto Race lt Patient Data gt lt Detection Result gt ID Vent Rate 60 bpm cha Soft iii fee ne A nine Pacemaker No Sex Male P R T axis 44 40 44 SE 3 Rhythm H Technician gt Regent Nico Tit ae RIA lt System Setting gt eo Gain 10mm mV A E EIA 107 QUEDAS A EY ERES Y d 005 150Hz SE AFS Off 4 Version MEDIANA YM3031 Ver 0 1 0 06 a Figure 3 12 Format 3 R 6x2 12 Lead ECG waveform prints in 6x2 Figure 3 13 Format 6x2 YM303i 3channel Resting ECG System Operators Manual Rhythm Lead This parameter is applied for format 2 R and 3 R The rhythm lead is selected with the keypad The figure 3 14 shows selective options if you want go next page press the right
6. manufacture Heart Rate Beep Warning Beep LCD Light Off LCD Brightness Communication Paper Select Print Setup Menu List Patient Data Entry SD Card ECG List Default Setting Auto mode Gain mm mV Speed mm s Report Format Rhythm Lead Interpretation Print Median Beat Print Detail Result Muscle Filter No of Copy Manual mode Gain mm mV Speed mm s Report Format Rhythm Lead Muscle Filter Patient data Patient ID Last name Fist name Date of birth Sex Height Weight Race Pacemaker Physician Technician Room No Medication1 Medication2 Commenti Comment2 M3R LIL Off Blank Blank Blank 00 00 0000 male 0 0 No No Off Off Off 100 RS 232 Roll Enter Enter to edit 1block Enter Hospital name Physician Technician Location No Cart No Language Date format Date Time format Time hh mm Units Lead Label AC Line Filter Hz Low Pass Filter Hz High Pass Filter Hz AFS 0 0 English DD MM YYYY unchanged 12hr unchanged cm kg IEC location dependent 150 0 05 On ECG Sample Acquisition Auto Save Lead fail Detection No On Pace Pulse Detection Off Key Press Beep Warning Beep Heart Rate Beep LCD Light off min LCD Brightness Communication Paper Select Patient Data Entry Off On Off 20 100 RS 232 Roll Patient ID Required No The Others Yes SD Card ECG List YM303i 3channel Resting ECG System Operator s Manual
7. LIL II aVR aVL aVF Speed mm s 5 10 25 50 V1 V2 V3 V4 V5 V6 Report Format M1R M2R M3R M6R Custom Lead Rhythm Lead MER L IL II aVR aVL aVF MIR 1 01 110 laVR laVL aVF V1 V2 V3 V4 V5 V6 V1 V2 V3 V4 V5 V6 Muscle Filter 25Hz 35Hz Off M2R LI WIL aVR laVL aVF V1 V2 V3 V4 V5 V6 Custom Lead YM303i 3channel Resting ECG System Operator s Manual 41 Gain This parameter sets the input gain If the gain value is big height ot ECG signal will be tall Manual Gain 10mm mV Speed 25mm s Report Format M3R Rhythm Lead IRIRI Muscle Filter Off Figure 3 21 Gain setting Manual mode Speed This parameter sets the paper speed If the speed value is big print speed will be fast 10mm mV 25mm s Report Format Rhythm Lead Muscle Filter M3R 1 10 Off Figure 3 22 Speed set Manual mode If press the Gain button at Home Screen it will be switched input gain among 5 10 and 20mm mV without enter the configuration menu If press the Speed button at Home Screen it will be switched print speed among 5 10 25 50 mm s without enter the configuration menu Report format The manual operation mode has 4 types report formats it is selected using keypad Manual Gain Speed Report Format Rhythm Lead Muscle Filter 10mm mV 25mm s M3R III Off Figure 3 23 Report format Manual mode YM303i 3channel
8. Operator s Manual 51 52 AC Line filter Select the AC line filters Set the AC line filter to your local AC power line rating 50Hz or 60Hz System Setup Units cm kg Lead Label IEC AC Line Filter 60Hz Low Pass Filter 150Hz High Pass Filter 0 04Hz AFS On ECG Sample Acquisition Post Auto Save No Lead Fail Detection On Pacer Pulse Detection Off 2 Key Press Beep Off Figure 3 43 AC Line filter select High Pass filter Select cutoff frequency of the high pass filter System Setup Units Lead Label IEC AC Line Filter 60Hz Low Pass Filter 150Hz High Pass Filter 0 04Hz AFS On ECG Sample Acquisition Post Auto Save No Lead Fail Detection On Pacer Pulse Detection Off A Key Press Beep Off Figure 3 44 High Pass Filter select Low Pass filter Select cutoff frequency of the low pass filter System Setup Units cm kg Lead Label IEC AC Line Filter 60Hz Low Pass Filter 150Hz High Pass Filter 0 04Hz AFS On ECG Sample Acquisition Post Auto Save No Lead Fail Detection On Pacer Pulse Detection Off 2 Key Press Beep Off Figure 3 45 Low Pass Filter select 3 Press the Filter button to adjust high pass filer and low pass filter at Filter the home screen YM303i 3channel Resting ECG System Operators Manual AFS AFS stand for Anti Floating System The AFS reduce wondering or drifting on base line System Setup Units cm kg Lead Label IEC AC Line Filter 60Hz Low Pass Filter 150Hz High
9. button and back for the left button Gain 10mm mV Speed 25mm s Report Format 3x4 Rhythm Lead Interpretation Print Median Beat Print Detail Result Muscle Filter No of Copy Figure 3 14 Rhythm lead select Automatic mode Interpretation This option selects the interpretation report print or not Yes for print No for not print interpretation result 10mm mV 25mm s Report Format 3x4 Rhythm Lead Interpretation Print Median Beat Print Detail Result Muscle Filter No of Copy Figure 3 15 Interpretation print Print Median Beat Median Beat print option This option works when the Interpretation option set to Yes 10mm mV 25mm s Report Format 3x4 Rhythm Lead Interpretation Print Median Beat Print Detail Result Muscle Filter No of Copy Figure 3 16 Median Beat print YM303i 3channel Resting ECG System Operator s Manual 39 40 Print Detail Result Detail result print option This option works when the Interpretation and Print Median Beat options set to Yes 10mm mV 25mm s Report Format 3x4 Rhythm Lead Il Interpretation Yes Print Median Beat No Print Detail Result No Muscle Filter Off No of Copy 1 Figure 3 17 Detail result print Muscle Filter The muscle filter select 10mm mV 25mm s Report Format 3x4 Rhythm Lead Il Interpretation Yes Print Median Beat No Print Detail Result No Muscle Filter Off No of Copy 1 Figure 3 18 Muscle F
10. dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 sec Floors should be wood concrete or ceramic tile If floors 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 Mains power quality should be that of a typical commercial or hospital environment If the user of the YM303i electrocardiograph requires continued operation during power mains interruptions it is recommended that the YM303i electrocardiograph be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level YM303i 3channel Resting ECG System Operator s Manual 97 Table 6 3 Electromagnetic Immunity IEC60601 1 2 IEC 60601 Compliance Immunity Test Electromagnetic Environment guidance test level level The YM303i electrocardiograph is intended for use in the electromagnetic environment specified below The customer or the user of the YM303i electrocardiograph should assure that it is used in such an environment Portable and mobile RF communications equipment should be used no closer to
11. Paper Select Z fold Roll Print Setup Menu List Patient Data Entry SD Card ECG List 1P 1B Default Setting Enter Hospital Name Enter the name of hospital using number pad Alphabets are assigned to number pad The left or right cursor button for shift other alphabets System Setup Hospital Name Physician Enter to edit Technician Enter to edit Location No 0 Cart No 0 Language English Date Format DD MM YYYY Date 01 01 2000 Time Format 12hr PM Time hh mm 00 27 Figure 3 31 Hospital Name YM303i 3channel Resting ECG System Operators Manual Physician Insert new physician or edit listed physician Listed physicians will be used lt Patient Data gt section of report Move the cursor on Physician item and press the ENTER button to enter the physician edit menu There are 8 physicians are available to list Write or Modify Move the cursor to Select column using the left lt or right cursor button Press the number of list to write or modify using number pad and press the ENTER button It will move to the line of select and type the first name and last name First name and last name section is switched with the left 4 or right cursor button Delete Move the cursor to Delete column using the left lt q or right cursor button Press the number of list to delete using number pad and press the ENTER button It will be deleted System Setup Hospital Name Physician Enter to e
12. l block 59 3 3 4 Patient Data Menu Patient Data New Patient Enter Patient ID Last Name First Name Date of Birth 00 00 0000 Height 0 Weight 0 gt Sex Male Patient Data Race No Pacemaker No Physician Technician Room No 0 Medication1 No Medication2 No Comments Comments Me Figure 3 64 Patient Data editor The patient data menu is made for note the patient information This information will be printed on the report and saved with ECG data when save button pressed or automatically saved at the Auto save mode New patient Yes No Pacemaker Yes No Patient ID 0 9 20 characters Physician Last name A Z 20 characters Technician Fist name A Z 20 characters Room No 0 9 4 digits Date of birth Medication1 No digitalis diuretics Sex male female antidepress steroids nitrtes ace Height 0 9 3 digits cytostatics Weight 0 9 3 digits Medication2 No digitalis diuretics Race No Caucasian black Asian oriental antidepress steroids nitrtes ace Hispanic native American pacific Island cytostatics Hawaiian Mongolian Comment A Z 20 characters Comment A Z 20 characters 0 If the PATIENT button is pressed at home screen it will be enter the Patient menu for patient data edit 60 YM303i 3channel Resting ECG System Operators Manual 3 3 5 File Management Menu File Management Copy Manual Save Internal Memory ECG List SD Card ECG List Delete All ECGs SD Card Init
13. 12 shows test result summary OK means the test is passed Fail means the test is not passed N A means the test is not performed This result summary page is printable and useful when you ask some technical Print Test Result Summary LCD Test Buzzer Test Keypad Test Thermal Printer Test support RS232 Test LAN Test SD Card Test USB Test Not Implemented Patient Cable Test ECG Acquisition Module Test Figure 4 14 Print Test Result Summary 4 6 Battery Maintenance If the device has not been used 2 or more months the internal battery will be exhausted If battery operation is needed at exhausted battery situation connect AC power line more than 6 hours for charging The battery should be removed from the device if placed in storage or will not be used for a long period Refer to the service manual for battery replacement YM303i 3channel Resting ECG System Operator s Manual Ia 4 7 Firmware Update The YM3031 is designed to updateable its firmware for performance enhancement or firmware recovery Firmware update is using USB memory device Depend on memory bender it may be incompatible with the YM303i If upgrade fails try using different bender s memory If any problem during firmware update contact the MEDIANA service center Caution Battery operation hazard Operate with AC power Do not off power during firmware update If lost power during firmware update it may serious error occurred Caution Trained
14. Em Network symbol This symbol means TCP IP terminal USB device symbol This symbol means Universal Serial Bus terminal 12 YM3031 3channel Resting ECG System Operators Manual 1 4 Symbols on the Packaging of YM303i Symbol Description Function Humidity limit information This symbol means acceptable range of humidity during it is transported and stored 10 to 95 non condensing Temperature limit information This symbol means acceptable range of temperature 20C to 60 C Keep dry This symbol means that the product avoid expose in rain or wet environment during it is transported and stored Upper side symbol This symbol indicates up side of package When the packages moved or stored keep the direction The point of arrow is Up side Recycle symbol This symbol means the package made from recycled materials 1 5 Service information Technical support and purchase of accessories are available at below contacts MEDIANA Co Ltd TEL 82 70 7092 9967 FAX 82 33 742 5483 YM303i 3channel Resting ECG System Operator s Manual 13 14 YM3031 3channel Resting ECG System Operators Manual Chapter2 Getting start YM303i 3channel Resting ECG System Operator s Manual 16 YM3031 3channel Resting ECG System Operators Manual Chapter2 Getting start 2 1 Intended use Caution The YM303i is intended to be used in a hospital and hospital facilities environment by trained medical personnel
15. Off LCD Brightness Communication Paper Select Print Setup Menu List Patient Data Entry SD Card ECG List Default Setting Off Off Off 100 RS 232 Roll Enter Enter to edit 1block Enter Figure 3 60 Print Setup Menu List YM303i 3channel Resting ECG System Operator s Manual 57 Patient Data Entry The device prints the patient data in the report System Setup Heart Rate Beep Warning Beep LCD Light Off LCD Brightness Communication Paper Select Print Setup Menu List Patient Data Entry SD Card ECG List Default Setting Off Off Off 100 RS 232 Roll Enter Enter to edit 1block Enter Patient Data Height Weight Sex Race Pacemaker Physician Technician Room No Medication1 Medication2 Patient ID Required Figure 3 61 Patient Data Entry Edit SD Card ECG List This parameter selects printing area of stored ECG list in SD card 1P The most recent page will be printed 1B 1block 100 EA of list form selected data will be printed System Setup Heart Rate Beep Warning Beep LCD Light Off LCD Brightness Communication Paper Select Print Setup Menu List Patient Data Entry SD Card ECG List Default Setting Off Off Off 100 RS 232 Roll Enter Enter to edit 1block Enter Figure 3 62 SD Card ECG List print set YM303i 3channel Resting ECG System Operators Manual Default Setting If use this option the device will changes to its original settings by
16. Pass Filter 0 04Hz AFS On ECG Sample Acquisition Post Auto Save No Lead Fail Detection On Pacer Pulse Detection Off 2 Key Press Beep Off Figure 3 47 AFS Setting ECG Sample Acquisition This parameter is selecting the timing of ECG signal acquisition beginning Pre sample mode If this parameter set to PRE the pre sampling buffer is enabled It means a report created with the ECG data acquitted before the RUN button pressed Post sample mode If this parameter set to POST the pre sampling buffer is disabled It means a report created with the ECG data acquitted after the RUN button pressed This parameter applies to only Automatic mode press RUN button LI hh hd dd 1444144141 lt Pre sample gt lt Post sample z Figure 3 48 Pre sample vs Post sample System Setup Units Lead Label IEC AC Line Filter 60Hz Low Pass Filter 150Hz High Pass Filter 0 04Hz AFS On ECG Sample Acquisition Post Auto Save Lead Fail Detection Pacer Pulse Detection 2 Key Press Beep Figure 3 49 Pre sample vs Post sample Auto Save If this parameter set to Yes the device automatically saves the ECG data at internal or external option memory every record This parameter applies to only Automatic mode YM303i 3channel Resting ECG System Operator s Manual 53 System Setup Units cm kg Lead Label IEC AC Line Filter 60Hz Low Pass Filter 150Hz High Pass Filter 0 04Hz AFS On ECG Sample Acquisition Post Auto Save N
17. Qty1 250Vac T6 3A in battery protection Standard 9 6V 2700mAh Large 9 6V 3800mAh Standard 100 basic reports Automatic Mode or 3hours continuous operation without printing Large 200 basic reports Automatic Mode or 4hours continuous operation without printing Battery Charge Time Approximately 5hours Physical Dimension 311X 242 X 85 WxLxH mm Weight without paper Approximately 2 4kg Environmental Temperature range 10 45 Operating Conditions Humidity range 20 95 non condensing Atmosphere Pressure 700 to 1060 hPa Temperature range 15 50 Humidity range 20 95 non condensing Atmosphere Pressure 500 to 1060 hPa EU Directives for medical devices I5013485 2003 Medical devices Quality management IS014971 2007 Medical devices Application of risk General Battery Capacity Storage Transportation Condition IEC60601 1 1988 A1 1991 A2 1995 General requirements for Safety IEC60601 1 4 2000 General Requirements for safety Collateral standard Programmable electrical medical systems ISO10993 1 2003 Biological evaluation of medical devices Part 1 Evaluation and testing 94 YM3031 3channel Resting ECG System Operators Manual Compliance continued IEC60601 2 25 1993 A1 1999 Particular requirements for Electrocardiograph the safety of electrocardiographs IEC60601 sub clause 36 IEC60601 1 2 2007 Electromagnetic compatibility Requirements and tests IEC61000 3 2 2000 Harmonic c
18. Reply from 198 18 0 26 bytes 32 time lt ims TTL 128 Reply from 198 18 0 20 bytes 32 time lt ims TTL 128 Reply from 198 18 0 20 bytes 32 time lt ims TTL 128 Reply from 198 18 09 20 bytes 32 time lt ims TTL 128 Ping statistics for 198 18 0 20 Packets Sent 4 Received 4 Lost lt x loss Approximate round trip times in milli seconds Minimum Ams Maximum ms Average Gms Figure 4 12 LAN Test ping Test 5 Lost 0 lt O loss gt means passed the test 4 5 8 SD Card Test This test is provided to check the external storage device SD card option 4 5 9 Voltage Level Test This menu checks the voltage level of major modules in the device The test is will be start automatically when entered this menu Voltage Level Test ves ue P Main Voltage Checking OK dE Motor Voltage Checking OK Header Voltage Checking OK 1 ue Voltage Level Test a Did the Test OK 9 0 1 Yes 2 No CJL Figure 4 13 Voltage Level Test 72 YM303i 3channel Resting ECG System Operators Manual 4 5 10 Patient Cable Test This test is provided to check the patient cable Connect all leads with a ECG simulator or short all leads 4 5 11 ECG Acquisition Module Test This test is provided to check the ECG acquisition module If this test is not passed please contact to service center 4 5 12 Print Test Result Summary This menu is located second page of Maintenance menu It shows summary of tests result Figure 4
19. any part of the YM303i electrocardiograph including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommend separation distance 3 Vrms BS 1 2 p 150 kHz to 80 Conducted RF d 1 2 p 80MHz to 800MHz IEC 61000 4 6 Ess Rad atad RF 3 V m d 2 3 p 800MHz to 2 5GHz 80MHz to IEC 61000 4 3 200MHz where Pis the maximum output power rating of the transmitter in watts W according to Sien the transmitter manufacturer and dis the 800MHz to recommended separation distance in metres 2 5GHz 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 H Interference may occur in the vicinity of equipment marked with the following symbol Doll NOTE 1 At 80 MHz and 800 MHz 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 a 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
20. before using the YM3031 68 o MAR nanee Mensa dll 69 Al DEMONS taton lee EE 70 A A eee 70 rs TE A IN EE 70 A A KEE EE 70 Mo EH le ek 71 GE EE 71 GE DEE 72 EE EE EE 72 45 Voltage Level EE 72 DEE Cable EE 73 4 5 11 ECG Acquisition Module Test EE 73 Ar 12 PRAT lest RESU ee le on IR 73 BE ag EE ie e EE 73 Te ii aL ARYA ere 74 Chapters Troubleshooting erre 79 5 1 Possible problems and solutions LES ue on 79 5 2 Error message descriptions ener reen erne n renerne reen renerne reen 81 A ERR 81 DALON BAEN enee 81 DZS LOW Ba e TEE 81 5 24 Printer Cover Open or End Ol e 82 EE IMC ENO ee ene ee ne ee 82 5 20 Patient ID CNG EO EE EE 82 SIZE POM UA bebe 83 A O eee ee eR ee ORE A ARIA a ee ed 83 BIO SHES D e EE EE SE E ODE LUI dE 84 SZ o arco 84 4 YM303i 3channel Resting ECG System Operators Manual AA e SS AAA 84 LA SU AA A 85 o EE 85 A O 85 A SA AAA A 86 Dee WAS E NGS EW OF Al ORESPRRE PRESERO ROROFIRI baleen ane A 86 5 2 18 Send Error PR RA ERRE e 86 A Ele lata 87 5 2 20 Print Directory EEEe ie 87 5 2 21 Input Saturation Warning Emmor nerne nerne renere ere e rer rr rrrrrere 87 AA A A A 88 ER Ree E Ero EE 88 A A 88 A EE O 89 Chapter6 Specification Bee 93 YM303i 3channel Resting ECG System Operator s Manual YM3031 3channel Resting ECG System Operators Manual Chapter1 Important Product information YM303i 3channel Resting ECG System Operator s Manual YM3031 3chann
21. its internal battery If devices connected to other devices or to parts of systems only when it has been made certain that there is no danger to the patient the operators or the environment as a result Connect equivalent ground when use with other devices It is possible that noises beyond guaranteed from immunity requirements of IEC60601 1 2 any radio frequency transmitting equipment and other sources of electrical noise such as cellular ohones can result in disruption of the device operation Remove all the metal accessories of patient wears before the perform measurement Do not use the device or any accessories if damaged Operator shall not touch patient and device simultaneously During use of device avoid contact between the metal part of device and the patient Do not touch the patient the patient cable or the device while defibrillator is operating When connect the patient with several electrical device it may increase electrical shock hazard by leakage current Do not connect the electrode or the patient cable with any other electrical device or its ground terminal Disconnect the device from the power line before cleaning or disinfecting its surface Do not use this device along with high frequency electrical operative equipment since it may damage the equipment or the patient 10 YM303i 3channel Resting ECG System Operators Manual Caution Indicates a potential hazard If not avoided this hazard may res
22. location in which the YM303i electrocardiograph is used exceeds the applicable RF compliance level above the YM303i electrocardiograph should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the YM303i electrocardiograph b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 98 YM3031 3channel Resting ECG System Operators Manual Table 6 4 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the YM303i electrocardiograph The YM303i electrocardiograph is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the YM303i electrocardiograph can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the YM303i electrocardiograph as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter in meter Rated Maximum MHz to 2 5GH Output power of 450 kHzto 80 MHz 80MHz to 800MHz SRO AE E Transmitter in watt For transmitters rated at a maximum output power not listed above the recommended separation distance din metres m can be determined using the equation applicable to the fre
23. personnel or service engineer only Firmware update is effect on all the operations so firmware update is doing by trained personnel or service engineer Caution All setting values will be lost All setting values of Automatic mode Setup Manual mode Setup and System Setup will be lost during firmware update Caution Default set after firmware update After new firmware update completed the device should set to the default If not set to default the device is not normal operation 1 Connect the YM303i with AC power line 2 Allsetting value of Automatic mode setup Manual mode setup and System setup will be lost during firmware update Before firmware updating please orint out setting value of the device MENU gt System Setup gt Print Setup Menu List 3 Turn the YM303i off Press the power button to tune the device off A Preparing a firmware saved USB memory Important firmware file must located in update folder Make a update folder at root folder and copy the firmware file Ex If USB memory device has E drive E update YM303i Vx xx bin 5 Connect USB memory and YM303i 6 Turn the device on Press the power button to tune the device on 74 YM303i 3channel Resting ECG System Operators Manual 7 Press the ESC button and the ENTER button during start up screen shows to enter the firmware update mode Press the ECS button and the ENTER button to firmware update STOP mode If not recogni
24. see s3 1 3 Home Screen It will be adjusted automatically pleas wait until ECG signal is stabled and try again 10mm mV Automatic 0 03Hz 150Hz 60Hz AFS EMG 3x4 R 08 26 2010 PM01 24 sp Figure5 21 Saturation warning YM303i 3channel Resting ECG System Operator s Manual 87 5 2 22 Pre Sample Error This message means Menu 3 System Setup 3 ECG Sample Acquisition is set Pre but not enough samples in the buffer to analyze Pleas wait more than 10second after YM3031 is turned on or any menu screen is closed Pre Sample Error Not acquired yet Press ESC key Figure5 22 Print Directory error 5 2 23 Update Error This message means device could not recognition a USB memory device Please check the USB memory device Firmware update N Caution Update Error Check USB AC power operation only Do not off the device until firmware update complete Recognition Reading Writing Figure5 23 Update Error 5 2 24 Update Error Il This message means there are no firmware data file bin to update It is occurred when 1 installed version is newer than the version you trying to update 2 installed version is same version you trying to update 3 other model s firmware file Check the version and model of the firmware file Firmware update Caution Update Error Check Firmware Name amp Ver AC power operation only Do not off the device until firmware update complete Recogn
25. 01 24 SD Figure 2 4 home screen YM303i 3channel Resting ECG System Operators Manual 2 6 Connecting with patient 1 Lay down the patient on the bed and get rest 2 Connect to the patient with the YM303i Use the patient cable provided by MEDIANA Co Ltd and plugin the patient cable connector on the right side of the YM3031 3 Connect the electrodes with leads Figure 2 5 shows chest electrode and clamp electrode Connect Chest electrodes with lead C1 to C6 and Clamp electrodes with lead R L F and F Screw to clockwise the hold screw of electrode for tight contact Loose contact may cause noise on the ECG signal Figure2 5 chest electrode left clamp electrode right 4 Locate the patient bundle on the center of the patient YM303i 3channel Resting ECG System Operator s Manual 25 26 5 Attach the electrode to the body of patient The figure 2 6 shows the position of electrodes it is important to acquit or analyze of ECG signal The electrodes positions and contact conditions affect the ECG signal quality and interpretation result If patient s skin is too dry put some water and if too much hair at the electrode attaching place then it needs shaving Bad contact condition with skin and electrode may cause added noise on the ECG signal Chest Lead 00 Figure 2 6 ECG Lead system All leads has label as shown in figure 2 6 Match the electrodes and the leads as shown in figure 2 6 and label d
26. 02 03 Printed in Korea 2011 2014 MEDIANA Co Ltd All rights reserved e epes Bd G n ral Wahis 53 1030 Brussels Belgium CE 0434 CONTENTS Chapter1 i Important Product Information DT 9 1 1 General information 9 1 2 Safety information asta 10 t3 SsymbOlS Marked n YM303 EE 12 1 4 Symbols on the Packaging of MSDS o ed oo dre ao 13 Te Hee MI ON e o e LANA 13 Chapter2 Getting start SE 17 P N o o A ER TT IT EE 17 ZA LME BEE e EEN 18 222 Ne OV ON iaia died na od eat na ot 19 ee AUS LED EE 19 E TEE 19 Z3 eg E EE Le ENEE EN 2 4 YM3031 Ordering Information 23 PASATEN A E A A A EE 23 2 6 Connecting with patient 25 Chapter3 Operating IATA AAA AAA 29 E EE 29 E SEAT TO TT TT 29 ENEE ee EE 29 dal HON SAA R 30 gt 2 bGGMeasufe menta A eni 31 3 2 1 Automatic A 31 SM ANUS te 32 3 3 The Setup GE TE EE 33 3 3 1 Automatic modeMenu r n n n 33 2 3 2 Manual mode Menu o 41 SSIS SYS ng Oe WO NEN EE 45 3 3 4 Patient Data Menu Re eee ee AE Ee 60 3 3 5 File Management Menu 61 5 SO Maintenance MENU EE 61 YM303i 3channel Resting ECG System Operator s Manual Chapter4 Device Maintenance Per er Te eee eee ere ree ee SS SES SEES Tee er eee SES SES SES ee TEA 65 4 1 Loading Printer EE 65 ol o o EE 65 1 12 ele Wie Paper load et e el e de a e lea dan 66 Pei 67 4 IA eLo te deV EE 67 AAA ee Bee 67 BES nee Bee EE 67 AO HN are tepne Nedd ME 68 o e DEE 68 PS o N N E 68 4 4 Checklist
27. CD Brightness Communication Paper Select Print Setup Menu List Patient Data Entry SD Card ECG List Default Setting Off Off Off 100 RS 232 Roll Enter Enter to edit 1block Enter Figure 3 57 LCD Brightness adjust Communication This parameter is selecting communication port 232 for RS 232 serial port and TCP for TCP IP LAN port Patient Data Entry SD Card ECG List Default Setting System Setup Heart Rate Beep Off Warning Beep Off LCD Light Off Off LCD Brightness 100 Communication RS 232 Paper Select Roll Print Setup Menu List Enter Enter to edit Enter 1block System Setup Heart Rate Beep Warning Beep LCD Light Off LCD Brightness Communication 000 000 000 000 000 000 000 000 4000 Port No Figure 3 58 Communication port select YM303i 3channel Resting ECG System Operators Manual Paper Select This parameter is selecting the loaded paper type Z for z fold type paper and R for Roll type paper System Setup Heart Rate Beep Warning Beep LCD Light Off LCD Brightness Communication Paper Select Print Setup Menu List Patient Data Entry SD Card ECG List Default Setting Off Off Off 100 RS 232 Roll Enter Enter to edit 1block Enter Figure 3 59 Paper type set Print Setup Menu List If the cursor move to this filed and press the ENTER button the device will print all setting value System Setup Heart Rate Beep Warning Beep LCD Light
28. ECG Figure5 15 Copy error Il YM303i 3channel Resting ECG System Operator s Manual 85 5 2 16 Delete Error 5 2 17 Change Error 5 2 18 Send Error 86 This message is occurred when you trying delete at File Management menu It means there are no data to delete in selected storage Internal memory or SD card Delete Error No Data Figure5 16 Delete error This message occurred when you trying Change function but there are no ECG data saved to change in Internal Memory or SD Card Change Error No Data Figure5 17 Change error This message occurred when you trying Send function but there are no ECG data saved to change in Internal Memory or SD Card Send Error No Data Figure5 18 Send error YM3031 3channel Resting ECG System Operators Manual 5 2 19 Print Error This message occurred when you trying Print function but there are no ECG data saved to change in Internal Memory or SD Card Print Error No Data Figure5 19 Print error 5 2 20 Print Directory Error This message occurred when you trying Print Directory function but there are no ECG data saved to change in Internal Memory or SD Card Print Directory Error No Data Figure5 20 Print Directory error 5 2 21 Input Saturation Warning Error This message with warning beep appears when the analog signal saturate It is displayed on Signal Quality Indication section
29. Figure 3 65 File Management menu Stored data are could be management at this menu Copy Extra report printing of last recorded ECG at automatic mode Manual save Save the last recorded ECG at automatic mode manually Internal memory ECG list Show the list of ECGs recorded in internal memory SD Card ECG list Show the list of ECGs recorded in SD card Delete All ECGs Delete all ECGs recorded in internal memory and SD card SD Card ECG Init Initialize a SD card Before using a new SD card must be initialized 3 3 6 Maintenance Menu There are menus for operation testing of the device Bellow items available Demonstration mode LAN test LCD test SD card test Buzzer test USB test Keypad test Patient cable test Thermal print test ECG acquisition module test RS232 test Print test result summary For more detail information please refer to Chapter4 Device Maintenance gt 4 6 Maintenance Menu YM303i 3channel Resting ECG System Operator s Manual 61 62 YM3031 3channel Resting ECG System Operators Manual Chapter4 Device Maintenance YM303i 3channel Resting ECG System Operator s Manual 64 YM3031 3channel Resting ECG System Operators Manual Chapter4 Device Maintenance 4 1 Loading Printer Paper Roll type and z fold type paper can be used on the YM3031 Figure 4 1 shows ending mark of roll and Z fold type paper Ending mark is located back side of roll type paper and front side of z fold type paper If ending m
30. M3031 has a soft power button Press to switch on off the device When off the device press longer 2 2 2 Power Status LED The YM303i has 3 power status LEDs Table 2 1 Power Status LEDs LED i LED Name f Description Funetion De Lemon Saig Green come Ac poverine Solid Green Connect AC power line a off The device is off Solid Green The device is on Off Battery Operation at device On 7 Battery Charging Blinking Orange The battery is charging Solid Orange The battery is fully charged The buttons of YM303i have more than one function There is 2 2 3 Keypad Gai an example button 1 works as number 1 at text input situation ain e and gain hotkey at home screen Table 2 2 Keypad of YM303i Description Function 1 Number 1 Gain Adjust input gain 5 10 20mm mV 2 Number 2 Speed Adjust printing speed 5 10 25 50mm sec 3 3 Number 3 Filter Filter Hotkey for enter to filter select menu 4 Number 4 5 Number 5 G mode Hotkey for change grouping of ECG waveform J Go din OD Q displayed on LCD screen 6 Number 6 C mode Hotkey for change channel of grouped ECG waveform displayed on LCD screen 7 Number 7 Save Hotkey for last acquisition data save 8 Number 8 Copy Hotkey for extra report printing of last recorded ECG at O E S e E lt automatic mode 9 Number 9 File Hotkey for ECG data management YM303i 3channel Resting ECG System Operator s Manual 19
31. Resting ECG System Operators Manual MIR This format is printed 1 rhythm lead MEDIGATE HOSPITAL i d L EKG LANDE RILLAXT LE DS CASE ee Dp OCA TON BUS SU ENELAI ice LAN Es 25mm 10mm mV BSS AFS Off SHEE 19 52 Figure 3 24 Format MIb M2R This format is printed 2 rhythm leads MEDIGATE HOSPITAL 1 i I EE dE Sl ME E L LA EER E E i 2 y n Lo HA BYGE A HA A RA HA a E IALIA I LEA md Cr wi S EE CATE N LA CR Bs SAG EUA AN A Z5mm s 10mm mV Ra 60Hz AFS Of ESRI 19 52 Figure 3 25 Format M2R M3R This format is printed 3 rhythm leads MEDIGATE HOSPITAL La Letz WAL LL mn Ent GANA Lal IN LA HA E NES AN ni A s aE GEESS ISL EAS CAS EAN A TA AE ERA AREA LE iL D 4 A enke A ER En ET GE A TERRA MACELLERIA LI A 25mm s 10mm mV SSS AFS Off pr 19 32 Figure 3 26 Format M3R M6R This format is printed 6 rhythm leads MEDIGATE HOSPITAL I kr rest er REX loa if ip EFS HRK n I f 1 A 1 UL RAE TEA A PE RENE LS AE ER SS A MAL LAE EIA REA WE E Dit OS E E RA E E LETI De 7 E SR Stars ES O ee o PE A A A F lave avL aVL Figure 3 27 Format M6R YM303i 3channel Resting ECG System Operator s Manual 44 Rhythm Lead This menu applied on the report format There are some options of rhythm lead 10mm mV 25mm s Report Fo
32. YM3031 3 Channel Resting ECG System L09521 Revision 02 et MEDIANA Note The information in this manal applies to YM303i 3channel resting ECG system Due to continuing product innovation specifications in this manual are subject to change without notice Warranty The information contained in this document is subject to change without notice MEDIANA Co Ltd makes no warranty of any kind with regard to this material including but not limited to the implied warranties or merchantability and fitness for a particular purpose MEDIANA shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing performance or use of this material Revision History The document part number and revision number indicate its current edition The revision number changes when a new edition is printed in accordance with the version of the documentation Minor corrections and upgrades which are incorporated at reprint do not cause the revision number to change The document part number changes when extensive technical changes are incorporated Supplier MEDIANA CO Ltd 132 Donghwagongdan ro Munmak eup Wonju si Gangwon do Korea Tel 82 70 7092 9967 Fax 82 33 742 5483 w MEDIGATE INC 42 10 Taejanggongdan gil Wonju si Gangwon do Korea Tel 82 33 747 3552 Fax 82 33 747 3691 YM303i Operators Manual Part Number Revision L09521 02 Date of Revision 2014
33. YYYY Date 01 01 2000 Time Format 12hr PM gt Time hh mm 00 27 Figure 3 39 Time format select 50 YM303i 3channel Resting ECG System Operators Manual Time Move the cursor on Time field and set the current time with number pad Example1 gt If current time is 2 30pm and desired time format is 12h Then type the flowing numbers using number pad Type 0 2 3 0 Example2 gt If current time is 2 30pm and desired time format is 24h Then type the flowing numbers using number pad Type 1 4 3 0 System Setup Hospital Name Physician Enter to edit Technician Enter to edit Location No 0 Cart No 0 Language English Date Format DD MM YYYY Date 01 01 2000 Time Format 12hr PM Time hh mm 00 27 Figure 3 40 Time set Units Move the cursor on Units field and select desire units System Setup Units Lead Label IEC AC Line Filter 60Hz Low Pass Filter 150Hz High Pass Filter 0 04Hz AFS On ECG Sample Acquisition Post Auto Save No Lead Fail Detection On Pacer Pulse Detection Off 2 Key Press Beep Off Figure 3 41 Units select Lead Label Move the cursor on Lead Label field and select desire labels System Setup Units cm kg Lead Label IEC AC Line Filter 60Hz Low Pass Filter 150Hz High Pass Filter 0 04Hz AFS On ECG Sample Acquisition Post Auto Save No Lead Fail Detection On Pacer Pulse Detection Off 2 Key Press Beep Off Figure 3 42 Lead label select YM303i 3channel Resting ECG System
34. al 20 Description Function 0 Number 0 Patient Patient Hotkey for enter to patient data editor ee ENTER confirming of a selected parameter RON RUN Hotkey for make a report ESC go to upper menu or exit menu me STOP Stop printing at manual mode Stop acquisition or printing at automatic mode MENU MENU enter to configuration menu A Up cursor press to move the cursor up AUTO AUTO Auto mode press to select to automatic mode 4 Lett cursor press to move the cursor left e w Down cursor press to move the cursor down EE Manual Manual mode press to select to manual mode gt Right cursor press to move the cursor right It works at home screen YM303i 3channel Resting ECG System Operators Manual 2 3 YM303i contents a YM303i Device 1EA b Clamp Electrodes 1Pack 4EA c Chest Electrodes 1Pack 6EA d Patient Cable 1EA e Roll Paper 1Roll f Z fold Paper 1EA g Program and Manual 1EA SE ES e h AC Power Cable 1EA Figure 2 2 YM303i contents Basic The above pictures vary from the original in some points YM303i 3channel Resting ECG System Operator s Manual 21 22 Options i SD Card m Disposable Adapter 1Set 10EA j Serial Cable 1EA n Disposable Electrode Round A gt a w A Been do a Ca va 6 99 es A k Ground Cable 1EA o Disposable Electrode Tab Manual 1EA fB MEDIANA Figure 2 3 YM303i co
35. arameter list of Automatic configuration Gain mm mV 5 10 20 Speed mm s 5 10 25 50 Report Format 2x6 3x4 2 R 3 R 6x2 Rhythm Lead I II III aVR aVL aVF V1 V2 V3 V4 V5 V6 Interpretation Yes No Print Median Beat Yes No Print Detail Result Yes No Muscle Filter 25Hz 35Hz Off No of Copy 0 1 2 3 4 5 6 7 8 9 Gain Select the input gain rate Selectable options are 5 10 or 20mm mV If the report format is selected as 6x2 the gain is fixed as 5mm mvV Report Format Rhythm Lead Interpretation Print Median Beat Print Detail Result Muscle Filter No of Copy Figure 3 6 Gai YM303i 3channel Resting ECG System 10mm mV 25mm s 3x4 Il Yes No No Off 4 n Automatic mode Operators Manual Speed Select the paper speed Selectable options are 5 10 25 or 50mm s If the report format is selected as 6x2 the speed is fixed as 25mm s Report Format Rhythm Lead Interpretation Print Median Beat Print Detail Result Muscle Filter No of Copy 10mm mV 25mm s 3x4 Il Yes No No Off 1 Figure 3 7 Speed Automatic mode If press the Gain button at Home Screen it will be switched input gain among 5 10 and 20mm mV without enter the configuration menu If press the Speed button at Home Screen it will be switched print speed among 5 10 25 50 mm s without enter the configuration menu Report format The YM303i has 5 different styles of rep
36. ark shows up reload new paper Figure 4 1 The paper ending mark left Roll type right Z fold type NOTE Ending mark of the paper could be changed without notice 4 1 1 Roll type paper loading 1 Press the PUSH button to open the paper compartment 2 Put the shaft into grad of roll type paper and insert it to paper container by following the shaft guide NOTE The shafts are not for single use do not throw it away 3 Release the paper and must be positioned exactly on the cover roller before the cover is closed NOTE Check the paper type at the device Figure 4 2 Roll type paper loading YM303i 3channel Resting ECG System Operator s Manual 65 4 1 2 Z fold type paper loading 1 Press the PUSH button to open the paper compartment AN I sg Ya 2 Put the Z fold paper to the paper container If roll paper guide is remained remove it The black maker is lower side NOTE The shafts are not for single use do not throw it away 3 Fold out the first page of paper to the right and close the cover NOTE Check the paper type at the device Figure 4 3 Z fold type paper loading Caution Use only MEDIANA Co Ltd supplied paper If use other products it may make poor quality printing or damage on the device YM303i 3channel Resting ECG System Operators Manual 4 2 Cleaning Caution e When cleaning the equipment wipe it with sponge or something like
37. at 12hr PM y Time hh mm 00 27 System EE Setup Technician Select M Delete Delete 1 NO Ss Name First Name 0 Y OO _ O1 E WN A System Setup Technician Select 1 Delete 1 Last Name First Name z Figure 3 33 Technician List edit YM303i 3channel Resting ECG System Operators Manual Location No When using multiple devices from multiple locations each device can be assigned a location number System Setup Hospital Name Cart No When using multiple devices from multiple carts each device can be Physician Enter to edit Technician Enter to edit Location No 0 Cart No 0 Language English Date Format DD MM YYYY Date 01 01 2000 Time Format 12hr PM Time hh mm 00 27 Figure 3 34 Location Number assigned a cart number Hospital Name Physician Enter to edit Technician Enter to edit Location No 0 Cart No 0 Language English Date Format DD MM YYYY Date 01 01 2000 Time Format 12hr PM Time hh mm 00 27 Figure 3 35 Cart Number Language When the cursor moved on Language parameter and press the ENTER button it will be shown up the selection box Set the desired language with number pad System Setup Hospital Name Physician Enter to edit Technician Enter to edit Location No 0 Cart No 0 Language English 1 English Date Format DD MM Y Y Y 2 Espa ol Date 01 01 2010 3 Italiano Time Format 12hr PM 5 tc Time hh mm 00 27 i
38. dit Technician Enter to edit Location No 0 Cart No 0 Language English Date Format DD MM YYYY Date 01 01 2000 Time Format 12hr PM Time hh mm 00 27 System Setup Physician Delete First Name Select 1 Last Name ONO BOD System Setup Physician Delete 1 First Name Select 1 Last Name 0 NO O1 SOND Figure 3 32 Physician List edit YM303i 3channel Resting ECG System Operator s Manual 47 48 Technician Insert new technician or edit listed technician Listed technician will be used lt Patient Data section of report Move the cursor on Technician item and press the ENTER button to enter the technician edit menu There are 8 technician are available to list Write or Modify Move the cursor to Select column using the left lt q or right cursor button Press the number of list to write or modify using number pad and press the ENTER button It will move to the line of select and type the first name and last name First name and last name section is switched with the left 4 or right cursor button Delete Move the cursor to Delete column using the left lt q or right cursor button Press the number of list to delete using number pad and press the ENTER button It will be deleted System Setup Hospital Name Physician Enter to edit Technician Enter to edit Location No 0 Cart No 0 Language English Date Format DD MM YYYY Date 01 01 2000 Time Form
39. e Handle the electrode with care so that its inside surface is not scratched YM303i 3channel Resting ECG System Operator s Manual 11 1 3 Symbols marked on YM303i Symbol Description Function Classification of electrical protection symbol This symbol 19 means the device is CF type cardiac floating protection applied EU Consult instructions for Use This symbol means read manuals or descriptions from manufacture AN EU Warning or Caution This symbol indicates hazard High Voltage Caution This symbol means high voltage parts included EU Manufacturer information The manufacturers information shows with this symbol EU Made Date The made date of the product shows with this symbol aer EU Representatives information The manufacturers EU representative information shows with this symbol EU Model name This symbol means model name of product LOT EU Lot number This symbol means lot number of product EU Serial Number This symbol means serial number of product EU Electronics and Battery Disposal Information This symbol means that the product and battery should be recycled separately from household waste When this E product reaches its end of life follow the local laws and Wm regulations of disposal The improper disposal of waste electronic equipment from the consumer may be subject to fines pn SD card symbol This symbol indicates SD card slot y GND symbol This symbol means equivalent ground terminal
40. e maintenance and paper does not Ge di er position verifying the paper direction come 2777 s the loaded paper Z fold hould MEDIANA Co Ltd supplied by MEDIANA US apes Snowe use Bett supplied Co Ltd Check if the loaded paper type and setting value is Printer ejects blank paper continuously Set that the paper type as loaded paper Menu System Setup Paper Select matched Printer works but Check if the printer of Refer to Chapter4 Device maintenance and some line doesn t ge paper got dirty cleaning the thermal printer print Check the Paper guide when roll paper use only Printer crumples Check the print cover if Refer to Chapter4 Device maintenance and Up paper it is opened loading the paper Check the paper loaded at center of the paper container YM3031 3channel Resting ECG System Operators Manual 5 2 Error message descriptions The following errors are may occurred at YM303i to notify the user to take the necessary response 5 2 1 Critical error This message with warning beep appears when the device occur the critical problem After that the device automatically shut down After a while turn on If problem persists contact qualified service personnel or MEDIANA service center Critical Error Please Wait Figure5 1 Critical error 5 2 2 Low Battery This message is occurred when not enough battery to any operation When this message shows up all opera
41. el Resting ECG System Operators Manual Chapterl Important Product Information 1 1 General information The product YM303i bears the CE marking CE indicating its conformity with the provisions of the Council Directive 93 42 EEC as amended by 2007 47 EC concerning medical devices and fulfills the essential requirements of Annex of this directive It is class lla MDD equipment The product Is designed to comply with IEC60601 requirements It Is a protection class type CF device The product complies with the electromagnetic immunity requirements of standard IEC 60601 1 2 EN 60601 1 2 Electromagnetic Compatibility Medical Electrical Equipment The radio interference emitted by this device is within the limits specified in CISPR11 EN5501 1 class B This manual is an integral part on the device It should always be kept near the device Close observance of the information given in the manual is a prerequisite for proper device performance and correct operation and ensures patient and operator safety This manual is in conformity with the device specifications and Standards on safety of electro medical equipment valid at the time of printing All rights are reserved for device circuits techniques and software program appearing in this manual To ensure patient safety the specified measuring accuracy and interference free operation we recommend using only original MEDIANA components The user is responsible for applicat
42. eration set to on the device will make a beep sound when heart a peak detected Heart Rate Beep Warning Beep LCD Light Off LCD Brightness Communication Paper Select Print Setup Menu List Patient Data Entry SD Card ECG List Default Setting System Setup Off Off Off 100 RS 232 Roll Enter Enter to edit 1block Enter Figure 3 54 Heart Rate Beep On Warning Beep If this operation set to on the device will make a beep sound when warning situation occurred System Setup Heart Rate Beep Warning Beep LCD Light Off LCD Brightness Communication Paper Select Print Setup Menu List Patient Data Entry SD Card ECG List Default Setting Off Off Off 100 RS 232 Roll Enter Enter to edit 1block Enter Figure 3 55 Warning Beep On YM303i 3channel Resting ECG System Operator s Manual 55 LCD Light off This parameter sets back light off time of LCD for saving battery If the 5 is selected the device will be turned off the back light when no button pressed within 5 minutes System Setup Heart Rate Beep Warning Beep LCD Light Off LCD Brightness Communication Paper Select Print Setup Menu List Patient Data Entry SD Card ECG List Default Setting Off Off Off 100 RS 232 Roll Enter Enter to edit 1block Enter Figure 3 56 LCD Backlight off time set LCD Brightness This parameter is adjusting brightness of LCD Heart Rate Beep Warning Beep LCD Light Off L
43. ery fully The battery is not charged charged or too The battery is replaced We recommend Is the battery used more short operating Hanse ch replace old battery with new one supplied by an 6 month MEDIANA Co Ltd Menu Systems Seno Ve power n Li A utton is presse ack light will be LCD light off setting P 5 LCD is too dark turned on Menu System Setup Adjust LCD Brightness value Bigger value is LCD Brightness setting brighter Abnormal ae Is an error message See the 5 2 Error message descriptions and overlapped display shown Device dose not respond to any button pressed The height of ECG The gain value decides height of ECG signal wave is too big or Check the gain value Adjust the Gain value recommend too small 10mm mV occurred follow it and restart device Is an error message See the 5 2 Error message descriptions and occurred follow it and restart device The speed value decides length of ECG signal Adjust the Speed value recommend 20mm s If you want 2 5sec 5sec or 10sec printing the The length ECG wave is too short Check the speed value or too long report format should be changed Menu Auto Manual gt Report Format YM303i 3channel Resting ECG System Operator s Manual 79 Table 5 1 Possible problems and solutions list continued Possible Solutions Check electrodes if it All the electrode needs to acquit ECG signal puts wrong place or make sure all electrode
44. heck Error 82 This message is occurred when RUN button is pressed at MENU gt System Setup gt Patient Data Entry gt Pat ID Check set to Yes but not entered patient ID Input the patient ID or MENU gt System Setup gt Patient Data Entry gt Pat ID Check set to No Patient ID Error Press ESC key and ID Required Figure5 6 Patient ID Check error YM3031 3channel Resting ECG System Operators Manual 5 2 7 Save Error This message is occurred when Save button is pressed at MENU gt System Setup gt Patient Data Entry gt Pat ID Check set to Yes but not entered patient ID Input the patient ID or MENU gt System Setup gt Patient Data Entry gt Pat ID Check set to No Save Error Press ESC key and Check ID Figure5 7 ID Check error 5 2 8 Save Error Il This message is occurred when Save button is pressed at Manual Model The ECG data save function is valid only Automatic model Save Error Press ESC key and Check Mode Figure5 8 Mode error 5 2 9 Save Error III This Message is occurred when Save button is pressed without ECG measurement Please try again after ECG measurement at Automatic mode Save Error Press ESC key and Measure ECG Figure5 9 ID Data empty error YM303i 3channel Resting ECG System Operator s Manual 83 5 2 10 Date Input Error This message with warning beep appears when the date is
45. ifference between IEC and AHA shown in Table 2 4 If the connection is wrong it may makes bad effect on signal or result Table 2 4 IEC lead and AHA Lead Limb Lead Chest Lead EC CO A A A AE A e AHA FA mv a A va YM303i 3channel Resting ECG System Operators Manual Chapter3 Operating YM303i 3channel Resting ECG System Operator s Manual 28 YM3031 3channel Resting ECG System Operators Manual Chapter3 Operating 3 1 Screens 3 1 1 Startup screen 3 1 2 Boot Screen At this chapter it will be described major screens of the YM3031 and its functions The figure 3 1 shows the startup screen of the YM3031 It is the first screen on the LCD after the device is turned on Startup screen shows BIOS version and waiting progress bar for the firmware update event For more detail information of the firmware update refer to the firmware update section Figure 3 1 Startup screen The figure 3 2 shows the boot screen The YM303i is ready to operate during this screen shown Boot screen shows model name and firmware version of the device Figure 3 2 Boot screen YM303i 3channel Resting ECG System Operator s Manual 29 3 1 3 Home Screen The figure 3 3 shows Home screen of the YM3031 The home screen shows parameters of the YM3031 and ECG waveforms It may look different depending on the parameters setting and input signals ete ssa e fara E gt
46. ilter select 3 If press the Filter button at home screen filter adjust window will be Filter opened No of Copy This option is select how many extra copies will be printed The Copy Print mark will be located on the first page of extra report s Gain 10mm mV Speed 25mm s Report Format 3x4 Rhythm Lead Il Interpretation Yes Print Median Beat No Print Detail Result No Muscle Filter Off No of Copy 1 Figure 3 19 No of Copy set If press the Copy button at home screen last printed report will be printed Automatic mode only If power off the device last printed report in memory will be lost YM303i 3channel Resting ECG System Operators Manual 2 3 2 Manual mode Menu 1 Switch to Manual mode manual Press the MANUAL button for switch to manual operation mode All parameter of manual mode is changed only at manual mode 2 Press the MENU button to enter the configuration menu menu Press the MENU button for configuration menu and move the cursor a on Manual and press the ENTER button It is impossible to enter the configuration menu during other ENTER cc Se ECG na SUN unction operate such as report printing or acquisition Configuration Manual System Setup Patient Data File Management Mainternance 10mm mV 25mm s Report Format 3x4 Rhythm Lead 1 11 141 Muscle Filter Off Figure 3 20 Manual mode setting 3 The parameters of Manual mode Gain mm mV 5 10 20 M3R
47. ion of accessories from other manufacturers The warranty does not cover damage resulting from the use of unsuitable accessories and consumables from other manufacturers The Se Salte given in this manual is classified as follows Caution Indicates a potential hazard If not avoided this hazard may result in minor personal injury and or product property damage YM303i 3channel Resting ECG System Operator s Manual 9 1 2 Safety information Warning Indicates a hazard If not avoided the hazard can result death or serious injury e Avoid humidity high temperature dust in the air salt or sulfuric material and avoid the unventilated place or the direct sunlight Avoid vibration or mechanical shock Avoid fire and explosion hazard An explosion hazard may result from the use of flammable anesthetics skin cleansing agents and disinfectants Dispose of the packaging material observing the applicable waste control regulations Keep the packaging material out of children s reach Check the voltage rating before you connect the device to an electrical outlet to ensure that the required voltage and frequency are those o indicated on product label or manual In order to secure electrical safety connect the power cable to an independent grounded electrical outlet only If use multi tap inevitably use the one provided with earth pin by all means If in doubt the integrity of the AC power source the device must be operated from
48. ition Reading Writing Figure5 24 Update Error Il 88 YM303i 3channel Resting ECG System Operators Manual 5 2 24 Update Error Ill This message occurred when not enough internal power to firmware update Please connect AC power line and try again Firmware update Caution WARNING LOW BATTERY AC power operation only Program is shutting down Do not off the device until firmware update complete Recognition Reading Writing Figure5 25 Update Error III YM303i 3channel Resting ECG System Operator s Manual 89 90 YM3031 3channel Resting ECG System Operators Manual Chapter6 Specification YM303i 3channel Resting ECG System Operator s Manual 92 YM3031 3channel Resting ECG System Operators Manual Chapter6 Specification Display Type 4 3 inch color TFT LCD Computerized Electrocardiograph Acquisition amp Analysis 12Leads simultaneously Internal Voce External Option 5000 ECGs in SD Card AC differential 5mV Using a USB memory device AC Line Filter 50 60Hz Low Pass Filter 40 100 150Hz Filter High Pass Filter 0 04 0 05 0 16 0 1 0 3Hz Muscle Filter 25 35Hz Anti Floating System AFS Voltage axis 8dots mm Time axis 16dots mm een Roll 80mm W X 30m L per typ Z fold 80mm W X 80mm L X 300 sheets YM303i 3channel Resting ECG System Operator s Manual 93 Electrical Power Supply AC or Battery operation AC Input 100 240VAC 50 60Hz 7OVA
49. leaning the printer head 4 3 1 Storing thermal paper 1 Store the paper in suitable rooms at a temperature between 18 C and 24 C 65 F and 75 F and relative humidity between 40 and 60 2 Avoid direct contact of the paper with carbon and carbonless forms chat papers and adhesives containing tributly phosphate dibutyl phthalate or any other organic solvents document protectors envelopes and sheet separators containing plasticizers solvents or solvent based products containing alcohols ketones esters or other substances from this chemical group 3 Printout paper discoloration may occur at unsuitable environment temperature humidity or period with in 1 year 4 4 Checklist before using the YM303i 68 Following list is needed to visual check before every using the YM3031 for your safety Did the device get any physical damage on surface Did the device get wet Did the AC cable get any physical damage Did the patient cable get any physical damage Is the safety labels attached on right place YM303i 3channel Resting ECG System Operators Manual 4 5 Maintenance Menu The YM3031 has Maintenance Menu It is provide testing functions demonstration and system information 1 Press the MENU button to enter the Configuration menu Configuration Auto System Setup Patient Data File Management Mainternance Figure 4 5 Enter to the Maintenance Menu 2 Move the cursor on the Maintenance and p
50. nment as described below Table 6 1 Electromagnetic Emissions IEC60601 1 2 The YM303i electrocardiograph uses RF energy RF emission only for its internal function Therefore its RF Group 1 ep CISPR 11 emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emission CISPR 11 oer Il Harmonic emissions IEC61000 3 2 esa Voltage fluctuations flicker emissions Complies IEC61000 3 3 96 YM303i 3channel Resting ECG System Operators Manual Table 6 2 Electromagnetic Immunity IEC60601 1 2 Immunity Test IEC 60601 test level Compliance level Electromagnetic Environment guidance Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 1 1 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT gt 95 dip in UT for 5 sec 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output Lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60
51. not entered or is out of the realistic range month 1 12 day 1 31 Check the date and then input again Date Error Press ESC key and Input Again Figure5 10 Date input error 5 2 11 Time Input Error This message with warning beep appears when the time is not entered or is out of the realistic range min 1 59 hour 1 0 12 24 Check the time and then input again Time Error Press ESC key and Input Again Figure5 11 Time input error 5 2 12 Figure Input Error This message means not valid number typed Each IP addresses field can have a value from 0 through 255 Please type valid number Figure Error Press ESC key and Input Again Figure5 12 Figure input error 84 YM3031 3channel Resting ECG System Operators Manual 5 2 13 Password Input Error This message means entered password is not matched Password Error Press ESC key and Input Again Figure5 13 Wrong Password error 5 2 14 Copy Error Manual Mode doesn t have Copy operation This message means the Copy button is pressed at Manual model Change the operation mode to Automatic model Copy Error Press ESC key and Check Mode Figure5 14 Copy error 5 2 15 Copy Error Il The Copy function prints using previous ECG data which acquitted at Automatic model This message means there are no available data in buffer Copy Error Press ESC key and Measure
52. ntents Options The above pictures vary from the original in some points YM303i 3channel Resting ECG System Operators Manual 2 4 YM303i Ordering Information Table 2 3 YM303i Ordering Information No Ordering Code Name Um Ce dii el am Zold Paper Jemen p Re 7 m Tea RE Lo AI0201 Disposable FlectrodeCTab Pack 2 5 Installation 1 Install the YM303i in place where avoid humidity high temperature dust in the air salt or sulfuric material and avoid the unventilated place or the direct sunlight 2 Connect provided AC power cable with the YM303i YM303i 3channel Resting ECG System Operator s Manual 23 24 3 Plug the AC power cord to independent grounded AC outlet recommended Connect the ground cable when use no grounded AC outlet Don t arrange in parallel the power line and the patient cable it may makes noise in signal 4 Press the power button to turn on the YM303i The power button is pressed Power On LED turn on and shows up the startup screen and the boot up screen 5 When booting sequence complete the home screen shows up in LCD If the home screen shows up it means the YM3031 it ready for acquisition monitor input signals and enter to configuration menus See the Screens description for detail information The home screen is may be different because of setting value 10mm mV Automatic 0 03Hz 150Hz 60Hz AFS EMG 25mm s 3x4IR 08 26 2010 PM
53. o Lead Fail Detection On Pacer Pulse Detection Off gt Key Press Beep Off Figure 3 50 Auto Save Lead Fail Detection This function is detecting lead fail situation It means bad connection the device and the patient occurred If lead fail is detect it will be shown at the home screen of Lead fail indication section see the Home Screen p26 Units cm kg Lead Label IEC AC Line Filter 60Hz Low Pass Filter 150Hz High Pass Filter 0 04Hz AFS On ECG Sample Acquisition Post Auto Save No Lead Fail Detection On Pacer Pulse Detection Off s Key Press Beep Off Figure 3 51 Lead Fail Detection Pacer Pulse Detection If this parameter set to on pacemaker detecting mark printed with reports System Setup Units cm kg Lead Label IEC AC Line Filter 60Hz Low Pass Filter 150Hz High Pass Filter 0 04Hz AFS On ECG Sample Acquisition Post Auto Save No Lead Fail Detection On Pacer Pulse Detection Off a Key Press Beep Off Figure 3 52 Pacemaker Detector 54 YM303i 3channel Resting ECG System Operators Manual Key Press Beep If this option set to on the device will make a beep sound when a key pressed System Setup Units Lead Label AC Line Filter Low Pass Filter High Pass Filter AFS cm kg IEC 60Hz 150Hz 0 04Hz On ECG Sample Acquisition Post Auto Save Lead Fail Detection Pacer Pulse Detection a Key Press Beep No On Off Off Figure 3 53 Key Press Beep On Heart Rate Beep If this op
54. ort formats The report styles are identified by ECG waveform matrix The automatic report includes interpretation result and detail result Display format and Print format are independent at Automatic mode Report Format Rhythm Lead Interpretation Print Median Beat Print Detail Result Muscle Filter No of Copy 10mm mV 25mm s 3x4 Il Yes No No Off 4 Figure 3 8 Report format Automatic mode YM303i 3channel Resting ECG System Operator s Manual 35 2x6 12 Lead ECG waveform prints in 2x6 MEDIGATE HOSPITAL ID ABCDEFGHYIK 2 nu KA Ag 10 me T a aa en Van ve Ann ir i E mms 10mm mV Bo so 19 52 EE d MEDIANA YM303i Ver 0 1 0 06 Figure 3 9 Format 2x6 YM303i 3channel Resting ECG System Operators Manual 3x4 12 Lead ECG waveform prints in 3x4 MEDIGATE HOSPITAL I WIA AA AN bh A LU BW A IS As Auto mms 10mm mV ID ABCDEFGHYIK Sex Male Age 10 gt EAN EE E Y Y V VE UV i ASIN PH Sd Hiii SE ES DI EH TE ES RER Le HER I vai a NAVAS 005 150Hz 60Hz AFS Off lt Patient Data gt lt Detection Result gt ID ABCDEFGHYIK Vent Rate 60 bpm First Name MMMMMMMMMM PR Interval 164 ms Last Name LMNOPQRSTU QRS M ms Date of Birth 2000 08 29 Height 100 Ce QT QTc 374 374 ma Age 0 Weight 50 Kg PP RR 9 996 ms nelle Yes Sex P R T axis 144 40 45 Room No
55. pattern will be printed If printing quality is not good cleaning the printer head Printing quality is not improved after cleaning please contact to service center Thermal Printer Test Repon Thermal Printer Test Report i J een ig 0a Rie E e DEE ER D a UUU ONU 5 g m Y Ze Figure 4 9 Thermal Printer Test 4 5 6 RS232 Test The RS232 test is provided to check the RS232 communication module Before this testing pin 2 and 3 are should be shorted Figure 4 10 shows pin layout of device Use a Metal Clip to Short Pins 2 and 3 in COM Port 9 8 7 6 5 4 3 2 1 RS232 Test re You Ready 1 Yes 2 No Figure 4 10 RS232 Test YM303i 3channel Resting ECG System Operator s Manual 71 4 5 7 LAN Test This test is provided for the TCP IP module option testing LAN Test Connect PC and Device with LAN Cable Open Command Window on PC Type ping 198 18 0 20 See Operator e Manual Check ping test result Did the Test OK 1 Yes 2 No Figure 4 11 LAN Test 1 Enter the LAN Test menu Figure 4 11 2 Connect PC and the device with cross cable directly 3 Please wait until the limited connection icon M on the icon tray of windows 4 Run a command window and type ping 192 18 0 20 Start Run cmd C WWINDOWS system32 cmd exe 0 x C WDocuments and SettingsWmedigate gt ping 198 18 09 20 Pinging 198 18 6 26 with 32 bytes of data
56. quency 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 Table 6 5 Cables IEC60601 1 2 Length m Complies with Power cable Unshielded RF emissions CISPR 11 ClassB Group1 Harmonic emissions IEC61000 3 2 RS232C cable Shielded 18 Voltage fluctuations flicker emission IEC61000 3 3 Electrostatic discharge ESD IEC61000 4 2 Electric fast transient burst IEC61000 4 4 Conducted RF IEC61000 4 6 E L FAC 37 Radiated RF IEC61000 4 3 Shielded YM303i 3channel Resting ECG System Operator s Manual 99
57. ress the ENTER button When password prompt shows up enter the code 3031 Maintenance Demonstration Mode LCD Test Buzzer Test Keypad Test Thermal Printer Test RS232 Test LAN Test SD Card Test USB Test Patient Cable Test ECG Acquisition Test Maintenance Print Test Result Summary Firmware Version Bootloader Version 0 01 Main Application Version 0 01 EA module Version 0 01 PMC Version 0 01 Figure 4 6 Maintenance Menu YM303i 3channel Resting ECG System Operator s Manual 69 4 5 1 Demonstration Mode If Demonstration mode is enabled ECG signal displays on the LCD with out signal source 4 5 2 LCD Test LCD test menu is useful to find some LCD problems If you found some problems using this menu contact to the service center Figure 4 7 LCD Test 4 5 3 Buzzer Test Buzzer test is provided to check sound warning signal When buzzer test is started you can hear 4 times beep sound 4 5 4 Keypad Test Keypad test is provided to check the button of YM3031 When the test is started red outline shows up on a target button If the target button is not pressed the test will be finished Keypad Test Press Corresponded Key as on Screen MENU ESC a STOP AUTO MANUAL gt Figure 4 8 Keypad Test 70 YM303i 3channel Resting ECG System Operators Manual 4 5 5 Thermal Printer Test Thermal printer test is provided to check the thermal printer module At this test the print test
58. rmat M3R Rhythm Lead II Muscle Filter Off 1 0100 2 aVR aVL aVF 3 V1 V2 V3 4 V4 V5 V6 5 Custom Lead Il V2 aVF 6 Custom Lead Edit Figure 3 28 Rhythm lead select Muscle Filter The muscle filter is reducing noise from muscles 10mm mV 25mm s Report Format M3R Rhythm Lead CI II III Muscle Filter Off Figure 3 29 Muscle Filter select 3 If press the Filter button at home screen filter adjust window will be Filter opened YM303i 3channel Resting ECG System Operators Manual 3 3 3 System Setup Menu 1 Press the MENU button to enter the configuration menu MENU a If press the MENU button at Home Screen it will be shown the Configuration menu Move the cursor on System setup and press the ENTER button to enter the submenu of Auto configuration ENTER RUN If other function is running such as Acquisition Analysis or Printing could not enter the configuration menu Configuration Auto System Setup Patient Data File Management Mainternance System Setup Hospital Name Physician Technician Location No Cart No Language Date Format Date Time Format y Time hh mm Enter to edit Enter to edit 0 0 English DD MM YYYY 01 01 2000 12hr PM 00 27 System Setup Units Lead Label AC Line Filter Low Pass Filter High Pass Filter AFS cm kg IEC 60Hz 150Hz 0 03Hz On ECG Sample Acquisition Auto Save Lead Fail Detection Pacer Pulse Detection a Key Pres
59. s Beep Post No On Off Off System Setup Heart Rate Beep Warning Beep LCD Light Off LCD Brightness Communication Paper Select Print Setup Menu List Patient Data Entry SD Card ECG List Default Setting Off Off Off 100 RS 232 Roll Enter Enter to edit 1B Enter Figure 3 30 System configurations YM303i 3channel Resting ECG System Operator s Manual 45 46 The System Setup has 3pages of parameters The triangle A and inverted triangle W mark left side of parameter list means more page exist Press the up or down cursor button to move to parameter These parameters are applied on Automatic mode and Manual mode both Selectable items blow Hospital name A Z 20 characters Physician A Z 9 characters Technician A Z 9 characters Location No 0 9 3 digits Cart No 0 9 3 digits Language English Espafiol Italiano Indonesian Jezyk Pols Date format DD MM YYYY MM DD YYYY YYYY MM DD Date Time format 12hr 24hr Time hh mm Units cm kg in lb Lead Label IEC AAMI AC Line filter Hz 60 50 off High Pass filter Hz 0 04 0 05 0 1 0 16 0 3 Low Pass filter Hz 40 100 150 off AFS On Off ECG Sample Acquisition Pre Post Auto Save On Off Lead Fail Detection On Off Pacer Pulse Detection On Off Key Press Beep On Off Warning Beep On Off Heart Rate Beep On Off LCD Light off min Off 1 3 5 10 30 LCD Brightness 20 40 60 80 100 Communication RS 232 TCP IP
60. s puts right place and comes off contacts well Check if electrodes got The electrodes should be replaced new one any damaged supplied by MEDIANA Co Ltd heck if pati EE The patient cable should be replaced new one t d dort can t recognize a EE supplied by MEDIANA Co Ltd Old ECG signal If patient s skin is too dry put some water and Check if the place is not if too much hair at the electrode attaching Too much noise clean added in ECG wave place then it needs shaving Is the RUN button pressed ECG signal needs time to become stable immediately after electrode Check the ECG signal using LCD and press ECG LIT attached the RUN button to print Check if the patient small patient cable or device The patient patient cable or device dose not did contact durin contact during operation Unexpected 8 BOP interpretation result shows up operation Are there any heavy When YM303i is operated with heavy energy energy consume electrical consume electrical devices i e electric blanket devices operation near electric heater or electric cooker may cause the patient bed heavy noise in ECG signal Set that the AC filter is compatible with the Verify setting of the local supply voltage and frequency filters HPF 0 16Hz LPF 100Hz AFS On are recommended Is the printer cover Close the printer cover si ia opened rinter Works DU A 8 Is the paper loaded on Refer to Chapter4 Devic
61. that wetted with soapy water and never use the detergent using alcohol ammonia or acetone as main ingredient 4 2 1 Cleaning the device 1 Unplug the AC power cord from AC outlet 2 Do not spray to the device directly instead cleaning with soft moist cloth 3 Dry enough before use the device 4 2 2 Cleaning patient cable 1 Disconnect the cable from the device before cleaning or disinfecting it When disconnecting the cable be sure to pull on the connector not on the cable 2 Clean the cable by rubbing it down with a cloth moistened with soap water Use a disinfectant for disinfection Do not immerse the cable in liquid 4 2 3 Cleaning electrodes 1 Clean reusable electrodes immediately after using it 2 Peel off the adhesive foil before cleaning the electrodes rests of the adhesive can be removed with benzene 3 Then use warm water and a small brush to clean the electrodes of cream or gel Do not use pointed or sharp objects for cleaning 4 Disinfect the electrodes with alcohol free disinfectant Ensure that connectors and sockets do not become wet YM303i 3channel Resting ECG System Operator s Manual 67 4 2 4 Cleaning the printer head 4 3 Storing 1 Unclean printer head can be cause of reducing print quality 2 Open the printer cover and then wipe it softly without rubbing it too hard by wetting swab with 90 alcohol 3 After cleaning dry printer head sufficiently and then use it Figure 4 4 C
62. tions are stopped and turned off YM3031 needs AC power connection immediately and the battery should be charged Low Battery Connect AC Power Line Figure5 2 Low Battery error 5 2 3 Low Battery ll This message is occurred when not enough battery to print operation Connect AC power line with YM303i to print operation Low Battery Not enough battery to print Press ESC key and Connect AC Figure5 3 Low Battery error Il YM303i 3channel Resting ECG System Operator s Manual 81 5 2 4 Printer Cover Open or End of Paper 5 2 5 Paper Type Error This message is occurred with beep sound when printing start or printing with printer cover is opened or no paper in printer conditions At printing start The message shows up with 4times beep sound At printing Automatic mode The message shows up with 4times beep sound Manual mode The message shows up with beep sound until STOP button is pressed or new paper is reloaded Cover Open or End of Paper Press ESC key and Check Printer Figure5 4 Printer cover open or No paper detect This message means setting paper type and loaded paper type is not matched Set the paper type at MENU gt System Setup gt Paper Select When paper type is set to Roll and Z fold paper is loaded it will be not occurred error massage Paper Type Error Press ESC key and Check Paper Figure5 5 Printer Type Error 5 2 6 Patient ID C
63. tton to turn on the YM3031 If already turned on press the ESC button to show the home screen Switch to the Manual mode manual Press the MANUAL button to Manual mode Operation mode setting available only home screen Connect the YM303i with a patient Put electrode to a patient and connect with patient cable For more detail information refers to the Electrodes position and Leads connection Press the RUN button to begin ECG signal recording enter In manual operation mode recording begins the RUN button pressed aoe immediately Press the STOP button to stop recording Ss In manual operation mode the recording will continue the STOP SE button is pressed Caution Do not print more than 30min in the manual mode It may result in break down or reduction of life time of the device YM303i 3channel Resting ECG System Operators Manual 3 3 The Setup Menu MENU Press the MENU button at Home Screen to enter the Configuration a menu The Figure 3 4 shows Configuration menu and submenu of YM303i Move the cursor on items using Up cursor key or Down cursor key and press the ENTER button to open the submenu Enter to submenu of Auto mode This item is toggled by current Configuration operation mode If the current O ree operation mode changes to System Setup Manual mode this item will be Patient Data toggled to Manual File Management E menu of m inn Enter to submenu of System Setup
64. ult in minor personal injury and or oroduct property damage e The electrocardiograph is intended to be used in a hospital and hospital facilities environment by trained medical personnel e It was designed as Class Protection Type CF device Therefore the electrocardiograph is suitable for direct application to the cardiac e Make arrangement so that patient cable may not be twisted e The electrodes passed the toxicity test performed by a certified institute However they may cause problems with the skin when applied for an excessive period of time Therefore use them for measurement only e Clean up where the electrode will be attached by the wet with water No alcohol or Hydrogen Peroxide cotton wool e When the defibrillator is operation the ECG signal may be interfered by the defibrillator operation but it will be recovery when the defibrillator stops working e lt is recommended to use the device at the environment where AC rated power is provided and it is required to use the charging battery power source during emergency situation or during inevitable movement On the other hand when using battery charge it for at least 6 hours and then use it e After operation has finished in order preventing malfunction clean the equipment and accessories e When cleaning the equipment wipe it with sponge or something like that wetted with soapy water and never use the detergent using alcohol ammonia or acetone as main ingredient
65. urrent emissions IEC61000 3 3 1995 A2 2005 Voltage fluctuations Flicker Emissions IEC61000 4 2 1995 A1 1998 A2 2001 Electrostatic Discharge ESD Electromagnetic IEC61000 4 3 2006 Radiated RF electromagnetic field Compatibility IEC61000 4 4 2004 Electrical fast transient burst IEC61000 4 5 2006 Surge current IEC61000 4 6 2007 Conducted disturbances induced by RF field IEC61000 4 8 1993 A1 2001 Power frequency 50 60Hz magnetic field IEC61000 4 11 2004 Voltage dips short interruption and voltage variation on power supply input lines CISPR11 EN55011 RF Emissions Group 1 Class B EN1041 1998 Information supplied by the manufacturer Labeling with medical devices EN980 2003 Graphical symbols for use in the labeling of Marking medical devices YM303i 3channel Resting ECG System Operator s Manual Manufacturer s Declaration Warning For best product performance and measurement accuracy use only accessories supplied or recommended by manufacturer Use accessories according to the manufacturers directions for use and your facility s standards The use of accessories and cables other than those specified may result in increased emission and or decreased immunity of the YM303i electrocardiograph The YM303i Electrocardiograph is suitable for use in the specified electromagnetic environment The customer and or user of the YM303i electrocardiograph should assure that it is used in an electromagnetic enviro
66. zed the USB memory or not found firmware file ENTER RUN then the device will be boot as normal mode A N FOR USE BY QUALIFIED MEDICAL PERSONNEL ONLY SEE OPERATORS GUIDE FOR INSTRUCTIONS i M303Boot V0 0 1 et MEDIANA Figure 4 15 Startup Screen 8 When firmware file is recognized the firmware update procedure will be start Firmware update N Caution Application update Please wait AC power operation only Do not off the device until firmware update complete Recognition Reading Writing 80 Ki Figure 4 16 Application Update 9 After firmware update complete turn off the device and remove the USB memory device 10 Turn the device on and set to default setting Default Setting will be found at MENU System Setup YM303i 3channel Resting ECG System Operator s Manual 75 70 YM3031 3channel Resting ECG System Operators Manual Chapters Troubleshooting YM303i 3channel Resting ECG System Operator s Manual 78 YM3031 3channel Resting ECG System Operators Manual Chapter5 Troubleshooting MEDIANA Co Ltd Service center TEL 82 70 7092 9967 FAX 82 33 742 5483 5 1 Possible problems and solutions Table 5 1 Possible problems and solutions list Possible Solutions Check if the AC power can t turn on the line is disconnected device Check if the internal The battery needs connect AC power line to battery needs charge charge at least 6 hours Is the batt

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