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E3KOM-7.00

CardioTouch3000 Operation Manual

Safety Instructions for Electricity

Please note the following precautions before using the product.

•

Is the power supply cord proper? (100-240Vac)

•

Is every cord connected properly to the product?

•

Is the grounding connected correctly? (Otherwise, noise can occur.)

•

There is a risk of electric shock if the Rest stand of the equipment is damaged or
can not be fixed to the product. Do not use the product and immediately ask
the manufacturer and the seller for repair

NOTE

Magnetic and electrical fields are capable of interfering with the proper
performance of the device. For this reason, make sure that all external devices
operated in the vicinity of the device comply with the relevant EMC requirements. X-
ray equipment or MRI devices are possible sources of interference as they may emit
higher levels of electromagnetic radiation.

NOTE

This device is classified as follows, in accordance with IEC60601-1.

Its classification against electric shocks is Class

Ⅰ

, Type CF defibrillation -

proof applied part.
Degree of protection against harmful ingress of water: Ordinary
It is not proper to use this product near a flammable anesthetic or solvent.
Continuous operation.
IEC/EN60601-1-2 (Electromagnetic Compatibility Requirements) standard :
Class A

NOTE

Diagnosis provided by

CardioTouch3000

must be confirmed by a qualified

medical professional.

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Содержание CardioTouch3000

Страница 1: ...CardioTouch3000 Operation Manual Ver 7 00 2019 05 23 www ebionet com...

Страница 2: ...runs for 1 year 2 years in EU But the warranty for accessories runs for 6 months This product is guaranteed against faulty workmanship for a period of 1 year Under this warranty we undertake to repair...

Страница 3: ...lways welcomes your enquiries Please contact us In the event of a malfunction or failure contact Service Dept Of Bionet Co Ltd along with the model name serial number date of purchase and explanation...

Страница 4: ...allation due to customer s unskilled installation For offering service when a foreign substance is introduced or mis cleaned by the customer Fee charged 1 The warranty does not cover cleaning adjustin...

Страница 5: ...urer or service agents are not responsible for damage resulting from inappropriate use or carelessness WARNING There may be serious injuries fatal accidents or financial damages if you violate this in...

Страница 6: ...d humidity range for Storage Transport are 5 40 C and 10 90 respectively Near electronic heaters High humidity or ill ventilated place Place where excessive shock or vibration may occur Place exposed...

Страница 7: ...erformance of the device For this reason make sure that all external devices operated in the vicinity of the device comply with the relevant EMC requirements X ray equipment or MRI devices are possibl...

Страница 8: ...patient at the same time WARNING Do not contacts with the patient while operate the machine It may cause serious danger to the users Use only the provided cable A warning that other cables and access...

Страница 9: ...as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the ME EQUIPMENT or ME SYSTEM including cables specified by the manufacturer NOTE The EMISSIONS ch...

Страница 10: ...proper use of the device Safety Sign To signify that the instruction manual must be read Reading the instruction manual before starting work or before operating equipment General prohibition sign Def...

Страница 11: ...C Power Connection Indicator Manufacturer name and address Authorized European representative Waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be...

Страница 12: ...7 6 System Installation 27 7 System Start 28 Chapter 2 Preparation For Electrocardiography 31 1 Location of Electrodes 32 2 Electrode Connection 33 3 Starting ECG recording 35 4 Basic Setup 36 5 LCD M...

Страница 13: ...5 Switching menu 99 6 Patient information 100 7 Data search 100 8 Data transfer 101 9 Data import 103 Chapter 4 System Management 105 1 Maintenance and Cleaning 106 2 Regular Check up 106 3 Trouble Sh...

Страница 14: ...ording ECGs during Defibrillation 4 Product Features 5 Product Configuration Basic Components and Accessories Optional Components Body Configuration Front Panel Graphic Display LCD Control Panel Power...

Страница 15: ...be operated conveniently during bedside visits or emergency conditions 2 Indication for Use The CardioTouch3000 ECG Analysis System is intended to acquire analyze display and record electrocardiograp...

Страница 16: ...ihood that a defibrillation procedure will be necessary If polarizing electrodes are used we recommend disconnecting the lead wires from the patient before delivering the shock Electrode defibrillatio...

Страница 17: ...e package and check the items below are included Also be sure to check for any damage to the body and accessories Basic Components and Accessories CardioTouch3000 Body 1 EA Dimension 290 W 300 D 97 5...

Страница 18: ...TIONS You may have distortion or signal noise when you use nonstandard or other brand accessories We strongly recommend you use only the authorized accessories which we supply WARNING How to replace b...

Страница 19: ...19 120 E3KOM 7 00 CardioTouch3000 Operation Manual Body Configuration Top View Handle Printer Cover Printer Cover Switch LCD Control Panel...

Страница 20: ...E3KOM 7 00 CardioTouch3000 Operation Manual Front View Printer Cover Switch Rear View Protective Ground Terminal Power Switch AC Power Connection Port Fuse 250V 5A High breaking type USB Port RJ45 LA...

Страница 21: ...re is a risk of electric shock if the Rest stand of the equipment is damaged or can not be fixed to the product Do not use the product and immediately ask the manufacturer and the seller for repair NO...

Страница 22: ...E3KOM 7 00 CardioTouch3000 Operation Manual Front Panel During device boot up you can see the system software version and the Bionet name Rotary key Power status Battery status Button Graphic display...

Страница 23: ...USB Memory Barcode Displays Network Connection Status Displays Battery Status or AC Power Connection Status Displays ECG Sensitivity with One of 2 5 5 10 20 and Auto mm mV Displays Printing Speed Wit...

Страница 24: ...rhythm data on A4 size or continuous paper 10sec are saed and are printed vas an output form after processing Process the recorded data with or without revision and print them out It operates the pro...

Страница 25: ...us A red light indicator lets you know that the battery is charging and a green light indicator lets you know the batter is fully charged Green light indicates connection with an AC adapter Rotary Swi...

Страница 26: ...0mm mV or in the absence of ECG record it is possible to record a max of 200 ECG Display Battery Power Status Battery Fully Charged Battery Charge Half Full Battery Charge Low Battery Almost Fully Dra...

Страница 27: ...aterials Power Connection The equipment needs electrical power to operate Plug in one end of the power cable to wall socket and the other to CardioTouch3000 Patient Cable Connection Connect the patien...

Страница 28: ...company name will be displayed when the switch is turned on and then after approx 10 seconds the initial menu selection will appear on the screen as shown in the figure below You can move to the main...

Страница 29: ...s information Barcode reader or USB Keyboard connection mark USB memory connection mark Network status mark wired wireless Move to the Network Setup screen by touching the icon The error icon will ap...

Страница 30: ...easier for you to use the main page of ECG file management Menu Description Going to Patient List To skip to previous page To skip to next page To check the patient s information To search the data by...

Страница 31: ...Attach Electrodes Countermeasures for Bad Lead Connection 3 Starting ECG recording 4 Basic Setup General Patient Information Input Sensitivity Setup Printing speed Setup 5 Screen Printing 6 Rhythm Mod...

Страница 32: ...ight Leg LL F Left Leg RA R Right Arm LA L Left Arm Chest electrodes are located as follows V1 C1 Fourth Intercostal Space At The Right Border Of The Sternum V2 C2 Fourth Intercostal Space At The Left...

Страница 33: ...L while you can connect electrodes for the chest to the terminal of V1 C1 V2 C2 V3 C3 V4 C4 V5 C5 and V6 C6 How to Attach Electrodes Lay down the patient on the bed and let the patient relax Attach t...

Страница 34: ...ad fault is set to ON in System Setup and will NOT be displayed when set to OFF The following two cases could cause a lead fault error First case leads are detached from the patient s body In this cas...

Страница 35: ...lectrocardiogram of the patient Press the COPY button to print out the previously saved 10 second data or modified data Press the RHYTHM key to monitor the ECG waveform through the printer not through...

Страница 36: ...the rotary key the desired menu and changed configuration values can be set easily Same functionality can also be achieved with the touch screen by pressing and changing the desired information on th...

Страница 37: ...odify select values in the same manner as menu movement shown above When you select either 5mm sec 12 5mm sec 25mm sec 50mm sec or 50mm sec at the Speed Setting POP UP the POP UP window will disappear...

Страница 38: ...o set the data after inputting the user can press OK button on the keyboard and if the user wants to cancel the setting pressing ESC button will do it and the keyboard window will disappear NOTE When...

Страница 39: ...be shown exactly when loading the keypad window Enter an age and select the year of birth for 1 year old enter age in the form of week or day for 1 year old Automatic diagnosis is available from post...

Страница 40: ...n pressing OK button the information will be saved while pressing cancel button will cancel the setting The default of the Gender line will be set as a Female NOTE Patient information will be initiali...

Страница 41: ...orted by Bionet Input methods supported by Bionet International standards USB Products below are tested and confirmed by Bionet No Manufacturer Product name Product image 1 Symbol LS 2208 2 ZEBEX Z 31...

Страница 42: ...0mm mV Users can also set it to Auto which will automatically set the sensitivity level for each channel for example limb electrodes I II III aVR aVL aVF to 10 mm mV and chest electrodes V1 V2 V3 V4 V...

Страница 43: ...al will be recorded in 25mm for one second Therefore the 12 5 mm sec width is equal to half of the 25 mm sec width the 5 mm sec with is equal to 1 5 of the 25 mm sec width The 50mm sec width is equal...

Страница 44: ...uto Displayed heart rate is the average of 4 heartbeats NOTE The heart rate detection range is 30 to 300 bpm and the error range is 2 6 Rhythm Mode Printing In rhythm mode printing the measured ECG si...

Страница 45: ...system will stop printing and the display system setting after indicating the following message NOTE Even if ECG output speed is set as 100 mm sec it is not supported when outputting monitoring NOTE...

Страница 46: ...channel form that are set up by the user 10 seconds ECG recording When one of 3ch 1rhy 6ch 1rhy 12ch 3ch 3rhy and beat is selected for the channel form press the RECORD key to display the saving time...

Страница 47: ...rhythm will be recorded as I V6 at the same time for 10 seconds 3CH 3 I III will be recorded for the first 2 5 seconds aVR aVF for the next 2 5 seconds V1 V3 for the next 2 5 seconds and V4 V6 for th...

Страница 48: ...48 120 E3KOM 7 00 CardioTouch3000 Operation Manual Rhythm Report Form 3CH Rhythm Report Form 6CH...

Страница 49: ...49 120 E3KOM 7 00 CardioTouch3000 Operation Manual Rhythm Report Form 12CH Record Report Form 3CH 1 RHY...

Страница 50: ...50 120 E3KOM 7 00 CardioTouch3000 Operation Manual Record Report Form 3 CH 3 RHY Record Report Form 6 CH 1 RHY...

Страница 51: ...51 120 E3KOM 7 00 CardioTouch3000 Operation Manual Record Report Form 12 CH Record Report Form BEAT REPORT TEXT...

Страница 52: ...52 120 E3KOM 7 00 CardioTouch3000 Operation Manual Record Report Form BEAT REPORT VECTOR Record Report Form BEAT REPORT GUIDE...

Страница 53: ...Duration RA R Amplitude RD R Duration SA S Amplitude SD S Duration QRSD QRS Duration QRSA QRS Amplitude TA T Amplitude STA ST Amplitude QTc collect Q T Interval ST60A ST 60ms Amplitude ST80A ST 80ms A...

Страница 54: ...cardia if P QRS and T are all reversed on Lead I aVR and aVL as well as lead II and III are switched with each other As you proceed from V1 to V6 R wave is reducing on Chest lead For patients with dex...

Страница 55: ...ilter type sensitivity printing speed channel form and rhythm number if more than one rhythm is recorded Copy Mode can be entered by pressing the COPY key following an EKG recording After pressing the...

Страница 56: ...ely it will start printing after showing the message as below When printing is abnormally completed the state of the system setting will be displayed after showing the message as shown below for a sec...

Страница 57: ...g at each window The main page shows Basic Setup After finishing the settings press OK to save the new information or press Cancel to cancel it You can choose Exit or ESC button to exit from the setup...

Страница 58: ...the Basic button then the focus will go to the Date item By using the touch screen or rotating the rotary switch choose the Date yyyy mm dd or Time hr min sec then the keypad will show up You can set...

Страница 59: ...rdinates for setting calibration will appear as shown below Follow the instructions shown on the screen and then the coordinates will be set up Please input the information in the right place otherwis...

Страница 60: ...ese Rumanian Russian Spanish and Turkish Select the language you want to use and click the OK button and then you can use the service in the chosen language NOTE Patient information previously entered...

Страница 61: ...licking the Start Option button a small menu window will appear and you can select the initial page you want to have among MAIN FILE ECG Units This menu is to select the units for height and weight of...

Страница 62: ...ate format on the top of the paper can be changed while printing out monitoring and recording results if you choose Date Type from the Basic Setup menu Choose the date format to be used and then click...

Страница 63: ...r two type of LCD screen for easy reading of wave form In case of choosing Black color it reflect wallpaper as black color and wave color turn to green color In case of choosing White color the wallpa...

Страница 64: ...ed through the Configure If the Configure is setup as automatic IP DHCP the Device IP Subnet Mask Gateway value is received automatically from the DHCP server on your network If the Configure is set t...

Страница 65: ...MS Server to connect is shown on the input box choose Search button to conduct an additional search If no IP of the intended BMS Server to connect is shown on the input box choose Manual mode to perfo...

Страница 66: ...stem Setup Network and Set the Device as Wireless When selection is done properly the Survey button on the bottom will be activated 2 Select the Survey button to search for the AP The AP is to be sear...

Страница 67: ...ime the security key input window will appear if the Encrypt field is On NOTE The user should set the AP Search and Security Key in order to use the wireless network If there is no security set on the...

Страница 68: ...be attempted and the message describing the connection status will appear 6 When the message reporting a proper connection appears click the Close button When connection is successful the wireless ico...

Страница 69: ...can appear Hospital Setup When selecting the Hospital menu at the left side of the Setup page Hospital Setup page will show up at the right side You can input the names of the hospital and doctor More...

Страница 70: ...0 Operation Manual ECG Setup When selecting the ECG menu at the left side of the Setup page ECG Setup page will show up at the right side In ECG Setup menu there is AUTO button to set up and change se...

Страница 71: ...12CH 3CH printing To print 3 channels at the same time I III aVR aVF V1 V3 V4 V6 If you want to change the channel press RHYTHM on the control panel 6CH printing To print 6 channels at the same time I...

Страница 72: ...ze menu Report will be selected and when clicking it again Continue will be selected Default is set as Continue Report To print out 10 second data in the form of Report Continue The leads will be prin...

Страница 73: ...ecording paper will already have it The grid marking setup can be done using output format selection mode Press rotary key or touch the intended field to select among the Grid selection items and then...

Страница 74: ...time for 10 seconds 3CH 3 10 second ECG will be recorded as I II and III for the first 2 5 seconds aVR aVL and aVF for the next 2 5 seconds V1 V2 V3 for the next 2 5 seconds and V4 V5 V6 for the next...

Страница 75: ...et up the additional beat report printing When you select the Beat Form menu a small POP UP menu will appear at the bottom and it will disappear when choosing OFF Text Vector or Guide Default is set a...

Страница 76: ...is chosen you can use all of the 3 leads while when 3CH 1 6CH 1 or Long Time is chosen you can use the first value only Default is set as II V1 V5 so when 3CH 1 6CH 1 is chosen you can use the lead I...

Страница 77: ...using the buffering function during selection of 0 10 seconds NOTE If setting up as ON diagnosis button should be used only after signalling is stabilized Upon ON setup diagnosis and output can be af...

Страница 78: ...ilters could help to reduce or remove those unwanted signals from the output of the device To change filter information enter the Filter Setup Menu either by moving the selection block over and select...

Страница 79: ...at the bottom of the Output Form There are three types of an AC power noise filter 60Hz 50Hz and OFF When set to OFF the filter will not be applied If the filter is set to 50Hz or 60Hz then the AC fil...

Страница 80: ...e any unwanted signal with frequencies above 40Hz Low Pass Filter values will appear on the bottom of the printout form if LPF setting is OFF then as LPF Off if the LPF setting is 40Hz then as LPF 40H...

Страница 81: ...per lead fault can occur In that case you can choose whether to have the lead fault message on the ECG Main page or not Selecting Lead Fault menu will switch between ON and OFF in the menu with ON tur...

Страница 82: ...Lead Fault message might not be shown and the wave types of all Leads might be indicated If LL Lead becomes Fault the wave type of II and V1 V6 Leads will not be indicated If a Lead Fault occurs duri...

Страница 83: ...when monitoring or recording You can select ON or OFF by clicking the Pacemaker item When it is on the location of the pacemaker will be printed out while when it is off it will not be printed out NO...

Страница 84: ...set the device to ring an alarm sound when a QRS beat has generated while it is in waiting mode Users can either set the alarm ON or OFF by selecting the menu with ON turning on and OFF turning off th...

Страница 85: ...Touch3000 in demo mode When it is set to ON 60bpm Sinus Normal Rhythm signal will be displayed on the device and DEMO sign will appear on the upper part of the LCD screen Users can test rhythm diagnos...

Страница 86: ...anel and the ECG data will be automatically saved but when No is selected the ECG data will not be saved Default is set as Yes When the Print Out menu has the focus click it to set up Yes or No When Y...

Страница 87: ...ernally transferred if is USB ECG data will be automatically saved to the external USB memory In addition if it is set up as Server data will be automatically transferred to PC Server IP among Network...

Страница 88: ...ppear At User Security Set setup it is possible to change Factory Setting and User Password At Manufacture Set setup it is possible to change Upgrade and Device Options please contact the Bionet Servi...

Страница 89: ...CardioTouch3000 Net Device Wired Configure Manually Device IP 192 168 30 224 Subnet Mask 255 255 255 0 Gate way 192 168 30 1 BMS Server 0 0 0 0 Hospital blank Doctor blank Quick Print Off Lead Fault...

Страница 90: ...7 00 CardioTouch3000 Operation Manual Low Pass Filter 150Hz EMG Filter Off ECG Store Yes Print Out Yes Export None Target PC Method Manual Format EKG Delete Yes JPEG Size 1024 x 768 Patient informatio...

Страница 91: ...l data in Files will be deleted Change PW User Password can be configured User Password is the number entered for Factory and Data Erase The password should be a 4 digit number NOTE The default User P...

Страница 92: ...not to touch the conductive parts or ground when you attach each electrode to the patient s body CAUTIONS The supplied ECG patient cable should be used only for ECG measurements and not use for breat...

Страница 93: ...CardioTouch3000 Operation Manual Chapter 3 ECG File Management 1 Display and Function 2 Data Printing 3 Data Deleting 4 System Setup 5 Switching Menu 6 Patient Information 7 Data Search 8 Data Transf...

Страница 94: ...nnection State of battery or AC power connection Button to print out the chosen saved data Button to delete the data Button to set up the environment of File Management Button to move to other main sc...

Страница 95: ...Page information Main Setup Delete Print 2 Data Printing When selecting a saved data at the ECG file management page by using rotary key or touch screen the focus will appear at the data list Press th...

Страница 96: ...ess the Select button one data will be deleted but if you press the All button all data in the list will be deleted In order to help the user not to make a mistake when deleting the data a message sho...

Страница 97: ...n of the ECG When you click the menu Retain will be set up and when clicking the menu again Delete will be set up Default is set as Delete Delete To set up the patient information is deleted when you...

Страница 98: ...ansfer the selected data All To transfer all data All New To transfer the newly saved data When clicking the Format button a line window will show up and it will disappear when selecting EKG MFER ECG...

Страница 99: ...in Method menu for other formats Selected is the only option 5 Switching Menu When selecting the Main button at the main page of File management a line window will show up You can choose ECG to go to...

Страница 100: ...below Information other than patient name cannot be changed 7 Data Search When clicking the Search button at the ECG data file management page you will see a Patient Search window as shown below If y...

Страница 101: ...el When pressing the NETWORK key a message will show up asking which menu you want to select If you transfer a selected data a message with progress speed or other information will be shown as below I...

Страница 102: ...transmit data to PC immediately after measuring 2 When transmitting multiple sets of measurements rather than sending all data at once we recommend users to transmit individual records after each mea...

Страница 103: ...RECORD key on the control panel When pressing the RECORD key Import File List screen will be shown as below If the external device is not connected to CardioTouch3000 the error message will be shown...

Страница 104: ...3000 Operation Manual If you select the All menu in the Import File List screen a system message with progress speed will be shown as below After receiving all data from the external device a system m...

Страница 105: ...105 120 E3KOM 7 00 CardioTouch3000 Operation Manual Chapter 4 System Management 1 Maintenance and Cleaning 2 Regular Check up 3 Trouble Shooting 4 Manufacturer Declaration...

Страница 106: ...bmerge the product or the ECG cable into any liquid or detergent Also make sure there is no liquid in the product or the cable Disposal of your old appliance 1 When this crossed out wheeled bin symbol...

Страница 107: ...ld not be used with the AC power s grounding and please connect it to the metal around the patient s bed or the building When The external USB keyboard is not working properly Connect the external USB...

Страница 108: ...eck and input right password 6 Enter password length error Please re enter your password When wrong number of characters is entered as password Please check and input valid and correct password 7 The...

Страница 109: ...Check server PC s networking conditions and USB memory and retry 16 Recharge Battery When the battery level is Low Please connect power cable or charge battery 17 Printer Time out Printer stops worki...

Страница 110: ...ttach the electrode on patient body When the conductivity between patient body and electrode is weak Apply some water to reusable electrodes and reattach them 25 No ECG Recorded Data When the user tri...

Страница 111: ...4 3 3 V m 80 MHz 2 7 GHz 80 AM at 1 kHz Immunity to Proximity Fields from RF wireless Communications Equipment IEC 61000 4 3 Table 9 in IEC 60601 1 2 2014 Electrical Fast Transient Burst Immunity IEC...

Страница 112: ...y to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The CardioTouch3000 is suitable for use in all establishments other than domestic and may be used in domestic e...

Страница 113: ...1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruption...

Страница 114: ...ed separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m 80 MHz to 800...

Страница 115: ...nting or relocating the CardioTouch3000 b Over the frequency range 150 kHz to 80 MHz field strength should be less than 3 V m Recommended separation distances between portable and mobile RF communicat...

Страница 116: ...cable 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...

Страница 117: ...tion Thermal Print Head Roll Paper Report Paper Width A4 Letter 215mm 8 5 Length A4 297mm 11 7 Letter 279mm 11 Resolution 8dot mm 0 125mm pitch Patient data ID Name Age Gender Height Weight Basic Meas...

Страница 118: ...AN WIFI option Safety Conformity Class I Type CF Defibrillation proof applied Part Environmental Operating Temperature 5 40 Operating Humidity 10 90 RH Atmospheric Pressure 70 106KPa Dimensions 290 W...

Страница 119: ...the date of purchase Date of purchase yyyy mm dd Customer Hospital Address Name Contact No Seller s Name Manufacturer s Name Thanks for purchasing CardioTouch3000 This product is a medical machine Thi...

Страница 120: ...et com U S A sales service representative Bionet America Inc 2691 Dow Ave Suite B Tustin CA 92780 U S A Toll Free 1 877 924 6638 Fax 1 714 734 1761 e mail support bionetus com Website www bionetUS com...

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