Bionet Cardio P1 Operation Manual
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Bionet Cardio P1 Operation Manual

Electrocardiograph
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Electrocardiograph
Cardio P1
Operation Manual
Ver. 1.00
2023. 04. 04
www.ebionet.com
Copyright © 2023 By Bionet CO., LTD. All rights reserved

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  • Page 1 Electrocardiograph Cardio P1 Operation Manual Ver. 1.00 2023. 04. 04 www.ebionet.com Copyright © 2023 By Bionet CO., LTD. All rights reserved...
  • Page 2 V 1.00 REVISION HISTORY Revision No. Date Contents Page 1.00 2023.04.04 First Written 2023.04 2 / 123 Doc. # : BN-CP1-OPM-303...
  • Page 3 Federal law restricts this device to sale by or on the order of a physician Note The product does not have shelf life. Its expected use life is 3 years. After 3 years, though the product still works normally, it is recommended to have it checked by Bionet. 2023.04 3 / 123...
  • Page 4 Tel : +49-30-240-374-52 E-mail : bionetEU@ebionet.com Website: www.ebionet.com ※ 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 of failure. 2023.04 4 / 123...
  • Page 5 - Mishaps such as dropping the product. - Using the third party replacements or options not specified by our company. - Non-Bionet technicians or agency technicians in the process of repair. 3. Other cases - Breakdowns by natural disasters (fire, salt damage, flood damage, earthquake, etc.) - When a consumable part has reached the end of its life (accessories) 2023.04...
  • Page 6 V 1.00 Warnings, Cautions, and Notes The following terms are used throughout this manual to emphasize important and critical  information. You must read these statements to help ensure safety and to prevent product damage.  The manufacturer or the product distributor is not liable for any loss or damage to the product caused by incorrect use or negligence in product maintenance.
  • Page 7 DO NOT connect power DO NOT disjoint or until the product is disassemble the equipment. completely installed. (Bionet is not liable for broken products caused by It may cause damage to attempted disassembly.) the product. 2023.04 7 / 123...
  • Page 8 Please note the following precautions before using the product. Is the power supply cord proper? • 1. Cardio P1 : 5Vdc, Max. 0.5A Is every cord connected properly to the product? • There is a risk of electric shock if the Rest stand of the equipment is damaged or not be •...
  • Page 9 V 1.00 as relocating or re-orienting the equipment. Caution Warning: MR-unsafe! DO NOT expose the device to a magnetic resonance (MR) environment. The device may present a risk of projectile injury due to the presence  of ferromagnetic materials that can be attracted by the MR magnet core.
  • Page 10 V 1.00 Safety Messages The following messages are applied throughout the product. Certain statements may also appear elsewhere in the manual. WARNING: ACCIDENTAL SPILLS — If the equipment is penetrated with liquid, take it out of service and have it checked by a service technician before using it again. DO NOT allow liquids to enter the equipment to prevent electric shock or equipment malfunction.
  • Page 11 V 1.00 levels of electromagnetic radiation. WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. WARNING: EXPLOSION HAZARD - Do NOT use in the presence of flammable anesthetics vapors or liquids.
  • Page 12 V 1.00 For safety reasons, all connectors for patient cables and lead-wires are designed to prevent inadvertent disconnection, should someone pull on them. For devices installed above the patient, adequate precautions must be taken to prevent them from dropping on the patient. WARNING: TREADMILLS - Avoid rapid changes in treadmill speed and/or grade during a stress test.
  • Page 13 If you have questions concerning the disposal of the product, please contact Bionet or its distributor. CAUTION: EQUIPMENT DAMAGE — Equipment intended for emergency application must not be exposed to low temperatures during storage and transport to avoid moisture condensation at the application site.
  • Page 14 V 1.00 Safety Symbols Symbols Contents Auto operation / Event Marker Key Power (USB data) cable insertion direction indication Power (USB data) cable connection indication Manufacturer Commented [ 장사 1]: Manufactory -> Manufacturer 수정함 Authorized Distributor in the European Community Waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately.
  • Page 15 V 1.00 Use no hooks; Absolutely no Fragile; Handle with care hand hooks should attached to pull the parcel Keep away from rain Symbols Contents Attention Consult accompanying documents Consult Instructions for Use: This symbol advises the reader to consult the operating instructions for information needed for the proper use of the equipment.

  • Page 16: Table Of Contents

    V 1.00 Table of Contents Chapter 1. General Rules ..................18 1) Product Overview ............................18 2) Recording ECGs during Defibrillation ....................20 3) Product Characteristics ..........................20 4) Product Configuration ........................... 22 5) Installing System .............................. 30 6) System the Start ............................... 37 Part I.
  • Page 17 V 1.00 4) Manufacturer Declaration ......................... 112 Chapter 6. Product Specifications ..............119 Specifications or functions indicated on user manual are subject to change without notification for the improvement of product. 2023.04 17 / 123 Doc. # : BN-CP1-OPM-303...

  • Page 18: Chapter 1. General Rules

    ECG examination with a single push of a button. The CardioSync which is the operation software of Cardio P1 is installed on a standalone PC. For all configurations, an independent PC is used that can be positioned for patient convenience. For device to ECG measurement is Cardio P1.
  • Page 19 Do not expose the Cardio P1 to liquids. d. The Cardio P1 should not be used in the presence of flammable liquids or gases, dust, sand, or any other chemical substances.

  • Page 20: Recording Ecgs During Defibrillation

    If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Only use the Cardio P1 with the power supply provided. Attempted use with other power sources may cause irreparable damage and invalidate the warranty.
  • Page 21 V 1.00 - The 12 channel rhythms are continuously printed simultaneously in real time. - The heart rate, PR interval, RR interval, QRS interval, QT interval, QTc interval, P-R-T axis, and SV1/RV1/R+S size required for diagnosis are automatically calculated and provided on the report along with the ECG.

  • Page 22: Product Configuration

    V 1.00 4) Product Configuration The Cardio P1 system is comprised of the following components. Cardio P1 1) CardioSync - Software that analyzes and records the measured ECG - Installed on a PC. 2) Cardio P1 - Device to ECG measurement Basic Configuration and Accessories Make sure to open the package box and see if the following components are contained.
  • Page 23 V 1.00 ① Body (1ea) - Cardio P1 90.75(W) x 103.5(H) x 24.93(D)mm ② Patient Cable (1ea) - Length 1,400mm (Max) ③ Power (USB Data) Cable (1ea) - Length 2,450mm (Max) ④ Disposable electrodes (1set) ⑤ ECG clips (1set) ⑥ Hanger (1ea) ⑦...
  • Page 24 V 1.00 ▣ Bottom View ① ① ID Label : Part to attach ID Label ▣ Side View ① ① Power (USB Data) Cable Connection Port 2023.04 24 / 123 Doc. # : BN-CP1-OPM-303...
  • Page 25 Bionet. Caution When using the device (Cardio P1) connected to the PC, the mouse may malfunction. In this case, reconnect the device's power (USB) cable to the PC. 2023.04 25 / 123 Doc.
  • Page 26 V 1.00 CardioSync Main Screen Graphic Display Window Auto and Event Key 2023.04 26 / 123 Doc. # : BN-CP1-OPM-303...
  • Page 27 ⑤ Menu button for indicating patient ID and name and entering patient information ⑥ Indicate Retry queue (sending failure list management) icon ⑦ Access status of external devices (barcode reader) ⑧ Access status of Cardio P1 ⑨ Menu button for network connection status and setup ⑩ Button for expand/collapse Side Menu ⑪...
  • Page 28 V 1.00 Setup menu button Display manual button Show manual 10) Minimize button 11) Show contact us 12) Logout button 13) Close button ⑫ Side Menu bar Indicate heart rate Lead Fault status display and lead position display window button AUTO button Menu button for indicating ECG record mode (one of the 10s, 1m, 3m, 5m, 10m, 20m and 30m) and setup...
  • Page 29 V 1.00 Function Key Panel ② ① ③ ▣ Button Auto / Event. 1. Long Press (more than 3 seconds) Perform the operation that is the most frequently performed in the saving, transmission, and printing of data in the ECG diagnosis test ①...

  • Page 30: Installing System

    5) Installing System Installation Precautions Note the following when installing the Cardio P1 - Use the equipment within the ambient temperature of 10~40℃ and humidity of 30~85%. - Check the connection of the power cord and handle the patient cable with care.
  • Page 31 V 1.00 How to install the Software Add software for the description below. ① Close every application before beginning installation. ② Execute “SqlLocalDB.msi” under your CD-ROM drive, download folder or USB memory. ③ Follow each instruction on each step. < Step 1> <...
  • Page 32 V 1.00 <Step 3 > < Step 4 > < Step 5 > 2023.04 32 / 123 Doc. # : BN-CP1-OPM-303...
  • Page 33 V 1.00 ④ Execute “setup.exe” or “Cardio P1 ECG_X.XX.XXX_YYYYMMDD.msi” under your CD-ROM drive, download folder or USB memory. ⑤ Follow each instruction on each step. < Step 1 > < Step 2 > 2023.04 33 / 123 Doc. # : BN-CP1-OPM-303...
  • Page 34 V 1.00 < Step 3 > < Step 4 > < Step 5 > 2023.04 34 / 123 Doc. # : BN-CP1-OPM-303...
  • Page 35 Repair or disassembly of the equipment can only be performed by those who have product repair qualifications recognized by Bionet. Bionet is not liable for any problems arising from the disassembly and modification of equipment by an unqualified person. General Precautions Please be aware of the following guidelines to ensure safe usage of the software.
  • Page 36 V 1.00 LAN Network Generally, the LAN networks are configured based on a star topology. You can group Individual computers together via layer-n-switch. Other data traffic is separated by other VLAN networks. Configure the network according to this manual and your network specifications. LAN connection specifications are described in the following standards.

  • Page 37: System The Start

     Security of the network is the sole responsibility of the network operator.  Bionet recommends the following to guarantee the security of the network.  Define access authorization for the configuration of the host system so that no unauthorized alterations of the system can occur.
  • Page 38 V 1.00 Login Enter your ID and password. Roles and privileges are assigned to individual users and may affect each user's scope of access to areas of the workflow and available functions. If a function is colored in gray and cannot be entered, it means that the user logged in does not have the privileges to perform the (greyed) task or the task is not available in the current screen.
  • Page 39 V 1.00 If you know the following on the ECG initial screen, you can use it more conveniently. Menu explanation Enter patient information or confirm contents ECG screen Patient management screen Worklist screen File screen Print execution Print setting System setting Help Company information.
  • Page 40 Move to the retry queue (error file management while sending to the server) screen Indicate the connection of barcode reader Indicate Cardio P1 connection Indicate or setup network status Indicate or setup the current date or time Indicate or setup the print speed...
  • Page 41 V 1.00 Note Function keys available in Cardio P1 - F9 Button : Auto - F10 Button : Save - F11 Button : Export - F12 Button : Print 2023.04 41 / 123 Doc. # : BN-CP1-OPM-303...
  • Page 42 V 1.00 The following is the patient examination data management screen that moves when the ‘Patient List’ menu is selected. Followings are recommended to know on the exam request data managing screen for more convenient usage. Menu Explanation Search for data by entering search conditions Move to the exam screen Add patient information Edit patient information...
  • Page 43 V 1.00 Note Applicable matters when editing patient information. Basic Item (ID, Name, Birth) : DB, All files Additional items (ETC.) : DB, User decides whether to apply to all files Following is the ECG data file managing screen when selecting ‘Worklist’ menu. Followings are recommended to know on the data file managing screen for more convenient usage.
  • Page 44 V 1.00 Menu Explanation Search for data after entering searching conditions Move to the exam screen Get Worklist Menu button that appears when PACS or GDT is connected Search condition setting Check patient information Following is the ECG data file managing screen when selecting ‘File’ menu. Followings are recommended to know on the data file managing screen for more convenient usage.
  • Page 45 V 1.00 File export File import File preview Check patient information Note Applicable matters when editing patient information Basic Item (ID, Name, Birth) : DB, All files Additional Item (ETC.) : DB, User decides whether to apply to all files or the current file The following is the Retry Queue data management screen that moves when (Retry Queue...
  • Page 46 V 1.00 Followings are recommended to know on the Retry Queue managing screen for more convenient usage. Menu Explanation Send selected data Delete selected data Note icon is indicated on the right top corner only if there is an error while sending files.

  • Page 47: Part I. Using Ecg

    V 1.00 Part I. Using ECG 2023.04 47 / 123 Doc. # : BN-CP1-OPM-303...

  • Page 48: Chapter 2. Ecg Recording Preparation

    V 1.00 Chapter 2. ECG Recording Preparation 1) Attaching the Electrodes If clicking (Lead Fault Information indication) located in the middle of upper menu bar of ECG main screen, the image will show to indicate the location for attaching the lead. Make sure to attach electrode to the patient body as follows to record standard 12 lead ECG.

  • Page 49: Electrode Connection

    Connect the patient cable to the port on the underside of body and connect limb electrodes to the terminals of ‘RL(N), LL(F), RA(R), LA(L)’ of patient cable connected in the Cardio P1 and chest electrodes to the terminals ‘V1(C1), V2(C2), V3(C3), V4(C4), V5(C5) and V6(C6)’...

  • Page 50: Start Recording Ecg

    V 1.00 Actions to Take for Poor Lead Connection Enter the ECG mode after turning the power switch on and confirm the waved of all the leads. At this time, it is available to confirm the degree of noise in wave as well as connection status while indicating the message in case of lead fault.

  • Page 51: Basic Setup

    V 1.00 - If wave shown on the LCD screen is normal, press ‘AUTO’ key to record ECG of a patient. - To stop the operation during ECG measurement or saving, press the ‘STOP’ button. 4) Basic Setup General Information When moving to the ECG window, a screen consisting of up, left, and right menu bars and a graphic display window is displayed on the screen.
  • Page 52 V 1.00 Screen Output Output the signals of currently measured ECG on the LCD on a real-time basis Make sure to check signals on the output prior to starting diagnosis and test after confirming that all the lead signals correctly come out The screen output background color of the ECG waveform can be selected from either white or black and can be changed in the Setup ...
  • Page 53 V 1.00 Enter ID Enter the unique number used in the hospital to classify the patient's treatment results. If you select ‘ID’ input, you can enter your ID. Note ., “, <, >, ?, /, *, |, :, \ & symbols shall not be used when entering ID. When entering ID, make sure to enter only alphabets and numbers.
  • Page 54 V 1.00 Enter Age Enter the patient's age manually. For Age, enter the age in years for children over 1 year old, and enter weeks or days for children under 1 year old. Note Age is automatically calculated when entering birthday. If age is not entered, adult diagnosis is provided.
  • Page 55 However, default setting of entry might be different for each product. Therefore, it is required to confirm how Bionet Corporation supports such entry. Entry method supported on products of Bionet Corporation: International standards,  Following is the list of products connected to products of Bionet and tested hereof.  2023.04 55 / 123...
  • Page 56 V 1.00 Manufacturer Product name Product image Symbol LS-2208 Z-3110 ZEBEX Honeywell MS5145 Honeywell DS2208 Note Barcode reader includes initialization code in each product. Confirm the entry method in the user manual and initialize. 2023.04 56 / 123 Doc. # : BN-CP1-OPM-303...
  • Page 57 V 1.00 Measurement Time Setting The measurement time setting is used when you want to perform a 10-second recording measurement or output 1CH for a long time. It can be set to 1, 3, 5, 10, 20, or 30 minutes, and at this time, it is output with the set lead. Note Usually, Lead II is the largest, so you can set Lead II, but if the lead II waveform is small, select another lead with the largest and best output.
  • Page 58 V 1.00 Setup Output Speed This is the function to adjust signal width on output. There are five values available as 5mm/sec, 12.5mm/sec, 25mm/sec, 50mm/sec, and 100mm/sec. 25mm/sec means that ECG signal is recorded on 25mm for 1 second. Note - 12.5mm/sec is always shown if setting the recording mode as 3, 5, 10, 20 and 30min.
  • Page 59 V 1.00 Setup Signal Scale If the scale of output signal is too high and is duplicated with signals in neighboring channel, or if the scale of output signal is too low making it difficult to decipher, this function is used to adjust the signal scale.
  • Page 60 V 1.00 Setup Print Printer Setup the printer to print. If you click the Properties button, you can use the normal Windows printer settings. 10s Print Form Setup diagnosis output form. 2023.04 60 / 123 Doc. # : BN-CP1-OPM-303...
  • Page 61 V 1.00 Form Output form Explanation Record ECG for I, II and III for the first 10 seconds, aVR, aVL and aVF for the next 2.5 seconds, V1, V2 and V3 for the next 2.5 seconds and V4, V5 3CH+3 and V6 for the next 2.5 seconds.
  • Page 62 V 1.00 Output the representative beat and each of the diagnosis parameters and Vector indicate and output vectors of QRS in arrow It outputs the representative bit and each diagnostic parameter and ST Map outputs the ST map. ST Map Type When selecting the bit form as ST Map, you can select the style of drawing the ST Map.
  • Page 63 V 1.00 Note Normaly, the lead II is the largest, so you can set the lead II, but if the waveform is small, select the other lead with the largest and best waveform. Print Page Settings related to the printout Page(s) Set the number of prints.
  • Page 64 V 1.00 Comments Select whether to output the observations added to the record results. HRV parameters Select whether to output HRV parameters when outputting records. Diagnosis Caps Lock When outputting a record, the diagnosis name is output in uppercase. Masking Set to de-identify patient information when printing.
  • Page 65 V 1.00 Diagnosis Output Form (3CH + 3RHY) Diagnosis Output Form (3CH +1RHY) 2023.04 65 / 123 Doc. # : BN-CP1-OPM-303...
  • Page 66 V 1.00 Diagnosis Output Form (6CH +1RHY) Diagnosis Output Form (12CH) 2023.04 66 / 123 Doc. # : BN-CP1-OPM-303...
  • Page 67 V 1.00 Diagnosis Output Form (6CH+1(ST)-Dot) Diagnosis Output Form (6CH+1(ST)-Bar) 2023.04 67 / 123 Doc. # : BN-CP1-OPM-303...
  • Page 68 V 1.00 Diagnosis Output Form (BEAT REPORT - TEXT) Diagnosis Output Form (BEAT REPORT - VECTOR) 2023.04 68 / 123 Doc. # : BN-CP1-OPM-303...
  • Page 69 V 1.00 Diagnosis Output Form (BEAT REPORT - GUIDE) Diagnosis Output Form (BEAT REPORT – ST Map(D)) 2023.04 69 / 123 Doc. # : BN-CP1-OPM-303...
  • Page 70 V 1.00 Diagnosis Output Form (BEAT REPORT - ST Map(B)) 2023.04 70 / 123 Doc. # : BN-CP1-OPM-303...
  • Page 71 V 1.00 * Explanation of BEAT REPORT Variables PR : PR Interval PA : P Amplitude PD : P Duration QA : Q Amplitude QD : Q Duration RA : R Amplitude RD : R Duration SA : S Amplitude SD : S Duration QRSD : QRS Duration QRSA : QRS Amplitude...
  • Page 72 V 1.00 Note Dextrocardia People normally have heart on the left side of chest. However, there are cases where heart is on the right side of chest, and this is called dextrocardia. Followings are possible symptoms of dextrocardia. - P, QRS and T are all reversed in Lead I. - Lead II and III are switched in aVR and aVL.

  • Page 73: Disclosure

    V 1.00 5) Disclosure If clicking button in the menu bar at the bottom of ECG main screen, the screen is converted to disclosure function. Disclosure function is to save ECG data in the equipment memory and show them when performing disclosure menu. Once disclosure window is performed, previously saved ECG data for 30 minutes are shown with 1CH, while indicating the pre-set mode interval (10sec, 1min, 3min, 5min, 10min, 20min and 30min) in rectangular area so that users are able to output diagnosis in selected area and...
  • Page 74 V 1.00 button. ⑥ EKG Wave Data update button from the time of entry into the Disclosure to the current time. ⑦ Switch to Live mode button ⑧ Select output lead ⑨ Select the output size ⑩ Output speed selection Here is the Disclosure live mode screen.
  • Page 75 V 1.00 Asystole Asystole Pause Pause Irregular Irregular RonT R on T Arrhythmia Template Diagnostic Name Description PVC Bigeminy Occurs when two or more bigeminal cycles (a ventricular beat followed by a non-ventricular beat) are detected. PVC Trigeminy Occurs when two or more trigeminal cycles (a ventricular beat followed by two non-Ventricular beats) are detected.

  • Page 76: Perform Diagnosis With One Key ('Auto' Key)

    Occurs when a ventricular complex is detected within the repolarization period of a Non-ventricular beat. Note Diagnosis provided by Cardio P1 must be confirmed by a qualified medical professional. 6) Perform Diagnosis with One Key (‘AUTO’ Key) ‘AUTO’ key is to acquire ECG during the diagnosis mode setup period and proceeds functions of saving, transmitting, and printing after diagnosis.
  • Page 77 V 1.00 If you select the 'Settings' button on the left menu bar of ECG, you can change the setting conditions. You can setup ECG related setups in each group. ‘Default’ button is shown on the setup currently shown on the screen. If saving changed information after all the setups, select ‘Ok’...
  • Page 78 V 1.00 Record Make settings related to ECG measurement. You can set the lead fault, heartbeat alert, and preview as follows. Lead Fault In case of unstable contact of lead on patient cable, there might be lead fault. In this case, it is available to setup whether to indicate lead fault message.
  • Page 79 V 1.00 QRS Sound You can set the sound output according to the QRS beat. When it is set to On, a sound is generated from the QRS beat, and when it is Off, no sound is produced. Preview Preview shows the results of measurement in advance after performing the diagnosis with record, auto and network keys.
  • Page 80 V 1.00 Display Make settings related to the screen display. You can set the background color and demo display as follows. background color You can set the background for drawing the graph. In the case of Grid, a red grid and black signal are displayed on a white background, and in the case of Black, a green signal is displayed on a black background.
  • Page 81 V 1.00 AC filter is a power noise removing filter and can be setup to off, 50Hz and 60Hz. ‘Off’ means not to remove power noise. 50Hz and 60Hz indicate to remove 50Hz of power noise and 60Hz of power noise, respectively. Europe and China use 50Hz and Korea and America use 60Hz as setup value.
  • Page 82 V 1.00 Level This is the automatic diagnosis level setup menu for 10 seconds of recording. In case of ‘Basic,’ diagnosis reference value is higher showing only the severe diagnosis names. In case of ‘Professional,’ various diagnosis contents are shown according to the standard diagnosis values.
  • Page 83 V 1.00 General Language Select the language you want to use, click the ‘OK’ button, and re-run the program to convert to the selected language. Note Even if language is set to be the one other than ‘English,’ some of the terms including diagnosis name might be shown in English.
  • Page 84 V 1.00 Auto return after Exam - Off : Return to the measurement screen after the end of the test - Worklist: After the inspection is finished, it goes to the Worklist screen. - Review: Go to the Review screen after completing the test. Date Format Setup the date format.
  • Page 85 V 1.00 Doctor Information Enter doctor name. Location Information Enter location name. User List Manage who will use the program. User Add Click Add user to enter a new user. User Name : Enter the user name Password : Enter the user's password. 2023.04 85 / 123 Doc.
  • Page 86 V 1.00 Retype Password: Confirm by re-entering the user password. Role : Enter the user's permissions. In case of ‘Admin,’ user has authority over all functions, such as system setting, diagnosis setting, inspection, general setting and etc. In case of ‘Physician,’...
  • Page 87 V 1.00 Off, 10min, 20min, 30min can be set and the equipment is automatically shut down if not used for the set time. Single Sign On When Single Sign On is set, security can be compromised. It is recommended that this setting is only defined for device that are single or limited user.

  • Page 88: Part Ii. Data & System Management

    V 1.00 Part II. Data & System Management 2023.04 88 / 123 Doc. # : BN-CP1-OPM-303...

  • Page 89: Chapter 3. Manage Data Requested For Exam

    V 1.00 Chapter 3. Manage Data Requested for Exam 1) Screen and function setup ① ② ③ ④ ⑤ ① Top list search menu button ② Search condition setting button ③ Retrieve patient information button ④ Delete selected information button ⑤...

  • Page 90: Function

    V 1.00 2) Function Search You can enter search conditions by clicking the search condition menu at the top right of the screen. The search condition menu window is activated only when PACS is linked. After selecting items, enter your search criteria. You can search by selecting ID, Name, or Accession No.

  • Page 91: Chapter 4. Manage Data Files

    V 1.00 Chapter 4. Manage Data Files 1) Screen and Function Setup ① ② ③ ④ ⑤ ⑥ ① File list search menu button ② View selected patient information button ③ Selected file preview button ④ File export button ⑤ File import button ⑥...

  • Page 92: Function

    It is available to change and print speed, gain, and print form on the preview screen. View Patient Information It is available to confirm or change patient information on selected files. Note Bionet provides Adult diagnosis and Pediatric diagnosis. 2023.04 92 / 123 Doc. # : BN-CP1-OPM-303...

  • Page 93: Setup

    V 1.00 3) Setup If clicking ‘setup’ button on the menu, ‘file setup’ window pops up. Connect to Server PACS, GDT, Web server or EMS/HIS can be selected from the menu to select the server interlocked with the equipment. After selecting the type of server to be linked, select the ‘Edit’ button to display the server setting window.
  • Page 94 A. None No connection with the server. B. PACS Setting Device Information AE Title, Port Enter information such as AE Title and Port of Cardio P1. Modality Enter the Modality of ECG 2023.04 94 / 123 Doc. # : BN-CP1-OPM-303...
  • Page 95 V 1.00 Worklist Server Settings IP, Port, AE Title Worklist Enter information such as the server's IP, AE Title, Port, etc. Server connection check You can check the worklist server connection by pressing the 'Echo Test' button after entering the information of the worklist server. Click the "Ping Test" button to check the task list and ping.
  • Page 96 V 1.00 enter the worklist screen. Store Server Settings IP, Port, AE Title Enter information such as IP, AE Title, and Port of the Store server. Echo Test & Ping Test After entering the store server information click the “Echo Test” button or “Ping Test” button to check the connection to the store server.
  • Page 97 A screen for setting related settings such as Work type, GDT Directory, Component name, File name, Image type appears. Work type It sets how the GDT function of the device operates. - Server: Cardio P1 receives requests and commands. - Client: Cardio P1 sends requests and commands. 2023.04 97 / 123...
  • Page 98 V 1.00 Directory Enter the format of sharing folder information and date information to be used by GDT protocol. Path Enter the shared folder path to be used by the GDT protocol ex) \\192.168.30.162/GDTShare User ID & Password Enter shared folder access ID & password Date Date information format setting YYYYMMDD, MMDDYYYY, DDMMYYYY...
  • Page 99 V 1.00 Component Receiver (EMR/HIS) Name: Enter the EMR name to use for the GDT protocol Short Name: Enter EMR abbreviation Sender (Device) Name: Enter the device name to use for the GDT protocol Short Name: Enter device abbreviation File Type Select the image format of the data file to be shared with the GDT protocol.
  • Page 100 V 1.00 WEB Setting When web transmission is selected, additional information must be set through the Setting menu. A screen for setting related settings such as DNS Server, URL, ID, PW, and Path appears. The web address to connect to. User ID to use on the web to connect to.
  • Page 101 V 1.00 Shared Folder The path within the server to transfer the file to. If you select the input window of each item, a keyboard window appears, and you can enter the relevant content. D. EMR / HIS Edit Network Path Enter network path ID &...
  • Page 102 The Dicom format with MFER, XML, and Image format is RAW can only support a 10- second ECG test. Auto Delete after Transmission Set whether to delete the file in Cardio P1 after completing the file transfer to the server. When set to ‘On’, the device file is deleted after file transfer. Note The Delete option only applies when sending to the server.

  • Page 103: Transmit Data

    V 1.00 Dicom File Creation Option Image Format Determines the image format to use when transferring Dicom files. You can choose from PDF, BMP, JPEG, and RAW. Window Width Specifies the image size in JPG, BMP format. Window Center Specifies the center of the image in JPG, BMP format. 4) Transmit Data 2023.04 103 / 123...

  • Page 104: Import Data

    Files failed to be sent are indicated on ‘Retry Queue’ screen. Such files can be re-sent. 5) Import Data It is available to import bionet format files saved on USB memory by using ‘Import’ button on the control panel from file screen.
  • Page 105 If clicking ‘open’ button after selecting data to be loaded on the equipment, data can be loaded on the equipment. Note You can only import bionet format files with the following extensions.  ekgx, ltecg, stecg 2023.04 105 / 123...

  • Page 106: Chapter 5. System Management

    Chapter 5. System Management 1) Maintenance and Cleanliness Cardio P1 can be maintained to be clean by using the various methods. However, it is required to use recommended methods as below to avoid damage or contamination on the device. If using substances (not allowed substances) that can damage on the product, warranty is not applied even during the warranty period.

  • Page 107: Regular Examination

    2) Regular Examination Make sure to have safety examination on a regular basis for at least once a year on Cardio P1 just like other medical equipment. Refer to the service manual provided by our company for exam items.
  • Page 108 V 1.00 System message Message Causes Solution "Do you want to save new disclosure data from now? Click Yes to When data is stored in Click 'Yes' if you want to discard the old data Disclosure, when there is delete existing data, or 'No' and save the new one.
  • Page 109 V 1.00 File Message Causes Solution "The study record being exported will be Click 'Yes' if you wish to When the Cancel button is discarded. cancel or 'No' if you do not pressed when exporting a file Are you sure to wish to cancel.
  • Page 110 V 1.00 Setup Message Causes Solution When device AE Title is Please check device AE Enter the correct value and entered incorrectly when title. try again setting PACS When device port is entered Please check device Enter the correct value and incorrectly when setting up port.
  • Page 111 Password and retry. Confirmation success when Verification successful. interworking with Web Server and EMR/HIS Please check the When Bionet WorlistCom's IP Enter the correct value and Bionet WorlistCom's is entered incorrectly when try again setting EMR/HIS When the Server IP is entered Enter the correct value and Please check server IP.
  • Page 112 V 1.00 The system erased all When you click 'Delete all files' data. during factory reset Do you want to Confirmation procedure when Click 'Yes' if you agree or restore default clicking 'Restore Default' 'No' if you do not agree settings? during factory reset The system is made...
  • Page 113 V 1.00 Mains terminal CISPR 11 Group1, Class A disturbance voltage EN 55011 CISPR 11 Group1, Class A Radiated disturbance EN 55011 IEC 61000-3-2 Class A Harmonic Current Emission EN 61000-3-2 Pst: 1 Voltage change, Plt: 0.65 IEC 61000-3-3 Voltage fluctuations and Tmax:0.5 EN 61000-3-3 Flicker Emission...
  • Page 114 Guidance and manufacturer’s declaration – electromagnetic emissions The Cardio P1 is intended for use in the electromagnetic environment specified below. The customer or the user of the Cardio P1 should assure that it is used in such an environment. Emissions test...
  • Page 115 Guidance and manufacturer’s declaration – electromagnetic immunity The Cardio P1 is intended for use in the electromagnetic environment specified below. The customer or the user of the Cardio P1 should assure that it is used in such an environment. Electromagnetic...
  • Page 116 Guidance and manufacturer’s declaration – electromagnetic immunity The Cardio P1 is intended for use in the electromagnetic environment specified below. The customer or the user of the Cardio P1 should assure that it is used in such an environment. 2023.04 116 / 123 Doc.
  • Page 117 Portable and mobile RF communications equipment should be used no closer to any part of the Cardio P1, including cables, than the Conducted RF 3 Vrms 3 V rms recommended separation distance IEC 61000-4-6 150 kHz to 80MHz...
  • Page 118 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Cardio P1 is used exceeds the applicable RF compliance level above, the Cardio P1 should be observed to verify normal operation.
  • Page 119 V 1.00 V1= 3 Vrms = 3 V/m E1= 3 V/m 0.01 0.12 0.12 0.23 0.37 0.37 0.74 1.17 1.17 2.33 3.70 3.70 7.37 11.70 11.70 23.30 For transmitters rated at a maximum output power not listed above, the recommended separation distance in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where...
  • Page 120 V 1.00 Digital Sampling Rate - 8,000Hz Filters AC (50/60 Hz, -20dB or better), Muscle (25~35Hz, -3dB or better), Baseline Drift (0.05Hz, 0.1Hz, 0.2Hz, -3dB or better), Low Pass Filter(off, 40Hz, 100Hz, 150Hz) Patient Data ID, Name, Birthday, Age, Gender, Height, Weight, Race, Smoke, Department, Room No., Study Desc., Accession No., Referring Physician Basic Measurement...
  • Page 121 Make sure to use biocompatibility certificate authorized with international standards or provided for electrodes Caution Make sure to have the experts (health care professional) present when using Cardio P1 for patients who had surgery with heart aiding machines 2023.04 121 / 123...
  • Page 122 Telephone: Seller Name Manufacturer Name ※ Thank you for purchasing Cardio P1. ※ This item is ‘medical device.’ ※ This product has passed through quality management and strict inspection. ※ Compensation criteria for the repair, replacement, or refund of this product follow ‘consumer damage compensation regulations’...
  • Page 123 Toll Free: 1-877-924-6638 / Fax: 1-714-734-1761 / E-mail: support@bionetus.com Website: www.bionetus.com European sales & service representative Bionet Europe GmbH 2Li Bessemerstr. 51, D-12103 Berlin, Germany Tel: +49-30-240-374-52 / E-mail: bionetEU@ebionet.com Website: www.ebionet.com Bionet Co., Ltd Model Name: Cardio P1 2023.04 123 / 123 Doc. # : BN-CP1-OPM-303...

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