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Vathin DVM-D1 User Manual
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Vathin DVM-D1 User Manual

Digital video monitor
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User Manual of Digital Video Monitor
Name
Prepared By
Reviewed By
Approved By
Distributed
To
Hunan Vathin Medical Instrument Co., Ltd.
Date
Date
Date
User Manual
0/61
Page
Release
Date
Effective
Date
Competent
Department
QP-DMR-DVM06-001
No.
Controlled
Status
R&D
Version No.: A
Department
Revision No.: 1

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Summary of Contents for Vathin DVM-D1

  • Page 1 Hunan Vathin Medical Instrument Co., Ltd. User Manual User Manual of Digital Video Monitor 0/61 QP-DMR-DVM06-001 Name Page Controlled Release Status Prepared By Date Date Effective Reviewed By Date Date R&D Competent Version No.: A Approved By Date Department Department Revision No.: 1...
  • Page 2 ◆For use with Vathin endoscope. ◆Before use, thoroughly review this manual. ◆Please keep all instruction manuals in a safe, accessible place. ◆If you have any questions or comments about this manual, contact Vathin Medical. Hunan Vathin Medical Instrument Co., Ltd.

  • Page 3: Table Of Contents

    Content CONTENT ......................................1 1. IMPORTANT INFORMATION - READ BEFORE USE ......................3 1.1. Intended Use ................................3 1.2. Contraindication ..............................3 1.3. Repair and Refit ..............................3 1.4. Keywords ................................4 1.5. Warnings and Cautions ............................4 2. SYMBOLS ...................................... 6 3. SYSTEM ......................................7 3.1.
  • Page 4 10. TROUBLESHOOTING ................................46 APPENDIX 1. ELECTROMAGNETIC COMPATIBILITY .......................48 APPENDIX 2. INFORMATION ABOUT WI-FI .........................52 APPENDIX 3. CYBERSECURITY .............................55...

  • Page 5: Important Information - Read Before Use

    If, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and to your national authority. This Instruction for Use only applies to the Vathin Digital Video Monitor. See relevant manuals for other products from Vathin Medical.

  • Page 6: Keywords

    Failure to observe these warnings or precautions may result in injury to the patient or damage to the product. Hunan Vathin Medical Instrument Co., Ltd. is not responsible for any system damage or patient injury caused by the improper use of the product.
  • Page 7 Portable RF communications equipment (including peripherals such as antenna cables and external  antennas) should be used no closer than 30 cm (12 inches) to any part of the DVM-D1, including cables specified by the Vathin Medical. Otherwise, degradation of the performance of this equipment may result.

  • Page 8: Symbols

    Note Please note that your organization is responsible for the following areas, which should be • implemented according to your local policy: • Network setup • Ensuring availability and confidentiality of the network • Ensuring confidentiality and integrity of physical devices •...

  • Page 9: System

    General warning sign Manufacturer Date of manufacture, followed by Refer to instruction manual YYYY-MM-DD Indicates that the product can be used only with a prescription Rx only Serial number from a U.S. physician as required by the appropriate regulations of Authorized representative in the European Community/European Keep dry...

  • Page 10: Digital Video Monitor

    DVM-D1 1*26-pin, 2*14-pin DVM-D2 1*26-pin, 2*16-pin 3.2. Compatible Endoscopes The Digital Video Monitor has been designed to be used in conjunction with the Vathin endoscope and medical monitor. The compatible equipment is listed below. Model Compatible endoscopes Model Single-use Flexible...

  • Page 11: Checking The Package Contents

    Optional components that have not been ordered will not be provided.. Check all items in the package with the components shown below. Check each item for damage. Please contact Vathin Medical if any component is missing or damaged. Items...
  • Page 12 HDMI cable 1 pc Endoscope connection cable A Endoscope connection cable B User's manual 1 pc Multilingual User's Manual（CD） 1 pc (optional) Reset pin 1 pc U Disk (optional) 1 pc...

  • Page 13: Structure And Function

    Structure and Function 4.2. Part Menu Functions Displays the image after the endoscope is connected; touch Display screen. Press and hold to turn on the product, and press to turn off the Power button product. USB interface 3.0 Connect external devices, such as USB stick here. Insert a pin and press the reset button in the hole to restore to Reset button factory settings.

  • Page 14: Preparation And Operation

    Insert the video endoscope cable here to connect the video (26-pin) endoscope to the product. Video endoscope interface Insert the video endoscope cable here to connect the video (14-pin for DVM-D1, 16-pin endoscope to the product. for DVM-D2) HDMI interface Connect an external high-definition monitor for display expansion here.

  • Page 15: Preparation And Inspection

    Caution Do not use any sharp object to operate the touch screen of the product; otherwise, the screen  may be damaged. Never apply excessive force to the connector; otherwise, the product may be damaged.  5.1. Preparation and Inspection Warning To power supply problems, a power supply with medical certification specified in the manual is ...

  • Page 16: Switching On And Setup

    Vathin medical trolley or the recommended screws for installation. The recommended screw specifications are: screws with a maximum depth of 6mm Ensure sufficient power capacity and stable power supply before use. Severe fluctuations in  power supply must be regulated using a power regulator or UPS power supply.
  • Page 17 For access to some key functions your need to enter the user password. Initial user password of  the product is vathin. Plear reset the user password during the firts login. Otherwise it may cause patient data leakage. If you forget your administrator account or password while using the Digital Video Monitor, please ...

  • Page 18: Inspecting The System

    5.3.4 After logging into the account, the real-time image will be displayed. Icons on screen turn green and their functions are available. 5.3.5 If the Digital Video Monitor is functioning without connecting the power supply, check the battery level of the equipment, and charge it when the battery is low. 5.3.6 Set the image parameters of the Digital Video Monitor according to Chapter 6.4 image parameter adjustment interface.

  • Page 19: Operating The Digital Video Monitor

    5.6. After Use 5.6.1 Disconnect the Vathin endoscope from the product. For information on how to dispose of the Vathin endoscope, refer to its user manual. 5.6.2 Press the power button to turn off the product. Remove the mains plug from the wall outlet to disconnect Digital Video Monitor from mains.

  • Page 20: Menu Functions

    6. Menu Functions Note This product sets up user account management and authority management, and related functions  are only open to users with authority. This product manual does not describe the authority of each user, and the authority of each user is subject to the actual authority provided by this product. Each device can only have one administrator account set up,Administrator account ...
  • Page 21 6.1.3 After creating an administrator account, the device automatically returns to the login interface and logs in using the created administrator account and password 6.1.4 When using this device not for the first time, there is no need to create an administrator button. Simply enter the administrator account password to access the administrator account.

  • Page 22: Basic Function Menu

    Description of basic function icons Reference Icon Name Function section Basic functions Icon for the Basic Functions menu. Tap this button or the Vathin endoscope camera Photo capture 6.2.1 button to capture the image.
  • Page 23 Tap this button to start recording a video. Tap it Video Recording 6.2.2 again to stop recording Freezing Tap this button to freeze the center image. 6.2.3 Tap this button to perform a manual white balance White Balance 6.2.4 operation on the center image. Tap to call up the quick preview interface to Quick preview icon preview the currently taken image.
  • Page 24 After taking a photo, the quick preview icon displays the current number of photos after the photo is added. Note Keep the Vathin endoscope as still as possible to prevent obscure images during photo capture.  6.2.2. Video Recording xx:xx:xx 1.
  • Page 25 Vathin Medical does not provide any accessories (e.g. white cap) for white balance.

  • Page 26: Patient Information Menu

    6.2.5. REMOTE function 1) Connect D-SUB9 cable or REMOTE cable according to related digital video recorder and Digital Video Monitor.Preparation work can also refer to Chapter 5.2.4. 2) Press the button on the endoscope handle to complete the REMOTE function, control the recording of videos and images.

  • Page 27: File Management Menu

    6.4. File Management Menu 6.4.1. File Management Menu Tap icon to enter the file management menu. 6.4.2. Playback Photos/Videos In the File management menu, tap the icon to open the intended folder. Tap the corresponding image/video for playback. viewing patient report forms. Note The captured images/videos are stored separately based on user name, capturing date, and ...
  • Page 28 6.4.3. File edit After selecting a file, tap the icon to enter the file editing menu to copy, clip, rename, delete the file. 6.4.4. Exporting files Before you export files, ensure that connection to the PACS server has been set up or USB flash drive connected to the Digital Video Monitor.
  • Page 29 Export to PACS: After selecting a picture or video, click the "DICOM" button, input patient ID, name of attending physician, patient name, patient age, patient gender, and tap the confirmation button. Then wait for the file transfer to complete. Warning Users are not recommended to use USB to import and export data.

  • Page 30: Image Parameter Adjustment

    Note: Please complete the DICOM setting first and test the network link successfully before transferring DICOM  files. Only DICOM format can be used for export to PACS server. See table below for more information about  file formats. Always check if the entered patient data is correct before exporting to PACS. ...
  • Page 31 6.5.2 Image parameter reset In the parameter adjustment menu, tap the icon to reset the image parameters to their initial state. 6.5.3 Image rotation Tap the icon to rotate the image interface 180 °. 6.5.4 Image mode selection Image mode switching function, corresponding to respiratory , urology , nasopharyngeal digestive...

  • Page 32: System Settings Menu

    In the image mode parameter adjustment interface, image parameters can also be adjusted and saved. 6.6. System Settings Menu Click the icon to enter the System Settings Menu for user settings, network settings, display and brightness settings, sound settings, time zone and language settings.
  • Page 33 Description of System Settings Menu Reference Item Name Function section Tap to enter the user Settings interface for user management, 6.6.1 including password modification, exit login other User settings permissions. Network Tap to enter the network settings interface for connecting wired 6.6.2 networks and local area networks.
  • Page 34 The equipment has user settings function. Users can set relevant permission content as needed. When the current user is an administrator, they have the authority to modify passwords, create users, delete users, add hospital information, modify report templates, add avatars, and log out. 2) When the current login account is a regular user, it has the authority to modify password, add avatar, and log out.
  • Page 35 6.6.1.2 Create a user account In the administrator account, select the account that needs to be modified, enter the new password, confirm the new password, and click confirm to complete the password modification. 6.6.1.3 Delete a user account In the administrator account, After selecting the account that needs to be deleted, enter the administrator password and click confirm to complete the deletion of the user account.
  • Page 36 6.6.1.4 Add hospital information In the user settings interface, modify the hospital name and icon, and click on modify to save the setting. 6.6.1.5 Report template In the report template window, you can add, modify, and delete reports 6.6.1.6 Add avatar Click the add avatar button to select the avatar icon and modify the current user's avatar 6.6.1.7 Log out Click the logout button to exit the current account and return to the login interface...
  • Page 37 Caution Turn on the operating system firewall function of the workstation computer.  When connecting to a network, make sure that the device is connected to a private Local Area  Network and that the private network is secure. Reliability of the network needs to be confirmed when network settings are updated.
  • Page 38 When connecting to a wireless network, start scanning the network, select the corresponding wireless network, and enter a password to connect to the network. 6.6.3. Display and brightness Under the system settings interface, click on the display and brightness options to enter the display and brightness settings interface.
  • Page 39 6.6.4. Volume Under the system settings interface, click on the sound settings option to enter the sound settings interface, where you can set the speaker and microphone 6.6.5. Battery and storage Under the system settings interface, click on the battery and storage settings option to enter the battery and storage settings interface, where you can view the current device's battery and storage information Battery: displays the percentage of battery charge;...
  • Page 40 6.6.6. Time zone and language Under the system settings interface, click on the Time Zone and Language Settings option to enter the Time Zone and Language Settings interface. You can select the current system language, system time, and time zone information Language: After clicking, you can select the system language.
  • Page 41 Network and that the private network is secure. Otherwise, the files cannot be transferred. Under the system settings interface, click on the DICOM settings option to enter the DICOM settings interface, where you can configure DICOM services and query patient information 6.6.7.1 DICOM configuration Configure DICOM sites and PACS servers to send images, recordings, and medical records from the host to the DICOM server through wired or wireless network connections, or query patient information...
  • Page 42 6.6.7.2 Patient inquiry After connecting to the PACS server, patient information can be filtered and queried through keywords Information needed Explanation Host address Current PACS server address Filter Fields Set filter fields, providing three types of fields: patient number, patient name, and registration number;...

  • Page 43: System Update

    6.7 System update On the device information page, view information about the digital video monitor, such as software version, available disk space, etc. Please contact your local sales agent or after sales for an upgrade 6.8. Reporting a problem Please contact your local sales agent or after sales. 6.9 Clear data If a digital video monitor is to be handled by a third party or needs to be disposed, it is advised to delete all sensitive data.

  • Page 44: Device Information

    • UserAdministrator will be reset to default password. • Wireless network settings • DICOM, PACS server settings Clear the data: • Press the Settings enter UserAdministrator password and press Continue • Press Clear data . A dialog box appears informing of the consequences and asking to confirm. •...

  • Page 45: Cleaning And Disinfection

    7. Cleaning and Disinfection The product should be cleaned and disinfected before and after each use. It is recommended to clean and disinfect the product according to the following instructions before and after use. Any deviations from the instructions shall be assessed properly to determine its effectiveness and potential adverse consequences to ensure that it continues to achieve its intended purpose.

  • Page 46: Disinfection

    8.3. Returning the Digital Video Monitor for Repair Vathin Medical shall have the right to request the technical department or equivalent at the customer's site to repair the product under the proper guidance of Vathin Medical. Any defective Vathin Digital Video Monitor must be disposed of by the person authorized by Vathin Medical.

  • Page 47: Disposal

    Chapter 7 must be followed. Vathin Medical reserves the right to return contaminated medical equipment to the sender. 8.4. Disposal At the end of product life, clean and disinfect the Digital Video Monitor. Before disposing of the Digital Video Monitor, it is advised to follow these steps to erase all data: •...

  • Page 48: Troubleshooting

    Screen brightness Manual adjustment Wi-Fi IEEE 802.11b/g/n/ac 2.4G,5G LAN connection IEEE 802.11 1000base-T USB connection USB3.0 A-type Expected service life 5 years Electrical power (Digital Video Monitor) Input Power 15V DC, 4.2A max Internal battery 10.8V DC 9000mAh Power adapter Power supply requirement 100–240 V AC;...
  • Page 49 download and installation process! Restart the digital video monitor 1. Press and hold the power button until the shutdown dialog appears, then tap 'Confirm' in the dialog, and wait for the device to complete the shutdown. (no light in power button). If the machine can not complete the normal shutdown.

  • Page 50: Appendix 1. Electromagnetic Compatibility

    Appendix 1. Electromagnetic Compatibility Essential Performance The product is designed to provide images for observation, excluding short-term automatically recoverable reduction caused by electromagnetic interference. The following cable information is given for EMC reference only. Cable Max. cable length Qty. Category Shielded/unshielded AC power cable 1.8 m...

  • Page 51: Emi Compliance

    Statement The product is designed compatible with the high-frequency surgical equipment, i.e. it is allowed to  keep working or standby near the high-frequency surgical equipment. In case of interrupted AC input voltage, the product will shut down, and once the power supply is ...
  • Page 52 Table 3. Fields near the radio-frequency wireless communication devices Immunity test level Test frequency Band (MHz) (MHz) Professional medical environment 380–390 Pulse modulation 18 Hz, 27 V/m 430–470 FM, ±5 kHz deviation, 1 kHz sine, 28 V/m 704–787 Pulse modulation 217 Hz, 9 V/m 800–960 Pulse modulation 18 Hz, 28 V/m 1720...
  • Page 53 disturbances induced 6 V in ISM bands between 0.15 MHz and 80 MHz by radio-frequency 80% AM at 1 kHz fields Table 6. Proximity magnetic fields Immunity test levels Modulation Test frequency Professional healthcare facility environment Pulse modulation 134,2 kHz 65 A/m 2,1 kHz Pulse modulation...

  • Page 54: Appendix 2. Information About Wi-Fi

    Appendix 2. Information About Wi-Fi Warnings Please take attention that changes or modification not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation.

  • Page 55: Frequency Band

    radiator & your body. ce matériel est conforme aux limites de dose d'exposition aux rayonnements, FCC / CNR-102 énoncée dans un autre environnement.cette eqipment devrait être installé et exploité avec distance minimale de 20 entre le radiateur et votre corps. The user manual for local area network devices shall contain instructions related to the restrictions mentioned in the above sections, namely that: the device for operation in the band 5150-5250 MHz is only for indoor use to reduce the potential for...
  • Page 56 RED Certification: 1: 2.412-2.472GHz 2: 5.15-5.25GHz 3: 5.25-5.35GHz 4: 5.47-5.725GHz 5: 5.725-5.875GHz...

  • Page 57: Appendix 3. Cybersecurity

    USB interface. If the installation package name, RAS authentication, installation package hash value, or any parameter is inconsistent with the Vathin rule, the installation will be rejected. Even if this installation package works properly on other Android systems, it will be judged as illegal software by the Digital Video Monitor.
  • Page 58 Wireless Wireless The device uses a WPA_Supplicant to support communication communication WPA2 Wireless communication as TKIP and CCMP. The authentication and integrity of the communication is provided by the underlying FIPS 140-2 compliant chipset wireless driver. Wi-Fi option supports WPA2 Enterprise for mschapv2. IEEE 802.3 The device uses a standard Gigabit Ethernet communication...
  • Page 59 Main known vulnerabilities of each component including explanations of why they are acceptable for this application are continuously updated by Vathin. Contact your local Vathin representative for an up to date list with this information. Vulnerabilities with a low CVSS score are omitted as a consequence of the medium security risk rating of the digital video monitor.
  • Page 60 Hunan Vathin Medical Instrument Co., Ltd. 1/F, Building 12, Innovation and Entrepreneurship Service Center, No 9 Chuanqi west road, Jiuhua Economic Development Zone, 411100， Xiangtan, Hunan, China Website: www.vathin.com Email: service@vathin.com Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
  • Page 61 Hunan Vathin Medical Instrument Co., Ltd. User Manual User Manual of Digital Video Monitor 39/61 QP-DMR-DVM06-001 Name Page Release Notes Version Modificatio Prepared/ Modification Description n Date Modified By 2023.03.15 New Document Yanglin Feng Add new model DVM-D2 2024.04.15 Add worklist operation process and add...

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