Hunan Vathin Medical Instrument Co., Ltd. User's Manual Name User Manual of Digital Video Monitor Page 0/30 Prepared By Date Release Date Reviewed By Date Effective Date Approved By Date Competent Department No. QP-DMR-DVM02-003 Controlled Status R&D Department Version No.: A Revision No.: 0 Distributed To Release Notes Version No. Modification Date Modification Description A/0 2021.01.
le User's Manual Digital Video Monitor DVM-B1 DVM-B2 Rx only Caution: Federal law restricts this device to sale by or on the order of a physician. ◆For use by trained clinicians/physicians only. ◆For in-hospital use. ◆For use with Vathin endoscope. ◆Before use, thoroughly review this manual. ◆Please keep all instruction manuals in a safe, accessible place. ◆Have any questions or comments about this manual, contact with Vathin Medical. Hunan Vathin Medical Instrument Co., Ltd. Version No.
Table of Contents 1. Important Information - Read Before Use .................................................................................... 2 1.1. Intended Use ................................................................................................................................. 2 1.2. Contraindication............................................................................................................................. 2 1.3. Repair and Refit............................................
8.1. Storage ........................................................................................................................................ 23 8.2. Battery Maintenance .................................................................................................................... 23 8.3. Return the Digital Video Monitor for repair .................................................................................. 23 8.4. Disposal .................................................................
1. Important Information - Read Before Use Please read these safety instructions carefully before using Digital Video Monitor. The instruction for use may be updated without further notice. Copies of the current version are available upon request. Please note that no clinical procedure is explained or discussed in this manual. The product can be operated only by a physician who has received clinical endoscopy training. Therefore, no clinical endoscopy procedure is explained or discussed in this manual.
1.3. Repair and Refit The product does not contain any user-repairable components. Never disassemble or refit or attempt to repair the product, which may cause injury to the patient or operator, damage to the product and/or failure to achieve the intended purpose. The product can be repaired only by the person authorized by Hunan Vathin Medical Instrument Co., Ltd. 1.4.
Do not use the product during the defibrillation process. Warning To avoid the risk of electric shock, do not simultaneously touch the power socket, the docking connector or the bracket of the product when handling with the patients. To minimize the risk of contamination, always clean and disinfect the product as specified in Chapter 7 after each use. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.
2. Symbols Symbols ℞ only Expression Symbols Expression CE marking of conformity Waste Bin symbol,indicating that waste mustbe collected according tolocal regulation and collection schemes fordisposal of electronic andelectrical waste (WEEE) General warning sign Manufacturer Refer to instruction manual Country of manufacture:CN(china) Production date, followed by YYYY-MM-DD. Indicates that the product can be used only with a prescription from a U.S.
Only for indoor use Tested to comply with FCC Standards-medical Equipment Fragile, handle with care Model number Medical device Unique device identifier Protective earth (ground) Direct current 3. System The product is designed as the system controller of endoscopic image observation system to display, record and print endoscopic images. Certain functions described below can only be enabled when the necessary equipment is connected to the product.
3.2.2. Compatible Monitor Item Recommended parameter Screen brightness ≥ 300 cd/m² Color gamut BT.709 or SMPTE-C, 72% NTSC Resolution 480/60 p,480/60 i, 576/50 p, 576/50 i, 720/60 p, 720/50 p, 1080/50 i, 1080/50 p, 1080/60 p, 1080/30 p, 1080/60 i Monitoring technology Bright LED backlight technology Input signal type DVI-D or HDMI Video bandwidth < 165 MHz TMDS: 600 mV for each differential line Input impedance: 50 ohm Monitor size 8.5", 10", 15",19", 21",24", and 26" Contrast ≥ 1000/1 4.
4.2.
Trolley 1pcs 4.3. Structure and Function No. Part Function 1. Power button Long press the power button to turn on the product, and press it to turn off the product. 2. Power indicator It is used to indicate the battery power status.
The light is blue and keep on when the device is on. And it flashes when the device is being charged and when the battery is low. 3. Display screen It is used to display the image after the endoscope is connected, and it is a touch screen. 4. LAN interface It is used to connect to the local area network through the network cable. 5. HDMI interface It is used to connect an external high-definition monitor for display expansion. 6. USB interface 3.
*It is recommended to use a φ 1 mm and 10 mm long pin. 11. Video endoscope The video endoscope cable can be inserted to this socket to cable connector socket connect the video endoscope and the product. 12. Ventilation holes Cool hardware during use. 13. Bracket It is used to support the product on a plane surface. 5. Preparation and Operation When using the product for the first time, please refer to this User's Manual and install the product according to the following steps.
To avoid the risk of electric shock, only the appropriately approved medical electrical equipment are allowed to be connected with the product. The product can only be connected to a medical display screen that has been qualified as per IEC 60601-1.
4. Connect the Digital Video Monitor with medical display or PC as needed. 5. Install the endoscope to the Digital Video Monitor by inserting the endoscope connector into the endoscope socket (No. 10 in Section 4.3 Structure and Function) properly as the arrow indicated. 5.3. Power-on and Setting Warning When the loss of built-in power supply under normal working condition would result in unacceptable risks, the medical electrical equipment must be connected to an appropriate external power supply.
5.4. Inspection of the System Warning If any irregularity be observed during the inspection, do not use the Digital Video Monitor. Damage or irregularity may compromise patient or user safety and may result in more severe equipment damage. 1. Inspect photographing, recording function of the equipment. Please refer to Section 5.5.1 Photo-shooting and Section 5.5.2 Video Recording. 2. Inspect the endoscope function according to the instruction for use of the endoscope. 3.
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. Some key functions need to enter the user password when using,The initial user password of this product is 123456, you can reset the user password according to the instructions in the manual.
White balance The white balance adjustment is required before surgery. 6.1.2 Patient information Tap it to enter the patient information mode. 6.1.1 Patient information Tap it to return to the basic function interface / Photo preview Photo preview zone, will be updated after the image being taken. Tap it to preview the latest images. 6.1.3 WiFi Used to indicate the WiFi connection/disconnection 6.3.
Caution Once the patient information being entered, the photos and videos taken will be appended with the patient information until the patient information is cleared. Note The image showed in the image zone will be cleared after the patient ID is modified. 6.1.2. White Balance Adjustment This adjustment procedure is used to display the correct image color on the monitor. Be sure to always adjust the white balance in the following cases: * Before observation.
balance. 3. Maintaining the stable condition in step 1, tap the icon on the screen. Icon will appear in the upper right corner of the image. When the icon disappears. the white balance adjust is complete. 6.1.3. Photo-shooting 1. There are two methods to take photos. * Press the photographing button on the endoscope * Tap Icon on the screen. 2. When taking photos, icon when the icon appears in the upper right corner of the screen.
the figure below. Description of file management-related icons Icon Name Function Reference section File management Icon for the file management interface. 6.2 File editing You can tap the icon or long press a folder/file to enter the selection mode, and then perform multiple selection, cutting, renaming, and deletion operation on the file or folder. USB storage device management Used to indicate the connection of USB storage device.
Note The Photos/Videos taken are stored according to date and patient ID, and the file folder is named accordingly.For example, if the operation date is Sept. 17, 2020, patient ID is 12, the file path will be: >2020-09-17>12. If the patient ID is not set: A "pictures/medias" folder will be generated in the date folder after photo-shooting/video-recording, and the file path will be: >2020-09-17>picture/medias, The image are stored in PNG format, video are stored in MP4 format. 6.2.3.
Screen adjustment Used to adjust the brightness,sharpness,gamma,red saturation,green saturation,blue saturation / Calendar Used to set the date and time / Equipment information Used to view the equipment information / User account Used to set the user accounts Erase data Used to erase internal files and user data Network setting Used to set languages, Wifi and LAN / / 6.3.1 6.3.1. WiFi Setting Warning Please connect the Digital Video Monitor to a reliable network.
Note: Digital Video Monitor uses WIFI direct connection to connect to mopria-supported WIFI printers for printing. The expected communication data involves medical and health data. Digital Video Monitor can be connected to the local Internet through the RJ45 interface to obtain the network synchronization time. The intended communication involves the interaction of network synchronized time data. 7. Cleaning and Disinfection The product should be cleaned and disinfected before and after each use.
7. Repeat Steps 1 to 6 until the Digital Video Monitor is clean. 7.2. Disinfection 1. Disinfection Solution: isopropanol (alcohol) concentration 70–80%; 2. Preparation: add 80 cc of 95% isopropanol (alcohol) to 20 cc of purified water (PURW) (or use the EPA registered medical disinfectant wet wipes containing at least 70% isopropanol; all the appropriate safety precautions and manufacturer’s instructions must be followed). 3.
8.4. Disposal After the product's service life expires, you should remove the monitor, and dispose of the battery and the monitor separately according to local regulations by using the disposal equipment that meets appropriate national and local regulations. 9. Technical Specification 9.1.
Power adapter Power supply requirement 100–240 V AC; 47–63 Hz; 1.62–0.72 A Output Power 15V DC,4.
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 Shielded/unshielded Qty. Category AC power cable 1.8 m Unshielded 1 set AC power supply DC power cable 1.3 m Unshielded 1 set DC power supply USB cable 2.
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 restored, it can be manually restored by the operator. The degradation in such case is acceptable because it will neither cause unacceptable risks nor impair basic safety or essential performance.
Rated power frequency magnetic field 30 A/m 50 or 60 Hz IEC 61000-4-8 Table 3.
Table 5. Signal input/output ports Phenomenon Basic EMC standards Conducted disturbances induced by radio-frequency fields IEC 61000-4-6 Immunity test level Professional medical environment 3 V, 0.15–80 MHz 6 V in ISM bands between 0.
Appendix 2. Information About Wifi 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.
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.
1:2.412-2.472GHz 2:5.15-5.25GHz 3:5.25-5.35GHz 4:5.47-5.725GHz 5:5.725-5.
[Manufacturer Name, Registrant Name, and After-sales Service Provider]: Hunan Vathin Medical Instrument Co., Ltd. [Production Address, Manufacturer's Domicile, and Registrant's Domicile]: 1/F, Building 12, Innovation and Entrepreneurship Service Center No. 9 Chuanqi West Road, Jiuhua Economic Development Zone, 411100 Xiangtan, Hunan China [Manufacturer and Registrant Contact] Tel.: +86-21-34781226 +86-731-55558558 Website: www.vathin.com Email: service@vathin.com Lotus NL B.V.
