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[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

:

 [email protected] 

 

Lotus NL B.V. 
Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. 
[email protected] 

+31645171879, +31626669008

 

 

 

 

 

No.: QP-DMR-DVM02-0

03

 

Version Number/Revision Number A/0 

Issue Date: ****.**.** 

 

Summary of Contents for DVM-B1

Page 1: ... QP DMR DVM02 003 Prepared By Date Release Date Controlled Status Reviewed By Date Effective Date Approved By Date Competent Department R D Department Version No A Revision No 0 Distributed To Release Notes Version No Modification Date Modification Description Prepared Modified By A 0 2021 01 19 New Document ...

Page 2: ...estricts 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 ...

Page 3: ......

Page 4: ... and Inspection 11 5 2 Installation of Digital Video Monitor 12 5 3 Power on and Setting 13 5 4 Inspection of the System 14 5 5 Operation of the Digital Video Monitor 14 5 6 After Use 14 6 Function 14 6 1 Basic Function Interface 15 6 1 1 Enter Patient Information 16 6 1 2 White Balance Adjustment 17 6 1 3 Photo shooting 18 6 1 4 Video Recording 18 6 2 File Management Interface 18 6 2 1 Enter the ...

Page 5: ... 8 3 Return the Digital Video Monitor for repair 23 8 4 Disposal 24 9 Technical Specification 24 9 1 Standard Applied 24 9 2 Specification 24 10 Troubleshooting 25 Appendix 1 Electromagnetic Compatibility 26 Appendix 2 Information About Wifi 30 ...

Page 6: ...iliar with the intended use warnings cautions and contraindications mentioned in these instructions 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 1 1 Int...

Page 7: ...ve 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 Warning As a BF type application component the endoscope connected to the product must not be directly applied to the heart The leakage current at the BF type applica...

Page 8: ...n using the product to examine patients always prevent the metal parts of the endoscope or its accessories from touching any metal part of other components of the system Keep all the electrical equipment away from any liquid In case of any splash onto the product stop it immediately and contact Vathin Medical Wearing suitable protective filtering spectacles when the laser is used Otherwise eye dam...

Page 9: ...with a prescription from a U S physician as required by the appropriate regulations of USA Batch code Authorized representative in the European Community European Union Keep dry Humidity limitation Temperature limitation Atmospheric pressure limitation Keep away from sunlight Catalog number Indicates the manufacturer s catalog number so that the medical device can be identifie Type BF Applied Part...

Page 10: ...d to the product For information about the compatible endoscope and other equipment please refer to their Instruction for use 3 1 Digital Video Monitor No Model Specification of endoscope port 1 DVM B1 14PIN 2 DVM B2 16PIN 3 2 Product Compatibility The Digital Video Monitor has been designed to be used in conjunction with Vathin endoscope and medical monitor The compatible equipments are listed be...

Page 11: ...ential line Input impedance 50 ohm Monitor size 8 5 10 15 19 21 24 and 26 Contrast 1000 1 4 Checking the Package Contents 4 1 Package Contents Open the product packaging to ensure that all the components are provided Check all the 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 Quantities Pic...

Page 12: ...8 USB cable 1 pcs HDMI cable 1 pcs User s manual 1 pcs Multilingual User s Manual CD 1 pcs Reset pin 1 pcs 4 2 Optional Accessories Items Quantities Pictures U Disk 1 pcs pylons 1pcs ...

Page 13: ...s 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 ...

Page 14: ...5 HDMI interface It is used to connect an external high definition monitor for display expansion 6 USB interface 3 0 It is used to connect external devices such as U disk 7 USB interface 3 0 It is used to connect external devices such as U disk 8 Power jack It receives 15V DC input and provides the power supply for the entire system No Part Function 9 USB 2 0 It can be connected to a PC for image ...

Page 15: ...unction impaired safety and or equipment damage may be caused Do not place any equipment on top of the product otherwise the product may be damaged Do not install the product near any strong electromagnetic radiation source e g microwave therapy equipment shortwave therapy equipment and MRI Otherwise the product may malfunction Before each procedure inspect the Digital Video Monitor as instructed ...

Page 16: ...nstallation of Digital Video Monitor Warning To avoid risk of electric shock this equipment must only be connected to a supply mains with protective earth Electric shock and or fire may be caused if the product is not properly grounded All the system components shall be powered off before connecting them Only appropriate cables can be used for the product Otherwise the product may be damaged or ma...

Page 17: ... Basic Function interface Section 6 1 Basic Function Interface will appear by default 2 The real time image will be displayed on the screen Icons on the screen turn green and their function are available 3 If battery will be used check battery capacity of the equipment and charge when the battery is low 4 Set the parameters of Digital Video Monitor according to section 6 3 System Setting Interface...

Page 18: ...e Digital Video Monitor Warning When advancing or withdrawing a Vathin endoscope always watch the real time endoscopic image on the monitor 1 Enter patient information Enter the patient information according to Clause 6 1 1 2 Adjust the white balance Adjust the white balance according to Clause 6 1 2 3 Perform examination related function of the Digital Video Monitor please refer to Chapter 6 Func...

Page 19: ...om the right to the left of the screen 6 1 Basic Function Interface Description of basic function icons Icon Name Function Reference section Basic function Icon for the basic function interface 6 1 File management Icon for the file management interface 6 2 System setting Icon for the system setting interface 6 3 Photo shooting Tap this button or the Vathin endoscope camera button to take the image...

Page 20: ...emory A prompt will be given in case of insufficient memory Memory Storage space is not enough Battery capacity Used to indicate the remaining battery capacity Battery capacity Low power capacity 6 1 1 Enter Patient Information 1 Tap to enter the Patient Information interface Tap the input box on the screen to enter patient information through the keyboard that appears Icon can be used to enter th...

Page 21: ...inging it in contact with the endoscope Contact of the endoscope with a non sterilized object may result in cross contamination Caution When adjusting the white balance make sure the light built in the distal end is on and take care not to expose the distal end of the endoscope to external light Otherwise it may cause an incorrect white balance adjustment 1 The adjustment procedure is used to disp...

Page 22: ...e Vathin endoscope as still as possible to prevent obscure images during the photo shooting 6 1 4 Video Recording Tap icon to start recording and the icon will turn red will appear on the upper right corner of the screen to indicate the recording time Tap again to end the video recording and will disappear The video has been taken when Video saved successfully on the screen Note The maximum allowa...

Page 23: ...nection of USB storage device When connecting a storage device you can choose to copy cut files to a USB storage device If no USB storage device is connected the icon is gray which means this function cannot be used Medical record Used to edit the medical records 6 2 3 Save Medical record Used to save pictures of medical records 6 2 3 Print Used to print the medical records where Wifi connection i...

Page 24: ... Record icon enter the patient ID to enter the record sheet interface Select the Case Template the report will be showed on the screen Select date of the report fill the Report ID and related information select patient photos fill in the diagnosis and treatment outcomes click to save picture of the record click the print icon to select HP s WiFi printer for printing Click the Erase icon to erase t...

Page 25: ...ease refer to Appendix 3 Information About Wifi On the area of wifi setting turn on WiFi and enter a valid password to connect to the network After the network is connected normally the network connection symbol appears in the status bar of the screen 6 3 2 LAN setting Warning When connecting to a network make sure that the device is connected to a private local area network and that the private n...

Page 26: ...Digital Video Monitor from any mains power supply remove any accessories and make sure the Digital Video Monitor is completely turned off before cleaning and disinfection You should take the following steps to clean and disinfect the product according to good medical practices 7 1 Cleaning 1 Recommended detergent enzymatic mild pH of 7 9 and low foam Enzol or equivalent 2 Prepare the cleaning solu...

Page 27: ...perations according to local guidelines and the storage environment requirements in this manual 8 2 Battery Maintenance In order to extend the service life of the battery it is recommended to fully charge the product at least once every three months The battery can last over 6 hours The temperature range during charging should be controlled within 10 35 C If the battery needs to be replaced never ...

Page 28: ...Equipment Part 1 2 General requirements for basic safety and essential performance Collateral Standard Electromagnetic disturbances Requirements and tests 9 2 Specification Item Specifications Function White balance Manual Data record Videos MP4 photos png Memory 64G memory Language setting English Français 日本語 中文简体 Deutsch Español Time setting Manual Internet based self calibration Monitor 12 1 1...

Page 29: ...ine the cause and solve it If the problem still exists after troubleshooting please contact your local dealer Phenomenon Possible cause Recommended measures The device cannot be turned on The battery is low or the battery is protected Connect the power adapter to charge the battery or wake up the protected battery and then press the power button to start the machine No image The device cannot reco...

Page 30: ...ll be observed The equipment with above mentioned ESSENTIAL PERFORMANCE is intended used in Professional healthcare facility environment except for any places that is near the RF shielding room of the ME system for magnetic resonance imaging MRI with high electromagnetic interference intensity Warning It is required to avoid using the product next to or stacked with other equipment Otherwise impro...

Page 31: ...adio frequency emission CISPR 11 Group 1 Class A Professional medical environment Harmonic distortion IEC 61000 3 2 Class A Professional medical environment Voltage fluctuation and Flicker IEC 61000 3 3 Compliance Professional medical environment Caution The emission characteristics of the product make it suitable for use in industrial areas and hospitals CISPR 11 Class A If being used in the resi...

Page 32: ...7 Hz 28 V m 5240 5100 5800 Pulse modulation 217 Hz 9 V m 5500 5785 Table 4 Input AC power supply ports Phenomenon Basic EMC standards Immunity test level Professional medical environment Electrical fast transient burst IEC 61000 4 4 2 kV 100kHz repetition frequency Line to line surge IEC 61000 4 5 0 5 kV 1 kV Line to ground surge IEC 61000 4 5 0 5 kV 1 kV 2 kV Conducted disturbances induced by rad...

Page 33: ...rts Phenomenon Basic EMC standards Immunity test level Professional medical environment Conducted disturbances induced by radio frequency fields IEC 61000 4 6 3 V 0 15 80 MHz 6 V in ISM bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz ...

Page 34: ... si le brouillage est susceptible d en compromettre le fonctionnement For licence exempt equipment with detachable antennas the user manual shall also contain the following notice in a conspicuous location Under Industry Canada regulations this radio transmitter may only operate using an antenna of a type and maximum or lesser gain approved for the transmitter by Industry Canada To reduce potentia...

Page 35: ... sont réservés uniquement pour une utilisation à l intérieur afin de réduire les risques de brouillage préjudiciable aux systèmes de satellites mobiles utilisant les mêmes canaux ii le gain d antenne maximal autorisé pour les appareils dans les bandes 5250 5350 MHz et 5470 5725 MHz doivent respecter le pire limiter et iii le gain d antenne maximal autorisé pour les appareils dans la bande 5725 582...

Page 36: ...32 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 37: ...epreneurship 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 Koningin Julianaplein 10 1e Verd 2595AA The Hague Netherlands peter lotusnl com 31645171879 31626669008 No QP DMR DVM02 003 Version Number Revision Number A...

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