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Summary of Contents for Sometech TRUE EYE
- Page 1 Before using the product, please read this user's manual carefully for safety, and thoroughly learn how to install and operate before using the product. ‘This product is a medical device.' UM42L Rev.1 / Jan,2021...
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Page 2: Table Of Contents
Table of contents 1. Overview ................................1 2. Intended use ................................. 1 3. Indications................................2 4. Contraindications ..............................2 5. Intended user ............................... 2 6. Symbols information ............................2 7. Warning, Caution, Note ............................ 4 8. Warnings ................................4 9. Cautions ................................. 5 10. -
Page 3: Overview
It consists of an all-in-one type main unit (camera control unit + light source + recorder) and a 3D camera head, which are used together to provide 3D images. The TrueEYE rigid laparoscope should only be used with camera head sold by Sometech. The TrueEYE rigid laparoscope can be used in Full-HD or UHD (4K) to deliver high-resolution images depending on the camera head. -
Page 4: Indications
3. Indications The laparoscope is designed for use in gynecological and general procedures that doctors deem suitable for their patients. The laparoscope is designed for use by surgeons in diagnostic and therapeutic procedures. Laparoscopy uses include removal of the gallbladder and appendix, hernia correction, gastrointestinal anastomosis, laparoscopic gastroscopy and examination of the abdominal cavity, appendix, gallbladder and liver. - Page 5 Standard Designation Symbol Number and Symbol Symbol Title Reference Number Authorized representative in the European ISO 15223-1 - 5.1.2 Community ISO 15223-1 5.2.7 Non-sterile ISO 7000 - 0434A Caution ISO 15223-1 - 5.4.4 ISO 7010-W001 General warning ISO 7000 0626 Keep Dry ISO 15223-1 –...
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Page 6: Warning, Caution, Note
7. Warning, Caution, Note Please read this manual carefully and follow the instructions exactly. Words such as warnings, cautions, and notices contain important content and should be reviewed carefully. Warning: Indicates a risk to the safety of the patient or user. Failure to follow the warning may result in injury to the patient or user. -
Page 7: Cautions
9. Cautions This device is restricted and must only be sold by order of a doctor. Store the laparoscope in a clean, dry place when not in use. The exterior of the laparoscope is stainless steel and is generally resistant to rust, however rusting cannot be completely prevented. -
Page 8: Product Description
11. Product Description 11.1 TrueEYE Laparoscope Model Name Direction of view Working length Insertion portion width Tri-00 (10⌀) 0° ± 10° Ø 10mm ± 10% 375mm ± 10% Tri-30 (10⌀) 30° ± 10° Ø 10mm ± 10% 375mm ± 10% 6 / 20 UM42L Rev.1... - Page 9 Distal End The direction of view is divided into 0° and 30° depending on the intended purpose. This is a window glass that protects two objective lenses. A bundle of fiber optics that illuminates light on a subject. 7 / 20 UM42L Rev.1...
- Page 10 Marking Sometech logo-indicates that it is manufactured by Sometech The marking of ‘TrueEYE’ is the top of the scope. Direction of view – It is marked as 0° or 30. Laparoscope eyepiece and camera fastener. Scope's serial number Product name...
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Page 11: Associated Equipment
11.2 Associated equipment MiDAS I Camera control unit The front panel of the main unit has a touch screen, which provides access to a variety of menus including controls to adjust light level, zoom, white balance, and more. *Technical Specifications Performance Item Input Electrical... - Page 12 Real endo VLS-200 Camera head The camera head is connected to the main unit to create 3D images and transmit them to it. There are several control functions that can be accessed through the button key pad on the top of the camera head.
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Page 13: How To Use
12. How to use Precautions for use You must read carefully this manual and follow correctly the instruction before usage. This product must be handled by trained person. This product is not allowed to use any other purpose except original purpose of use. Clean and sterilize according to'Instructions for Reprocessing' in this product manual. -
Page 14: Archive Management Method
Inject carbon dioxide (CO ) gas into the abdominal cavity to inflate the tummy (abdomen). Make an artificial path (hole) in the abdomen with an endoscopic trocar. Adjusts the light intensity. If possible, start from the lowest level and increase it gradually Insert the laparoscope connected to the camera head in the trocar. -
Page 15: Instructions For Reprocessing
14. Instructions for Reprocessing Sometech has validated that the device can be reprocessed and re-use. However, it is the responsibility of the person performing the work to ensure that the reprocessing operation is performed using the equipment, materials, and personnel from the reprocessing facility to achieve the desired results. - Page 16 Cleaning procedure 1. Clean for 1 minute under tap water 2. Soak the rigid Laparoscope in detergent for 15 minutes. While submersing, obtain a softbristled brush, dip brush head into solution. Brush debris from the tip until visibly clean. 3. Rinse thoroughly the device with tap water for 1 minute. - Check for foreign substances.
- Page 17 [Stain] [Deformation] ⚫ Observe the written document at a distance of the working distance from the distal end of the laparoscope to ensure it is clearly visible, in good focus, and not dark or blurry Condition of Use (X) Condition of Use (O) ⚫...
- Page 18 ⚫ Check the equipment used together according to each instruction manual. 1) Check the video image quality through the Test object. 2) As shown in the figure, the image quality inspection is completed only when the two crosshairs are completely aligned. When adjusting the alignment, proceed without using 3D glasses (polarizing Note glasses).
- Page 19 Sterilization Ethylene Oxide (EtO) After following the cleaning instructions above, perform the following sterilization procedure. Before sterilization, each device must be double wrapped and follow the following criteria. Preconditioning Time: 2 hours Minimum product temperature at chamber: Not less than 10℃ Chamber temperature &...
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Page 20: Environmental Conditions For Transport/Storage
15. Environmental Conditions for Transport/Storage Observe the following environmental conditions fo transport and storage: ⚫ Temperature: -20°C to + 60°C ⚫ Humidity: 10% to 95% ⚫ Pressure: 50kPa to 106kPa 16. Disposal Disposal of this medical device requires no special measures. Dispose of the device following relevant national regulations and in accordance with hospital procedures. -
Page 21: Warranty And Service
17. Warranty and Service 1. This product is manufactured through continuous quality control and production process. 2. In the event of a breakdown during the normal use of the consumer, the head office service center provides free repair during the warranty period. 3. - Page 22 Sometech Inc 1201, 1204, Ace High-end Tower II, 61 Digital-ro 26 gil, Guro-gu, Seoul, Republic of KOREA Tel: +82(2) 2025-6600 / Fax: +82(2) 869-1005 www.sometech.com Certification Experts B.V. (brand name: CE Medical) Amerlandseweg 7, 3621 ZC Breukelen, The Netherlands 20 / 20...
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