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Summary of Contents for Bowa ERGO 310D
- Page 1 Instructions for use MN031-600-S2...
- Page 3 Legend Trigger Finger switch Shaft Jaws Rotation wheel Handle with operating lever HF cable with COMFORT plug Knife Active electrodes BOWA-IFU-MN031-600-ERGO310D-S2-EN-20190116...
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Page 4: Intended Use
1 Intended use 1.1 Purpose: The ERGO 310D is an instrument for vessel sealing arterial and venous blood vessels and vascularized tissue in laparoscopic and open surgery procedures in many different surgical disciplines (including but not restricted to general surgery, gynecology, urology, thoracic surgery, etc.). - Page 5 Do not use vessel sealing for tissue groups with unknown content. Proceed cautiously when performing sealing in the vicinity of sensitive structures, such as nerves or ureter. Avoid grasping too much tissue for sealing – the jaws should not be full. BOWA-IFU-MN031-600-ERGO310D-S2-EN-20190116...
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Page 6: General Safety Instructions
Do not use the product if its expiry date has elapsed. Do not use defective instruments. All serious incidents arising in connection with the product must be reported to the manufacturer and the competent authority of the member state in which the user is established. BOWA-IFU-MN031-600-ERGO310D-S2-EN-20190116... - Page 7 The HF cable may cause interference to imagery on monitors: Never route the HF cable alongside a camera cable. Do not lay the HF cable in loops. Consult the operating manuals of the BOWA HF generators for additional information on interference with other devices.
- Page 8 EMC Information Medical electrical devices are subject to special EMC precautions, so please observe the following directions. BOWA accessories are intended only for connection to HF devices specified by BOWA. Use of the accessories on medical devices from manufacturers other than those described may lead to elevated emissions or reduced interference immunity.
- Page 9 Incorrect HF generator configuration settings and limited visibility can lead to patient injuries: Carry out operations only with adequate visibility. Use only the ligation program of BOWA ARC generators with bipolar ligation current. Prepare the tissue to be sealed so it is as free as possible in order to avoid unintentional clamping.
- Page 10 Set the demand pacemaker to a fixed frequency. Ensure that the pacemaker does not come into contact with the HF electrode. Keep a fully operational defibrillator within reach Carry out a postoperative pacemaker check. BOWA-IFU-MN031-600-ERGO310D-S2-EN-20190116...
- Page 11 In bipolar HF surgery, tissue coagulation is achieved by applying a high-frequency AC current, which generates heat. The ERGO 310D ligation instruments are surgical invasive instruments for use in laparoscopic or open surgery. They are used through surgically generated access openings in conjunction with products for endoscopic use, such as trocars and optics.
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Page 12: Operation
Connect the HF cable to a bipolar socket of the HF device The output power and mode is automatically set on the BOWA ARC generator with the Plug’n Cut COMFORT instrument detection. Perform a thorough visual inspection and functional test before using the ligation instrument. - Page 13 Clean the electrodes of the jaws regularly with a moist cloth. Risk of injury due to sharp blade Do not activate the trigger of the blade during cleaning of the electrodes. Inserting the instrument Close the electrodes using the handle. Insert the instrument in the trocar sleeve. BOWA-IFU-MN031-600-ERGO310D-S2-EN-20190116...
- Page 14 If there is a short-circuit in the area of the sealing instrument or if the sealing instrument is not in contact with tissue during activation, a warning will be displayed on the HF device. Please check the instrument and reactivate. BOWA-IFU-MN031-600-ERGO310D-S2-EN-20190116...
- Page 15 Before cutting, ensure that the tissue has been reliably sealed. Cut only in the sealed area. To cut, pull the trigger and then release it. The tissue is cut in the centre of the sealed area. BOWA-IFU-MN031-600-ERGO310D-S2-EN-20190116...
- Page 16 5 Disposal DANGER Infection hazard! To avoid spreading germs and infections, sterilize the instrument before it leaves the hospital or surgical practice. Always dispose of medical products, packaging materials and accessories in accordance with applicable national regulations and statutes. BOWA-IFU-MN031-600-ERGO310D-S2-EN-20190116...
- Page 17 7 Transport 1. When transporting the instrument, make sure that it is protected from: • severe mechanical effects, such as shock, dropping or impact, • direct sunlight, • X-rays, • heat sources. 2. The instrument must be dry during transport. BOWA-IFU-MN031-600-ERGO310D-S2-EN-20190116...
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Page 18: Technical Specifications
8 Technical specifications Technical specifications 775-000 Max. voltage 200 Vp sinusoidal Approved BOWA ARC generators with vessel sealing HF device software: • ARC 350 - REF 900-351 • ARC 400 - REF 900-400 Approved LIGATION, ARCSeal programs BOWA-IFU-MN031-600-ERGO310D-S2-EN-20190116... -
Page 19: Symbols On The Packaging
Labeling Labeling Follow the instructions Reference number for use Quantity Single use only Batch code Do not resterilize Sterilized with ethylene Keep away from oxide sunlight Expiry date Keep dry Manufacturer Do not use if the packaging is damaged BOWA-IFU-MN031-600-ERGO310D-S2-EN-20190116... - Page 20 0123 BOWA-electronic GmbH & Co. KG CE Marked according to Heinrich-Hertz Strasse 4–10 Medical Device 93/42/EWG D-72810 Gomaringen │ Germany Phone: +49 (0) 7072-6002-0 Fax: +49 (0) 7072-6002-33 info@bowa-medical.com www.bowa-medical.com...
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