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Summary of Contents for Bowa ERGOact
- Page 1 Instructions for Use ERGOact 12578EN-S1...
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Page 3: Key
Shaft tube Release button for disassembly Insert with jaw Rotation wheel Activation key COMFORT plug (for coagulation only) Handle Maryland insert Kelly insert Fenestrated insert BOWA-IFU-12578-ERGOACT-S1-EN-20230206 Instructions for Use ERGOact... - Page 4 Handle Shaft tube Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S1-EN-20230206...
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Page 5: Table Of Contents
8.2 Device-specific information ..................16 8.3 Inspection ......................18 8.4 Sterilisation packaging ...................19 9 Ambient conditions ....................19 9.1 Transport and storage ...................19 9.2 Operation .......................19 10 Technical data ......................19 11 Disposal ........................20 12 Symbols on packaging ..................20 BOWA-IFU-12578-ERGOACT-S1-EN-20230206 Instructions for Use ERGOact... -
Page 6: Applying The Instructions For Use
1 Applying the instructions for use These instructions for use are part of the device. BOWA-electronic GmbH & Co. KG assumes no liability and provides no warranty whatsoever for any damage or consequential damage arising from non-compliance with these instructions for use. -
Page 7: Symbols And Markings
Death, DANGER Immediate risk severe injury Death, WARNING Possible risk severe injury CAUTION Possible risk Minor injuries NOTE Possible risk Property damage Tips: Tips to make your work easier or supplementary information for a procedure. BOWA-IFU-12578-ERGOACT-S1-EN-20230206 Instructions for Use ERGOact... -
Page 8: Intended Purpose
2 Intended Purpose Electrosurgical equipment for cutting and coagulation of tissue. 2.1 Indications The ERGOact instruments are designed for the grasping, bipolar coagulation and separation of biological tissue during minimally invasive surgery. BOWA recommends using this device on the BOWA ARC generators. -
Page 9: Safety Instructions
Cables must never be inserted or removed while the device is activated. • Do not repair or service defective devices: Check the device for damage, in particular for the integrity of the insulation, after reprocessing and before use. BOWA-IFU-12578-ERGOACT-S1-EN-20230206 Instructions for Use ERGOact... -
Page 10: Use-Related
electrosurgical operations! • If necessary, use a suitable tester (e.g. BOWA REF 050-230) to check if the device is in proper working order. • The "BF" / "CF" applied part of the HF device used is extended by the instrument connected to it. -
Page 11: Patients With Pacemakers
Medical electrical devices are subject to special EMC precautions, so please follow the below-mentioned instructions. The BOWA accessory is only intended to be connected to BOWA specified HF devices. Using the accessory with medical devices from other manufacturers can result in ... -
Page 12: Description
In bipolar HF surgery, tissue coagulation is achieved by applying a high-frequency AC current, which generates heat. The ERGOact bipolar coagulation instrument is an invasive surgical instrument for use in laparoscopic or open surgery. It is used through surgically produced access openings in conjunction with devices for endoscopic use, such as trocars and optics. -
Page 13: Assembly
Once the shaft with insert is completely and correctly positioned inside the handle, the instrument’s jaws move when the rear handle shank moves. The instrument is now completely assembled. BOWA-IFU-12578-ERGOACT-S1-EN-20230206 Instructions for Use ERGOact... -
Page 14: Operation
Risk of patient injury due to tissue clamping, especially with limited visibility! Prepare the tissue to be coagulated by freeing it as far as possible to prevent it from becoming pinched! Perform the operation only with adequate visibility. Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S1-EN-20230206... - Page 15 Never use the AUTOSTART function. Do not switch on the HF current before the jaws are in contact with the tissue to be coagulated. Activating the instrument accidentally can cause injuries to the patient. BOWA-IFU-12578-ERGOACT-S1-EN-20230206 Instructions for Use ERGOact...
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Page 16: Removal
Inserts with damaged jaws must be replaced. 6.5 After use Prepare the laparoscopy instrument after use (see chapter 8 “Pre-conditioning”). 6.5.1 Spare parts To order spare parts, contact your BOWA dealership or visit our website: www.bowa- medical.com Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S1-EN-20230206... -
Page 17: Dismantling
You have now separated the shaft from the handle. 4. Gently rotate the insert until it detaches. 5. Pull the insert out of the shaft tube. The instrument is now dismantled. BOWA-IFU-12578-ERGOACT-S1-EN-20230206 Instructions for Use ERGOact... -
Page 18: Pre-Conditioning
The medical device manufacturer cannot be held liable if other types of cleaning agents and disinfectants are used. 8.2 Device-specific information Insulated parts must not come into contact with hard, sharp or heavy products, as this could damage the electrical insulation. Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S1-EN-20230206... - Page 19 Pre-conditioning BOWA has verified a service life of 50 cycles under the condition of proper and professional use and preparation; the actual service life may be higher or lower depending on the demands placed on the product. Re-conditioning step Description Manual pre-cleaning Soak the dismantled device at room temperature (<25°C) for at least...
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Page 20: Inspection
Description Steam sterilisation Sterilise the product while assembled or dismantled. Steam BOWA recommends steam sterilisation using the fractionated vacuum method sterilisation with a sterilisation time of 3–20 minutes and a temperature of 134–137°C in a suitable sterilisation packaging. BOWA has validated:... -
Page 21: Sterilisation Packaging
9 Ambient conditions 9.1 Transport and storage BOWA recommends storing the products in their original packaging until their first use. Store the products in a location where they are protected against direct sunlight. Transport and store the instrument in a dry environment. -
Page 22: Disposal
Symbol Meaning Follow the instructions for Keep away from direct sunlight Product number Keep dry Batch Manufacturer Approval mark United Quantity Kingdom CE mark and identification Medical device 0123 number of notified body Use-by date Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S1-EN-20230206... - Page 24 BOWA MEDICAL BOWA-electronic GmbH & Co. KG Heinrich-Hertz Strasse 4–10 72810 Gomaringen l Germany Phone: +49 7072-6002-0 Fax: +49 7072-6002-33 CE marking as per info@bowa-medical.com 2017/745 regulations www.bowa-medical.com...
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