Table of Contents
Advertisement
Quick Links
Advertisement
Table of Contents
Subscribe to Our Youtube Channel
Related Manuals for Bowa ERGOact
Summary of Contents for Bowa ERGOact
- Page 1 Instructions for Use ERGOact 12578EN-S0...
-
Page 3: Key
Shaft tube with insert Release button for disassembly Rotation wheel Activation key COMFORT plug (for coagulation only) Handle Maryland insert Kelly insert Fenestrated insert BOWA-IFU-12578-ERGOACT-S0-EN-20210715 Instructions for Use ERGOact... - Page 4 Handle Shaft tube Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S0-EN-20210715...
-
Page 5: Table Of Contents
9.2 Device-specific information ..................19 9.3 Inspection .......................21 9.4 Packaging .......................22 10 Environmental conditions ............... 22 10.1 Storage and transport ..................22 11 Technical data ................. 23 12 Disposal ..................23 13 Symbols on packaging ..............24 BOWA-IFU-12578-ERGOACT-S0-EN-20210715 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 Symbol / marking Meaning Prerequisite for an activity Activity with one step Activity with several steps in strict sequence Result of preceding activity • List (first level) • List (second level) Emphasis Emphasis BOWA-IFU-12578-ERGOACT-S0-EN-20210715 Instructions for Use ERGOact...
-
Page 8: Purpose
2 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. • If necessary, use a suitable tester (e.g. 050-230) to check the device is in proper working order. BOWA-IFU-12578-ERGOACT-S0-EN-20210715 Instructions for Use ERGOact... -
Page 10: Use-Related
Never route the HF cable alongside a camera cable. Do not lay the HF cable in loops. Consult the instructions for use of the BOWA HF generators for additional information on interference with other devices. Instructions for Use ERGOact... -
Page 11: Patients With Pacemakers
Set the demand pacemaker to a fixed frequency. Ensure that the pacemaker does not come into contact with the jaws. Have an operable defibrillator to hand. Carry out a postoperative pacemaker check. BOWA-IFU-12578-ERGOACT-S0-EN-20210715 Instructions for Use ERGOact... -
Page 12: Emc Information
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 13: Mode Of Operation
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 14: Procedure During Use
“Assembly”, page 13). 3. Attach the instrument to a connection cable suitable for the HF generator being used (see “Connection combinations”, page 12). The use of BOWA connection cables is recommended, since the plug connections of other manufacturers do not have to comply with the technical standards. -
Page 15: Assembly
3. Introduce the shaft tube with insert into the completely opened handle until you here it click into place. 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-S0-EN-20210715 Instructions for Use ERGOact... -
Page 16: Operation
The instrument is assembled, see section “Assembly”, page 13. W A R NI N G Risk of patient injury! Use only compatible HF generators (see BOWA declaration of compatibility). Select the settings of the HF device to the mode required for the ... -
Page 17: During The Operation
Activating the instrument accidentally can cause injuries to the patient. 1. Position the branches at the operation site. 2. Turn the rotation wheel (with the jaws open) to adjust the angle of the jaws. BOWA-IFU-12578-ERGOACT-S0-EN-20210715 Instructions for Use ERGOact... -
Page 18: Removal
Risk of patient injury due to damaged or broken-off parts! Always check the instrument before use. All parts must be present. 1. Close the jaws by closing the handle. 2. Withdraw the instrument from the trocar sleeve. Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S0-EN-20210715... -
Page 19: After Use
Inserts with damaged jaws must be replaced. Prepare the laparoscopy instrument after use (see section “Pre-conditioning”, page 19). 7.5.1 Spare parts To order spare parts, contact your BOWA dealership or visit our website: www.bowa- medical.com BOWA-IFU-12578-ERGOACT-S0-EN-20210715 Instructions for Use ERGOact... -
Page 20: Dismantling
You have now separated the shaft from the handle. 4. Gently rotate the insert clockwise until it comes loose. 5. Pull the insert out of the shaft tube. The instrument is now dismantled. Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S0-EN-20210715... -
Page 21: Pre-Conditioning
The medical device manufacturer cannot be held liable if other types of cleaning agents and disinfectants are used. 9.2 Device-specific information Insulated parts must not come into contact with hard, sharp or heavy products, as this could damage the electrical insulation. BOWA-IFU-12578-ERGOACT-S0-EN-20210715 Instructions for Use ERGOact... - Page 22 (each step taking 1 minute at >10°C). An A value of >3000 must be respected. Thermal BOWA recommends a temperature of 90°C for at least 5 minutes and disinfection the use of demineralised water. Drying is carried out according to the WD programme and depends on Drying the total load.
-
Page 23: Inspection
Re-conditioning step 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. -
Page 24: Packaging
The original packaging is intended for storing non-sterile instruments before they are used for the first time. Protect the packaging from moisture and both direct and indirect sunlight. The shipping box is not intended for storing the sterile device. Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S0-EN-20210715... -
Page 25: Technical Data
Technical data 11 Technical data Maximum voltage COAG instruments: 250 V COMFORT recognition The BOWA COMFORT instruments with instrument identification Plug’n Cut COMFORT are compatible with the following software versions of your generator: • ARC 400 from V2.2.1 • ARC 350 from V2.1.1 Use with software version 1.x.x is not possible because an... -
Page 26: Symbols On Packaging
Symbol Meaning Follow the instructions for Keep away from direct sunlight Product number Keep dry Batch Manufacturer Conforms to Russian Quantity standards CE mark and identification Medical device 0123 number of notified body Use-by date Instructions for Use ERGOact BOWA-IFU-12578-ERGOACT-S0-EN-20210715... - Page 28 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...
Need help?
Do you have a question about the ERGOact and is the answer not in the manual?
Questions and answers