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 Safety instructions

 8

Instructions for Use ERGOact

BOWA-IFU-12578-ERGOACT-S0-EN-20210715

3.2  Use-related

•  

Make sure that the HF cable is correctly attached to the instrument and to the HF 

generator by means of the correct connectors. 

•  

Run a function test using a gauze soaked in saline solution before use. 

•  

Always insert the bipolar instrument into the body under visual control.

•  

Only activate the jaws with adequate visibility.

•  

For coagulation of closely situated structures such as nerves or the ureter, proceed with 

the utmost caution and keep your distance.

•  

The jaws must not be too full. Never grasp too much tissue for coagulation.

•  

Improper use of HF current can lead to burns and explosions:



Perform electrosurgical operations only with insufflation of non-flammable gases 

(CO

2

).



Avoid direct skin contact with HF cables.



Avoid contact with flammable gases and liquids.

•  

Improper use of the device can cause injury to the patient::



Avoid skin-to-skin contact between the HF cable and the patient.



When plugging in or removing the HF cable, always take hold of the connector, never 

pull on the cable itself.



Do not place the instrument on the patient. This will prevent injury if the HF is 

inadvertently activated.



Avoid contact with metallic objects (clips, stents, etc.) in the area around the active 

jaws. They can affect energy output and lead to undesired effects.

•  

The jaws can get hot enough to cause a thermal lesion.

•  

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 instructions for use of the BOWA HF generators for additional 

information on interference with other devices.

Содержание ERGOact

Страница 1: ...12578EN S0 Instructions for Use ERGOact en...

Страница 2: ......

Страница 3: ...EN 20210715 Instructions for Use ERGOact 1 Key Handle COMFORT plug Rotation wheel Shaft tube with insert Activation key for coagulation only Release button for disassembly Jaw Maryland insert Kelly i...

Страница 4: ...2 Instructions for Use ERGOact BOWA IFU 12578 ERGOACT S0 EN 20210715 Handle Shaft tube...

Страница 5: ...ormation 10 4 Mode of operation 11 5 Procedure during use 12 5 1 Connection combinations 12 6 Assembly 13 7 Operation 14 7 1 Before use 14 7 2 Function test in the operating theatre 14 7 3 During the...

Страница 6: ...p the instructions for use accessible to operating theatre personnel Give the instructions for use to each successive owner or user of this device Always update the instructions for use whenever you r...

Страница 7: ...ce DANGER Immediate risk Death severe injury WARNING Possible risk Death severe injury CAUTION Possible risk Minor injuries NOTE Possible risk Property damage Tips to make your work easier or suppleme...

Страница 8: ...vasive surgery BOWA recommends using this device on the BOWA ARC generators 2 2 Contraindications The medical device must not be used if in the opinion of an experienced surgeon or according to the cu...

Страница 9: ...oducts concerned Comply with the validated parameters for each cycle Comply with the legal regulations applicable in your country as well as the hygiene regulations of the hospital Do not use gas ster...

Страница 10: ...th insufflation of non flammable gases CO2 Avoid direct skin contact with HF cables Avoid contact with flammable gases and liquids Improper use of the device can cause injury to the patient Avoid skin...

Страница 11: ...lectrosurgical operations The BF CF application part of the HF device used is extended by the instrument connected to it Electrical safety is improved through the use of plastic trocars 3 2 1 Patients...

Страница 12: ...ces Using the accessory with medical devices from other manufacturers can result in higher emission levels or reduced interference immunity NOTE Combining medical devices is only safe if the lowest po...

Страница 13: ...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 The active...

Страница 14: ...e plug connections of other manufacturers do not have to comply with the technical standards 4 Do not exceed the maximum permissible voltage 5 Always perform a thorough visual inspection and function...

Страница 15: ...of the jaw and rotate anti clockwise to tighten Shaft with insert is now ready to mount on the handle 3 Introduce the shaft tube with insert into the completely opened handle until you here it click...

Страница 16: ...tivation using the finger switch or foot switch The activation signal sounds when the finger switch or foot switch is activated WARNING Risk of patient injury Use only compatible HF generators see BOW...

Страница 17: ...ing pinched Perform the operation only with adequate visibility WARNING Risk of patient injuries from hot jaws and release of steam Instrument tips may still be hot immediately after HF power has been...

Страница 18: ...s been grasped by the jaws and is coagulated 7 4 Removal 1 Close the jaws by closing the handle 2 Withdraw the instrument from the trocar sleeve WARNING Incomplete coagulation Never use the AUTOSTART...

Страница 19: ...ing page 19 7 5 1 Spare parts To order spare parts contact your BOWA dealership or visit our website www bowa medical com WARNING Defective worn or contaminated jaws can cause the instrument to malfun...

Страница 20: ...ar handle shank 2 Press the black button on the top of the handle 3 Release the shaft by pulling it out of the handle and make sure the rear handle shank does not lower again You have now separated th...

Страница 21: ...ice 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...

Страница 22: ...lean and disinfection stage the shaft tube is inserted into a rinsing sleeve and the handle is attached to an injector nozzle Insert is placed in a wire basket in the opened state Ensure that the cabl...

Страница 23: ...motion 2 Check the insert for damage and corrosion Shaft tube 1 Check the insulation of the shaft tube for damage Re conditioningstep Description Steamsterilisation 7 Steam sterilisation5 Sterilisethe...

Страница 24: ...table sterilisation container The packaging must meet the following requirements DIN EN ISO 11607 1 Suitable for steam sterilisation resistant to temperatures up to 137 C sufficient steam permeability...

Страница 25: ...n 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...

Страница 26: ...0715 13 Symbols on packaging Symbol Meaning Symbol Meaning Follow the instructions for use Keep away from direct sunlight Product number Keep dry Batch Manufacturer Quantity Conforms to Russian standa...

Страница 27: ......

Страница 28: ...design changes l Copyright by BOWA electronic Gomaringen l Germany 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...

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