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Applying the instructions for use

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

Instructions for Use ERGOact

           5

Danger levels in warning notices:

Tips:

Other symbols and markings:

Symbol Danger level Probability of occurrence

Consequences of 

non-compliance

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 supplementary information for a 

procedure.

Symbol / marking

Meaning

Prerequisite for an activity



Activity with one step

 1. 
 2. 

Activity with several steps in strict sequence

Result of preceding activity

•  

List (first level)

•  

List (second level)

Emphasis

Emphasis

Summary of Contents for ERGOact

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

Page 2: ......

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 27: ......

Page 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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