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 Pre-conditioning

 20

Instructions for Use ERGOact

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

Re-conditioning cycles 50 (depending on the intensity of use)

Re-conditioning step Description
Manual pre-cleaning

1.A  Soak

1

Soak the dismantled device at room temperature (<25°C) for at least 5 

minutes immediately, but no later than 2 hours after use. Only use 

enzymatic, aldehyde-free disinfectants which are suitable for 

disinfecting medical devices (e.g., DGHM or FDA approval or CE 

marking). Remove all visible debris with a soft plastic brush. BOWA 

recommends the use of Gigasept® Instru AF (Schülke & Mayr GmbH). 

1.B  Ultrasound 

2

Place the individual parts of the device in the ultrasonic bath for at least 

5 minutes. BOWA recommends the use of Gigasept® Instru AF (Schülke 

& Mayr GmbH).

2  

Rinsing

Thoroughly rinse the individual parts of the device for at least 1 minute 

at room temperature (<25°C) under flowing water (drinking water 

quality or better). Allow residual water to drip off sufficiently. 

Automatic cleaning, thermal disinfection and drying

Mechanical 

clean 

3

For the mechanical clean 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 cable is not kinked or pinched.

Use a washing and disinfecting device (WD) with certified efficiency (to 

ISO 15883 and a neutral to slightly alkali (max. pH 11.5), enzymatic 

cleaning agent without critical constituents. Depending on the 

concentration, agents including alcohol- and/or aldehyde-containing 

ingredients may be used. 

BOWA recommends the use of neodisher® MediClean forte (Chemische 

Fabrik Dr. Weigert) at 55°C for 10 minutes. 

The intermediate rinse must comprise two rinsing steps using 

demineralised water (each step taking 1 minute at >10°C).

Thermal 

disinfection

4

An A

0

 value of >3000 must be respected.

BOWA recommends a temperature of 90°C for at least 5 minutes and 

the use of demineralised water. 

Drying

Drying is carried out according to the WD programme and depends on 

the total load. The maximum temperature is 100°C for 25 minutes. If 

necessary, dry with filtered compressed air at max. 3 bar. 

6

Inspection

After machine cleaning and disinfection, carry out a visual inspection to 

check for residues. 

Repeat the re-conditioning process if necessary. 

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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