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Technical data

BOWA-IFU-13120-ERGOECO-S0-EN-20220420 Instructions for Use ERGOeco

11 Technical data

BOWA recommends using this device on the BOWA ARC generators.

The medical devices, packaging material and accessories must be disposed of in

accordance with any applicable country-specific regulations and laws.

12 Symbols on packaging

Maximum voltage

COAG instruments: 250 V

HAZARD

Risk of infection due to transmission of germs!



To avoid transmitting germs and infections, sterilise the instrument

before it leaves the hospital or surgical practice.

Symbol

Definition

Symbol

Definition

Follow the instructions

for use

Keep away from direct

sunlight

Catalogue number

Keep dry

Batch code

Manufacturer

Quantity

Conforms to Russian

standards

Medical device

0123

CE mark and identification

number of notified body

Use-by date

Summary of Contents for ERGOeco

Page 1: ...13120EN S0 Instructions for Use ERGOeco en ...

Page 2: ......

Page 3: ...WA IFU 13120 ERGOECO S0 EN 20220420 Instructions for Use ERGOeco 1 Key Handle Rotation wheel Shaft tube Erbe plug Release button for disassembly Insert with Jaw Maryland insert Kelly insert Fenestrated insert ...

Page 4: ...Key 2 Instructions for Use ERGOeco BOWA IFU 13120 ERGOECO S0 EN 20220420 Handle with plug versions Shaft tube 2 pin 28 mm 2 pin 22mm Erbe ...

Page 5: ...ed 9 3 2 1 Patients with pacemakers 10 3 3 EMC information 10 4 Mode of operation 11 5 Procedure during use 11 6 Assembly 12 7 Operation 13 7 1 Before use 13 7 2 Function test in the operating theatre 13 7 3 During the surgery 14 7 4 Removal 15 7 5 After use 15 7 5 1 Spare parts 15 8 Disassembly 16 9 Reprocessing 17 9 1 General information 17 9 2 Device specific information 17 9 3 Check for damage...

Page 6: ...nstructions for use in particular the Safety chapter see chapter 3 Safety instructions carefully and thoroughly before use Keep the Instructions for use in a safe place throughout the service life of the device Keep the Instructions for use accessible to operating theatre personnel Hand the Instructions for use to any subsequent owner or user of this device Always update the Instructions for use w...

Page 7: ...r2 pin22mm Kelly 770 682 770 683 ERGOeco fenestrated for2 pin22mm fenestrated 770 684 770 685 ERGOeco Maryland for2 pin28mm 2 pin28mm Maryland 770 690 770 691 ERGOeco Kelly for2 pin28mm Kelly 770 692 770 693 ERGOeco fenestrated for2 pin28mm fenestrated 770 694 770 695 REF Name of spare part 360 mm 460 mm ERGOeco handleforErbe cable4 5m 770 605 ERGOeco handlefor2 pin22mm cable4 5m 770 606 ERGOeco h...

Page 8: ...e and consequences of the hazard personal injuries Measure for preventing the hazard Symbol Danger level Probability of occurrence Consequences of non compliance HAZARD Immediate hazard Death severe injury WARNING Possible hazard Death severe injury CAUTION Possible hazard Minor injury NOTICE Possible hazard Property damage Tips to make your work easier or supplementary information explaining a wo...

Page 9: ...t be used if in the opinion of an experienced physician or according to the current technical literature such usage could endanger either the patient e g due to their general condition or other persons Do not use the medical device if its surgical techniques are contraindicated Never use the medical device on the heart central circulatory system or central nervous system Symbol marking Definition ...

Page 10: ...d 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 sterilisation or hot air sterilisation as these methods can damage the device To avoid burns thermal overload please comply with the following Make sure that all electrical plug connections are correctly seated Do not strain the devices beyond t...

Page 11: ...ue for coagulation Improper use of HF current can lead to burns and explosions Perform electrosurgical operations only with 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 to skin contact between the HF cable and the patient When plugging in or remov...

Page 12: ...heck 3 3 EMC information Since medical electrical devices are subject to special EMC precautions please comply with the following information The BOWA accessory is only intended to be connected to BOWA specified HF devices Using the accessory with medical devices from other manufacturers may result in higher emission levels or reduced interference immunity NOTICE Combining medical devices is safe ...

Page 13: ... positioned by a rotary wheel on the handle 5 Procedure during use 1 Prior to use clean and sterilise the new product that is shipped in non sterile condition from the factory 2 Check to make sure that all individual parts are present and mount the instrument see chapter 6 Assembly 3 Connect the HF generator you plan to use to a matching instrument handle see chapter 1 1 Scope of validity 4 Do not...

Page 14: ... it to tighten it The shaft with insert is now ready to be mounted on the handle 3 Whilst ensuring that the jaws are closed introduce the shaft tube with insert into the completely opened handle until you hear it click into place When the shaft with insert is aligned correctly and fully seated inside the handle moving the rear handle shank will cause the instrument s jaws to move The instrument is...

Page 15: ...ed and closed using the handle 2 Check the activation by means of the foot switch The activation signal is emitted during activation of the foot switch WARNING Risk of patient injury Only use compatible HF generators Select the settings of the HF device according to the requirements of the intervention Only use suitable devices and accessories wherever possible Only use intact and sterilised devic...

Page 16: ...njury due to tissue pinching especially with limited visibility Expose the tissue to be coagulated as much as possible to prevent it from becoming pinched inadvertently Only perform the operation if you have clear 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 switched off Maintain sufficient dista...

Page 17: ...RT function Do not switch on the HF current before the jaws are in contact with the tissue to be coagulated and ensure that they are within the surgical field of view Inadvertentactivation of the instrumentcan cause injuries tothe patient WARNING Incomplete coagulation due to soiled jaws Regularly clean the jaws with a damp cloth or a sterile plastic brush if tissue adheres to them WARNING Risk of...

Page 18: ...handle shank to keep it open 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 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 disassembled 1 2 3 ...

Page 19: ...ice manufacturer shall not 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 devices as this could damage the electrical insulation CAUTION Risk of infection from water splashes and steam during manual pre cleaning Wear a face mask and protective clothing Adequate ventilati...

Page 20: ...e shaft tube is inserted into a rinsing sleeve and the handle is attached to an injector nozzle The opened insert is placed in a wire basket Make sure that the cable is not kinked or pinched Use a washing and disinfecting device WD with certified efficiency complying with ISO 15883 and a neutral to mildly alkaline max pH 11 5 enzymatic cleaning agent without critical constituents Depending on the ...

Page 21: ...2 Check the insert for damage and corrosion Shaft tube 1 Check the insulation of the shaft tube for damage Insert 1 Check the jaws for cleanliness and damage 2 Check the insulation of the insert for damage Steamsterilisation 6 Steam sterilisation5 The device can be sterilised while it is assembled or dismantled BOWA recommends steam sterilisation using the fractionated vacuum method with a sterili...

Page 22: ...607 1 Suitable for steam sterilisation resistant to temperatures up to 137 C sufficient steam permeability Regular maintenance sterilisation container 10 Ambient conditions 10 1 Storage and transport The original packaging is intended for storing non sterile instruments prior to their first use Protect the packaging from moisture and both direct and indirect sunlight CAUTION Brittle or defective i...

Page 23: ...ws 12 Symbols on packaging Maximum voltage COAG instruments 250 Vp HAZARD Risk of infection due to transmission of germs To avoid transmitting germs and infections sterilise the instrument before it leaves the hospital or surgical practice Symbol Definition Symbol Definition Follow the instructions for use Keep away from direct sunlight Catalogue number Keep dry Batch code Manufacturer Quantity Co...

Page 24: ... 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 33 info bowa medical com www bowa medical com CE marking as per regulation 2017 745 ...

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