Bowa ERGO 315R Instructions For Use Manual Download Page 46

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11 Symbols on packaging

BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219

11.

Symbols on packaging

Symbol

Meaning

Consult the instructions for use

Product number

Lot

Quantity

Use-by date

Sterilised using ethylene oxide

Single use only

Do not resterilise

Do not use if packaging is damaged

Keep away from direct sunlight

Keep dry

Manufacturer

0123

CE mark and identification number of notified body

Conforms to Russian standards

Date of manufacture

Caution

Medical device

Summary of Contents for ERGO 315R

Page 1: ...MN031 554 S3 en Instructions for use...

Page 2: ...ERGO315R S3 EN 20210219 Key Blade with blade holder Blade rod Push rod Jaw Electrodes Teeth Mounting marking Slotted ring for blade rod latching Blade mount Blade Grip area Blade holder Spring latch C...

Page 3: ...031 554 ERGO315R S3 EN 20210219 3 Handle Cable with handswitch Handswitch Connector for BOWA ARC generator Mounting marking Locking mechanism Rotation wheel Push buttons Blade trigger Jaw actuation le...

Page 4: ...Key 4 BOWA IFU MN031 554 ERGO315R S3 EN 20210219 Cleaning adapter Cleaning brush Reprocessing basket lid Cleaning adapter jaw handle Cleaning adapter push rod...

Page 5: ...ions 9 3 Safety instructions 9 3 1 Device related 9 3 2 Use related 10 3 2 1 Patients with pacemakers 12 3 3 EMC information 12 4 Mode of operation 13 5 Assembly 14 6 Operation 24 6 1 Before use 24 6...

Page 6: ...onic bath 35 8 5 Machine based reprocessing in a CDM 36 8 5 1 Preparation for machine based reprocessing cleaning adapter 36 8 5 2 Placing the parts in the reprocessing basket 38 8 6 Inspection 41 8 7...

Page 7: ...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 receive additional i...

Page 8: ...compliance DANGER Immediate risk Death or serious injuries WARNING Possible risk Death or serious injuries CAUTION Possible risk Minor injuries NOTE Possible risk Property damage Tips Tips to make yo...

Page 9: ...hysician or according to current specialist literature such use would endanger the patient for example due to the patient s general condition or if other contraindications are present 3 Safety instruc...

Page 10: ...buckling or crushing The lowest maximum voltage of the product must not be exceeded In order to avoid the risk of injuries and electric shocks for the patient and the operating personnel ensure that t...

Page 11: ...de surfaces They can affect energy output and lead to undesired effects The electrode tip may still be hot enough to cause burns immediately after deactivating the HF power The HF cable may cause inte...

Page 12: ...cturers can result in higher emission levels or reduced interference immunity Never perform outpatient operations on patients with pacemakers In cases of patients with pacemakers consult the cardiolog...

Page 13: ...e other electrode to produce the desired localised tissue effect With this method sealing of a vessel or tissue segment carrying blood is achieved by HF current in combination with supplementary press...

Page 14: ...mbly 14 BOWA IFU MN031 554 ERGO315R S3 EN 20210219 5 Assembly Assembling the vessel sealing instrument Assemble the vessel sealing instrument in the sequence shown below Inserting the push rod into th...

Page 15: ...FU MN031 554 ERGO315R S3 EN 20210219 15 Insert the push rod into the completely opened jaw with the electrodes fully opened Align the teeth of the push rod with the orange marking on the jaw Attaching...

Page 16: ...19 The blade with blade holder and mounting aid are supplied sterilised 1 Remove the blade with blade holder and mounting aid from the sterile package 2 Insert the jaw with mounted push rod and closed...

Page 17: ...5 Assembly BOWA IFU MN031 554 ERGO315R S3 EN 20210219 17 3 Separate the blade holder from the mounting aid by pressing down the blade holder in the grip area...

Page 18: ...holder for blade assembly To mount the blade grasp the blade holder in the grip area Position the blade mount on the blade as indicated by the markings on the blade holder and slide the blade rod in t...

Page 19: ...MN031 554 ERGO315R S3 EN 20210219 19 1 Visually check the blade for correct assembly The blade holder has a cleaning tip for cleaning the blade groove Keep it until the end of the surgery to clean the...

Page 20: ...EN 20210219 Inserting the blade rod into the push rod Insert the blade rod with the assembled blade into the push rod Align the spring latch of the blade rod with the slotted ring of the push rod and...

Page 21: ...21 Mounting the jaw on the handle Assemble the jaw and handle 1 Insert the jaw into the handle until it audibly engages Ensure that the mounting aid keeps the jaws closed and that the orange marking...

Page 22: ...the mounting aid from the jaw and dispose of it 4 Check the vessel sealing instrument for proper opening gripping and latching by actuating the handle 5 Check the blade for ease of motion by actuating...

Page 23: ...g the cable with the handswitch 8 Attach the connection cable by inserting the handswitch in the handle 9 Clamp the cable in the guide groove of the handle The handswitch can be operated from either s...

Page 24: ...sories as described in the key Use only intact and sterilised devices Risk of patient injuries from burns or explosion Avoid contact with flammable gases and liquids such as skin cleansers disinfectan...

Page 25: ...ited visibility Prepare the tissue to be sealed so it is as free as possible in order to avoid unintentional clamping Only carry out the operation with adequate visibility Risk of patient injury due t...

Page 26: ...e to be sealed between the electrodes 6 Close the electrodes to grasp the tissue Never grasp too much tissue The tissue is grasped 7 Latch the handle The tissue is clamped 8 Using the handswitch of th...

Page 27: ...hen release it The tissue will be cut through the middle of the sealed area 6 4 Removal WARNING Risk of patient injury due to damaged or detached parts Check the vessel sealing instrument after each u...

Page 28: ...g instrument WARNING Risk of burns from hot electrode surfaces Do not touch the electrode surfaces immediately after use Risk of burns from current carrying parts Disconnect the cable from the HF gene...

Page 29: ...0219 29 7 2 Deviating from the assembly Dismantling the handswitch From the back press the connection cable handswitch out of the handle Dismantling the handle and jaw 1 Unlock the handle 2 Press the...

Page 30: ...1 554 ERGO315R S3 EN 20210219 3 Then press the two push buttons on the rotation wheel simultaneously and pull the handle off the jaw Dismantling the jaw and push rod With the electrodes fully open pul...

Page 31: ...de Be careful with the blade during dismantling To avoid punctures and lacerations always use a suitable aid for blade disassembly Risk of blade breakage due to incorrect dismantling Carefully pull th...

Page 32: ...ger of microbial transmission To clean the instrument correctly it is essential to remove the replaceable blade Vessel sealing instruments must always be cleaned disinfected and sterilised before use...

Page 33: ...20 times Push rod up to 20 times Blade rod up to 20 times Cable up to 20 times Reprocessing of the vessel sealing instrument comprises the following steps Dismantling Soaking Manual removal of contam...

Page 34: ...fectant for at least 5 minutes immediately after use at the latest after 2 hours and remove coarse dirt residues with a plastic brush To soak the jaw BOWA recommends a small tube filled with liquid e...

Page 35: ...blade groove of the jaw with the cleaning tip on the blade holder 2 Rinse all individual parts from the inside and outside after brushing with a suitable rinsing gun for at least 15 s 5 pulses of 3 s...

Page 36: ...ing in a CDM NOTE Cleaning adapter and reprocessing basket BOWA has validated machine based reprocessing using the cleaning adapters in the reprocessing basket optionally available 8 5 1 Preparation f...

Page 37: ...8 Reprocessing BOWA IFU MN031 554 ERGO315R S3 EN 20210219 37 Mounting the cleaning adapter on the handle Mounting the cleaning adapter on the push rod...

Page 38: ...processing basket Avoid bending the instrument components when clipping them into the holders Press the instrument components into the holders with equal pressure on both ends 1 Connect the cleaning h...

Page 39: ...DGHM or FDA approval or a CE mark in accordance with EN ISO 15883 A program suitable for the instrument with adequate rinse cycles is selected2 Sterile water or water with a low microorganism count m...

Page 40: ...aning and disinfection products The manufacturer accepts no responsibility for the use of other cleaning and disinfection products Cleaning and disinfection 1 Place the reprocessing basket in the CDM...

Page 41: ...s authorised representative in such cases After cleaning visually inspect each of the instruments and test them for proper operation Replace any damaged parts DANGER Risk of patient burns with brittle...

Page 42: ...able for steam sterilisation resistant to temperatures up to 137 C sufficient steam permeability Regular maintenance sterilisation container Check the instrument components for completeness Autoclave...

Page 43: ...NSI AAMI ISO 17665 formerly EN 554 ANSI AAMI ISO 11134 Sterilisation time3 20 minutes at 121 C 3 20 minutes at 132 134 C If the less effective gravitation sterilisation method is used additional valid...

Page 44: ...st Strong mechanical stresses such as shock fall or impact Direct exposure to sunlight Heat sources e g heat exchanger air conditioning unit 2 Transport or store the instrument in a dry environment Th...

Page 45: ...mpatible with the following software versions of your generator ARC 400 from V2 2 1 ARC 350 from V2 1 1 The use with software version 1 x x is not possible because an update to a higher version is not...

Page 46: ...for use Product number Lot Quantity Use by date Sterilised using ethylene oxide Single use only Do not resterilise Do not use if packaging is damaged Keep away from direct sunlight Keep dry Manufactu...

Page 47: ......

Page 48: ...technical and design changes Copyright by BOWA electronic Gomaringen Germany BOWA electronic GmbH Co KG Heinrich Hertz Strasse 4 10 72810 Gomaringen Germany Phone 49 7072 6002 0 Fax 49 7072 6002 33 i...

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