adeor Bipolar Forceps Reusable Instructions for Use

EN

Bipolar Forceps Reusable INSTRUCTIONS FOR USE BIPOLAR FORCEPS English Product group: HF Forceps

The surgeon must determine the appropriate type of treatment for each individual case in cooperation with the internist and the anaesthetist. Typical HF surgical interventions include    

adeor medical AG Martinshof 5 83626 Valley Germany



Attention: The instruments are supplied non-sterile and must be cleaned thoroughly and, if required, disinfected and sterilized before the first and every subsequent use.



Warning: Legal regulations stipulate that the instruments may only be acquired by or on behalf of a physician. Warning: Please read the information in this leaflet carefully. Improper use and care or use for unintended purposes can lead to premature wear or risks for patients and users. Intended use: Bipolar forceps made by adeor medical AG are intended for use in all areas of open surgery. They are designed to grasp, manipulate and coagulate tissue. They are connected through a suitable bipolar cable with the bipolar output of a HF generator and may be used only with bipolar coagulation current. adeor bipolar forceps must be operated with the following parameters: Frequency range between 300 kHz and 1,000 kHz; maximum generator operating voltage 600 Vp.

IFU Bipolar Forceps – adeor medical AG



Dermatology: hair and wart removal ENT: polyp removal, bipolar hemostasis Gynaecology: electro-conization of the portio, sterilization by bipolar coagulation of the fallopian tube Urology: transurethral resection of the prostate, bladder tumour or bladder wall papillomas; cutting and coagulation in transabdominal surgery Laparoscopy and cystoscopy: Removal of polyps General surgery: primary sections, separating tissue, plastic surgery, hemostasis, coagulation Neurosurgery: Bipolar coagulations

Contraindications: The bipolar forceps should not be used if the physician determines that the risk to the patient outweighs the benefits. Bipolar forceps made by adeor medical AG should not be used for tubal sterilization or tube coagulation for sterilization. Do not use on patients with cardiac pacemakers or other active implants. No or limited HF surgical interventions should take place:  

  

for patients with implantable cardiac pacemakers or pacemaker electrodes in areas where flammable or explosive materials are present, for example in the gastro-intestinal tract (fire and explosion hazard) in acute emergency situations in the case of severe coagulation disorders in the case of severely impaired pulmonary or cardiovascular functions

Attention: Instruments for electrosurgery may only be used by persons who are specially trained or instructed.

page 9

EN

Bipolar Forceps Reusable Safety instructions:  Checking, using and handling electrosurgical instruments is the responsibility of the user.  Before the first and every other application, each instrument must be cleaned thoroughly, disinfected and sterilized.  Before each use, the instrument must be inspected for wear and visible damage, such as cracks, fractures or damage to the insulation, in particular areas such as the blade, tip, groove, connector, lock and moving parts. Check the insulation thoroughly.  Do not use damaged instruments.  Do not use the instruments in the presence of flammable or explosive substances.  Do not place the instrument on top of the patient.  Perform coagulation only if the contact surfaces are in the visible area. Do not touch any other metal instruments during the procedure.

Processing

Reprocessing / Number of processing cycles / Service life: The product life span and number of treatment cycles depend on how carefully the product is handled and whether the product processing instructions are followed. The service life may be reduced by a nonspecifiable timeframe depending on which type of applications the product is used for or due to repeated processing. After a maximum of 100 applications, the forceps need to be checked for functionality as well as for the correct state of insulation and connector. If the forceps are damaged, especially at the insulation or the connector, you must dispose of the product or send it to the manufacturer for repair. Preparation and transport: The instruments must be stored and transported to the processing location in a closed container to avoid damaging the instruments or contaminating the environment.

IFU Bipolar Forceps – adeor medical AG

Warning: A manual processing procedure was not validated as the product is not suitable on the basis of its design (grooves for grasping and difficult-to-access places at the base). Automatic cleaning: Note The reprocessing and disinfection procedures are validated according to current valid standards. Mechanical reprocessing and disinfection Cleaning and disinfection procedure were validated on a WD BHT INNOVA® M3 device under the following program: 1 2

Cleaning phase Cleaning phase

3

Rinse

4

Thermic disinfection

Cleaner: 0.5% neodisher Weigert).

1 min 30°C / 86°F 6 min 55°C / 131 °F 1 min demin. water 5 min 90°C / 194°F demin. water

Mediclean

Forte

(Dr.

Check visible surfaces for residues after mechanical cleaning/disinfecting. Repeat the cleaning procedure if necessary. Drying In accordance with the program for the washer and disinfector. Sterilization / Autoclaving Packaging The product should be single wrapped in sterile pouches (e.g., paper-laminate ASSURE Plus sterilization pouches – foil accord. ISO 11607)

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EN

Bipolar Forceps Reusable Sterilization process Steam sterilization using fractionated prevacuum procedure. The maximum load for the steriliser may not be exceeded. Pre-vacuum method: 4 min, 132 °C / 272 °F Drying time: the autoclave calculates the time of the drying process adeor recommends a drying time of 20 min. The pouch/forceps have to be visibly dry at the end of the sterilization process. Note: The sterilization procedure was validated according to current standards. Attention: We do not take any responsibility for reusing tools if the instruments are used for patients with Creutzfeldt-Jakob-, Scrapie- or BSEinfection. Non-stick Bipolar forceps: The polished tips are made of silver (with gold plating) and may tarnish which does not affect the function of the instruments. You can restore the original shine by rubbing the nonstick bipolar forceps with a silver polishing cloth. Functional testing: The instruments must be checked for functionality before each use. Visually inspect the instruments for cleanliness and carry out a function test. If necessary, repeat the reprocessing process until the instrument looks clean. Surface damage, such as scratches, cracks, nicks, notches etc., or bent parts mean that the instruments need to be repaired and may not be used. Do not use damaged instruments. Warning: Malfunction, instrument failure, damaged insulation Action required by user: Perform a visual inspection/functional testing. It is the responsibility of the user to ensure IFU Bipolar Forceps – adeor medical AG

that the instruments are used in line with the intended purpose. Warning: Non-sterile residue on the forceps Action required by user: Clean before first use and sterilize according to the processing instructions. Warning: Electrical loading capacity of the electrodes exceeded Action required by user: Follow manufacturer‘s instructions electrical loading; see “Intended use”.

for

Warning: Disinfectant has not evaporated completely Action required by user: Follow the instructions disinfection.

for

thermal

Warning: Instruments were not cleaned properly Action required by user: Clean the instruments according to the processing instructions. Warning: Moisture penetration, corrosion Action required by user: Follow storage and packaging instructions.

Repairs/service delivery for repairs at adeor medical AG: Do not perform repairs. Service and repair work must be carried out by trained and qualified personnel only. Please contact the manufacturer for service and repair queries. Attention: Before you send defective products back for repair, these products must have undergone the entire reprocessing process as described in the processing instructions. Please enclose a statement or page 11

EN

Bipolar Forceps Reusable evidence of cleaning, disinfection sterilization with your return.

and

Handling: Surgical instruments should always be treated with the utmost care during transport, cleaning, care, sterilization and storage, in particular pointed tips and other sensitive areas. Generator connections: Forceps made by adeor medical AG are approved for use with the following generators: ERBE Elektromedizin GmbH Type Item no. max. bipolar coagulation power VIO 300 D 10140-100 ≤ 200 Watt VIO 200 D 10140-200 ≤ 120 Watt VIO 300 S 10140-300 ≤ 200 Watt VIO 200 S 10140-400 ≤ 120 Watt VIO 100 C 10140-500 ≤ 80 Watt VIO 50 C 10140-550 ≤ 50 Watt ICC 350 ICC 350 ≤ 150 Watt ICC 300 ICC 300 ≤ 150 Watt ICC 200 ICC 200 ≤ 150 Watt ICC 80 ICC 80 ≤ 50 Watt ICC 50 ICC 50 ≤ 50 Watt ACC 451 ICC 451 ≤ 120 Watt ACC 450 ICC 450 ≤ 120 Watt ACC 430 ICC 430 ≤ 120 Watt SUTTER Medizintechnik GmbH Type

Item no.

BM-780 II

360080-01

max. bipolar coagulation power ≤ 70 Watt

KARL STORZ GmbH & Co. KG Type

Item no.

max. bipolar coagulation power ≤ 120 Watt

AUTOCON® II 200 AUTOCON® II 400

205322 20 205352 20 ≤ 120 Watt

COVIDIEN IFU Bipolar Forceps – adeor medical AG

Type

Item no.

Force FX™ ForceTriad ™ Force EZ™ SurgiStat™

Force FX™ ForceTriad ™ Force EZ™ SurgiStat™

max. bipolar coagulatio n power ≤ 70 Watt ≤ 95 Watt ≤ 70 Watt ≤ 30 Watt

BOWA-electronic GmbH & Co. KG Type

Item no.

ARC 400 ARC 350 ARC 303 ARC 250 ARC 100

900-400 900-351 900-303 900-250 900-100

max. bipolar coagulation power ≤ 350 Watt ≤ 350 Watt ≤ 120 Watt ≤ 120 Watt ≤ 100 Watt

Olympus Surgical Technologies Europe Type Item no. max. bipolar coagulation power ESG-100, WB991036 ≤ 120 Watt 220-240 V ESG-100, WB991046 ≤ 120 Watt 100-120 V ESG-400 WB91051W ≤ 320 Watt Söring GmbH Type

Item no.

max. bipolar coagulation power ≤ 100 Watt ≤ 100 Watt ≤ 100 Watt

MBC 600 MBC 600 MBC 601 MBC 601 MBC 601 MBC 601 UAM UAM MBC 200 MBC 200 ≤ 140 Watt BCC 140 BCC 140 ≤ 140 Watt LAMIDEY NOURY MEDICAL Type

Item no.

Optima 4 Optima 3 Optima 2 MC 2 MC 3 MC 4

Optima 4 Optima 3 Optima 2 MC 2 MC 3 MC 4

max. bipolar coagulation power ≤ 370 Watt ≤ 370 Watt ≤ 200 Watt ≤ 70 Watt ≤ 100 Watt ≤ 100 Watt

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EN

Bipolar Forceps Reusable Integra LifeSciences Corporation Type

Item no.

Elektrotom® 621 Elektrotom® 630

Elektrotom® 621 Elektrotom® 630

max. bipolar coagulation power ≤ 95 Watt ≤ 95 Watt

Gebrüder Martin GmbH & Co. KG Type Item no. max. bipolar coagulation power Minicutter 80-008-03≤ 70 Watt 04 ME 102 80-010-02≤ 80 Watt 04 ® maxium , 80-042-00≤ 320 Watt m-Version 04 maxium®, i80-042-02≤ 320 Watt Version 04 maxium®, e- 80-042-04≤ 320 Watt Version 04 ME MB 3, 80-040-11≤ 100 Watt m-Version, 04 220-240 V ME MB 3, 80-040-11≤ 100 Watt m-Version, 10 100-127 V ME MB 3, i- 80-040-12≤ 100 Watt Version, 04 100-127 V ME MB 3, i- 80-040-12≤ 100 Watt Version, 10 100-127 V ME 411 80-041-01 ≤ 80 Watt

Aesculap AG / B. Braun Melsungen AG Type

Item no.

GN300 GN640 GN060

GN 300 GN640 GN060

max. bipolar coagulation power ≤ 80 Watt ≤ 100 Watt ≤ 50 Watt

Suitable connection cables:

IFU Bipolar Forceps – adeor medical AG

adeor bipolar forceps can be used with the following bipolar connection cables for the above generators: Cable connection, generator ERBE Elektromedizin GmbH, KARL STORZ GmbH & Co. KG ERBE Elektromedizin GmbH – ICC series, international Aesculap AG / B. Braun Melsungen AG, Gebrüder Martin GmbH & Co. KG, Sutter Medizintechnik GmbH COVIDIEN, LAMIDEY NOURY MEDICAL, BOWA-electronic GmbH & Co. KG, ERBE Elektromedizin GmbH – VIO series, Olympus Surgical Technologies Europe, Söring GmbH Cable connection, forceps European flat plug 2-pin plug (US male connector)

These cables may be connected only to the bipolar output of electrosurgical devices. Please follow the generator instructions on connecting these cables before using the bipolar forceps. HF generators pose a number of risks, such as incorrect operation, unintended high-frequency burns, ignition of flammable liquids and gases (risk of explosion). Packing/Storage: Some parts of these instruments can be easily damaged. They should therefore be stored individually in their packaging or in a protective container with individual compartments. Take special care that there are no chemicals nearby to avoid corrosion. The instruments must be packaged in accordance with ISO 11607 for sterilized devices. The sterilized instruments should be stored in a dry, clean and dust-free environment at moderate temperatures of 5°C to 40°C.

page 13

EN

Bipolar Forceps Reusable Warranty: adeor medical AG provides customers with tested, fault-free products. All our products are designed and manufactured to meet highest quality standards. However, should problems occur, please contact our customer service team. Liability is excluded for products that were modified from the original product, used for other than the intended purposes, handled or used improperly. adeor medical AG does not accept liability for incidental or consequential damages. This warranty is null and void if repairs are carried out by companies that are not authorized for repair by adeor medical AG. Proper disposal of bipolar forceps: If the bipolar forceps can no longer be used due to wear or damage, they must be disposed of properly. This means that the forceps need to be dissembled, impurities removed and the instruments must be sterilized again before disposal (see processing instructions).

Caution: Please follow instructions

Manufacturer / Date of manufacture

Order number

Lot number

Prescription device only (USA)

Symbols and their meaning:

1304

CE including Notified Body code

Follow operating instructions Medical Device Protect the product against moisture and condensation

Protect the product against direct sunlight

The product is delivered non-sterile

IFU Bipolar Forceps – adeor medical AG

page 14

US

Bipolar Forceps Reusable INSTRUCTIONS FOR USE BIPOLAR FORCEPS US Product group: HF Forceps

sterilization procedures and should not be used for these procedures. The types of surgery intended include:        

adeor medical AG Martinshof 5 83626 Valley Germany Attention: The instruments are supplied non-sterile and must be cleaned thoroughly and, if required, disinfected and sterilized before the first and every subsequent use.

ENT Gynecology (except for use in female sterilization) Urology General surgery Neurosurgery Laryngeal Surgery Orthopedic Surgery Thoracic Surgery

Contraindications: The bipolar forceps should not be used if the physician determines that the risk to the patient outweighs the benefits. Bipolar forceps made by adeor medical AG should not be used for tubal sterilization or tube coagulation for sterilization. Do not use on patients with cardiac pacemakers or other active implants. No or limited HF surgical interventions should take place: for patients with implantable cardiac pacemakers or pacemaker electrodes in areas where flammable or explosive materials are present, for example in the gastro-intestinal tract (fire and explosion hazard) in acute emergency situations in the case of severe coagulation disorders in the case of severely impaired pulmonary or cardiovascular functions

Warning: Legal regulations stipulate that the instruments may only be acquired by or on behalf of a physician.



Warning: Please read the information in this leaflet carefully. Improper use and care or use for unintended purposes can lead to premature wear or risks for patients and users.

 

Intended use: The adeor medical Non-stick Bipolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. adeor bipolar forceps must be operated with the following parameters: Frequency range between 300 kHz and 1,000 kHZ; maximum generator operating voltage 600 Vp.

Attention: Instruments for electrosurgery may only be used by persons who are specially trained or instructed.

The adeor medical Non-stick Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for

IFU Bipolar Forceps – adeor medical AG





Safety instructions:  Checking, using and handling electrosurgical instruments is the responsibility of the user.  Before the first and every other application, each instrument must be cleaned thoroughly, disinfected and sterilized.

page 15

US

Bipolar Forceps Reusable 

   

Before each use, the instrument must be inspected for wear and visible damage, such as cracks, fractures or damage to the insulation, in particular areas such as the blade, tip, groove, connector, lock and moving parts. Check the insulation thoroughly. Do not use damaged instruments. Do not use the instruments in the presence of flammable or explosive substances. Do not place the instrument on top of the patient. Perform coagulation only if the contact surfaces are in the visible area. Do not touch any other metal instruments during the procedure.

Reprocessing / Number of processing cycles / Service life: The product life span and number of treatment cycles depend on how carefully the product is handled and whether the product processing instructions are followed. The service life may be reduced by a nonspecifiable timeframe depending on which type of applications the product is used for or due to repeated processing. After a maximum of 100 applications, the forceps need to be checked for functionality as well as for the correct state of insulation and connector. If the forceps are damaged, especially at the insulation or the connector, you must dispose of the product or send it to the manufacturer for repair. Preparation and transport: The instruments must be stored and transported to the processing location in a closed container to avoid damaging the instruments or contaminating the environment. Processing Warning: A manual processing procedure was not validated as the product is not suitable on the basis of its design (grooves for grasping and difficult-to-access places at the base).

Automatic cleaning: Note The reprocessing and disinfection procedures are validated according to current valid standards. Mechanical reprocessing and disinfection Cleaning and disinfection procedure were validated on a WD BHT INNOVA® M3 device under the following program: 1 2

Cleaning phase Cleaning phase

3

Rinse

4

Thermic disinfection

Cleaner: 0.5% of a cleaning detergent containing less than 5% nonionic and anionic surfactants, pH value 10.4 – 10.8 (e.g., Neodisher Mediclean Forte Dr. Weigert). Check visible surfaces for residues after mechanical cleaning/disinfecting. Repeat the cleaning procedure when necessary. Drying In accordance with the program for the washer and disinfector. Sterilization / Autoclaving Packaging The product should be single wrapped in sterile pouches. (e.g. paper-laminate ASSURE Plus sterilization pouches – foil accord. ISO 11607) Sterilization process Steam sterilization using fractionated prevacuum procedure (sterilization device compliant to EN 285 in its current revision and validated according to EN ISO 17665-1 in its current revision). Gravity method:

IFU Bipolar Forceps – adeor medical AG

1 min 30°C / 86°F 6 min 55°C / 131 °F 1 min demin. water 5 min 90°C / 194°F demin. water

15 min, 132 °C / 272 °F page 16

US

Bipolar Forceps Reusable Drying time:

the autoclave calculates the time of the drying process

Pre-vacuum method: 4 min, 132 °C / 272 °F Drying time: the autoclave calculates the time of the drying process adeor recommends a drying time of 20 min.

Action required by user: Perform a visual inspection/functional testing. It is the responsibility of the user to ensure that the instruments are used in line with the intended purpose. Warning: Non-sterile residue on the forceps

The pouch/forceps have to be visibly dry at the end of the sterilization process.

Action required by user: Clean before first use and sterilize according to the processing instructions.

Note: The sterilization procedure was validated according to current standards.

Warning: Electrical loading capacity of the electrodes exceeded

Additional Information The maximum load for the steriliser may not be exceeded.

Action required by user: Follow manufacturer‘s instructions electrical loading; see “Intended use”.

Attention: We do not take any responsibility for reusing tools if the instruments are used for patients with Creutzfeldt-Jakob-, Scrapie- or BSEinfection. Non-stick Bipolar forceps: The polished tips are made of silver (with gold plating) and may tarnish which does not affect the function of the instruments. You can restore the original shine by rubbing the nonstick bipolar forceps with a silver polishing cloth. Functional testing: The instruments must be checked for functionality before each use. Visually inspect the instruments for cleanliness and carry out a function test. If necessary, repeat the reprocessing process until the instrument looks clean. Surface damage, such as scratches, cracks, nicks, notches etc., or bent parts mean that the instruments need to be repaired and may not be used. Do not use damaged instruments. Warning: Malfunction, instrument failure, damaged insulation

IFU Bipolar Forceps – adeor medical AG

for

Warning: Disinfectant has not evaporated completely Action required by user: Follow the instructions disinfection.

for

thermal

Warning: Instruments were not cleaned properly Action required by user: Clean the instruments according to the processing instructions. Warning: Moisture penetration, corrosion Action required by user: Follow storage and packaging instructions. Repairs/service delivery for repairs at adeor medical AG: Do not perform repairs. Service and repair work must be carried out by trained and qualified personnel only. Please contact the manufacturer for service and repair queries. Attention: Before you send defective products back for repair, these products must have undergone the entire reprocessing process as described in the processing page 17

US

Bipolar Forceps Reusable instructions. Please enclose a statement or evidence of cleaning, disinfection and sterilization with your return. Handling: Surgical instruments should always be treated with the utmost care during transport, cleaning, care, sterilization and storage, in particular pointed tips and other sensitive areas. Suitable connection cables: adeor bipolar forceps can be used with bipolar connection cables that are suitable for use with generators that meet the required operating parameters. Cable connection, forceps European flat plug

highest quality standards. However, should problems occur, please contact our customer service team. Liability is excluded for products that were modified from the original product, used for other than the intended purposes, handled or used improperly. adeor medical AG does not accept liability for incidental or consequential damages. This warranty is null and void if repairs are carried out by companies that are not authorized for repair by adeor medical AG. Proper disposal of bipolar forceps: If the bipolar forceps can no longer be used due to wear or damage, they must be disposed of properly. This means that the forceps need to be dissembled, impurities removed and the instruments must be sterilized again before disposal (see processing instructions).

2-pin plug (US male connector) Symbols and their meaning: These cables may be connected only to the bipolar output of electrosurgical devices. Please follow the generator instructions on connecting these cables before using the bipolar forceps. HF generators pose a number of risks, such as incorrect operation, unintended high-frequency burns, ignition of flammable liquids and gases (risk of explosion). Packing/Storage: Some parts of these instruments can be easily damaged. They should therefore be stored individually in their packaging or in a protective container with individual compartments. Take special care that there are no chemicals nearby to avoid corrosion. The instruments must be packaged in accordance with ISO 11607 for sterilized devices. The sterilized instruments should be stored in a dry, clean and dust-free environment at moderate temperatures of 5°C to 40°C. Warranty: adeor medical AG provides customers with tested, fault-free products. All our products are designed and manufactured to meet IFU Bipolar Forceps – adeor medical AG

Follow operating instructions

Protect the product against moisture and condensation

Protect the product against direct sunlight

The product is delivered non-sterile

Caution: Please follow instructions

page 18

Bipolar Forceps Reusable

US

Manufacturer / Date of manufacture

Order No.

Lot number

Prescription device only (USA)

1304

CE including Notified Body code

Medical device

IFU Bipolar Forceps – adeor medical AG

page 19