ERAGON-Forceps and Scissors Monopolar Instruction Manual

Important general notes and instructions for use Ensure that this product is used only as intended and described in this instruction manual, by ad­ equately trained and qualified medical personnel. Maintenance and repair may only be carried out by authorized specialized technicians. Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for the planned application and if the performance characteristics and safety requirements are met. Reprocess the products before every application and before returning them for repairs as required by the instruction manual in order to protect the patient, user or third parties. Subject to technical changes! Due to continuous development of our products, illustrations and technical data may deviate slightly from the data in this manual.

Safety instructions and levels of danger Symbol

Level of danger

WARNING! Failure to observe can result in death or serious injury. CAUTION! Failure to observe can result in slight injury or damage to the product. IMPORTANT! Failure to observe can result in damage to the product or surroundings. NOTE! Tips for optimum use and other useful information.

GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35--0 Telefax: +49 70 43 35--300 MANUFACTURER [email protected] www.richard--wolf.com

USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: +1 84 79 13 11 13 Telefax: +1 84 79 13 14 88 sales&[email protected] www.richardwolfusa.com

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW17 0HB Telephone: + 44 20 89 44 74 47 Telefax: + 44 20 89 44 13 11 [email protected] www.richardwolf.uk.com

BELGIUM / NETHERLANDS N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 9031 Gent Drongen Telephone: +32 92 80 81 00 Telefax: +32 92 82 92 16

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette 51100 Reims Telephone: +33 3 26 87 02 89 Telefax: +33 3 26 87 60 33

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a 1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 14 05 51 51 45

[email protected]

[email protected] www.richard--wolf.at

[email protected] www.richard--wolf.be Marketing Office U.A.E RICHARD WOLF Middle East P.O. Box 500283 AL Thuraya Tower 1 9th Floor, Room 904, Dubai Telephone: + 9 71 43 68 19 20 Telefax: + 9 71 43 68 61 12 [email protected] www.richard--wolf.com

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INDIA RICHARD WOLF India Private Ltd. JMD Pacific Square No. 211 A, Second Floor Behind 32nd Milestone Gurgaon -- 122 001 National Capitol Region Telephone: + 91 12 44 31 57 00 Telefax: + 91 12 44 31 57 05 [email protected] www.richard--wolf.com

GA-S 025

Contents 1

Intended use...

1

2

Indications and field of use...

1

3

Contraindications...

1

4

Combinations...

1

5 5.1

Illustration... Legend and identification...

2 2

6 6.1 6.2 6.2.1 6.2.2 6.3 6.3.1

Use... Preparation... Handle with lock... Working with the lock:... Working without the lock... Additional notes and instructions for use... HF applications...

3 3 3 3 4 4 5

7 7.1 7.2

Checks... Visual check... Function check...

6 6 6

8 8.1 8.2 8.3

Reprocessing and maintenance... Disassembly before cleaning... Reprocessing procedure... Low-temperature sterilisation...

7 7 8 9

9

Technical data and order data... 10

10

Spare parts and accessories... 10

11 11.1

Operating, storage, transport and shipping conditions... 10 Disposal of product, packaging material and accessories... 10

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1

Intended use

The forceps and scissors are used for endoscopically controlled holding, manipulating and cutting as well as for the dissection of soft tissue parts and organs. Minor hemorrhages can be coagulated using HF current in conjunction with the products marked for this use. Holding, grasping and dissection forceps are used to hold, manipulate and dissect soft tissue parts or organs, suture mate­ rial, needles etc. These products offer thermal tissue treatment if marked accordingly. Biopsy and excision forceps, hook punches are used to transsect tissue or withdraw tissue for biopsies, as well as thermal tissue treatment if the products are marked accordingly. Scissors, hook scissors are used for cutting and transsecting tissue, as well as thermal tissue treatment if the products are marked accordingly. These products are exclusively intended for use by medical staff and may only be used by medically qualified and adequately trained persons.

2

Indications and field of use

3

Contraindications

4

Combinations

For examination, diagnosis and / or therapy with endoscopic accessories. These instruments are used in the medical disciplines of: Surgery Urology Thoracoscopy Gynecology

CJD - Creutzfeldt Jakob Disease or vCJD - Variant of Creutzfeldt-Jakob Disease BSE - Bovine Spongiform Encephalopathy; so-called mad cow disease (e.g. Creutzfeldt-Jakob Disease) TSE - Transmissible Spongiform Encephalopathy On the basis of the patient's general condition the doctor in charge must decide whether the planned use is possible or not. Follow the laws and regulations valid in your country. For further notes and instructions please refer to the latest medical literature. Contraindications directly related to the product are presently unknown. The forceps and scissors are used in conjunction with endo­ scopes and endoscopic accessories (such as trocar sleeves). In addition, the monopolar forceps and scissors are used in conjunction with monopolar HF devices and suitable HF cables.

WARNING ! Do not combine products incorrectly! Injuries of the patient, user or others as well as damage to the product is possi­ ble. Follow the instruction manual of the products used in combination with this product. Follow the "Notes and instructions on HF applications", order no.: GA-S 002 as well as the HF device manufacturer's instructions.

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5

Illustration 1

3

2

4

5

6

#

7

A

9

10

11

8

B

C

5.1

Legend and identification Item

Designation

1

Jaw section / scissors

2

Sheath tube, insulated

A

With HF connector (monopolar) and lock

3

Luer lock cap with tab

B

With lock without HF connector

4

Luer connector

C

With HF connector (monopolar) without lock

5

Star wheel

6

HF connector (unipolar)

#

Product no.

7

Movable grip

8

Lock

9

Fixed grip

10

Locking lever

11

Trigger

Symbol

Item

Designation Grip variants:

Designation Caution, consult ACCOMPANYING DOCUMENTS !

REF

Order no. Lot designation

SN

Serial no. Identification in conformity with EEC directive 93/42/EEC on medical products, is only valid if the product and/or its packaging is provided with this identification. Products of category IIa and above, as well as sterile products or products with measuring function of category I, are additionally marked with the code no. of the notified body (0124).

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6

Use CAUTION ! The products have only limited strength ! Applying excessive force will cause damage, impair the function and therefore endanger the patient. Due to the small dimensions required, the products have only limited strength. Use these products only to grasp and ablate small, soft tissue portions or organs. Immediately before and after each use, check the products for damage, loose parts and completeness. Make sure that no missing parts remain in the patient. Do not use the products if they are damaged or incomplete or have loose parts.

6.1

Preparation

3

Carry out a visual check: see sections 7 and 7.1 Close the luer connector (4) using the luer lock cap (3) (fig. 1).

4

Fig. 1 6.2

Handle with lock

6.2.1

Working with the lock: Turn the locking lever (10) from position I to position II (Fig. 4). The lock (8) is activated. Closing the forceps: the lock (8) engages automatically in the required position (Fig. 3). Opening the forceps: Push the trigger (11). (Fig. 3) The lock (8) disengages.

11

Fig. 2

10

11

Fig. 3

3

8

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6.2.2

Working without the lock Turn the locking lever (10) from position II to I (Fig. 4).

10

Fig. 4

Carry out a function check: see section 7.2

6.3

Additional notes and instructions for use

Function of the star wheel (5): The star wheel (5) serves to turn the grasped tissue portion or organ to a specific position (5) (Fig. 5).

7 5

Fig. 5

NOTE ! Increasing the pressure onto the movable grip (7) reduces the rotatability of the star wheel (5).

IMPORTANT ! Insert and retract the forceps and scissors only with closed jaws.

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6.3.1

HF applications

Follow the "Notes and instructions on HF applications", order no.: GA-S 002 as well as the HF device manufacturer's instructions.

CAUTION ! Electrical conductivity due to irrigation fluids! The user must choose the irrigation fluid as required by the application and the irrig­ ation fluid must have a low electrical conductivity. Do not use NaCl solution ! CAUTION ! The forceps and scissors with monopolar HF connection may only be used in conjunction with HF surgical devices and only at a maximum recurring peak volt­ age of 2 KV and are only suitable for short-time coagulations of smaller hem­ orrhages. Any use with forced coagulation or spray coagulation over 2 kV is not permiss­ ible! WARNING ! Danger of injury if the monopolar forceps and scissors are not visible through the scope ! Inadvertent tissue damage as well as damage to the distal end of the endoscope and instrument parts are possible. Use the monopolar forceps and scissors only within the given specifications (volt­ age endurance, mode of operation) Activate the the monopolar forceps and scissors only when the live HF part is fully visible through the scope and touches the area to be treated. CAUTION ! Careful if HF voltage is too high ! Danger of injury if the insulation of the HF instruments is damaged ! Exceeding the maximum recurring peak voltage of the HF instrument in conjunc­ tion with HF surgical devices and/or selecting the wrong mode of operation can destroy the insulation and cause leakage currents. The patient, user or others can suffer thermal tissue damage. CAUTION ! Danger of injury from HF instruments with damaged insulation ! The insulation of reprocessed or aged products can be damaged causing thermal tissue damage on/in the patient and user. HF instruments with damaged insulation must be replaced. Do not use again.

HF device

Apply the neutral electrode. See Notes and Instructions on HF Applications, order no. GA-S 002 Connect the HF connection cable (product no.: 8106.xxx) with the HF con­ nector (6) and the HF surgical device. (Fig. 6)

6 NOTE ! Encrusted and soiled jaws or cutting edges impair the HF performance dur­ ing the intervention.

Fig. 6

5

Dissolve any encrustations or soiling on the coagulation surfaces with 3% hydrogen peroxide solution (H2O2-solution) and wipe off with a gauze pad. Then rinse with sterile water.

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Checks CAUTION ! Be careful if products are damaged or incomplete ! Injuries of the patient, user or others are possible. Run through the checks before and after each use. Do not use the products if they are damaged, incomplete or have loose parts. Return damaged products together with any loose parts for repair. Do not attempt to do any repairs yourself.

7.1

Visual check

2

Check the instruments, in particular their distal sections, as well as the accessor­ ies, for damage sharp edges not suitable for the application loose or missing parts rough surfaces Check the luer lock cap (3) for damage and replace if necessary. Check the insulation of the HF cable for damage. Replace the HF cable if the insulation is damaged. Check the insulation of the sheath tube (2) for mechanical damage and dielec­ tric breakdown (punctures). (Fig. 7) Do not use the forceps and scissors if the insulation is damaged. Any lettering, labeling or identification necessary for the safe intended use must be legible. Missing or illegible inscriptions and labels that can lead to wrong handling and reprocessing must be reinstated.

Fig. 7

CAUTION ! Damaged surface in the joint area of the forceps ! The joint pin may loosen. Check for surface changes, such as fissures, at the joint pin (fig. 8)

Fig. 8 7.2

Function check

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Check that the jaws open and close properly. Check that the jaw section (1) can be rotated with the star wheel (5) .

6

8

Reprocessing and maintenance WARNING ! Creutzfeldt Jakob Disease ! If the patient is suspected of having Creutzfeldt-Jakob Disease (CJD) or a variant of Creutzfeldt-Jakob Disease (vCJD) or the latter have been diagnosed, adequate measures must be taken to prevent possible transmission to other patients, users and third parties. For this purpose, apply the country-specific reprocessing guidelines and regula­ tions. IMPORTANT ! Further notes and instructions on reprocessing are described in manual GA-J020 “Reprocessing of RICHARD WOLF Heat-stable Instruments“ and must be fol­ lowed.

8.1

Disassembly before cleaning Remove the luer lock cap (3) (Fig. 9).

3

Fig. 9 Figure 10 on the section on manual cleaning in the reprocessing instructions on page 8

Fig. 10

7

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8.2

Reprocessing procedure

The table below describes the validated reprocessing method for Eragon forceps, scissors and punches.

IMPORTANT ! Due to the product design and the materials used it is not possible to define a specific limit of the maximum allowable reprocessing cycles. The life cycle of medical products is defined by their function and adequate handling. Before defective products are returned for repair, they must have gone through the entire reprocessing cycle. The user must make sure that the reprocessing process including the ressources, material and personnel are suited to reach the required reprocessing results. The state of the art and national laws require that validated processes be fol­ lowed. IMPORTANT ! Further notes and instructions on reprocessing are described in manual GA-J020 “Reprocessing of RICHARD WOLF Heat-stable Instruments“ and must be followed. Reprocessing guide: Preparation at the point of use:

Directly after use, remove any coarse soiling from the instruments. Immediately after use, rinse out hollow spaces with a 5 ml syringe filled with water. Do not use any fixing or setting agents or hot water (>40°C) as this will bake the residues to the surfaces and may have a negative impact on cleaning.

Transport:

Safe storage and transport of the instruments to the reprocessing room in a closed container to prevent damage to the instruments and contamination of the environment.

Precleaning:

Before cleaning, remove the luer lock cap (3) (see section 8.1) Rinse out instruments for 20 seconds or, in pulsed mode, with 5 pressure surges (3 - 4 bar) using a water cleaning gun.

Cleaning:

Manual cleaning

Machine cleaning

See figure 10 1. Immerse instruments in a cleaning solution for at least 5 minutes. 2. Clean instruments with a soft brush until all visible contaminants are removed. 3. Rinse out instruments for 20 seconds or, in pulsed mode, with 5 pressure surges (3 - 4 bar) using a water cleaning gun. Clean the jaw section of the instrument and hinge area using a brush.

Pre-clean the instruments manually before automatic ma­ chine cleaning. Place the instruments in open condition onto the inserts of the MIC rack cart. Vario-TD program (without disinfection cycle) 4 min of pre-cleaning using cold water. Empty 5 min of washing at 55° C using neodisher FA (Dr. Weigert) 0.5% Empty 3 min of neutralization with warm tap water (>40°C) Empty 2 min of intermediate rinsing with warm tap water (>40°C). Empty

Disinfection:

1. 2.

Immerse instruments in an approved disinfectant Carry out thermal machine disinfection taking into account solution, for exposure time refer to the the national requirements regarding the A0 value (see DIN manufacturer's instructions. EN ISO 15883). Then rinse the instruments thoroughly with fully demineralized water for at least 15 seconds using a cleaning gun.

Drying:

Manual drying: Dry outside of instruments using a sterile lint-free dispos­ able cloth or swab, dry any hollow spaces with filtered compressed air.

Care:

After manual / machine disinfection, if required: Sparingly oil the joint of the jaw section (1) with 1 drop of instrument oil. - All other surfaces must be oil-free! Remove any excess oil.

Function check, maintenance:

Check visually for cleanliness. If necessary, repeat the reprocessing procedure until the instrument appears visu­ ally clean. Carrying out a visual check: see section 7.1

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Drying of instruments using the washer / disinfector drying cycle. If necessary, additional manual drying can be achieved using a sterile lint-free disposable cloth or swab. Dry hol­ low spaces with filtered compressed air.

8

Assembly before sterilization

Do not close the luer connector (4) with the luer lock cap (3) until just before use.

Sterilization:

Sterilization with the fractional prevacuum cycle (ISO13060/ISO17665) complying with the relevant national statutory regulations. Temperature exposure time: 4 min at 134°C +4°C (273°F +7°F) 132°C +4°C (270°F +7°F) Drying time: 10 - 20 min Maximum sterilization temperature: 138°C

Validation:

The following test instructions, materials and machines were used during validation: Machine cleaning agent: alkaline cleaning agent 0.5% neodisher FA (Dr. Weigert) Manual cleaning agent: enzymatic cleaning agent 0.5% neodisher MediClean (Dr. Weigert) Manual disinfectant: Cidex (Advanced Sterilization Products) Automatic washer / disinfector: G 7735 CD Miele Washer / disinfector rack: MIC rack cart

Additional instructions:

8.3

The user is obliged to validate his process in accordance with DIN EN ISO 17664.

Low-temperature sterilisation Low-temperature process / Agent: Hydrogen peroxide STERRAD 50 / 100S / 200 / NX

and 100 NX

Low-temperature process / Agent: Peracetic acid STERIS SYSTEM 1 / STERIS SYSTEM 1E

IMPORTANT ! The low-temperature process STERRAD  and STERIS SYSTEM 1  / STERIS SYSTEM 1E have been certified for endoscopes and endoscopic accessories only with regard to their material compatibility. By no means should these low-temperature methods STERRAD  and STERIS SYSTEM 1  / STERIS SYSTEM 1E be used alternately. Possible interaction between these sterilization processes can cause damage to the instruments..

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Technical data and order data

10

Spare parts and accessories

See flyer BB-S 025 “Overview of technical data and order data”

Illustration

-

Product no.

Designation, technical data

15 023.153

Luer lock cap

8106.032 8106.052 8106.132 8106.152 8106.031 8106.051

HF Monopolar Connection Cable, 3 m (ERBE / ACC / ICC / VIO) HF Monopolar Connection Cable, 5 m (ERBE / ACC / ICC / VIO) HF Monopolar Connection Cable, 3 m (ERBE T series) HF Monopolar Connection Cable, 5 m (ERBE T series) HF Monopolar Connection Cable, 3 m (Martin / Berchtold / Aesculap) HF Monopolar Connection Cable, 5 m (Martin / Berchtold / Aesculap)

8106.033 8106.053 8106.034 8106.054

HF Monopolar Connection Cable, 3 m (Bovie / Valleylab / Erbe Int.) HF Monopolar Connection Cable, 5 m (Bovie / Valleylab / Erbe Int.) HF Monopolar Connection Cable, 3 m (Eschmann and other devices with 4 con­ nectors) HF Monopolar Connection Cable, 5 m (Eschmann and other devices with 4 con­ nectors)

The products can be combined as required provided the relevant technical data and intended uses are observed. For the total overview please refer to the latest catalog sheets and brochures or contact Richard Wolf or your representative.

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Operating, storage, transport and shipping conditions Operating conditions

+10°C to +40°C, 30% to 75% rel. humidity, atmospheric pressure 700 hPa to 1060 hPa

Storage, transport and shipping condi­ tions

-20°C to +60°C, 10% to 90% rel. humidity, atmospheric pressure 700 hPa to 1060 hPa

NOTE ! To prevent damage during transport or shipment of the products we recommend using the original packaging material.

11.1

Disposal of product, packaging material and accessories

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For the disposal comply with the country-specific laws and regulations. For further information please contact the manufacturer.

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