Richard Wolf ERAGON modu blades 839x0407 Instruction Manual

Important general notes and instructions Make sure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified medical personnel, Maintenance and repair must be carried out by authorized experts. 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 appli­ cation and if the performance characteristics and safety requirements are met. The product must not be altered in any way. Reprocess the product in accordance with the manual before every use and before return shipment to protect the pa­ tient, user and third parties. This manual is an integral part of the product and must be stored in such a way that it is accessible at any time during its entire life cycle. This manual must be passed on to any subsequent owner or user. Immediately on receipt, check the product and its accessories for completeness and possible damage. Should the shipment give rise to complaints, please inform the manufacturer or supplier immediately. Subject to technical changes! Due to ongoing developments the illustrations and technical data may deviate slightly.

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!

User tips for optimum device use and other useful information.

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GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300 MANUFACTURER [email protected] www.richard-wolf.com

USA RICHARD WOLF Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Toll Free: 001 (800) 323 - 9653 Phone: 001 (847) 913 - 1113 Fax: 001 (847) 913 - 1488 [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 [email protected] www.richard-wolf.be

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F-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 A-1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 14 05 51 51 45

[email protected]

[email protected] www.richard-wolf.com

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

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

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Contents 1

Technical description...

1

2

Intended use...

1

3

Indications and field of use...

1

4

Contraindications...

1

5

Combinations...

1

6 6.1 6.2

Illustration... Legend and identification... Symbols...

2 2 3

7 7.1 7.2 7.2.1 7.2.2 7.3 7.3.1 7.3.2 7.4 7.4.1 7.5

Use... Preparation... Assembly... Assembling the control rod, sheath tube and handle... Installing the scissor attachment (1)... Disassembly... Disassembling the scissor attachment (1)... Disassembling the sheath tube and control rod... Additional notes and instructions for use... Function of star wheel... HF applications...

4 4 4 4 5 7 7 7 8 8 9

8 8.1 8.2

Checks... 10 Visual check... 10 Function check... 10

9 9.1

Reprocessing and maintenance... 11 Reprocessing procedure... 12

10

Technical data and order data... 14

11

Spare parts and accessories... 14

12 12.1

Operating, storage, transport and shipping conditions... 14 Disposal of product, packaging material and accessories... 14

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1

Technical description The "Metzenbaum" Scissors ents: Scissor attachment, sterile Disposable item Control rod Sheath tube Handle

2

Intended use

consist of the following compon­

The scissors are used for endoscopically controlled holding, manipulating and cutting, as well as dissection and tissue removal of soft tissue parts and organs. The scissors can also be used for cutting suture material. Minor hemorrhages can be coagulated by means of monopolar HF current. This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons.

3

Indications and field of use

4

Contraindications

For examination, diagnosis and therapy with endoscopic accessories in various medical disciplines such as surgery, urology, thoracoscopy and gynecology. Contraindications directly related to the product are presently unknown. On the basis of the patient's general condition the doctor in charge must decide whether the planned use is possible or not. For further notes and instructions please refer to the latest medical literature. CJD - Creutzfeldt Jakob Disease or a 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. Comply with 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.

5

Combinations The "Metzenbaum" Scissors are used in conjunction with monopolar HF devices, trocar sleeves, endoscopes with working channel and endoscopic accessories.

CAUTION! Do not combine products incorrectly! Injuries of the patient, user or others as well as damage to the product is pos­ sible. The different products can only be used together if their intended uses and relev­ ant technical data (such as working length, diameter, peak voltage, etc.) are the same. 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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Illustration

1.2

1.1

1 2.2

2 2.1

3.3

3.2 3.1

3

4

4.1 4.2

4.3 Fig. 1 6.1

Legend and identification Item

Designation

Item

Designation

1

Scissor attachment

4

Handle

1.1

Threaded sleeve

4.1

HF connector

1.2

Elastic insulation

4.2

Movable grip

2

Control rod

4.3

Fixed grip

2.1

Spring collet, resilient

2.2

Nose

#

Product no.

3

Sheath tube

3.1

Star wheel

3.2

Pushbutton

3.3

Groove

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2

6.2

Symbols Symbols

Designation Follow the instruction manual

REF

Order no.

LOT

Lot designation Manufacturing date Quantity To be used before: Do not reuse.

Do not re-sterilize

STERILE C

Sterilization by radiation Manufacturer

Do not use if packaging is damaged

During storage, protect against the sun Store under dry conditions 30° 10° 60%

Temperature range

Humidity limitation Identification in conformity with EEC directive 93/42/EEC on medical products, is only valid if the pro­ duct 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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Use WARNING! Do not reprocess disposable items! The life cycle of products marked as disposable items is designed to endure only one single application on a single patient. If disposable items are reprocessed for further use, the product properties can be impaired and / or changed and this may endanger the patient, the user and others. Possible dangers / risk factors are: stability problems damage to the product considerable impairment of the function severely increased risk of infection Biocompatibility problems If disposable items are reprocessed for further use, the product responsibility lies with the user or reprocessor, respectively. In this case, the manufacturer can no longer guarantee the safety and perform­ ance of the product. CAUTION! The products have only limited strength! Applying excessive force will cause damage, impair the function and therefore endanger the patient. 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.

7.1

Preparation

7.2

Assembly

7.2.1

Assembling the control rod, sheath tube and handle Insert the control rod (2) into the sheath tube (3) as shown in fig. 2. The nose (2.2) must engage in the groove (3.3) (Fig. 2a)

Check assembly: see section 7.2 Carry out a check: see sections 8 and 8.1 Connect the instrument via the HF connection cable (see accessories) to the HF generator. Check the power setting on the HF generator.

2

3

2.2 Fig. 2

3.3

Fig. 2a

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IMPORTANT! Hold the movable grip (4.2) loosely during assembly. Insert the sheath tube (3) with the control rod (2) installed into the handle (4). (Fig. 3) The sheath tube (3) clicks automatically into place. This will cause the movable grip (4.2) to move downward.

3

4 4

4.2

Fig. 3

7.2.2

Installing the scissor attachment (1) Figure 4: Check the scissor attachment (1) and sterile packaging for damage. Take the scissor attachment (1) out of the sterile packaging. To prevent any damage to the elastic insulation (1.2), hold the scissor at­ tachment (1) by the knurled threaded sleeve. Hold the scissors by the sheath tube (3) and not by the handle (4). Grip (4.2) moves freely, open position. Introduce the scissor attachment (1) into the sheath tube (3).

1

1.2

1.1

3

4.2 Fig. 4

5

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Figure 5:

NOTE! Do not hold the instrument by its handle (4)!

Screw the threaded sleeve (1.1) and the sheath tube (3) into each other against a slight resistance as far as it will go (fig. 5) When screwed on the grip (4) will close automatically.

4

3

1.1

Fig. 5 Function test: Open and close the scissors. If the scissors cannot be opened or closed, repeat the assembly procedure assuring that the movable grip can move freely.

CAUTION! HF arcing ! If the scissor attachment (1) is not fully screwed into the sheath tube (3) up to the stop, it may cause damage to the elastic insulation (1.2) when closed and may cause electric sparking when activating the HF current. During assembly, check for a smooth blend and possible damage of the instru­ ment. (Fig. 6)

1.2

1.2

Transition

right

wrong 1

Transition

3

1

3

Fig. 6

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7.3

Disassembly

7.3.1

Disassembling the scissor attachment (1)

1

Unscrew the scissor attachment (1) and discard (disposable item). (Fig. 7) As for disposal, the country-specific regulations apply.

Fig. 7 7.3.2

Disassembling the sheath tube and control rod Figure 8:

IMPORTANT! Do not hold the movable grip (4.2) during disassembly!

Push the pushbutton (3.2) on the star wheel (3.1) and pull off the sheath tube (3) in direction of arrow. The sheath tube (3) disengages from the handle (4). The movable grip (4.2) wil automatically move upwards.

3.2 3

3.1

4.2

Fig. 8

Pull the control rod (2) out of the sheath tube (3) (fig. 9)

3

2 Fig. 9

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7.4

Additional notes and instructions for use

7.4.1

Function of star wheel

CAUTION! The elastic insulation (1.2) on the scissor attachment may become damaged by sharp edges of the access instruments (trocar sleeves) when inserted in re­ moved. Insert and withdraw the scissors only when they are completely closed. Make sure that the scissors are well aligned when inserted and removed. Do not insert or withdraw the scissors jerkily. Do not apply excessive force during insertion and removal. If the elastic insulation (1.2) is damaged, replace the scissor attachment (1) by a new, sterile one.

NOTE ! Increasing the pressure onto the movable grip (4.2) reduces the rotatability of the star wheel (3.1). The star wheel (3.1) serves to turn the tissue or organ held between the jaws to a specific position (Fig. 10).

3.1

4.2

Fig. 10

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7.5

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!

1.1

In conjunction with HF surgical devices, the scissors with mono­ polar HF connection may only be used at a recurring peak voltage of max. 2 kV and lend themselves only to short-time coagulation of small hemorrhages. Any use with forced coagulation or spray coagulation over 2 kV is not permiss­ ible! CAUTION! If sparking occurs in the area of the threaded sleeve (1.1) (e.g. as a result of excessive HF voltages), discard the scissor attachment and replace it by a new one. (Fig. 11)

Fig. 11

WARNING! Danger of injury if the scissors are not in the operator's field of view! Inadvertent tissue damage as well as damage to the distal end of the endoscope and instrument parts are possible. Use the scissors only within the scope of specifications (electric strength, mode of operation). Activate the scissors only after the part conducting HF current has become fully visible through the scope and contact is made with the intended treatment area. 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.

HF device

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 re-use. Apply the neutral electrode.

4.1

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 (3.1) and the HF surgical device. (Fig. 12)

NOTE!

Fig. 12

9

Encrusted and soiled jaws or cutting edges impair the HF performance dur­ ing the intervention! Dissolve any encrustations or soiling on the coagulation surfaces with 3% hydrogen peroxide solution (H2 O2 -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. IMPORTANT! For sterile products: Sterility is only guaranteed if the packaging is undamaged and has not been opened before. Do not use the product if the sterile packaging is damaged or the use-by-date has been exceeded.

8.1

Visual check

3

Replace the HF cable if the insulation is damaged. Check the insulation of the sheath tube (3) for mechanical damage and dielec­ tric breakdown (punctures). (Fig. 13) Do not use sheath tubes (3) 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. 13 8.2

Check the instruments and accessories for the following: damage surface changes (e. g. corrosion) sharp edges not suitable for the application loose or missing parts rough surfaces Check the insulation of the HF cable for damage.

Function check

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Check that the jaws open and close properly. Check that the scissor attachment (1) can be rotated via the star wheel (3.1). Check the cutting function.

10

9

Reprocessing and maintenance WARNING! Creutzfeldt-Jakob Disease! If the patient is suspected of having the Creutzfeld Jakob Disease (CJD) or a vari­ ant of the Creutzfeld Jakob Disease (vCJD) or one of these diseases has 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. CAUTION! Danger of creeping currents during HF applications! It is not permissible to oil the area of the handle joints (4)! The handle (4) is maintenance-free! After use, disassemble the scissor attachment (1) and discard!

1

fig. 14 Illustration 15 on the section on manual cleaning in the reprocessing instructions see page 11

fig. 15

11

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9.1

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 permissible number of reprocessing cycles. The service life of medical products is defined by their function and gentle handling. Before defective products are returned for repair, they must have gone through the entire reprocessing cycle. The user is obliged to make sure that the reprocessing process including the res­ sources, material and personnel is suited to reach the required reprocessing res­ ults. 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 these must be followed. Reprocessing guide: Preparation at the point of use:

Directly after use, remove any coarse soiling from the instruments. If more than 6 hours have elapsed between use and reprocessing, rinse out the hollow spaces of the instrument with a 5 ml syringe filled with water. Do not use fixing agents or hot water (>40°C) as this will cause residues to be baked to the surface and it may jeopardize the cleaning success.

Transport:

Safe storage, transport and shipment of the instruments to the reprocessing room in a closed container to prevent dam­ age to the instruments and contamination of the environment.

Precleaning:

Disassembling the instruments before cleaning : see section 7.3 Rinse out the sheath tube (3) for 20 seconds or, in pulsed mode, with 5 pressure surges (3 - 4 bar) using a cleaning gun.

Ultrasonic cleaning

Immerse the instruments in a cleaning and disinfecting solution approved for use in ultrasonic baths. Before, the chan­ nels of the instruments must be filled with this solution. Exposure time: 5 min Frequency: 35 kHz Temperature max.: 45°C After ultrasonic cleaning: Rinse out the sheath tube (2) for 20 seconds or in pulsed mode with 5 pressure surges (3 - 4 bar) using a cleaning gun. Dry the outside of the instruments manually using a sterile lint-free disposable cloth or swab, dry any hollow spaces using filtered compressed air (pulsed with 5 pressure surges, 3 - 4 bar).

Cleaning:

Manual cleaning

Machine cleaning

See illustration 15 1.Immerse instruments in a cleaning solution for at least 5 minutes. Before, fill the sheath tube (3) with this solution. 2.Brush handle (4), control rod (2), and sheath tube (3) for at least 5 seconds using a soft brush in order to remove any residues. 3.Rinse out the sheath tube (3) with a 5 ml syringe filled with a cleaning solution. 4.Then rinse out the instruments for 20 seconds or in a pulsed mode with 5 pressure surges (3 - 4 bar) using a cleaning gun.

Pre-clean the instruments manually before automatic ma­ chine cleaning. Place the instruments in disassembled and open condition into the trays of the MIC cart. Vario-TD program (without disinfection cycle) 4 min of pre-cleaning using cold water. Empty Wash with a cleaning agent for 6 min at 55° C Empty Neutralize with cold tap water for 3 min Empty 2 min of intermediate rinsing with cold tap water Empty

Disinfection:

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1.Immerse instruments in an approved disinfectant solu­ Carry out thermal machine disinfection following the na­ tion, for exposure time refer to the manufacturer's in­ tional requirements regarding the A0 value (see DIN EN structions. ISO 15883). Fill the channels with this solution before. 2.Then rinse the instruments thoroughly with fully demin­ eralized water for at least 15 seconds using a cleaning gun.

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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.

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.

Care:

The instruments are maintenance-free.

Function check, maintenance:

Check visually for cleanliness. If necessary, repeat the reprocessing procedure until the instrument appears visu­ ally clean. Carry out a visual check: see section 8.1

Assembly before sterilization

See section 7.2.2 Assemble the control rod (2) in the sheath tube (3). Install the handle (4) after sterilization.

Sterilization:

Sterilization using the fractional pre-vacuum method (ISO13060/ISO17665) in compliance with the national require­ ments. 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 min Maximum sterilization temperature: 138°C

IMPORTANT! The instruments cannot be reprocessed in the Sterrad! Validation:

Additional instructions:

13

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

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Technical data and order data Scissor attachment

4393.040 METZEN­ BAUM SCISSORS ATTACH­ MENT MONO

11

SHEATH TUBE INSULATED Ø 5.5MM

TENSION ROD Ø 5MM

WL 260 mm

WL 330 mm

WL 450 mm

SL 240 mm

SL 310 mm

SL 430 mm

8392934

8393934

8394934

8392935

8393935

8394935

HANDLE PISTOL SHAPED MONO Complete instrument consisting of: • Scissor attachment • Control rod without lock • Sheath tube rotatable • Handle 83930073

Model / type 83920407 83930407 83940407

Spare parts and accessories Product no.

Designation, Technical data

8106.032 8106.052 8106.132 8106.152 8106.031 8106.051 8106.033 8106.053 8106.034 8106.054

HF CONNECTION CABLE MONO L 3M HF CONNECTION CABLE MONO L 5M HF CONNECTION CABLE MONO L 3M HF CONNECTION CABLE MONO L 5M HF CONNECTION CABLE MONO L 3M HF CONNECTION CABLE MONO L 5M HF CONNECTION CABLE MONO L 3M HF CONNECTION CABLE MONO L 5M HF CONNECTION CABLE MONO L 3M HF CONNECTION CABLE MONO L 5M

The products can be combined as required provided the relevant technical data and intended uses are obser­ ved. 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

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

Storage, transport and shipping conditions

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

Disposable items, sterile products

Follow instructions on package !

IMPORTANT! Store sterile products in their original packaging until use. Incorrect storage may lead to loss of sterility. NOTE! To prevent damage during transport or shipment of the products we recommend using the original packaging material.

12.1

Disposal of product, packaging material and accessories For the disposal follow the relevant regulations and laws valid in your country. For further information please contact the manufacturer.

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