Modular Forceps and Scissor System Instructions 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.

0

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 4.1 4.2

Contraindications and side effects... Contraindications... Side effects...

1 1 1

5 5.1 5.2

Combinations... HF application and combinations... Compatibility of “modu line” and "RIWO GRIP"...

1 2 2

6 6.1 6.2

Darstellung... Legend and identification... Bildzeichen...

3 3 4

7 7.1 7.2 7.2.1 7.2.2 7.2.3 7.3 7.3.1 7.4 7.4.1 7.4.2 7.5 7.6 7.7

Use... 5 Preparation... 5 Handle with lock... 5 Preparing the lock... 5 Working with lock... 6 Working without lock... 7 Disassembly of modular forceps/scissors... 8 Disassembly of jaw insert from sheath... 8 Assembly of modular forceps/scissors... 9 Assembly of jaw insert... 9 Assembly of sheath to handle... 9 Disassembly/assembly of semimodular forceps/scissors... 11 Function of the wheel... 11 Additional instructions for use... 11

8 8.1 8.2

Checks... 12 Visual check... 12 Functional check... 12

9 9.1 9.2 9.2.1 9.3

Reprocessing and maintenance... Disassembly before cleaning... Figures for reprocessing instructions... Manual cleaning... Reprocessing procedure...

10

Technical data and order data... 17

11

Spare parts... 17

12 12.1

Operating, storage and transport and shipping conditions... 17 Disposal of product, packaging material and accessories... 17

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14 14 14 14 15

I

1

Technical description

2

Intended use

3

Indications and field of use

The forceps and scissor system contains semimodular and modular instruments. The semimodular instruments comprise 2 individual elements: Handle Sheath tube with fixed inner part. The modular instruments comprise 3 individual elements: Handle Sheath tube Inner parts The modular/semimodular forceps and scissors are used for endoscopically con­ trolled grasping, manipulating and cutting as well as dissection and biopsy of soft tissue/organs. The modular scissors can also be used for cutting suture material. Minor bleeding can be coagulated with unipolar HF current using the products marked correspondingly.

For examination, diagnosis and/or therapy with endoscopic accessories in various disciplines, such as surgery, urology and gynecology, performed by adequately trained and qualified personnel.

4

Contraindications and side effects

4.1

Contraindications. CJD - Creutzfeldt Jakob Disease or a vCJD - Variant of the 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 and guidelines. Contraindications directly related to the product are presently unknown.

4.2

Side effects

5

Combinations

No side effects are to be expected if the system is used as intended. The forceps and scissors of the system are used in conjunction with endoscopes and endoscopic accessories (e.g. trocar sleeves). In addition, the monopolar forceps and scissors are used in conjunction with mo­ nopolar 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 are possi­ ble. Only the instrument combinations listed in flyer BB-S 027 are permissible ! Follow the instruction manuals of the products used in conjunction with this prod­ uct. Follow the "Notes and instructions on HF applications", order no.: GA-S 002 as well as the HF device manufacturer's instructions.

1

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5.1

HF application and combinations IMPORTANT! Only the handles with HF connection (6) are suitable for use with high--frequency current. Uninsulated (i.e. bare metal) sheaths (2 b) can only be combined with handles which do not have an HF connector. . Insulated sheaths (2 a) can be combined with all handles. The inner parts can be combined with both insulated and uninsulated sheaths of the same working length. Use distally curved instruments (12) only in conjunction with fixed handle (H) and flexible trocar sleeves.

5.2

Compatibility of “modu line” and "RIWO GRIP" NOTE! The successor generation of the modular forceps and scissors “modu-line” distin­ guishes itself by the distally extended insulation compared to the “RIWO GRIP“ system. modu line

RIWO GRIP

The insulation extends further distally

The insulation stops before the joint

The joint area is covered = insulated

The joint area is not covered = not in­ sulated

IMPORTANT! Do not combine „modu-line“ jaw inserts with “RIWO GRIP” sheath tubes because the sheath tube does not fully insulate the jaw insert (see adjacent drawing)

The jaw inserts and the sheath tubes can be distinguished and combined by the following characteristics:

Sheath tube„moduline“ Knurled collar is black

Sheath tube “RIWO GRIP” Knurled collar is blue

Jaw insert „modu-line“

“ “ as distinctive mark

Jaw insert “RIWO GRIP”

= combinable

= not combinable

NOTE! The different handles are compatible with both the “modu-line” system and the “RIWO-GRIP” system.

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2

6

Darstellung A

6

D 1

B

3

1

1

3 8

10

13 14

5

9 10

9

0124

8393.0009

MXXXXXX

5

4 7 6

H

9 10

Abb. 1

9

3

14

12

6

G MXXXXXX

15

6.1

4 7 9 5

0124

11

9

3 8

3 9 10

2b

4

6

F

3 9 10

7 5 6 7 4

E

C

2a

8

3

1

9

5

4 7

Legend and identification

3

Item

Designation

Item

Designation

A B C D E F G H

Example: Grasping/dissecting forceps Example: biopsy forceps Example: scissors Handle, axial (1) Handle, axial (2) Handle (1) Handle (2) Handle, fixed

1 2a 2b

Jaw insert Sheath, insulated Sheath, unisulated

3 4 5 6 7 8 9 10 11 12 13 14 15

Knurled locking collar Movable grip Fixed grip HF connector (unipolar, monopolar) Locking mechanism Thumbwheel Identification no. Lot no. Sheath, firmly connected to jaw insert Sheath, fixed, with distally curved internal part. Sealing cap 887.00 Luer connector Luer cap, secured

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6.2

Bildzeichen Symbol

Designation Follow the instruction manual

REF

Order number

LOT

Lot designation Identification in conformity with Medical Product Directive 93/42/EEC, only valid if the product and/or the packaging is marked 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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4

7

Use How to handle and use the products is shown by example of the non--axial handle. The same applies to axial handles accordingly.

7.1

Preparation Check assembly: chapter 7.4) Run through the checks: chapter 8

7.2

Handle with lock

7.2.1

Preparing the lock Push locking lever (a) from postion “I” to “II” (fig. 2). Lock (7) engages automatically.

a

7

MXXXXXX

II

0124

a

I

7 a

7

Fig. 2

5

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7.2.2

Working with lock Close forceps. Lock (7) engages automatically. Open forceps/scissors. Push the finger plate (b) or trigger (b) (fig. 3). Lock (7) is disengaged. The forceps/scissors can be opened.

b 0124 MXXXXXX

7 b

7 b

7

Fig. 3

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6

7.2.3

Working without lock

Push locking lever (a) from position “II" to “I" (fig. 4) . Actuate movable grip (4). Forceps/scissors work without lock (7).

a 0124

I II

MXXXXXX

a

7 4 7 a

Fig. 4

7

4

a

7

4

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7.3

Disassembly of modular forceps/scissors NOTE: Always disengage lock before disassembly. Push locking lever (a) from position “II" to “I" (see chapter 6.2.3)

Hold forceps/scissors, as shown in fig. 5. Axial handles (D), (E) The fixed grip (5) is in axial position, the movable grip (4) is facing upward. Handles (F), (G) The movable grip (5) is facing upward, the movable grip (4) is in axial position. Turn knurled locking collar(3) in direction of arrow and pull off sheath (2), (fig. 5).

4

D,E

2

3

5

5

F, G

Fig. 5 7.3.1

2

3

4

Disassembly of jaw insert from sheath Hold sheath (2) firmly, turning the jaw insert in direction of arrow and remove insert from sheath (2), (fig. 6).

2

Fig. 6

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1

8

7.4

Assembly of modular forceps/scissors

7.4.1

Assembly of jaw insert Hold sheath (2) firmly and insert jaw insert (1) in sheath (2) so that guide keys (c) engage in grooves (d), (fig.7) . Turn jaw insert (1) in direction of arrow as far as it will go. The jaw insert (1) is locked in the sheath (2), (fig. 7) .

1

Fig. 7

c

d

c

d

2

NOTE: If the jaw insert is not locked in the sheath, the sheath cannot be fixed to the han­ dle. 7.4.2

Assembly of sheath to handle NOTE: Deactivate the lock before assembly To deactivate the lock, push locking lever (a) from position “II” to “I” (see chapter 6.2.3) Hold forceps/scissors, as shown in fig. 8. Axial handles (D), (E) Fixed grip (5) is in axial position, the movable grip (4) facing downward. Handles (F), (G) Fixed grip (5) is facing upward, the movable grip (4) is in axial position.

D, E

5

4 F, G

Fig. 8

9

5

4 GA-S 026

Hold grip housing firmly Slide sheath (2) with fastened/fixed jaw insert (11) into the handle. Turn jaw insert (11) until it clicks into place (fig. 9). The movable grip (4) will move upward. Screw on knurled collar (3) as indicated by the arrow (fig.9).

D, E

11

2

3

F, G 11

4

2

3

Fig. 9

4

IMPORTANT! Before sterilization: To prevent stress cracks and to ensure unimpeded steam access, loosen knurled locking collar (3) at least 1 full turn. Before the intervention: Firmly tighten knurled locking collar (3). IMPORTANT ! Sterilize the luer cap (13) and the luer cap, secured, (15) separately from the sheath. Before surgery: Firmly attach the luer cap (13) as well as the luer cap, secured, (15) to the luer connector (14).

13 1

Fig. 10

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14 2

15 14

1

2

10

7.5

Disassembly/assembly of semimodular forceps/scissors Procedure for disassembly/assembly of semimodular forceps/scissors as described in chapters 7.3 and 7.4. Chapters 7.3.1 and 7.4.1 are not applicable.

7.6

Function of the wheel The rotation wheel (8) serves to turn grasped tissue/organs to a specific position. (fig. 11) . Depending on the use, work may be facilitated by engaging the lock on the handle.

8

0124 MXXXXXX

Fig. 11 7.7

Additional instructions for use CAUTION! In applications with high-frequency current use the modular/semimodular forceps/ scissors only with a maximum recurring peak voltage of up to 2.0 kV. Use with forced or spray coagulation over 2.0 kV is not permissible. The products are only suitable for brief (short-time) coagulations of minor bleed­ ing. CAUTION! Excessive force can lead to breakage of or damage to the products. Due to the small dimensions required the products have only limited strength. Use these instruments only to grasp and ablate small portions of tissue of the kinds defined in chapter 1. Immediately after use check the instruments for damage and for parts which may have broken off. Ensure that these parts do not remain in the patient.

11

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8

Checks CAUTION ! The products have only limited strength ! Exerting 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. Ensure that no missing instrument parts remain in the patient. Do not use products which are damaged, incomplete or have loose parts.

8.1

Visual check Check instruments and accessories for damage, sharp edges and rough surfaces. Check jaw inserts for defective cutting edges and corroded parts and replace, if necessary (fig. 12). Check insulation of HF cable and sheaths and replace, if necessary,(fig. 12) .

Fig. 12 Any lettering, labeling or identification necessary for the safe intended use must be legible. Missing or illegible lettering, labeling or identification which may lead to wrong handling and reprocessing must be restored. CAUTION ! Check for surface changes (e.g. hair cracks) in the area of the hinge pin (fig. 13)

Fig. 13

8.2

The pin may loosen if the surface is damaged.

Functional check Check jaws for easy opening and closing (fig. 14). Verify that the sheath / jaws can be rotated easily by means of rotating wheel (8), (fig.14). . If you cannot rotate the sheath / jaws, disassemble the forceps/scissors again (as shown in chapter 7.4)

8

Fig. 14

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12

Hold the forceps/scissors as shown in fig. 15 and rotate jaw insert (1). If the jaw insert (1) can be rotated the sheath (2) needs to be replaced.

2

1

Fig. 15

13

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9

Reprocessing and maintenance WARNING ! Creutzfeldt- Jakob Disease ! If the patient is suspected of having the Creutzfeldt- Jakob Disease (CJD) or a variant of the Creutzfeldt- Jakob Disease (vCJD) or such a disease has been diagnosed, adequate measures must be taken to prevent a possible transmission to other patients, users and third parties. For this purpose, apply the country- specific reprocessing regulations and guidelines. IMPORTANT! In semimodular forceps/scissors the jaw insert (1) cannot be removed.

CAUTION! Leakage currents! Do not oil the handles or the star wheel in the joint area, as this may cause a leakage current. The handles are maintenance­free !

9.1

Disassembly before cleaning Siehe Kapitel 7.3 Unscrew the luer cap (13), remove the luer cap, secured, (15), fig. 16.

13 14

15

Fig. 16

9.2

Figures for reprocessing instructions

9.2.1

Manual cleaning

IMPORTANT! Do not clean the plastic parts with metal or sharp-edged tools (e.g. brushes).

11

14 2

G E

F

MXXXXXX

0124

Fig. 17 The following tables describe the reprocessing methods and processes used by Richard Wolf GmbH for validation.

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9.3

Reprocessing procedure IMPORTANT! If used as intended and following the manufacturer's instruction manual, it is not necessary to limit the number of possible reprocessing cycles. Careful and gentle handling of medical products during the entire reprocessing process has an essential influence on the service life of the products. Before returning defective products for repair, they must have been subjected to the entire reprocessing cycle. The user must ensure that the reprocessing process including the resources, materials and staff are suitable to achieve the required results. The national and international requirements regarding the validation of the user's reprocessing process must be followed. IMPORTANT! Further notes and instructions on reprocessing are described in manual GA-J020 “Reprocessing of RICHARD WOLF heat-stable Instruments“ and must be followed. IMPORTANT! Do not sterilize the products in hot-air sterilizers.

IMPORTANT! Danger of breakage! If glass syringes or rigid plastic syringes with Luer connector are used for rinsing out the sheaths with fixed distally curved internal part (12), as a result of the long lever arm and the excessive force generated the luer connector (14) can break. Do not use glass syringes or other rigid syringes for the manual cleaning of sheath tubes with fixed distally curved internal part (12), fig. 18.

Fig. 18

15

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Reprocessing guide: Preparation at the point of use:

Directly after use, remove any coarse soiling from the instruments. If there are more than 6 hours between use and reprocessing, rinse out the hollow spaces of the instrument with a 5 ml syringe filled with water. Do not use any fixing agents or hot water (>40°C) as this would bake any residues to the surfaces and have a negative impact on the cleaning success.

Transport:

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

Pre-cleaning:

Disassembling the instruments before cleaning : see sections 7.3 and 9.1 Rinse out the handle (3) and sheath tube (2) for 20 seconds or in pulsed mode with 5 pressure surges (2.5- 4 bar) using a cleaning gun.

Ultrasonic cleaning

Immerse jaw inserts in a cleaning and disinfecting solution approved for use in ultrasonic baths. Before, the channels of the instruments must be filled with this solution. Exposure time: 10 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 (2.5- 4 bar) using a clean­ ing gun. Brush the jaw section (1.1) with a soft brush to remove any residues. Dry outer surfaces of instruments manually with the help of a sterile lint-free disposable cloth or swab, dry hollow spa­ ces with filtered compressed air (in pulsed mode by applying 5 pressure surges, 2.5 - 4 bar).

Cleaning:

Manual cleaning

Machine cleaning

See section 9.2.1, Fig. 17 1.Immerse instruments in a cleaning solution for at least 5 minutes. Before, fill the sheath tube (2) with this solution. 2.Brush the handle (3), the jaw section (1.1), the joints, the sheath tube (2) and the knob attachment (H) for at least 5 seconds with a soft brush to remove any residues. 3.Rinse out the sheath tube (2) 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 (2.5 - 4 bar) using a cleaning gun.

Pre-clean the instruments manually before automatic ma­ chine cleaning. Place the instruments in dismantled and opened status into the inserts on the MIS 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:

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 with regard to the A0 value (see DIN structions. EN ISO 15883). Fill the instrument channels with this solution before. 2.Then rinse the instruments thoroughly with 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.

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 sections 7.4 Install the jaw section (1) in the sheath tube (2). Install the handle (3) after sterilization.

Packaging:

Wrap instruments for sterilization as required by the standard.

Sterilization:

Sterilization with the fractional pre-vacuum 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

Storage:

Store the sterilized instruments in a dry, clean and dust-free environment at moderate temperatures of 5°C to 40°C.

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Drying of instruments in the drying cycle of the washer-dis­ infector. 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.

16

Validation:

The following test instructions, materials and machines were used for 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: MIS rack cart

Additional instructions:

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

10

Technical data and order data Designation, Technical data Forceps/scissors (semi-modular); Ø 3.5 mm; Working lengths 240 mm, 310 mm Forceps/scissors (modular); Ø 5 mm; Working lengths 240 mm, 310 mm, 430 mm Forceps/scissors (modular); Ø 10 mm; Working lengths 240 mm, 310 mm

11

Spare parts Illustration

Model/Type-no.

Designation

15023205

Luer cap

15023153

Luer cap, secured

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

12

Operating, storage and 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 conditions

-- 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.

12.1

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

17

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