Flexible Forceps and Scissors Instructions for Use

Richard Wolf reserves all rights in this document, in particular relating to reproduction, distribution, public communication and public dissemination. This document may not be modified, and texts and images must not be reproduced or translated without the express prior permission of Richard Wolf GmbH.

Copyright © RICHARD WOLF GmbH

Subject to technical changes! Due to ongoing development, the product descriptions, figures, and technical data may deviate slightly from the current state. For further information about our products, please contact Richard Wolf GmbH or a local representative.

Manufacturer

Distributor

RICHARD WOLF GmbH Pforzheimer Straße 32 75438 Knittlingen GERMANY Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300

RICHARD WOLF Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 USA Toll Free: 001 (800) 323-9653 Phone: 001 (847) 913-1113 Fax: 001 (847) 913-1488

www.richard-wolf.com

www.richardwolfusa.com

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GA-S004-en-US V3.0

Contents 1

General information ...

4

1.1

Safety instructions and levels of danger...

4

1.2

Symbols...

4

2

General safety instructions and guidance for use ...

5

3

Product description...

5

4

Indications for use ...

6

4.1

Statement ...

6

4.2

User and patient population ...

9

5

Contraindications and side effects ...

9

5.1

Contraindications...

9

6

Combinations ...

9

6.1

Overview of permissible combinations and requirements ...

9

7

Illustration ... 10

8

Checks... 11

8.1

Visual checks ... 11

8.2

Function check ... 12

8.3

Service life ... 12

9

Use ... 12

9.1

Preparation / Commissioning ... 13

9.2 9.2.1

General notes and instructions for use... 13 Forceps with overload protection ... 13

10

Reprocessing and maintenance ... 14

10.1

Reprocessing procedure – flexible forceps ... 17

11

Technical description... 23

11.1

Technical data ... 23

11.2

Operating, storage, transport and shipping conditions ... 25

12

Spare parts ... 25

13

Disposal... 26

14

Warranty and Customer Service ... 26

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1

General information

1.1

Safety instructions and levels of danger WARNING This signal word is used to indicate a potentially dangerous situation. Not avoiding this situation can result in death or extremely serious injuries.

CAUTION This signal word is used to indicate a potentially dangerous situation. Not avoiding this situation can result in minor or moderate injury.

ATTENTION This signal word without warning sign is used to indicate a potential danger of material damage.

NOTICE This signal word indicates additional useful information for the reader, such as hints for easier operation as well as cross references.

1.2

Symbols

Symbols

Designation Follow the manual Medical device Product number Serial Number Lot code Manufacturer Manufacturing date Number, amount

Data Matrix Code

Federal law restricts this device to sale by or on the order of a physician.

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Symbols

Designation CE marking in conformity with Directive 93/42/EEC on medical products or EU Regulation 2017/745 on medical devices. Only valid, if the product and/or packaging is marked with this identification. Products as of category IIa, sterile products and products of class I, products with measuring function of class I, as well as reusable surchical instruments are additionally marked with the four-digit code number of the competent authority. The CE identification on the title page of these instructions for use relates exclusively to the Richard Wolf main product or, if serveal identical products are described, to the Richard Wolf product with the highest classification. The CE identification of the other Richard Wolf products and, if applicable, of products made by other manufacturers, described in these instructions for use results exclusively from the identification on the product and/or packaging.

2

General safety instructions and guidance for use The product must only be used as intended following the 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 application and if the performance characteristics and safety requirements are met. The product must not be altered in any way. Reprocess the products in accordance with the manual before every use and before return shipment to protect the patient, 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. Any severe incident occurring in conjunction with this product must be reported to the manufacturer.

CAUTION Federal law restricts this device to sale by or on the order of a physician.

3

Product description Flexible forceps and scissors are used for grasping, manipulating, and cutting, as well as for the dissection and biopsy of tissue parts, organs, or foreign bodies via natural, artificial, or surgically created access passages.

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4

Indications for use

4.1

Statement Multipurpose forceps – flexible

6

8278.011

FLEX. BIOPSY FORCEPS Ø 1.7 MM WL 1000 MM

7223.60

FLEX. BIOPSY FORCEPS Ø 1 MM WL 600 MM

7264.611

FLEX. BIOPSY FORCEPS Ø 2.2 MM WL 1000 MM

8278.01

FLEX. BIOPSY FORCEPS Ø 2.2 MM WL 750 MM

7265.611

FLEX. BIOPSY FORCEPS Ø 2 MM WL 800 MM

8278.021

FLEX. GRASPING FORCEPS Ø 1.7 MM WL 1000 MM

7223.65

FLEX. GRASPING FORCEPS Ø 1 MM WL 600 MM

7264.601

FLEX. GRASPING FORCEPS Ø 2.2 MM WL 1000 MM

7265.601

FLEX. GRASPING FORCEPS Ø 2 MM WL 800 MM

828.10

FLEX. GRASPING FORCEPS 10FR WL 325 MM

8953.60

FLEX. GRASPING FORCEPS 3.5FR WL 550 MM

828.03

FLEX. GRASPING FORCEPS 3FR WL 230 MM

828.131

FLEX. GRASPING FORCEPS 3FR WL 380 MM

828.605

FLEX. GRASPING FORCEPS 3FR WL 530 MM

828.651

FLEX. GRASPING FORCEPS 3FR WL 920 MM

8734.656

FLEX. GRASPING FORCEPS 4FR WL 600 MM

8734.686

FLEX. GRASPING FORCEPS 4FR WL 600 MM

828.05

FLEX. GRASPING FORCEPS 5FR WL 315 MM

828.051

FLEX. GRASPING FORCEPS 5FR WL 550 MM

8735.685

FLEX. GRASPING FORCEPS 5FR WL 550 MM

8736.685

FLEX. GRASPING FORCEPS 6.6FR WL 550 MM

828.07

FLEX. GRASPING FORCEPS 7FR WL 365 MM

827.17

FLEX. GRASPING FORCEPS 7FR WL 375 MM

828.17

FLEX. GRASPING FORCEPS 7FR WL 375 MM

829.10

FLEX. BE FORCEPS 10FR WL 325 MM

829.03

FLEX. BE FORCEPS 3FR WL 230 MM

829.131

FLEX. BE FORCEPS 3FR WL 380 MM

829.603

FLEX. BE FORCEPS 3FR WL 530 MM

8734.606

FLEX. BE FORCEPS 4FR WL 600 MM

829.05

FLEX. BE FORCEPS 5FR WL 315 MM

829.051

FLEX. BE FORCEPS 5FR WL 550 MM

829.07

FLEX. BE FORCEPS 7FR WL 375 MM

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829.601

FLEX. BE FORCEPS Ø 3FR WL 920 MM

The products are used for grasping and manipulation, as well as for the dissection and sampling of tissues, organs, and foreign bodies. Multipurpose scissors – flexible 828.244

FLEX. SCISSORS 4FR WL 230 MM

830.07

FLEX. SCISSORS 7FR WL 375 MM

830.17

FLEX. SCISSORS 7FR WL 375 MM

The products are used for cutting and dissecting tissue and organs. The products are used for endoscopic procedures in surgery, orthopedics, urology, gynecology, pneumology, and ENT. Surgery ⊳ Laparoscopic procedures (a) Orthopedics ⊳ Arthroscopic procedures on the hips (b) Urology ⊳ Therapeutic procedures in the lower urinary tract (c) ⊳ Diagnostic procedures in the lower urinary tract (d) ⊳ Diagnostic procedures in the upper urinary tract (e) ⊳ Therapeutic procedures in the upper urinary tract (f) Gynecology ⊳ Diagnostic and therapeutic hysteroscopy (g) Pneumology ⊳ Diagnostic and therapeutic procedures in bronchoscopy (h) ENT ⊳ Diagnostic and therapeutic endoscopic procedures in ENT (i) The table below lists the applications and relevant indications of the medical devices grouped by specialism: Indication Product number

Medical device

(a)

7223.60

FLEX. BIOPSY FORCEPS Ø 1 MM WL 600 MM

x

x

7223.65

FLEX. GRASPING FORCEPS Ø 1 MM WL 600 MM

x

x

7264.601

FLEX. GRASPING FORCEPS Ø 2.2 MM WL 1000 MM

x

7264.611

FLEX. BIOPSY FORCEPS Ø 2.2 MM WL 1000 MM

x

7265.601

FLEX. GRASPING FORCEPS Ø 2 MM WL 800 MM

x

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(b)

(c)

(d)

(e)

(f)

(g)

(h)

(i)

7

7265.611

FLEX. BIOPSY FORCEPS Ø 2 MM WL 800 MM

827.17

FLEX. GRASPING FORCEPS 7FR WL 375 MM

8278.01

FLEX. BIOPSY FORCEPS Ø 2.2 MM WL 750 MM

x

8278.011

FLEX. BIOPSY FORCEPS Ø 1.7 MM WL 1000 MM

x

8278.021

FLEX. GRASPING FORCEPS Ø 1.7 MM WL 1000 MM

x

828.03

FLEX. GRASPING FORCEPS 3FR WL 230 MM

x

828.05

FLEX. GRASPING FORCEPS 5FR WL 315 MM

x

828.051

FLEX. GRASPING FORCEPS 5FR WL 550 MM

828.07

FLEX. GRASPING FORCEPS 7FR WL 365 MM

x

828.10

FLEX. GRASPING FORCEPS 10FR WL 325 MM

x

828.131

FLEX. GRASPING FORCEPS 3FR WL 380 MM

x

828.17

FLEX. GRASPING FORCEPS 7FR WL 375 MM

x

828.244

FLEX. SCISSORS 4FR WL 230 MM

828.605

FLEX. GRASPING FORCEPS 3FR WL 530 MM

x

828.651

FLEX. GRASPING FORCEPS 3FR WL 920 MM

x

829.03

FLEX. BE FORCEPS 3FR WL 230 MM

x

x

829.05

FLEX. BE FORCEPS 5FR WL 315 MM

x

x

829.051

FLEX. BE FORCEPS 5FR WL 550 MM

x

x

829.07

FLEX. BE FORCEPS 7FR WL 375 MM

x

x

829.10

FLEX. BE FORCEPS 10FR WL 325 MM

x

x

829.131

FLEX. BE FORCEPS 3FR WL 380 MM

829.601

FLEX. BE FORCEPS Ø 3FR WL 920 MM

x

x

829.603

FLEX. BE FORCEPS 3FR WL 530 MM

x

x

830.07

FLEX. SCISSORS 7FR WL 375 MM

830.17

FLEX. SCISSORS 7FR WL 375 MM

8734.606

FLEX. BE FORCEPS 4FR WL 600 MM

x

8734.656

FLEX. GRASPING FORCEPS 4FR WL 600 MM

x

8

x x

x

x

x

x

x

x x

x

x

x

x x x

x x

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8734.686

FLEX. GRASPING FORCEPS 4FR WL 600 MM

x

x

8735.685

FLEX. GRASPING FORCEPS 5FR WL 550 MM

x

x

8736.685

FLEX. GRASPING FORCEPS 6.6FR WL 550 MM

x

x

8953.60

FLEX. GRASPING FORCEPS 3.5FR WL 550 MM

4.2

User and patient population

x

x

These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons. Patient group The product is intended for adult patients. The patient group intended for the application of the medical product herein described is not limited with regard to ethnicity, gender, body height and weight.Before use, the attending physician must make sure that the product in view of its dimensions or settings can be used safely in the patient.

5

Contraindications and side effects

5.1

Contraindications Contraindications directly related to the product are presently unknown. If medical contraindications for the mentioned indications are known, the use of the products is not permitted. On the basis of the patient's general condition the doctor in charge must decide whether or not the planned use is possible.

6

Combinations CAUTION Be careful not to combine products incorrectly! Injuries of the patient, user or others as well as damage to the product are possible. n The products must only be used jointly if the intended use and the relevant technical data such as working length, diameter, etc. are the same. n Also follow the instruction manuals of the products used in conjunction with this product.

6.1

Overview of permissible combinations and requirements The products are used with: ⊳ Endoscopes, endoscopic cameras, and light sources ⊳ Endoscopic devices ⊳ Endoscopic instruments and accessories

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7

Item

Illustration

Description

Item

Description

4

Hinged connection

Jaw sections 1

Example: Flexible scissors

2

Example: Flexible grasping forceps

3

Example: Flexible biopsy excision forceps Other flexible forceps and scissors and their jaw sections: see section 11.1 Technical data

Handle types 5

Scissor handle

7

Sliding handle

5.1

Fixed grip

7.1

Grip

5.2

Movable grip

7.2

Thumb ring

6

Forceps handle with overload protection

6.1

Fixed grip

8

Data matrix code

6.2

Movable grip

9

Cleaning connection (luer connection)

6.3

Overload protection

#

Model no.

10

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8

Checks WARNING Injury due to damaged or incomplete products! Injuries of the patient, user and others are possible. n Run through the checks before and after each use. n Do not use the products if they are damaged, incomplete or have loose parts. n Do not attempt to do any repairs yourself.

ATTENTION Return damaged or incomplete products together with any loose parts for repair. Repairs must be carried out by authorized experts only.

8.1

Visual checks 1. Check all products – particularly the distal part of the products – and accessories for: ð Damage ð Sharp edges ð Loose or missing parts ð Rough surfaces 2. Any inscription, lettering, or labeling necessary for the safe intended use must be legible. 3. Check the flexible sheath for kinks and damage. ð Do not use defective products. Grasping forceps and foreign body grasping forceps

WARNING Damaged surface around forceps joint! The joint pin may come loose. Check for surface changes such as hairline cracks on the joint pin/jaw section. Do not use any products that show signs of surface damage; send affected items in for repair.

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11

¯ Check jaw sections for damage. ð If the jaw section teeth are damaged, stop using the grasping forceps. Scissors and biopsy excision forceps ¯ Check the jaw section for defective cutting edges. ð The cutting edges of the jaw sections must be sharp.

8.2

Function check ¯ Check that the jaw sections open and close properly.

8.3

Service life ATTENTION For the service life of the products, careful and gentle handling during use and during the entire reprocessing process is essential When used as intended and following the instructions in the manufacturer's instructions for use, it is not necessary to limit the service life of the medical products. If one or several criteria of the described checks are not passed, the medical product must be replaced or returned for repair (by the OEM or a repair facility authorized by the OEM) if necessary.

9

Use WARNING Limited product stability! Excessive force will cause damage, impair the function, and therefore endanger the patient. Do not use the products if they are damaged or incomplete or have loose parts. Immediately before and after each use, check the products for damage, loose parts, and completeness. Only use the products to grasp and remove small sections of tissue.

WARNING Make sure that no parts of the product remain in the patient.

CAUTION Limited product stability! Conduct visual checks before and after each use. Do not use damaged products.

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ATTENTION Do not kink or rotate the flexible sheath (spiral sleeve), or allow it to bend with too tight a radius.

9.1

Preparation / Commissioning ¯ Perform the checks: see section 8 .

9.2

General notes and instructions for use WARNING Risk of injury if product is inserted or withdrawn with open jaw section! Risk of unintentional tissue damage and damage to the distal end of the sheath tube/endoscope and jaw section. Only insert and withdraw instruments with the jaw section closed and with visual guidance in place.

9.2.1

Forceps with overload protection NOTICE When closing the forceps handle, you will begin to feel resistance at a certain point due to the overload protection feature. The overload protection feature is intended to protect the joint mechanism from excess force during use. The forceps handle can still be closed all the way.

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10

Reprocessing and maintenance WARNING Danger of infection! The products and accessories are delivered in unsterile condition. If unsterile products are used there is the danger of infection for the patient, user and others. The products must be reprocessed at least once before their first use and before every further use. The user is obliged to make sure that the reprocessing process including the resources, materials and staff is suitable to achieve the required results.

WARNING Danger of transmitting microorganisms! To protect the service staff, only send in products for repair that have been reprocessed according to the latest state of the art in hygiene. n Adhere to the reprocessing sequence described in the instructions for use.

ATTENTION n

n

n

Use only cleaning agents and disinfectants whose efficacy and material compatibility with endoscopes and endoscopic accessories has been tested and approved by the chemicals manufacturer. ð Examples of suitable active agents for chemical disinfection: - Ortho-phthalaldehyde - Ethandial, didecyldimethylammonium chloride - Formacedal, glutardialdehyde - Sodium carbonate peroxyhydrate Disinfectants meeting the test criteria of the VAH (Association for Applied Hygiene R.S.), FDA or other national certification bodies may also be used Do not use disinfectants containing peracetic acid without corrosion protection, phenols or chlorine components for the reprocessing of RICHARD WOLF products.

CAUTION Maximum number of reprocessing cycles Due to the product design and the materials used it is not possible to specify a defined limit of the maximum permissible reprocessing cycles. The service life of medical products is determined by their function and gentle handling. Before returning defective products for repair, they must have gone through the entire reprocessing cycle. The user is obliged to make sure that the reprocessing process including the resources, material and personnel are suitable for achieving the required results. The state of the art and national laws require that validated processes be followed.

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CAUTION Injury due to damaged or incomplete products! Injuries of the patient, user and others are possible. n Run through the checks before and after each use. n Do not use the products if they are damaged, incomplete or have loose parts. n Do not attempt to do any repairs yourself!

ATTENTION Product damage if non-released reprocessing processes are used.

ATTENTION Do not sterilize the products in hot-air sterilizers.

NOTICE Do not use cleaning agents, scouring agent or solvents for device care.

NOTICE Brand-new products. Before reprocessing or commissioning, remove all protective films and transport guards from the products and accessories.

NOTICE For immersion time and concentration follow the instructions of the chemicals manufacturer.

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NOTICE Observe the following when cleaning the products: Products with long channels: Pull through the cleaning brush. ð Insert the cleaning brush into the channel with the brushless side first and pull out the brush on the other side of the channel. Other products/parts: Use a brush pass ð Move the cleaning brush forwards and backwards once.

n

n

Example:

1 x pull through

1 brush pass

Fig. 1 Required equipment Image

Product no.

-

68601

TRAY (WXHXD) 432x100x150MM

68602

TRAY (WXHXD) 760x100x150MM

8691

CLEANING BRUSH for surface cleaning, straight, PACK = 10 PCS, for single use

86.90

CLEANING BRUSH for surface cleaning, angled, reusable

6199.00

WATER JET CLEANING PISTOL (please note the pressure surge specifications)

-

Designation, Technical data

LINT-FREE DISPOSABLE CLOTH INSTRUMENT OIL

For manual cleaning -

16

COLD TAP WATER (DRINKING WATER) 10–25°C

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For sterilization 33004

10.1

UNIVERSAL PERFORATED BASKET 4

Reprocessing procedure – flexible forceps FLEXIBLE FORCEPS

First treatment at lo- Remove any large particles of contamination from the products immediately after use. cation of use Do not use chemicals (e.g., aldehydes) or hot water (>40°C) for pre-cleaning. This could cause residues to stick. Do not use physiological saline solution for irrigation purposes. This can cause corrosion. Preparation for transport To avoid damage to the products and environmental contamination, the products must be securely stored in a sealed container. For safe transportation, we recommend the use of the universal instrument sieve basket, low (model 33004). Preparation before cleaning

WARNING! Perform either machine or manual reprocessing. If available, machine reprocessing is preferred over manual reprocessing. ⊳ See Machine reprocessing ⊳ See Manual reprocessing

Assemble before cleaning Machine reprocessing

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Attach the cleaning clamp

17

Pre-cleaning for the machine-cleaning process

WARNING! Do not use any metal or sharp instruments (e.g., metal brushes) to clean the products. Rinse the product under cold running water with the jaw section open for at least 10 seconds. Using cold tap water, rinse the luer connection with five five-second pulses of pressure (2.5– 4 bar) using a cleaning gun (model 6199.00). Using cold tap water, rinse the jaw sections with five five-second pulses of pressure (2.5– 4 bar) using a cleaning gun (model 6199.00). Perform ultrasound: Place the product in a certified cleaning/disinfection solution (e.g. Cidezyme) that is approved for ultrasound for 5 minutes. Follow the manufacturer’s instructions for application concentration and exposure time. Perform ultrasound in accordance with the instructions for the approved cleaning and disinfection agent/solution. NOTE: Temperatures above 50°C can cause blood incrustation. Using cold tap water, rinse the jaw sections with five five-second pulses of pressure (2.5– 4 bar) using a cleaning gun (model 6199.00).

Machine cleaning

WARNING! Do not use maintenance products or drying aids. The application of maintenance products and the use of chemical drying aids (e.g., rinse aids) during machine reprocessing can impair the function, technical material characteristics, and biocompatibility of endoscopes and endoscopic accessories. Place the products in a sieve tray in the washer-disinfector; the products must be rolled up with the jaw section open. Keep the jaw section open using cleaning clamps. Connect the luer connection to the washer-disinfector so that it will be rinsed. Start the cleaning program on the washer-disinfector. Machine disinfection Perform machine thermal disinfection in accordance with the national A0 value requirements (see DIN EN ISO 15883). Machine drying Dry the product using the washer-disinfector drying cycle at a maximum temperature of 100°C. If necessary, additional manual drying can be performed using a lint-free, single-use cloth or a drying cabinet. Dry hollow spaces with filtered compressed air. Perform inspection and maintenance. ⊳ See Inspection and maintenance

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Manual reprocessing Pre-cleaning for the manual cleaning process

WARNING! Do not use any metal or sharp instruments (e.g., metal brushes) to clean the products. Rinse the product under cold running water with the jaw section open for at least 10 seconds. Using cold tap water, rinse the luer connection with five five-second pulses of pressure (2.5– 4 bar) using a cleaning gun (model 6199.00). Using cold tap water, rinse the jaw sections with five five-second pulses of pressure (2.5– 4 bar) using a cleaning gun (model 6199.00). Perform ultrasound: Place the product in a certified cleaning/disinfection solution (e.g Cidezyme) that is approved for ultrasound for 5 minutes. Follow the manufacturer’s instructions for application concentration and exposure time. Perform ultrasound in accordance with the instructions for the approved cleaning and disinfection agent/solution. NOTE: Temperatures above 50°C can cause blood incrustation. Rinse the product under cold running water for at least 10 seconds.

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Manual cleaning

Place the products (rolled up and with the jaw section open) in a box (e.g., model 68601) filled with a certified cleaning solution (e.g Cidezyme); soak for 5 minutes at room temperature. Ensure that the surfaces are in full contact with the cleaning solution. Follow the manufacturer’s instructions for application concentration and exposure time. With the products submerged, brush the outer surfaces, particularly the jaw section, with a cleaning brush (model 86.90) until all visible contamination has been removed. Using cold tap water, rinse the open jaw sections with five five-second pulses of pressure (2.5–4.0 bar) using a cleaning gun (model 6199.00). Using cold tap water, rinse the luer connection with five five-second pulses of pressure (2.5– 4.0 bar) using a cleaning gun (model 6199.00). Rinse the product under cold running water for at least 10 seconds.

Manual drying

Dry the outer surfaces of the products using a lint-free, single-use cloth or a drying cabinet.

Manual disinfection

Place the products in a box (e.g., model 68601) filled with certified disinfection solution (e.g Cidezyme) at room temperature. Ensure that the surfaces are in full contact with the disinfection solution. Follow the manufacturer’s instructions for application concentration and exposure time. Wipe the outer surfaces of the product with a lint-free, single-use cloth until all of the air bubbles have been removed. Rinse the products under cold running water.

Manual drying

Dry the outer surfaces of the products using a lint-free, single-use cloth or a drying cabinet. Perform inspection and maintenance. ⊳ See Inspection and maintenance

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