Arthro Line Arthroscopy punches 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, illustrations and technical data may deviate slightly from the current state. For further information about our products please contact Richard Wolf GmbH or your representative.

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

www.richard-wolf.com

2

GA-B209

Contents 1

General information ...

4

1.1

Safety instructions and levels of danger...

4

1.2

Symbols...

5

2

General safety instructions and guidance for use ...

6

3

Product description...

7

4

Intended use...

8

5

Indications ...

9

6

Contraindications and side effects ... 11

6.1

Contraindications... 11

6.2

Side effects... 11

7

Combinations ... 12

7.1

Overview of permissible combinations and requirements ... 12

8

Illustration ... 13

9

Checks... 14

9.1

Visual checks ... 14

9.2

Function check ... 14

9.3

Service life ... 15

10

Use ... 16

10.1

Preparation / Commissioning ... 16

11

Reprocessing and maintenance ... 17

11.1

Reprocessing sequence – Punches ... 19

11.2

Reprocessing sequence – Suction punches ... 25

12

Technical description... 33

12.1

Technical data ... 33

12.2

Usage, storage, transport, and shipping conditions ... 34

13

Spare parts ... 35

13.1

Spare parts ... 35

14

Disposal... 35

GA-B209

3

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.

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

4

GA-B209

1.2

Symbols

Symbols

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

Data Matrix Code

CE identification with code number of the competent authority in conformity with Directive 93/42/ EEC on medical products or EU regulation 2017/745 on medical products. Only valid if the product and/or the packaging is marked with this identification. Products where a notified body is not involved in the conformity assessment procedure are marked with the CE-identification without the code number of the notified body. 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.

GA-B209

5

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 and the competent authority of the country where the user and/ or patient resides.

6

GA-B209

3

Product description The arthroscopy punches described are used to remove soft tissue, cartilage, or other non-bony tissue using natural or surgically created access points. The suction punches described also make it possible to suction tissue particles, as well as secretions, blood, irrigation fluid, and foreign bodies.

GA-B209

7

4

Intended use Punches 89140.0101

PUNCH W 5.5MM H 1.6MM

89140.0102

PUNCH W 4.6MM H 1.6MM

89140.0103

PUNCH W 5.5MM H 1.6MM

89140.0105

PUNCH W 4.6MM H 1.6MM

89140.0122

PUNCH W 4.6MM H 1.6MM

89140.0202

HOOK PUNCH W 3MM H 1.6MM

89140.0205

HOOK PUNCH W 3MM H 1.6MM

89140.0302

BASKET PUNCH W 6.5MM H 2.1MM

89140.0305

BASKET PUNCH W 6.5MM H 2.1MM

89140.0402

HOOK PUNCH W 4MM H 2.1MM

89140.0405

HOOK PUNCH W 4MM H 2.1MM

89140.0502

SCISSORS PUNCH W 2.4MM H 2.1MM

89140.0505

SCISSORS PUNCH W 2.4MM H 2.1MM

89140.0602

PUNCH W 5.7MM H 4MM

89140.0605

PUNCH W 5.7MM H 4MM

891432101

PUNCH WL 180MM H 1.6MM

891432102

PUNCH WL 180MM H 1.6MM

891432103

PUNCH WL 180MM H 1.6MM

891432122

PUNCH WL 180MM H 1.6MM

The products are used to remove soft tissue, cartilage, or other bony tissue. Arthroscopic suction punches 89140.0027

SUCTION PUNCH Ø 2.7MM

89140.0045

SUCTION PUNCH Ø 4.5MM

The products are used to remove soft tissue, cartilage, or other non-bony tissue, and to suction tissue particles produced during ablation, as well as secretions, blood, irrigation fluid, and foreign bodies. User The product is exclusively intended for use by specialized medical personnel and may only be used by medically qualified and adequately trained persons.

8

GA-B209

5

Indications The products are used for arthroscopic interventions. The use of the medical devices is listed according to the arthroscopic interventions performed on the corresponding joints: ⊳ Arthroscopic interventions on the elbow (a) ⊳ Arthroscopic interventions on the foot (b) ⊳ Arthroscopic interventions on the knee (c) ⊳ Arthroscopic interventions on the ankle (d) ⊳ Arthroscopic interventions on the hip (e) ⊳ Arthroscopic interventions on the shoulder (f) ⊳ Arthroscopic interventions on the hand, fingers, toes (g) For the individual products, the indications are broken down in the following table. The same indications apply for accessories of the listed medical devices.

Medical device

Indication (a)

(b)

x

x

(c)

(d)

(e)

(f)

89140.0027

SUCTION PUNCH Ø 2.7MM

89140.0045

SUCTION PUNCH Ø 4.5MM

x

x

89140.0101

PUNCH W 5.5MM H 1.6MM

x

x

89140.0102

PUNCH W 4.6MM H 1.6MM

x

x

89140.0103

PUNCH W 5.5MM H 1.6MM

x

x

89140.0105

PUNCH W 4.6MM H 1.6MM

x

x

89140.0122

PUNCH W 4.6MM H 1.6MM

x

x

89140.0202

HOOK PUNCH W 3MM H 1.6MM

89140.0205

HOOK PUNCH W 3MM H 1.6MM

89140.0302

x

x

x

x

x

x

x

x

x

x

BASKET PUNCH W 6.5MM H 2.1MM

x

x

89140.0305

BASKET PUNCH W 6.5MM H 2.1MM

x

x

89140.0402

HOOK PUNCH W 4MM H 2.1MM

x

x

89140.0405

HOOK PUNCH W 4MM H 2.1MM

x

x

89140.0502

SCISSORS PUNCH W 2.4MM H 2.1MM

x

x

89140.0505

SCISSORS PUNCH W 2.4MM H 2.1MM

x

x

89140.0602

PUNCH W 5.7MM H 4MM

x

x

89140.0605

PUNCH W 5.7MM H 4MM

x

x

89140.0704

BASKET PUNCH W 4.2MM

x

89140.0706

BASKET PUNCH W 4.2MM

x

GA-B209

x

x

(g)

9

89140.0804

BASKET PUNCH W 5.2MM

x

89140.0806

BASKET PUNCH W 5.2MM

x

891432101

PUNCH WL 180MM H 1.6MM

x

x

891432102

PUNCH WL 180MM H 1.6MM

x

x

891432103

PUNCH WL 180MM H 1.6MM

x

x

891432122

PUNCH WL 180MM H 1.6MM

x

x

Patient population The intended patient population is not restricted to ethnics, age, gender, body height and weight. Before use the attending physician must ensure that the product can be safely used in terms of its dimensions or settings.

10

GA-B209

6

Contraindications and side effects

6.1

Contraindications There are currently no known contraindications directly related to the products. Medical contraindications exclude the use of the products concerned. The responsible physician must decide on the basis of the patient's general condition whether the intended use is possible or not.

6.2

Side effects When used as intended, there are no known side effects related to the products.

GA-B209

11

7

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.

7.1

Overview of permissible combinations and requirements The products are used with: ⊳ Endoscopic cameras and light sources ⊳ Endoscopic devices ⊳ Suction and irrigation pumps ⊳ Endoscopic instruments and accessories ⊳ Surgical instruments and accessories ⊳ Various implants and accessories

12

GA-B209

8

Illustration

Legend and identification Item

Designation

Item

Designation

A

Standard punch

1

Jaw section

B

Suction punch

2

Outer sleeve

3

Locking collar

4

Suction connector

5

Push rod (see in section 11.2 Reprocessing sequence – Suction punches)

6

Pressure rod

7

Sleeve

8

DataMatrix code

#

Model no.

GA-B209

13

9

Checks WARNING Injuries by damaged or incomplete products! Injuries of the patient, user and others are possible. n Do not use the products if they are damaged, incomplete or have loose parts. n Run through the checks before and after each use.

ATTENTION Send in damaged or incomplete products together with any loose parts for repair. Repair only by authorized experts.

9.1

Visual checks WARNING Damaged surface in the hinge area of the forceps! The hinge pin may become loose. Check for surface changes, such as hairline cracks, at the hinge pin / jaw section. Do not use products with damaged surfaces. Return the products for repair. 1. Check instruments, in particular in the distal region, and accessories for: ð Damage ð Sharp edges ð Loose or missing parts ð Rough surfaces 2. Any inscription, lettering, or labeling necessary for safe and correct use must be legible. 3. The cutting surfaces of the jaw sections must be sharp.

Fig. 1

9.2

Function check ¯ Check the opening and closing of the jaw sections for easy operation.

14

GA-B209

9.3

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.

GA-B209

15

10

Use WARNING The products have only limited strength! Excessive force will cause damage, impair the function and therefore endanger the patient. n Immediately before and after use, check the products for damage, loose parts and completeness. Make sure that no missing instrument parts remain in the patient. n Do not use products which are damaged or incomplete or have loose parts.

WARNING Risk of injury when inserting and retracting instruments with the jaw section open! Inadvertent tissue damage, damage to the jaw section, and damage to products used in the product combination may occur. Only insert and retract instruments with the jaw section closed and under visual control.

10.1

Preparation / Commissioning 1. Check assembly: see section 11.1 Reprocessing sequence – Punches. 2. Perform visual checks: see section 9.1 Visual checks. 3. Perform function check: see section 9.2 Function check.

16

GA-B209

11

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.

NOTE Brand new products. Before reprocessing, remove all protection foils and transport locks from the products and accessories.

GA-B209

17

NOTE For chemicals whose material compatibility has been approved by Richard Wolf for the reprocessing of Richard Wolf products, please refer to the listing in document GA-J055. This document can be requested from Richard Wolf or downloaded from our website. RICHARD WOLF in the Internet www.richard-wolf.com/en/solutions/reprocessing/ Required equipment n

Image

-

18

Product no.

Designation, Technical data

509.81

DISINFECTION BOX W 400 MM L 600 MM

6860.901

DISINFECTION BASIN W 200mm L 552mm not steam-sterilizable, Outside dimensions: 552 x 200 x 165 mm Inside dimensions432 x 150 x 100 mm

7970403

CLEANING BRUSH Ø 3MM TL 400MM for Ø 1.6-2.5 mm channels, brush length 30 mm, PACK = 10 PCS, color: red, for single use

7970404

CLEANING BRUSH Ø 4MM TL 400MM for channel Ø 2.6 – 3.5mm, brush length 30mm, PACK = 10 PCS, color: yellow, for single use

7970407

CLEANING BRUSH Ø 7MM TL 400MM for Ø 4.6-6.5 mm channels, brush length 48 mm, PACK = 10 PCS, color: purple, for single use

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 (cleaning gun)

200532

INSTRUMENT OIL

-

LINT-FREE DISPOSABLE CLOTH

GA-B209

Image

Product no.

Designation, Technical data

-

-

SYRINGE (20 ML)

-

COLD TAP WATER (drinking water quality) 10 °C – 25 °C

Manual cleaning Sterilization 85844001

11.1

UNIVERSAL INSTRUMENT SIEVE, LOW Outside dimensions: 530 x 250 x 108 mm

Reprocessing sequence – Punches PUNCHES

Initial treatment at the point of use

1. Immediately after use, remove coarse soiling from the products. 2. If there is more than 6 hours between use and reprocessing, rinse out the hollow spaces with cold tap water and narrow channels (e.g., stopcocks) with a 20 ml syringe filled with water. ð Do not use cleaning agents (e.g., aldehydes) or hot water (> 40°C) for precleaning. These can bake contaminant residues to the surfaces. ð Do not use physiological saline solution for rinsing. This may promote corrosion. Preparation for transport ¯ To avoid damage to the products and contamination of the environment, safe storage in a closed container is required. ð For safe transport, we recommend the universal instrument sieve, low (model 85844001).

Preparation before cleaning

GA-B209

Disassembly before cleaning Open the sheath mechanism in the cleaning position: 1. Turn the sleeve (7) clockwise as far as it will go. 2. Actuate the movable handle. ð The pressure rod (6) moves automatically into the cleaning position.

19

WARNING! Perform either machine or manual reprocessing. If machine reprocessing is possible, this is generally preferable to manual reprocessing. ⊳ see Machine reprocessing ⊳ see Manual reprocessing Machine reprocessing Precleaning for the machine cleaning process

WARNING! Do not use metallic materials or equipment with sharp edges (e.g., metal brushes) to clean the products. ¯ Rinse the products under cold, running tap water for at least 10 seconds. Machine cleaning WARNING! Do not use any care products or drying aids. The application of care products and the use of chemical drying aids (e.g., rinse aid) during machine reprocessing can lead to functional, material-related, and biocompatible impairments to endoscopes and endoscopic accessories. 1. Place products in the load carrier with the jaw section and sheath mechanism open. 2. Start the washer-disinfector's cleaning program. Machine disinfection Carry out thermal machine disinfection following the national requirements with regard to the A0 value (see DIN EN ISO 15883). Machine drying Dry the products with the drying cycle of the washer-disinfector at max. 100°C. If necessary, additional drying can be achieved manually using a lint-free disposable cloth or, alternatively, a drying cabinet. 1. Dry hollow spaces with filtered compressed air. 2. Perform checks and maintenance. ð see Checks and maintenance

Manual reprocessing Precleaning for the manual cleaning process

¯ Rinse the products under cold, running tap water for at least 10 seconds.

Manual cleaning

1. Immerse the products in a basin (e.g., model 509.81) filled with an approved cleaning solution for 6 minutes at room temperature. Make sure that the surfaces are completely covered by the cleaning solution. ð Observe the manufacturer's application concentration and exposure time. 2. Brush the outer surfaces with a cleaning brush (model 86.90) under the liquid surface level for at least 10 seconds or until the instrument appears clean. 3. Thoroughly rinse the jaw section and sheath mechanism for 20 seconds each or in pulsed mode with 5 pressure surges (2.5–4.0 bar) with cold tap water using a cleaning gun (model 6199.00). 4. Rinse the product under cold, running tap water for at least 10 seconds.

20

GA-B209