Reprocessing Baskets 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 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

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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 purpose ...

7

5

Indications ...

8

6

Contraindications and side effects ...

8

6.1

Contraindications...

8

6.2

Side effects...

8

7

Combinations ...

8

7.1

Overview of permissible combinations and requirements ...

8

8

Illustration ...

9

9

Checks... 10

9.1

Visual inspection ... 10

9.2

Function check ... 10

9.3

Service life ... 10

10

Use ... 11

10.1 10.1.1 10.1.2 10.1.3

Preparation / Commissioning ... 11 Opening the reprocessing basket... 11 Loading the reprocessing basket ... 11 Closing the reprocessing basket ... 11

10.2 10.2.1 10.2.2 10.2.3 10.2.4

General notes and instructions for use... 11 Reprocessing basket 38009 (38044.11) for hysteroscopes and discoscopes ... 11 Reprocessing basket 38008 (38044.211) for mini laparoscope ... 12 Reprocessing basket 38006 (38044.311) for hysteroscope with exchangeable sheath ... 13 Reprocessing basket 38003 (38045.111) for URS, mini nephroscopes, and sonotrodes... 14

11

Reprocessing and maintenance ... 18

11.1 11.1.1 11.1.2 11.1.3

Reprocessing sequence for reprocessing basket ... 19 Machine reprocessing ... 19 Checks and maintenance ... 19 Validation... 20

12

Technical description... 21

12.1

Technical data ... 21

12.2

Operating, storage, transport and shipping conditions ... 21

13

Spare parts ... 22

13.1

Spare parts ... 22

14

Disposal of product, packaging material and accessories ... 22

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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.

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

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1.2

Symbols

Symbols

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

Data Matrix Code

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.

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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.

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Product description The reprocessing baskets are used for holding endoscopes and endoscopic accessories in order to perform machine reprocessing, sterilization, and storage.

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Intended purpose Reprocessing baskets 38003

PERFORATED BASKET, UPPER URINARY TRACT 1

38004

PERF. BASKET FOR CYSTOSCOPE/TELESCOPE

38005

PERFORATED BASKET FOR DISCOSCOPE

38006

PERFORATED BASKET FOR HYSTEROSCOPE 1

38007

PERF. BASKET FOR VIDEO MEDIASTINOSCOPE

38008

PERFORATED BASKET FOR TELESCOPE

38009

PERFORATED BASKET FOR HYSTEROSCOPE 2

38010

PERFORATED BASKET FOR STEREO TELESCOPE

38011

PERFORATED BASKET FOR NEPHROSCOPE

38012

PERFORATED BASKET FOR MORCESCOPE

38013

PERFORATED BASKET FOR CYSTO-URETHROSCOPE

The products are used to store medical devices and accessories during machine reprocessing and sterilization.

User The products should be used by specialist personnel with appropriate training or qualifications.

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Indications The products are used for machine reprocessing, sterilization, storage, and transportation. Patient group The application is not linked to a specific patient group.

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Contraindications and side effects

6.1

Contraindications There are currently no known contraindications directly related to the product.

6.2

Side effects No side effects directly related to the product are known if the system is used as intended.

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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 should be used as outlined in the technical data (section 12.1) and as appropriate for the type and size of the instrument.

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Illustration

Item

Designation

Item

Designation

1

Fixing hook

A

Irrigation adapter, screw-on

2

Bracket for cold light connection part

B

Irrigation adapter, screw-on

3

Utensil basket

C

Irrigation adapter, plug-in

4

Locking mechanism

D

Adapter for sealing cap

E

Sealing element

F

Valve holder

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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 inspection 1. Check the products and accessories for: ð Damage ð Surface changes (e.g., corrosion, cracks) ð Sharp edges not compatible with the intended application ð Loose or missing parts ð Rough surfaces 2. Any inscription, lettering, or labeling necessary for safe use as intended must be legible.

9.2

Function check ¯ Check the closing function of the locking mechanism (4) and holding bracket (H).

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.

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Use WARNING Restricted stability of the products! Excessive force will cause damage to the products, impair their function, and therefore endanger the patient. Do not use the products if they are damaged or incomplete or have loose parts. Check the products for damage, loose parts, and completeness immediately before and after each use.

10.1

Preparation / Commissioning

10.1.1

Opening the reprocessing basket 1. Open the locking mechanism (4). ð The lid will spring open. 2. Lift up the lid and remove it.

10.1.2

Loading the reprocessing basket ¯ Unscrew the cold-light connection part and place it on the relevant holder (2).

10.1.3

Closing the reprocessing basket ¯ Hook the fixing hooks (1) into the basket base and close the basket lid with the locking mechanism (4).

10.2

General notes and instructions for use

10.2.1

Reprocessing basket 38009 (38044.11) for hysteroscopes and discoscopes ATTENTION Before machine reprocessing Connect irrigation tubes to all connections (e.g., working channel, irrigation and suction channel, etc.) and open the stopcocks.

ATTENTION Before sterilization, screw on the screw connections only loosely in order ü to allow a sufficient flow of the sterilization medium. ü to avoid stress cracks. n Tighten all screw connections before use.

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Hysteroscope 8986.401

Loading for machine reprocessing

Irrigation tube Loading for sterilization

Fig. 1

10.2.2

Reprocessing basket 38008 (38044.211) for mini laparoscope ATTENTION Before machine reprocessing Manually preclean the contact surfaces on the instrument before screwing on the irrigation adapter (B) (64164.031). Replace sealing element (E) with irrigation adapter (B) and remove the membrane valve. Connect irrigation tubes to all connections (e.g., working channel, irrigation and suction channel, etc.) and open the stopcocks.

ATTENTION Before sterilization Remove irrigation adapter (B) (64164.031) and screw on sealing element (E) with membrane valve. Only connect the screw connections loosely so that: ü sufficient sterilization medium can flow in and ü stress cracks are prevented. n Tighten all screw connections before use.

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Mini laparoscope 8920.401

Loading for machine reprocessing

Irrigation tube Loading for sterilization

Fig. 2

10.2.3

Reprocessing basket 38006 (38044.311) for hysteroscope with exchangeable sheath ATTENTION Before machine reprocessing Manually preclean the contact surfaces on the instrument before screwing on the irrigation adapter (C) (64164.033). Attach the irrigation adapter (C), ensuring that it engages properly. Outer and inner sheath must be accommodated in appropriate receptacles in the mobile unit. Connect irrigation tubes to all connections (e.g., working channel, irrigation and suction channel, etc.) and open the stopcocks.

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ATTENTION Before sterilization Remove irrigation adapter (C) (64164.033). Place outer and inner sheath in the reprocessing basket. Only connect the screw connections loosely so that: ü sufficient sterilization medium can flow in and ü stress cracks are prevented. n Tighten all screw connections before use. Hysteroscope with exchangeable sheath 8753.411

Loading for machine reprocessing

Irrigation tube

Loading for sterilization

Fig. 3

10.2.4

Reprocessing basket 38003 (38045.111) for URS, mini nephroscopes, and sonotrodes ATTENTION Before machine reprocessing Connect irrigation tubes to all connections (e.g., working channel, irrigation and suction channel, etc.) and open the stopcocks.

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ATTENTION Before sterilization, screw on the screw connections only loosely in order ü to allow a sufficient flow of the sterilization medium. ü to avoid stress cracks. n Tighten all screw connections before use. Retaining bracket (H)

open

closed

The retaining bracket (H) is used to fasten the endoscope correctly in the reprocessing basket. ¯ Insert the endoscope into the appropriate brackets and close the retaining bracket (H) by moving it in the “closed” arrow direction.

Fig. 4 URS 8702.514, 8703.514

Loading for machine reprocessing

Irrigation tube Loading for sterilization

Fig. 5

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ATTENTION Before machine reprocessing If the washer-disinfector’s load carrier offers the option of a receptacle to rinse the sonotrodes, connect the sonotrodes to the load carrier (Fig. 14a). Otherwise, manually clean the inside of the sonotrodes and then place them in the appropriate receptacles in the reprocessing basket (Fig. 14b). Remove the membrane valve from the telescope and screw the valve holder (F) back on. Connect irrigation tubes to all connections (e.g., working channel, irrigation and suction channel, etc.) and open the stopcocks.

ATTENTION Before sterilization Insert the membrane valve into the valve holder (F) and screw on the valve holder (F). Only connect the screw connections loosely so that: ü sufficient sterilization medium can flow in ü stress cracks are prevented n Tighten all screw connections before use. URS 8708.534

Loading for machine reprocessing

Irrigation tube

Loading for sterilization

Fig. 6

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Compact surgical fiber uretero-renoscopes 8702.524/.534, 8703.524/.534, mini nephroscope 8968.421, and sonotrodes

Loading for machine reprocessing (when sonotrodes are connected to the load carrier)

Irrigation tube Loading for machine reprocessing (inside of sonotrodes cleaned manually)

Irrigation tube Loading for sterilization

Fig. 7

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11

Reprocessing and maintenance WARNING Danger of infection! The products and accessories are delivered in unsterile condition. The use of unsterile products represents an infection hazard for patients, users and others. Products must be reprocessed at least once before the first use and each further use. The user must make sure that the reprocessing process including the resources, material and personnel yield 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.

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

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

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

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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 n

www.richard-wolf.com/en/solutions/reprocessing/

11.1

Reprocessing sequence for reprocessing basket

11.1.1

Machine reprocessing Machine cleaning

ATTENTION Do not use care products or drying aids The application of care products as well as the use of chemical drying aids (e.g. rinse aid) during machine processing can cause functional, material and biocompatible impairments on endoscopes and endoscopic accessories. 1. Place the product in the washer-disinfector’s pull-out rack. 2. Start the cleaning program of the W/D device. Machine disinfection Carry out thermal machine disinfection following the national requirements with regard to the A0 value (see DIN EN ISO 15883). Machine drying in W/D Dry the products by the drying cycle of the W/D device at max. 100 °C. Additional manual drying can be achieved using a lint-free disposable cloth or, alternatively, a drying cabinet if required. ¯ Inspection and maintenance work ð See section Checks

11.1.2

Checks and maintenance Visual inspection 1. Check visually for cleanliness. Repeat the processing procedure if necessary until the product is clean. 2. Carry out a visual check. ð See section Visual inspection Checking functionality ¯ Carry out a function check. ð See section Function check

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11.1.3

Validation Machine n n

n

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Washer-disinfector: G7836CD (Miele) Program: – 2 min pre-wash with cold faucet water (10°C–25°C) – Drain – 5 min wash with detergent at approx. 55°C (application concentration according to manufacturer’s specification) – Drain – 3 min wash with demineralized water (10°C–25°C) – Drain – 2 min wash with demineralized water (10°C–25°C) – Drain Detergent: 0.5% neodisher MediClean (Dr. Weigert)

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