Camera Heads Reprocessing Basket 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

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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 ...

7

6

Contraindications and side effects ...

7

6.1

Contraindications...

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6.2

Side effects...

7

7

Combinations ...

8

7.1

Overview of permissible combinations and requirements ...

8

8

Illustration ...

9

8.1

Legend and identification ...

9

9

Checks... 10

9.1

Visual check ... 10

9.2

Function check ... 11

9.3

Service life ... 11

10

Application ... 12

10.1

General notes and instructions for use... 12

10.2 10.2.1

Preparation / Commissioning ... 12 Opening/closing the reprocessing basket ... 12

10.3 10.3.1

Loading the reprocessing basket ... 13 Rearranging the reprocessing basket ... 16

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

13.2 13.2.1

Replacing spare parts ... 22 Replacing the spring lock ... 22

14

Disposal of product, packaging material and accessories ... 23

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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 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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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 basket for camera heads consists of: n n n n

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basket base basket lid Spring lock Silicone chains

Intended purpose Reprocessing baskets 38002

PERFORATED BASKET FOR CAMERA HEAD

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.

NOTE Read and follow the operating instructions for the camera heads used in combination with the baskets as well as those supplied with the washer-disinfectors and sterilizers.

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

4 5.1

1 5.2

5

2

5.3

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Fig. 1

8.1

Legend and identification

Item

Designation

Item

Designation

1

basket lid

5

Set of silicone chains consisting of:

2

basket base

5.1

1 x silicone chain, 6 beads

3

Spring lock

5.2

6 x silicone chain, 7 beads

4

Retaining hook

5.3

1 x silicone chain, 8 beads

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9

Checks 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 any products that are damaged or incomplete. n Return damaged products for repair. n Do not attempt to do any repairs yourself.

9.1

Visual check 1. Check the product and the accessories for: ð Check for surface changes (e. g. corrosion). ð damage ð sharp edges ð loose or missing parts 2. Check the silicone chains for damage. 3. Replace damaged silicone chains. ð Please refer to section 8 Illustration 4. Hook the outer silicone balls of the silicone chains into their respective holders.

Fig. 2

NOTE We recommend replacing the silicone chains after 200 reprocessing cycles at the latest. 5. Any inscriptions or identification necessary for the safe intended use must be legible. ð Missing or illegible inscriptions, labels and identifications that may lead to wrong handling or reprocessing must be reinstated.

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9.2

Function check 1. Check the spring lock for correct functioning. 2. Replace the spring lock if defective. ð Please refer to section 13.2.1 Replacing the spring lock

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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Application 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 each use, check the products for damage, loose parts and completeness. n Do not use the products if they are damaged or incomplete or have loose parts.

10.1

General notes and instructions for use ¯ Check the product for damage, loose parts, and completeness immediately before and after each use. ð Do not use the product if it is damaged and/or incomplete or has loose parts.

10.2

Preparation / Commissioning

10.2.1

Opening/closing the reprocessing basket Opening the reprocessing basket 1. Place the reprocessing basket onto a level surface. 2. Open the spring lock. 3. Lift off the basket lid.

Fig. 3 Closing the reprocessing basket 1. Engage the retaining hook in the basket base.

Fig. 4

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2. Close the basket lid with the spring lock.

Fig. 5

10.3

Loading the reprocessing basket Delivery condition of the reprocessing basket

Fig. 6

ATTENTION Disconnect the protective cap (if there is one) from the connector before placing the camera heads shown below into the basket. ¯ Set the camera head down on the silicone chains with 7 and 8 links in the lower part of the basket.

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Logic HD camera head Image shows type 85525902 LOGIC HD CAMERA HEAD CABLE 3 M

Fig. 7 Image shows type 85525922 LOGIC HD CAMERA HEAD CABLE 3 M

Fig. 8 Logic 4K camera head, Image shows type 85525942 LOGIC 4K CAMERA HEAD Logic HD camera head green

Fig. 9

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Logic HD PENDUAL camera Image shows type 5525933 LOGIC HD PENDUAL CAMERA HEAD CABLE 3 M head

Fig. 10 Image shows type 5525933 LOGIC HD PENDUAL CAMERA HEAD CABLE 3 M with angled camera head

Fig. 11

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10.3.1

Rearranging the reprocessing basket For the Flex HD camera head and the Performance camera head, reposition two 7-bead silicone chains in the reprocessing basket. 1. Remove the 7-bead silicone chains from their holders (A).

A

A

Fig. 12 2. Hook the outer silicone balls of the 7-bead silicone chains into their holders (B).

B

B

Fig. 13

ATTENTION Place the camera heads listed below into the basket with their plug protection caps in place. 3. Place the camera head and cable onto the silicone chains in the basket base.

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Flex HD camera head The illustration shows model 5521902, LOGIC HD CAMERA HEAD, CABLE 2.5M

Fig. 14 Performance camera head The illustration shows model 5514901, PERFORMANCE CAMERA HEAD, CABLE 4M

Fig. 15

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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 9 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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