Perforated Sterilization Basket System 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

2

GA-J043

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 ...

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

8.1

Diagram: Example showing how the sterilization perforated basket system is loaded ...

9

9

Checks... 11

9.1

Visual inspection ... 11

9.2

Function check ... 11

9.3

Service life ... 11

10

Use ... 12

10.1

General notes and instructions for use... 12

11

Reprocessing and maintenance ... 14

11.1 11.1.1 11.1.2 11.1.3

Reprocessing sequence for reprocessing basket ... 15 Machine reprocessing ... 15 Checks and maintenance ... 15 Validation... 16

12

Technical description... 17

12.1

Technical data ... 17

12.2

Operating, storage, transport and shipping conditions ... 17

13

Spare parts ... 18

13.1

Spare parts ... 18

14

Disposal of product, packaging material and accessories ... 19

GA-J043

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-J043

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.

GA-J043

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-J043

3

Product description The instrument baskets consist of: n n n n n

4

Perforated basket lower part Perforated basket lid Instrument holder Locking mechanism on both sides Silicone holders

Intended purpose Sterilization tray or basket 33001

UNIVERSAL PERFORATED BASKET 1

33002

UNIVERSAL PERFORATED BASKET 2

33003

UNIVERSAL PERFORATED BASKET 3

33004

UNIVERSAL PERFORATED BASKET 4

33005

UNIVERSAL PERFORATED BASKET 5

33006

PERFORATED BASKET FOR SMALL PARTS

The products are used to store medical devices before, during, and after sterilization.

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

5

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

GA-J043

7

6

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.

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 should be used as outlined in the product description and as appropriate for the type and size of the instrument. Refer to the loading templates, order no. BB-J049-xx.

8

GA-J043

8

Illustration

8.1

Diagram: Example showing how the sterilization perforated basket system is loaded

GA-J043

9

10

GA-J043

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. 3. Replace damaged silicone holders.

9.2

Function check Not applicable.

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-J043

11

10

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

General notes and instructions for use Opening the instrument basket 1. Set the instrument basket down on a level surface and open the locking mechanisms (A) on both sides. 2. Lift the lid off the perforated basket.

Fig. 1 Loading the instrument holders 1. Select silicone holders that are appropriate for the instruments being placed in the instrument basket. ð Observe the instrument diameters and the diameter specifications for the silicone holders. 2. Attach the selected silicone holders to the pins on the support bars.

Fig. 2 3. Attach the support bars to the instrument holders, position them horizontally, and latch them into place by applying some pressure.

Fig. 3

12

⊳ A lower instrument holder and a higher instrument holder on top of this can be placed in the high instrument basket.

GA-J043

Fig. 4 ¯ It is also possible to install locking pins (B) (option) on the base of the basket in order to hold handles in place, for example.

Fig. 5 We recommend using an additional silicone stopper for instruments whose diameter is smaller than the mesh width.

Fig. 6 Loading the instrument basket

ATTENTION Once loaded, instrument baskets must not be able to rotate during packaging, transportation, and storage, as this may cause the instruments to come loose from the silicone holders.

¯ Place the instruments and the endoscopic accessories in the silicone holders; see the loading example in section 8.1 Diagram: Example showing how the sterilization perforated basket system is loaded. ð Insert small parts in the small parts strainer (optional). ð Load the instrument baskets with a maximum of 8.5 kg. ð Instrument diameters of 1.0 mm to 14.5 mm are permitted, depending on the silicone holder. ð Read and follow the operating instructions provided with the products you are using. Closing the instrument basket ¯ Set the lid of the instrument basket down on the lower part of the instrument basket and close the locking mechanisms (A) on both sides.

GA-J043

13

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.

14

GA-J043

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

GA-J043

15

11.1.3

Validation Machine n n

n

16

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)

GA-J043

12

Technical description

12.1

Technical data

Type no.

Designation, technical data

33005 (8584.1202)

INSTRUMENT BASKET HIGH, STANDARD

33003 (8584.1212)

INSTRUMENT BASKET, BNDL

33002 (8584.1302)

INSTRUMENT BASKET, BNDL

33001 (8584.1312)

INSTRUMENT BASKET, BNDL Maximum perforated basket load: 8.5 kg

12.2

Operating, storage, transport and shipping conditions ATTENTION Do not use the reprocessing baskets to dispatch endoscopes or endoscopic accessories.

ATTENTION To prevent damage during transport or shipment of products, we recommend using the original packaging material. Operating conditions

Sterilization as appropriate for the endoscopes placed inside the reprocessing baskets and the endoscopic accessories

Storage conditions

As appropriate for the endoscopes placed inside the reprocessing baskets and the endoscopic accessories

Transport conditions, empty reprocessing basket

Temperature: -20°C to +40°C Rel. humidity: 10% to 90% Atmospheric pressure: 700 hPa to 1,060 hPa

Reprocessing conditions, empty reprocessing basket

Machine cleaning / disinfection Steam sterilization with a fractionated prevacuum procedure at 134°C (272°F) Gas sterilization (EtO)

GA-J043

17

13

Spare parts

13.1

Spare parts The products can be custom-combined, taking into account their technical data and intended purpose. For a full overview, please refer to the latest catalogs and brochures or get in touch with Richard Wolf or your representatives.

Type no.

Designation, technical data

8584.2001

LOCKING MECHANISM, LONG

8584.2002

LOCKING MECHANISM, SHORT

8584.2003

WIDE LABELING

33006 (8584.3003)

SYSTEM SMALL PARTS STRAINER

64019127, 64082153 (8584.8205)

LOCKING PIN

8584.8201

SUPPORT BAR

8584.8203

SUPPORT BAR

8584.9111

SILICONE HOLDER

8584.9112

SILICONE HOLDER

33305 (8584.9201)

SILICONE HOLDER, CLOSED, 3 ITEMS

33306 (8584.9211)

SILICONE HOLDER, OPEN, 3 ITEMS

33307 (8584.9501)

SILICONE HOLDER, CLOSED, 5 ITEMS

33308 (8584.9511)

SILICONE HOLDER, OPEN, 5 ITEMS

33309 (8584.9701)

SILICONE HOLDER, CLOSED, 7 ITEMS

33310 (8584.9711)

SILICONE HOLDER, OPEN, 7 ITEMS

18

GA-J043

14

Disposal of product, packaging material and accessories WARNING Danger of infection when disposing of contaminated products! Incorrect handling during product disposal can lead to injuries and infections of the user or others. Take safety precautions for the safe disposal of the products.

ATTENTION To avoid contamining the environment, mind the safety precautions during product disposal and adhere to the country-specific laws and regulations.

GA-J043

19