RUCK

I/A Handle 19 G, Tip angled 45°

General instructions for reprocessing

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General instructions for reprocessing

Information about reprocessing of medical devices of Fritz Ruck Ophthalmologische Systeme GmbH According to DIN EN ISO 17664

0123 General instructions for reprocessing – for reusable medical devices of Fritz Ruck Ophthalmologische Systeme GmbH REF QA200030 Rev. 02.0 July 2020 All rights reserved. Reproduction of any kind without express permission is not permitted! © Fritz Ruck Ophthalmologische Systeme GmbH De-Saint-Exupéry-Str. 10 60549 Frankfurt am Main Germany Tel: +49 (0) 800 0005898 Fax: +49 (0) 800 000899 E-Mail: [email protected] Internet: www.ruck-gmbh.de

Content Abbreviations ... 5 1.

Introduction ... 5

Applicable standards ... 6

Validity ... 6

Limitation of reprocessing ... 6

Cautions and warnings ... 6

Initial treatment at the place of use ... 7

Treatment before cleaning ... 8

Cleaning and disinfection ... 8

Drying ... 9

10.

Maintenance and examination ... 10

11.

Packaging ... 10

12.

Sterilization ... 10

13.

Storage ... 11

14.

Transport ... 11

15.

Additional information ... 11

Appendix ... 13

Abbreviations Fritz Ruck GmbH

Fritz Ruck Ophthalmologische Systeme GmbH

KRINKO

Kommission für Krankenhaushygiene und Infektionsprävention

CDD

Cleaning- and disinfection device

CJD

Creutzfeldt-Jakob-Disease

vCJD

variant Creutzfeldt-Jakob-Disease

1. Introduction The medical products from Fritz Ruck Ophthalmologische Systeme GmbH (Fritz Ruck GmbH), which are intended for reuse, are placed on the market in non-sterile condition and must always be processed properly before each use. The reprocessing of reusable medical devices that are intended for sterile use generally includes the following individual steps, which we also consider essential to protect patients, users and third parties from possible health risks: Preparation Cleaning, disinfection and drying Maintenance and examination Labelling Packaging Sterilization However, the responsibility for effective reprocessing lies with the respective reprocessor of the medical devices, considering the information provided by the manufacturer. As part of this responsibility, it should be noted that all reprocessing procedures must be validated. This means that: basically, only device- and product-specific validated procedures for cleaning, disinfection and sterilization are used, the used equipment is regularly maintained and checked and the validated reprocessing parameters are adhered to for each reprocessing cycle. It should be noted that the person(s) responsible for the reprocessing of the medical devices is(are) knowledgeable in order to carry out a proper and quality-assured reprocessing. With the provision of this general reprocessing instruction according to DIN EN ISO 17664, the reprocessor has validated procedures available which enable the reusable products of Fritz Ruck GmbH to be reprocessed properly. It ensures that safety and performance are guaranteed before the first and every further use.

2. Applicable standards DIN EN ISO 17664.

3. Validity Tab. 1: Fritz Ruck GmbH products intended for reprocessing in the appendix describes all products for which this general reprocessing instruction applies.

4. Limitation of reprocessing Tab. 1: Fritz Ruck GmbH products intended for reprocessing in the appendix describes the maximum permissible reprocessing cycles for each product.

5. Cautions and warnings The cautions and warnings are presented as follows:

CAUTION Cautions require special attention and serve to prevent damage to the device. Non-compliance with this warning can lead to damage of property or the environment. R##

WARNING Warnings have highest importance. They contain warnings about possible physical injuries. Observe without exception. R## The following cautions and warnings apply to these reprocessing instructions:

CAUTION Improper handling can damage sensitive products, e.g. the I / A handles or the phaco needles. R01

CAUTION A sudden cooling phase or cool irrigation fluid can cause stress cracks due to the high temperature difference. R02

WARNING The reprocessing of medical devices that are intended for single use is not permitted. A (repeated) reprocessing with subsequent use can lead to risks for patients, users and third parties. R03

WARNING Residues of cleaning agents that remain on the product due to improper rinsing can cause serious damage to the patient. R04

WARNING Effective sterilization is only possible on dry, cleaned and disinfected products. R05

WARNING Exceeding the maximum permissible reprocessing cycles can impair the performance and safety of the medical device and become a risk for patients, users and third parties. R06

WARNING Deviations from the reprocessing methods described can both impair the sterilization efficiency and lead to damage to the products. R07

6. Initial treatment at the place of use 6.1.

Clean the used products in accordance to your requirements for occupational health and infection protection immediately after use. Pay particular attention to the following: For initial treatment, generally use water that has at least drinking water quality. Separate connected medical devices. Pay attention to the instructions for use, to the information in the relevant chapter of the accessories manual for Qube pro and to Tab. 1: Fritz Ruck GmbH products intended for reprocessing from the appendix (e.g: phaco handle and phaco needles.). If necessary, disassemble products according to the instructions in the relevant chapter in the accessories manual for Qube pro (e.g: oil infusion unit). Remove coarse dirt under running water. You can use soft, lint-free cloths or soft brushes as an aid. Do not use detergents. Do not use metal brushes or steel wool.

6.2.

Place the used products properly in suitable closed systems, such as instrument trays or sterile goods containers: Be careful not to damage sensitive products (see cautions R01). Use dry disposal to prevent corrosion and maintain the value of the products. Ideally, the transport system is suitable for going through the subsequent process of machine reprocessing.

6.3.

Apply the products to the reprocessing unit for medical devices within one hour after use.

7. Treatment before cleaning 7.1.

Carry out an initial treatment of the products used as described under 6.1 Initial treatment at the place of use if not already done.

7.2.

7.3.

Perform an ultrasonic cleaning with the following process parameters: Detergent:

Dr. Weigert, neodisher MediClean forte

Concentration:

Duration:

5 Min.

Temperature:

Room temperature

Frequency:

35 kHz

When loading, make sure that all surfaces can come into contact with the cleaning solution without restrictions.

7.4.

After ultrasonic cleaning, rinse the inner lumen of hollow instruments at least once with a 20 ml syringe filled with deionized water (see warning R04).

8. Cleaning and disinfection 8.1.

We recommend using a cleaning and disinfection device (CDD) that complies with the ISO 15883 series for machine cleaning.

8.2.

When loading the CDD, note that all surfaces can come into contact with the cleaning solution without restrictions.

8.3.

Connect all inner lumens of the product to the rinsing connections and ensure that there are no disconnections during the process: There is a risk of carryover of cleaning agent residues if inner lumens are not effectively rinsed (see warning note R04). Use existing Luer connectors if possible. If you connect accessories without a Luer-connector (e.g. silicone sleeves), they must be secured against disconnection from the flushing port using adapters or other measures.

8.4.

Secure small parts that cannot be secured in any other way in special small parts baskets.

8.5.

The following procedure has been validated for the proof of machine cleaning and disinfection for reusable products from Fritz Ruck GmbH:

Miele PG 8535

CDD Process step

Pre-rinse

Cleaning

Neutralization

Intermediate rinse

Final rinse and thermal disinfection

8.6.

Parameter Duration

1 Min.

Detergent

Tap water

Temperature

Cold water inlet

Duration

10 Min.

Detergent

Dr. Weigert, Neodisher MediClean forte

Concentration

0,5 %, in tap water

Temperature

55 °C - 1,5 °C

Duration

1 Min.

Detergent

Dr. Weigert, Neodisher Z

Concentration

0,1%, in deionized water

Temperature

Cold water inlet

Duration

1 Min.

Detergent

Deionized water

Temperature

Cold water inlet

Duration

5 Min.

Detergent

Deionized water

Temperature

90 °C + 1,5 °C

The steps Neutralization and Intermediate rinse are very important to prevent alkaline carryover of cleaning agent residues (see warning note R04).

8.7.

The specified parameters for thermal disinfection correspond to an equivalent A0 value of 3000 according to ISO 15883–1. Higher A0 values are therefore covered by this validation.

9. Drying 9.1.

It is necessary that the products are dried after automatic cleaning and disinfection.

9.2.

The following CDD–program has proven itself in practice: Process step Drying

9.3.

Parameter Duration:

15 Min.

Temperature:

109 °C ± 1,5 °C

After machine drying, note the additional information in Tab. 1: Fritz Ruck GmbH products intended for reprocessing from the appendix and carry them out

9.4.

Validation of the drying process is within the responsibility of the operator. Make sure that only dry products are handed over to the following process steps (see warning note R05).

10. Maintenance and examination 10.1. Carry out a visual check for the cleanliness and functionality of the products. Pay special attention to clogged inner lumens. 10.2. Use a magnifying glass or a microscope as an aid. 10.3. The criteria for sorting out products are as follows: Corroded surfaces. Damaged surfaces, cables or plugs. Deformed phaco tips or I/A handles. 10.4. If a visual inspection reveals that a product is not clean, carry out steps 8. & 9. Cleaning, disinfection and drying again. 10.5. Now, if necessary, assemble disassembled products according to the instructions in the respective chapter in the accessories manual for Qube pro.

11. Packaging 11.1. Before sterilization, the products must be packed in a sterile barrier system suitable for the following sterilization process, storage and transport, which is adapted to the properties of the product. If necessary, with a protective packaging. 11.2. In accordance with EN ISO 11607–1, packaging that meets the following requirements is suitable: Enable sterilization. Ensure of sterility when stored correctly. 11.3. The reprocessing process was validated by Fritz Ruck GmbH in sterile bags, which consist of a combination of paper and film with a seal in accordance to EN ISO 11607–1.

12. Sterilization 12.1. Please note that only dry, cleaned and disinfected products may be sterilized (see warning R05). 12.2. We expressly recommend the use of a sterilization process according to the standard EN ISO 17665 – Sterilization of health care products – Moist heat. 12.3. The following procedure has been validated to demonstrate successful sterilization for reusable products from Fritz Ruck GmbH:

Steam autoclave

Lautenschläger ZentraCert

Procedure:

Steam sterilization (fractional pre-vacuum process)

Pre-vacuum cycles:

At least 3

Temperature:

134 °C + 1,5 °C

Duration:

3 Min.

Drying time:

12.4. The drying time depends on the device used and the load. The operator is responsible for validating the drying time. 12.5. Allow the products to cool down completely at room temperature (see caution R02). 12.6. Exceeded sterilization duration > 3 Min are covered by this validation and do also lead to products that are free from living microorganisms.

13. Storage 13.1. Always store processed products packaged, dry, dust-protected, clean and free of pests. 13.2. The final storage period must be validated by the operator, depending on the packaging used.

14. Transport 14.1. Use suitable means for inner-clinical transport in order not to endanger the integrity of the sterile barrier.

15. Additional information All described procedures and recommendations of Fritz Ruck GmbH are based on validation by independent, accredited test laboratories. Deviations from the described method or the cleaning agents used are fundamentally possible but are in the responsibility of the operator and must be validated separately. Since operations in ophthalmology pose a risk with regard to the transmission of the CJD or vCJD, the KRINKO guideline Hygiene Requirements for the Reprocessing of Medical Devices recommends a sterilization holding period of at least 5 minutes at 134 °C in combination with an alkaline cleaning (see Appendix 7 of the guideline). For all Fritz Ruck GmbH products that are covered by these reprocessing instructions, it has been demonstrated that a sterilization holding time of 5 minutes does not result in any material changes that limit the performance or the safety of the medical device.

Appendix Tab. 1: Fritz Ruck GmbH products intended for reprocessing

REF

02BI39 02BI40 02BI44 02BI46

Description Cable for Diathermy, Bipol E, 3 m for bipolar forceps and endothermic pencils Cable for Diathermy, Bipol E, 1,80 m for bipolar forceps and endothermic pencils Cable for internal diathermy for metal forceps and endothermic pencils Cable for bipolar diathermy for plastic forceps and endothermic pencils

Permissible reprocessing cycles

Disassembly

See accessories manual

Additional information for drying Dry plug with filtered compressed air. Do not exceed 2.5 bar Dry plug with filtered compressed air. Do not exceed 2.5 bar Dry plug with filtered compressed air. Do not exceed 2.5 bar Dry plug with filtered compressed air. Do not exceed 2.5 bar Dry plug with filtered compressed air. Do not exceed 2.5 bar

See accessories manual

02BI47

Cable for diathermy, Bipol E for bipolar plastic forceps and pencils

See accessories manual

02IA21

I/A Handle 21 G, Tip angled 45° (with Sleeve)

Disassemble sleeve!

02IA30

I/A Handle 19 G, straight

Disassemble sleeve!

02IA31

I/A Handle 19 G, Tip angled 45°

Disassemble sleeve!

02IA32

I/A Handle 19 G, straight (with Sleeve)

Disassemble sleeve!

02IA33

I/A Handle 19 G, Tip angled 45° (with Sleeve)

Disassemble sleeve!

02IA34

I/A Handle 19 G, Tip angled 30° (with Sleeve)

Disassemble sleeve!

02IA36

Bimanual Aspiration Handle 21 G (with sandblasted tip, Ø 0,35 mm)

02IA37

Bimanual Aspiration Handle 21 G (with sandblasted tip, Ø 0,25 mm)

02IA38

Bimanual Irrigation Handle 21 G (with sandblasted tip, two ports Ø 0,5 mm)

02PH42

Phaco Handle, Titan

Disassemble sleeve and phaco needle!

02PH58

Phako Wrench 5R (Stainless Steel)

02ÖL10

Oil Injection Unit

See accessories manual

02ÖL32

Connection Tube for Silicone Oil Injection

Dry inner lumina with filtered compressed air. Do not exceed 2.5 bar

03PH50

Phako Tip `E`, 30°, Ø 1,2 mm / 0,9 mm (low bubble)

03PH51

Phako Tipl `E`, 45°, Ø 1,2 mm / 0,9 mm (low bubble)

03PH55

Phako Tip `Turbo`, 30°, Ø 1,2 mm / Ø 0,7 mm (low bubble)

03PH59-45

Phako Tip `Turbo`, 45°, Ø 0,8 mm / Ø 0,5 mm (low bubble)

03PH60

Phako Tip Fragmentation, 30°, 20 G, Ø 0,85 mm / Ø 0,65 mm

03PH61-30

Phako Tip `E`, 30°, Ø 0,9 mm / Ø 0,7 mm (low bubble)

03PH61-45

Phakonadel `E`, 45°, Ø 0,9 mm / 0,7 mm (low bubble)

03PH62

Phako Tip `Turbo`, 30°, 0,89 mm (low bubble)

03PH62B

Phaco Tip bent 'Turbo', 30°, Ø 0.89mm

Remove the sleeve, unscrew the needle from the handle. First delivery: Separate phaco tip and phaco wrench. Remove the sleeve, unscrew the needle from the handle. First delivery: Separate phaco tip and phaco wrench. Remove the sleeve, unscrew the needle from the handle. First delivery: Separate phaco tip and phaco wrench. Remove the sleeve, unscrew the needle from the handle. First delivery: Separate phaco tip and phaco wrench. Remove the sleeve, unscrew the needle from the handle. First delivery: Separate phaco tip and phaco wrench. Remove the sleeve, unscrew the needle from the handle. First delivery: Separate phaco tip and phaco wrench. Remove the sleeve, unscrew the needle from the handle. First delivery: Separate phaco tip and phaco wrench. Remove the sleeve, unscrew the needle from the handle. First delivery: Separate phaco tip and phaco wrench. Remove the sleeve, unscrew the needle from the handle. First delivery: Separate phaco tip and phaco wrench.

Dry inner lumina with filtered compressed air. Do not exceed 2.5 bar Dry inner lumina with filtered compressed air. Do not exceed 2.5 bar Dry inner lumina with filtered compressed air. Do not exceed 2.5 bar Dry inner lumina with filtered compressed air. Do not exceed 2.5 bar Dry inner lumina with filtered compressed air. Do not exceed 2.5 bar Dry inner lumina with filtered compressed air. Do not exceed 2.5 bar Dry inner lumina with filtered compressed air. Do not exceed 2.5 bar Dry inner lumina with filtered compressed air. Do not exceed 2.5 bar Dry inner lumina with filtered compressed air. Do not exceed 2.5 bar Dry inner lumina with filtered compressed air. Do not exceed 2.5 bar

REF

Description

Permissible reprocessing cycles

03PH62RB

Phaco Tip reverse bent 'Turbo', 30°, Ø 0.89mm

03PH63

Phaco Tip `Mini Turbo`, 30°, (for incision size 1,8 mm)

03PH63B

Phaco Tip bent 'Mini-Turbo', 30°, Ø 0.8mm

03PH63RB

Phaco Tip reverse bent 'Mini-Turbo', 30°, Ø 0.8mm

03PH66

Phaco Tip Fragmentation 30°, 23 G, Ø 0,60 mm / Ø 0,50 mm

03PH68

Phaco needle wrench

First delivery: Separate phaco tip and phaco wrench.

03PH80

Silicone sleeve ´standard´, light-blue, soft 19g

Disassembly from the handle

03PH87

Silicone Infusion Sleeve, Limpid, 21g, Small Incision Technique

Disassembly from the handle

03PH90

Test chamber

Disassembly from the handle

Disassemble from Day Cassette System.

Dry inner lumina with filtered compressed air. Do not exceed 2.5 bar

03QA20

Side Element For Cassette Body

Disassembly Remove the sleeve, unscrew the needle from the handle. First delivery: Separate phaco tip and phaco wrench. Remove the sleeve, unscrew the needle from the handle. First delivery: Separate phaco tip and phaco wrench. Remove the sleeve, unscrew the needle from the handle. First delivery: Separate phaco tip and phaco wrench. Remove the sleeve, unscrew the needle from the handle. First delivery: Separate phaco tip and phaco wrench. Remove the sleeve, unscrew the needle from the handle. First delivery: Separate phaco tip and phaco wrench.

Additional information for drying Dry inner lumina with filtered compressed air. Do not exceed 2.5 bar Dry inner lumina with filtered compressed air. Do not exceed 2.5 bar Dry inner lumina with filtered compressed air. Do not exceed 2.5 bar Dry inner lumina with filtered compressed air. Do not exceed 2.5 bar Dry inner lumina with filtered compressed air. Do not exceed 2.5 bar

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