MATHYS balanSys BICONDYLAR leggera Instruments Processing Instructions

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Table of contents

1.

Objective

4

2.

Scope

4

3.

Symbols

5

4. Important information for processing / Recommendations for processing  6 4.1 Cleaning agent 6 4.2 Water 6 4.3 Aids for manual cleaning 6 4.4 Safety measures 7 4.5 Restrictions 7 4.6 Notes 8 5. Processing cycle 5.1 Transport after use to processing (CSSD) 5.2 Assembly / Disassembly for optimal cleaning 5.3 Cleaning and disinfection 5.3.1 Instructions for manual pre-cleaning of cleaning category 1 instruments 5.3.2 Instructions for manual pre-cleaning of cleaning category 2 instruments 5.3.3 Instructions for manual pre-cleaning of cleaning category 3 instruments 5.3.4 Instructions for mechanical cleaning and disinfection (all cleaning categories) 5.4 Maintenance / Care and function check 5.5 Packaging 5.6 Sterilisation 5.7 Storage

9 10 11 16 19 19 28 34 35 54 55 56

6.

Number of processing cycles

57

7.

Customer service information

57

8. 8.1 8.2 8.3

Annex – Quick starter Manual pre-cleaning Mechanical cleaning (in the WD) Steam sterilisation with fractionated pre-vacuum

58 58 58 58

9. Overview of the balanSys BICONDYLAR leggera instruments

59

balanSys BICONDYLAR – leggera instruments – 3

1. Objective

These processing instructions represent a recommendation according to the requirements of SN EN ISO 17664 and apply to all balanSys BICONDYLAR leggera instruments in order to achieve cleanliness and sterility for these instruments. Mathys Ltd Bettlach (hereafter referred to as «Mathys») has validated the methods recommended in these instructions based on the normative specifications for reusable surgical instruments and their instrument trays. The processor is responsible for effective and safe processing with its individual equipment, cleaning chemicals and trained staff. Alternative processing steps may be performed, but must be validated by the processor. If these processing instructions are in conflict with country-specific applicable cleaning, disinfection and sterilisation requirements, laws or regulations, these requirements, laws or regulations have priority over the recommendations from Mathys. The hospital management and the central sterile services department (CSSD) must be aware of these processing instructions in order to ensure a safe and effective reprocessing. This is important to prevent damage affecting the environment, persons and material, or abuse.

2. Scope The contents of the processing instructions refer to the transport after use to processing, disassembly, cleaning, disinfection, assembly, maintenance / care, functional check, sterilisation, packaging and storage of the instruments from orthopaedic surgery.

4 – balanSys BICONDYLAR – leggera instruments

3. Symbols

Symbol

Description

Symbol

Description

Non-sterile

Turn in the direction of the arrow

Do not re-use

Move back and forth

Do not resterilize

Move to the right

CE marking medical devices of Risk Class I

Move to the left

CE marking medical devices of Risk Class II and III

Compress

Caution – consult the instructions for use for important cautionary information

Move back and forth

Date of manufacture

Move in the direction of the arrow

Batch code

Maintenance

Catalogue number

Rinsing

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4. Important information for processing / Recommendations for processing 4.1 Cleaning agent • A mildly alkaline-enzymatic cleaning solution is recommended (pH 10 – 11). • Cleaning solutions that are too concentrated, too acidic or alkaline, or that contain aldehydes, mercury, active chlorine, chloride, bromine, bromide, iodine or iodide, may damage the instruments. Such cleaning solutions are to be avoided. • Low-foam cleaning solutions should be used to ensure visibility of the instruments. • Mathys advises against the use of drying or neutralising agents. • Always follow the manufacturer’s instructions for preparing and using the solutions. 4.2 Water • Attention must be paid to the quality of the water used. The deionised water (hereafter DI water) used for rinsing should microbiologically be at least of drinking water quality. • Use of hard water (> 14° dH) is to be avoided. The softer the water used, the better contamination can be removed and visible mineral residues avoided. • If only water (without the addition of cleaning solution) is used for cleaning, Mathys recommends a water temperature of no more than 45° C (113° F), since otherwise proteins will be fixed on the instrument, making removal difficult. • The last rinse in mechanical cleaning is to be performed with DI water. 4.3 Aids for manual cleaning • Mathys advises against the use of metal brushes or metal sponges, since these could damage the protective oxide layer. This can lead to corrosion. • Use of steamers is not recommended, since the high temperature fixes proteins to the surface. • Any use of saline solutions is to be avoided, since this leads to corrosion of the instruments. • Brushes must be decontaminated and sterilised or disposed of after use.

6 – balanSys BICONDYLAR – leggera instruments

4.4 Safety measures • Personnel who come into contact with potentially or actually contaminated surgical instruments must be trained with regard to generally accepted hygienic protective measures (protective clothing, mouth and nose protection, goggles, cut-resistant gloves, work shoes, etc.) and be able to use them. • High-risk patients with prion diseases such as Transmissible Spongiform Encephalopathy (TSE), Creutzfeldt-Jakob disease (CJD) and its variants (vCJD) must be operated on with disposable instruments whenever possible. • It must be clarified in advance that the patients, as well as the staff (operating theatre and CSSD personnel), do not react with allergic reactions due to material intolerance (various steels and plastic materials) upon direct contact with instruments. • Particular care must be taken when handling cutting instruments (reamers, drill bits, rasp, chisels), as they pose a risk of injury to the patients on the one hand and to the staff (operating theatre and CSSD personnel) on the other. • Furthermore, the instruments may be exposed to body fluids that contain the hepatitis or HI virus («AIDS virus») or other pathogens. • Before returning any instruments to Mathys, these instruments must undergo a full processing cycle in order to exclude a risk of infection. • If contaminated instruments are sent to external treatment facilities for processing, they must be manually pre-cleaned, visually clean and dry in their specific instrument tray, and additionally stored in a sterilisation container. The sterile container must be closed, sealed and marked with a Biohazard label. • Before being returned to Mathys, contaminated leased instrument trays must undergo a complete processing cycle in order to avoid danger to third parties. This also applies to the return of contaminated individual instruments, and to repairs. • Brush and clean the instruments below the surface of the cleaning solution to avoid formation of aerosols and thus a risk of infection. 4.5 Restrictions • Instruments for single use may be used only once and never reprocessed or resterilised, not even if they are removed from the package but not contaminated or used. The single-use instruments are to be disposed of after use. • This also includes single-use instruments that were packaged and delivered sterile, removed from the package and inserted into individual trays. • In the case of aluminium, a protective oxide layer (often also colour-anodized) is created through electrochemical surface treatment, providing good corrosion resistance. Nonetheless, alkaline cleaning solutions (pH ≥ 11), use of DI water and thermal disinfection represent influencing factors that lead to colour changes and degradation of the oxide layer. These cleaning instructions also apply to titanium alloys.

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4.6 Notes • The plastics used by Mathys in the instruments are not suitable for washer-disinfectors that work at temperatures > 141° C (> 285° F). The plastic surfaces of instruments with plastic components could be damaged by this. • Heavy objects must not be placed on sensitive instruments, as this could impair the function of the instruments. • The Mathys instrument trays may be loaded only with instruments manufactured and / or marketed by Mathys. • Instrument trays, inserts and lids must be cleaned separately from the instruments. • Non-sterile leased instrument trays delivered to the hospital must undergo a complete processing cycle before they may be used. This applies also to the return of leased instrument trays or defective instruments, as well as to repairs. • New instruments must undergo mechanical cleaning at least three times before use in order to build up the protective oxide layer. • If necessary, after drying in the WD the instruments must be dried with medical compressed air before being serviced. For maintenance / care, the instruments must be completely dry. • Only instruments by Mathys Ltd Bettlach may be used for the placement of implants by Mathys Ltd Bettlach (see the respective surgical technique); instruments by other legal manufacturers may not. • No additional lettering of any kind may be applied to the instruments. • The instruments are packaged separately and delivered in non-sterile condition. The packaging materials must be disposed of in accordance with the local and country-specific regulations.

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5.1 Transport after use to processing (CSSD) After the use of the instruments, they must be transported in a specific instrument tray by Mathys in order to avoid defects due to transport. This instrument tray in turn must be transported in a closed container to the CSSD in order to protect the personnel and the environment from risks of contamination and infection.

Table 1: Overview of the reprocessing according to SN EN ISO 17664: Procedure Initial treatment at the place of use

Reusable surgical instruments Condition

Dry

• Recommendation: Immediate reprocessing after use • Up to max. 1 hour

Wet / moist

• Immerse into cold deionised water (Liquid or wetted cloths) • Up to max. 6 hours

Decontamination

Preparation Cleaning

Rinsing Disinfection

Mechanical

–

Ultrasound

+

Combined manual and mechanical

+

Strongly alkaline (pH > 11)

–

Mildly alkaline-enzymatic (pH 10 – 11)

+

Neutral

–

Acidic

–

Thermal 90° C (194° F)

+

Tmax (Time)

15

Functional check

Mandatory Care product based on paraffin / Mandatory white oil (biocompatible, steam-sterilisable and steampermeable)

Maintenance

Sterilisation

–

Final rinse with deionised water 1

Drying Maintenance

Manual

Moist heat (steam) 2

+

Ethylene oxide, formaldehyde, plasma + Validated method – Non-validated method

10 – balanSys BICONDYLAR – leggera instruments

–

Thermal disinfection according to DIN EN ISO 15883 2 Preferred sterilisation method according to SN EN ISO 17664 1

5.2 Assembly / Disassembly for optimal cleaning Prior to manual processing in the CSSD, the instruments must be removed from their specific instrument tray. Subsequently, for manual as well as for mechanical cleaning the instruments that consist of several components and are designed for disassembly must be properly dismantled into their individual components (see list below) in order to ensure sufficient and efficient processing. It must be ensured that no small parts are lost. If this should happen anyway, it is extremely important to report this to your Mathys Partner. 5.2.1 Assembly and disassembly of • balanSys TRS Proximal • balanSys TRS Distal • balanSys TRS Ankle Holder • balanSys TRS Cutting Block

Fig. 1a

Fig. 1d

Fig. 1b

Fig. 1e

Fig. 1c

Fig. 1f

Fig. 1g

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5.2.2 Assembly and disassembly of • balanSys Silicone Handle • balanSys Intramedullary Rod

Fig. 2a

Fig. 2b

5.2.3 Assembly and disassembly of • balanSys Spacer Block Femur • balanSys Spacer Block Tibia 8 / 9 or balanSys Spacer Block Tibia 8 / 10.5 • balanSys Spacer Block Tibia 10.5 / 11.5 • balanSys Spacer Block Tibia 13 / 15.5

Fig. 3a

Fig. 3b

5.2.4 Assembly and disassembly of • balanSys Spacer Block Femur • balanSys Spacer Block Tibia 13 / 15.5 • balanSys Spacer Shift Plate + 5

Fig. 3c

12 – balanSys BICONDYLAR – leggera instruments

Fig. 3d

5.2.5 Assembly and disassembly of balanSys • Femur Sizing / Rotation Guide with / without AP • balanSys Handle Femoral Siz. / Rotation Guide • balanSys Femur Rotation Bearing Large and Small • balanSys Femur Rot. Bearing Short Large and Small • balanSys Femur Stylus

Fig. 4a

Fig. 4b

Fig. 4c

Fig. 4d

Fig. 4e

Fig. 4f

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5.2.6 Assembly and disassembly of • balanSys Ligament Tensor • balanSys Spacer 8G • balanSys Femoral Feeler 8G • balanSys Drill Guide 4in1 CuttBlock 8G

Fig. 5a

Fig. 5b

Fig. 5c

Fig. 5d

Fig. 5e

14 – balanSys BICONDYLAR – leggera instruments

Fig. 5f

5.2.7 Assembly and disassembly of • balanSys Trial Inlay • Adapter Trial Inlay

Fig. 6a

Fig. 6b

5.2.8 Assembly and disassembly of • balanSys TRS Eminentia Shackle • balanSys TRS Intramedullary Shackle

Fig. 7a

Fig. 7b

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5.2.9 Assembly and disassembly of • balanSys TRS Eminentia Shackle rotating • balanSys TRS Intramedullary Shackle

Fig. 8a

Fig. 8b

5.3 Cleaning and disinfection For cleaning the instrumentation, Mathys recommends using a combined manual and mechanical cleaning process with a mildly alkaline-enzymatic cleaning solution (pH from 10 to 11) using DI water (according to SN EN 285) to achieve optimum and thorough cleaning results. In the case of manual pre-cleaning, all blind holes and boreholes, slits and crevices as well as other visible design features must be rinsed thoroughly with tap water and, if necessary, pre-cleaned with a nylon brush. Instruments that have a cleaning position must be set to the same before manual pre-cleaning. With regard to manual pre-cleaning, the entire instrumentation is divided into three cleaning categories (Tab. 2).

16 – balanSys BICONDYLAR – leggera instruments

Table 2: Overview of the cleaning categories of the balanSys BICONDYLAR leggera instrumentation Cleaning categories

Description

Cleaning steps

Medium

1

These instruments have no design features that are challenging for the cleaning process (open design).

These instruments do not need to be prepared manually and can be fed directly into the mechanical cleaning (WD).

No manual pre-cleaning necessary. The instruments may be placed directly into the WD.

–

2

These instruments have blind holes and / or boreholes, slits, crevices, contacting areas and / or rinsing shadows, i. e. areas not cleaned due to surface coverage during the treatment process.

Instruments that have a cleaning position must be set to the same before manual pre-cleaning.

Clean instruments of organic residues immediately after use in the CSSD with surface and / or lumen brushes 1 made of nylon under the water surface.

• Surface and / or lumen brushes made of nylon

If necessary, plastic syringes and water jet guns must be used for rinsing.

• Plastic syringes

Please open instruments with hinges to expose the surfaces as much as possible, and brush the insides of any cavities along their entire length while simultaneously filling and emptying them with running tap water.

–

Poorly accessible areas or precisely matching surfaces can be rinsed more thoroughly with a plastic syringe or a water jet gun (do not use steamers); alternatively, contaminations can be removed using a nylon brush 1.

• Tap water (cold)

These instruments must be cleaned of visible organic residues by means of surface and / or lumen brushes made of nylon beneath the water surface. Plastic syringes and water jet guns (no steamers!) must also be used.

• Tap water (cold)

• Water jet guns

• Plastic syringes • Water jet gun

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Cleaning categories

Description

Cleaning steps

Medium

3

Instruments that have a cleaning position must be set to the same before manual pre-cleaning.

In addition to the cleaning steps of category 2, instruments must be treated with a mildly alkaline cleaning solution at room temperature for 5 minutes 2 and a frequency of 35 to 47 kHz in an ultrasonic bath. The temperature of 45° C (113° F) must not be exceeded in the ultrasonic bath.

• Mildly alkalineenzymatic cleaner 0.5 % neodisher MediClean forte 2 (v / v) in DI water 3 (≤ 45° C (113° F)

After the ultrasonic bath, the instruments must be thoroughly rinsed. The final rinse must be carried out with deionised water.

• DI water 3

If there are any traces of blood or other contamination on the instrument or in the rinse water, all manual processing steps must be repeated.

–

These instruments have, in addition to the characteristics of category 2, several components interacting in a complex manner.

In addition to the manual pre-cleaning of category 2, ultrasonic cleaning must be performed.

• Ultrasonic bath (Sonorex RK1028H, Bandelin)

Nylon brushes must be decontaminated and sterilised or disposed of after use. Do not use steel brushes. Recommendation of exposure time, concentration, temperature and pH according to the product data sheet of the detergent manufacturer (Dr. Weigert GmbH). 3 Water quality according to SN EN 285. 1 2

Optimum cleaning is ensured if the instruments are properly reprocessed within one hour after transport to the CSSD. To do this, the contaminated instruments must be removed from the instrument tray and, after disassembly, cleaned of any residues of body fluids as quickly as possible while being held beneath the water surface (tap water or mildly alkaline-enzymatic cleaning solution) to prevent drying and corrosion. If necessary, specific surface and lumen brushes made of nylon, plastic syringes and water jet guns (no steamers!) can be used for rinsing. Extensive rinsing of the instruments with demineralised water after manual pre-cleaning prevents detergent residues on them. The pre-cleaned instruments are then placed into a suitable cleaning basket (e. g. mesh screen) for the mechanical cleaning in the washer-disinfector (WD). If it is not possible to clean the instruments within this specified time, Mathys recommends immersing the instruments into deionised water at room temperature. However, it is also possible to wrap the instruments for up to 6 hours into cloths moistened with deionised water at room temperature.

18 – balanSys BICONDYLAR – leggera instruments

5.3.1 Instructions for manual pre-cleaning of cleaning category 1 instruments The instruments in this category have no specific design features and do not require manual pre-cleaning.

5.3.2 Instructions for manual pre-cleaning of cleaning category 2 instruments The instruments of this category must be manually pre-cleaned with surface and lumen brushes made of nylon, plastic syringes and a water jet gun until no visible residues are left.

5.3.2.1 balanSys Chisel Centering Guide

Fig. 9a

Fig. 9b

Cleaning position: The rotary knob must be in the vertical position.

balanSys BICONDYLAR – leggera instruments – 19

5.3.2.2 balanSys Positioner for Tibial Plateau

Fig. 10 Cleaning position: By rotating the head of the threaded rod, the two bolt guides on the left and right of the threaded rod must be exposed so that the part that can be screwed out folds backwards easily. Thus, the two guide holes of the bolts can also be rinsed effectively.

5.3.2.3 balanSys TRS Intramedullary Shackle

Fig. 11a

20 – balanSys BICONDYLAR – leggera instruments

Fig. 11b

5.3.2.4 balanSys TRS Eminentia Shackle rotating

Fig. 12a

Fig. 12b

Fig. 12c

Turn the screw with the hexagonal screwdriver to the middle position between the lower and upper stopper.

Pull the rod out of the head of the instrument until it stops, and turn it by 90°.

Fig. 12d

Fig. 12e

Cleaning position

Fig. 12f

Fig. 12g

balanSys BICONDYLAR – leggera instruments – 21