Artex Facebow Processing Instructions

INSTRUCTIONS FOR PROCESSING

Porus buttons (218607 / 218609), tray handle (217928), bite fork partial (217611/217611UNI), bite fork full (217661) and Nasion adapter (217695) must be reprocessed as described in the following reprocessing instructions due to their semi-critical contact with the patient.

EN

All other components of the Artex facebow can be treated with spray or wipe disinfection for reprocessing. Please pay special attention to the overview table in the Section on Specific aspects for the reprocessing of the Artex facebow!

95

2176

28

2179

07

2186

217661

10

217611/217611UNI

I N S T R U CITNI S OTNRSUFCOTR I OCNLSE A FO NR I NPGRA ON CD E SCSAI N RG E

PROCESSING (CLEANING, DISINFECTION, AND STERILIZATION) OF COMPONENTS (SEMI-CRITICAL CONTACT)

CLEANING AND DISINFECTION

Fundamental points

If possible, an automated procedure (WD (WasherDisinfector)) should be used for cleaning and disinfection of the components. A manual procedure – even in case of application of an ultrasonic bath – should only be used if an automated procedure is not available; in this case, the significantly lower efficiency and reproducibility of a manual procedure has to be considered.

All components with semi-critical contact to the patient are to be cleaned, disinfected, and sterilized prior to each application; this is required as well for the first use after delivery of the unsterile components (cleaning and disinfection after removal of the protective packaging, sterilization after packaging). An effective cleaning and disinfection is an indispensable requirement for an effective sterilization of the components. You are responsible for the sterility of the components with semi-critical contact to the patient. Therefore, please ensure that only sufficiently device and product specifically validated procedures will be used for cleaning, disinfection, and sterilization, that the used devices (WD, sterilizer) will be maintained and checked regularly, as well as that the validated parameters will be applied for each cycle. Additionally, please pay attention to the legal provisions valid for your country as well as to the hygienic instructions of the doctor´s practice or of the hospital. This applies particularly to the different guidelines regarding the inactivation of prions (not relevant for USA). For all further components (without contact to the patient) standard surface disinfection may be applied (not content of this reprocessing instruction).

Basics

EN

The pre-treatment step is to be performed in both cases.

Pre-treatment Please remove coarse impurities of the components directly after application (within a maximum of 2 h). Procedure: 1. Disassemble the components as possible (see chapter Specific aspects). 2. Rinse the components at least 1 min under running water 1 (temperature < 35 °C/95 °F). If applicable (see chapter Specific aspects): Rinse all lumens of the components five times by application of a single-use syringe (minimum volume 5 ml). 3. Remove manually all visible impurities by use of a clean and soft brush (or a clean, soft, and lint-free cloth) only to be for this, in no case metal brushes or steel wool. If applicable (see chapter Specific aspects) 2: Brush holes by use of a conical interdental brush. 4. Rinse again at least 1 min under running water. If applicable (see chapter Specific aspects): Rinse all lumens of the components five times by application of a single-use syringe (minimum volume 5 ml).

1 In case of application of a cleaning and disinfection detergent for this (e.g. in consequence of personnel´s safety) please consider, that this should be aldehyde-free (otherwise fixation of blood impurities), possess a fundamentally approved efficiency (for example VAH/DGHM or FDA/EPA approval/clearance/registration or CE marking), be suitable for the disinfection of instruments made of metallic or plastic material, and be compatible with the components (see chapter „material resistance„). Please consider, that a disinfectant used in the pre-treatment step serves only the personnel`s safety, but cannot replace the disinfection step later to be performed after cleaning. 2 Still remaining remnants of registration material easily can be removed after cooling-down in a refrigerator.

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INSTRUCTIONS FOR PROCESSING

Automated cleaning/disinfection (WD (Washer-Disinfector))

EN

Pay attention to following points during selection of the WD:

1. Transfer the disassembled components in the WD (pay attention that the components have no contact). If applicable (see chapter Specific aspects): Use a small pieces basket for this.

- fundamentally approved efficiency of the WD (for example CE marking according to EN ISO 15883 or DGHM or FDA approval/clearance/registration)

2. Start the program.

- possibility for an approved program for thermal disinfection (A0 value > 3000 or – in case of older devices - at least 5 min at 90 °C/194 °F; in case of chemical disinfection danger of remnants of the disinfectant on the components) - fundamental suitability of the program for instruments as well as sufficient rinsing steps in the program - post-rinsing only with sterile or low contaminated water (max. 10 germs/ml, max. 0.25 endotoxin units/ml), for example purified/highly purified water - only use of filtered air (oil-free, low contamination with microorganisms and particles) for drying - regularly maintenance and check/calibration of the WD Pay attention to following points during selection of the cleaning detergent: - fundamental suitability for the cleaning of instruments made of metallic or plastic material - additional application – in case of non-application of a thermal disinfection – of a suitable disinfectant with approved efficiency (for example VAH/DGHM or FDA/EPA approval/clearance/registration or CE marking) compatible to the used cleaning detergent - compatibility of the used detergents with the components (see chapter „material resistance„) Pay attention to the instructions of the detergent manufacturers regarding concentration, temperature and soaking time as well as post-rinsing.

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Procedure:

3. Remove the components of the WD after end of the program. 4. Check and pack the components immediately after the removal (see chapters „check„, „maintenance„, and “packaging„, if necessary after additional post-drying at a clean place). The fundamental suitability of the components for an effective automated cleaning and disinfection was demonstrated by an independent accredited and recognized (§ 15 (5) MPG) test laboratory by application of the WD G 7836 CD, Miele & Cie. GmbH & Co., Gütersloh, (thermal disinfection) and the cleaning detergent Neodisher medizym (Dr. Weigert GmbH & Co. KG, Hamburg) considering to the specified procedure.

I N S T R U CITNI S OTNRSUFCOTR I OCNLSE A FO NR I NPGRA ON CD E SCSAI N RG E

Manual cleaning and disinfection

Procedure:

Pay attention to following points during selection of the cleaning and disinfection detergents:

Cleaning

- fundamental suitability for the cleaning and disinfection of instruments made of metallic or plastic material - in case of application of an ultrasonic bath: suitability of the cleaning detergent for ultrasonic cleaning (no foam development) - application of a disinfectant with approved efficiency (for example VAH/DGHM or FDA/EPA approval/ clearance/registration or CE marking) compatible with the used cleaning detergent - compatibility of the used detergents with the components (see chapter „material resistance„) Combined cleaning/disinfection detergents should not be used. Only in case of extremely low contamination (no visible impurities) combined cleaning/disinfection could be used. - Pay attention to the instructions of the detergent manufacturers regarding concentration, temperature and soaking time as well as post-rinsing. Please use only freshly prepared solutions as well as only sterile or low contaminated water (max. 10 germs/ml) as well as low endotoxin contaminated water (max. 0.25 endotoxin units/ml), for example purified/highly purified water, and a soft, clean, and lint-free cloth and/or filtered air for drying, respectively.

EN

1. Soak the disassembled components for the given soaking time in the cleaning solution so that the components are sufficiently covered. Pay attention that there is no contact between the components and no remaining air in the cavities. Assist cleaning by careful brushing with a soft brush and ultrasonic treatment (duration at least once the required soaking time in addition to brushing). If applicable (see chapter Specific aspects): Rinse all lumens of the components at least five times at the beginning and at the end of the soaking time by application of a single-use syringe (minimum volume 5 ml). Brush holes by use of a conical interdental brush. 2. Then, remove the components of the cleaning solution and post-rinse them at least three times intensively (at least 1 min) with water. If applicable (see chapter Specific aspects): Rinse all lumens of the components at least five times at the beginning and at the end of the soaking time by application of a single-use syringe (minimum volume 5 ml). 3. Check the components (see chapters „check„ and „maintenance„). Disinfection 4. Soak the disassembled components for the given soaking time in the disinfectant solution so that the components are sufficiently covered. Pay attention that there is no contact between the components and no remaining air in the cavities. If applicable (see chapter Specific aspects): Rinse all lumens of the components at least five times at the beginning and at the end of the soaking time by application of a single-use syringe (minimum volume 5 ml).

13

INSTRUCTIONS FOR PROCESSING

5. Then, remove the components of the disinfectant solution and post-rinse them at least five times intensively (at least 1 min) with water.

EN

If applicable (see chapter Specific aspects): Rinse all lumens of the components at least five times at the beginning and at the end of the soaking time by application of a single-use syringe (minimum volume 5 ml). 6. Dry and pack the components immediately after the removal (see chapter „packaging„, if necessary after additional post-drying at a clean place). The fundamental suitability of the components for an effective cleaning and disinfection was demonstrated by an independent accredited and recognized (§ 15 (5) MPG) test laboratory by application of the cleaning detergent Cidezyme/Enzol and the disinfectant Cidex OPA (Johnson & Johnson GmbH, Norderstedt) considering the specified procedure.

Only hand-tighten screws. If too much force is applied, the precision instrument may be damaged!

PACKAGING Please insert the cleaned and disinfected components single-use sterilization packagings (single packaging), which fulfill the following requirements (material/ process): - EN ISO/ANSI AAMI ISO 11607 (for USA: FDA clearance) - suitable for steam sterilization (temperature resistance up to at least 142 °C (288 °F), sufficient steam permeability) - sufficient protection of the components as well as of the sterilization packagings to mechanical damage

CHECK STERILIZATION Check all components after cleaning or cleaning/disinfection, respectively, on corrosion, damaged surfaces, and impurities. Do not further use damaged components (for limitation of the numbers of re-use cycles see chapter „reusability„). Still dirty components are to be cleaned and disinfected again.

Please use for sterilization only the listed sterilization procedures; other sterilization procedures must not be applied. Do not sterilize the other components without contact to the patient.

MAINTENANCE Steam sterilization Do not mount prior to packaging and sterilization (no sterilization of the other components without contact to the patient admitted) Ball bearings, threads and attachments must be lubricated regularly with Ballistol oil or a food-safe silicone grease!

- fractionated vacuum/dynamic air removal procedure 3 or gravity displacement procedure 4 (with sufficient product drying 5) - steam sterilizer according to EN 13060/EN 285 or ANSI AAMI ST79 (for USA: FDA clearance) - validated according to EN ISO 17665 (valid IQ/OQ (commissioning) and product specific performance qualification (PQ)) - maximum sterilization temperature 138 °C (280 °F; plus tolerance according to EN ISO 17665)

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I N S T R U CITNI S OTNRSUFCOTR I OCNLSE A FO NR I NPGRA ON CD E SCSAI N RG E

- sterilization time (exposure time at the sterilization temperature): Area

fractionated vacuum/dynamic air removal

gravity displacement

USA

at least 4 min at 132 °C (270 °F), drying time at least 20 min 5

at least 30 min at 121 °C (250 °F), drying time at least 20 min 5

at least 3 min 6 at 132 °C (270 °F)/134 °C (273 °F)

at least 20 min at 121 °C (250 °F)

other countries

The fundamental suitability of the components for an effective steam sterilization was demonstrated by an independent accredited and recognized (§ 15 (5) MPG) test laboratory by application of the steam sterilizer HST 6x6x6 (Zirbus technology GmbH, Bad Grund) and the fractionated vacuum/ dynamic air removal procedure as well the gravity displacement procedure. For this, typical conditions in clinic and doctor´s practice as well as the specified procedure were considered. The flash/immediate use sterilization procedure must not be used. Do not use dry heat sterilization, radiation sterilization, formaldehyde and ethylene oxide sterilization, as well as plasma sterilization.

STORAGE

MATERIAL RESISTANCE Please take care that the listed substances are not ingredients of the cleaning or disinfection detergent:

EN

- organic, mineral, and oxidizing acids (minimum admitted pH-value 6.5) - lyes (maximum admitted pH-value 8.5, neutral/enzymatic cleaner recommended) - organic solvents (for example: acetone, ether, alcohol, benzine) - oxidizing agents (for example: peroxide) - halogens (chlorine, iodine, bromine) - aromatic, halogenated hydrocarbons Please do not clean any components by use of metal brushes or steel wool. Please do not applied acidic neutralization agents or any rinse aids. Please do not expose any components to temperatures higher than 142 °C (288 °F)!

REUSABILITY The components can be reused – in case of adequate care and if they are undamaged and clean – 50times. The user is responsible for each further use as well as for the use of damaged and dirty components (no liability in case of disregard).

Please store the components after sterilization in the sterilization packagings at a dry and dust-free place.

3 at least three vacuum steps 4 The less effective gravity displacement procedure must not be used in case of availability of the fractionated vacuum procedure. 5 The effectively required drying time depends directly on parameters in sole responsibility of the user (load configuration and density, sterilizer conditions, ...) and by this is to be determined by the user. Nevertheless, drying times less than 20 min must not be applied. 6 respectively 18 min (inactivation of prions, not relevant for USA)

15

16

n.a.

n.a.

217928 Tray handle

Bite fork partial

Bite fork full

217611/ 217611 UNI

217661

n.a.

218610

n.a.

n.a.

218635 Support bracket right/left (pair)

218608 Removable axis pins (pair)

Axis plane indicator optional

n.a.

218606 Set screws

n.a.

5 ml (single-use syringe with needle)

217695 Nasion adapter

rinsing volume

5 ml (single-use syringe)

article specification

218607 Porus buttons 218609

Art. no

n.a.

n.a.

n.a.

n.a.

tooth brush

tooth brush

interdental brush conical (3-6.5 mm), tooth brush interdental brush conical (3-6.5 mm), tooth brush tooth brush

brush

Rinse five times; brush off outside and inside

five-times rinsing inside, brushing outside and inside

manual cleaning/ disinfection

not admitted

not admitted

not admitted

not admitted

standard basket

standard basket

small parts basket

small parts basket

small parts basket

automated cleaning/ disinfection

soaking not admitted not (standard surface admitted disinfection)

soaking not admitted not (standard surface admitted disinfection)

soaking not admitted not (standard surface admitted disinfection)

soaking not admitted not (standard surface admitted disinfection)

after removing the Rinse five times; universal joint: Brush brush off outside off outside and inside and inside

after removing the Rinse five times; universal joint: Brush brush off outside off outside and inside and inside

after removing the Rinse five times; universal joint: Brush brush off outside off outside and inside and inside

after removing the support bracket: Brush off outside and inside after removing the nasion bar: Brush off outside and inside

pretreatment

specific/additional procedure in case of

sterilization

maximum admitted cycle number

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

not admitted

not admitted

not admitted

not admitted

n.a.

n.a.

n.a.

n.a.

lubrication standard standard 50 not procedure procedure admitted

lubrication standard standard 50 not procedure procedure admitted

lubrication standard standard 50 not procedure procedure admitted

lubrication standard standard 50 not procedure procedure admitted

lubrication standard standard 50 not procedure procedure admitted

Maintenance

packaging

EN without contact to the patient

without contact to the patient

without contact to the patient

without contact to the patient

semi-critical B

semi-critical B

semi-critical B

semi-critical B

semi-critical B

recommended classification according to RKI/BfArM/KRINKO guideline (only Germany, with respect to intended use)

SPECIFIC ASPECTS

INSTRUCTIONS FOR PROCESSING

n.a.

218613

n.a.

n.a.

n.a.

218632 Adapter to bow

217696 Adapter screw

217633

n.a.

n.a.

n.a.

217634 Collar screw

218696 Toggle nut, complete

218697 Toggle screw

Fork mounting

n.a.

218695 Nasion support

Nasion bar

n.a.

218693 Set screw for nasion

n.a.

n.a.

Support bracket screw

218692 Fixing screw for nasion

218616

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

soaking not admitted not (standard surface admitted disinfection)

soaking not admitted not (standard surface admitted disinfection)

soaking not admitted not (standard surface admitted disinfection)

soaking not admitted not (standard surface admitted disinfection)

soaking not admitted not (standard surface admitted disinfection)

soaking not admitted not (standard surface admitted disinfection)

soaking not admitted not (standard surface admitted disinfection)

soaking not admitted not (standard surface admitted disinfection)

soaking not admitted not (standard surface admitted disinfection)

soaking not admitted not (standard surface admitted disinfection)

soaking not admitted not (standard surface admitted disinfection)

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

not admitted

not admitted

not admitted

not admitted

not admitted

not admitted

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

not admit- n.a. ted

not admitted

not admitted

not admit- n.a. ted

not admitted

without contact to the patient

without contact to the patient

without contact to the patient

without contact to the patient

without contact to the patient

without contact to the patient

without contact to the patient

without contact to the patient

without contact to the patient

without contact to the patient

without contact to the patient

For drawings and further information about articles see IFU of Artex facebow on www.amanngirrbach.com/instruction-manuals.

not admitted

not admitted

not admitted

not admitted

not admitted

not admitted

not admitted

not admitted

not admitted

not admitted

not admitted

I N S T R U CITNI S OTNRSUFCOTR I OCNLSE A FO NR I NPGRA ON CD E SCSAI N RG E

EN

17

AU F B E R E I T U N GSA N W E I S U N G

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