Reusable Instruments Cleaning, Sterilization and Care Instructions

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Instructions for Use Special notice Rx only

 lease read the following information and operating instructions carefully! P Caution: Federal law restricts this device to sale by or on the order of a physician. The device may only be used by qualified medical staff in accordance with these user instructions.

PAJUNK® does not recommend any particular treatment method. Professional medical staff are responsible for the way in which the device is used and for patient selection. In addition to these instruction for use, the relevant information also applies according to the corresponding specialist literature and current state of the art and knowledge. Failure to comply with the user instructions invalidates the warranty and puts patient safety at risk. If used in combination with other products, it is essential that the compatibility information and user instructions for these other products are taken into account. A decision regarding the combined use of devices from different manufacturers (where they do not constitute treatment units) is the responsibility of the user. The device must not be used under any circumstances if there are good reasons to suspect incompleteness or damage. Device description/ compatibility Please see the current declaration of conformity for product numbers and the scope of these instructions for use. T he useful life of the instrument depends to a very large extent on careful handling and the performance of appropriate care and maintenance measures. Warning: The product is not suitable for MRI use! Warnings for reusable product: 1.

 lease make absolutely sure that you clean and sterilise all devices delivP ered in non-sterile condition before using them for the first time! If an instrument has been contaminated, always process it immediately 2. after use (see instructions for manual pre-cleaning)! 3. The device is to be subjected to a visual and functional check before every use. 4. Sort damaged or faulty instruments and replace them. 2

further warning indications: 1. When using multiple components, familiarise yourself with their operation before use by checking connections and passages. Caution: Sharp object warning. The device or device components may, 2. depending on the type of tip, have sharp edges or tips. Various infectious pathogens can be transmitted if a stab wound occurs. For practical purposes, the most important of these are the human immunodeficiency virus (HIV), the hepatitis B virus (HBV) and the hepatitis C virus (HCV). 3. You must routinely take general precautions for handling blood and bodily fluids when using and disposing of the device, due to the risk of contact with blood-borne pathogens. Processing General information  henever you are working with contaminated instruments, follow the persoW nal protection guidelines of the trade association and similar organisations. Wear appropriate protective equipment and ensure that you have had the necessary vaccinations.  isk of infection: Incorrect processing of instruments puts patients, users and third R parties at risk of infection and can impair the performance of the instrument. Instruments used on patients known to have or suspected of having Creutzfeldt-Jakob disease or other prion diseases must be disposed of after one use in accordance with specific national requirements.  lways comply with the procedures, equipment and devices validated for the A user / operator / central sterilisation unit and check them for compatibility with the information provided here.  hen making up and using solutions, comply with the information on concenW tration and exposure time provided by the manufacturers of the chemicals. Non-compliance can damage the instrument. Further information on instrument processing can be found at www.a-k-i.org

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in the application: 1. Take care to use products of suitable dimensions (diameter, length), especially when treating obese patients and children. 2. Please note that the continued use of a device of the same type must be assessed cumulatively as described in the legislation on medical devices, even after the device has been exchanged or replaced.

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Preparation at the place of use If an instrument has been contaminated, always clean it immediately after use. To prevent material from drying and adhering to the instrument, large particles of contamination, corrosive solutions and medicinal products must be removed immediately after application of the medicinal product, for example by wiping and rinsing (dry disposal). Transport Use suitable transport containers to transport instruments to the reprocessing site in order to rule out the possibility of them constituting a hazard or undergoing external contamination. Dry disposal is always preferred, whenever possible. Avoid long storage times. Preparation before mechanical cleaning If an instrument has been contaminated, always process it immediately after use. If the instrument is a multi-piece device, dismantle it into its constituent parts (see chapter on instructions for dismantling). Pre-cleaning the surfaces: Use a brush (no steel brush) or sponge to remove visible contamination or heavy dirt from the surface of the instrument under cold running water (<40 °C; drinking water quality). Pre-cleaning cavities / lumens: Use a suitable brush (no steel brush) to clean the working channels, lumens and cavities of the instrument under cold running water (<40 °C; drinking water quality). Rinse gaps, grooves and cavities approx. 10 seconds with a pressurised water pistol, fitted with an irrigation attachment if necessary. Manual cleaning / manual disinfection Manual disinfection is not necessary.  arning: Exclusively manual processing is not permitted. Manual cleaning W must always be followed by mechanical cleaning and disinfection. Mechanical cleaning and disinfection Instrument sets must only be cleaned and disinfected in a suitable cleaning and disinfection machine (CDM). Use the Vario TD programme to clean thermostable instruments. PAJUNK® has validated and approved the following cleaning and disinfection process in accordance with DIN EN ISO 17664 or DIN EN ISO 15883: • Vario TD process parameters: • 1 minute pre-washing with cold tap water, drinking water quality, <40 °C • Draining • 3 minute pre-cleaning with cold tap water, drinking water quality, <40 °C • Draining 4

If Neodisher® MediZym is used: • 10 minutes cleaning at 45 °C (+5/-1 °C), dosage acc. to the following table and demineralised water • Draining • 3 minutes rinsing with demineralised water (<40 °C) • Draining • 2 minutes rinsing with demineralised water (<40 °C) • Draining • 5 minutes thermal disinfection at 93 °C (± 2 °C) (A0 =3000) and demineralised water • Draining • 30 minutes hot air drying at >60 °C (in the cleaning chamber) Chemical Manufacturer Category Neodisher Dr. Weigert Alkaline deterMediclean forte gent Dr. Weigert Enzymatic Neodisher MediZym detergent

pH value Dosage 10.4 - 10.8* 0.5 % (5 ml/l) 7.6 - 7.7 *

0.5 % (5 ml/l)

* Data in accordance with manufacturer data sheet

Connect individual parts with lumens and channels directly to the cleaning and disinfection machine. Connect non-dismountable instrument sets with cleaning channel, if any, directly on the Luer-Lock port to the special lumencleaning element in the cleaning and disinfection machine. When selecting the cleaning programme, bear in mind the material from which the instrument to be cleaned is made (e.g. stainless steel for medical instruments, chromed surface, aluminium). Always comply with the instructions of the device and detergent manufacturers. Drying The instrument may need to be manually dried after cleaning. Maintenance, inspection and care Leave the instrument set to cool to room temperature. Perform a visual check on the cleaned and disinfected instrument, paying attention to cleanliness, completeness, damage and dryness. If any contamination or residue is found during this check, the instrument must undergo another complete cleaning and disinfection process. 5

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If Neodisher® Mediclean forte is used: • 10 minutes cleaning at 55 °C (+5/-1 °C), dosage acc. to the following table and demineralised water

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Any parts of the instrument that are found to be damaged, incomplete, corroded, bent, broken, torn or worn must be removed or replaced. Dry the instrument again if there is any residual moisture. Instruments with damaged or missing chrome coating may not be used. Disposable wearing parts must be used only once. Always check wearing parts (silicone seals, sealing caps, O-rings, sealing inserts) for damage prior to use, and replace them if necessary. Reassemble the dismantled instrument set according to the assembly instructions. PAJUNK® recommends that instruments be handled carefully and gently, and that this user manual be closely followed, in order to maximise their useful life. The useful life of the instrument depends to a very large extent on careful handling and the performance of appropriate care and maintenance measures. Packaging system Only use standardised and permitted packaging systems in accordance with EN 868 parts 2-10, EN ISO 11607 parts 1+2, DIN 58953. Sterilisation  arning: Instruments used on patients known to have or suspected of having W Creutzfeldt-Jakob disease or other prion diseases must be disposed of after one use in accordance with specific national requirements. PAJUNK® has validated and approved the following process: Steam sterilisation The fully mounted instrument must be sterilised in accordance with a validated steam sterilisation process (e.g. steriliser according to DIN EN 285 and validated according to DIN EN 17665-1). When following the fractionated vacuum procedure, sterilise according to the 134 °C/ 3-bar programme, with a minimum holding time of 5 minutes (in accordance with the recommendations issued by the Robert Koch Institute and the German Federal Institute for Drugs and Medical Devices). The drying time is 30 minutes. Allow devices / instruments to cool to room temperature before using them again. Keep instrument sets that have undergone steam sterilisation in suitable containers used only for this purpose. Transport to the place of use Use suitable transport systems. Reprocessing restriction The end of device life is determined primarily by wear, damage caused by use, careful handling and appropriate storage. Frequent reprocessing in accordance with the reprocessing instructions supplied by the manufacturer does not affect the instruments‘ performance. 6

Devices sent to PAJUNK® for repair under warranty or at the user‘s expense must be thoroughly cleaned and sterilised before being sent back. Sterility must be noted on the covering letter or package. Use and storage conditions Temperature limit

+10 °C to +30 °C

Humidity limitation

20 % to 65 %

Keep away from sunlight Keep dry General information The devices are manufactured in accordance with globally applicable guidelines for hazardous substances.  ny serious incident that has occurred while using the device should be reporA ted to the manufacturer and the corresponding authorities of the country the user and/or patient are residing in. PAJUNK® GmbH Medizintechnologie, Karl-Hall-Strasse 1, 78187 Geisingen, Germany. Key to symbols used in labelling Manufacturer Catalogue number

Consult instructions for use Rx only Caution: Federal law restricts this

Do not use if package is damaged

device to sale by or on the order of a physician

Keep dry

Advice

Humidity limitation

Information

Caution Date of manufacture Batch code

Product is in conformity with the applicable requirements set out in Community harmonization legislation

Non-sterile

Quantity

Keep away from sunlight

Translation

Temperature limit

Medical device

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Repair