Instructions for Cleaning and Disinfection of Reusable Parts

Hygiene Instruction/Hygieneanweisung MasterScreen Series/MasterScreen BabyBody/Paed/MasterScope Body/Vyntus SPIRO, PNEUMO, IOS, APS

This hygiene instruction has been composed with the assistance of Adobe® Creative Suite® programs Adobe InDesign®, Adobe Photoshop®, Adobe Illustrator® and Adobe Acrobat®. The complete pages have been produced with Adobe InDesign® CS5.5 for PC and are also available as PDF files. Adobe Acrobat Reader is required in order to open these PDF files. Trademarks Adobe, Creative Suite, InDesign, Photoshop, Illustrator and Acrobat are registered trademarks of Adobe Systems Incorporated in the USA and/or other countries. Bodedex, Korsolex and Dismozon are registered trademarks of Bode Chemie. CIDEX, ENZOL and CYDEZYME are registered trademarks of Johnson & Johnson company. Prolystica 2X Concentrate Enzymatic Presoak and Cleaner, Revital-ox Resert Cleanisept Wipes, Desco Wipes DT, and Biguanid Fläche N are registered trademarks of Dr. Schumacher GmbH. neodisher is a registered trademark of Chemische Fabrik Dr. Weigert GmbH & Co.KG. Sidestream is a registered trademark of Respironics UK Ltd. Contact: Vyaire Medical GmbH Leibnizstrasse 7 97204 Hoechberg, Deutschland +49 931 4972-0 tel +49 931 4972-423 fax E-Mail: [email protected] Copyright All rights, also those of translations, are reserved. Written permission of Vyaire shall be obtained for the reproduction of the manual or an excerpt thereof by any means which includes printing, photostatic duplication, microfilms or any other process. Note Vyaire reserves the right to alter the information included in this document without notice. Subject to technical modifications. Copyright © 2019 by Vyaire Medical GmbH, Hoechberg

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Table of Contents Symbols for Notes on Safety in Instructions for Cleaning and Disinfection of ­Reusable Parts... 5 1. Introduction... 6 1.1 Use without MicroGard II filter... 10 1.2 Use with MicroGard II filter... 10 1.3 Disposal of the single patient use items / damaged reusable items.10 2. Pretreatment, Cleaning and Disinfection... 11 2.1 Basics... 11 2.2 Pretreatment... 11 2.2.1 General remarks... 11 2.2.2 How to perform a pretreatment... 12 2.3 Machinery Cleaning and Disinfection (Washer Disinfector)... 12 2.3.1 Procedure... 13 2.4 Manual Cleaning and Disinfection... 15 2.4.1 Procedure... 16 2.4.1.1.1 Using an ultrasonic bath to clean the volume sensor... 17 2.4.1.2 Disinfection... 17 3. Inspection... 19 4. Maintenance... 19 5. Packaging... 19 6. Sterilization... 19 7. Storage... 20 8. Material Resistance... 20 8.1 Other detergents and disinfectants... 21 9. Reusability... 24 10. Surface Cleaning and Disinfection... 24 10.1 How to perform a surface cleaning and disinfection... 26 11. Cleaning and Disinfection Table... 27 12. Single Patient Use Items Table... 38 13. Disassembly/Assembly Instruction for the Cleaning/ Disinfection Procedure... 40 13.1 MasterScreen Pneumo, Vyntus SPIRO, Vyntus PNEUMO... 40 13.1.1 Disassembly... 41 13.1.1.1 Disassembly of the P-tube... 41 13.1.2 Assembly... 42 13.2 MasterScreen IOS/Vyntus IOS... 43 13.2.1 Disassembly... 43 13.2.2 Assembly... 44 13.3 APS Pro/Vyntus APS... 44 13.3.1 Disassembly... 45 13.3.2 Assembly... 45 13.4 MasterScreen PFT... 46 13.4.1 Disassembly... 47 13.4.2 Assembly... 49 13.4.3 Disassembly “Snip” Option... 50 13.4.4 Compliance Option... 51

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13.4.4.1 Disassembly Compliance Option... 51 13.4.4.2 Assembly Compliance Option... 52 13.4.5 Rhinomanometry Option... 53 13.4.5.1 Disassembly Rhinomanometry Option... 53 13.4.5.2 Assembly Rhinomanometry Option... 55 13.5 MasterScreen Body/MasterScope Body... 56 13.5.1 Disassembly... 56 13.5.2 Assembly... 57 13.6 MasterScreen Body/Diff... 58 13.6.1 Disassembly... 58 13.6.2 Assembly...59 13.7 MasterScreen Body/Diff Realtime... 60 13.7.1 Disassembly... 60 13.7.2 Assembly...61 13.8 MasterScreen BabyBody... 62 13.8.1 Disassembly... 63 13.8.1.1 Disassembly of the PT -S... 63 13.8.2 Assembly...64 13.9 MasterScreen Paed... 65 13.9.1 Disassembly... 65 13.9.2 Assembly... 66 13.10 MasterScreen CPX... 67 13.10.1 Disassembly... 68 13.10.2 Assembly... 68 13.11 MasterScreen CPX with Option High/Low FiO2... 69 13.11.1 Disassembly... 70 13.11.2 Assembly... 70 Return of Goods in Medical Institutions... 71

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Symbols for Notes on Safety in Instructions for Cleaning and Disinfection of ­Reusable Parts Following the ANSI recommendations (American National Standards Institute) for safety notes, specific passages of the instruction manual are clearly marked as safety notes. Degree of Danger

Injury to Persons

Damage Use in case of: to Property

X

DANGER indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. This signal word is to be limited to the most extreme situations.

X

WARNING indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

X

(X)

CAUTION indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices.

Additional icons shown in the instruction manual:

X

X

See instruction manual and documents delivered with the equipment. Important and useful information. Information does not warn of dangerous or harmful situations.

Hints for use.

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1.

Introduction Always make sure to unplug the devices/systems before cleaning or disinfecting them. Regarding humidity and water that may get inside the units, the Vyaire devices correspond to the safety level IP 20. This means the device can be cleaned with a damp (but not soaking) cloth which does not produce lint. More detailed information can be found below. Chemicals required for operation or care of the unit must always be stored, prepared, and made available in specially marked vessels to prevent any accidental use. In the course of lung function testing, certain parts of the equipment can become contaminated by microorganisms, which creates the risk that these microorganisms can be transferred to the next test subject. To avoid cross-contamination, the test subject must not come in direct contact with the contaminated object or transport media such as droplets or aerosols. Contaminated aerosols can be transported by breathing and may be inhaled by the next test subject as the most measuring applications work with expiration and inspiration of breathing air.

The possible risk of infection can only be avoided if all of the contaminated parts are thoroughly cleaned and disinfected! Consequently, all parts should be cleaned and disinfected regularly.

As you are responsible for the health of the test subject please make sure: • that all reusable parts which are in the patient breathing path, must upon initial receipt be purified by stirring in deionised water for 5 minutes before the first application of a test subject, • that the basic conditions of the validation process (concentration, temperature, time, etc.) are maintained in every cycle, (For USA only: Cidex OPA Solution has been validated and is readily available on the market.) • that a “manual cleaning and disinfection procedure” is only applied if a bacterial/viral filter is used during the measurements (except DVT (see 2.4.1.1.1)) • that even if a bacterial/viral filter is used and regardless of the manual or mechanical cleaning and disinfection procedure used, all applied parts behind the filter are regularly cleaned and disinfected every 6 months,

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• that only a machinery cleaning and disinfection procedure is used and the applied parts are cleaned and disinfected after every test subject if no bacterial filter is used (except DVT (see 2.4.1.1.1)), • that all contaminated applied parts are cleaned and disinfected (according to your internal guidelines) or, if necessary, disposed of after measurements have been performed on high risk subjects (case history: e.g. tuberculosis) even if a bacterial filter is used.

Applied parts which come into contact with mucosa or pathologically changed skin or through which respiratory air passes during the lung function application are classified as semicritical with regard to the intended use. Prerequisite: Uninjured skin, no gum bleeding

If the user does not heed the instructions of this manual, the manufacturer is not liable. Please observe the legal provisions of your country and the hygiene requirements of the doctor‘s surgery or hospital in addition to the instructions given in this manual. Vyaire recommends/stipulates the usage of bacterial filters from the MicroGard II series which further reduce the risk of infection. This filter has a bacterial and viral filter efficiency of >99.999% (based on Nelson Lab Test and half year routine simulation at an external laboratory) against cross-contamination. Despite this high filtration efficiency, the flow resistance of this filter is negligible, with no impact on the measured values. This has been ascertained by means of a validation of the MicroGard II filter on all Vyaire lung function devices which can be used with a filter. If a bacterial filter is used, the applied parts behind the filter can be used longer as they do not have to be cleaned and disinfected after every subject.

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Filter Kit MG IIB (single patient use MicroGard IIB filter with single-use nose clip)

Filter Kit MG IIC (single patient use MicroGard IIC filter with single patient use mouthpiece and single patient use nose clip)

Always make sure: • that applied parts which come into direct contact with the subject (except single patient use items) are cleaned and disinfected prior to their first use, • that if there are changes on the material surfaces (cracks, brittleness), the respective parts are disposed of, • that single patient use items are disposed of after every subject.

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User guideline - Where to find applicable information and what to do

Use

see IFU

Switch off the device

see IFU

Disassemble

see Ch. 13

Yes

Single use item?

Dispose of

see Ch. 1.3

Dispose of

see Ch. 3

Package

see Ch. 5

Store

see Ch. 7

No Clean

see Ch. 2

Disinfect

see Ch. 2

Rinse

see Ch. 2

Dry

see Ch. 2

Checkup

see Ch. 3

Yes

Defective?

No Maintain

see Ch. 4

Transport or temporarily not used?

Yes

No Assemble

see Ch. 13

Recommission

see IFU

Abbreviations: „Ch.“: Chapter

Use

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see IFU

„IFU“: Instructions for Use

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1.1

Use without MicroGard II filter All applied parts must be cleaned and disinfected after every subject. See “11. Cleaning and Disinfection Table“. This is also valid if the measurement of one patient is interrupted for a longer period of time (> 4 h).

1.2

Use with MicroGard II filter All contaminated applied parts between filter and subject must be cleaned and disinfected after every measurement. Consult the Cleaning and Disinfection Table (chapter 11) for the components of the measuring head behind the MicroGard II filter. This is also valid if the measurement of one patient is interrupted for a longer period of time (> 1 h).

1.3

Disposal of the single patient use items / damaged reusable items Avoid contaminating yourself (e.g. use gloves). All single patient use items (see “12. Single Patient Use Items Table“) and damaged reusable items can be disposed of as domestic waste if they show a normal degree of contamination. In case of dangerous infectious diseases (e.g. tuberculosis) it is necessary to dispose of the single patient use items in special containers. In addition, please note the countryspecific disposal regulations.

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2.

Pretreatment, Cleaning and Disinfection

2.1

Basics This manual describes two cleaning and disinfection methods, i.e. manual and mechanical. Thorough pretreatment and cleaning to remove protein residues and gross con­ tamination is the precondition for an efficient disinfection of contaminated applied parts. Protein residues on these parts might prevent effective disinfection.

2.2

Pretreatment Always keep in mind that only a wiping disinfection method should be used to disinfect electrically powered applied parts.

2.2.1

General remarks The pretreatment is mandatory and is intended to protect the user. Ideally, it should be performed on the spot directly after usage (within at most 2 h). Coarse impurities must be removed from the applied parts by using running, soft (low lime content) water or a disinfectant solution. If the MicroGard II filter is consistently used, a pretreatment of the applied parts behind the filter only has to be performed when the end of the defined cleaning and disinfection cycle has been reached. Reason: The bacterial filter prevents coarse impurities getting into the applied parts behind the filter.

Both detergent and disinfectant should • be aldehyde-free to avoid blood impurities fixation, • have a proven efficacy (e.g. VAH/DGHM or CE label or a high level disinfectant legally marketed in the US), and • be suitable for the disinfection of the applied parts and compatible with regard to material resistance (see chapter “8. Material Resistance”).

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2.2.2

How to perform a pretreatment Please disassemble all contaminated parts as far as it is possible to do so without tools (see chapter “13. Disassembly/Assembly Instruction for the Cleaning/Disinfection Procedure”). Pretreatment with brushes is performed as follows: • Rinse under soft running water, or • Soak in cleaning solution, or • Soak in disinfectant solution. Only use a soft brush or a clean and soft cloth to manually remove impurities. Metal brushes, steel wool or other scrubbing materials are not suitable. Rinse all larger tubes (MS PFT, MS Diff SB etc.) for at least one minute with running soft water or a disinfectant solution. Movable parts must be moved several times during the precleaning. For special applications with the use of small applied parts, rinse all smaller applied parts and thin tubes three times with soft water or a disinfectant solution using a disposable syringe. The minimum volume of the syringe (5 - 100 mL) should match the size of the applied part.

2.3

Machinery Cleaning and Disinfection (Washer Disinfector) Always keep in mind that only a wiping disinfection method should be used to disinfect electrically powered applied parts. When you choose a cleaning and disinfection device (washer disinfector), please make sure: • that the washer disinfector is approved according ISO 15883 and, if used in the USA, is legally marketed in the USA

Thermal disinfection on its own is not possible due to the materials used! • that a tested program for the chemical disinfection of thermolabile instruments up to a temperature of not exceeding 60 °C (140 °F) is used, • that the program is adapted for the applied parts and contains sufficient rinsing cycles, • that the water for the rinsing is either sterile and of low microbial count (at most 10 CFU/mL) water or ideally DI water / demineralized water is used, • that the air used for drying is filtered (oil-free, low microbial count, and lowparticle), and • that the washer disinfector is maintained and checked at regular intervals.

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When choosing a detergent and disinfectant, please make sure: • that the system is adapted for the cleaning of instruments consisting of metal and plastic, • that the disinfectant used is suitable and has a proven efficacy (e.g. - VAH/DGHM or CE label for Europe - high level disinfectant legally marketed in the US) • that the disinfectant is compatible with the detergent used, • that the chemical substances used do not corrode applied parts (see chapter “8. Material Resistance”), and • that the specifications given by the manufacturer concerning concentrations, temperatures, reaction times, and safety precautions of the detergent and disinfectant are strictly observed.

2.3.1

Procedure 1. Put the applied parts into the washer disinfector. Make sure that the parts do not touch each other. If necessary: Connect all the applied parts and all tubes with the rinser connection of the washer disinfector by means of a suitable rinsing basket. 2. Start the program. 3. When the program has ended, remove the applied parts from the washer disinfector. 4. Inspect and pack up the dried applied parts as soon as they have been removed from the device; if necessary, the parts can be dried a second time in a clean and dust-free place (see chapter “3. Inspection”, “4. Maintenance”, “5. Packaging” and “7. Storage”). The suitability of the applied parts for an efficient machinery cleaning and disinfection has been confirmed by an independent accredited test laboratory. The test laboratory used the washer disinfector G “7836 CD” (chemothermal disinfection, Miele & Cie. GmbH & Co., Guetersloh), the detergent “neo­disher® Medizym“, and the disinfectant “neodisher® Septo DN” (Dr. Weigert GmbH & Co. KG, Hamburg). The procedure described above was used. The proof of the general suitability for the applied parts for effective cleaning with “Prolystica 2x concentrate presoak and cleaner” (Steris Corporation) has been furnished by Steris for effective manual and/or automated process. With a RDG, cleaning or cleaning plus disinfection can be used, i.e. all processes can either be used individually or in combination. It is essential that the cleaning and disinfection process used ensures effective cleaning and disinfection. Important notes on mechanical cleaning / disinfection The instruments (applied parts) of the Masterscreen and Vyntus family (Vyntus Spiro, Vyntus Pneumo, Vyntus IOS, and Vyntus APS) can be subjected to mechanical cleaning and chemicothermal disinfection in a RDG at 60°C. The following RDG-program would be suitable for the applied parts of the above mentioned product line.

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Using Neodisher Medizym/Neodisher Septo DN (cleaning / disinfection): • Prerinsing with cold DI water/demineralized water (20 °C) for 5 minutes • Chemicothermal cleaning with DI water/demineralized water (55-60 °C) with Neodisher Septo DN (0.2% solution) for 5 minutes • Chemicothermal disinfection with DI water/demineralized water (55-60 °C) with Neodisher Septo DN (1% solution) for 5 minutes • Intermediate rinsing with cold DI water/demineralized water for 3 minutes • Final rinsing with warm DI water/demineralized water (55-60 °C) for 9 minutes • Drying in the RDG at a maximum temperature of 60 °C for 10 minutes Prolystica 2x (only cleaning) • Prerinsing with cold DI water / demineralized water (20 °C) for 5 minutes • Cleaning with warm DI water / demineralized water (45-50 °C) with Prolystica 2x concentrate (enzymatic detergent, 4mL/l) for 5 minutes • Rinsing with warm DI water/demineralized water (60 °C) for 10 minutes • Drying in the RDG at a maximum temperature of 60 °C for 10 minutes Refer to chapter 2.4.2.2 for details on the disinfection process with Revital OX Resert after the cleaning step with Prolystica 2 X Upon removal from the RDG, make sure that there are no moisture residues left on the applied parts and they don’t show any signs of tears and brittleness.

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2.4

Manual Cleaning and Disinfection Always make sure: • that a MicroGard II filter is used during the measurement of a test subject (does not apply to cardiopulmonary exercise testing; please refer to chapter 11, 13.10; - this reduces the contamination of the applied parts behind the filter; - that if a MicroGard II bacterial filter is used on all components distal to the filter, it should be cleaned and disinfected every 6 months - a manual cleaning and disinfection still has to be performed. • that only a wiping disinfection method is used to disinfect electrically powered applied parts.

When you choose a suitable detergent and disinfectant, please make sure: • that the safety precautions of the manufacturer are observed, • that they are adapted for the cleaning and disinfection of instruments consisting of metal and plastic, • that the detergent is adapted - if applicable - for the ultrasonic cleaner (no frothing), • that the disinfectant used has a proven efficacy (e.g. VAH/DGHM or CE label or a high level disinfectant legally marketed in the US) and that it is compatible with the selected detergent, • that the chemicals used are compatible with the applied parts (see chapter “8. Material Resistance”), • that the specifications given by the manufacturer concerning concentrations and reaction times are observed by all means, • that only freshly prepared solutions are used, i.e. only sterile or of microbial count (at most 10 CFU/mL) and ideally DI water / demineralized water is used, • that combined detergents/disinfectants are (preferably) not used. The use of combined detergents/disinfectants is only permissible if there is a very low degree of contamination (no visible impurities). If MicroGard II bacterial/viral filters are used, it can be assumed that the degree of contamination of the applied parts behind the filter is very low. Only use filtered (oil-free and particle-free) air for active drying.

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2.4.1

Procedure 1. Disassemble all contaminated applied parts (see chapter 13) without tools. 2. Clean all disassembled components in the detergent solution and brush them thoroughly to remove dirt adhesions. Use a soft brush. Metal brushes, steel wool, or other scrubbing materials are not suitable. Thoroughly brush the inside and outside of all larger tubes with an appropriate brush or clean soft cloth that is used only for this purpose. Where applicable (see “11. Cleaning and Disinfection Table” rinse all smaller applied parts and thin tubes three times at the beginning and at the end of the reaction time with a disposable syringe. The minimum volume of the syringe (5-100 mL) should match the size of the applied part. Make sure that thick tubes are completely covered/filled with cleaning solution and no air bubbles remain in the tube. 3. The disassembled components should remain in the cleaning solution for the entire reaction time. Longer reaction times can have a negative impact on the material resistance and function. Make sure that all cavities are free of air bubbles and sensitive applied parts do not touch each other. Prolystica 2X Concentrate Enzymatic Presoak and Cleaner Cleaning solution

0.4 % (4 mL per liter)

Reaction time

5 Min

Water temperature

warm water, approximately 45 °C or 113 °F (do not exceed 55 °C / 131 °F)

Cidezyme Cleaning solution

1.6 %

Reaction time

5 Min

Water temperature

max. 25 °C (max. 77 °F)

4. Rinse the disassembled components according to the manufacturer’s specifications. Rinsing must be performed with water of at least drinking water quality (optionally with DI water/demineralized water). Residues and concentrations of the cleaning solution are completely removed from the instruments. Rising can be performed by immersing the disassembled components in a rinsing bath for 10 minutes or by thorough brushing them under running water (3 cycles). 5. The disassembled components now undergo an active drying process. Make sure that only filtered (oil and particle-free) air is used for drying. This step can be omitted, if the components are disinfected immediately after cleaning. 6. Inspect all applied parts (see chapter “3. Inspection” and “4. Maintenance”). Attention: After active drying (also see chapter 2.4.1.2 subitem 3) take care that there are no moisture residues left on the applied parts and they don’t show any signs of tears and brittleness.

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2.4.1.1.1

Using an ultrasonic bath to clean the volume sensor Different from the general manual cleaning and disinfection, it is important to use an ultrasonic bath to clean the volume sensor insert (982094). The ultrasonic cleaner S40H/4,25I (part no. 991741) can be used for this purpose. Procedure: Remove the Triple V/DVT (see chapter 13, particularly 13.10) directly after measuring. - Rinse the volume sensor for 30 sec in both directions with flowing, tempered (20 - 40 °C) water deficient in lime. - Afterwards, run an alkaline ultrasonic bath at 25-45 kHz, US-power above cavitation line, in a dipping bath prepared with superalkaline, foam-inhibited disinfectant concentrate (e.g. 2 vol% elc A25 from Elma Hans Schmidbauer GmbH&Co KG) for 7 min at 60 °C. • to prepare the dipping bath, use deionized water. • during the ultrasonic bath, the volume sensor insert must be upright in the basket with the filtering screen on top. - Rinse the parts in the dipping bath at ca. 50 °C for 6 min with deionized water. With pieces of complicated shape (e.g. the DVT), use the ultrasonic sound for support. Please make sure to change the jetting liquid after every cleaning cycle to prevent the disinfectant solution from concentrating. Now the cleaning and rinsing procedure is completed and an immediate disinfection can be performed wet- in- wet. If the disinfection does not take place then, dry all parts directly after cleaning and rinsing. The actual disinfection can then be performed manually. It is either possible to run the general procedure of a manual disinfection (see chapter 2.4.1.2) or to run the disinfection in an ultrasonic bath as well. - In order to do so, run an aldehyde- and phenolfree alcaic ultrasonic disinfection at 25-45 kHz, US-power above cavitation line, in a dipping bath prepared with an aldehyde- and phenolfree alcaic disinfectant at 60 °C for 15 min. - It is important to perform yet another rinsing process afterwards (see description above). Note: all-thermic disinfection at temperatures > 60 °C in an ultrasonic bath are not applicable for Vyaire application parts.

2.4.1.2 Disinfection 1. Place all disassembled components into the prepared disinfectant solution. Longer reaction times can have negative impacts on the material resistance and function. Make sure that all parts and thick tubes are completely covered / filled with disinfectant solution and no air bubbles remain in the tubes and sensitive applied parts do not touch each other. Rinse all smaller applied parts and thin tubes three times at the beginning and at the end of the reaction time using a disposable syringe with disinfectant solution. The minimum volume of the syringe (5-100 mL) should match the size of the applied part. The disassembled components should remain in the disinfectant solution for the entire reaction time.

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Revital-Ox Resert (disinfection only) After preparation of Revital-OX Resert, make sure that the solution is still active to ensure the required high-level disinfection. Prior to the use, the solution should be verified with a R60 test strip (Steris Corporation); the reaction color on the strip should correspond to that of an active solution (compare to figure on the strip packaging). Revital-OX Resert* Disinfecting solution

1.5 %

Reaction time

8 Min

Water temperature

≥ 20 °C (max. 55 °C) (≥ 68°F (max. 131 °F))

Cidex OPA Solution Disinfecting solution

100 %

Reaction time

12 Min

Water temperature

≥ 20 °C (68 °F)

* Global brand names of Revital-OX Resert: Revital-Ox Resert High Level Disinfectant (US/Australia/New Zealand/Europe/Middle East), Revital-Ox Resert High Level Disinfectant – Chemosterilant (only Canada), Resert XL HLD High Level Disinfectant (other countries – Latin America/Asian/Pacific region)

2. Rinse the disassembled components according to the manufacturer’s specifications. Rinsing must be performed with water of at least drinking water quality (optionally with DI water/demineralized water). -Residues and concentrations of the disinfectant solution are completely removed from the instruments. Rising can be performed by immersing the disassembled components in a rinsing bath for 10 minutes or by thorough brushing them under running water (3 cycles). Special instructions for tubes: Rinse all thick tubes under running water for at least 1-2 minutes as specified above. Rinse all smaller applied parts and thin tubes three times using a dis­ posable syringe with water as specified above. The minimum volume of the syringe (5-100 mL) should match the size of the applied part. 3. The disassembled components now undergo an active drying process. Make sure that only filtered (oil and particle-free) air is used for drying. 4. Inspect all applied parts (see chapter “3. Inspection” and “4. Maintenance”). 5. Once all components are completely dry, they are packaged (see chapter ”5. Packaging”) and stored in a clean and dust-free place. The suitability of the applied parts for an efficient manual cleaning and disinfection has been confirmed by an independent accredited test laboratory. The test laboratory used the detergent “Cidezyme®/Enzol®“ and the disinfectant “CIDEX® OPA Solution” (Johnson & Johnson GmbH, Norderstedt). The procedure described above was used. Proof of the general suitability for the applied parts for effective disinfection with “Revital OX Resert”(Steris Corporation) was provided by Steris for the manual process.

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3.

Inspection Inspect all applied parts after the pretreatment, after the cleaning, and after the disinfection. Pay heed to corrosion, damaged surfaces, split-offs, discolorations, and impurities and withdraw damaged applied parts. Applied parts which are still dirty have to be cleaned and disinfected again.

4.

Maintenance The applied parts which have been taken apart have to be put together again according to the instruction (see chapter “13. Disassembly/Assembly Instruction for the Cleaning/Disinfection Procedure”. Biologically harmless instrument oils are only permissible for certain applied parts so that their functioning is not impaired after the disinfection (flap valve). After cleaning and disinfection, the o-rings have to be lubricated with “ChristoLube MCG111“. For ordering Art.-No. V-892075 please contact: Vyaire Medical GmbH Leibnizstrasse 7 97204 Hoechberg Germany +49 931 4972-365 tel +49 931 4972-423 fax www.Vyaire.com

5.

Packaging Please package all applied parts in sealable single disposable packaging to protect them against environmental influences such as dust, humidity, germs, or access by unauthorized persons.

6.

Sterilization A sterilization with steam, moist heat or rays is not permitted.

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Hygiene Instruction/Hygieneanweisung MasterScreen Series/MasterScreen BabyBody/Paed/MasterScope Body/Vyntus SPIRO, PNEUMO, IOS, APS

7.

Storage The packed applied parts must be stored in a dry and dust-free place.

8.

Material Resistance When you choose a detergent and disinfectant, please make sure that they do not contain the following ingredients: • organic, mineral, and oxidizing acids (minimum pH-value 5.5), • strong bases (maximum pH-value 9.5, neutral/enzymatic detergent recommended), • organic solvent (e.g. alcohols, ethers, ketones, benzines), • oxidizers (e.g. hydrogen peroxides) (except Descogen I and Revital OX Resert; see 8.1), • halogens (chlorine, iodine, bromine), • aromatic/halogenated hydrocarbons. Never clean the applied parts with metal brushes, steel wool or other scrubbing materials. All applied parts must not be exposed to temperatures above 60 °C (140 °F)!

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