Vitalograph Pneumotrac Flowhead PN 77900 Cleaning Instructions Issue 1

Vitalograph

Pneumotrac IV PN 77900 Cleaning Instructions

07834 Issue 1

Flowhead Cleaning Instructions Applicable to Vitalograph Pneumotrac using Vitalograph Number 4 Fleisch Flowhead Assembly PN 77934 Hygiene Policy Vitalograph spirometers are not designed to be, nor supplied as, sterile. Vitalograph intends that a new Bacterial Viral Filter (BVF) be used for every subject to prevent cross contamination. Using a BVF provides a significant level of protection of the subject, the device and the user against cross contamination during spirometry manoeuvres. The interior of a Vitalograph flowhead does not require decontamination where a new BVF is used for each subject. When used according to Vitalograph recommendations, Vitalograph spirometers are considered non-critical or low risk with regard to infection control. The exterior of the flowhead may be cleaned in line with local requirements for hand held objects1. If a higher level of decontamination is required, then cleaning may be followed by disinfection as outlined below.

Cleaning the Flowhead Exterior Recommended cleaning method where a new BVF is used for every subject:

1

Flowhead Complete

2

Flowhead Tubing

3

Pneumotrac Device

Fig 1: Flowhead Complete, Flowhead Connection Tubing and Pneumotrac Device

1. Disconnect both ends of flowhead tubing from the pressure ports on the flowhead and the device. 2. Use a 70% isopropyl alcohol impregnated cloth to thoroughly clean the case exterior of the flowhead and the flowhead tubing. Visually inspect and repeat until visibly clean.

3. Reassemble by reconnecting both ends of flowhead tubing to the pressure ports on flowhead and the device. 1

Vitalograph (2019), “Hygiene Policy”. Internal Vitalograph policy. Document number: SOP_0523.

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Vitalograph

Pneumotrac IV PN 77900 Cleaning Instructions

07834 Issue 1 4. Vitalograph recommends that calibration verification be carried out following reassembly to verify correct operation and accuracy. Instructions for calibration verification are contained in the Spirotrac® software instructions for use provided with the Pneumotrac device.

Decontamination by Cleaning and Disinfection This is the recommended cleaning method where the user suspects that the flowhead interior may have become contaminated or if a user’s local requirement includes disinfection.

Cleaning of Flowhead Interior 1. Disconnect the flowhead tubing from the flowhead and the device. Disassemble the Fleisch flowhead:

1 Flowhead Complete 2 Flowhead End Cap 3 Flow Conditioning Mesh (x2) 4 Fleisch Element Assembly 5 O-Ring (x6) 6 Flowhead Body Tube 7 Pressure Ports 8 Flowhead Cone Lubrication: Silicone Grease Fig 2: Flowhead Assembly

2. Remove flowhead cone and flowhead end cap. 3. Remove flow conditioning meshes from inside the cone and end cap. Examine for damage or contamination. If meshes are damaged or blocked, discard and replace with new parts.

4. Remove flowhead body tube from Fleisch element assembly. To do this, firstly remove O-Ring from the smaller diameter side of the fleisch element assembly (same side the flowhead cone was removed from) and then place the Fleisch element assembly on a hard, flat surface with the largest diameter at the top (this is the end that the flowhead end cap was removed from). Push down on the flowhead body tube with thumbs and forefingers until it reaches the flat surface. A final pulling and twisting action will separate the parts.

5. Cleaning. Swill Fleisch element assembly vigorously in warm soapy water. Do not attempt to “rub” or “scrub” at capillaries.

6. Wash the flowhead end cap, flowhead body tube, flow conditioning meshes and flowhead cone in warm soapy water. Rub surfaces to remove any visible soiling. Page 3 of 7 Pneumotrac PN 77900 Cleaning Instructions 07834- Issue 1

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Vitalograph

Pneumotrac IV PN 77900 Cleaning Instructions

07834 Issue 1

7. Ensure all parts are visibly clean. If not visibly clean repeat the cleaning process. 8. Rinse with potable tap water. If disinfection is required, proceed to disinfection steps after rinsing, otherwise proceed straight to drying.

Disinfection 1. Prepare disinfectant solution as per the disinfectant manufacturer’s recommendation. Always follow the safety guidelines given by the manufacturer of the disinfectant chemicals.

2. Disinfect Fleisch element assembly, flowhead end cap, flowhead body tube, flow conditioning meshes and flowhead cone by immersion in the solution. Ensure Fleisch element assembly and flowhead body are immersed vertically and tap to remove air bubbles from interiors. Flush all surfaces to remove air bubbles. Soak parts for the time period recommended by the disinfectant manufacturer

3. Rinse with potable tap water. Table 1: Recommended Disinfectants Disinfectant

Type of testing

Revital-Ox Resert High Level Disinfectant (Active germicide; Hydrogen Peroxide)

Vitalograph 2021: Compatibility testing to 35 hours immersion

Revital-Ox Resert High Level Disinfectant – Chemosterilant (Active germicide; Hydrogen Peroxide) Resert XL HLD High Level Disinfectant (Active germicide; Hydrogen Peroxide) PeraSafeTM Instrument Sterilant (Rely+OnTM) (Active germicide: 0.2% peracetic acid)

Vitalograph 2021: Compatibility testing to 44 hours immersion

Drying 1. Tap the Fleisch element assembly gently several times with the capillaries formed by the coil orientated vertically to remove excess water.

2. Arrange disassembled parts separately so that any remaining water can drain and air can circulate, e.g. on a drying rack. Drying the Fleisch element assembly may require leaving it in a warm place overnight. If available, a drying cabinet is ideal.

3. Leave to dry completely before reassembling.

Reassembly of Fleisch Flowhead 1. Examine Fleisch element assembly and flowhead body tube to ensure that no liquid or particles remain in the holes or grooves.

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Vitalograph

Pneumotrac IV PN 77900 Cleaning Instructions

07834 Issue 1

2. Check O-rings for damage and ensure correct positioning within the grooves. 3. Apply a very small amount of silicone grease to the O-Rings (4 centre o-rings only, 2 end o-rings must not be greased). Wipe off any visible amounts of grease. Ensure that the tiny annular holes on the outside of the Fleisch element assembly are not blocked.

4. Refer to Figure 2: Flowhead Assembly to view placement of parts for reassembly. 5. Replace flowhead body tube onto Fleisch element assembly. Ensure the pressure ports on the flowhead body tube are nearest to the largest diameter (this is the end that the flowhead end cap was removed from) of the Fleisch element assembly.

Figure 3: Replacing the flowhead body onto the Fleisch element

6. Ensure that flowhead body tube is pushed fully home, and rotate it so that the pressure ports are approximately 180° opposite the end of the Fleisch element coil.

1

1

Pressure Ports

2

Flowhead Body Tube

3

End of the Fleisch Element Coil

2 3 Figure 4: Orientating the Fleisch element coil at 180° to the pressure ports

7. Fit flow conditioning meshes to both flowhead cone and flowhead end cap as shown in Figure 2. 8. Re-fit the end O-ring that was removed from the smaller diameter side of the fleisch element assembly (same side the flowhead cone was removed from) which was specified in step 4 of disassembly of flowhead.

9. Push flowhead end cap onto the larger diameter of the Fleisch element assembly and push flowhead cone onto the smaller diameter.

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Vitalograph

Pneumotrac IV PN 77900 Cleaning Instructions

07834 Issue 1

10. Reconnect flowhead tubing. Vitalograph recommends that a calibration verification be carried out following reassembly to verify correct operation and accuracy. Instructions for calibration verification are contained in the Spirotrac software instructions for use provided with the Pneumotrac device. Consumables Ordering Information Cat. No

Description

28350 28501 28572 28554 28553

BVF - Bacterial/Viral Filters (50) Eco BVF – Bacterial/Viral Filters (100) Eco BVF and Disposable Nose Clip (80) Eco BVF with Bite Lip (75) Eco BVF with Bite Lip and Disposable Nose Clip (75) 3-L Precision Syringe Flow Conditioning Mesh (10) (Replacement) Flowhead Complete (Replacement) Flowhead Cone (Replacement) Flowhead End Cap (Replacement) Flowhead Connection Tube (Replacement) O-Ring (15) (Replacement) USB Cable (Replacement) Feet (Replacement) Silicone Grease Pack (Replacement)

36020 77933 77934 77939 77938 79192 2120013 41543 77935 32254SPR

References 1. Vitalograph (2019), “Hygiene Policy”. Internal Vitalograph policy. Document number: SOP_0523.*

Bibliography 1. Bentz, J. R. (2019). “Bacterial Filtration Efficiency (BFE) at an Increased Challenge Level Final” Study Number 1138681-SGI; “Viral Filtration Efficiency (VFE) at an Increased Challenge Level Final” Study Number 1138680-S01. Internal reports for Vitalograph Ireland Ltd dated 17 January 2019. Nelson Laboratories, Salt Lake City.* 2. Bracci, M. et al (2011). "Risk of bacterial cross infection associated with inspiration through flowbased spirometers." American Journal of Infection Control 39(1): 50-55. DOI: https://doi.org/10.1016/j.ajic.2010.04.215. 3. Dunne, C (2019). “Calibrated Flow Bioburden testing of Vitalograph Alpha Flow Heads” Dated 16 July 2019. Internal report for Vitalograph Ireland Ltd.* 4. FDA (2015) “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff” U.S. Food & Drug Administration. 5. FDA (2018). “What are Reusable Medical Devices?” U.S. Food & Drug Administration. Accessed 4 July 2019, from https://www.fda.gov/medical-devices/reprocessing-reusablemedicalPage 6 of 7 Pneumotrac PN 77900 Cleaning Instructions 07834- Issue 1

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Pneumotrac IV PN 77900 Cleaning Instructions

07834 Issue 1 devices/what-are-reusable-medical-devices 6. Kendrick, A. H. et al (2003). "Infection control of lung function equipment: a practical approach." Respiratory Medicine 97(11): 1163-1179. DOI: https://doi.org/10.1016/S0954-6111(03)00223-3 7. Loveday, H. P. et al (2014). "epic3: National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in NHS Hospitals in England." Journal of Hospital Infection 86: S1-S70. DOI: https://doi.org/10.1016/S0195-6701(13)60012-2. 8. NHS (2017). Community Infection Prevention and Control Guidance for General Practice. Infection Prevention Control. UK. Accessed 28 May 2019, from https://www.infectionpreventioncontrol.co.uk/ 9. Rutala, W. A., D. J. Weber and HICPAC (2008). “Guideline for Disinfection and Sterilization in Healthcare Facilities.” CDC Infection Control Accessed 28 May 2019, from https://www.cdc.gov/infectioncontrol/guidelines *Available by request

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