Cleaning Instructions
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Vitalograph Model 4000 Cleaning Instructions 07801 Issue 1
Cleaning Instructions for Vitalograph Model 4000 Respiratory Screeners and Monitors Applicable to all Vitalograph model 4000 screening and monitoring devices including variants of the asma-1, Lung Monitor, copd-6 and Lung Age.
Figure 1: Vitalograph 4000 series device, complete
Hygiene Policy Vitalograph respiratory monitors and screeners are not designed to be, nor supplied as, sterile. Where devices are intended for multi-person use, 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 4000 series device flowhead does not require decontamination where a new BVF is used for each subject. When used according to Vitalograph recommendations, Vitalograph respiratory monitors and screeners are considered non-critical or low risk with regard to infection control. The exterior of the flowhead may be cleaned in line with the user’s local requirements for hand held objects.
Cleaning of a Device used for a Single Test Subject 1. Where the device is used for a single test subject, a plastic mouthpiece may be used. (A plastic mouthpiece is supplied with 4000 series devices intended for single patient use. Alternatively, disposable SafeTway mouthpieces may be used for single patient use). 2. Weekly cleaning of the mouthpiece and outside surfaces of the device is recommended. A cloth impregnated with 70% isopropyl alcohol may be used. 3. Where used, the plastic mouthpiece may be washed in warm soapy water and then rinsed in clean water. 4. The device should be cleaned before and after an extended period of storage. 5. Store the device in a clean and dust free environment (e.g. the supplied storage pouch).
Preventing Cross-Contamination of Subjects in Clinic Use 1. Where the device is for multi-person use, Vitalograph intends that a new BVF be used for every test subject to prevent cross contamination. Used BVFs should be disposed of at the end of the test session. Note: Used BVFs constitute minimally soiled waste from human healthcare and should be disposed of in line with local requirements. 2. Before use by the next subject, the outside surfaces of the device should be cleaned with a cloth impregnated with 70% isopropyl alcohol. 3. The device should be cleaned before and after an extended period of storage. 4. Store the device in a clean and dust free environment (e.g. the supplied storage pouch). 5. If you suspect that the flowhead of a device intended for multi-person use has become contaminated, it should be replaced. 6. There is no planned preventive maintenance for this medical device. Page 1 of 2
Vitalograph Model 4000 Cleaning Instructions 07801-Issue 1 DT_0244-1
Vitalograph Model 4000 Cleaning Instructions 07801 Issue 1
Spares & Consumables Ordering Information Cat. No
Description
28501
Eco BVF (100)
28572
Eco BVF + Disposable Noseclips (80)
20933
2024 Eco-SafeTway Mouthpieces (50)
40167
Pouch Spare (x10)
40168
Plastic Mouthpiece (20)
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-reusablemedical-devices/whatare-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/ 1. 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
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Vitalograph Model 4000 Cleaning Instructions 07801-Issue 1 DT_0244-1