Vitalograph 4000 Respiratory Screeners and Monitors Instruction Manual

Vitalograph 4000 Respiratory Screeners and Monitors

Product Information

Vitalograph Model 4000 Respiratory Screeners and Monitors

The Vitalograph Model 4000 is a screening and monitoring device used for respiratory testing. It includes variants of the asma-1,Lung Monitor, copd-6 and Lung Age. The device is designed for single patient use or for multi- person use in clinical settings. To ensure proper hygiene, cleaning instructions must be followed.

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.

Hygiene Policy

Cleaning of a Device Used for a Single Test Subject:

1. For single patient use, a plastic mouthpiece is provided with the device. Alternatively, disposable SafeTway mouthpieces may be used.
2. Weekly cleaning of the mouthpiece and outside surfaces of the device is recommended using a cloth impregnated with 70% isopropyl alcohol.
3. 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. A new BVF (bacterial/viral filter) should 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 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.

Spares & Consumables Ordering Information

Bibliography

1. Bentz, J. R. (2019). Bacterial Filtration Eciency (BFE) at an Increased Challenge Level Final Study Number 1138681-SGI; Viral Filtration Eciency (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 owbased 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/

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

Product Usage Instructions

Follow the below instructions for proper usage of the Vitalograph Model 4000 Respiratory Screeners and Monitors:

1. For single patient use, use the provided plastic mouthpiece or disposable SafeTway mouthpieces.
2. For multi-person use in clinical settings, use a new BVF for every test subject to prevent cross-contamination. Dispose of used BVFs at the end of the test session.
3. Clean the mouthpiece and outside surfaces of the device weekly using a cloth impregnated with 70% isopropyl alcohol. For plastic mouthpieces, wash in warm soapy water and rinse in clean water.
4. Clean the device before and after an extended period of storage using a cloth impregnated with 70% isopropyl alcohol.
5. Store the device in a clean and dust-free environment, such as the supplied storage pouch.
6. If the flowhead of a device intended for multi-person use has become contaminated, replace the flowhead.
7. There is no planned preventive maintenance for this medical device.

Note: Refer to the spares and consumables ordering information for replacement BVFs, mouthpieces, and storage pouches.

References

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• Guidelines Library | Infection Control | CDC
• Infection Prevention Control

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