8
Care and Cleaning Of The LungLife
A new mouthpiece should be used for each subject. A delay of at least 5 minutes should be allowed
between subjects to allow settling of previously aerosolized particles in the measuring device.
It is recommended that the device be regularly cleaned according to the guidelines of the user’s
facility. The disinfection materials and procedures applied in the users’ facility may be more
appropriate than the methods outlined below. In the event of visible contamination of the flowhead
element, it should be cleaned or disinfected as described in the accompanying table. The device
should be replaced in the event of damage, or if visibly contaminated.
The frequency of cleaning and disinfecting is dependent on the facility’s risk assessment, usage, and
test environment, but it should be at least monthly or every 100 subjects (300 blows).
It is recommended that the device be replaced annually or test and calibration serviced at least
annually. There is no planned preventive maintenance for this medical device.
Table of Materials Used and Cleaning/Disinfection Methods
This listing provides clinical users with information to allow the assessment of other suitable cleaning
and disinfecting procedures available in their facility.
All external parts of the LungLife require cleaning, i.e. the removal of visible particulate contamina-
tion. Do not attempt to insert any object or to clean the rotor or stator in the measuring system.
This device is not designated as a ‘sterile’ device. Wiping with a 70% Isopropyl Alcohol impregnated
cloth provides a suitable form of cleaning and low-level disinfection for the case exterior. Repeat this
at least weekly to prevent a build-up of grime from normal handling and use.
Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals
or equipment.
Definitions of cleaning and disinfection are as defined in “Sterilization, Disinfection and Cleaning of
Medical Equipment:
Guidance on Decontamination from the Microbiology Committee to Department of Health Medical
Devices Directorate, 996”
Recommendations for chemical disinfectants are derived from the PHLS publication “Chemical
Disinfection in Hospitals” 993.
Part
Material
Cleaning Recommendation
Disinfection Recommendation
Body
PC/ABS
Wipe with a damp cloth
Alcohol wipe (IPA 70-90%)
Fascia
Polycarbonate
Wipe with a damp cloth
Alcohol wipe (IPA 70-90%)
Buttons
Synthetic Rubber Wipe with a damp cloth
Alcohol wipe (IPA 70-90%)
