Cosmed Q-NRG, User Manual, Page: 89 / 152

87/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2
Chapter 5 - Maintenance COSMED srl
Cleaning and Disinfection
Introduction
During resting energy expenditure testing, parts which come in direct contact with patient’s skin, mucosa, or
through which respiratory air passes, can become contaminated by microorganisms which can be transferred to the
next test patient. Even small condensation droplets or aerosols are considered possible contaminants. To minimize
the risk of possible cross-infection, all contaminated parts must be thoroughly reprocessed or discarded after use.
Note
: Device and reusable parts are NOT supplied cleaned. Perform cleaning and disinfection procedure prior
the very first use.
COSMED components which come in contact with mucosa or non-intact skin are categorized as “semi-critical”
devices and require high-level disinfection according to applicable guidelines (i.e. Reprocessing Medical Devices
in Health Care Settings: Validation Methods and Labeling. FDA Guidance for Industry and Food and Drug
Administration Staff Document issued on: March 17, 2015). All other components are categorized as “non-critical”.
The cleaning and disinfection procedures, shown below, have been validated by an independent test laboratory.
Re-processable parts, when maintained properly and reprocessed per these instructions, should function within
specifications for a minimum of 50 cycles. Verify proper functioning of applicable parts after reprocessing by
performing both Flowmeter and Gas Analyzers calibration, ensuring that calibrations passes.
Warning Do not sterilize the device and its accessories or disposable parts. The internal components are not
compatible with sterilization techniques.
Detergent and disinfectant solutions recommended by COSMED
• Detergent: Enzymatic detergent (e.g.: Cidezyme®/Enzol® (Johnson & Johnson)).
•
High level disinfectant: Orthophthalaldehyde 0,55% (e.g.: CIDEX® OPA Solution (Johnson & Johnson)).
• Disinfectant: AHP® (Accelerated Hydrogen Peroxide) RTU spray (e.g. Oxivir® Tb RTU (Sealed Air)).
Detergent and disinfectant precautions
When you are using the recommended detergent and disinfectant, please make sure that:
• Safety precautions of the manufacturer are observed.
• The specifications given by the manufacturer concerning concentrations and reaction times are observed.
• Only filtered (oil-free and particle-free) air is used for active drying.
Compatible cleaning and disinfectant agents
Make sure that the following components are not present:
• Organic, mineral, and oxidizing acids (min pH=5.5).
•
Strong bases (max pH=9.5, neutral/enzymatic detergent recommended).
• Organic solvent (e.g. alcohols, ethers, ketones, benzines).