Cosmed Quark CPET, Руководство пользователя

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44 - System Cleaning & Maintenance - Cleaning & Disinfection
8. Adequate ventilation is required in the disinfection area to evacuate the chemical vapors from glutaraldehyde (if used). Use lidded containers for
the disinfectant solution when appropriate. The inhalation of fumes from disinfectant solutions or skin contact with liquid disinfectants can be
hazardous to personnel.
Warning: Particular precautions should be taken when testing patients with high risk communicable diseases (i.e.
Tuberculosis, Multidrug Resistant Staphylococcus infections, etc.). When such conditions are present the clinical need
for performing the test should justify the risks.
When performing the disinfection:
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Do not use alcohol or other liquids containing Gluteraldehyde on the exterior surface of the equipment.
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Do not use abrasive powders or glass cleaners containing alcohol or ammonia on the plexiglas component (mixing chamber or canopy) of
the equipment.
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Do not steam autoclave any component other then rubber reusable masks (plastic adapter and clips should be removed).
Warning: Do not immerse any parts in liquid unless indicated (see following sections)
During testing , parts which directly come in contact with the skin and mucosa of subjects, or their respiratory gases can become contaminated by
microorganisms which can be transmitted to the next test subject. Even small droplets of condensation or aerosols are considered possible
contaminants. To avoid cross-contamination, all contaminated parts must be thoroughly disinfected or disposed of.
COSMED components which come into (direct or indirect) contact with mucosa or broken skin are classified as “semi-critical” devices and require
high-level disinfection according to applicable regulatory bodies. All other components are classified as non-critical.
The cleaning and disinfection procedure has been validated by an independent test laboratory
Applicable parts, when maintained properly and reprocessed in accordance with these instructions, should function within specifications for a
minimum of 50 cycles. Verify proper functioning of applicable parts after the cleaning and disinfection process by performing both Flowmeter and
Gas Calibration ensuring that calibration factors are within acceptable range.
The following chemicals were used for the validation, and are recommended for use:
Detergent: Cidezyme®/Enzol® (Johnson & Johnson)
Disinfectants: CIDEX® OPA Solution (Johnson & Johnson), Clinell Sporicidal Wipes (Gama Healthcare)
It is the responsibility of the users to:
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Follow instructions carefully
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Replicate recommended cleaning conditions and methods in their environment
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Observe legal provisions of their country and hygiene requirements of their organization, in addition to the instructions provided by this
manual
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Assign trained and qualified individuals to be responsible for the handling, cleaning and decontamination of the devices
To avoid contamination and ensure optimal performance:
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Equipment and applied parts MUST BE cleaned and disinfected prior to their first use
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Single-use items MUST BE disposed of after every test
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Parts which show defects on the material surfaces (cracks, brittleness) are disposed of
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Standard precautionary measures (hand hygiene, gloves, gown, mask, face shields) are taken as necessary
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Devices are disinfected immediately after use
Chemicals for disinfection must be:
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Applied thoroughly to all surfaces of the items to be disinfected
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Used according to instructions and expiration deadlines of the manufacturer are observed to ensure effective application
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Always stored and prepared in clearly marked containers to prevent accidental use