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7
Additional Requirements for Multi Patient Use
CAUTION:
•
When the AKITA JET is used by multiple patients (e.g. in a hospital) it is essential to reduce
the risk of cross contamination between patients. Therefore it is required to follow hygienic
rules set out in the following subsections of the instructions for use.
•
If an AKITA JET control unit is used by several patients, every patient should only use their
personal nebuliser set (nebuliser plus connecting tubes) and Smart Cards. After treatment
these personal parts must be removed from the AKITA JET control unit.
•
If nebulisers are centrally cleaned and hygienically prepared in the hospital, it is important to
ensure that only sufficiently device-specific and product-specific validated processes are used
for cleaning, disinfection and sterilisation and that the validated parameters are maintained
for every cycle.
•
The cleaning and disinfection procedure used must be recognized as effective (e.g. in the list
of tested and recognized disinfectants and procedures issued by the Robert Koch
Institute/DGHM) and already validated in all cases.
•
If another procedure is used, its effectiveness must be confirmed during validation. CE-
approved chemical disinfectants may also be used, provided they satisfy the requirements for
material resistance.
•
In addition, follow the hygiene regulations of the hospital or the medical practice.
7.1
Precautions When Inhaling
CAUTION:
•
Instruct each patient before first use of the AKITA JET Inhalation System
•
Request patients to disinfect hands before use
•
Each patient shall be provided with her/his individual tubing
•
Change tubes upon patient change
•
The applied part is the nebuliser and the first 10 cm of the tube.
7.2
Immediately After Use
Immediately after each treatment, all parts of the AKITA JET nebuliser must be cleaned of medication
residue and contamination.
To do this:
•
Disconnect Nebuliser from tubing, tubing is not subject to hygienic preparation
•
Remove excess medication.
•
Disassemble the nebuliser into its individual parts as described in the following figure.
