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EN
7.1 BASIC INSTRUCTIONS
For TRACHEOPORT
®
JUNIOR, there are no mandatory
prescribed specifications in terms of times or time limits for
maintenance as per Medical Devices Operator Ordinance
beyond the requirements for cleaning/disinfection specified in
the instructions for use. If reprocessing for reuse is performed,
technical function checks as specified in the Medical Devices
Operator Ordinance are required. In the commercial field,
checks performed on a regular basis may be required in the
scope of accident prevention regulations that apply at the
workplace. For non-stationary electrical equipment, these
checks are due at least every 24 months. Information in this
regard can be obtained from the competent occupational
insurance associations.
Regular thorough cleaning and disinfection of the tubes and
the application parts, as well as operation of the device in
accordance with the instructions for use, is assumed.
Check the air filter on the underside of the device on a regular
basis. To do this, withdraw the cover and examine the colour of
the air filter. If you discover discolourations/deposits/moisture:
send the device to the manufacturer or to an authorised
specialist company.
If the device
is to be used for another patient,
or if oversuctioning
of the device has occurred, professional reprocessing at the
manufacturer‘s establishment or at an authorised specialist
company in accordance with the Medical Devices Operator
Ordinance (MPBetreibV), the Medical Devices Act (MPG) and
the Federal Association for Medical Technology (BV-Med)
guideline is required.
For your partners and customers, Andreas Fahl Medizintechnik-
Vertrieb GmbH offers unproblematic, fast reprocessing and
checking of Fahl suctioning devices.
If the device is to be used for another patient or if it changes
owner, the device must be reprocessed in accordance with
the Medical Devices Operator Ordinance, the Medical Devices
Act and the Federal Association for Medical Technology
guideline. For a contaminated device that has been exposed
to oversuctioning to be reused, it must first be repaired by
the manufacturer, by a certified partner of Andreas Fahl
Medizintechnik-Vertrieb GmbH or by a specialist dealer who
has been authorised by Andreas Fahl Medizintechnik-Vertrieb
GmbH.
For partners and customers, Andreas Fahl Medizintechnik-
Vertrieb GmbH offers unproblematic, fast reprocessing and
examination / technical safety checks for Fahl suctioning
devices.
If the device is to be used for another patient, all parts that
come into contact with suctioning fluid (container, lid, overflow
protector) must, as a matter of principle, be cleaned and
then disinfected. See in this regard the individual cleaning
instructions (see Section 6.3). In addition, filters, suction tubes,
Fingertip etc. must be replaced.
•
Perform a visual inspection of the device, including tubes,
secretion container and device connection cable, each time
before you use the device.
Replace damaged cables and tubes immediately!
•
Maintenance, or opening and repair of the device,
must only be performed by the manufacturer or by
an authorised specialist company. When doing this,
technical and hygiene-related precautions, the safety
instructions as well as the servicing instructions for
TRACHEOPORT
®
JUNIOR must be observed.
•
This device can be returned for repair to Andreas Fahl
Medizintechnik-Vertrieb GmbH either directly or via the
dealer from whom you have purchased the device.
•
Before the device is sent in, all secretion container and tube
components must be cleaned and then disinfected. The
device itself must be subjected to a surface disinfection
•
Andreas Fahl Medizintechnik-Vertrieb GmbH neither
warrants faultless function, nor does Andreas Fahl
Medizintechnik-Vertrieb GmbH accept liability for damage to
persons or property, if
• no original parts are used,
• the instructions regarding proper use in these instructions
for use are disregarded,
• assembly, readjustments, modifications, extensions and
repairs are carried out by specialists who have not been
authorised by Andreas Fahl Medizintechnik-Vertrieb
GmbH.
•
No warranty claims are accepted in the event of damages or
malfunctions that have arisen due to the use of accessories
or consumables from external companies.
•
The regulations and instructions that apply to the respective
field of application must be observed.
7.2 REPROCESSING FOR REUSE
The handling of the device has a decisive impact on the reliability
and safety of the device. The hygiene measures described in
the preceding sections are necessary to protect patients and
users and to maintain the functional reliability of the suctioning
device. They do not replace reprocessing by the manufacturer
or an authorised specialist.
Before being passed on to a new patient/user, the
suctioning device must be reprocessed in accordance with
the manufacturer‘s specifications.
How can you identify a contaminated suctioning device?
The condition of the air filter is one (but not the only) possible
sign pointing to contamination. Perform a visual inspection of
the air filter (on the device underside) (Figure 9). To do this, you
must remove the cover. If the air filter is moist or contaminated,
or if it shows deposits, the device has been exposed to
oversuctioning and is contaminated.
In this case, the suctioning device must be repaired by
the manufacturer or by an authorised specialist company.
Special inspection and reprocessing measures are
required for this.
CAUTION!
Even if you cannot ascertain that the device has been
exposed to oversuctioning, the device must nevertheless
be repaired by the manufacturer or by an authorised
specialist company. The device can thereafter be used
again.
7.0 MAINTENANCE / REPROCESSING FOR REUSE IN
ANOTHER PATIENT
Figure 9
Air filter for quick visual in
-
spection for possible conta-
mination
