Fahl TRACHEOPORT COMPACT, Инструкция по эксплуатации

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37
EN
7.1 BASIC INSTRUCTIONS
For TRACHEOPORT
®
COMPACT is suitable for use in the home
as well as in facilities such as clinics, physicians‘ offices, etc. To
ensure safe and proper operation, a visual and functional check
must be performed before each use of the device to determine
any possible damage. The cleaning, disinfection and care
instructions as described in Section 5 are to be observed. The
replacement intervals for accessories and wear components
must also be observed. The device may only be used if it is free
of defects. There are no additional manufacturer instructions for
maintenance.
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.
If the device is to be used for a new patient, it must be
professionally reprocessed by the manufacturer or an
authorised specialist company in accordance with the
relevant medical device standards. Reprocessing for
reuse requires the performance of safety-related functional
checks by qualified personnel.
For your partners and customers, Andreas Fahl Medizintechnik-
Vertrieb GmbH offers unproblematic and fast reprocessing of
devices.
• Maintenance / repair of the device, as well as the
reprocessing for reuse, may only be performed by the
manufacturer or an authorised specialist company.
•
This device can be returned for maintenance/repair to
Andreas Fahl Medizintechnik-Vertrieb GmbH either directly
or via the dealer from whom you have purchased the device.
•
Remove all accessory parts before shipping the device. The
device itself must be subjected to a surface disinfection.
Liability of Andreas Fahl Medizintechnik-Vertrieb GmbH for
personal injury and property damage is excluded if, among
other things:
•
no original parts are used,
•
the instructions regarding proper use in these
instructions for use are disregarded,
• assembly, readjustments, modifications, extensions
and repairs are performed 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
inspection for possible
contamination