Fahl TRACHEOFIRST COMPACT, Instructions For Use Manual

Page: 34 / 48

34
EN
Careful handling of the device has a decisive impact on the
reliability and safety of the device. A daily visual inspection
of the device for external damage and contamination is
indispensable.
The cleaning measures described in the following must be
carried out even when the device is not being used regularly.
Regular replacement of the filters for TRACHEOFIRST
®
COMPACT at 4-week intervals and function checks at intervals
of not more than 3 months are mandatory in order to ensure the
functionality of the device.
These hygiene measures are necessary measures to protect
patients and users and to maintain the functional reliability of
the suctioning device.
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.
CAUTION!
The suctioning device is a single patient product and must
only be used for one patient, since otherwise there is a risk
of infection. This suctioning device can be reprocessed
for reuse in another patient. When doing this, observe the
instructions in this regard provided in the instructions for
use, particularly in Section 7. (Maintenance / reprocessing
for reuse in other patient). The manufacturer accepts no
liability for unauthorised and incorrect reprocessing of
this device by external companies!
6.1 BASIC INSTRUCTIONS
The suctioning device must be cleaned in accordance with
the following cleaning and maintenance instructions.
The following instructions are the result of long years of
experience. Shorter cycles may be required, depending on the
application and the users‘ experience.
● A daily visual inspection of the device for external damage
and contamination is indispensable.
● We recommend that you document all maintenance and
replacement processes in writing as a matter of principle.
● Depending on the field of application of the device, e.g. in
the nursing field, additional precautions must be taken
before starting with suctioning, in order to ensure that the
safety of the patient, the user and third parties is not
jeopardised. These include for instance thorough disinfection
of hands and/or wearing of disposable gloves.
● Disconnect the mains connection cable from the device
before cleaning the device.
● The cleaning measures described do not replace the
respective regulations valid for the establishment!
● Observe the instructions for use of the manufacturers
of the disinfectants, particularly the information regarding
concentration and material compatibility.
● Disinfection of the device should only be performed with the
agents specified by the manufacturer, in order to avoid
damage to the device.
● CAUTION !
Some disinfectant solutions stain the lid components
and connecting tubes somewhat. This has no impact on
the properties of the materials though.
● Basically, the reprocessing instructions given in Section 7
must be observed when the device is used for another
patient.
● Partial cleaning in an automatic washer-disinfector (secretion
container and container lid) is in principle also possible.
Thermal disinfection is performed at a temperature of 93°C.
● Care must be taken to ensure that the suctioning device and
the suction tubes are stored under hygienic conditions!
6.1.1 BACTERIAL FILTER
The bacterial filter prevents microorganisms and secretions
from penetrating into the device and from being blown out of
the device, and thus serves to protect the users and the device.
● The filter cannot be cleaned or disinfected
● For reasons of hygiene, we recommend replacement at least
every 4 weeks. If the filter is strongly contaminated, it must
be replaced immediately.
● In order to prolong the service life of the bacterial filter, it is
advisable to fill the secretion container only to approximately
half its capacity. Always use an original bacterial filter.
● CAUTION !
The suctioning device must not be operated without
bacterial filter.
● Make sure you always have a sufficient number of spare
filters available.
6.1.2 AIR FILTER
The air filter prevents microorganisms and secretions from
being blown out of the device, and thus serves to protect the
users and the device.
● The filter cannot be cleaned or disinfected
● For reasons of hygiene, we recommend replacement at least
every 4 weeks. If the filter is strongly contaminated, it must
be replaced immediately. If the air filter is moist, or if
you detect deposits, please observe Section 6.2 of these
instructions.
● In order to prolong the service life of the air filter, it is
advisable to fill the secretion container only to approximately
half its capacity. Always use an original air filter.
● CAUTION!
The suctioning device must not be operated without air
filter.
● Make sure you always have a sufficient number of spare
filters available.
6.1.2 SUCTION TUBE
● In order to prevent encrustation of the suction tube with dried
secretions, the tube must be flushed with clear water
after each suctioning process. This can be accomplished
by suctioning the water through the Fingertip into the
secretion container with the aid of the suctioning device.
Please only fill the secretion container to approximately half
its capacity.
● We additionally recommend disinfection with one of the
instrument disinfectants recommended on page 36 at least
once every day. Observe the respective instructions for use
of the disinfectants!
● To dry the suction tube, it is advisable to hang it up. The clip
included in the first delivery can be used for this.
● Frequent cleaning / disinfection / sterilisation can cause the
suction tube to become discoloured and the material to
become brittle. We therefore recommend replacement at
least every 4 weeks.
6.0 CLEANING, DISINFECTION, REPROCESSING