Maintenance/Reprocessing For Reuse In Another Patient; Basic Instructions; Reprocessing For Reuse; Air Filter - Fahl NEBUFIRST Instructions For Use Manual

7.0 MAINTENANCE / REPROCESSING FOR REUSE
IN ANOTHER PATIENT
EN
7.1 MAINTENANCE / REPROCESSING FOR
REUSE
The NEBUFIRST
®
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.
•
ENo 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.
INHALATOR is suitable for use in the home
7.2

REPROCESSING FOR REUSE

The handling of the inhalation 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 inhalation device. They do not replace reprocessing by the
manufacturer.
If the device is to be used for another patient, 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.

7.2.1 AIR FILTER

● The air filter must be replaced each time when the device is
used for another patient.

7.2.2 NEBULISER

● The nebuliser, including the PEP cap, must be replaced
each time when the device is used for another patient.

7.2.3 AIR TUBE

● The air tube must be replaced each time when the device is
used for another patient.
7.2.4 ATTACHMENTS AND ADAPTERS
● The mouthpiece, nosepiece, inhalation mask, tracheostoma
mask and adapter must be replaced each time when the
device is used for another patient.
7.2.5 DEVICE SURFACE
● If the device is to be used for another patient, the entire sur-
face of the device must be cleaned with a moist cloth (never
use a wet cloth) and must then be disinfected with one of the
surface disinfectants recommended on page 14.
Some disinfectants can cause discolouration of the material,
which does not affect the functionality of the device though.
Make sure that the device has first been disconnected from the
mains power supply!
The device must never be autoclaved, rinsed under running
water or immersed in liquids!
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