Maintenance / Reprocessing For Reuse In Another Patient; Basic Instructions; Reprocessing For Reuse; Device Surface - Fahl NEBUSTEAM Gebrauchsanweisung

6.0 MAINTENANCE / REPROCESSING FOR REUSE IN
ANOTHER PATIENT
6.1

BASIC INSTRUCTIONS

For the NEBUSTEAM Inhaler, there are no mandatory
®
prescribed specifications in terms of times or time limits
for maintenance as per the Medical Devices Operator
Ordinance (MPBetreibV) 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.
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.
For your partners and
Medizintechnik-Vertrieb GmbH offers unproblematic, fast
reprocessing and checking of Fahl inhalation devices.
• Maintenance, or opening and repair of the device
may only be performed by the manufacturer or by an
authorised specialist company.
• 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.
• Remove all accessory parts before shipping the device.
The device itself must be subjected to a surface
disinfection.
• Andreas Fahl Medizintechnik-Vertrieb GmbH neither
warrants faultless function, nor will 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.
customers, Andreas Fahl
6.2

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.

6.2.1 DEVICE SURFACE

• If the device is to be used for another patient, the entire
surface 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.
CAUTION
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!

6.2.2 STEAM TANK

Depending on the application frequency and the water
hardness, a white layer of lime scale may form in the steam
tank after a certain period of time. When processing for
repeated use, we recommend descaling of the steam tank
(see Section 5.8. Descaling).

6.2.3 ACCESSORIES

CAUTION
The accessories must be replaced each time when the
device is used for another patient:
• Inhalation masks (tracheostomy mask, small face mask,
medium-sized face mask, large face mask)
• Aromatherapy-/condensate tank
• Measuring beaker
• Suction tube
• Protective cap mask connection
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