7
Operating Instruction
TNI
soft
Flow
50
homecare system
1.3.1) This manual
•
Exact adherence to the following instructions is a prerequisite for the safe and intended operation
of the
TNI
soft
Flow
50
and its supplied parts. Any non-observance will endanger an effective
therapy.
•
With regard to the fundamental requirements of the currently valid directive for medical devices, the
instructions for use describe the present state of the device, including software and supplies.
1.3.2) Appropriate application
•
The
TNI
soft
Flow
50
is not intended for life-support measures!
•
A therapy may only be started on prescription.
•
Only healthcare professionals may adjust the prescribed flow rate.
•
The
TNI
soft
Flow
50
is a system designed for nasal insufflation therapy. It can be used clinically
in inpatient and intensive care as well as in homecare to provide respiratory assistance to spontane-
ously breathing patients.
•
A nasal supply of respiratory gases leads to a positive airway pressure (PAP) depending on flow
rates. This has to be considered if the PAP could cause the patient to show undesirable results. The
TNI
soft
Flow
50
is not intended for artificial life-support measures.
•
The
TNI
soft
Flow
50
is not suitable for treating acute failure of respiratory functions.
•
The
TNI
soft
Flow
50
may not be used for invasive ventilation.
•
The
TNI
soft
Flow
50
may not be used in case of complete closure of the upper airways.
•
The
TNI
soft
Flow
50
may not be used on patients whose airways are circumvented by a bypass.
•
Due to humidification and a more comfortable aerial application, side effects such as an irritation of
the nasal mucosa, blocked nose, and (with patients suffering from blood-clotting disorder) bleedings
of the nose, are quite unlikely with the use of the
TNI
soft
Flow
50
. If such symptoms occur, the
humidity needs to be set to a higher level (see chapter 4.1.2 “
Setting Humidity”
).
•
When not in use, the
TNI
soft
Flow
50
should not be left switched on for several hours.
•
Do not use the device if you suffer from epileptic attacks or very agitated sleep.
•
Do not let children play with the hoses or the cables to eliminate the danger of strangulation and
the inhalation or swallowing of small parts.
1.3.3) Correct use
•
The unit’s housing may only be opened by authorized personnel.
•
Excluded from this is equipment which can be removed for usage and cleaning purposes
without using tools.
•
Prior to opening, the device has always to be switched off and the system has to be discon-
nected from the mains.
•
If the
TNI
soft
Flow
50
is not being used over a long period of time,
o switch off the
TNI
soft
Flow
50,
o disconnect the power cord from the socket,
o remove the applicator and
o make sure that there is no water in the “humidification chamber auto fill” nor in the
“water chamber humidifier homecare”.
•
Prior to switching on, the
TNI
soft
Flow
50
always has to be checked for correct assembly.
•
Check all parts for damages and defects.
•
In case of any abnormality, switch off the power switch and disconnect the system from the
