TNI softFlow 50, Руководство по эксплуатации

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Operating Instruction TNI soft Flow 50 homecare system
1) Description of
TNI soft
Flow
50
1.1) Method
TNI soft Flow is a system managing therapy with nasal insufflation which will be used for the treat-
ment of sleep-related breathing disorders in clinical intensive care and stationary settings as well
as in homecare settings.
A constant, humidified and warm flow, which may also combined with oxygen, is applied to the
nose via applicator (thin nasal cannula which act as an interface to the patient).
Therapy with nasal insufflation basically improves ventilation.
1.2) Intended use
Therapy with nasal insufflation (TNI) is intended for additional treatment on patients with partial
or global respiratory failure (insufficiency), such as COPD (chronic obstructive pulmonary disorder,
ILD (interstitial lung disease) to relieve also breathing (respiratory) musculature and to improve
ventilation as well as mucociliary clearance.
Therapy with nasal insufflation may only be commenced with a medical prescription.
Therapy with nasal insufflation is not intended for life-support purposes.
This therapy is done on an individual basis according to the medical diagnosis. It can be applied
on a daily basis (e.g. under sleeping period) or sporadically if needed.
TNI soft Flow 50 may be used on adults and children. Please note that different special applicators
are available for adults and children.
The patient should be in good condition if therapy is realized at home and the device is operated
by the patient. Otherwise, the operation of the device has to be performed by a qualified third
person (e.g. nurse). This has to be considered especially if the device is used by infants or toddlers.
For patients which are not compliant to the device, please refer to 1.3).
The
TNI
soft
Flow
50
can be placed on an even horizontal surface inhouse and is used as a
stationary device. The location can be changed as needed but during transit no operation is
allowed.
In homecare settings the respective components have to be cleaned periodically. See chapter 5,
“Hygienic measures”
1.3) Safety notes
• Please read the following instructions carefully as they contain important information on the safe and
responsible handling of the TNI soft Flow 50 .
• An initial training has to be performed before the device can be used
• The following instructions remain the responsibility of the user of this unit.
• Any non-observance will cause danger!
• The device can be used in a sitting or lying position. It is not allowed to move around with a running
device. If an infant or a toddler uses the device, a qualified third person has to ensure proper use.
• No modification of this equipment is allowed.
• Although a selftest of the device is performed during start-up, it is recommended to remove and
insert the applicator after start-up to verify the correct alarm functionality.
• Do not use the TNI soft Flow 50 if you show allergic reactions when in contact with silicon.