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Warning: instructions for use and usage
Read these instructions for use carefully before using these products and follow the instructions precisely. Miniflow may only
be used by those with detailed knowledge of these instructions for use, which must be strictly observed. Miniflow may only
be used for the purpose described in the chapter intended use. Miniflow may only be used in combination with an appropriate
ventilator or a suitable surge tank with a pressure-regulating unit and appropriate patient monitoring.
The masks, prongs and bonnets may only be used in combination with a Miniflow and only with knowledge of these instructions
for use.
All warnings and instructions must be followed.
The use of devices (e.g. ventilator and humidifier) which are used in combination with Miniflow is described in the instructions
for use of these devices. Such instructions for use must also be followed.
1.
Intended use
1.1.Miniflow
Miniflow is a single use product for nCPAP therapy / non invasive ventilation therapy in treating neonates and premature infants
in intensive care units. In such cases, Miniflow serves as the patient interface. It is used in combination with a ventilator, which
controls the nCPAP pressure and supports Miniflow with the necessary gas flow.
1.2.Masks, Prongs and Bonnets
The bonnets, masks and prongs are products for use during nCPAP therapy / non invasive therapy when treating neonates and premature
infants. They are to be used in combination with the Miniflow nCPAP generators. The bonnets, which are available in different sizes, are
used for fixation of the nCPAP generator, mask and prongs. The bonnets are single-use. The masks and prongs are single-use products
made of silicone, which connect the nCPAP system to the patient. Their different sizes enable a patient-friendly connection which is as
leakage-proofed as possible.
Warning:
•
Only for clinical use.
•
The patient's oxygen saturation must be continuously monitored during use.
•
The products may only be used by trained personnel.
•
Miniflow, masks, single use bonnets and prongs are single use products for a single patient only. Do not reuse or reprocess
these products.
•
The bonnets, masks and prongs should only be used in combination with a Miniflow.
•
Miniflow may only be used in combination with a ventilator or a surge tank with a pressure-regulating unit.
•
When using a suitable surge tank with a pressure-regulating unit, the minimum flow of the system indicated in the
corresponding instructions for use must be observed.
2.
Functional principle and technical specification
2.1.Miniflow
The Miniflow is a patient interface which can be used in CPAP mode or during non-invasive ventilation in combination with a ventilator or
a bubble CPAP system. Miniflow can be connected to the inspiratory and expiratory tubes and thus to the ventilator. The CPAP parameters
are adjusted and controlled on the ventilator.
Inside Miniflow, the expiratory and inspiratory gas flows are separated until they reach the prong adapter. The prong adapter is flexible
and its angle can be adjusted to the baby's size and anatomy to simplify fixation.
A silicon prong or mask, chosen to suit to the baby's size, is connected to the prong adapter. The prong or the mask ensure gentle contact
between the CPAP system and the baby's nose.
Miniflow itself is fastened to a bonnet on the baby's head.
Technical data:
Expiration connector:
Weight:
2.2.Masks, Prongs and Bonnets
A divided fleece is sewn onto the upper side of the polyamide bonnet. A foam wedge (Minifoam for Miniflow) is placed between
the fleece parts and the Miniflow is placed in this and secured with a separate hook and loop tape. The straps additionally included
are used to stabilise the masks or prong position and, with their ends of hook and loop tape, they can be placed anywhere on
the bonnet fabric. The masks and prongs are made of 100% silicone. They all have holes for inserting the strips for fixation to
the bonnet. In addition, they include a pair of holes for inserting the Medijet or Miniflow prong connectors.
10mm
10g
User Manual Miniflow
Inspiration connector:
nCPAP pressure:
10mm
0-20 cmH2O
EN
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