Medin Miniflow REF 4000, Инструкция по эксплуатации

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User Manual EN 7
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. Depending on the version, the bonnets are either
single-use or reusable. 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:
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
fle i leàa dàitsàa gleà a à eàadjustedàtoàtheà a ’sàsizeàa dàa ato àtoàsi plif àfi atio .à
áàsili o àp o gào à ask,à hose àtoàsuitàtoàtheà a ’sàsize,àisà o e tedàtoàt
he prong adapter. The prong or the mask ensure gentle
o ta tà et ee àtheàCPáPàs ste àa dàtheà a ’sà ose.
Miniflow ®
itselfàisàfaste edàtoàaà o etào àtheà a ’sàhead.
Technical data:
Expiration connector: 10 mm Inspiration connector: 10 mm
Weight: 10 g nCPAP pressure: 0-20 cm H
2
O
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 Velcro strap. The straps additionally included are
used to stabilise the masks or prong position and, with their Velcro ends, they can be placed anywhere on the bonnet fabric.
Theà eusa leà o etsàa eàe uippedà ithàaàVel oà losu eà hi hàisàpla edài àtheà e t eàofàtheàpatie t’sàfo ehead.àTheài te fa
e is
secured in this Velcro closure. The bonnets have special fleece surfaces for securing the strap. 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.

Only for clinical use.

The p
atie t’sào ge àsatu atio à ustà eà o ti uousl à o ito edàdu i gàuse.

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.