Pediflow
®
Manual
EN
medin Medical Innovations GmbH
Adam-Geisler-Str. 1
D-82140 Olching
+49 8142-44846-0
www.medingmbh.com
OP_Pediflow
®
5
Warning: Manual and use
Read these instructions for use carefully before using the products, and follow the instructions closely.
Pediflow
®
may only be used by individuals with a thorough knowledge of these instructions for use, in accordance
with these instructions for use, and
Пor tСО purposО НОsМrТЛОН unНОr tСО sОМtТon СОКНОН ‘IntОnНОН purposО’έ
Pediflow
®
may only be used in combination with a suitable ventilator and suitable patient monitoring.
The masks and the headgear may only be used in combination with a Pediflow
®
and only with knowledge of these
instructions for use.
The warnings and information must be observed
Use of devices used in combination with Pediflow
®
is described in the respective instructions for use of the devices.
Users must also comply with these instructions for use.
1.
Intended purpose
1.1 Pediflow
®
The Pediflow
®
is used in combination with a ventilator or device for CPAP therapy and/or non-invasive
ventilation of newborns and infants. The generator must be used under the supervision of expert, specially
trКТnОН stКПП Тn К МlТnТМКl sОttТnР or СomО tСОrКpв, КnН tСО pКtТОnt’s oбвРОn sКturКtТon must ЛО monТtorОН Кt tСО
same time. The Pediflow
®
is a single-use product.
1.2 Headgear
The headgear is a product for use for nCPAP therapy or non-invasive ventilation of newborns and infants. It is
to be used in combination with Pediflow
®
. The headgear is available in one size and is used to secure the
Pediflow
®
and the mask.
The mask is a single-use product made of silicone and establishes the connection between the Pediflow
®
and
the patient.
Warnings:
Only for clinical use or home therapy use
Use only with simultaneous monitoring of patient's oxygen saturation
Use only by and under the supervision of expert staff or staff who have been trained in the device
Use only in combination with a suitable ventilator
For single use
For use only on order of a physician
In the event of questions and problems during home use, please contact the corresponding hospital or
the attending medical/nursing staff
Check pressure points regularly (at least once daily)
Visual inspection of materials, patient, cleanliness and patency of the openings
Ensure that the headgear does not get into the patient's mouth
2.
Principles of function and technical specification
2.1 Pediflow
®
Pediflow
®
is a patient interface which can be used for CPAP respiratory support - and/or for non-invasive ventilation
in combination with a ventilator. Pediflow
®
is connected to the inspiration and expiration tubing and thus with the
ventilator. The ventilation parameters are adjusted and controlled on the ventilation device. The ventilation device
also provides the necessary gas flow.
In the Pediflow
®
, the expiration and the inspiration gas flow are separate from each other until they reach the mask.
The mask is flexibly connected with the Pediflow
®
by means of a ball joint. This enables the position of the Pediflow
®
to be adapted to the nasal anatomy and size of the baby and thus facilitates attachment.
The Pediflow
®
is secured to the patient using the headgear.
Technical data:
Expiration connection:
7.4 mm
Inspiration connection:
7.4 mm