Idiomas disponibles
Idiomas disponibles
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 for the purpose described under the section headed 'Intended purpose'.
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 trained staff in a clinical setting or home therapy,
and the patient's oxygen saturation must be monitored at the 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:
2.2.Headgear, mask
The headgear is made of PET. The upper side has a hook and loop fastener for attaching the Pediflow and the mask. The straps
on the side are used for securing and they stabilize the mask position as well as the Pediflow. These can be placed with their
hook and loop fastener as desired on the straps of the headgear.
The mask is made of 100% silicone. There is additionally an attachment with loops for the straps of the headgear.
All manuals and user guides at all-guides.com
7,4mm
Pediflow Manual
Inspiration connection:
EN
7,4mm
4
