Medin NC3 - Description of the Device and Conditions for Use; Intended use

medin Medical Innovaons GmbH
Adam-Geisler-Str. 1
82140 Olching, Germany
+49 8142 448 460
info@medin-medical.com
www.medin-medical.com
IFU_medin-NC3 EN
Rev 05 Status as of 28.04.2021
7 of 68
2 Descripon of the Device and Condions for Use
Warning:
- The medin-NC3® is intended only for clinical use or transport within the hospital.
- The medin-NC3® may only be used while the paent’s oxygen saturaon is being monitored at the
same me.
- The medin-NC3® may only be used by expert sta who have been trained for the device and under
their supervision.
- Use of the CPAP modes only in combinaon with the Medijet® nCPAP generator.
- Use of the nasal cannula mode only in combinaon with Nuow® nasal cannulas approved by medin.
- The medin-NC3® is a CPAP device. It is suitable only for paents who can breathe spontaneously and
not for paents who are dependent on arcial respiraon.
- The medin-NC3® may not come into contact with ammable anesthesia gases or other ammable
materials while in use.
- The medin-NC3® should not be operated in an oxygen-enriched environment.
- US legislaon spulates that this device may only be sold to or on the instrucons of a doctor (for
USA: Rx only).
- Use only in a securely assembled, upright posion.
- The medin-NC3® must not be used for the simultaneous treatment of mulple paents.
Indicaons
nCPAP or High Flow therapy are used in the paent's various respiratory problems. These may be caused by
immaturity of the lung (RDS [1]), infecons (pneumonia [2]), or factors related to delivery/development (TTN [3],
broncho-/tracheomalacia [4]). In addion, nCPAP or High Flow therapy are used for respiratory support following
extubaon [5].
Expected clinical benet
nCPAP leads to an increase in lung volume (FRC - funconal residual capacity) and thus to the (re-)opening of
alveoli (air sacs). In addion, nCPAP can improve the supply of oxygen, stabilize the airways, smulate breathing,
and reduce breathing eort [6].
Contraindicaons
nCPAP or High Flow therapy are contraindicated if certain clinical situaons, anatomic malformaons or the degrees
of severity of a disease necessitate intubaon and mechanical venlaon or make nCPAP treatment impossible.
Side eects
Possible general side eects caused by nCPAP therapy are, on the one hand, skin damage due to excessive pressure
over the interface on the skin [7], and on the other hand, too much (posive or negave) pressure can lead to lung
injury (pneumothorax) [8]. The air which facilitates the paent’s breathing during the nCPAP therapy can also get
into the gastrointesnal region to some extent, due to the noninvasive applicaon. This can lead to distenon and/
or food intolerances to the point of voming [9].
2.1 Intended use
The medin-NC3® CPAP driver is used in combinaon with the Medijet® nCPAP generator to administer CPAP therapy
or with a suitable Nuow® nasal cannula to administer High Flow therapy to premature infants and neonates. The
medin-NC3® must be used under the supervision of expert, specially trained sta in a clinical seng or during
intrahospital transport, and the paent’s oxygen saturaon must be monitored at the same me.