Medin NC3 - Operating staff; Alternative respiration systems; Combination with other devices and ancillary equipment; Expected locations of the operator, patient and other persons

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
8 of 68
2.2 Operang sta
The medin-NC3® must be operated by a doctor or by an individual with the necessary technical skills acng on a
doctor’s instrucons. Consequently, all operang sta must have a detailed knowledge of these instrucons for
use and have undergone training in the device.
2.3 Alternave respiraon systems
An alternave CPAP system or respiraon system (e.g. bag valve unit) must always be available while the medin-NC3®
is in use.
2.4 Combinaon with other devices and ancillary equipment
The medin-NC3® may only be combined with devices or consumables (e.g. CPAP ancillary equipment) not menoned
in these instrucons for use aer consulng the manufacturer.
Use of ancillary equipment that is not approved puts the paent at risk and may impair the proper funconing
of the device.
Warning:
If the medin-NC3® is connected to another device or system, the requirements of IEC 60601-1:2005 chapter 16
and the requirements with regard to EMC according to IEC 60601-1-2 must be met, otherwise the device funcon,
electrical safety and EMC of the medin-NC3® are not guaranteed.
2.5 Expected locaons of the operator, paent and other persons
During use of the medin-NC3®, no specially dened posion of the user, paent or other persons is specied.
2.6 Technical descripon of funcon
2.6.1. Principles of funcon
The medin-NC3® is a CPAP driver that can be used in combinaon with the Medijet® nCPAP generator to administer
CPAP therapy. The role of the medin-NC3® in this CPAP system is to provide the necessary, possibly oxygen-enriched
ow volume of the gas, which is fed to the nCPAP generator Medijet® via the tubes connected to the paent and
is converted into CPAP pressure within the generator. In addion, there is the opon to connect Nuow® nasal
cannulas and perform High Flow therapy.
An internal electronic blender combines the oxygen coming from an external source and ambient air provided by
an integrated blower and administers the total volume so that the ow volume of the gas reaching the paent is
enriched with oxygen as necessary to any oxygen level between 21% and 100%.
The ow volume of the gas mix can be set by the operator within a range of 0 L/min to 17.5 L/min depending on
the mode selected. Depending on the mode selected, the medin-NC3® provides a constant ow volume of the
gas which creates a constant CPAP pressure in the CPAP generator Medijet® or evaluates the CPAP pressure signal
measured in the Medijet® in order to react to the paent’s respiraon. In the event of apnea, the medin-NC3®
triggers a higher ow pulse which triggers a pressure impulse in the CPAP generator Medijet® with increased CPAP
pressure. In High Flow mode, the medin-NC3® provides a constant ow up to a maximum of 8 L/min (following
conrmaon from the user up to a maximum of 12 L/min).
The monitor which is part of the medin-NC3® displays the parameters selected by the user, the sensors’ readings,
the length of me that CPAP pressure has been applied by Medijet® in the form of a graph, and any alarms.
The medin-NC3® can operate for up to four hours without mains power thanks to its rechargeable baeries.