Medin medinCNO, Руководство пользователя

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+49 8142 448 460
info@medin-medical.com
www.medin-medical.com
medin Medical Innovations GmbH
Adam-Geisler-Str. 1
D-82140 Olching
OP_medinCNO EN
Rev 12 Stand 06.03.2019
6 von 68
2 Description of the Device and Conditions for Use
2.1 Intended purpose
The medinCNO
®
CPAP driver is used in combination with the Medijet
®
nCPAP generator to administer CPAP
therapy to premature infants and newborns. The medinCNO ® must be used under the supervision of expert,
specially trained staff in a clinical setting, and the patient’s oxygen saturation must be monitored at the same
time.
Warning:
-
The medinCNO ® is intended for clinical use only.
- The medinCNO
®
may only be used while the patient’s oxygen saturation is being monitored at the
same time.
- The medinCNO
®
may only be used by and under the supervision of expert staff who have been
trained in the device.
-
For use only in combination with the Medijet ® nCPAP generator.
- The medinCNO
®
is a CPAP device. It is suitable only for patients who can breathe spontaneously
and not for patients who are dependent on artificial respiration.
- The medinCNO
®
may not come into contact with flammable anaesthesia gases or other flammable
materials while in use.
- The medinCNO ® may not be operated in an oxygen-enriched environment.
- US legislation stipulates that this device may only be sold to or on the instructions of a doctor (for
USA: Rx only).
2.2 Operating staff
The medinCNO
®
must be operated by a doctor or by an individual with the necessary technical skills acting on
a doctor’s instructions. Consequently, all operating staff must have a detailed knowledge of these instructions
for use and have undergone training in the device.
2.3 Alternative respiration systems
An alternative CPAP system or respiration system (e.g. bag valve unit) must always be available while the
medinCNO
®
is in use.
2.4 Combination with other devices and ancillary equipment
The medinCNO ® may be combined with devices or consumables (e.g. CPAP ancillary equipment) not mentioned
in these instructions for use only after consulting the manufacturer.
Use of ancillary equipment that is not approved puts the patient at risk and may impair the proper functioning
of the device.
Warning:
If the medinCNO
®
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
function, electrical safety and EMC of the medinCNO
®
are not guaranteed.