Medin NC3 - Overview of the General Technical Description

Standards and approvals
Meaning The medin-NC3® is manufactured in accordance with a cered
quality assurance system according to EN ISO 13485, EN ISO 9001,
EU direcve 93/42/EEC, Annex II without secon 4. The nCPAP
device meets the basic requirements of council direcve 93/42/
EEC, Annex I.
Classicaon according to EC direcve
93/42/EEC
Class IIb
IEC cercaon 60601-1, 60601-1-2, 60601-1-8
Protecon class Class II device
IP protecon class IP20
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
11 of 68
2.6.3. Overview of the general technical descripon
Informaon on these points can be found in the chapters indicated:
• Condions for use, transport and storage: see chapter 3.5
• Characteriscs and accuracies of the device: see chapter 3.2.2
• Informaon on the installaon of the device: see chapter 3
• Descripon of the supply gases required: see chapter 3.3
• Descripon of the power supply: see chapter 3.2
• Repairs and an exchange of parts may only be made by trained, professional service per-
sonnel and only in accordance with the instrucons in the Maintenance Manual, observing
warnings in the manual and in these instrucons for use: chapter 9.3
• Changes and modicaons to the medin-NC3® are not permied without the permission of
the manufacturer: see chapter 9.4