Medin NC3 User manual

Instruc ons for use
medin-NC3®
REF 3000

medin Medical Innovaons GmbH
Adam-Geisler-Str. 1
82140 Olching, Germany
[phone]
[email protected]om
www.medin-medical.com
IFU_medin-NC3 EN
Rev 05 Status as of 28.04.2021
2of 68
The medin-NC3® contains baeries and electrical components. Consequently it cannot be
disposed of in domesc waste but must be collected separately and recycled in accordance
with local regulaons. (WEEE direcve 2012/19/EU)
CE mark according to the current conformity assessment procedure and declaration of conformity
(see website).
Classicaon (MDD 93/42/EEC Annex IX): IIb
Classicaon (MDR (EU) 2017/745 Annex VIII): IIb
medin Medical Innovaons GmbH
Adam-Geisler-Str. 1 – 82140 Olching – Germany
[phone] – www.medin-medical.com – inf[email protected]
Made in Germany
OP_NC3 REV 05 Correct as of: 28.04.2021
The user is obligated to report all serious incidents which occur in connecon with the product to the manufacturer as
well as the competent authority of the member state/country in which the user is located. Serious incidents are dened as
malfuncons, breakdowns or changes in the characteriscs or the performance or inadequacies in the labeling or instrucons
for use of a medical device which directly or indirectly lead to, could have led to or could lead to the death or a serious
worsening in the state of health of a paent, user, or another person.

medin Medical Innovaons GmbH
Adam-Geisler-Str. 1
82140 Olching, Germany
[phone]
[email protected]om
www.medin-medical.com
IFU_medin-NC3 EN
Rev 05 Status as of 28.04.2021
3of 68
© 2021 medin Medical Innovaons GmbH. All rights reserved. Printed in Germany.
This publicaon may not – in whole or in part – be reproduced, stored in a database or data backup system nor
transmied, photocopied or recorded in any form electronically or mechanically without the prior wrien permission
of medin Medical Innovaons GmbH.
This document may be revised, exchanged or replaced by other more current documents by medin Medical
Innovaons GmbH at any me without prior noce. Ensure that you have the most current version of this document;
for any quesons, please contact Customer Service of medin Medical Innovaons GmbH or alternavely you can
download the most current version from our homepage at www.medin-medical.com. Although we exercised the
greatest possible care in compiling the informaon in this manual, it cannot replace a professional assessment.
medin Medical Innovaons GmbH reserves the right to make changes to the devices described (including the
soware), independent of the content of this manual and without prior noce. Unless otherwise specically agreed
to in wring, medin Medical Innovaons GmbH is not obligated to communicate revisions, updates or changes to
the devices (including soware) described in the manual to the owner or operator.
The devices may be operated, maintained and upgraded only by correspondingly trained professionals. medin
Medical Innovaons GmbH is responsible with regard to the devices only within the scope of the limited warranty
condions listed in the operang manual for the device.
medin Medical Innovaons GmbH is not responsible for loss, costs, expenses, inconveniences or damages which
may result from the misuse of the product or the use of parts not originang from medin Medical Innovaons GmbH
when replacing components or in the event of a change, destrucon or removal of the serial number.
medin Medical Innovaons GmbH provides circuit diagrams, component part lists, descripons, calibraon
instrucons or other informaon upon request which helps appropriately trained personnel repair device parts
which are idened by medin Medical Innovaons GmbH as being repairable.
Informaon on medin Medical Innovaons GmbH’s own trademarks or trademarks from third pares used is
available at: www.medin-medical.com/de/Patents.html. Product and/or company names marked with the symbol
® may be trademarks and/or registered trademarks of other manufacturers.

medin Medical Innovaons GmbH
Adam-Geisler-Str. 1
82140 Olching, Germany
[phone]
[email protected]om
www.medin-medical.com
IFU_medin-NC3 EN
Rev 05 Status as of 28.04.2021
4of 68
Table of contents.......................................................................................................................................................... 4
1 Introducon ....................................................................................................................................................... 6
1.1 About these instrucons for use .............................................................................................................. 6
1.2 General liability condions ....................................................................................................................... 6
2 Descripon of the Device and Condions for Use ............................................................................................. 7
2.1 Intended use ............................................................................................................................................ 7
2.2 Operang sta .......................................................................................................................................... 8
2.3 Alternave respiraon systems ................................................................................................................ 8
2.4 Combinaon with other devices and ancillary equipment ...................................................................... 8
2.5 Expected locaons of the operator, paent and other persons ............................................................... 8
2.6 Technical descripon of funcon ............................................................................................................. 8
2.6.1. Principles of funcon ................................................................................................................. 8
2.6.2. Technical data ............................................................................................................................ 9
2.6.3. Overview of the general technical descripon ........................................................................ 11
3 Installaon of the medin-NC3® – Condions ................................................................................................... 12
3.1 Assembly ................................................................................................................................................ 12
3.2 Power supply .......................................................................................................................................... 13
3.2.1. Mains operaon ....................................................................................................................... 13
3.2.2. Baery operaon ..................................................................................................................... 13
3.2.3. Replacing the external baery ................................................................................................. 14
3.2.4. Power supply unit .................................................................................................................... 14
3.3 Gas feed ................................................................................................................................................. 15
3.4 External data interfaces .......................................................................................................................... 15
3.4.1. RS232 data interface ................................................................................................................ 15
3.4.2. USB interface ........................................................................................................................... 16
3.4.3. Cable ........................................................................................................................................ 16
3.4.4. Output data (live and trend data) ............................................................................................ 17
3.5 Environmental condions (operaon / transport / storage) .................................................................. 20
4 First Use ........................................................................................................................................................... 22
4.1 CPAP system components ...................................................................................................................... 22
4.2 Connecng the medin-NC3® and seng up the CPAP system ............................................................... 23
4.3 Starng up the system ........................................................................................................................... 27
5 Operaon ......................................................................................................................................................... 28
5.1 Operator console .................................................................................................................................... 29
5.2 Display screen ........................................................................................................................................ 30
5.3 Basic CPAP sengs ................................................................................................................................. 31
5.4 O2 ush ................................................................................................................................................... 32
Table of contents

medin Medical Innovaons GmbH
Adam-Geisler-Str. 1
82140 Olching, Germany
[phone]
[email protected]om
www.medin-medical.com
IFU_medin-NC3 EN
Rev 05 Status as of 28.04.2021
5of 68
5.5 Push (not in High Flow mode) ................................................................................................................ 33
5.6 CPAP mode ............................................................................................................................................. 34
5.7 Leak-Assist............................................................................................................................................... 35
5.8 Apnea CPAP mode .................................................................................................................................. 36
5.9 Backup funcon ..................................................................................................................................... 38
5.10 NIPPV mode ........................................................................................................................................... 38
5.11 High Flow mode ..................................................................................................................................... 39
5.12 Mode change ......................................................................................................................................... 40
5.13 Alarm sengs ........................................................................................................................................ 40
5.14 Trend ...................................................................................................................................................... 42
5.15 Standby .................................................................................................................................................. 42
6 Switching O .................................................................................................................................................... 44
6.1 Soware switch-o ................................................................................................................................ 44
6.2 Hardware switch-o ............................................................................................................................... 44
6.3 Disconnecon ......................................................................................................................................... 44
6.4 Disposal and recycling ............................................................................................................................ 44
7 Accessories ...................................................................................................................................................... 46
7.1 medin accessories................................................................................................................................... 46
7.2 Components of the rest of the CPAP system .......................................................................................... 48
8 Alarms and Error Messages ............................................................................................................................. 49
8.1 Error messages during system start-up .................................................................................................. 49
8.2 Error messages during operaon ........................................................................................................... 50
8.3 Emergency program................................................................................................................................ 55
8.4 Indicator lights ........................................................................................................................................ 56
9 Cleaning and Maintenance .............................................................................................................................. 57
9.1 Cleaning .................................................................................................................................................. 57
9.2 Device maintenance ............................................................................................................................... 57
9.3 Repairs .................................................................................................................................................... 58
9.4 Device modicaons .............................................................................................................................. 58
9.5 Power supply unit (cleaning, maintenance, repairs and modicaons) ................................................ 58
9.6 Filter ....................................................................................................................................................... 59
10 Electromagnec Compability ......................................................................................................................... 60
10.1 Electromagnec transmission ................................................................................................................ 60
10.2 Electromagnec immunity ..................................................................................................................... 61
11 Symbols ............................................................................................................................................................ 64
12 Abbreviaons.................................................................................................................................................... 66
13 List of References.............................................................................................................................................. 67
14 History of the Soware Versions and Hardware Changes ............................................................................... 68