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
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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
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© 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
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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
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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

medin Medical Innovaons GmbH
Adam-Geisler-Str. 1
82140 Olching, Germany
[phone]
[email protected]om
www.medin-medical.com
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1 Introducon
Warning:
The medin-NC3® may not be modied without permission from the manufacturer and subsequent appropriate
examinaons and tesng to guarantee connued safe use.
Warning: Warnings must be followed in order to prevent possible serious consequences for the paent or the
operator.
Aenon: This indicates hazards that could damage the device or impair its funconality.
Please note: This indicates how the medin-NC3® can be used more eciently.
Keep these instrucons for use close to the medin-NC3® and easily accessible.
The current instrucons for use are also always available in the download area of our homepage at
www.medin-medical.com.
Please contact the dealer or go directly to the manufacturer if you have any quesons or comments about these
instrucons for use.
Warning:
- Read these instrucons for use carefully before using the products, and follow the instrucons,
warnings and ps closely.
- The medin-NC3® may only be used by individuals with a thorough knowledge of these instrucons
for use, in accordance with these instrucons for use for the purpose described under the secon
headed "Intended use".
- The use of the equipment and consumables used in combinaon with the medin-NC3® (e.g. nCPAP
generators and humidiers) is described in the relevant instrucons for use. Users must also comply
with these instrucons for use.
1.1 About these instrucons for use
These instrucons for use contain informaon about starng up, using and maintaining the medin-NC3®. They also
contain safety informaon, describe the device's funcons and give an overview of the ancillary equipment needed.
Users must be very familiar with the informaon and warnings given in these instrucons for use in order to
operate the medin-NC3® safely. Nonetheless, they are no substute for training.
The instrucons and warnings are categorized as follows:
1.2 General liability condions
The general terms of trade of medin Medical Innovaons GmbH (hereinaer referred to as medin) are binding.
medin accepts no responsibility or liability for the safe use of the medin-NC3® if the device is serviced or repaired
by individuals who have not received appropriate specialist training or if an operaon that does not comply with
correct use is performed. medin also accepts no responsibility or liability for the safe use of the medin-NC3® if
the funcon tests and maintenance that are specied are not carried out. The user is responsible for respecng
maintenance and funcon test intervals. In addion, the operaon of the medin-NC3® requires one-me training of
the user by a qualied person; both individuals must comply with the intended use as well as with the operang sta.
The service life of the device is dened as 8 years.
medin accepts no liability for damage caused by failure to comply with these instrucons.

medin Medical Innovaons GmbH
Adam-Geisler-Str. 1
82140 Olching, Germany
[phone]
[email protected]om
www.medin-medical.com
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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.

medin Medical Innovaons GmbH
Adam-Geisler-Str. 1
82140 Olching, Germany
[phone]
[email protected]om
www.medin-medical.com
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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.

Dimensions (L x W x H) 34 x 25 x 25 cm
Weight 6.25 kg
Gas feed system Computer-controlled electronic gas mixer with integrated oxygen
sensor and integrated blower; ow-controlled
Seng range: 0 L/min to 17.5 L/min (in 0.1 L/min increments)
Control range: 2 L/min to 17.5 L/min
Accuracy: ± 1 L/min (2 to 10 L/min)
± 2 L/min (10 to 17.5 L/min)
Gas feed Air: Ambient air, internal blower
Oxygen: 300 to 700 kPa (= 3.0 to 7.0 bar)
Gas connecon Connector standard: DISS or NIST (as preferred)
Paent ow outlet Dimensions M22 (OD) or F15 (ID)
CPAP pressure meter connecon Luer-type – 4.3 mm ID
Power supply 1x internal baery, 1x external baery (oponal), 14.4 V DC, run
me approx. 2 hours per baery, rechargeable
External power supply 100 to 240 V AC / 50 to 60 Hz
Display 7.0“ – color, 800 x 480 pixel
Data Paent pressure (diagram and measurement)
Trend: CPAP, FiO2, RR, push frequency, ow, rate, I:E (up to 28 days)
CPAP Measurement range 0 to 20 mbar (in 0.1 mbar increments)
Vericaon: Redundant measurement by two sensors
Accuracy: ± 1.3 mbar
Push (inspiraon support) Seng range
Addional ow during the inspiraon push with up to 70% of the
basic ow:
Min: 0 L/min
Max: 17.5 L/min (basic ow + push ow)
Duraon 200 ms to 3 seconds
Manual and automac triggering of pushes
Accuracy: Analogous to the accuracy of the basic ow, aer the
adjustment me has expired
Leak-Assist Leakage compensaon (± 5 L/min to maintain the target pressure)
in all CPAP modes (not in High Flow mode)
RR (respiraon rate) Oponal display of the measured respiratory rate, no display up to
120 breaths per minute, in CPAP and Apnea CPAP mode
Apnea me 2 to 30 s (in 1 s increments)
Tinsp. 0.2 to 3.0 s (in 0.1 s increments)
Triggering Pressure trigger, based on the CPAP pressure sensivity, ±0.2 to
±1.0 mbar (in 0.1 mbar increments)
medin Medical Innovaons GmbH
Adam-Geisler-Str. 1
82140 Olching, Germany
[phone]
[email protected]om
www.medin-medical.com
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Warning:
The medin-NC3® may not be modied without permission from the manufacturer and subsequent appropriate
examinaons and tesng to guarantee connued safe use.
2.6.2. Technical data
Basis of measurement: DIN 1343 at 0°C, 1013.25 mbar and 0% air humidity (0/1013)

Environmental condions
Operaon Temperature: 15 to 40°C
Relave humidity: 5% to 95% (not condensing)
Storage Short-term/transport: Temperature: -20 to +50°C
Relave humidity: 5 to 95%
(not condensing)
Long-term: Temperature: Room temperature
(about 20°C)
Relave humidity: 20 to 80%
(not condensing)
Descripon of the modes
CPAP Standard CPAP; addional funcon: Leak-Assist
Apnea CPAP CPAP with apnea detecon (automacally generated pushes);
addional funcons: Backup (backup rate: 5 to 120 L/min as a
funcon of Tinsp. (minimum 0.2 s), Leak-Assist
NIPPV Bi-level CPAP with measurement of the I:E rao as a funcon of
the set rate and inspiraon me (minimal I:E rao 1:1.5), addional
funcon: Leak-Assist
High Flow Flow emission for Nuow® nasal cannulas in ow range of 0 to 12
L/min, adjustable O2 ush
Standby No ow, deacvated alarms, sengs made are saved, keeps
medin-NC3® ready for use
Soware sengs
Languages EN, DE, FR, IT, NL, ES, EL, CS, PL, NO, DA, SV, RU, LT, ZH, TR, JA, RO
Pressure units mbar or cmH2O
Pressure scale Three sengs: 0 to 10, 0 to 15 and 0 to 20 mbar
Respiraon rate Oponally shown in display
FiO2Oxygen concentraon
Seng range: 21 to 100% (in 1% increments)
Measurement range: 21 to 100%
Alarm sengs: ± 2-5% dierence
O2 ush (level: +5, +10, +15% (vol.) above set target oxygen
concentraon) for 60 s
Accuracy:
± 5% (2 to 4 L/min),
± 2% (from 4 L/min)
Alarms Visual (LED & display) and acousc (adjustable push alarm sengs)
Alarm countdown
Safety Mechanical overpressure valve (opening pressure 6 kPa (= 60 mbar))
External data USB/RS232 port, export of live and trend data
Operang me The medin-NC3® can be used for connuous, long-term operaon
up to 4 weeks without a restart in the interim.
medin Medical Innovaons GmbH
Adam-Geisler-Str. 1
82140 Olching, Germany
[phone]
[email protected]om
www.medin-medical.com
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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
[phone]
[email protected]om
www.medin-medical.com
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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

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a) Trolley plate
b) Knurled screw
3 Installaon of the medin-NC3® – Condions
Before pung the medin-NC3® into service, the following must be borne in mind:
Figure 3-1: a) Trolley plate; b) Knurled screw
3.1 Assembly
Warning:
- The medin-NC3® must always be securely assembled in an upright posion throughout the enre
me that it is in use.
- The medin-NC3® must not be covered while in use, and none of the openings or venlaon slits
must be blocked.
- The overpressure valve should not be blocked during the enre duraon of operaon of the medin-
NC3®.
- A damaged medin-NC3® may not be used.
- Do not load the trolley with more than the permissible weight. The maximum permissible weight
(safe working load) is 40 kg (88 lb).
- The respiratory air humidier should be placed lower than the paent.
Aenon:
- Lock the wheel brakes of the trolley before you begin the installaon.
- Release the brakes before you move the trolley in order to avoid pping.
- Do not lean against the trolley.
- Ensure that all accessories are correctly assembled on the trolley.
- The trolley may p if the oor has an incline of more than 5°.
The medin-NC3® must always be securely assembled before the device is started up. To do this, it is placed on the
baseplate of the trolley (ancillary equipment REF 5008) such that the feet lie in the intended grooves and then it
is xed in place manually using the knurled screw (Figure 3-1– b).
The medin-NC3® can now be transported on this trolley provided that the oxygen supply is also aached to the
trolley. However, if the medin-NC3® becomes damaged during this transport or due to rough handling, its funcon
must be checked by a service technician. It is not allowed to be used unl then!

• with UK plug REF 39-116
• with plug for USA/Japan REF 39-117
• with Australian plug REF 39-118
• with Chinese plug REF 39-127
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3.2 Power supply
3.2.1. Mains operaon
The power supply unit (REF 30-113) of the medin-NC3® may only be connected to a power supply with the
following properes:
• Voltage: 100 – 240 V~ (alternang current)
• Frequency: 50 – 60 Hz
• Strength of current: at least 1.1 A
The power supply unit of the medin-NC3® has a C7 appliance inlet for connecon to the mains grid. The power line
between the power supply unit of the medin-NC3® and the mains grid must therefore meet the following condions:
• Power supply side: plug appropriate for the country
• Device side: C8 plug in accordance with EN 60320
• Minimum rated voltage: the minimum rated voltage of the power line must be at least as high as the
voltage of the local mains supply (recommended: 240 V)
• Minimum rated current: 1.1 A
• Maximum length 2 meters (in order to achieve EMC in accordance with DIN EN 60601-1-2)
Spare power lines with EU plugs can be ordered under REF 39-115 (supplied as standard as part of the power
supply unit). Alternave power lines for other countries are available under these numbers:
Aenon:
The medin-NC3® may only be run on the local mains grid using the power supply unit provided by the manufacturer
(REF 30-113) and suitable power lines, otherwise the funconality and EMC of the device cannot be guaranteed.
The device is disconnected from the mains by pulling the power supply unit cable of the medin-NC3® out of the
electrical outlet. Thus when assembling the medin-NC3®, it should be ensured that this plug is always freely
accessible and can be disconnected from the mains without diculty. The medin-NC3® does not contain any
switch which disconnects it from the mains.
3.2.2. Baery operaon
The medin-NC3® contains an internal as well as an external baery and can work on a fully charged baery for
up to four hours.

Input power: 100 to 240 V AC / 50 to 60 Hz / 1.5 A
Output power: 24 V DC / 3.75 A (SELV - Safety Extra Low Voltage), limited power source
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Figure 3-2: Ba ery charge status display
The charge status of the internal and external ba ery is displayed in the top le -hand area of the medin-NC3®
screen (Figure 3-2).
A full ba ery is shown with a symbol with  ve bars. As soon as only two bars remain, the ba ery symbol is shown
in red and the medin-NC3® should be connected to the mains soon. As soon as there is only one bar le , the
ba ery alarm is triggered.
A en on:
When the medin-NC3® is running on ba ery power, an alarm is sounded when the internal ba ery is low. If this
happens it is essen al that the device be connected to an external power source without delay.
Please note:
If the medin-NC3® ba ery is completely depleted, it can only be recharged very slowly which greatly increases the
recharging  me (up to 5 hours). In addi on, the ba ery will be damaged by this exhaus on and will need to be
replaced sooner. Since the ba ery of the medin-NC3® also recharges while switched o , it is recommended that
the medin-NC3® be regularly charged during longer periods of storage.
3.2.3. Replacing the external ba ery
Before replacing the external ba ery, the medin-NC3® must be switched o . Now the external ba ery can be safely
replaced. To replace the external ba ery, open the ba ery compartment by removing the screw and remove the
external ba ery. A er inser ng the new external ba ery, close the ba ery compartment securely.
A en on:
The external ba ery may not be replaced during opera on of the medin-NC3®.
3.2.4. Power supply unit
The power supply unit of the medin-NC3® may only be used according to its imprinted input and output power.
Disconnect the power supply unit from the mains during thunderstorms.
Warning:
If the medin-NC3® is not connected to the mains, the internal ba ery also discharges while the device is switched
o , that is, if the medin-NC3® is to later be used on rechargeable ba ery power, it must be recharged beforehand.
If the alarm Ba ery low – Connect power supply unit does not disappear despite connec ng the power supply
unit and dele ng the alarm text (e.g. by triggering a push no  ca on or a higher-priority alarm (red)), there may
be a defect of the medin-NC3®. Contact a service technician and do not use this medin-NC3® for the  me being.

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3.3 Gas feed
In order to operate the medin-NC3®, it must be supplied with oxygen from an external source that meets the
following condions:
Medicinal oxygen:
- 300 to 700 kPa (=3.0 to 7.0 bar)
- Oxygen content: ≥ 99.5%
- H2O ≤ 67 ppm (V/V) (free from condensate)
Ambient air:
- Provided by an integrated blower
Aenon:
The funconality of the medin-NC3® can only be guaranteed if the oxygen supplied to it is free from condensate
water, oil and contaminants. If this is not guaranteed, the medin-NC3® could be damaged.
In order to avoid res, oxygen must not come into contact with oil or grease. It is therefore essenal to ensure that
all parts of the medin-NC3® and the CPAP system which come into contact with oxygen (e.g. gas feed tubes, O2inlet
to the medin-NC3®, paent outlet, paent tubes and Medijet®) remain free from oil and grease.
Gas feed connecons:
The medin-NC3® can be ed as standard with NIST or DISS gas feed connecons as the customer prefers. The
tube kits to connect the device to the external gas source must also meet the selected standard.
3.4 External data interfaces
The medin-NC3® can be connected to a system for archiving and processing paent data.
Aenon:
Only devices and systems which are approved for medical use and which meet the relevant electrical safety and
EMC standards may be connected to the medin-NC3® data interfaces. Integraon into such systems can lead to risks
for paents, operators or third pares which were not previously known. The person in charge of the integraon
must determine, analyze, evaluate and manage these risks.
Changes to the system can lead to new risks. Such changes include, for example:
• Changes to the conguraon
• Connecon of addional elements
• Removal of elements
• Update of connected devices
• Upgrade of connected devices
3.4.1. RS232 data interface
The RS232 data interface of the medin-NC3® can be used to retrieve internal device data. In addion, there is the
opon to prompt an export of the trend data in the trend by pressing the corresponding buons. The interface
delivers live data during normal operaon or trend data during export which must be received and saved by a
computer or data management system. Serial data with the following sengs are issued:

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a) b) c) d)
-Data type: serial
-Baud rate: 115200
-Data bits: 8
-Parity: none
-Stop bits: 1
-Handshaking: none
To connect the medin-NC3® to a system for archiving and processing pa ent data, a crossover RS232 cable ("null
modem cable") can be used (see Figure 3-3: RS232 and USB cable with ferrite). Nonetheless, the func on of the
medin-NC3® must be observed to avoid disrup ons by the en re system with regard to electromagne c in uences.
The protocol speci ca on for integra on into a system for archiving and processing pa ent data can be found in
sec on 3.4.4.
3.4.2. USB interface
The USB interface is purely a service interface, for example, to install so ware updates. Its cover should be opened
only by trained personnel.
3.4.3. Cable
The cables to be used (RS232 / USB) must contain a ferrite (REF 39-125; Würth Elektronik – type: 742-711 32, gray
or black) with a double wound cable in accordance with Figure 3-3.
Figure 3-3: RS232 and USB cable with ferrite
A) RS232 cable without ferrite b) RS232 cable with a ferrite that is s ll open whereby the cable must be carried
through the core twice, that is, wrap the ferrite core once. c) RS232 cable with ferrite d) USB cable with ferrite (the
cable must also be carried through the ferrite core twice as in the case of RS232 cable)

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Aenon:
The data interfaces of the medin-NC3® may be used only with the cables, including ferrite core, specied above, of
type 742-711-32 from the manufacturer Würth Elektronik with double winding. The connected computer system
must meet the medically relevant requirements with regard to electrical safety and EMC, otherwise the funconality
and EMC of the medin-NC3® cannot be guaranteed.
3.4.4. Output data (live and trend data)
3.4.4.1. Live data
The live data of the medin-NC3® contain the paent pressure, the set ow, the measured oxygen concentraon,
informaon whether a push is currently being emied, all alarms, the set addional push ow and the current mode.
In addion, date, me, device name and soware version are regularly indicated. The live data are automacally
and constantly indicated in normal operaon. However, they are not saved in the medin-NC3®. If the live data are
of interest, they must be recorded and saved by a computer or data system, otherwise the data will be lost. The
exact structure of the live data is described below:
Every 10 min., a line with these data is indicated:
- ***;
- Date;
- Time;
- Device name (can be set in the service menu);
- VXXXX (CPU soware version);
In the interim, the following data are provided every 0.1 second (separated by ";" ) via the USB interface:
- The currently measured CPAP pressure (in CPAP and Apnea CPAP mode) in XX.X mbar
- Set target ow in XX.X L/min for the basic CPAP level; in the case of addional acvaon of the
Leak-Assist, the target ow + correcon ow is emied.
- Measured oxygen concentraon FiO2 XXX%;
- Current push acvity X: 2 = Backup acvely running (independent of whether there is currently a
push or not), 1 = push acve (without backup), 0 = no push acve;
- High-priority alarms (acve alarms are indicated by a bit set at the corresponding site). The sum of
all acve alarms XXXX is given:
▪0x0001: Disconnecon
▪0x0002: CPAP pressure high (xed)
▪0x0004: Feed pressure high
▪0x0008: Gas feed oxygen
▪0x0010: Gas feed air
▪0x0020: Device error – paent pressure measurement
▪0x0040: Flow stopped, reacvaon via alarm reset
▪0x0100: Device error – restart necessary

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- Medium-priority alarms XXXX:
▪0x0001: Baery almost empty – Connect power supply unit
▪0x0002: CPAP pressure high (adjustable)
▪0x0004: CPAP pressure low (adjustable)
▪0x0008: Oxygen concentraon high
▪0x0010: Oxygen concentraon low
▪0x0020: Internal temperature too high
- Low-priority alarms XXXX:
▪0x0001: Fan blocked
▪0x0004: Leak-Assist
▪0x0008: Power supply unit disconnected
▪0x0010: External baery low
▪0x0020: External baery temperature
- Addional ow set during the push XX.X L/min
▪Mode X:
▪C = CPAP
▪A = Apnea CPAP
▪N = NIPPV
▪H = High Flow
Example of live data:
***;2016-04-04;14:09:11;medin-nc3 1004;V1.00;***
07.0;08.7;021;0;0000;0000;0000;03.8;C
07.9;08.7;021;0;0000;0000;0000;03.8;C
07.9;08.7;021;0;0000;0000;0000;03.8;C
07.7;08.7;021;0;0000;0000;0000;03.8;C
07.5;08.7;021;0;0000;0000;0000;03.8;C
06.7;08.7;021;0;0000;0000;0000;03.8;C
3.4.4.2. Trend data
The trend data are divided into two parts: The rst part contains logles of saved alarms and device starts. This
recording contains the data of the last device uses and will connue to be saved even if the medin-NC3® is switched
o. The second part of the trend data is deleted each me the medin-NC3® is switched o. It saves the data since
the last device start, however for a maximum of 28 days. It contains the CPAP pressure, the set ow, the measured
oxygen concentraon, the set addional push ow, the mode, respiratory rate, informaon whether the backup
was acve, the push rate Rinsp, the minimum and maximum possible push rate, the maximum pressure during the
pushes, the set inspiraon me and the set apnea me.
The structure of the trend data is shown below as an example:
###;2016-04-07;14:20:14;medin-nC3 1004;V1.00;alarm record;###
start;2015-04-04;10:59; alarm;04;11:07;0000;0008;0000;for 14:48
alarm;04;1:50 PM;0000;0004;0000;for 12:30 AM
alarm;04;2:14 PM;0002;0002;0000;for 12:36 AM
###;2016-04-07;14:20:15;medin-nc3 1004;V1.00;trend record;###
CPAP; ow;FiO2;Finsp;Mode; RR;BU;Rinsp;Pinsp;Tinsp;Tapn;
05.6; 07.0; 021; 00.0; C;018; ; ; ; ; ;
05.6; 07.0; 021; 00.0; C;018; ; ; ; ; ;
05.5; 07.0; 024; 01.0; A;024; -; 000; ; 0.3;10.0;
05.9; 07.5; 024; 01.0; A;018; -; 000; ; 0.3;10.0;
02.5; 06.0; 026; 02.5; N; ; ; ; ; ; ;
04.1; 06.0; 036; 03.7; N; ; ; ; ; ; ;
***;2016-04-07;14:20:51;medin-cnt1004;record complete;###

- ###;
- Date: YYYY-MM-DD; (current date, set in the service menu)
- Time: HH:MM:SS; (current me, set in the service menu; switching to
local me or daylight savings me (summer me) must
be performed manually)
- Device name: medin-NC3 ZZZZ (can be set in the service menu)
- SW version: VXXXX (installed main soware version)
- Alarm record; ###
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Start of alarm recording:
Start and alarm recording:
- For each device start, date and me are saved as such:
start; YYYY-MM-DD;HH:MM;
- For each new alarm, day, me, all acve alarms of high, medium and low priority and the duraon
(min:sec) of the alarms are saved:
alarm; DD; HH:MM;HHHH;MMMM;LLLL;for MM:SS
The alarm coding takes place analogously to the coding in the live data (for detailed informaon, see chapter
3.4.4.1). The date is only shown as a day. The month can be determined using the last prior start entry. The alarm
duraon is indicated in minutes and seconds from the start of the alarm unl its end.
Recording the set and measured values:
The trend data contain all values saved in the trend and addional values since the last me the device was switched
on. Every 20 seconds, a line is saved. If a value is not available in the current mode, it is replaced with blank spaces.
The structure is as follows:
- Average value of the CPAP pressure in XX.X mbar
- Set ow in XX.X L/min + if applicable, correcon ow with acvated Leak-Assist
- Measured FiO2 in XXX%
- Addional set push ow in XX.X L/min
- Current mode: C = CPAP, A = Apnea CPAP, N = NIPPV, H = High Flow, - = Standby
- Measured respiraon rate in XXX / min
- Status of backup (B = acvely running; -= currently not acvely running or generally o)
- Push frequency Rinsp in XXX / min
- Maximum CPAP value during the push in XX.X mbar
- Set push length Tinsp in X.X sec
- Set apnea me in XX.X sec
Please note:
When reading the trend data, there may be me delays upon receipt at the computer or data system. For this
reason, when reading the data, wait unl the last line (***;2016-0407;14:22:51;medin-nc3® 1004;record complete;) has
been issued. Only then have the trend data been fully received.

Environmental condions for the medin-NC3® during operaon:
Temperature: 15°C to 40°C
Relave air humidity: Air humidity 5% to 95% (not condensing)
Moisture: The device is to be kept dry during operaon.
Ambient pressure: 700 hPa to 1100 hPa
Oxygen environment: O2 content < 25%
Altude: ≤ 3000m above sea level
Cleanliness: The hygiene regulaons valid for the hospital are to be observed. In addion,
the medin-NC3® is to be operated under standard hospital ambient condions.
Environmental condions for the power supply unit during operaon:
Temperature: - Between 0°C to 60°C
- Do not use power supply unit in locaons exposed to signicant
temperature uctuaons
Moisture: - Use only in dry rooms
- Relave air humidity ≤ 90%, not condensing
- Do not use in locaons exposed to signicant amounts of moisture or
condensate formaon
- Do not use in locaons exposed to signicant environmental stress
- Do not use outdoors
Vibraons: Do not use in locaons exposed to constant vibraon.
Environmental condions for the medin-NC3® during transport/short-term storage:
Temperature: -20°C to 50°C (longer-term storage only at room temperature)
Relave air humidity: 5% to 95% (not condensing)
Moisture: During transport and storage, the medin-NC3® must be protected from wet
condions.
Cleanliness: The medin-NC3® must be protected from contaminaon during transport
and storage.
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3.5 Environmental condions (operaon / transport / storage)
The medin-NC3® must not be used in rooms at risk of explosion, near to ammable substances or close to locaons
exposed to splash water.
Warning:
The medin-NC3® is not suitable for use near magnec resonance imaging equipment (MR-unsafe) or electrosurgical
equipment.
During operaon, the medin-NC3® should not be used in the direct vicinity of other electronic devices or stacked.
If use as described above is nonetheless necessary, this device and other devices should be observed to ensure
that they are working properly.