NOXtec:

Technical manual

Applicable to versions:

NOXtec 1000

NOXtec 2000

NOXtec 3000

Ingeniería y Técnicas Clínicas, S.A.

c/ Tungsteno 11-15. Pol. Ind. El Olivar
Rev. 6 - 09/2018 E-28500 Arganda del Rey (Madrid) SPAIN
Tel +34 918 719 950 – Fax +34 918 706 601
www.itcsal.com itcsal@itcsal.com
 NOXTEC: TECHNICAL MANUAL

Contents
1. Definitions and abbreviations ......................................................................................................................... 4

2. Introduction to this manual ............................................................................................................................. 5

3. Safety warnings .................................................................................................................................................... 6

4. General description of the device ................................................................................................................. 8

4.1. Intended use................................................................................................................................................. 9

5. Battery inspection............................................................................................................................................. 11

6. Package content................................................................................................................................................ 12

7. Parts and accessories ................................................................................................................................... 13

8. Device set-up and calibration procedures ............................................................................................. 17

8.1. Device set-up............................................................................................................................................. 17

8.1.1. Turn the device on by the internal switch............................................................................... 17

8.1.2. Standard verification ........................................................................................................................ 17

8.1.3. Device configuration ......................................................................................................................... 18

8.2. Calibration of the device ...................................................................................................................... 18

8.2.1. Gases monitor..................................................................................................................................... 18

8.2.2. Proportional valves............................................................................................................................ 21

8.2.3. Respiratory flow sensors ............................................................................................................... 22

8.2.4. Dosing flow sensor............................................................................................................................ 23

9. Maintenance ....................................................................................................................................................... 24

9.1. Cleaning ....................................................................................................................................................... 24

9.2. Spare part list........................................................................................................................................... 24

9.3. Replacing the gases sensor block .................................................................................................. 25

9.4. Replacing the device enclosure........................................................................................................ 26

9.5. Back panel components substitution ............................................................................................ 27

9.6. Replacing the power supply ............................................................................................................... 27

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9.7. Replacing the battery or the smart charger ............................................................................. 28

9.8. Electronic component replacement............................................................................................... 29

9.9. Replacing a manifold ............................................................................................................................. 29

9.10. Changing the unit configuration .................................................................................................. 30

9.11. Remote access to the unit ............................................................................................................ 30

9.12. Accessing to technical service windows ................................................................................. 31

Dosing window.................................................................................................................................................... 31

Monitor window ................................................................................................................................................. 33

Command window ............................................................................................................................................ 34

Logs window ........................................................................................................................................................ 35

10. Technical service routine ......................................................................................................................... 36

Description of the table .................................................................................................................................. 36

11. Warranty ......................................................................................................................................................... 39

12. Technical specifications ............................................................................................................................ 40

12.1. Physical specifications ..................................................................................................................... 40

12.2. Operating and storage conditions ............................................................................................. 40

12.3. Monitoring module ............................................................................................................................ 40

12.4. Dosing module .................................................................................................................................... 41

12.5. Electrical Specifications .................................................................................................................. 41

12.6. Electromagnetic and RF specifications ................................................................................... 42

13. Troubleshooting ............................................................................................................................................ 46

13.1. Key points of dosing .......................................................................................................................... 47

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1. Definitions and abbreviations

Abbreviation Description

NO Nitric Oxide

NO2 Nitrous Oxide

O2 Oxygen

N2 Nitrogen

ppm Parts per million

m Meters

mm Millimetres

kg Kilograms

L Litters

h Hour

min Minutes

s Seconds

C Degree Celsius

V Volts

A Amperes

Hz Hertz

W Watts

EMC Electromagnetic compatibility

RF Radio frequency

“Bias flow” Flow of gas provided to the patient from the respiratory device

Flow of NO provided to the patient circuit that is mixed with the Bias
“Dosing flow”
Flow to dose NO to the patient

Acronym of Electrically Erasable Programmable Read-Only Memory.

Type of memory that can be programmed, erased and
EEPROM
reprogrammed electrically. Data remain stored when the memory
is not powered electrically

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2. Introduction to this manual

This manual is a guide for servicing NOXtec. The essential and safety aspects for servicing
NOXtec are described in this document.

It is very important to read this manual before servicing NOXtec. Images and diagrams are
included to facilitate the maintenance of the device.

This document is subject to periodic revisions.

Should you need clarifying doubts or response to questions regarding this manual or NOXtec,
please contact with the manufacturer in:

Ingeniería y Técnicas Clínicas, S.A.

c/ Tungsteno, 11-15. Pol. Ind. El Olivar
E-28500 – Arganda del Rey – Madrid – Spain
Phone: +34 91 871 99 50
Fax: +34 91 870 66 01
e-mail: itcsal@itcsal.com

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3. Safety warnings

- Read and follow the instructions and recommendations in this manual.

- Read this manual before servicing NOXtec.
- The use of accessories, transducers and cables other than those specified by ITC,
S.A. may lead to an increase in emissions or a decrease in the immunity of the
device.
- NOXtec is intended for using by healthcare professionals only. This device may
cause radiofrequency interference or may disturb the operation of devices in its
vicinity. Mitigations may be necessary, such as reorientation or relocation of the
NOXtec or shielding.
- NOXtec needs special cautions regarding EMC and needs to be installed and
commissioned in accordance with EMC information supplied.
- Portable and mobile RF communications devices can affect the normal operation
device.
- NOXtec should not be used adjacent or stacked with other devices. If it is
necessary to use it adjacent or stacked, the device should be observed to verify
normal operation in the configuration in which it will be used.
- Do not touch the cover of NOXtec if it is damaged to avoid electrocution by
accessing to 220 VAC.
- To avoid the risk of electric shock, this device should only be connected to the main
with protective earth.
- In case of failure of the internal power supply of the device or other component, do
not replace it or any other internal component by yourself. Stop using the unit as
soon as reasonably possible and call the specialized service.
- Do not open the unit if you are not previously trained by the manufacturer for
servicing the product. Don’t touch never ever the internal electronics boards
without using the proper electrostatic discharge protection elements.
- The unit has inside an Ion-Lithium battery to keep the power in case of electrical
failure. If required, this battery must be replaced by qualified and trained personnel
only. Incorrect replacement of this component may cause a serious hazardous
situation including very high temperatures, fire or explosion.

Replacement of the system battery must be carried out by qualified trained

personnel in accordance with the manufacturer's instructions.

- Once NO treatment is concluded, it is highly recommended to close the NO

cylinders and manually vent the inlet pressurized lines to depressurize the system.
- User is responsible of replacing the N2 / NO cylinder once it is exhausted to avoid
dangerous situations to the patient. Note that the option of automatic cylinder
exchange can be deactivated by the user, in which case the device does not
guarantee continuing supplying gas if the cylinder in operation is exhausted.
- The estimated treatment time of the cylinder in operation reported in the User
Interface is referential only.

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The manufacturer will disclose the circuit schemes, drawings, replaceable component list,
calibration instructions or that information required by the technical support for servicing the
unit or replace those components replaceable into the device.

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4. General description of the device

NOXtec is a device for measuring and monitoring nitric oxide. This device is intended to be
use in inhale NO therapies for adults, children and new-borns. In addition, NOXtec monitors
the concentration of NO, NO2 and O2 received by the patient.

The dosing, monitoring and user interface modules are autonomous and independent. This
means that, in a hypothetical failure situation in one of the modules, the other will continue
operating normally, ensuring patient safety.

The alarm thresholds of the monitoring module are pre-programmed in an EEPROM, so that
faults in the user interface will not affect to the therapy applied to the patient or to the
monitor of gases.

The NOXtec dosing module has an automatic NO cylinder change system that increases unit
autonomy and patient safety. Additionally, this module includes a venting system to ensure
that the internal circuit is vented before dosing the patient minimizing undesirable
concentrations of NO2 during treatment.

The device has a venting port for the evacuation of all the gases released into the device that
guarantees no concentration of NO in the treatment room. This has to be connected to the
extraction system or driven out of the room. Note that gas exhaled by the patient is not
conducted to the vent port and should be treated independently.

1. Screen (LCD touch screen) 9. Manual purging for cylinder 1 (for 1000 and
2000)
2. Control button
10. Cylinder 1 inlet connection (for 1000 and
2000)
3. On/Off button
11. Cylinder 1 pressure sensor connection (for
4. Ethernet port (for technical support only) 1000 and 2000)
12. Cylinder 2 pressure sensor connection (for
5. RS232 port (for connection with ventilator) 1000 ONLY)
6. Calibration gas inlet 13. Cylinder 2 inlet connection (for 1000 ONLY)
14. Manual purging for cylinder 2 (for 1000
7. Manual purge of calibration gas only)
8. Venting outlet 15. Power cord connection

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16. Water trap 21. Electrical connector for the differential

pressure respiratory flow sensor (for
17. Manual dosing bypass 1000 only)

19. NO dosing outlet (for 1000 and 2000) 22. Access lid for the gases (NO, NO2 and O2)
sensor manifold
20. Hot wire respiratory flow sensor connector
(for 1000 only)

4.1. Intended use

NOXtec is designed to dose certain concentration of NO to patients requiring this gas for
inhale treatment in concentrations from 0 to 100 ppm. The device is intended for the
treatment of persistent pulmonary hypertension in new-borns, in post-surgery patients with
severe heart disease, acute respiratory distress syndrome and other respiratory diseases.

NOXtec measures the patient's respiratory flow and calculates the N2/NO flow (depending
on the NO concentration in the cylinder) required to dose certain concentration of NO to the
patient. It also takes a sample of the gas supplied to the patient to measure the
concentration of O2, NO and NO2 in the mixture received by the patient.

The device should be used by trained medical personnel for the treatment of new-borns,
children and adults. Patients with special needs such as new-borns or children should be
cared for by healthcare personnel throughout the treatment.

The device must be connected to the mains and includes an internal battery for powering it
during few hours. No connectivity to a server is required. The device is used in combination
with 15mm or 22mm ventilation tubing. Use only the disposable recommended by the
manufacturer.

It is not expected that the patient interacts with the device. It should be handled by qualified
healthcare personnel only.

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NOXtec should be used indoors, in dry places and with a temperature between 0 and 40C.
The device is intended for use in a hospital environment. It incorporates a manual dose
bypass that can be used in case of device failure.

NOXtec must only be installed by qualified personnel as well.

NOXtec is intended for the treatment or alleviation of diseases. The computer has an RS232
port for synchronizing information with human ventilators. Use only with compatible
ventilators certified by ITC S.A. The software of the unit can be updated locally or remotely but
only by authorized and qualified personnel.

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5. Battery inspection
NOXtec has an internal battery to power the unit in case of main failure. This is a Lithium
battery that must be verified in the annually inspection of the device or remotely in the
monthly inspections.

The maximum number of charge/discharge cycles is 300 times. If the number of cycles is
higher than 275 times, replace the battery. For verifying the number of charge/discharge
cycles of the battery, access to the menu “Help/device”.

Additionally, replace the battery if it is 20 years old or older. Manufacturing date of the
battery can be verified in the same menu “Help/device”.

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6. Package content
Unpack the product and check the following items are in the package:

- Nitric Oxide Monitor and Deliver System NOXtec (or only monitor in the case of
NOXtec 3000)
- Instruction for Use
- Power cord
- Disposable new-born patient circuit kit – differential pressure
- Disposable adult patient circuit kit – differential pressure
- Disposable new-born patient circuit kit – hot wire
- Disposable adult patient circuit kit – hot wire

Note: Keep the package in case you the device needs to be shipped.

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7. Parts and accessories

WARNING: Do not use or attach to the device items not specified by the manufacturer.

Power cord

Fig. 7-1

Pressure regulator for cylinder N2/NO

(For 1000 and 2000)

Fig. 7-2

Pressure regulator for calibration cylinder

Fig. 7-3

Gases sensors block

Fig. 7-4

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Neonate water trap

Fig. 7-5

Adult water trap

Fig. 7-6

New-born differential pressure sensor (for

1000 ONLY). Blue port is connected to the inlet
of flow (to the ventilator)

Fig. 7-7

Adult differential pressure sensor (for 1000

ONLY). Blue port is connected to the inlet of
flow (to the ventilator)

Fig. 7-8

New-born hot wire sensor (no released yet. for

1000 ONLY)

Fig. 7-9

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Adult hot wire sensor (for 1000 ONLY)

Fig. 7-10

Dose tube (for 1000 and 2000)

Fig. 7-11

Sampling gas tube

Fig. 7-12

Elbow connector “Luer Lock” (for 1000 and

2000)

Fig. 7-13

Straight connector 15M-15F with port of 7.6

mm (for 1000 and 2000)

Fig. 7-14

Straight connector 22M-22F with port of 7.6

mm (for 1000 and 2000)

Fig. 7-15

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Straight connector 22M-22M with port of 7.6

mm (for 1000 and 2000)

Fig. 7-16

New-born corrugated tube Ø15 mm L = 300

mm (for 1000 and 2000)
Fig. 7-17

Adult corrugated tube Ø22 mm L = 300 mm

(for 1000 and 2000)
Fig. 7-18

EGA connector

Fig. 7-19

Function Specification Manufacturer Reference Length

3bias, phase, neutral and earth of 10A

220 V AC Generic Generic 1.8m
220v, IEC C13

Hot wire 6bias, special wire for hot wire Sensirion N/A 1.5 m

(optional, only for synchronization with

RS232 ventilators) Male, DB9 female, 9 ways, 3x Multicomp 11.99.6218 1.8m
twisted pairs.

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8. Device set-up and calibration procedures

8.1. Device set-up

8.1.1. Turn the device on by the internal switch

1. With a screwdriver, remove the four screws located on the left side of the device.

2. Remove the cover.

3. Very carefully, press the switch indicated in the picture below.

4. Put the cover in the same position it was when it was removed.

5. Screw on the four screws with the screwdriver.

8.1.2. Standard verification

1. Check cylinder (inlet) leaking.

2. Checking leaking in the dosing module.

3. Check leaking in the monitor module.

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4. Check leaking in sensor block.

5. Check alarms sound.

8.1.3. Device configuration

1. Set the treatment NO cylinder conecntration.

2. Set the cylinder size.

3. Set the calibration gas NO and NO2 concentrations (see section “8.2.1 Gases
monitor”).
4. To do an automatic sensor calibration (see section “8.2.1 Gases monitor”).
5. To do a proportional valves automatic calibration (see section “8.2.2 Proportional
valves”).

8.2. Calibration of the device

8.2.1. Gases monitor

Normally calibrated by the user. Must be calibrated at least every two weeks, but it is
recommended more often.

To perform automatic calibration, connect the calibration cylinder regulator to the calibration
gas inlet port (“Calibration”).

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Fig. 8-1

Slowly open the calibration cylinder and check its pressure in the regulator gauge. Close it for
30 seconds and verify the pressure is not dropping meaning the regulator is not leaking.

If the cylinder is opened quickly, the pressure in the regulator can increased suddenly
creating a potential hazardous situation.

Close the cylinder and reject the pressure regulator if it is leaking.

Enter or check calibration target values for NO and NO2 according to the calibration cylinder
label following the next steps:

Note: Calibration parameters for oxygen cannot be modified by the user.

The automatic calibration can be performed following the next steps:

Note: Remove the sampling tube from the water-trap as shown in the video before starting
the calibration process.

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Before starting the calibration, the sampling tube must be removed from the water-trap to
ensure the correct offset condition.

Fig. 8-2

When the calibration is taking place, the User Interface appears as below.

Fig. 8-3

WARNING: The calibration process is indicated with the text “cal” in the monitor
measurements.

At the end of the calibration process, the result is presented in red when fail or in green when
it was performed successfully (see Fig 8-4).

Fig. 8-4

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WARNING: Reconnect the sampling tube to the water trap at the end of the calibration as
it is shown in the video.

8.2.2. Proportional valves

Used for the automatic dosing. Once a quarter at the beginning.

To perform calibration of the proportional valves, connect the NO cylinder regulator to the NO
input port (“INLET”).

Fig. 8-5

Slowly open the cylinder and check its pressure in the regulator gauge. Close it for 30
seconds and verify the pressure is not dropping meaning the regulator is not leaking.

If the cylinder is opened quickly, the pressure in the regulator can increased suddenly
creating a potential hazardous situation.

Close the cylinder and reject the pressure regulator if it is leaking.

The calibration of the proportional valves can be performed following the next steps:

Note: Remove the dose tube from the respiratory circuit as shown in the video before
starting the calibration process and connect it in the scavenging port.

When the calibration is taking place, the User Interface appears as below:

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Fig. 8-6

At the end of the calibration process, the result is presented in red when fail or in green when
it was performed successfully (see Fig 8-7).

Fig. 8-7

WARNING: Reconnect the dose tube to the respiratory circuit at the end of the calibration
as it is shown in the video.

8.2.3. Respiratory flow sensors

Mainly for verification. For the verification of the respiratory flow sensor, follow the next steps:

1- Connect an externa flow sensor in serie with the respiratory flow sensor of the
device.

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2- Select the correct respiratory flow sensor in Setting/dosing/resp sensor.

3- Select 5 values in the rage of 2 to 100 L/min for the adult sensors and from 1 to
60L/min for the neonate sensor and check the difference with the external flow
sensor. It should be in the range of +/-12% from 0 to 10L/min and lower than 7%
in the rest of the scale.

8.2.4. Dosing flow sensor

For the calibration of the dosing flow sensor, follow the following steps:

1- With the manual flow regulator in position cero, and with the device in standby,
change the offset of the dosing flow until reading is between 0.1 and 0.5 mL/min.

2- With the manual flow regulator in position “H”, and connecting an external flow
sensor in the dosing outlet, change the gain and the shift in such a way that the
dosing flow measurement is into the range of +/-2% of the measurement in the
external sensor.

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9. Maintenance

WARNING: Do no replace internal components of the device for other not specified by the
manufacturer, specially the power supply and the battery.

9.1. Cleaning

WARNING: Before cleaning the device turn it off and disconnect it from the main.

Clean the device with a damp cloth. After cleaning, dry de device properly.

Do not sterilise the device in any of the autoclavable process.

Do not use grace or oil with the device. It is incompatible with the device.

9.2. Spare part list

The internal components that can be replaced by the specialised technical support and the
risk associated to the replacement is presented in the next Table.

Component Description Replacement Associated risk

description
01NTMGMG00 Plastic Box set, includes back aluminium Section 8.4 Possible
supports for NOXtec electrostatic
discharge
01NTMNPG0A Manifold with calibration gas sensors: NO, Section 8.3 None
NO2 and O2, including PCB battery power
01NTMGMG01 Fan Main Box for cooling with ward Section 8.5 None
01NTMGEG02 Power supply Section 8.6 Possible partial or
total break of the
device
01NTMGEG06 Battery 95Watt Section 8.7 High temperature
or explosion of
01NTMGEG07 Power Management Module Section 8.7 the battery
01NTDSEG00 Dosing electronic board Section 8.8 Possible
electrostatic
discharge
01NTDSPG0A Gases input manifold - MF1 for NOXtec Section 8.9 None
01NTDSPG0B Dosing manifold - MF2 for NOXtec Section 8.9 None
01NTDSPG0C Venting manifold - MF3 Section 8.9 None

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01NTDSPG15 Dosing flow sensor Section 8.9 None

01NTDSPG16 Dosing outlet connector Section 8.5 None
01NTDSPG24 Manual Dial Flowmeter Section 8.4 None
01NTSGMG00 Bias flow sensor module Section 8.4 Possible
electrostatic
discharge
01NTMNEG0A Monitoring electronic board Section 8.8 Possible
electrostatic
discharge
01NTMNPG0C Calibration Gas Manifold - MF6 Section 8.9 None
01NTMNPG02 Water traps receptacle Section 8.4 Possible
electrostatic
discharge
01NTUIEG00 LCD 10.1' Section 8.4 Possible injured
01NTUIEG01 Control PC Section 8.8 Possible
electrostatic
01NTUIEG03 HDMI cable (smallest head) Section 8.8 discharge
01NTUIEG04 Cable USB Section 8.8
01NTUIEG05 Optical encoder module with control Section 8.4

The steps for replacing the internal components of the device are described in the next
sections.

WARNING: Turn the device OFF and unplug it from the main before start replacing an
internal component of the device described in the next sections.

9.3. Replacing the gases sensor block

NO, NO2 and O2 sensors are all together in the same block. For replacing this block, follow the
next steps:

Sensor
block

Lid

Screews

Fig. 8-1

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1. Remove the lid of the left side of the device.

2. Remove the screws using a proper Allen tool.

3. Remove the sensor block manually.

4. Insert the new block of sensors.

5. Tight the screws with the corresponding Allen tool.

6. Close the aperture of the sensor by placing the lid.

Note: Proceed to make the sensor calibration once sensor block is replaced.

WARNING: Dispose the old block of sensors according to the local legislation or return it
back to the manufacturer.

9.4. Replacing the device enclosure

1. Remove the front and read screw protections from both sides of the device.
2. Remove the 8 screws from both sides of the device.

3. Remote the 10.1inch touch screen from the front of the device.
4. Pull the hanger of the back of the device to get the device out of the enclosure.
5. Press the safety moorings of the rail in the back of the device with your fingers.

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6. Remove the components from the internal right sides of the old enclosure and place
them in the same position in the new enclosure. Remember to fix the ground
connectors properly as well.
7. Remove the control button from the top side of the old box and fix in the same
position of the new box.
8. Remove the manual flow control from the left side of the old enclosure and install it in
the same position of the new box.
9. If it is required, replace other internal components of the device according to the
description in the next sections.
10. Place the device in the rear part of the new enclosure and locate the rail in the
corresponding position.
11. Push the device to introduce it completely into the enclose.
12. Place the 10.1inch touch screen in the front of the unit.
13. Screw on the 8 screws to close the device.
14. Place the screw cover of the sides of the device for hiding the screw.
WARNING: Replacement of the main device enclosure using appropriated electrostatic
discharge protection. These discharges can damage for the operator and can create
irreversible damages in the device.

9.5. Back panel components substitution

1. Repeat the steps from 1 to 5 of the previous section 8.4.
2. Replace the components of the back panel of the device carefully.

3. Repeat the steps 10 to 14 of the previous section 8.4.

9.6. Replacing the power supply

1. Repeat the steps from 1 to 5 of the section 8.4.

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2. Unscrew the power supply of the device and replace it using one with the same
specifications of the original one.

Power supply

3. Repeat the steps from 10 to 14 of the section 8.4.

9.7. Replacing the battery or the smart charger

1. Repeat the steps from 1 to 5 of the section 8.4.
2. Verify there is not liquid in the button of the device enclosure.
3. If it is dry, turn the device over to access to the button of the device where the battery
is located.
4. Remove the aluminium holders that hold the battery and the nylon screws holding the
battery charger.
5. Replace the battery and/or the charger using a new one.

6. Place the battery holders back using the corresponding screws and fix also the
battery charger. Ensure the connection between the battery and the charger are
properly connected and the charger is not forced in its position.
7. Turn the device over to normal position.
8. Repeat the steps from 10 to 14 of the section 8.4.

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9.8. Electronic component replacement

1. Repeat the steps from 1 to 5 of the section 8.4.
2. Check the position of the board(s) to be replaced. Remove the connected set of cable
of the board(s) to be replaced.

Dosis board

PC control

USB cable

HDMI cable

Monitor board

3. Repeat the steps from 10 to 14 of the section 8.4.

9.9. Replacing a manifold

1. Repeat the steps from 1 to 5 of the section 8.4.
2. The position of the different manifolds is shown in the figure below. Unscrew the
manifold to be replaced.
3. Disconnect carefully the pneumatic connections and electronic of the components of
the manifold.

MF2

MF3

MF5

MF1

MF4
4. Reconnect the pneumatic tubing and the electronic connector to
the new manifold.
5. Screw the new manifold in the right position.
6. Repeat the steps from 10 to 14 of the section 8.4.

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9.10. Changing the unit configuration

The calibration parameters of the unit can be changed by unlocking the user interface with
the "supervisor" user. When the user interface is unlock, a window appears where
confirmation to unlock is requested. If the user is changed to "supervisor" and the unlock
password is typed, the interface will be unlocked and the options "settings" and "calibrate" will
be available.

9.11. Remote access to the unit

It is not required to do a particular action for accessing to the device remotely. Connect the
ethernet cable to the LAN port in the back panel of the device. Call to the technical service to
notify them the device is connected and ready for remote assistance. If it is required
identifying the unit, connects a keyboard to the USB port in the back panel of the device and
press the combination of keys alt+tab. TeamViewer window will appear in the screen. The
device ID appears in the left side of the windows

WARNING: The LAN port connection of the device is intended exclusively to the remote
maintenance of the unit. Do not leave the device connected to the network unnecessarily.

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9.12. Accessing to technical service windows

NOXtec has implemented some Windows for making the technical support easier. That
windows are hidden and are not accessible by mean of the User Interface. It is required a
keyboard for accessing to that functionalities. It is highly recommended the technical staff do
not tell the user know about the existence of that windows to avoid unnecessary changes on
the device configuration. That windows are mainly:

Name Quick access Function of the window

Dosing configuration “D” or “d” To change the calibration parameters of the dosing
module as well as the real-time acquisitions (sampling
rate 2seconds) and the status information
Monitor configuration “M” or “m” To change the calibration parameters of the monitoring
module as well as the real-time acquisitions (sampling
rate 2seconds) and the status information
Communication “C” or “c” To display the commands sent to the dosing and
window monitoring module and the responses. It is also
displayed the boards connected to the computer
Log windows “L” or “l” To display the logging messages that is the changes in
the status of the monitor and the dosing module and
the changes in the dosing of the dosing module

WARNING: Do not access to the technical service windows unnecessary or share this
information with the final user. Inadequate changes in these parameters can cause the
improper configuration of the unit and miss operation.

Dosing window

The configuration windows for the dosing module is shown in next Figure. It is possible to
change the calibration parameters of the measurements (first column in the left), read the
data acquired by the module (central column) and the status of the module in this window.

In the calibration parameters table, most of the sensors have linear response and the
calibration is an adjustment to an order 1 polynomial: high pressure 1, high pressure 2, low
pressure 1, low pressure 2, regulated pressure, venting pressure and flow control voltage.

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The zero order is set in the column “offset” and the first order (Order1) is set om the column
gain and g shift in the way:

𝑂𝑟𝑑𝑒𝑟1 = Gain
2

The dosing flow is also calibrated to an order 1 function in a second step but there is a
linearization function hard code in the firmware that is an order 5 polynomial.

The hot wire and the differential pressure sensor used for measuring for the measurement
of the bias flow (respiratory flow) is fitted to a polynomial function in the way:

𝐹𝑙𝑜𝑤 = 𝐴 ∗ 2 ∗ 𝐴𝐷𝐶 + 𝐵 ∗ 2 ∗ 𝐴𝐷𝐶 + 𝐶 ∗ 2 ∗ 𝐴𝐷𝐶 + 𝑜𝑓𝑓𝑠𝑒𝑡

In the case of the hot wire sensor, A=0 and in the case of the differential pressure sensor it
is hard code in the firmware. The constants a, b and c are also hard code and the variable C
is the offset of the table, B is the gain of the table and C is the g shift. The calibration sensor
is sectioned in two ranges: from 0 to 10 and from 10 to the maximum value. There is a
different calibration for adults and for neonates because the sensors used are different.

WARNING: Do not use the adult bias flow sensor when using the device in neonate and vice
versa. It could create errors in the flow measurement.

In the measurements table, the values are shown in the same way they come from the
dosing board. Note that NOXtec 2000 has not implemented all the functionalities of NOXtec
1000. That measurements are identified with the text “N/A”.

The last parameter is calculated in the user interface and is the recommended manual flow
position for ensure the device is ready for dosing manually in case of emergency.

In the status table, there are specified the main parameters of the dosing module. The
meaning of the parameters is specified in the next table:
Parameter Meaning
Module status State of the module: standby, dosing or failure
Dosing mode Dosing mode selected, manual, semiautomatic, automatic and
real-time
Calib. In progress To show the state of the flow calibration process
ADC ok Show if the pressure and flow are acquired correctly
EEPROM ok If the access to the memory is correct for writing and reading
Target dose ok
Calibration ok
NO setting ok
Cylinder level ok
Selected cylinder
Selected flow controller
Alarm code
Battery status

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Bias flow sensor Bias flow sensor selected. The values can be HW (for the hot
wire), DP (for the differential pressure) and unknow value if there
is a failure in the configuration of the bias flow sensor
Bias flow status Status of the sensor. It should be 80 if it is correctly working, 81
if it is working but the offset is not set and other values if there
are errors
EVs state (EV6-EV1) Status of the electro valves: 0 is disable and 1 is enable
Audio off/pause If the alarm is muted: paused when it is high level or off when it is
not
Start-up errors/last

Monitor window

The configuration windows for the monitor module is shown in next Figure. It is possible to
change the calibration parameters of the measurements (first column in the left), read the
data acquired and check the status of the module. It is very similar to the dosing windows
described in the previous section.

In the case of the calibration table, all the parameters are fitted to first order polynomic as
described below. However, the last 2 parameters are to set the regiment of the of the
sampling pump: Target pressure (mbar) and target flow (mL/min). If everything is working
properly, the values of the pressure and flow of the gases sensor read by the ADC should be
in the range of +/- 5mbar and +/-5 mL/min of the target.

The values read by the ADC are as explained in the previous section for the dosing module.
Because the control of the battery of the device is controlled by the monitoring module, the
reading table also includes some information about the battery:
- Battery temperature in °C,
- Battery charge (%), that is an absolute value and also describe the state of the
battery
- Charge error in %, that is an indication of the accuracy of the battery charge.
- Battery current in mA.

The flow control and the pressure control are the control value that are sent to the sampling
pump and the flow regulator.

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In the status table, there are also described the parameters about the operation of the
module (see next Table).
Parameter Meaning
Module status State of the module: monitoring or failure
Calib in progress To show the status of the gases calibration process
ADC ok State of the acquisition of the gases measurements, pressure
and flow values
EEPROM ok If the access to the memory is correct for writing and reading
Calibration ok
Gases limits ok
Pump ok
Water trap
Alarm code
Waiting for stability
Battery status
Bias flow sensor
Start-up errors/last
EV state (EV2-EV1) Status of the electro valves: 0 is disable and 1 is enable
Audio off/paused If the alarm is muted: paused when it is high level or off when it is
not

Command window

This window is for showing in detail the commands and the answers that are exchanged with
the dosing and monitoring boards and to perform special operations and configuration of the
boards.

The window is split in two panels: for the dosing board and for the monitoring board. The
commands that can be send to the boards are described in the top of the windows.

WARNING: Do not send commands nor change the configuration of the.

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Logs window

This window is for showing the logs of the system that are registered when there is a change
of status in one of the module. That information can be exported and is save in the disk with
the identification of the patient. This information is NOT intended to be used by the user.

The entries in the log register are stamped with the date and time and also identify in what
module the information is save. If the log cannot be register in disk because the patient
identification was not properly set at the beginning, the failure will be register in the log file as
well.

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10. Technical service routine

The next table is the recommended for the periodical testing of the unit. It should be
submitted to ITC for analysis and storing it.

The information will be collected independelty for each inspected device and will be filled as
described below.

1. Date 2. Operator 3. Signature

4. Serial number 5. Start time 6. End time

9. Monitor
8. Dosing firmware
7. User Interface version firmware
version
version
Visual inspection (OK/FAIL)
15. Neonate
10. Main box 11. Screen 12. Back label 13. Touch 14. Control scroll 16. Adult water trap
water trap

General revision elements

19. Audible 20. Audible
17. Leaking in 18. Leaking in 21. Number of 22. Caducity
date of
alarm in alarm in 23. Error log analysis
dosing monitor cycles of battery sensor block
monitor dosing

Flow and pressure control

24. manual
25. Regulated P 26. Automatic 27. Sampling
regulation 28. Dosing flow calibration 29. Automatic
venting
PR1(bar) venting (monitor control vals) flow calibration
(OK/FAIL) Offset Gain Shift

Gases sensors
30. NO 31. NO2 32. O2 Calibration cylinder used
Offset Gain Shift Offset Gain Shift Offset Gain Shift 33. Pressure (mbar) 34. Calibration NO/NO2

35. Manual regulator calibration – Flow (mL/min)

A B C D E F G H I J K General aspect

36. Bias-flow verification

Adult differential pressure calibration Neonate differential pressure calibration
Hot wire calibration (L/min)
(L/min) (L/min)
TSI

NOXtec

Description of the table

Id Description Pass / Fail criteria
Minimum Maximum
1 Date when testing take place N/A N/A
2 Operator name. It should be accredited by the manufacturer N/A N/A
with the corresponding certification
3 Signature of the operator digital or hand written N/A N/A

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4 Serial number of the device. It is in the back label N/A N/A

5 Start time of the testing N/A N/A
6 End time of the testing N/A N/A
7 Version of software of the User Interface. It appears in Check with the
Help/device manufacturer
8 Version of firmware of the dosing module. It appears in Check with the
Help/device manufacturer
9 Version of firmware of the monitor module. It appears in Check with the
Help/device manufacturer
10 Visual inspection of the main box. It should not be broken or In good condition
damage in such a way that could represent a safety problem
for the device operator(s)
11 Visual inspection of the screen. It should not be broken or In good condition
damage in such a way that could represent a safety problem
for the device operator(s)
12 Visual inspection of the back label. Redable and the symbols
must be undoubeble clear
13 Touch functionality. The device should be operated with the Fully working and no shift in
touch scree. Aceess to some of the functionalities. the buttons
14 Control scroll. The device should be operated with the scroll. Fully working the wheel and
Aceess to some of the functionalities. the push
15 Connect the neonate watertrap and check that the monitor Detected
detects if properly. It is in monitor service windows (key “m”),
last column (water trap)
16 Connect the adults watertrap and check that the monitor Detected
detects if properly. It is in monitor service windows (key “m”),
last column (water trap)
17 Connect a pressure sensor in the outlet of the pressure 1.6 bar 2.4 bar
mode, select position C of the manual control and wait for
2min. Check the pressure in the pressure sensor
18 Connect a flow metter in the inlet of the water trap and wait 120mL/min 180mL/min
for 1min. Set the flow control to 150mL/min (default)
19 Ensure the unit has not error first. Close and vent both of the Audible alarm is audible.
treatment cylinders. Check if there is audible alarm Minimum of 60dbm
20 Ensure the unit has not error first. Remove the water trap. Audible alarm is audible.
Check if there is audible alarm Minimum of 60dbm
21 Write the number of cycles of the battery. It can be read in N/A 270 cycles
Help/device
22 Write the caducity date of the sensor. The manufacturing 0 year 1 year
date can be read in the sticker of the sensor block and
caducity is one year from that date
23 To be clarified in next releases N/A
24 Close the treatment and calibration cylinders. Press the Pressure goes to cero
purgig button and check the cylinder pressure in dosing
technical window (Key “d”)
25 Check the regulated pressure in dosing technical window (Key 1.6 bar 2.4 bar
“d”), measurement (central) table
26 To be clarified in next releases N/A

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27 To check the values of sensor flow and pressure control. In 200, 300 430, 570
the monitor technical windows (key “m”), check the values of
flow control and pressure control (Flow control, pressure
control)
28 Calibration parameters of the dosing flow sensor, offset, gain 500/ 6000/
and shift. It must be performed using an external flow metter, 1000/ 500 6000/
setting the cero (between 0.1 and 0.5mL/min) with the 5000
manual flow closed and the gain with the manual flow in
position “H”. offset/gain/shift
29 Automatic proportional valves (flow) process is pass properly. Pass properly
Access to it in Setting/calib/flow
30 After doing and passing properly the gases calibration offset, Pass properly
gain and shift of the NO measurement. Device must be
restarted after doing the calibration
31 After doing and passing properly the gases calibration offset, Pass properly
gain and shift of the NO2 measurement. Device must be
restarted after doing the calibration
32 After doing and passing properly the gases calibration offset, Pass properly
gain and shift of the O2 measurement. Device must be
restarted after doing the calibration
33 Pressure of the calibration cylinder during calibration 100 mbar 350 mbar
34 NO and NO2 concentration of the content of the calibration 50ppm/ 80ppm/
cylinder (NO/NO2) 9ppm 15ppm
35 Flow of the different positions of the manual flow regulators. - 20% + 20%
Connect a flow metter in the dosing outled and set all the
positions. Write also the general mechanical aspect of the
component. See original values in Setting/calib/bypass
36 Accuracy of the respiratory flow measurements. Checkig for -10% +10%
5 values along the whole range: 2 to 100L/min for adults
and from 1 to 60L/min for neonate

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11. Warranty
ITC, S.A. warrants this product for one year from the date of purchase, against any defect in
materials and workmanship employed in its manufacture.

The warranty includes repair, replacement or change of the product and / or components
without charge to the customer, including labour derived from the fulfilment of this warranty.
Transport costs are not included.

This warranty does not include disposable and consumable parts and accessories such as
gases sensors and calibration gases (included in maintenance contract, see conditions) or
patient circuits.

This warranty will not be valid under the following conditions:

- When the use, care and operation of the device have not been in accordance with the
instructions contained in this manual.
- When the product has been opened or maintained by personnel not authorized and
formed by ITC, S.A. or companies authorized by this manufacturer.
- When the fault is caused by incorrect use of the unit.

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12. Technical specifications

12.1. Physical specifications

Dimensions Main unit 190 x 300 x 345 mm

(height x width x length) Trolley 1245 x 700 x 640 mm
Main unit 8.4 kg
Weight
Trolley 47.5 kg
Cylinders Capacity 2 x 20 L
Materials Stainless steel AISI 304 and AISI 316 L, PTFE and ABS

12.2. Operating and storage conditions

Temperature Humidity Relative pressure

Operating conditions 10 – 40 C 15 – 90 % 65.0 – 101.5 kPa

Storage conditions -10 – 60  C 15 – 90 % 50.0 – 101.5 kPa

12.3. Monitoring module

NO: 4 electrodes

Measuring principle of gases sensors NO : 4 electrodes

2

O : partial pressure electrochemical sensor

2

NO: 0 – 160 ppm

Measuring range NO : 0 – 20 ppm

2

O : 0 – 100 %
2

NO: ± 10 % or ± 5 ppm

Measurement accuracy NO : 10 % or 0.2 ppm (whichever is higher)

2

O : ± 3,5 %
2

NO: 0.1 ppm

Resolution NO : 0.1 ppm

2

O:1%
2

NO: < 10 s

Response time NO : < 40 s

2

O : < 20 s
2

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Line flow sampling 90 – 250 mL/min (configurable, 150 mL/min by default)

Operational life of the sensors 12 months

12.4. Dosing module

Real time

Automatic
Dosing modes
Semi-automatic

Manual

NO flow 0 – 4 L/min
Measuring range
Flow 0 – 0.02 – 0.03 – 0.05 – 0.07 – 0.1 – 0.2 – 0.5 – 1 – 2 –
positions 3–4

Dosing interval NO 0 – 100 ppm (upgradeable on request)

Cylinder inlet pressure Minimum 3.5 Bar, nominal 4.5 Bar, maximum 5.5 Bar

Dosing accuracy ±5%

Dosing resolution 0.1 ppm

Dosing flow 0 – 4.5 L/min

Set-up time < 2 min fs

Screen Colour LCD 10.1”

12.5. Electrical Specifications

Voltage 100 – 240 VAC, 50 – 60 Hz, 300 mA max

Fuse 315mA, Ø5mm x 20mm, FSF5x20 250V,

Autonomy 4h
Battery
Charging time 2.5 h approx.

EN 60601-1-2:2007 + CORR:2010 / IEC 60601-1-2:2007

Standards
applied EN 60601-1:2006 + CORR:2010 + A11:2011 + A1:2013 + AC:2014 +
A12:2014 / IEC 60601-1:2005 + CORR:2006 + CORR2:2008 + A1:2012

Classification Class I, Type B

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12.6. Electromagnetic and RF specifications

Guide and manufacturing declaration– electromagnetic emissions

NOXtec is intended to be used in the electromagnetic environment specified below. The user of the
device must ensure the proper conditions for using the device.

Emissions testing Conformity Electro-magnetic environment - Guide

NOXtec uses RF energy only for its internal operation.

RF Emissions
Group 1 So, RF emissions are very low and it is unlikely they
CISPR 11
cause interferences in the electronic devices nearby

RF Emissions
Class B
CISPR 11

Harmonic emissions NOXtec is usable for all public establishment,

Class A
IEC 61000-3-2 including domiciliary environment and those
connected directly to the public low voltage network.
Voltage fluctuation and
flicker emissions Comply
IEC 61000-3-3

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Guide and manufacturer declaration – electromagnetic immunity

NOXtec is intended for its use in electromagnetic environment specified below. The user should
ensure the mentioned environment

Normative level
Electromagnetic environment -
Immunity test tested Conformity level
Guide
IEC 60601

Floors should be of wood,

Electrostatic ±6 kV per contact ±6 kV per contact concrete or ceramic. If the floor
discharge (ESD) is covered by synthetic materials,
IEC 61000-4-2 relative humidity should be at
±8 kV per air ±8 kV per air least 30%

±2 kV in main
±2 kV for main
power supply
Transients/quick power network Network quality should be as a
network
discharges typical Comercial environment of
IEC 61000-4-4 ±1 kV for inlets No applicable a hospital

±1 kV between
±1 kV line to line Network quality should be as a
Shock wave lines
typical Comercial environment of
IEC 61000-4-5
±2 kV ground line No applicable a hospital

<5% UT <5% UT
La calidad de la red de
(drop > 95% in UT) (caída >95% en UT)
alimentación debería ser la de un
for 0,5 cycles para 0,5 ciclos entorno comercial típico o la de
Caídas de tensión, 40% UT 40% UT un hospital.
interrupciones y (drop of 60% in UT) (caída 60% en UT) La calidad de la red de
variaciones de For 5 cycles para 5 ciclos alimentación debe estar
tensión en las controlada, protegida o libre de
líneas de entrada 70% UT 70% UT estos eventos.
de alimentación (caída 30% en UT) (caída 30% en UT) NOXtec continúa operando
IEC 61000-4-11 para 25 ciclos para 25 ciclos durante la interrupción de la red
>5% UT >5% UT de alimentación, esto es debido a
que NOXtec está alimentado por
(caída >95% en UT) (caída >95% en UT)
una batería.
para 5 s para 5 s

Los campos magnéticos a

Campo magnético
frecuencia de red deberían estar
a frecuencia de red
3 A/m 3 A/m a niveles característicos de una
(50/60 Hz)
localización típica de un entorno
IEC 61000-4-8
comercial típico o de un hospital.

NOTA: UT es la tensión de alimentación de corriente alterna antes de la aplicación del nivel de

ensayo.

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Guía y declaración del fabricante – inmunidad electromagnética

NOXtec está previsto para el uso en un entorno electromagnético especificado debajo. El cliente o el
usuario de NOXtec se debería asegurar que se use en dicho entorno

Nivel de ensayo
Ensayo de Nivel de
de la Norma IEC Entorno electromagnético - Guía
inmunidad conformidad
60601

Los equipos móviles y portátiles de

comunicaciones de RF no se deberían
usar más cerca de cualquier parte del
NOXtec, incluyendo los cables, que la
distancia de separación recomendada
calculada a partir de la ecuación
aplicable a la frecuencia del transmisor.

Distancia de separación recomendada

𝑑 = 1,17 √𝑃 150 kHz a 80 MHz

RF conducida 3V rms 3V rms

𝑑 = 1,17 √𝑃 80 MHz a 800 MHz
IEC 61000-4-6 de 150 kHz a 80 𝑑 = 2,33 √𝑃 800 MHz a 2,5 GHz
MHz
donde P es la máxima potencia de
RF radiada 3 V/m 3 V/m salida asignada del transmisor en vatios
IEC 61000-4-3 de 80 MHz a 2,5 de 80 MHz a 1 (W) conforme al fabricante del
GHz GHz (debido a las transmisor y d es la distancia de
limitaciones del separación recomendada en metros
laboratorio de (m).
pruebas)
Las intensidades del campo desde el
transmisor fijo de RF, según se
determina por un estudio
electromagnético del lugar , debería ser
a

menor que el nivel de conformidad en

cada rango de frecuencia. b

La interferencia puede ocurrir en la

vecindad del equipo marcado con el
siguiente símbolo:

NOTA 1: A 80 MHz y 800 MHz, se aplica el rango de frecuencia más alto.

NOTA 2: Estas directrices no se pueden aplicar en todas las situaciones. La propagación
electromagnética se ve afectada por la absorción y reflexión desde estructuras, objetos y personas.
a
Las intensidades de campo de los transmisores fijos, tales como estaciones base para radio
teléfonos (celulares/sin cables) y radios móviles terrestres, emisoras amateurs, emisiones de radio
AM y FM y emisiones de TV no se pueden predecir teóricamente con precisión. Para valorar el
entorno electromagnético debido a los transmisores fijos de RF, se debería considerar un estudio
del lugar electromagnético. Si la medida de la intensidad del campo en la localización en la que
NOXtec se usa excede el nivel de conformidad anterior de RF aplicable, se debería observar el
NOXtec para verificar el funcionamiento normal. Si se observa un funcionamiento anormal, pueden
ser necesarias medidas adicionales, tales como reorientación o relocalización del NOXtec.
b
Sobre el rango de frecuencia de 150 kHz a 80 MHz, la intensidad del campo debería ser menor
que 3 V/m.

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Distancias de separación recomendadas entre los equipos portátiles y móviles de comunicaciones

de RF y NOXtec

NOXtec está previsto para el uso en un entorno electromagnético en el que se controlan las
perturbaciones radiadas de RF. El cliente o el usuario de NOXtec puede ayudar a prevenir la
interferencia electromagnética manteniendo una distancia mínima entre el equipo portátil y móvil de
comunicaciones de RF (transmisores) y el NOXtec según se recomienda debajo, conforme a la
máxima potencia de salida del equipo de comunicaciones.

Máxima potencia de Distancia de separación conforme a la frecuencia del transmisor

salida asignada del m
transmisor 150 kHz a 80 MHz 80 MHz a 800 MHz 800 MHz a 2,5 GHz
W 𝑑 = 1,17 √𝑃 𝑑 = 1,17 √𝑃 𝑑 = 2,33 √𝑃
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,74
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
Para los transmisores asignados con una potencia máxima de salida no listados arriba, la distancia
de separación recomendada d en metros (m) se puede determinar usando la ecuación aplicable a
la frecuencia del transmisor, donde P es la máxima potencia de salida asignada en vatios (W)
conforme al fabricante del transmisor.

NOTA 1: A 80 MHz y 800 MHz, se aplica la distancia de separación para el rango de frecuencia
más alto.

NOTA 2: Estas directrices no se pueden aplicar en todas las situaciones. La propagación

electromagnética se ve afectada por la absorción y reflexión desde estructuras, objetos y personas.

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13. Troubleshooting

Problem Identification Solution(s)

Failure in gases calibration. An error appears at the end - Repeat the calibration
Sometime it could be of the calibration. The code process
happened that the sampling can indicate in what step the
- Ensure the sensors are not
pump do not recover the failure occur.
obsolete checking in the
correct operation regiment
user interface
or the calibration
parameters are out of - Check the correct
range connection of the calibration
gas and that the cylinder is
open

Low pressure is too high Low pressure out of range - Press the venting button of
alarm the gas channel

Low pressure is too low Low pressure out of range - Check the cylinder is
alarm connected to the device and
opened

Regulated pressure is too Regulated pressure alarm - Press the venting button
high of the cylinder in operation

High pressure too low High pressure out of range - Check the pressure
sensor is connected to the
device
- Check the cylinder is
opened
- Check the sensor and
cylinder are connected to
the same channel

Error in automatic flow Error in the calibration - Repeat the calibration of

controllers’ calibration process or flow the flow controller
compensation is out of
range - Check the cylinders are
correctly connected an
opened

When the unit is initiated There is a low-level error - Dosconect the dosing line
and is in the main windows, “Dosing: error in regulated from the ventilatory climb
the regulated pressure is pressure” and open the manual flow
out of range. control in position B or C
This happen when gases during few seconds until the
cylinders are open suddently error disappear

Battery error The charge of the battery - Leave the device

appears as very low (less connected to the main
than 10%) during 2h before using it
with patients

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Low battery error and the The low battery alarm - Unplug the main and plug
device appears like appears it after few seconds
disconnected from the main
The main connection symbol - Check the fuse in the
despite the main cable is
does not appear in top of botton of the main cord
connected
the battery at the right top connector
corner

Leaking in the outlet of the The device is underdosing - Call to the technical
dosing module support for verifying the
When the dosing outlet is
closed with the finder, it is device.
not pressurised after few
seconds

Monitor is measuring the When device start dosing or - Call to the technical
venting gas of the dosing the cylinder is exchange, a support for replacing the
module high concentration of NO is one-way valve of the outlet of
read in the User Interface the monitor module

Device is underdosing When the inlet of the - Leaking in the monitor

watertrap is closed with the module
finger, it is not doing vacuum
- Oneway valve in the outlet
of the monitor is leaking

Difference between the When the dosing outlet is - See section 13.1 for more
dosing set point and the closed with the finder and it information.
monitor measurement is pressurised after few
seconds (no leaking in the
oulet of the dosing module)
When the inlet of the
watertrap is closed with the
finger and it is doing vacuum
(no leaking in the monitoring
module)

13.1. Key points of dosing

Usually, there may be differences between the dosing set point and the monitor
measurement. These differences do not mean that the device is not working properly. The
dose is influenced by the following:

 Respiratory circuit configuration

The order of the components, leaks, turbulence, mixing chamber, humidity, distances, etc.

 Quality of the treatment gas

NO concentration, impurities.

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 Respiratory flow
Calibration and type use according to the application.

 Monitor calibration
Quality of the sensors, quality of the calibration gas, calibration frequency, etc.

 Dosing flow calibration

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