GraphNet advance - ts - neo

Invasive and non-invasive ventilation

Parte N°: 4012L2V

Version_07
August 2017
WARNINGS
The information contained in this manual may be subject to change without prior
notice. The manufacturer reserves the right to make any changes to the product
characteristics or design.

The use of this device in patients must be supervised by a medical specialist.

You should carefully read the instructions contained in this document before con-
necting the ventilator to a patient. The purpose of the information contained in this
manual is to describe the ventilator, its capacities, and possible configurations, but
cannot, and should not be considered a substitute for the exercise of necessary
judgment by competent professionals, who must decide and determine the mode
of use for each particular patient.

The following resources are OPTIONAL for GraphNet ts:

• The NEO-INF module that allows the ventilation of neonatal-infant patients.
• PRVC, SIMV (PRVC) and VSV modes.
• Spontaneous Breathing Trial (SBT) and Stress Index (IS)
• Oxygen therapy

To purchase and enable this feature contact TECME S.A. or contact your local
dealer.

TECME S.A.
Av. Circunvalación (N-O)
Agustín Tosco 3040 Los Boulevares
Ciudad de Córdoba Norte 5008 - Córdoba
Tel: (54-351) 414-4600
Fax: (54-351) 414-4605
E-mail: [email protected]
www.neumovent.com

Technical Director:
Lic. Julieta Catania
Bioquímica Clínica

AUTHORIZED BY ANMAT PM 1116-6

0086
Table of contents
1. General information.................................................................................... 1.1
1.1 Observed Requirements and Standards........................................................... 1.2
1.2 General Device Overview................................................................................. 1.2
1.3 Intended Use..................................................................................................... 1.2
1.4 Intended User.................................................................................................... 1.2
1.5 Intended Use Environment................................................................................ 1.2
1.6 Contraindications for use.................................................................................. 1.2
1.7 User support...................................................................................................... 1.3
1.8 Symbols used.................................................................................................... 1.3
1.9 Abbreviations, acronyms and variable names.................................................. 1.5

2. Warnings - Precautions - Notes................................................................. 2.1

2.1 Definition of Terms............................................................................................. 2.2
2.2 Warnings........................................................................................................... 2.2
2.3 Precautions....................................................................................................... 2.3
2.4 Notes................................................................................................................. 2.3

3. Description of the ventilator....................................................................... 3.1

3.1 Overview........................................................................................................... 3.2
3.2 Front Panel........................................................................................................ 3.2
3.3 Lower Block of Connections............................................................................ 3.10
3.4 Rear Panel...................................................................................................... 3.11
3.5 Upper Panel.................................................................................................... 3.11

4. Detailed summary of parts and sets ........................................................ 4.1

4.1 Rear cabinet...................................................................................................... 4.2
4.2 Pneumatic box (lower and upper)..................................................................... 4.5
4.3 Front cabinet................................................................................................... 4.10

5. Disassembly............................................................................................... 5.1
5.1 Opening the device........................................................................................... 5.2
5.2 Remove the upper pneumatic box.................................................................... 5.4
5.3 Disassembly of the CPU board and controller board........................................ 5.8
5.4 Disassembly of the power supply.................................................................... 5.10
5.5 Disassembly of the lower pneumatic box........................................................ 5.13
5.6 Disassembly of the output manifold................................................................ 5.18
5.7 Disassembly of the front panel, upper alarm light and locking flanges........... 5.19
5.8 Disassembly of the keyboard board................................................................ 5.21

6. Assembly..................................................................................................... 6.1
6.1 Introduction....................................................................................................... 6.2
6.2 Hoses connection on sensors board................................................................. 6.2
6.3 Hoses connection on upper pneumatic box...................................................... 6.8
6.4 Hoses connection on lower pneumatic box..................................................... 6.11

7. Routine maintenance.................................................................................. 7.1

7.1 General instructions.......................................................................................... 7.2
7.2 Cabinet.............................................................................................................. 7.2

8. Technical Specifications............................................................................. 8.1

8.1 Classification..................................................................................................... 8.2
8.2 Physical Characteristics.................................................................................... 8.2
8.3 Screen............................................................................................................... 8.2

Technical Maintenance Manuall | GraphNet advance neo ts i

8.4 Environmental Requirements........................................................................... .8.2
8.5 Pneumatic Specifications.................................................................................. 8.2
8.6 Electrical Specifications.................................................................................... 8.3
8.7 Ventilatory Parameter Adjustments................................................................... 8.3
8.8 Delivered Parameters....................................................................................... 8.5
8.9 Monitored Parameters....................................................................................... 8.5
8.10 Alarm Adjustment.............................................................................................. 8.5
8.11 Data Collection for Control and Monitoring......................................................... 8.6
8.12 Characteristics of the respiratory circuit.............................................................. 8.7
8.13 Electromagnetic Compatibility............................................................................. 8.7
8.14 Basic Operation of the Ventilator...................................................................... 8.10
8.15 Safety Mechanisms........................................................................................... 8.11
8.16 Expected service life......................................................................................... 8.13
8.17 Diagram of the Pneumatic Circuit of the Ventilator GraphNet advance and
GraphNet neo........................................................................................................... 8.14
8.18 Diagram of the Pneumatic Circuit of the Ventilator GraphNet ts..................... 8.15
8.19 Diagram of the Electric Circuit of the Ventilator GraphNet advance.............. 8.16
8.20 Diagram of the Electric Circuit of the Ventilator GraphNet neo...................... 8.17
8.21 Diagram of the Electric Circuit of the Ventilator GraphNet ts.......................... 8.18

Warranty............................................................................................................G.i

ii Technical Maintenance Manual | GraphNet advance neo ts

1 General information

CHAPTER CONTENTS

1.1 Observed Requirements and Standards

1.2 General Device Overview

1.3 Intended Use

1.4 Intended User

1.5 Intended Use Environment

1.6 Contraindications for use

1.7 User support

1.8 Symbols used

1.9 Abbreviations, acronyms and variable names

General information | GraphNet advance neo ts 1. 1

1.1 | Observed requirements • EN ISO 13485:2012/AC:2012 - Medical devices. Quality management systems.
and standards Requirements for regulatory purposes (ISO 13485:2003)

• EN 60601-1:2006 - Medical electrical equipment - Part 1: General requirements for

basic safety and essential performance (IEC 60601-1:2005).

• EN ISO 80601-2-12:2011/AC:2011 - Medical electrical equipment. Part 2-12: Par-

ticular requirements for basic safety and essential performance of critical care ven-
tilators (ISO 80601-2-12:2011/Cor 1: 2011).

• EN 60601-1-2:2007/AC:2010 - Medical electrical equipment. Part 1-2: General re-

quirements for basic safety and essential performance. Collateral standard: Elec-
tromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2007).

• EN 60601-1-6:2010 - Medical electrical equipment. Part 1-6: General requirements

for basic safety and essential performance. Collateral standard: Usability (IEC
60601-1-6:2010).

• EN 60601-1-8:2007/AC:2010 - Medical electrical equipment. Part 1-8: General re-

quirements for basic safety and essential performance. Collateral Standard: Gene-
ral requirements, tests and guidance for alarm systems in medical electrical equip-
ment and medical electrical systems (IEC 60601-1-8:2006).

• EN 60601-1-9:2008/AC:2013 - Medical electrical equipment - Part 1-9: General

requirements for basic safety and essential performance - Collateral Standard: Re-
quirements for environmentally conscious design (IEC 60601-1-9:2007/A1:2013).

• EN 62304:2006/AC:2008 - Medical device software. Software life cycle processes

(IEC 62304:2006).

• EN 62366:2008 - Medical devices. Application of usability engineering to medical

devices (IEC 62366:2007).

1.2 | General Device Overview GraphNet advance ts neo is a microprocessor-controlled mechanical ventilator
which incorporates the most advanced methods for ventilatory support. The elec-
tronic circuit operates two proportional valves which provide the gas flow neces-
sary to satisfy the selected configuration.

1.3 | Intended Use GraphNet advance was designed for use in adult, pediatric, and newborn-infant pa-
tients (including prematurely born); GraphNet ts was designed for use in adult, pe-
diatric, and newborn-infant patients (optional) and GraphNet neo for newborn-infant
(including prematurely born) patients; all of the aforementioned being patients that
require invasive and non-invasive ventilation, for a brief or prolonged period, with
monitoring of the main ventilation parameters being possible. The device includes
assistance for patients who may or may not be able to breathe on their own.

1.4 | Intended User GraphNet advance ts neo must be managed by or under the supervision of health
professionals with the appropriate training in ventilatory therapies, and especially
in the use of this ventilator.

1.5 | Intended use environment The ventilator was designed to be used in hospitals and health care centers, speci-
fically in intensive care wards, where the presence of competent professionals and
of the required facilities ensure the proper use of the equipment

1. 2 General information | GraphNet advance neo ts

1.6 | Contraindications for use It is NOT possible to use a ventilator when any of the following events occurs:

• Starting and operating the ventilator in the absence of competent medical profes-
sionals supervising the procedure.

• If there is no alternative ventilation method and equipment that can be used as a

backup.

• To drive an anesthesia machine. Never use it in the presence of flammable

anesthetic gases.

• Do not use nitric oxide, helium or mixtures containing helium.

• Connected the device to an inadequate electric mains power (e.g. without earth
connection).

• The ventilator is located in the vicinity of magnetic resonance equipment or signi-

ficant sources of electromagnetic radiation.

• With gas supply which do not meet medical grade specifications.

• During the inter hospital transfer of patients (mobilization outside the assigned
institution).

• Failure to strictly comply with the instructions for use, user and intended use en-
vironment for this ventilator.

• If the ventilator is located in an hyperbaric chamber.

1.7 | User support If you need technical support, please send an email to technical.assistance@tec-
me.com.ar. Please be sure to include the name of the institution to which the equi-
pment belongs, and the contact details where a response can be submitted.

1.8 | Symbols used

Keep upwards.

Keep dry.

Temperature limits.

Fragile.

Do not stack more than 5 boxes.

Moisture limit.

General information | GraphNet advance neo ts 1. 3

Manufacturer.

Not reusable.

Marking indicating compliance with the re-

quirements of European Council Directive
0086
(93/42/EEC) on medical devices.

Authorized representative in the European

Community.

Off (electric power).

On (electric power).

Warning.

Precaution.

Note.

Type B applied part

Reference the instruction manual.

Final disposal in accordance with the

WEEE (Waste Electrical and Electronic
Equipment) directive.

Degree of protection against ingress of par-

ticles (N1) and liquids (N2). IP Classification.
Alarm
Limits Access to alarm limit configuration.

Audio paused. Icon used to identify the

control and the on-screen warning of the
paused sound alarm signal.

Alarm off. Icon indicating that an alarm has

been deactivated.

Alarm limits.

Exhaled gas discharge port (from patient).

Connection for the expiration set.

1. 4 General information | GraphNet advance neo ts

Inhaled gas delivery port (to patient).

Connection port for the nebulizer.

Connection ports for the distal pneumota-

P1 P2 chograph hoses.
Connection port for the proximal
Prox pneumo-tachograph.
(GraphNet advance / neo)

O2% Connection port for the O2 cell.

CO2 Capnograph (GraphNet advance)

Ventilator in Standby. There is no ventilation

support in this state.

Indicates patient-initiated breaths.

States of charge of the internal battery.

Defective Battery

Rise Time. Control for the setting speed of

the configured inspiratory pressure.

On-screen display for enabled autoscale.

On-screen display for [Ctrl] key pressed.

On-screen display for passive humidifier

selected.

On-screen display for active humidifier se-

lected.

Screen lock.

Proximal pneumotachograph activated.

(GraphNet advance / neo)

On-screen display for maintenance requi-

red.

1.1.9 | Abbreviations, acronyms

and variable names %O2 Concentration of O2

General information | GraphNet advance neo ts 1. 5

ADL Adult (GraphNet advance / ts)

APRV Airway pressure release ventilation

Cpc Compliance of the patient circuit

Cdin Dynamic compliance

Cest Static compliance

Cmax Maximum compliance

CPAP Continuous positive airway pressure

Esc Escape

Esp. Expiration or expired

Expiration-end CO2 (GraphNet advan-

ETCO2 ce)

f Respiratory rate

F Espon Spontaneous respiratory rate

Respiratory rate:tidal volume ratio

F/VT (GraphNet advance / ts)

FiO2 Inspired oxygen fraction

fTOTAL Total respiratory rate

I:E Inspiratory time:expiratory time ratio

Insp. Inspiration or inspired

Lower inflection point (GraphNet

Lip advance / ts)
Mandatory minute ventilation
MMV (GraphNet advance / ts)

NEO-INF Neonate-Infant

O2 100% 100% oxygenation

Inflection points
P/V flex (GraphNet advance / ts)
Pressure during the first 100 ms (Gra-
P0.1 phNet advance / ts)
Lower hose inlet of expiratory pneu-
P1 motachograph
Upper hose inlet of expiratory pneu-
P2 motachograph

1. 6 General information | GraphNet advance neo ts

Paw Airway pressure

PCV Pressure controlled ventilation

PED Pediatric. (GraphNet advance / ts)

PEEP Positive end expiratory pressure

Maximum inspiratory pressure

Pimax (GraphNet advance / ts)

Pmax Maximum pressure

Pmin Minimum pressure

PSV Pressure support ventilation

Re Expiratory resistance

Ri Inspiratory resistance.

Synchronized intermittent mandatory

SIMV ventilation
Time-cycled, pressure-limited ventila-
TCPL tion

Te Expiratory time

Ti Inspiratory time

Upper inflection point (GraphNet

Uip advance / ts)

V̇ Flow.

VCO2 Eliminated CO2. (GraphNet advance)

VCV Volume control ventilation

V̇ E Expired minute volume

Spontaneous expiratory minute volu-

VE Espont me

VE Mandat Mandatory expired minute volume

VM Minute volume

Vmax Maximum volume.

Noninvasive ventilation (GraphNet

VNI advance / ts)

VT ó VT Tidal volume

Imposed work of breathing

WOBi (GraphNet advance / ts)

General information | GraphNet advance neo ts 1. 7

2 Warning - Precaution - Notes

CHAPTER CONTENTS

2.1 Definition of Terms

2.2 Warnings

2.3 Precautions

2.4 Notes

CHAPTER SUMMARY
Warnings, precautions and notes are used to highlight relevant information that the
reader must know. This chapter defines the meaning of the terms warning, pre-
caution, and note in the context of this manual, and summarizes some of the most
important definitions of each of them.

Warnings - Precautions - Notes | GraphNet advance neo ts 2. 1

2.1 | Definition of Terms
WARNING
• Means that it is possible to cause harm to
oneself or to others.

PRECAUTION
• Means that it is possible to damage the devi-
ce, or other equipment nearby.

NOTE
• Specifies the points of particular interest that must
be taken into account for proper application.

2.2 | Warnings WARNING

• GraphNet advance, ts and neo are not intended to function as a support
for anesthetic machines. The use of the ventilator in anesthesia admi-
nistration procedures is not considered as an intended use indication.
• Do not use the ventilator in the presence of flammable anesthetic ga-
ses. This can cause an accident by explosion or fire.
• ALWAYS use a water filter for compressed air at the AIR inlet of the
device. The use of this type of filters is necessary regardless of the
type of compressed air source used.
• Antistatic and electrically conductive hoses shall not be used, neither
in the ventilator pneumatic supply nor in the patient circuit.
• Operation with internal battery has a limited time. In the event of a
dead battery, immediately replace the main power or switch to an al-
ternative method of ventilation.
• To avoid risk of electric shock, this equipment must be connected to
an earthed power source. Neither remove the third pin (earth) of the
plug power cord, nor use a two-pin adapter.
• If the integrity of the external protective earth conductor is question-
able, the equipment must be powered by its internal battery.
• Observe separation distances it to other devices emitting high fre-
quency (e.g., cell or wireless phones, defibrillators, electrocautery de-
vices, etc.). Unwanted interference can be checked on the ventilator.

• Magnetic resonance equipment produces emissions that can damage

the ventilator permanently.
• Do not remove the back panel under any circumstances. Otherwise it
will be sufficient cause to void the warranty included in this manual.
If you remove the back panel, TECME S.A. shall not responsible for
the consequences that this may cause on the equipment or to people.
There may be a risk of electrocution if it is removed while the device is
in operation.
• Use only gases (air and O2) that meet medical grade requirements of
applicable rules.

2. 2 Warnings, Cautions and Notes | GraphNet advance neo ts

• Do not connect any accessory other than those specified as part of
the system.
• Do not use any device that may restrict the flow or pressure between
the output supply and the supply hoses that feed the ventilator. The-
refore, DO NOT USE pressure regulators with shutoff valves, or flow
meters.
• In the event of a significant leak, check the patient circuit to detect the
section with the leak. Replace or repair the segment to prevent any
inadequate change in ventilation.
• The expiratory flow sensor (pneumotachograph) contains in the inner
middle a membrane whose integrity is essential for the proper reading
of the expired volume. When cleaning this part, you must be careful
not to damage the membrane.
• While the ventilator is ventilating a patient, do not establish any con-
nection between it and a data network, or to any external equipment
that does not meet electrical safety requirements necessary to be
considered as an electromedical system or equipment.
• Only TECME S.A. or personnel authorized by the company may repla-
ce or modify the ventilator or its parts.
• Do not position the ventilator near any surfaces that can block the fan,
ventilation slits, audio alarm output or output of exhaled gases as this
could lead to:
- The overheating of the ventilator.
- The limitation of the practitioner’s ability to hear the alarms.
- The limitation of the exhaled gases output through the expiratory
valve, which could possibly result in potential damage.
• Adding accessories to the patient circuit can cause a change in the
pressure gradient through the system and directly affect the operation
of the equipment. Therefore, you must ensure that any change that
affects the patient ventilator circuit does not exceed the specified va-
lues for compliance and/or total inspiratory or expiratory resistance.
• The use of nebulizers or humidifiers can lead to increased resistan-
ce of the inspiratory and/or expiratory filters. Monitor the filters fre-
quently to prevent blockages or increased resistance.
• Do not use the ventilator in a hyperbaric chamber. The device is not
designed for use in that environment.
• Only use gases (air and oxygen) that meet the requirements for medi-
cal grade under applicable standards. Do not use nitric oxide, helium
or mixtures containing helium. The ventilator is not designed to be
used with these gases.
• The ventilator should be connected to a gas network that complies
with the ISO 7396-1:2007 standard because:
- As a high flow device, it may interfere with the operation of adjacent
equipment that uses the same gas.
- It may exceed the flow capacity for which the network was designed.
• To prevent potential internal contamination of the ventilator, always
use viral bacteria filters in the inspiratory and expiratory segments
during respiration.
• Deactivation of alarm signals or setting of extremely high or low limits
may cause the alarm signals not to activate during ventilation, with
the consequent decrease in the effectiveness of the alarm system in
warning of situations requiring professional supervision.

Warnings - Precautions - Notes | GraphNet advance neo ts 2. 3

2.3 | Precautions PRECAUTION

• Do not use solvents, acetone, chloroform or strong acidic substances or

chlorinated solvents to clean plastic parts or hoses in the patient circuit.
• DO NOT USE sodium hypochlorite solutions (bleach) to clean the “Hytrel”
patient circuit hoses.
• DO NOT USE pure alcohol anywhere, or cleaning solutions containing al-
cohol, or cleaners containing conditioners.
• The ventilator cabinet must not be subjected to sterilization with ethylene
oxide gas. This can cause irreparable damage to its components.
• Ethylene oxide can cause alterations in the surface of plastics and accele-
rate the aging of rubber components.
• If when switching on the equipment, after an extended time of disuse, the
system displays low battery power warnings, the ventilator must be con-
nected to a network of adequate power for a minimum period of 15 (fifteen)
hours. If these signals persist, they may indicate the need for a battery
replacement. In this case, contact the authorized service.

2.4 | Notes
NOTE

• Each programmed operative mode maintains its own values and is stored in
temporary memory while the computer stays on.
• It is not possible to start the calibration of the ventilator using only compres-
sed AIR.
• While a ventilator parameter value is being changed and is still not accepted,
the previous value remains active. Similarly, if the change is not accepted
within a maximum time of 15 seconds, the previous value is not modified.
• Follow the current standards in each country to dispose of the equipment,
obsolete parts or elements provided by other companies.
• When disposing of the oxygen cell, keep in mind that it is a waste containing
traces of lead (Pb).
• When disposing of the Li-Ion battery and the CPU board, keep in mind that
these are wastes containing residues of lead (Pb).

MAINTENANCE NOTICE
When the first 5000 hours of operation are completed, and thereafter, every
5000 hours, a tool icon appears at the Icons and messages bar. The presence
of the icon is deleted by the authorized service after the maintenance protocol
is performed.

2. 4 Warnings, Cautions and Notes | GraphNet advance neo ts

3 Description of the ventilator

CHAPTER CONTENTS

3.1 Overview

3.2 Front Panel

3.3 Lower block of connections

3.4 Rear Panel

3.5 Upper Panel

CHAPTER SUMMARY
This is a descriptive chapter which individualizes the ventilator parts and highlights,
in detail, each of their functions. The device is divided into four sections, grouping
the descriptions of related attributes.

Description of the ventilator | GraphNet advance neo ts 3. 1

3.1 | Overview The GraphNet advance neo y ts ventilator integrates user interface, connections
to the patient circuit, and connections to power sources (electric and pneumatic)
into its cabinet.

The user interface has a touch screen, fixed keys and a rotary knob which allows
for the management of all functions.

All connection points of the ventilator, whether they are electric or pneumatic, res-
pect the relevant standards.

For the purpose of its description, the ventilator is divided into four sections:

• Front panel.

• Lower block of connections.

• Rear panel.

• Upper panel.

3.2 | Front Panel

Fig. 3-1 Picture of GraphNet advance front panel.

References of the Fig. 3-1

1 Screen.

2 Alarm Signals - Light Indications of the alarm system.

3 Fixed keys.

4 Rotary knob.

5 Electric power source indicators.

3. 2 Description of the ventilator | GraphNet advance neo ts

3.2.1 | Screen The ventilator features a 12” touch screen which continuously displays the mo-
nitoring of the ventilator parameters, and various curves which can be selected
according to user preference.

NOTE
• The connection to an external monitor is available
through a VGA port, in order to visualize in real time
the same information that is shown in the main screen
of the ventilator.

The screen is sectioned to facilitate the interpretation of the information presented.

The characteristics of these fields are as follows.

3.2.1.1 | Control adjustments. The lower area of the screen displays the ventilator parameters involved in the ope-
rative mode (Fig. 3-2). These values can be adjusted by the user. As one or other
operative mode is selected, the amount and nature of these parameters may vary.

Fig. 3-2 Picture of a screenshot in which the field reserved for the controller
settings is highlighted (operative mode screen: SIMV (VCV) + PSV).

3.2.1.2 | Monitored data. The upper area of the screen houses the parameter values monitored by the ven-
tilator. On the left of this area, a label indicates the patient category, the operative
mode and, if possible to program backup ventilation, the operative mode configu-
red as a backup. This area also includes the date and current time. (Fig. 3-3)

Below some of the monitored parameters lie touch buttons. These buttons allow
for direct access to the configuration of the corresponding alarm. These buttons
display the limit value of such alarms at all times.

Description of the ventilator | GraphNet advance neo ts 3. 3

Fig. 3-3 Picture on a screen where the high portion has been highlighted,
dedicated to indicate the monitored parameters. On the left of this area, the
general data of ventilation are shown, such as the category of patient, the
operative mode, and the configured mode set up as backup ventilation.

The monitored parameters are:

• Peak flow - Inspiratory Peak flow (L/min)

Peak flow in liters per minute. In all modes the maximum flow of gas,
sent by the ventilator with each breath, is indicated.

• Ti - Inspiratory time (s)

It is indicated for each breath in all modes. The pause time is added
when programmed or when run manually.

• Te - Expiratory time (s)

Resulting expiratory time upgraded with each new breath.

• Current I:E - I:E

It indicates the inspiration/expiration resulting ratio.

• fTOTAL - Total rate (rpm)

Total rate (spontaneous and mandatory breaths) expressed in breaths
per minute.

• VT - Expirated tidal volume (L for ADL/PED and mL for NEO-INF)

Tidal volume breath by breath.

• VE - Expirated minute volume (L/min)

Value of the expiratory volume from the patient. This is a parameter
that is monitored in all operative modes. Updating this value is done on
a continuous basis.

• Oxygen - Oxygen Monitor (%)

It indicates the percentage of oxygen in the gas sent to the patient.

3. 4 Description of the ventilator | GraphNet advance neo ts

3.2.1.3 | Touch screen buttons. On the right-hand area of the screen, a series of touch buttons, associated with the
following features, appear:

Graphics (Displays screen graphics options).

Freeze (Freezes on-screen graphics).

Respiratory mechanics.

Save loop.

Nebulizer.

Help (help on the meaning of touch and fixed keys).

Stand by.

On the left-hand area of the screen, there are two touch buttons for rapid access to
modifying the limits of inspiratory pressure alarms.

Maximum inspiratory pressure.

Minimum inspiratory pressure.

Fig. 3-4 The right-hand toolbar, which identifies touch commands for certain
functions, and the left-hand toolbar which, among other things, indicates the
numeric monitoring of pressure, are highlighted.

Description of the ventilator | GraphNet advance neo ts 3. 5

3.2.1.4 | Left-hand toolbar On the left-hand area (see Fig.3-4) the following information is found:

• Battery status

Indicator of the battery charge status. The declared autonomy for the internal bat-
tery in the chapter Technical Specifications covers the status of full battery and low
battery.

Full battery (green icon).

Low battery (yellow icon).

Inoperative battery. Very low battery (red icon flashes).

Defective battery. Battery is unable to charge.

WARNING
• When the icon for inoperative battery appears,
the remaining charging time is unpredictable, and
main power source should be restored or repla-
ced with an alternative ventilation system.

• “Lung” icon
It is activated with every breath triggered by the patient.

• Peak pressure (Peak)

It indicates the peak pressure (maximum) achieved in each breath.

• Tracheal pressure (Trach)

It indicates the estimated tracheal pressure when the function Tube Compensation
is activated. (Only for GraphNet advance)

• Plateau pressure (Plateau)

It indicates the pressure maintained during inspiration when inspiratory pause has
been scheduled or when pressing [Insp/Exp Pause].

• Mean pressure (Mean)

It indicates the mean pressure of each breath.

• PEEP
It indicates the pressure of the end of the expiratory phase.

• Alarm limits of the inspiratory pressure

Corresponds to the alarm limit levels of the set maximum and minimum pressure
(chapter Alarms in the User´s manual, explains how to change these limits).

3.2.1.5 | Icons and messages Between the Monitored data and the graphics area there is a space dedicated to
bar and Onscreen alarm Icons and messages and Onscreen notices of the alarm system.

notices.
The toolbar that shows icons and messages reporting a particular state of the ven

3. 6 Description of the ventilator | GraphNet advance neo ts

tilator, or feature thereof, is located on the left-hand area of the screen. The
meanings of the icons are found in chapter General Information.

If the number of the active messages displayed on this toolbar are superior to the
space reserved for them, a rotating sample function is automatically activated. To
indicate the presence of messages not being shown at that time, an arrow icon will
appear in the upper right-hand corner of the toolbar. Every 5 s the messages rotate
in a way that all active messages are displayed. In Fig. 3-5 a sequence of three
statuses of the Toolbar icons and messages have been copied when there are 4
active messages.

Fig. 3-5 The three toolbars indicate the sequence of messages, when
functions are found to be active Volume compensation, Leakage compensa-
tion, Sigh, and Inspiratory pause.

The right-hand area is dedicated to a space for the emergence of On-screen noti-
ces of the alarm system. Whenever an alarm is triggered, the ventilator displays the
name of that alarm in this area. The name appears on a red or yellow background
which indicates the priority of that alarm.

Fig. 3-6 Picture in which the space reserved for the emergence of On-screen
notices of alarms is highlighted. In this case the alarm of Maximum inspiratory
pressure is found to be active.

3.2.2 | Alarm signals It corresponds to the visual light signals forming part of the alarm system.

Description of the ventilator | GraphNet advance neo ts 3. 7

3.2.2.1 | Frontal panel
Fig. 3-7 Appearance of the Alarm Signals area where alarm light
indicators are found.

• Inop. Vent.
It turns itself red if the ventilator goes into technical failure and remains inoperative.
At start-up, this indicator lights up momentarily during the initial automatic tests,
without signifying a technical failure. Alarm condition of maximum priority.

• High
Reserved for high priority alarms. It lights up red.

• Med - Low
Light signal accompanying alarms of medium to low priority. It lights up yellow.

3.2.2.2 | Upper panel On the top of the upper panel there is the upper light indicator, which is part of the alarm
system.

3.2.3 | Fixed keys Alarm limits setting

Alarms have preset values, but can be reprogrammed. By pressing

the key a menu appears with the alarms modifiable by the user.

Paused audio

Pressing the key once will pause the alarm beep during 30 s; pres-
sing the key twice will result in a pause of 60 s.

Selection of operative modes

Pressing this key leads to the menu OPERATIVE MODES, from

which you can select one of the enabled operative modes for the
current patient status.

Menu

This key allows for access to the main menu of the ventilator. Given
the importance of these key functions, a chapter in the User’s Manual
is especially dedicated to its description.

Screen Lock – Touch screen lock

Fixed key used to block the functions of the touch screen as well as
the fixed keys of the right-hand area of the front panel.

3. 8 Description of the ventilator | GraphNet advance neo ts

%O2 suction

Allows for ventilation with a concentration of O2 configurable for suc-

tion maneuvers. The time destined to suction can also be configured.

Manual Inspiration

While the ventilator is operating, pressing this key initiates a manual

inspiration, with the values of the selected mode. By pressing [Ctrl]
+ [Manual Insp.] a sigh will be initiated, if they are programmed.

Manual Inspiratory/Expiratory Pause

It suspends ventilation and maintains the inspiratory or expiratory

phase while the key is held down for a maximum of 7 s for inspira-
tion and 20 s for expiration. This command works in VCV, PCV, and
PRVC modes.

Ctrl

This key is always used in combination with another. Some exam-

ples of these functions are:
• [Ctrl] + [Alarm Limits] = 1) Alarms test. 2) Help message when an
alarm is activated.
• [Oxygen] + [Ctrl] = Change of the value in steps of ten units.
• [Ctrl] + [Ctrl] = Reset all sensors to zero.
• [Ctrl] + [Manual Insp.] = Sigh (if programmed).
• [Ctrl] + [Graphic] = 1) Refreshes screen. 2) Deletes the reference
loop on the screen but remains in memory.

Esc

It is a key with multiple, primary functions or in combination with

other keys. This key, among other functions, allows for:
• Restoring the light signal of any activated alarm.
• Cancelling or aborting of the current ongoing operation, returning
to the previous function.
• Closing an open menu while returning to the graphics display.
• Cancelling the current screen and returning to the main screen
(FIVE CURVES).
• Cancelling a maneuver in progress.

NOTE
• The touchscreen will remain blocked in the event that
any fixed key is pressed. If this situation continues for
more than 60 seconds, a message will appear in the
icons and message Bar.

3.2.4 | Rotary Knob The rotary knob is located on the lower right-hand corner of the front panel. This
knob rests on a luminous ring which lights up each time it is enabled for use. This
is the device which permits the modifying of the ventilator configuration, and with
which it is also possible to navigate through the enabled menus.

Some specific tasks can also be carried out by using the knob. For example, chan-
ges in scale, or the scrolling of the cursor over the graphics.

Description of the ventilator | GraphNet advance neo ts 3. 9

By pressing the knob, the executed modification is assimilated, or the submenu on
which it is positioned will be selected. The use of this device is very intuitive. When
it is necessary to use it will be described throughout this instruction manual.

3.2.5 | Electric power source This sector links two light indicators which inform on the status of the electric power
indicators supply of the ventilator. Refer to Table3-1.

Fig. 3-8 Light indicators reporting the status of the electric power supply.

Table 3-1 Electric power source light indicators

On/Off
Indicator Status
(Color)
110-220 VAC On (green). Ventilator powered by 110-220 VAC
Battery/Charge Off. mains.

110-220 VAC Off. Ventilator powered by its internal ba-

Battery/Charge On (Blue). ttery.

110-220 VAC On (green). Ventilator powered by 110-220 VAC

Battery/Charge On (green). mains. Battery charging time.

3.3 | Lower Block of This section only lists the items which form part of the block.
Connections

Fig. 3-9 Picture of the lower area of the ventilator.

References of the Fig. 3-9

1 Connection for the expiratory set.

2 Connections for pneumotachograph hoses of the expiratory valve.

3 O2 cell.

3. 10 Description of the ventilator | GraphNet advance neo ts

4 Connection for the nebulization hose.

5 Connection Towards Patient of the patient circuit.

6 Inlet for the capnograph connector. (GraphNet advance)

7 Connection for proximal pneumotachograph. (GraphNet advance/neo)

3.4 | Rear Panel The inlet openings for the gas connection, the electric power source input, and
the ventilator on/off switch are found on the rear panel. In the chapter Assembly
and Installation of the User´s manual, there is a description on how to execute the
connections.

Fig. 3-10 Picture of the rear panel of the ventilator.

References of the Fig. 3-10

1 Blower air outlet.

2 Audio output for the alarm audio.

3 RS-232 port.

4 Electric switch.

5 Input (AC filter) for the electric power source with fuse box.

6 Air inlet.

7 Oxygen inlet.

8 VGA port.

3.5 | Upper Panel On the upper part of the ventilator cabinet, there is the upper light indicator which
functions as a visual alarm signal, see Fig. 3-1.

Description of the ventilator | GraphNet advance neo ts 3. 11

4 Detailed summary of parts and sets

CHAPTER CONTENTS

4.1 Rear cabinet

4.2 Pneumatic box (lower and upper)

4.3 Front cabinet

CHAPTER SUMMARY
This chapter describes the components of the device and the relationship between
the same. The device is divided into three sections with the purpose of grouping
similar parts.

Detailed summary of parts and sets | GraphNet advance neo ts 4. 1

4.1 | Rear-Cabinet

4.1.1 | Casing

4.1.2 | Rear lid

4. 2 Detailed summary of parts and sets | GraphNet advance neo ts

4.1.3 | Speaker kit

References Part
1 Speaker
2 Acoustic box
3 Cord
4 Grille

4.1.4 | Fan kit

4.1.5 | ON-OFF key

Detailed summary of parts and sets | GraphNet advance neo ts 4. 3

4.1.6 | Battery

4.1.7 | Upper and lower metallic

chassis

4.1.8 | Lower cabinet support

4. 4 Detailed summary of parts and sets | GraphNet advance neo ts

4.2 | Pneumatic box
(lower and upper)

4.2.1 | Lower box

4.2.1.1 | Air inlet kit

Detailed summary of parts and sets | GraphNet advance neo ts 4. 5

References Part
1 3/4” Connector
2 O-ring
3 Porous metal filter
4 Screws
5 Body of entry of driving gas with 6 openings
6 Body of entry of driving gas

4.2.1.2 | Oxygen Intake Kit

References Part
1 9/16” Connector
2 O-ring
3 Porous metal filter
4 Screws
5 Body of entry of driving gas with 6 openings
6 Body of entry of driving gas

4.2.1.3 | Full gas control kit

4. 6 Detailed summary of parts and sets | GraphNet advance neo ts

4.2.1.3.1 | Gas control kit

References Part
1 2.0 kg/cm Air and oxygen regulators
2

2 Full proportional valve

3 Internal pneumotacograph

4.2.1.3.2 | Safety valve

4.2.1.3.3 | Full antisuffocation valve

Detailed summary of parts and sets | GraphNet advance neo ts 4. 7

4.2.1.4 | 0.7 kg/cm2 regulator

4.2.1.5 | No return air valve

4.2.1.5 | No return oxygen valve

4. 8 Detailed summary of parts and sets | GraphNet advance neo ts

4.2.2 | Upper box

4.2.2.1 | Sensors board

References Part
Honeywell flow sensors.
a: Air flow sensor
1
b: Oxygen flow sensor
c: Expiratory flow sensor
Pressure sensors.
2 a:Low pressure.MPX10DP
b:High pressure.MPX5700DP
3 Proportional PEEP valve
4 ON/OFF valves

4.3 | Front cabinet

Detailed summary of parts and sets | GraphNet advance neo ts 4. 9

4.3.1 | CPU board

4.3.2 | Touch screen control

board

4.3.3 | Alarm light board

4. 10 Detailed summary of parts and sets | GraphNet advance neo ts

4.3.4 | Main power source
4.3.4.1 | Supply board

4.3.4.2 | Power source cover

4.3.4.3 | Power source bracket

Detailed summary of parts and sets | GraphNet advance neo ts 4. 11

4.3.5 | Cabinet locking flanges

4.3.6 | CPU board support plate

4.3.7 | Frontal panel and mani-

fold

4. 12 Detailed summary of parts and sets | GraphNet advance neo ts

4.3.7.1 | Complete frontal panel

References Part
1 Encoder knob
2 Panel with film
3 Keyboard board
4 Display

Detailed summary of parts and sets | GraphNet advance neo ts 4. 13

4.3.7.2 | Full output manifold

References Part
1 Connection for expiratory valve.
Connections for pneumotachograph hoses of the expiratory
2
valve
Connection for proximal pneumotachograph (only for advance/
3
neo)
4 O2 cell
5 Connection for the nebulization hose
6 Connection Towards Patient of the patient circuit
7 Inlet for the capnograph connector (Only for advance)

4. 14 Detailed summary of parts and sets | GraphNet advance neo ts

5 Disassembly

CHAPTER CONTENTS

5.1 Opening the device

5.2 Remove the upper pneumatic box

5.3 Disassembly of the CPU board and controller board

5.4 Disassembly of the power supply.

5.5 Disassembly of the lower pneumatic box

5.6 Disassembly of the output manifold

5.7 Disassembly of the front panel, upper alarm light and locking
flanges.

5.8 Disassembly of the keyboard board.

CHAPTER SUMMARY
This chapter describes in detail the process for the disassembly of the device,
which, in turn, is divided into eight consecutive processes.

Disassembly | GraphNet advance neo ts 5. 1

5.1 | Opening the Device The disassembly process starts by opening the device, removing the rear cabinet
lid and rear cabinet; this procedure consists of the following stages.

Removing the rear cabinet lid:

• Lay the device down over a foam surface with the upper side close to the techni-
cian, and the front side facing down. Next, remove the rear lid of the device by
removing the eight M 4x0.7x16 Allen screws shown in the figure, using 2.5 mm
Allen keys.

Fig. 5-1 Details of the Allen screws to be removed.

Disconnection of the cables located at the rear lid:

• Lift the rear lid in order to disconnect the motherboard cables, which are indicated
on the label located on the back lid. This must be inspected again at the time of
connecting the cables and replacing the lid. The information contained on the
label is the following:

• Battery CON 27

• RS-232 CON 19

• Speaker CON 18

• Fan CON 23

• VGA output CON 9

Separation between the front cabinet and the rear cabinet

• Remove the six screws that separate the front cabinet from the back cabinet (Fig.
5-2). The sizes of the Allen screws on the front cabinet are M4x0.7x30 (location 3,
3mm Allen key), and on the rear cabinet are M4x0.7x16 (location 1, 2.5mm Allen
key), at the top of the cabinet, and M6x1x20 (location 2, 4mm Allen key) at the
bottom of the cabinet, between the two lower supports.

• Detach the two cabinets to disconnect power (Fig. 5-3), and then remove the
cabinet gasket.

5. 2 Disassembly | GraphNet advance neo ts

Fig. 5-2 Screws that must be removed in order to detach the cabinets.

Fig. 5-3 Mains disconnection: Main power source ground, main power source
AC cable, ON/OFF cable (CON 26).

Disassembly | GraphNet advance neo ts 5. 3

5.2 | Remove the upper In order to remove the upper pneumatic box, the steps listed bellow must be car-
ried out:
pneumatic box
• Disconnect the following cables from the sensor board: oxygen sensor, electro-
valves, sensors and proportional valves (Fig. 5-4, left).

• Remove the four M4X0.7X12 Allen screws holding the upper part of the pneu-
matic box, using a 2.5mm Allen key (Fig. 5-4, right).

Fig. 5-4 Disconnection of cables (left) and removal of Allen screws (right) for
disconnecting the upper box from the lower one.

• Disconnect the hoses from the multiple connector located at the upper pneumatic
box that come both from the output manifold and the pneumatic unit, leaving the
upper box free to be removed. In order to disconnect the Parker hoses from the
multiple connector located at the upper box, the hoses must be removed up to the
third section of the connector (Fig.5-5), and then they must be pulled.

NOTE
• The hoses must be cut with some pliers approximate-
ly 5 mm wide, which will allow reconnecting them
while preserving their integrity, preventing potential
disconnection and/or leak problems.

Fig. 5-5 Metallic connector.

• Disconnect the Festo air and oxygen hoses from the high pressure inlets, leaving
the upper box free to be removed.

5. 4 Disassembly | GraphNet advance neo ts

• The following images (Fig. 5-6, Fig. 5-7, Fig. 5-8 y Fig. 5-9) and table (Table 5-1),
detail the appropiate connection of the hoses. This could be useful for the recon-
nection procedure.

Table 5-1 Connecting the hoses of the pneumatic box

Multiple
connector -
Hoses Lower box Sensor board
pneumatic
box

PEEP Valve Expiratory port 1 V14 outlet (PEEP Valve)

Inlet 2 from V2, with outlet connected

P2 (1) P2 2 to the Festo “T” connector towards the
V4 outlet (purge) and inlet to from V6.
Inlet 2 from V3, with outlet connected
P1 (2) P1 3 to the Festo “T” connector towards the
V5 outlet (purge) and inlet to from V7.
Inlet 1 from V3, with outlet connected
Left proximal 4 to the Festo “T” connector towards the
connector (2) V5 outlet (purge) and Input 2 from V7
Proximal
Inlet 1 from V2, with outlet connected
Right proximal 5 to the Festo “T” connector towards the
connector (1) V4 outlet (purge) and Input 2 from V6
O2 Sensor Pro- Inlet 2 from V1, with outlet connected
Pctrl 6
tector to the Motorola MPX10 lower sensor
Manifold nebu- Manifold nebu- 7 Inlet 1 of V13
lizer lizer outlet
Festo “T” air
connector, locat- Inlet 1 from V12 (plastic connector)
Air nebulizer ed at the outlet A with outlet towards the V13 outlet
of the 2 kg/cm2
air regulator
Festo “T” con-
nector, located
Oxygen nebu- towards the Inlet 2 from V12 (metallic connector)
B
lizer outlet of the 2 with outlet towards the V13 outlet
kg/cm2 oxygen
regulator
Festo “T” connector with inlet 1 from
0.7 kg/cm2 regu-
0.7 regulator C V4 and V5, and inlet from V14 (PEEP
lator outlet valve)
Inlet 2 from V11, with outlet connected
D to the P2 connector from the Honey-
Air pneumota- Air pneumotaco- well air flow sensor
cograph graph Inlet 2 from V10, with outlet connected
E to the P1 connector from the Honey-
well air flow sensor
Inlet 2 from V9, with outlet connected
F to the P2 connector from the Honey-
Oxygen pneu- Oxygen pneu- well oxygen flow sensor
motacograph motacograph Inlet 2 from V8, with outlet connected
G to the P1 connector from the Honey-
well oxygen flow sensor
High pressure Festo air inlet - Upper Motorola MPX5700 sensor
air connector
High pressure Festo oxygen - Lower Motorola MPX5700 sensor
oxygen inlet connector
(1) The V6 outlet to Festo “T” towards the upper Motorola MPX10 sensor and P1 connec-
tor from the Honeywell exhalatory flow sensor.
(2) The V7 outlet towards P2 connector from the Honeywell exhalatory flow sensor.

Disassembly | GraphNet advance neo ts 5. 5

Fig. 5-6 Location of hoses at the output manifold.

Fig. 5-7 Location of hoses at the pneumatic unit

Fig. 5-8 Location of hoses at the multiple connector of the upper pneumatic
box

5. 6 Disassembly | GraphNet advance neo ts

Fig. 5-9 Location of sensors and valves at the sensor board

• Remove the pneumatic box lid, loosening the four nuts that hold it using a ¼”
socket wrench (Fig. 5-10).

Fig. 5-10 Disassembly of the pneumatic box lid.

• Using a 7/32” socket wrench, remove the 6 M3x0.5 nuts that hold the sensor
board to the upper box (Fig. 5-11).

Fig. 5-11 Removal of the sensor board from the upper box

Disassembly | GraphNet advance neo ts 5. 7

• Using a Phillips screwdriver, remove the 4 Parker 4x3/8 screws that hold the mul-
tiple connector to the upper box (Fig. 5-12).

Fig. 5-12 Disassembly of the multiple connector of the upper box

5.3 | Disassembly of the NOTE

CPU board and con- • Depending on the technical service needs, the CPU
board must be disconnected before or after discon-
troller board necting the power supply. However, both parts must
be disassembled in order to access the front panel.

In order to remove the CPU board, the following steps must be carried out:

• Firstly, disconnect the cables mentioned in Table 5-2, wich are located as it is
shown in Fig. 5-13.

• Take into account that is necessary using anti-static protection.

Fig. 5-13 Location of the connectors of the CPU board

5. 8 Disassembly | GraphNet advance neo ts

Table 5-2 Connections of the CPU board and CONTROLLER board
Connection on CON- Connection on
CABLE TROLLER BOARD CPU BOARD
Display cable - CON4
Backlight cable - CON3
DB9 connector of controller board cable P1 (serial cable) CON7
Red-black cable of controller board cable P1 (serial cable) CON32
Accu-touch membrane ribbon cable P2 -
Capnograph cable - CON31
CPU power supply cable - CON25
Left ribbon cable of the keyboard board - CON6
Right ribbon cable of the keyboard board - CON8

• Loosen the 3 M3x0.5 nuts that hold the CPU board to the metallic shielding (Fig.
5-14)

Fig.5-14 Loosen the three nuts that hold the CPU board to the board support
plate.

• Pull the board backwards, and then slide it upwards.

• In order to remove the controller board, the two M3x0.5 nuts that hold this board
to the metallic shielding must be loosened. (Fig. 5-15)

Fig. 5-15 Removal of the controller board

Disassembly | GraphNet advance neo ts 5. 9

5.4 | Disassembly of the In order to remove the power supply, the following steps must be carried out:
power supply.
• Remove the power source cover with a flat screwdriver, loosening the two
M3x0.5x6 screws (Fig. 5-16)

Fig. 5-16 Disconnection of the power source cover of the power supply

• Disconnect the ground cable (Fig. 5-17) and remove the M3x0.5x20 affixing sup-
ply screw, along with its washer, aluminum spacer and 3x0.5 nut (Fig. 5-18), using
a 2.5mm Allen key and a 7/32” socket wrench.

Having completed the above mentioned steps, remove the power supply from its
support, moving the three attachment spacers upwards.

Fig. 5-17 Disconnection of the grounding cable of the power supply support

5. 10 Disassembly | GraphNet advance neo ts

Fig. 5-18 Disconnection of the power supply support

• Loosen the M4x0.7 nut that attaches the lower section of the power supply sup-
port to the multiple, using a 7mm socket wrench (Fig. 5-19)

Fig. 5-19 Disconnection of the output power supply support

• Loosen the M3x0.5 nut that attaches the power supply support to the pneumatic
box, using a 6mm socket wrench (Fig. 5-20).

Fig. 5-20 Disconnection of the power supply support of the pneumatic box

Disassembly | GraphNet advance neo ts 5. 11

• Loosen the M3x0.5x22 screw that holds the power supply support to the box with a
spacer, a star washer and the grounding cable of the box (Fig. 5-21 and Fig. 5-22).

Fig. 5-21 Location of the power supply support spacer of the pneumatic box

Fig. 5-22 -Attachment screw of the pneumatic box to the power supply
support

• Remove the power supply support (Fig. 5-23)

Fig. 5-23 Remove the power supply support

5. 12 Disassembly | GraphNet advance neo ts

5.5 | Disassembly of the In order to remove the lower pneumatic box, the following steps must be carried out:
lower pneumatic box
• Disconnect both the corrugated hose for output manifold and the U-shaped sili-
cone-coated hose of the connector of the oxygen sensor protector (Fig. 5-24).

Fig. 5-24 Disconnection of the hoses of the oxygen sensor protector

• Remove the six M4x0.7 nuts that hold the lower box to the manifold (Fig. 5-25)

Fig. 5-25 Location of the nuts that hold the manifold to the lower box.

• Finally, detach the front cabinet from the lower pneumatic box (Fig. 5-26), passing
all manifold hoses through the holes of the lower box.

Fig. 5-26 Detach the lower box from the front cabinet.

Disassembly | GraphNet advance neo ts 5. 13

5.5.1 | Disassembly of the In order to disassemble the pneumatic unit, the following steps must be carried out:
pneumatic unit from the lower
• Disconnect the Festo high air and oxygen pressure hoses from their respective
box gas inlets.

• Remove the M4x0.7x6 screws with a 3mm Allen key, and their respective star
washers (Fig. 5-27).

Fig. 5-27 Disconnection of the M4x0.7x6 screws. The “A” screw is located
next to the 0.7 kg/cm2 regulator, while screw “B” is located next to the anti-
suffocation valve.

• Pull the pneumatic unit upwards, away from the lower pneumatic box housing
(Fig. 5-28)

Fig. 5-28 Separation of the pneumatic unit from the lower box

5. 14 Disassembly | GraphNet advance neo ts

• Remove the seal that attached the silicone-coated tube of the anti-suffocation
valve to the pneumotacograph (Fig. 5-29), and then remove the M4x0.7 nuts (Fig.
5-30) that hold the anti-suffocation valve to the 2kg/cm2 regulators

Fig. 5-29 Removal of the seal that holds the silicone-coated tube

Fig. 5-30 Disconnection of the attachment nuts that hold the anti-suffocation
valve to the 2 kg/cm2 regulators.

• In order to set the 0.7 kg/cm2 regulator free, cut the Parker hoses that connect this
regulator to the 2 kg/cm2 air and oxygen regulators using a set of cutting pliers.

• Remove the grub screws of the pneumotacograph, in order to detach it from the
proportional valves (Fig. 5-31).

Fig. 5-31 Disassembly of the pneumotachograph.

Disassembly | GraphNet advance neo ts 5. 15

• In order to disassemble the electrovalve support, do the following; firstly, loosen
the two M4x0.7 nuts along with the two M4x0.7x8 screws that hold this support to
the regulators supports (Fig. 5-32), then loosen the four M4x0.7x6 screws that
hold the proportional valves to the support (Fig. 5-33).

Fig. 5-32 Loosen the proportional valves support from the regulators support

Fig. 5-33 Disassemble the proportional valves from the corresponding

support

• Detach the pressure regulators from the proportional valves, pulling them out
(Fig. 5-34).

Fig. 5.33 Loosen the proportional valve from the pressure regulator.

5. 16 Disassembly | GraphNet advance neo ts

5.5.2 | Disassembly of the peri- In order to remove the peripherals from the lower box, the following steps must be
pherals from the lower box carried out:

• Loosen the M4x0.7x12 screw that holds regulator fixing bracket to the lower box
(Fig. 5-35).

Fig. 5-35 Loosen regulator fixing bracket to the lower box housing

• Remove the anti-suffocation inlet, taking into account that it is sealed to the lower
box (Fig. 5-36).

Fig. 5-36 Disassembly of the anti-suffocation inlet

• Loosen the Festo air and oxygen connectors (Fig. 5-37), using a fixed key.

Fig. 5-37 Loosen the Festo air and oxygen connectors

Disassembly | GraphNet advance neo ts 5. 17

• Finally, loosen the three M4x0.7x8 screws that connect the air and oxygen inlets
to the lower box, releasing them from the latter (Fig. 5-38).

Fig. 5-38 Loosen the air and oxygen inlets

5.6 | Disassembly of the In order to remove the output manifold from the front cabinet, the following steps
output manifold must be carried out:

• Remove the four M4x0.7 nuts that hold the manifold to the front cabinet (Fig.
5-39).

Fig. 5-39 Location of the nuts that attach the manifold to the front cabinet

NOTE
• The following step applies only to the GraphNet Ad-
vance equipment.

• Disconnect the Molex terminals of the multiple capnograph cable from their two
connectors (Fig. 5-40), taking into account the following connection diagram at
the time of assembling the aforementioned cable:

Tabla 5.3 Possible configurations of the capnograph connector cables

Cable 1 2 3 4 5 6 7
Light
Conf. 1 Purple Brown Yellow Green Red Orange
Blue
Conf. 2 White Brown Yellow Blue Transparent Red Orange
Conf. 3 Purple Black Yellow Blue White Red Orange
Conf. 4 White Black Brown Blue Green Red Orange

5. 18 Disassembly | GraphNet advance neo ts

Fig. 5-40 Capnograph cables connection scheme

• Remove the manifold from the front cabinet (Fig. 5-41)

Fig. 5-41 Disassembly of the output manifold

5.7 | Disassembly of the In order to remove the front panel, the following steps must be followed:
front panel, upper
• Pass through the respective slot, the light cable of the upper alarm and the ribbon
alarm light and loc- cable of the Accu-Touch membrane.
king flanges.
• Remove the four M3x0.5 nuts that hold the CPU board support plate to the front
cabinet (Fig. 5-42).

Fig. 5-42 Disconnection of the CPU board support plate

Disassembly | GraphNet advance neo ts 5. 19

• Remove the four M3x0.5 nuts that hold the display to the front panel (Fig. 5-43).

Fig. 5-43 Location of the nuts that hold the display to the front panel.

• Remove the three 4x1/4” Parker screws that hold the upper portion of the front
panel (Fig. 5-44), plus the seven remaining 3.5x12.5 screws that hold the front
panel to the front cabinet (Fig. 5-45), thus releasing the cabinet’s panel.

Fig. 5-44 Loosening the Parker screws

Fig. 5-45 Loosening the 3.5x12.5 screws

5. 20 Disassembly | GraphNet advance neo ts

• Using a Phillips screwdriver, remove the two Parker 4x3/8 screws that hold the
upper alarm light plate to the cabinet (Fig. 5-46).

Fig. 5-46 Removing the upper alarm light

• Remove the locking flanges located at the ends of the cabinet (Fig. 5-47). Take
into account that the ground cable is located only at the left end, and not at the
right end.

Fig. 5-47 Loosening the locking flanges

5.8 | Disassembly of the In order to remove the keyboard board from the front panel, the following steps
must be carried out:
keyboard board.
• Remove the encoder knob and nickel-plated nut of the front panel.

• Remove the eight M3x0.5 mm nuts that hold the keyboard board to the front
panel (Fig. 5-48).

Disassembly | GraphNet advance neo ts 5. 21

Fig. 5-48 Disassembly of the keyboard board.

NOTE
• When removing the keyboard board from the front
panel, consider that this has diffusers near the repre-
sentative fixed keys of the paused audio (30-60s) and
screen lock (padlock icon).

5. 22 Disassembly | GraphNet advance neo ts

6 Assembly

CHAPTER CONTENTS

6.1 Introduction

6.2 Hoses connection on sensors board

6.3 Hoses connection on upper pneumatic box

6.4 Hoses connection on lower pneumatic box

CHAPTER SUMMARY
This chapter describes the assembly process of the component parts of the venti-
lator, in order to avoid inappropriate connections that could cause malfunctioning
problems.

Assembly | GraphNet advance neo ts 6. 1

6.1 | Introduction During the assembly process of the component parts of the ventilator, it is neces-
sary to have a series of precaution in order to avoid inappropriate connections that
could cause malfunctioning problems.

Also each assembled part could have greater or lesser dificulty during the asembly
process, depending on the characteristics of each one.

Regarding the mechanic and electronic assembly, see Disassembly chapter follow
the inverse procedure that is described in it.

However, the pneumatic box connections are more complex, and that is the reason
whereby this chapter is included.

6.2 | Hoses connection on Connect the 4mm x 210mm PARKER PARFLEX hose in “Inlet 1” of the V12 valve
as shown below.
sensors board

Connect a 4mm x 70mm PARKER PARFLEX hose in the V12 “Outlet” and the V13
“Outlet”.

Connect five 4mm x 90mm PARKER PARFLEX hoses as described below:

• Connect to V7 “Outlet” and to the “P2” of the Honeywell expiratory flow sensor.

• Connect to V8 “Outlet” and to “P1” of the Honeywell O2 flow sensor.

6. 2 Assembly | GraphNet advance neo ts

• Connect to V9 “Outlet” and to “P2” of the Honeywell O2 flow sensor.

• Connect to V10 “Outlet” and to “P1” of the Honeywell Air flow sensor. Route over
the hose connected to “Inlet 1”, of V12.

• Connect to V11 “Outlet” and to “P2” of the Honeywell Air flow sensor. Route over
the hose connected to “Inlet 1”, of V12.

Connect the D.3x6x60mm Crystal tube according the following sequence:

1º. Connect to V1 “Outlet”.

2º. Route the hose under V2 and V3 inlet.

3º. Connect to the lower Motorola sensor. (see figure below)

Connect the 6x1x400mm FESTO PUN tube to the lower Motorola sensor, as
shown in the picture.

Assembly | GraphNet advance neo ts 6. 3

Connect the 6x1x400mm FESTO PUN tube to the upper Motorola sensor, as
shown in the picture below.

Connect two 4mm x 210mm PARKER PARFLEX hoses as described below:

• Connect to “Inlet 2” of V2.

• Connect to “Inlet 2” of V3.

6. 4 Assembly | GraphNet advance neo ts

Connect eight 4mm x 65mm PARKER PARFLEX hoses and one N°5 pneumatic
tube as described below:

• Connect to “Inlet 2” of V1.

• Connect to “Inlet 1” of V2.

• Connect to “Inlet 1” of V3.

• Connect to “Inlet 2” of V8.

• Connect to “Inlet 2” of V9.

• Connect to “Inlet 2” of V10.

• Connect to “Inlet 2” of V11.

• Connect to “Inlet 2” of V12.

• Connect the longer part of N° 5 tube to “Inlet 1” of V13.

Connect N°3 tube in the Motorola sensor, Honeywell sensor and V6 according the
following sequence:

1º Connect the 65 mm hose to the V6 “Outlet”.

2º Route the connected hose under the “Inlet 1” of V7.

3º Connect the shorter hose to “P1” of the Honeywell expiratory flow sensor.

4º Connet the longer hose to the “upper” Motorola sensor.

Assembly | GraphNet advance neo ts 6. 5

Connect the N° 4 hoses according the sequence below:

1º Connect the shorter hose to the “Inlet 2” of V7.

2º Connect the 70 mm hose to the “Outlet” of V3

3º Connect the longer hose to the “Outlet” of V5, routing as shown in the picture.

Connect the N° 4 hoses over the N°4 tube connected previously and follow the
next steps:

1º Connect the shorter hose to the “Inlet 2” of V6.

2º Connect the 70 mm hose to the “Outlet” of V2

3º Connect the longer hose to the “Outlet” of V4, routing over the shorter hose, as
shown in the picture.

6. 6 Assembly | GraphNet advance neo ts

Connect the N° 1 hoses over the tubes connected previously and follow the se-
quence below:

• Connect the 140 mm hose in the “Inlet” of V14.

• Connect the 90 mm hose in the “Inlet 1” of V5.

• Connect the 120 hose in the “Inlet 1” of V4.

Connect the N° 2 shorter hose in the “Outlet” of V14 as shown in the picture.

Assembly | GraphNet advance neo ts 6. 7

6.3 | Hoses connection on Connect the sensors board hoses to the multiple connector (connector 1 and 2) as
required below:
upper pneumatic box
• Connect the 1 to 7 hoses, as shown in the picture below. Do Not connect the C
hose.

• Once connected check that these are not kinked on the highlighted points of the
picture below.

• Connect A, B, D, E, F and G hoses, as specified in the picture bellow.

6. 8 Assembly | GraphNet advance neo ts

• Connect “C” hose to the C connector as shown below.

• Connect 4, 5, 6 hoses and route under the 2 and 3 hoses.

• Then connect the “1” multiple connector as shown on the picture below.

• Connect the 2, 3 hoses and route the 2 hose under the 3 hose.

Assembly | GraphNet advance neo ts 6. 9

• Then connect the “1” multiple connector as shown on the picture below.

• Once connected check that these are not kinked on the highlighted points of the
picture below.

6. 10 Assembly | GraphNet advance neo ts

6.4| Hoses connection on Route 1, 2, 3, 4 and 5 hoses under the pneumotachograph connector and then
connect the “U” silicone tube in the pneumotachograph elbow.
lower pneumatic box

Route 7 hose over the corrugated tube.

Assembly | GraphNet advance neo ts 6. 11

7 Routine maintenance

CHAPTER CONTENTS

7.1 General instructions

7.2 Cabinet

CHAPTER SUMMARY
There are some recommendations regarding cleaning conditions for the device.
This chapter includes guidelines on the necessary care on the topic, and key is-
sues to be observed to ensure proper operation of the respirator.

Routine maintenance | GraphNet advance neo ts 7. 1

7.1 | General instructions The GraphNet advance neo ts ventilators and the parts associated with the patient
circuit (tubes, connectors, accessory parts, etc.) are delivered clean, but not ste-
rilized.

NOTE
• The information provided for the cleaning and disin-
fection procedures of the different parts are offered
in the form of guidelines. These can be adapted to
the given routine of each service, provided that the
notices and warnings declared in the given chapter
are respected.
• To discard all device or obsolete parts or elements pro-
vided by other companies, follow the force standards
in each country.

7.2 | Cabinet The cabinet is formed by the casing and the front panel. Below, we detail the
cleaning and disinfection procedures for said parts.

7.2.1 | Casing The device casing must be cleaned and externally disinfected using one of the
following products:

• Hydroalcoholic cleaner, quaternary ammonium (such as benzalkonium chloride)

- solvent based.

• Glutareldehyde

• Where necessary, use the foam cleanser and wipe dry with a cloth.

PRECAUTION
• Do not clean the casing with abrasive chemical sol-
vents, nor acid or alkaline substances. Do not use
solvents, acetone, chloroform or strong acid substan-
ces or chlorinated solvents.

7.2.2 | Front Panel The cleaning recommendations for this section apply to both the display and the
tactile screen. For the cleaning, use a soft cloth, saturated with a solution of neutral
soap and warm water.

PRECAUTION
• Do not clean the screen with abrasive chemical sol-
vents, nor with acid or alkaline substances. Never
use substances containing ammonium. Never use
any type of alcohol.
• Do not spray the cleaning product directly onto the
screen.
• Before starting the cleaning and disinfection proces-
ses, turn off the ventilator.

7. 2 Routine maintenance | GraphNet advance neo ts

8 Technical Specifications

CHAPTER CONTENTS

8.1 Classification

8.2 Physical Characteristics

8.3 Screen

8.4 Environmental Requirements

8.5 Pneumatic Specifications

8.6 Electrical Specifications

8.7 Ventilatory Parameter Adjustments

8.8 Delivered Parameters

8.9 Monitored Parameters

8.10 Alarm Adjustment

8.11 Data Collection for Control and Monitoring

8.12 Characteristics of the respiratory circuit

8.13 Electromagnetic Compatibility

8.14 Basic Operation of the Ventilator

8.15 Safety Mechanisms

8.16 Expected Service Life

8.17 Diagram of the Pneumatic Circuit of the Ventilator GraphNet ad-

vance and GraphNet neo

8.18 Diagram of the Pneumatic Circuit of the Ventilator GraphNet ts

8.19 Diagram of the Electric Circuit of the Ventilator GraphNet advance

8.20 Diagram of the Electric Circuit of the Ventilator GraphNet neo

8.21 Diagram of the Electric Circuit of the Ventilator GraphNet ts

CHAPTER SUMMARY
This chapter summarizes the technical specifications that characterize GraphNet
advance/ts/neo. Some examples are: physical, electrical, and pneumatic specifica-
tions, environmental conditions, parameter setting, alarm tables, etc.

Technical Specifications | GraphNet advance neo ts 8. 1

NOTE
• If necessary, TECME S.A. will provide technical informa-
tion for the device (such as descriptions, diagrams, calibra-
tion instructions, etc.) to help qualified technical staff repair
parts defined as repairable by the manufacturer.

8.1 | Classification Table 8-1 Ventilator Classifications

Class IIb (Council Directive 93/42/EEC)
Risk
Class III (MERCOSUR/GMC/RES. No. 40/00)
Electrical insulation Class I – Type B (according to IEC 60601-1)
IP21 (“2” protected against objects with a diameter of ≥ 12,5
IP Protection
mm; “1” protected against vertically descending drops)
Operational Mode Continuous Operation (IEC 60601-1)

8.2 | Physical Characteristics Table 8-2 Physical Characteristics

Height 35 cm (13.8 in)
Width 36 cm (14.2 in)
Depth 32 cm (12.6 in)
Height including the pedestal 131 cm (51.6 in)
Weight not including the pedestal 9.8 kg (21.6 lb)
Weight including the pedestal 23.8 kg (52.5 lb)
Weight including accesories 27.25 kg (60 lb)
Width of the pedestal 51 cm (20.1 in) - 65 cm with lateral wheels (25.6 in).
Depth of the pedestal 52 cm (20.5 in) - 59 cm with in-line wheels (23.2 in)
A - Weighted sound pressure level Does not exceed 45.3 dBA at a distance of 1 m
A - Weighted sound power level Does not exceed 56.3 dBA

8.3 | Screen Table 8-3 Screen

Type Resistive sensitive touch screen / color TFT-LED
Size 12.1”
Resolution 800x600

8.4 | Environmental Require- Table 8-4 Environmental Requirements

ments Temperature Ambient pressure Humidity
Operation 15 °C – 35 °C 560 – 1030 hPa 15 - 95% non-condensing
Storage/Transport -10 °C – 55 °C 500 – 1060 hPa < 95% non-condensing

8.5 | Pneumatic Specification Table 8-5 Pneumatic Specifications

Supply gas Medical grade air and oxygen
Minimum supply pressure 280 kPa (40,61 psi)
Maximum supply pressure 600 kPa (87 psi)
Maximum limited pressure (relief valve) 120 ± 5 cmH2O.
The maximum working pressure is guaran-
Maximum working pressure teed by the upper limit of maximum pressure
when the inspiratory pressure is 120 cmH2O
adv/ts: 180 L/min (120 L/min for air compres-
Inlet flow (gas source)
sor) / neo: 60 L/min
Peak flow delivered by the ventilator adv/ts: 0.2 – 180 L/min. / neo: 0.2 – 40 L/min.
ADL: 130 L/min
Maximum resulting minute volume PED: 40 L/min
NEO-INF: 17 L/min
Internal compliance (of the ventilator) 0.16 ml/cmH2O

8. 2 Technical Specifications | GraphNet advance neo ts

Air: DISS 3/4” -16 male connector. Oxygen:
Ventilator connectors for gas supply
DISS 9/16” - 18 male connector
Air: DISS 3/4” - 16 female connector (both
Connectors for gas supply hoses ends). Oxygen: DISS 9/16” - 18 female
connector (both ends)

8.6 | Electrical Specification Table 8-6 Electrical Specifications

Main Supply Voltage: 100 – 240 V (automatic switching)
Frequency: 50 – 60 Hz
Maximum consumption :1,25 A at 100 V- 0,5 A at 240 V
Internal Battery Voltage: 11.1 V (continuous)
Electrical charge: 7,8 Ah (automatic recharge)
Autonomy: 2.5 hours.
Fuses F2L250V (250 V / 2 A – 0,5 mm x 20 mm).
Connectivity RS-232C / VGA

8.7 | Ventilatory Parameter NOTE

• When the ventilator is powered from the internal bat-
Adjustment tery, it has the same operational capacities as when it
is powered from the electrical network through the main
power cable, except that capnography is disabled.

Table 8-7 Ventilatory parameters adjustment

Parameter Range Increments(1) Initial value
ADL: 0,050 - 2,500
PED: 0,020 - 0,300
ADL: 0,010* ADL: 0,400(2)
NEO-INF:
Tidal Volume (L) PED: 0,001* PED: 0,050(2)
adv: 0,002 - 0,150
NEO-INF: 0,001* NEO-INF: 0,010(2)
ts: 0,005 - 0,150
neo: 0,002 - 0,350
0,2 to 1: 0,1 ADL: 48
0,2 - 180 (adv/ts)
Peak Flow (L/min) 1 to 20: 0,5 PED: 10
0,2 - 40 (neo)
20 to 180: 1 NEO-INF: 2,4
Minute Volume ADL: 1 - 50 ADL: 6,0
(MMV + PSV setting) PED: 1 - 50 0,100 PED: 4,0
(4) (L/min) (adv/ts) NEO-INF: N/A NEO-INF: N/A
Controlled ADL: 15
pressure (PCV) PCV + PEEP = 2 - 100 1 PED: 8
(cmH2O) NEO-INF: 8
ADL: 5
Support pressure
PSV + PEEP = 0 - 100 1 PED: 5
(PSV) (cmH2O)
NEO-INF: 5
ADL: 5(3)
PEEP/CPAP
0 - 50 1 PED: 5(3)
(cmH2O)
NEO-INF: 3(3)
Limited pressure
(in TCPL – NEO- 3 - 70 1 10
INF) (cmH2O)
Continuous TCPL
2 - 40 1 8
flow (L/min)
Inspiratory time ADL: 1,0(3)
(s) (in assist/control 0,1 - 10 0,01* PED: 0,6(3)
modes) NEO-INF: 0,5(3)
Inspiratory time Ti high 0.5 – 30 5.0
0,01*
(s) (APRV) Ti low 0.2 – 30 1.5
5:1 – 1:599 Results of the inspi-
I:E Ratio (in assist/control modes) 0,1:0,1 ratory time and the
150:1 – 1:60 (APRV) initial rate.

Technical Specifications | GraphNet advance neo ts 8. 3

ADL: 1 - 100. ADL: 12(3)
Respiratory rate
PED and NEO-INF: 1 PED: 25(3)
(rpm)
1 - 150. NEO-INF: 30(3)
Oxygen (concen-
21 - 100 1* 50
tration) (%)
ADL: Flow=3; Pres-
Triggering by flow: By flow: 0.1/0.5/1 sure=-1.5
Inspiratory sensi-
0.2 – 15 according to the PED: Flow=3; Pres-
tivity (Flow = L/min;
Triggering by pressure: detection value. sure=-1.5
Pressure = cmH2O)
-0.5 a –20 By pressure: 0.5 NEO-INF: Flow=1;
Pressure=-1.5
Expiratory sensi-
5% - 80% of the peak
tivity (for modes 5% 25%
flow
with PSV)
Programmable
0 – 2 (adv/ts)
inspiratory pause 0,25 0 (NO)
0 – 1 (neo)
(in VCV) (s)
Manual inspira-
7 (maximum) N/A N/A
tory pause (s)
Manual expiratory
20 (maximum) N/A N/A
pause (s)
No. of sighs: 1/2/3
No. of sighs: 1.
Rate: 5/10/15/20 per
hour Rate: 5 per hour
Sighs (in VCV)
Added volume: +0.1VT N/A Added volume:
(adv/ts)
– +1.0VT (The volume +30% (+0.3VT).
is added to the confi- Activated: No
gured VT)

Inspiratory flow Descending and cons-

N/A Descending ramp
waveform tant ramp (rectangular)

Leakage compen-
ADL: up to 50
sation in NIV (L/min) Non adjustable N/A
PED: up to 30
(adv/ts)
Leakage compen-
ADL: up to 15
sation for the rest
Non adjustable. N/A PED: up to 15
of the modes (L/
NEO-INF: up to 10
min)
Tube: Endotracheal or
Tube: Endotracheal
tracheostomy
Tube compensa- Diameter: 8 mm
Diameter: 4 – 12 mm N/A
tion (adv) Compensate: 50%
Compensate: 10%-
Activated: NO
100%
Continuous flow ADL: 1-80 ADL: 20
oxygen therapy PED: 1-60 1 PED: 10
(L/min) NEO-INF: 1-20 NEO-INF: 5

Oxygen therapy ADL: 50

oxygen concen- 21-100 1 PED: 50
tration (%) NEO-INF: 50

(1) An asterisk (*) next to some of the values in this column means that if you press [Ctrl]
before making a parameter change, larger or smaller increments can be obtained accor-
ding to the parameter in question.
(2) Initial factory values. By modifying mL/kg in setting IBW-based VT, these values may
change.
(3) These values are shown as a reference, and are to be found in VCV and PCV modes.
In order to know the initial values of each mode see the chapter ADL/PED and NEO-INF
Operative Modes of the User´s Manual.
(4) The Minute Volume is programmed only in MMV + PSV. For the rest of the modes, the
Minute Volume is the result of other parameters programming (see maximum values by
category in Table 10-5).

8. 4 Technical Specifications | GraphNet advance neo ts

8.8 | Delivered Table 8-8 Delivered Parameters
Parameters Parameter Accuracy
±(5 mL + 10% of the configured tidal volume) if
VT>50 mL
Inspiratory tidal volume
±(2 mL + 10% of the configured tidal volume) if
VT≤50 mL
Controlled pressure (PCV) ±(2 cmH2O + 4% of the programmed pressure)
Pressure support (PSV) ±(2 cmH2O + 4% of the programmed pressure)
End-expiratory pressure (PEEP) ±(2 cmH2O + 4% of the programmedpressure)
Oxygen concentration ± 3% (percentage units)

8.9 | Monitored Table 8-9 Monitored Parameters

Parameters Parameter Accuracy
<±(4 mL + 15% of the monitored inspiratory tidal volume) if
VT>50 mL
Inspiratory tidal volume
<±(2 mL +10% of the monitored inspiratory tidal volume) if
VT≤50 mL
<±(4 mL + 15% of the monitored expiratory tidal volume) if
VT>50 mL
Expiratory tidal volume
<±(2 mL +10% of the monitored expiratory tidal volume) if
VT≤50 mL
Peak pressure < ±(2 cmH2O + 4% of the monitored pressure)
Plateau pressure < ±(2 cmH2O + 4% of the monitored pressure)
Mean pressure < ±(2 cmH2O + 4% of the monitored pressure)
End-expiratory pressure < ±(2 cmH2O + 4% of the monitored pressure)
Concentration of oxygen ±( 2.5% (1) + 2.5% of the monitored value)
0 – 40 mmHg ±2 mmHg
41 – 70 mmHg ±5% of the reading
CO2
71 – 100 mmHg ±8% of the reading
101 – 150 mmHg ±10% of the reading
Respiratory rate ±1 rpm
(1) Percentage Units

8.10 | Alarm Adjustment Table 8-10 Alarm Adjustment

Alarm Limits Increment Initial Value
Maximum inspi- ADL: 40
ratory pressure 10 (or >min - 120) 1 PED: 30
(cmH2O) NEO-INF: 25
Minimum inspi- ADL: 5
ratory pressure 1 - 99 (or <max) 1 PED: 5
(cmH2O) NEO-INF: 2
ADL: >VTmin - 3,0
ADL: 0,010(2) ADL: 0,600
Maximum tidal PED: >VTmin - 0.500
PED: 0,005(1) PED: 0,075
volume(2) (L) NEO-INF: >VTmin -
NEO-INF: 0,005(1) NEO-INF: 0,015
0,250
ADL: 0 to <VTmax
ADL: 0,010 (2) ADL: 0,150
Minimum tidal PED: 0 to <VTmax
PED: 0,001 (1) PED: 0,025
volume(2) (L) NEO-INF: 0 to <VT-
NEO-INF: 0,001 (1) NEO-INF: 0,005
max
ADL: 7,23 (9,0 en
ADL: >VMmin - 55
Maximum minute 0,01/ 0,05/ 0,1/ 0,5/ MMV+PSV)
PED: >VMmin - 55
volume (expired) (4) 1,0 according to the PED: 1,91 (6,0 en
NEO-INF: >VMmin
(L/min) alarm limit value MMV+PSV)
- 55
NEO-INF: 0,40

Technical Specifications | GraphNet advance neo ts 8. 5

ADL: 2,41 (4,5 in
ADL: 0 to <VMmax
Minimum minute 0,01/ 0,05 /0,1 /0,5/ MMV+PSV)
PED: 0 to <VMmax
volume (expired)(4) 1,0 according to the PED: 0,63 (3,0 in
NEO-INF: 0 to <VM-
(L/min) alarm limit value MMV+PSV)
max
NEO-INF: 0,13
Concentration of High: 25 – 110 High: 60
1
O2 (%) Low: 19 – 95 Low: 40
Inadequate oxygen 18 or less (not confi-
N/A N/A
(%) gurable)
Disconnection N/A (not configurable) N/A N/A
ADL: 50(3)
Leakage out of
N/A (not configurable) N/A PED: 30(3)
range (L/min)
NEO-INF: 10
Apnea (s) 5 - 60 5 15
ADL/PED/NEO-
Low PEEP (cmH2O) 0-6 2
INF: 2
Maximum respira- ADL/PED: 30
3 - 160 1
tory rate (rpm) NEO-INF: 40
ETCO2 (mmHg) Max: >Min to 150 Max: 50
1
(adv) Min 1 to <Max Min: 30
Continuous high Alarm condition: 5 cmH2O above the configured PEEP level for
pressure over 15 s. Not configurable.
External power Not configurable. Whatever the cause of the event may be, the
failure ventilator automatically switches to battery operation.
Null or very low charge level. Replace by an alternative respiratory
Dead battery
method. Not configurable.
When the operation of the ventilator is suspended, replace by an
Inop. Vent.
alternative ventilatory method. Not configurable.
Not configurable. Alarm signals are triggered when excessive
Blower failure power consumption by the blower is detected (caused by increa-
sed resistance at the rotation of the blades).
(1) From 1 to 30 mL it increases per 0.001 L; from 30 to 100 mL it increases per 0.005 L,
and >100 mL it increases per 0.010 L.
(2) In all ventilatory modes, the VTmax is 1.5 IBW-based VT, and the initial VTmin is 0.5
IBW-based VT .
(3) The values declared for ADL and PED correspond to the NIV mode. For the rest of the
modes the Leakage out of range is triggered starting at 15 L/min. In NEO-INF the leakage
within range is the same for all modes.

8.11 | Data Collection for Con- Table 8-11 Data collection for control and monitoring
trol and Monitoring Parameter Method Involved Variables
Control, support and monitored
Accuracy Relative pressure transducers
pressures
Mesh pneumotachograph related Continuous flow, flow for controlled
Controlled flow
to differential pressure transducers volume generation
Variable opening pneumotacho-
graph related to the pressure
Monitored and plotted flows, and
Monitored flow differential transducer (optional
expired volumes
fixed opening pneumotachogra-
ph for the NEO -INF category)
It is derived from the correspon- Controlled, monitored and plotted
Volume
ding flow measurements volumes
Inspiratory and expiratory times,
Time Quartz crystal. respiratory rate, and I:E ratio.
Internal clock.

8. 6 Technical Specifications | GraphNet advance neo ts

Concentration
Galvanic cell Concentration of O2.
of O2
CO2 removal, CO2 pressure, mea-
CO2 (adv) Non-dispersive infrared surements of volumetric capno-
graphy

8.12 | Characteristics of the The information below corresponds to the patient circuit provided by TECME S.A.
respiratory circuit
WARNING
• The use of elements that are not provided by
TECME S.A. can lead to the improper operation
of the ventilator.

Table 8-12 Characteristics of the respiratory circuit

Adult: 0.38-0.81 at 30 L/min
Inspiratory resistance (cmH2O) Pediatric: 0.37-0.55 at 15 L/min
Neonatal: 0.07-0.24 at 2.5 L/min
Adult: 0.38-3.42 at 30 L/min
Expiratory resistance (cmH2O) Pediatric: 0.37-1.99 at 15 L/min
Neonatal: 0.07-0.48 at 2.5 L/min
Adult: 1.12-1.64
Compliance (mL/cmH2O) Pediatric: 0.75-1.33
Neonatal: 0.57-0.77
Proximal flow sensor: < 1
Dead space (ml) Adult / pediatric capnography adapter: < 5
Neonatal capnography adapter: < 1

8.13 | Electromagnetic Com- WARNING

patibility • The replacement of the accesories or cables (main
power supply or internal cabling) of the equipment
by anyone other than those approved by TECME
S.A. may result in decreased immunity, or increa-
sed emissions reported for GraphNet advance, ts
and neo.
• If using a RS232 serial communication cable, the
length cannot exceed 3 m.

Technical Specifications | GraphNet advance neo ts 8. 7

8.13.1 | Manufacturer State- Table 8-13 Electromagnetic Emissions Statement
ment: Electromagnetic GraphNet advance, ts and neo is intended to be used in the specified electromagnetic
Emissions environment. The customer and/or user of GraphNet advance, ts and neo must ensure it is
used in an electromagnetic environment as stated in this Table.
Emission Test Compliance Electromagnetic Environment
GraphNet advance, ts and neo uses RF energy
RF CISPR 11 only for its internal operations. Therefore, its RF
Group 1
Emissions emissions are very low and they are unlikely to cau-
se any interference in nearby electronic equipment.
RF CISPR 11
Class A
Emissions
IEC 61000-3-2 GraphNet advance, ts and neo can be used in all
harmonic emis- Class A establishments, except in households, and those
sions that are connected directly to the public low volta-
IEC 61000-3-3 Vol- ge power supply network feeding buildings used
tage fluctuations According to for domestic purposes.
/ discontinuous specifications
emissions

8.13.2 | Manufacturer State- Table 8-14 A-Electromagnetic immunity Statement

ment: Electromagnetic GraphNet advance, ts and neo is intended to be used in the electromagnetic specified
environment. The customer and/or user of GraphNet advance, ts and neo must ensure it is
Immunity
used in an electromagnetic environment as stated in this Table.
IEC 60601-1-2 Test Electromagnetic envi-
Immunity test Compliance level
level ronment
Floors must be wood,
IEC 610000-4-2 concrete, or ceramic. If
Electrostatic Contact: ± 6 kV. Contact: ± 6 kV. floors are covered with
Discharge Air: ± 8 kV. Air: ± 8 kV. synthetic material, the
(ESD) relative humidity must be
at least 30%.
The quality of the electrical
IEC 61000-4-4 ± 2 kV for power ± 2 kV for power
network must be equi-
Fast electrical lines. lines.
valent to that of a typical
transient in ± 1 kV for input/out- ± 1 kV for input/
commercial or hospital
bursts put lines. output lines.
environment.
The quality of the electrical
Differential mode: Differential mode:
network must be equi-
IEC 61000-4-5 ±1 kV. ±1 kV.
valent to that of a typical
Shock waves Shared mode: ± Shared mode: ±
commercial or hospital
2 kV. 2 kV.
environment.
The quality of the electrical
< 5% UT (low > 95% < 5% UT (low > 95%
network must be equi-
of UT) for 0.5 cycles. of UT) for 0.5 cycles.
valent to that of a typical
IEC 61000-4-11
commercial or hospital
Voltage dips, 40% UT (low of 60% 40% UT (low of 60%
environment. If the user
short interrup- of UT) for 5 cycles. of UT) for 5 cycles.
of GraphNet advance,
tions and vol-
ts and neo requires main-
tage variations 70% UT (low of 30% 70% UT (low of 30%
taining operation during
on line power of UT) for 25 cycles. of UT) for 25 cycles.
power outages, we re-
input
commend connecting the
< 5% UT (low > 95% < 5% UT (low > 95%
system to an uninterrupted
of UT) for 5 s. of UT) for 5 s.
power supply or a battery.
The supply frequency
IEC 61000-4-8 magnetic field must be
Supply frequen- characteristic of the
3 A/m. 3 A/m.
cy magnetic levels found in a typical
field (50-60 Hz) commercial or hospital
environment.
NOTE: UT is the voltage of the AC network before applying the test level.

8. 8 Technical Specifications | GraphNet advance neo ts

Table 8-15 B-Electromagnetic immunity Statement
GraphNet advance, ts and neo is intended to be used in the electromagnetic specified environment. The GraphNet advance, ts and neo
customer and/or user must ensure it is used in an electromagnetic environment as stated in this Table.
Immunity Test IEC 60601 Level test Compliance Electromagnetic Environment
Level
Do not use RF communications equipment, mobile and/or portable (in-
cluding cables), at a distance from GraphNet advance, ts and neo less
than the separation distance calculated from the equation applicable to
the transmitter frequency.
Recommended separation distance
3 Vrms
150 kHz – 80 Mhz 10 Vrms d = 0,35 P
outside ISM bands(1).
IEC 61000-4-6
conducted RF
10 Vrms
150 kHz – 80 MHz
within the ISM(1) 10 Vrms d = 1,2 P
bands.
d = 1,2 P
for 80 MHz - 800 MHz
IEC 61000-4-3 10 V/m
10 V/m
Radiated RF 80 MHz - 2,5 GHz
d = 2,3 P
for 800 MHz - 2,5 GHz
Where Pis the maximum power output of the transmitter in Watts (W)
according to the manufacturer, and d is the recommended separation
distance stated in meters (m) (2).
The strength of fields generated by fixed transmitters, as determined by
local electromagnetic tests(3) must be less than the compliance level for
each frequency range(4).
Interference can occur in the vicinity of the equipment marked with the
following symbol:

NOTE 1
For 80 MHz and 800 MHz apply the higher frequency range.
NOTE 2
This guide may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
(1) The ISM bands (industrial, scientific and medical) between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz;
26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
(2) Compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range of 80 MHz and 2.5 GHz are designed
to reduce the possibility that a portable/mobile communications device can cause interference if it is inadvertently introduced into the patient area.
For this reason, an additional factor of 10/3 has been added to the formula used for calculating the recommended separation distance for transmit-
ters in these frequency ranges.
(3) Field strengths from fixed transmitters, such as base stations for radio telephones (mobile or wireless) and land mobile radios, amateur radio,
AM and FM and TV broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic environment at the site, generated
by fixed RF transmitters, consider conducting a test in situ. If the measurement of the field strength where GraphNet advance,ts and neo is used
exceeds the above RF applicable compliance limits, GraphNet advance,ts and neo must be evaluated to ensure it can operate normally. If abnor-
mal performance is observed, it may be necessary to take additional measures, such as reorienting or relocating the equipment.
(4) Over the frequency range between 150 kHz and 80 MHz, field strengths shall be less than 10 V/m.

Technical Specifications | GraphNet advance neo ts 8. 9

8.13.3 | Manufacturer State- Table 8-16 Recommended Separation Distances Between the Ventilator and
ment: Separation Distan- Mobile/Portable Communications Devices
ces GraphNet advance, ts and neo is intended to be used in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer and/or user of GraphNet
advance, ts and neo can help prevent electromagnetic interference by maintaining a
minimum distance from RF communication equipment, mobile and portable (transmitters)
and the GraphNet advance, ts and neo as recommended in this table, according to the
maximum power output of the communications equipment.
Separation Distance According to the Frequency of the Transmitter (m)
Maximum 150 kHz – 80 150 kHz – 80
Output Power 80 MHz - 800 800 MHz 2,5
MHz out of ISM MHz Within ISM
of the Trans- MHz GHz
Bands bands
mitter (W)
d = 1,2 P d = 2,3 P
d = 0,35 P d = 1,2 P
0,01 0,04 0,12 0,12 0.23
0,1 0,11 0,38 0,38 0.73
1 0,35 1,2 1,2 2.3
10 1,1 3,8 3,8 7.3
100 3,5 12 12 23
For transmitters whose maximum output power is not included in the list above, the
recommended separation distance d in meters (m) can be determined using the equation
applicable to the frequency of the transmitter, where P is the maximum transmitter output
power in Watts (W) according to the manufacturer statement for the transmitter.
NOTE 1
For 80 MHz and 800 MHz, apply the separation distance for the wider range of frequencies.
NOTE 2
ISM bands (industrial, scientific and medical) between 150 kHz and 80 MHz are 6.765 MHz
to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz, and 40.66 MHz to
40.70 MHz.
NOTE 3
An additional factor of 10/3 has been incorporated into the formula used for calculating
the separation distance for transmitters operating in the ISM frequency band between 150
kHz and 80 MHz, and in the frequency range 80 MHz to 2.5 GHz to reduce the possibility
that communication equipment, mobile and/or portable, can cause interference if they are
inadvertently introduced in patient areas.
NOTE 4
These guidelines may not be applicable in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

8.14 | Basic Operation of GraphNet advance, ts and neo features a microprocessor control system that coor-
the Ventilator dinates the tasks arising from the programming of the device. All actions performed
by the ventilator are controlled by this system.

The gas flow to the patient is administered by two proportional valves, one for air
and the other for oxygen. The valves operate simultaneously, providing adequate
oxygen levels and the necessary characteristics of the flow wave.

The expiratory valve is governed by the operation of one proportional valve, which
controls on the one hand its opening or closing, which determines the end and start
of the inspiratory phase, respectively; and in the other hand regulates the PEEP
level, when this is configured.

The microprocessor is supplied with feedback signals from the sensors system on
the ventilator, which allows it to control and adjust the configured ventilation program.

Information regarding pressure is obtained from two relative pressure sensors, one
located near the patient outlet and the other near the ventilator assembly.

8. 10 Technical Specifications | GraphNet advance neo ts

Among its main functions, the patient outlet sensor supports delivered pressure
control in pressure control modes or pressure support modes. In addition, it is used
for triggering inspirations when pressure sensitivity, activation of alarm signals or
others are selected.

With respect to the sensor close to the ventilator assembly, it should be noted that its
main functions include graphing of pressure curves and activation of alarm signals.

Flow information is obtained by means of three differential pressure sensors, two

sensors related to the internal output pneumotachographs and a sensor associated
with the expiratory pneumotachograph (distal or proximal). The internal pneumo-
tachograph (Silverman mesh type) controls the flows and volumes driven by the
ventilator in the inspiratory phase, while the expirated flows are measured through
the expiratory pneumotachographs (distal and optionally proximal).

All the information obtained by the sensors is filtered using hardware anti-aliasing
filters before being sampled by the A/D converter. After the digitization process,
signals pass through FIR and IIR digital averaging filters that work on a fixed num-
ber of samples in order that they may be used for ventilator control and graphing.

A closed-loop controller is used for ventilator operation, which contributes to main-

taining consistency with respect to the delivery of flow, volume or pressure parame-
ters when changes occur in either the patient or the system. This is done through
feedback of the output signal to a comparator, which also takes into account the
magnitude of the variable programmed by the user. The difference obtained bet-
ween the two signals generates a correction signal (error signal) which drives the
system to reach the desired value.

A representative schematic diagram of the above-described concept is shown below:

CHANGES

VENTILATOR
INPUT + E (Controller/Effector)
PATIENT

(parameters
configured by the
user)
-
Flow or Presssure
Volume

FEEDBACK

Fig. 8-1 Schematic diagram of a closed-loop control system.

The device has a valve system that provides a communication channel between the
pressure transducers and ambient pressure. This will allow zeroing the transducers.
Simultaneously, air flow is driven to purge the lines of the expiratory pneumotacho-
graph, and avoid water deposits and humidity in the measuring element.

8.15 | Safety Mechanisms GraphNet advance, ts and neo has a complete safety system, which includes the
operating system that controls the microprocessor, and various components that
act independently of these.

• WATCHDOG: this is a system that monitors the operation of the electronic circuit,
and exerts its control regardless of the integrity of the latter. When it detects an
anomaly in the ventilator function, it allows it to suspend, and enables the Emer-
gency Ventilation mode.

Technical Specifications | GraphNet advance neo ts 8. 11

Watchdog can activate Emergency Ventilation in two different situations:

- After 30 s elapsed from turning on the ventilator, without selecting a patient cate-
gory on the first screen of initial calibration.

- When the microprocessor loses control of the sequence that regulates the venti-
lation program.

• EMERGENCY VENTILATION: Emergency Ventilation is a safety mechanism that

is activated in conditions of extreme necessity to provide temporary ventilation to
the patient until measures are taken to replace the ventilator with an alternative
ventilatory mechanism. This is not a valid operating mode.

Emergency Ventilation enables the delivery of breaths with similar characteristics

to those of the pressure controlled (PCV ). During the course of this event, only
peak pressure and respiratory rate are monitored. The preset values for ventilatory
parameters are shown in Table 8-15. The alarm limits are not enabled for changes.
Active alarms are for Maximum and Minimum pressure, and Maximum respiratory
rate, whose limits are shown on screen. The only additional enabled function is
Manual Insp.

Table 8-17 Ventilatory Parameters in Emergency Ventilation

Parameter Initial Value Range Observations
The pressure is limited by
Controlled pressu- maximum pressure alarm
10 cmH2O 2 – 30 cmH2O
re (PCV) at 30 cmH2O. This limit
cannot be changed.
Inspiratory time may be
Ti (inspiratory
0.70 s 0.10 – 3.00 s limited by the frequency
time)
value.
The frequency may be
Respiratory rate 20 rpm 1 – 100 rpm limited by the value of the
inspiratory time.
Detection by flow is not
Insp. Detection -2 cmH2O -0.5 – 20 cmH2O
enabled.
Concentration This parameter cannot be
50 -
of O2 changed.
Same value as in Same range as
Rise Time
PCV mode PCV mode

WARNING
• In the event that Emergency Ventilation is ac-
tivated, provide the patient with an alternative
ventilation mechanism, and find the cause that
generated this event. If it was activated by the de-
lay in accepting the first initial calibration screen,
restart the unit to ventilate the patient.

• SAFETY VALVE: located immediately before the outlet to the patient. It opens when
the pressure within the patient circuit reaches a value of 120 ± 5 cmH2O. The gas
mixture passes into an internal collector and is discharged to the outside.

• PRESSURE RELIEF VALVE: this valve allows the patient to breathe ambient air,
under the following conditions:

- When the device is de-energized.

8. 12 Technical Specifications | GraphNet advance neo ts

- When the respirator is out of order.

- When air pressure and oxygen pressure are simultaneously low.

- On standby.

• OPERATING GAS LEAKAGE: The gas that can seep into the unit is collected in
a common manifold, and directed towards the outside.

• LACK OF COMPRESSED AIR PRESSURE: compressed air is used as a control

gas of the pneumatic circuit. When this is lacking, oxygen can replace it. Further-
more, when the unit detects lack of air, it automatically switches to an O2 concen-
tration of 100%.

• LACK OF OXYGEN PRESSURE: in this case, the air takes the place of oxygen,
and the breaths are delivered with an O2 concentration of 21%.

• AUTO-ZEROING: every 10 minutes, or when the operator enables it (by pressing

[Ctrl] + [Ctrl]) all pressure sensors are zeroed. This restarts the readings, avoi-
ding offset errors of the measured pressures. During the first minutes of ventila-
tion, the ventilator can implement resets with a frequency greater than the one
stated. At each reset, a message is displayed in the Icons and messages bar
indicating that this procedure is being performed.

• CIRCUIT PURGE: to avoid obstruction and humidity leakage in the pressure sen-
sors, air is injected by the patient circuit, simultaneously with the resetting of pres-
sure sensors.

• ALARM SYSTEM: GraphNet advance, ts and neo has an alarm system to warn
on situations that pose some degree of risk to the patient or to the unit itself.
Some allow preventing the continuation of the condition that triggered it, others
just trigger signals to report its presence. For further information on how the alarm
system works, refer to the chapter Alarms in the User´s Manual.

• PARAMETER SETTING: to prevent inadvertent changes to the parameters, it is

required to execute the established sequences on the ventilator controls. Thus,
the pressure on a single key or knob, does no allow entering changes. Therefore,
the operator is always aware of the actions executed on the unit.

8.16 | Expected Service Table 8-18 Expected Service Life

Life Expected service life of the ventilator 10 years

Technical Specifications | GraphNet advance neo ts 8. 13

8.17 | Diagram of the pneumatic circuit of ventilator
GraphNet advance and GraphNet neo

8. 14 Technical Specifications | GraphNet advance neo ts

8.18 | Diagram of the pneumatic circuit of ventilator
GraphNet ts

Technical Specifications | GraphNet advance neo ts 8. 15

8.19 | Diagram of the electric circuit of ventilator
GraphNet advance

8. 16 Technical Specifications | GraphNet advance neo ts

8.20 | Diagram of the electric circuit of ventilator
GraphNet neo

Technical Specifications | GraphNet advance neo ts 8. 17

8.21 | Diagram of the electric circuit of ventilator
GraphNet ts

8. 18 Technical Specifications | GraphNet advance neo ts

Warranty

This device is sold pursuant to the warranty terms stated below, which are va-
lid only for direct purchase from TECME S.A. or purchase as new merchandise
through its vendors, distributors or agents.

TECME S.A. guarantees that this device will be free from manufacturing and ma-
terial defects for a period of twenty-four (24) months from the shipping date, as
long as it is correctly handled and maintained under conditions of normal use and
in the manner indicated in this manual. The sole obligation of TECME S.A. through
the warranty it issues is for the exchange or repair of parts that upon examination
show damage or defects. TECME S.A. is not responsible for subsequent damage
or special injuries.

The preceding warranty is not valid if the device has been repaired or altered by
unauthorized persons or if it has been subjected to abuse, misuse, negligence or
accident.

The warranty obligation is accepted by TECME S.A. under the following conditions:

1. When the buyer explains the defect or failure found.

2. When the defective unit is sent by pre-paid transport and within the wa-
rranty period.

3. When the label with the serial number is intact.

TECME S.A. is not responsible for any extended warranty that may be issued by
another vendor, unless specifically approved.

Warranty | GraphNet advance neo ts G. i