Invasive and Noninvasive Ventilation
Maintenance Technical Manual
Part N°: 4013L1V
Revision_03
March 2012
IMPORTANT
The information contained in this manual is subject to change without prior notice. The
manufacturer reserves the right to make any modifications to features or design.
The use of this equipment on patients should be supervised by a specialized doctor.
Carefully read the instructions in this document before connecting the ventilator
to a patient. The information included in this manual is intended to describe the
ventilator, its capacities, and possible configurations, but it cannot and shall not be
considered a substitute for the necessary good judgment of competent professionals, who should decide on and determine the method of use for each individual
patient.
TECME S.A.
Calle Pública s/n
Av. La Voz del Interior 5400
X5008HJY - Córdoba - Argentina
Tel: (54-351) 414-4600
Fax: (54-351) 414-4605
E-mail: asistencia.tecnica@tecme.com.ar
www.neumovent.com
Technical Directorate:
Ms. Julieta Catania
Clinical Biochemist
AUTHORIZED BY ANMAT PM 1116-6
Medes Ltd.
5 Beaumont Gate, Shenley Hill,
Radlett,Hertfordshire, WD7 7AR,
London, England, UK.
Tel/Fax: +44 1923 859 810
Table of Contents
1. Chapter I - Generalidades
1.1 Overview GraphNet advance............................................................................... 1.3
1.1.1 Observed requirements and standards....................................................... 1.3
1.1.2 General equipment description.................................................................... 1.3
1.1.3 Expected use............................................................................................... 1.3
1.1.4 Expected user.............................................................................................. 1.3
1.1.5 Expected use environment.......................................................................... 1.3
1.1.6 Contraindications......................................................................................... 1.3
1.1.7 User technical assistance............................................................................ 1.4
1.1.8 Symbols used.............................................................................................. 1.4
1.1.9 Abbreviations, acronyms and names of variables....................................... 1.6
1.2 Overview GraphNet neo.................................................................................... 1.11
1.2.1 Observed requirements and standards..................................................... 1.11
1.2.2 General equipment description.................................................................. 1.11
1.2.3 Expected use............................................................................................. 1.11
1.2.4 Expected user............................................................................................ 1.11
1.2.5 Expected use environment........................................................................ 1.11
1.2.6 Contraindications....................................................................................... 1.11
1.2.7 User technical assistance.......................................................................... 1.12
1.2.8 Symbols used............................................................................................ 1.12
1.2.9 Abbreviations, acronyms and names of variables..................................... 1.14
1.3 Overview GraphNet ts........................................................................................ 1.17
1.3.1 Observed requirements and standards..................................................... 1.17
1.3.2 General equipment description.................................................................. 1.17
1.3.3 Expected use............................................................................................. 1.17
1.3.4 Expected user............................................................................................ 1.17
1.3.5 Expected use environment........................................................................ 1.17
1.3.6 Contraindications....................................................................................... 1.17
1.3.7 User technical assistance.......................................................................... 1.18
1.3.8 Symbols used........................................................................................... 1.18
1.3.9 Abbreviations, acronyms and names of variables..................................... 1.20
2. Chapter II - Technical specifications
2.1 Technical specifications GraphNet advance..................................................... 2.3
2.1.1 Classification................................................................................................ 2.3
2.1.2 Physical characteristics............................................................................... 2.3
2.1.3 Screen......................................................................................................... 2.3
2.1.4 Environmental requirements........................................................................ 2.3
2.1.5 Pneumatic specifications............................................................................. 2.3
2.1.6 Electrical specifications................................................................................ 2.4
2.1.7 Ventilatory parameter adjustment................................................................ 2.4
2.1.8 Monitored parameters.................................................................................. 2.6
2.1.9 Alarm adjustment......................................................................................... 2.6
2.1.10 Obtaining control and monitoring data....................................................... 2.7
2.1.11 Electromagnetic compatibility.................................................................... 2.7
2.1.12 Basic respirator operation........................................................................ 2.10
2.1.13 Safety mechanisms................................................................................. 2.11
2.1.14 Respirator pneumatic circuit diagram...................................................... 2.13
2.1.15 Lifetime.................................................................................................... 2.14
Maintenance Technical Manual | GraphNet advance neo ts
i
2.2 Technical specifications GraphNet neo.......................................................... 2.16
2.2.1 Classification.............................................................................................. 2.16
2.2.2 Physical characteristics............................................................................. 2.16
2.2.3 Screen....................................................................................................... 2.16
2.2.4 Environmental requirements...................................................................... 2.16
2.2.5 Pneumatic specifications........................................................................... 2.16
2.2.6 Electrical specifications.............................................................................. 2.17
2.2.7 Ventilatory parameter adjustment.............................................................. 2.17
2.2.8 Monitored parameters................................................................................ 2.18
2.2.9 Alarm adjustment....................................................................................... 2.18
2.2.10 Obtaining control and monitoring data..................................................... 2.19
2.2.11 Electromagnetic compatibility.................................................................. 2.20
2.2.12 Basic respirator operation........................................................................ 2.23
2.2.13 Safety mechanisms................................................................................. 2.23
2.2.14 Respirator pneumatic circuit diagram...................................................... 2.25
2.2.15 Lifetime.................................................................................................... 2.26
2.3 Technical specifications GraphNet ts.............................................................. 2.28
2.3.1 Classification.............................................................................................. 2.28
2.3.2 Physical characteristics............................................................................. 2.28
2.3.3 Screen....................................................................................................... 2.28
2.3.4 Environmental requirements...................................................................... 2.28
2.3.5 Pneumatic specifications........................................................................... 2.28
2.3.6 Electrical specifications.............................................................................. 2.29
2.3.7 Ventilatory parameter adjustment.............................................................. 2.29
2.3.8 Monitored parameters................................................................................ 2.30
2.3.9 Alarm adjustment....................................................................................... 2.31
2.3.10 Obtaining control and monitoring data..................................................... 2.32
2.3.11 Electromagnetic compatibility.................................................................. 2.32
2.3.12 Basic respirator operation........................................................................ 2.35
2.3.13 Safety mechanisms................................................................................. 2.36
2.3.14 Respirator pneumatic circuit diagram...................................................... 2.38
2.3.15 Lifetime.................................................................................................... 2.39
3. Chapter III - Maintenance instructions...................................................... 3.1
3.1
3.2
3.3
3.4
3.5
3.6
adv maintenance 5000 hours or 1 year........................................................... 3.3
neo maintenance 5000 hours or 1 year........................................................... 3.4
ts 5000 maintenance hours or 1 year.............................................................. 3.5
adv maintenance 10000 hours or 2 years....................................................... 3.6
neo maintenance 10000 hours or 2 years....................................................... 3.7
ts maintenance 10000 hours or 2 years.......................................................... 3.8
4. Chapter IV - Subsystem diagnosis............................................................ 4.1
4.1
Operations......................................................................................................... 4.3
5. Chapter V - Disassembly............................................................................ 5.1
5.1
Opening and shutting down the equipment....................................................... 5.3
6. Chapter VI - Group details.......................................................................... 6.1
6.1
6.2
6.3
6.4
6.5
6.6
6.7
ii
Air intake........................................................................................................... 6.3
Oxygen intake................................................................................................... 6.3
GraphNet exhalation valve................................................................................ 6.4
Touch 10 PSI 0.7 Kg Regulator......................................................................... 6.4
2.8 Kg cm2 Air/oxygen regulator....................................................................... 6.5
Internal pneumotacograph................................................................................ 6.7
Full proportional valve....................................................................................... 6.7
Maintenance Technical Manual | GraphNet advance neo ts
6.8
6.9
6.10
6.11
6.12
6.13
6.14
6.15
Safety Valve...................................................................................................... 6.8
Anti air backup valve......................................................................................... 6.8
Anti oxygen backup valve................................................................................. 6.9
Full antisuffocation valve................................................................................... 6.9
Complete gas control...................................................................................... 6.10
Inner box with pneumatic set.......................................................................... 6.10
Full touch exit multiple connector.................................................................... 6.11
Full touch panel............................................................................................... 6.12
7. Chapter VII - Calibration.............................................................................. 7.1
7.1
7.2
7.3
Necessary items................................................................................................ 7.3
Observations..................................................................................................... 7.3
Operations......................................................................................................... 7.4
8. Chapter VIII - Final Control......................................................................... 8.1
8.1
8.2
8.3
Necessary items................................................................................................ 8.3
Observations..................................................................................................... 8.3
Operations......................................................................................................... 8.3
Appendix..........................................................................................................A.1
A.1
Tools needed.....................................................................................................A.3
Maintenance Technical Manual | GraphNet advance neo ts
iii
This Page Left Intentionally Blank
iv
Maintenance Technical Manual | GraphNet advance neo ts
1 Overview
Chapter contents
1.1
Overview GraphNet advance
1.1.1
Observed requirements and standards
1.1.2
General description of equipment
1.1.3
Expected use
1.1.4
Expected user
1.1.5
Expected use environment
1.1.6
Contraindications
1.1.7
User technical assistance
1.1.8
Symbols used
1.1.9
Abbreviations, acronyms and names of variables
Overview | GraphNet advance neo ts
1. 1
This Page Left Intentionally Blank
1. 2
Overview | GraphNet advance neo ts
1.1 | Overview
1.1.1 | Observed Requirements
and Standards
• UNE-EN 794-1:1997+A1:2001+A2:2009. Lung ventilators -- Part 1: Particular requirements for critical care ventilators.
• IEC 60601-1:2005. Medical electrical equipment -- Part 1: General requirements for
basic safety and essential performance.
• IEC 60601-1-2:2001+A1:2004. Medical electrical equipment -- Part 1-2: General
requirements for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests.
• IEC 60601-1-4:1997+A1:2000. Medical electrical equipment -- Part 1-4: General
requirements for safety - Collateral standard: Programmable electrical medical systems.
• UNE-EN 60601-1-8:2008. Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General
requirements, tests and guidance for alarm systems in medical electrical equipment
and medical electrical systems.
• IEC 60601-2-12:2001. Medical electrical equipment -- Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators.
• UNE-EN 980:2008. Graphical symbols for use in the labeling of medical devices.
• ISO 13406-2 Class II. Ergonomic requirements for work with visual displays based
on flat panels -- Part 2: Ergonomic requirements for flat panel displays
1.1.2 | General Equipment
Description
GraphNet advance is a mechanical respirator controlled by a microprocessor that
incorporates the most advanced ventilatory support methods. The electronic circuit
handles two proportional valves that provide the necessary flow of gases for the
selected configuration.
1.1.3 | Expected Use
The GraphNet advance respirator was designed to be used with all types of patients, adults, pediatric and neonate-infants that may require invasive and noninvasive ventilatory support for short or long periods of time, allowing the main
ventilatory parameters to be monitored. The equipment includes assistance for
patients who may or may not be able to breathe on their own.
1.1.4 | Expected User
GraphNet advance must be handled by or under the supervision of health professionals with the appropriate training in ventilatory therapies and especially in the
use of this respirator.
1.1.5 | Expected Use
Environment
The respirator was designed to be used in hospitals and health care centers. Specifically, in intensive care wards where the presence of competent professionals
and the necessary facilities ensure that the equipment is being used correctly.
1.1.6 | Contraindications
It is NOT possible to use the respirator when one of the following events is present:
• Starting and operating the respirator without competent medical professionals being
Overview | GraphNet advance neo ts
1. 3
present to supervise the process.
• If there is no alternative ventilation method and equipment that can be used as backup.
• Such as anesthesia machine drivers. Also, it must not be used if there are flammable
anesthetic gases present.
• Connected to an inappropriate power distribution network (e.g. ungrounded)
• The respirator is located near magnetic resonance equipment or significant electromagnetic radiation sources.
• With intakes of gases that do not meet medical grade specifications.
• During patient inter-hospital transfers (moving them out of the assigned institution).
• If the expected use, user and environment statements for this respirator are not strictly
observed.
1.1.7 | User Technical Assistance
If you need technical assistance, send an e-mail to asistencia.tecnica@tecme.
com.ar. Please make sure that you include the name of the institution to which you
belong and the contact information where an answer can be sent.
1.1.8 | Symbols Used
Keep upright.
Keep dry.
Temperature limits.
Fragile.
Do not stack more than 5 boxes.
Humidity limit.
Manufacturer.
Non-reusable.
1. 4
Overview | GraphNet advance neo ts
Marking that indicates compliance with the
requirements of the European Council Directive (93/42/CEE) regarding medical devices.
European Community authorized representative.
Off (power).
On (power).
Warning.
Caution.
Note.
Type B applied part.
Degree of protection against the entry of
particles (N1) and liquids (N2). IP Classification.
Alarm limit configuration access.
Audio paused. Icon used to identify the
control and on-screen warning of the paused auditive signal alarm.
Alarm disabled. Icon that indicates that an
alarm has been disabled.
Alarm limits.
Exhaled gases outlet port (from patient).
Exhalation set connection.
Inhaled gas delivery port (to patient).
Nebulizer connection port.
P1
P2
Prox
Distal pneumotacograph hose connection
ports.
Proximal
port.
pneumotacograph
connection
Overview | GraphNet advance neo ts
1. 5
O2%
O2 cell connection port.
Respirator on Standby. There is no respiratory assistance in this status.
It indicates respirations initiated by the patient.
Internal battery charge status.
Upload time. Control for the speed at which
to set up the configured inhalation pressure.
Autoscale enabled on-screen indication.
Screen capture in progress on-screen indication.
Nebulization enabled on-screen indication.
[Ctrl] key pressed on-screen indication.
Passive humidifier on-screen indication selected.
Active humidifier on-screen indication selected.
Screen lock.
Proximal pneumotacograph enabled.
Maintenance required on-screen indication.
1.1.9 | Abbreviations, Acronyms
and Names of Variables
1. 6
Overview | GraphNet advance neo ts
%O2
O2 Concentration
ADL
Adult
APRV
Pressure relief ventilation
Cdin
Dynamic complacency
Cest
Static complacency
Cmax
Maximum complacency
CPAP
Positive continuous airway pressure
Esc
Escape
Esp.
Exhalation or exhaled
ETCO2
End of exhalation CO2
f
Respiratory frequency
F Espon
Spontaneous respiratory frequency
F/VT
Respiratory frequency/tidal volume
ratio
FiO2
Inhaled oxygen fraction
fTOTAL
Total respiratory frequency
I:E
Inhalation time/exhalation time ratio
Insp.
Inhalation or inhaled
Lip
Upper inflexion point
MMV
Mandatory ventilation minute
NEO-INF
Neonate - infant
O2 100%
100% Oxygenation
P/V flex
Inflexion points
P0.1
Pressure during the first 100 ms
P1
Lower exhalation pneumotacograph
hose intake
P2
Upper exhalation pneumotacograph
hose intake
Paw
Airway pressure
PCV
Controlled pressure ventilation
PED
Pediatric
PEEP
End of exhalation positive pressure
Pimax
Maximum inhalation pressure
Overview | GraphNet advance neo ts
1. 7
1. 8
Overview | GraphNet advance neo ts
Pmax
Maximum pressure
Pmin
Minimum pressure
PSV
Support pressure ventilation
Prox
Proximal pneumotecograph
Ri
Exhalation resistance
Re
Inhalation resistance
SIMV
Synchronized intermittent mandatory
ventilation
TCPL
Time-cycled, pressure limited ventilation
Te
Exhalation time
Ti
Inhalation time
Uip
Upper inflexion point
V
Flow
VCO2
CO2 eliminated
VCV
Volume controlled ventilation
VE
Exhaled minute volume
VE Espont
Spontaneous exhaled minute volume
VE Mandat
Mandatory exhaled minute volume
VM
Minute volume
Vmax
Maximum volume
VNI
Non-invasive ventilation
VT ó VT
Tidal volume
WOBi
Imposed respiratory work
Chapter contents
1.2
Overview GraphNet neo
1.2.1
Observed requirements and standards
1.2.2
General equipment description
1.2.3
Expected use
1.2.4
Expected user
1.2.5
Expected use environment
1.2.6
Contraindications
1.2.7
User technical assistance
1.2.8
Symbols used
1.2.9
Abbreviations, acronyms and names of variables
Overview | GraphNet advance neo ts
1. 9
1.2 | Overview
1.2.1 | Observed Requirements
and Standards
• UNE-EN 794-1:1997+A1:2001+A2:2009. Lung ventilators -- Part 1: Particular requirements for critical care ventilators.
• IEC 60601-1:2005. Medical electrical equipment -- Part 1: General requirements for
basic safety and essential performance.
• IEC 60601-1-2:2001+A1:2004. Medical electrical equipment -- Part 1-2: General
requirements for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests.
• IEC 60601-1-4:1997+A1:2000. Medical electrical equipment -- Part 1-4: General
requirements for safety - Collateral standard: Programmable electrical medical systems.
• UNE-EN 60601-1-8:2008. Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General
requirements, tests and guidance for alarm systems in medical electrical equipment
and medical electrical systems.
• IEC 60601-2-12:2001. Medical electrical equipment -- Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators.
• UNE-EN 980:2008. Graphical symbols for use in the labeling of medical devices.
• ISO 13406-2 Class II. Ergonomic requirements for work with visual displays based
on flat panels -- Part 2: Ergonomic requirements for flat panel displays
1.2.2 | General Equipment
Description
GraphNet neo is a mechanical respirator controlled by a microprocessor that incorporates the most advanced ventilatory support methods. The electronic circuit
handles two proportional valves that provide the necessary flow of gases for the
selected configuration.
1.2.3 | Expected Use
The GraphNet neo respirator was designed to be used with neonate-baby (including premature) patients up to 10 kg in weight that may require invasive and noninvasive ventilatory support for short or long periods of time, allowing for the main
ventilatory parameters to be monitored. The equipment includes assistance for patients who may or may not be able to breathe on their own.
1.2.4 | Expected User
GraphNet neo must be handled by or under the supervision of health professionals
with the appropriate training in ventilatory therapies and especially in the use of
this respirator.
1.2.5 | Expected Use
Environment
The respirator was designed to be used in hospitals and health care centers. Specifically, in intensive neonatal care wards where the presence of competent professionals and the necessary facilities ensure that the equipment is being used
correctly.
1. 10
Overview | GraphNet advance neo ts
1.2.6 | Contraindications
It is NOT possible to use the respirator when one of the following events is present:
•Starting and operating the respirator without competent medical professionals being
present to supervise the process.
• If there is no alternative ventilation method and equipment that can be used as
backup.
• Such as anesthesia machine drivers. Also, it must not be used if there are flammable
anesthetic gases present.
• Connected to an inappropriate power distribution network (e.g. ungrounded)
• The respirator is located near magnetic resonance equipment or significant electromagnetic radiation sources.
• With intakes of gases that do not meet medical grade specifications.
• During patient inter-hospital transfers (moving them out of the assigned institution).
• If the expected use, user and environment statements for this respirator are not strictly
observed.
1.2.7 | User Technical Assistance
If you need technical assistance, send an e-mail to asistencia.tecnica@tecme.
com.ar. Please make sure that you include the name of the institution to which you
belong and the contact information where an answer can be sent.
1.2.8 | Symbols Used
Keep upright.
Keep dry.
Temperature limits.
Fragile.
Do not stack more than 5 boxes.
Humidity limit.
Manufacturer.
Non-reusable.
Overview | GraphNet advance neo ts
1. 11
Marking that indicates compliance with the
requirements of the European Council Directive (93/42/CEE) regarding medical devices.
European Community authorized representative.
Off (power).
On (power).
Warning.
Caution.
Note.
Type B applied part.
Degree of protection against the entry of
particles (N1) and liquids (N2). IP Classification.
Alarm limit configuration access.
Audio paused. Icon used to identify the
control and on-screen warning of the paused auditive signal alarm.
Alarm disabled. Icon that indicates that an
alarm has been disabled.
Alarm limits.
Exhaled gases outlet port (from patient).
Exhalation set connection.
Inhaled gas delivery port (to patient).
Nebulizer connection port.
P1
P2
Prox
1. 12
Overview | GraphNet advance neo ts
Distal pneumotacograph hose connection
ports.
Proximal
port.
pneumotacograph
connection
O2%
O2 cell connection port.
Respirator on Standby. There is no respiratory assistance in this status.
It indicates respirations initiated by the patient.
Internal battery charge status.
Upload time. Control for the speed at which
to set up the configured inhalation pressure.
Autoscale enabled on-screen indication.
Screen capture in progress on-screen indication.
Nebulization enabled on-screen indication.
[Ctrl] key pressed on-screen indication.
Passive humidifier on-screen indication selected.
Active humidifier on-screen indication selected.
Screen lock.
Proximal pneumotacograph enabled.
Maintenance required on-screen indication.
1.2.9 | Abbreviations, Acronyms
and Names of Variables
%O2
O2 Concentration
ADL
Adult
APRV
Pressure relief ventilation
Cdin
Dynamic complacency
Cest
Static complacency
Overview | GraphNet advance neo ts
1. 13
1. 14
Overview | GraphNet advance neo ts
Cmax
Maximum complacency
CPAP
Positive continuous airway pressure
Esc
Escape
Esp.
Exhalation or exhaled
f
Respiratory frequency
F Espon
Spontaneous respiratory frequency
F/VT
Respiratory frequency/tidal volume
ratio
FiO2
Inhaled oxygen fraction
fTOTAL
Total respiratory frequency
I:E
Inhalation time/exhalation time ratio
Insp.
Inhalation or inhaled
Lip
Upper inflexion point
MMV
Mandatory ventilation minute
NEO-INF
Neonate - infant
O2 100%
100% Oxygenation
P/V flex
Inflexion points
P0.1
Pressure during the first 100 ms
P1
Lower exhalation pneumotacograph
hose intake
P2
Upper exhalation pneumotacograph
hose intake
Paw
Airway pressure
PCV
Controlled pressure ventilation
PED
Pediatric
PEEP
End of exhalation positive pressure
Pimax
Maximum inhalation pressure
Pmax
Maximum pressure
Pmin
Minimum pressure
PSV
Support pressure ventilation
Re
Exhalation resistance
Ri
Inhalation resistance
SIMV
Synchronized intermittent mandatory
ventilation
TCPL
Time-cycled, pressure limited ventilation
Te
Exhalation time
Ti
Inhalation time
Uip
Upper inflexion point
V
Flow
Prox
Proximal pneumotecograph
VCV
Volume controlled ventilation
VE
Exhaled minute volume
VE Espont
Spontaneous exhaled minute volume
VE Mandat
Mandatory exhaled minute volume
VM
Minute volume
Vmax
Maximum volume
VNI
Non-invasive ventilation
VT ó VT
Tidal volume
WOBi
Imposed respiratory work
Overview | GraphNet advance neo ts
1. 15
Chapter contents
1.3
1. 16
Overview GraphNet ts
1.3.1
Observed requirements and standards
1.3.2
General equipment description
1.3.3
Expected use
1.3.4
Expected user
1.3.5
Expected use environment
1.3.6
Contraindications
1.3.7
User technical assistance
1.3.8
Symbols used
1.3.9
Abbreviations, acronyms and names of variables
Overview | GraphNet advance neo ts
1.3 | Overview
1.3.1 | Observed Requirements
and Standards
• UNE-EN 794-1:1997+A1:2001+A2:2009. Lung ventilators -- Part 1: Particular requirements for critical care ventilators.
• IEC 60601-1:2005. Medical electrical equipment -- Part 1: General requirements for
basic safety and essential performance.
• IEC 60601-1-2:2001+A1:2004. Medical electrical equipment -- Part 1-2: General
requirements for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests.
• IEC 60601-1-4:1997+A1:2000. Medical electrical equipment -- Part 1-4: General
requirements for safety - Collateral standard: Programmable electrical medical systems.
• UNE-EN 60601-1-8:2008. Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General
requirements, tests and guidance for alarm systems in medical electrical equipment
and medical electrical systems.
• IEC 60601-2-12:2001. Medical electrical equipment -- Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators.
• UNE-EN 980:2008. Graphical symbols for use in the labeling of medical devices.
• ISO 13406-2 Class II. Ergonomic requirements for work with visual displays based
on flat panels -- Part 2: Ergonomic requirements for flat panel displays
1.3.2 | General Equipment
Description
GraphNet ts is a mechanical respirator controlled by a microprocessor that incorporates the most advanced ventilatory support methods. The electronic circuit
handles two proportional valves that provide the necessary flow of gases for the
selected configuration.
1.3.3 | Expected Use
The GraphNet ts respirator was designed to be used with all types of patients, adults,
pediatric and new-born babies (optional with the NEO-INF module) that may require invasive and non-invasive ventilatory support for short or long periods of time,
allowing for the main ventilatory parameters to be monitored. The equipment includes assistance for patients who may or may not be able to breathe on their own.
1.3.4 | Expected User
GraphNet ts must be handled by or under the supervision of health professionals
with the appropriate training in ventilatory therapies and especially in the use of
this respirator.
1.3.5 | Expected Use
Environment
The respirator was designed to be used in hospitals and health care centers. Specifically, in intensive care wards where the presence of competent professionals
and the necessary facilities ensure that the equipment is being used correctly.
Overview | GraphNet advance neo ts
1. 17
1.3.6 | Contraindications
It is NOT possible to use the respirator when one of the following events is present:
• Starting and operating the respirator without competent medical professionals being
present to supervise the process.
• If there is no alternative ventilation method and equipment that can be used as
backup.
• Such as anesthesia machine drivers. Also, it must not be used if there are flammable
anesthetic gases present.
• Connected to an inappropriate power distribution network (e.g. ungrounded)
• The respirator is located near magnetic resonance equipment or significant electromagnetic radiation sources.
• With intakes of gases that do not meet medical grade specifications.
• During patient inter-hospital transfers (moving them out of the assigned institution).
• If the expected use, user and environment statements for this respirator are not strictly
observed.
1.3.7 | User Technical Assistance
If you need technical assistance, send an e-mail to asistencia.tecnica@tecme.
com.ar. Please make sure that you include the name of the institution to which you
belong and the contact information where an answer can be sent.
1.3.8 | Symbols Used
Keep upright.
Keep dry.
Temperature limits.
Fragile.
Do not stack more than 5 boxes.
Humidity limit.
Manufacturer.
Non-reusable.
1. 18
Overview | GraphNet advance neo ts
Marking that indicates compliance with the
requirements of the European Council Directive (93/42/CEE) regarding medical devices.
European Community authorized representative.
Off (power).
On (power).
Warning.
Caution.
Note.
Type B applied part.
Degree of protection against the entry of
particles (N1) and liquids (N2). IP Classification.
Alarm limit configuration access.
Audio paused. Icon used to identify the
control and on-screen warning of the paused auditive signal alarm.
Alarm disabled. Icon that indicates that an
alarm has been disabled.
Alarm limits.
Exhaled gases outlet port (from patient).
Exhalation set connection.
Inhaled gas delivery port (to patient).
Nebulizer connection port.
P1
P2
O2%
Distal pneumotacograph hose connection
ports.
O2 cell connection port.
Overview | GraphNet advance neo ts
1. 19
Respirator on Standby. There is no respiratory assistance in this status.
It indicates respirations initiated by the patient.
Internal battery charge status.
Upload time. Control for the speed at which
to set up the configured inhalation pressure.
Autoscale enabled on-screen indication.
Screen capture in progress on-screen indication.
Nebulization enabled on-screen indication.
[Ctrl] key pressed on-screen indication.
Passive humidifier on-screen indication selected.
Active humidifier on-screen indication selected.
Screen lock.
Maintenance required on-screen indication.
1.3.9 | Abbreviations, Acronyms
and Names of Variables
1. 20
Overview | GraphNet advance neo ts
%O2
O2 Concentration
ADL
Adult
APRV
Pressure relief ventilation
Cdin
Dynamic complacency
Cest
Static complacency
Cmax
Maximum complacency
CPAP
Positive continuous airway pressure
Esc
Escape
Esp.
Exhalation or exhaled
f
End of exhalation CO2
F Espon
Respiratory frequency
F/VT
Spontaneous respiratory frequency
FiO2
Respiratory frequency/tidal volume
ratio
fTOTAL
Inhaled oxygen fraction
I:E
Total respiratory frequency
Insp.
Inhalation time/exhalation time ratio
Lip
Inhalation or inhaled
MMV
Upper inflexion point
NEO-INF
Mandatory ventilation minute
O2 100%
100% Oxygenation
P/V flex
Inflexion points
P0.1
Pressure during the first 100 ms
P1
Lower exhalation pneumotacograph
hose intake
P2
Upper exhalation pneumotacograph
hose intake
Paw
Airway pressure
PCV
Controlled pressure ventilation
PED
Pediatric
PEEP
End of exhalation positive pressure
Pimax
Maximum inhalation pressure
Pmax
Maximum pressure
Pmin
Minimum pressure
PSV
Support pressure ventilation
Overview | GraphNet advance neo ts
1. 21
1. 22
Overview | GraphNet advance neo ts
Re
Exhalation resistance
Ri
Inhalation resistance
SIMV
Synchronized intermittent mandatory
ventilation
TCPL
Time-cycled, pressure limited ventilation
Te
Exhalation time
Ti
Inhalation time
Uip
Upper inflexion point
V
Flow
Prox
Proximal pneumotecograph
VCV
Volume controlled ventilation
VE
Exhaled minute volume
VE Espont
Spontaneous exhaled minute volume
VE Mandat
Mandatory exhaled minute volume
VM
Minute volume
Vmax
Maximum volume
VNI
Non-invasive ventilation
VT ó VT
Tidal volume
WOBi
Imposed respiratory work
2 Technical specifications
Chapter contents
2.1 Technical specifications GraphNet advance
2.1.1
Classification
2.1.2
Physical characteristics
2.1.3
Screen
2.1.4
Environmental requirements
2.1.5
Pneumatic specifications
2.1.6
Electrical specifications
2.1.7
Ventilatory parameter adjustment
2.1.8
Monitored parameters
2.1.9
Alarm adjustment
2.1.10
Obtaining control and monitoring data
2.1.11
Electromagnetic compatibility
2.1.12
Basic respirator operation
2.1.13
Safety mechanisms
2.1.14
Pneumatic circuit respirator diagram
Technical specifications | GraphNet advance neo ts
2. 1
This Page Left Intentionally Blank
2. 2
Technical specifications | GraphNet advance neo ts
Note
• If necessary, TECME will provide technical information
for the equipment (such as descriptions, diagrams, calibration instructions, etc.) to help qualified technical staff
repair parts defined as repairable by the manufacturer.
2.1.1 | Classification
Table 2.1-1 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)
IP Protection
IPX1
Operational Mode
Continuous Operation (IEC 60601-1)
2.1.2 | Physical Characteristics
Table 2.1-2 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)
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)
2.1.3 | Screen
Table 2.1-3 Screen
Type
Resistive sensitive touch screen / color TFT-LCD
Size
12.1”
Resolution
800x600
2.1.4 | Environmental
Requirements
2.1.5 | Pneumatic
Specifications
Table 2.1.-4 Environmental Requirements
Temperature
Ambient pressure
Humidity
Operation
15 °C – 35 °C
560 – 1030 hPa
15 - 95% non-condensing
Storage
-5 °C – 70 °C
500 – 1060 hPa
< 95% non-condensing
Table 2.1-5 Pneumatic specifications
Supply gases
Medical grade air and oxygen.
Minimum supply pressure
3.5 kg/cm2 (343.2 kPa – 50 psi).
Maximum supply pressure
7.0 kg/cm2 (686.4 kPa – 100 psi).
Maximum limited pressure (release valve)
120 ± 5 cmH2O.
Intake flow (gas source)
180 L/min (120 L/min air compressor).
Peak flow supplied by the respirator.
0.2 – 180 L/min.
Maximum resulting minute volume
ADL: 130 L/min.
PED 40 L/min.
NEO-INF: 17 L/min.
(Respirator) internal complacency
0.16 L/cmH2O.
Respirator connectors for gas supply
Air: DISS 3/4” – 16 male connector.
Oxygen: DISS 9/16” – 18 male connector.
Hose connectors for gas supply
Air: DISS 3/4” – 16 female connector (both
ends). Oxygen: DISS 9/16” – 18 female
connector (both ends).
Technical specifications | GraphNet advance neo ts
2. 3
2.1.6 | Electrical Specifications
Table 2.1-6 Electrical specifications
Main feed
Voltage: 100 – 240 V (automatic switch).
Frequency: 50 – 60 Hz.
Maximum consumption: 0.5 A to 110 V – 0.3 A to 220 V.
Internal battery
Voltage: 11.1 V (continuous).
Electric charge: 7.8 Ah (automatic recharge).
Autonomy: 2.5 hours (approximately). Data obtained for
ADL category patient, VCV mode, with default parameter
values.
Fuses
F2L250V (250 V / 2 A – 0.5 mm x 20 mm).
Connectivity
RS-232C.
NOTE
• When the respirator is fed from the internal battery, it
has the same operational capacity as when it is fed
from the power grid through the main feed cable except for capnography, which is disabled.
2.1.7 | Ventilatory Parameter
Adjustment
Table 2.1-7 Ventilatory parameters adjustment
Parameter
Tidal Volume (L)
ADL: 0,050 - 2,500
PED: 0,020 - 0,300
NEO-INF: 0,005 0,150
Minute Volume
(MMV + PSV setting)
(4) (L/min)
ADL: 1 - 50
PED: 1 - 50
NEO-INF: N/A
Controlled
pressure (PCV)
(cmH2O)
Support pressure
(PSV) (cmH2O)
Increments(1)
Initial value
ADL: 0,010*
PED: 0,001*
NEO-INF: 0,001*
ADL: 0,402(2)
PED: 0,051(2)
NEO-INF: 0,009(2)
0,100
ADL: 6,0
PED: 4,0
NEO-INF: N/A
PCV + PEEP = 2 - 100
1
ADL: 15
PED: 8
NEO-INF: 8
PSV + PEEP = 0 - 100
1
ADL: 5
PED: 5
NEO-INF: 5
PEEP/CPAP
(cmH2O)
0 - 50
1
ADL: 5(3)
PED: 5(3)
NEO-INF: 3(3)
Limited pressure
(in TCPL – NEOINF) (cmH2O)
3 - 70
1
10
Continuous TCPL
flow (L/min)
2 - 40
1
8
Inspiratory time
(s) (in assist/control
modes)
0,1 - 10
0,01*
Inspiratory time
(s) (APRV)
Ti high 0.5 – 30
Ti low 0.2 – 30
0,01*
5.0
1.5
I:E Ratio
5:1 – 1:599
(in assist/control modes)
150:1 – 1:60 (APRV)
0,1:0,1
Results of the inspiratory time and the
initial rate.
Respiratory rate
(rpm)
ADL: 1 - 100.
PED and NEO-INF:
1 - 150.
Oxygen (concentration) (%)
2. 4
Range
Technical specifications | GraphNet advance neo ts
21 - 100
ADL: 1,0(3)
PED: 0,6(3)
NEO-INF: 0,5(3)
ADL: 12(3)
1
PED: 25(3)
NEO-INF: 30(3)
1*
50
By flow: 0.1/0.5/1
according to the
detection value.
ADL: Flow=3; Pressure=-1.5
PED: Flow=3; Pressure=-1.5
NEO-INF: Flow=1;
Pressure=-1.5
Inspiratory sensitivity (Flow = L/min;
Pressure = cmH2O)
Triggering by flow:
0.2 – 15
Triggering by pressure:
-0.5 a –20
Expiratory sensitivity (for modes with
PSV)
5% - 80% of the peak
flow
5%
25%
Programmable
inspiratory pause
(in VCV) (s)
0–2
0,25
0 (NO)
Manual inspiratory pause (s)
7 (maximum)
N/A
N/A
Manual expiratory
pause (s)
20 (maximum)
N/A
N/A
Sighs (in VCV)
Inspiratory flow
waveform
By pressure: 0.5
No. of sighs: 1/2/3
No. of sighs: 1.
Rate: 5/10/15/20 per
hour
Rate: 5 per hour
Added volume: +0.1VT
– +1.0VT (The volume
is added to the configured VT)
N/A
Activated: No
Descending and constant ramp (rectangular)
N/A
Leakage compensation in NIV (L/min)
Non adjustable
N/A
Leakage compensation for the rest
of the modes (L/
min)
Non adjustable.
N/A
Tube compensation
Added volume:
+30% (+0.3VT).
Descending ramp
ADL: up to 50
PED: up to 30
ADL: up to 15
PED: up to 15
NEO-INF: up to 10
Tube: Endotracheal or
tracheostomy
Diameter: 4 – 12 mm
Compensate: 10%100%
Tube: Endotracheal
N/A
Diameter: 8 mm
Compensate: 50%
Activated: NO
(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 according to the parameter in question.
(2) Initial factory values. By modifying mL/kg in setting IBW-based VT, these values may
change (see chapter Initial Verification and Calibration).
(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.
(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 17-5).
Technical specifications | GraphNet advance neo ts
2. 5
2.1.8 | Monitored Parameters
Table 2.1-8 Monitored parameters
Parameter
±2 cmH2O or ±10%
Plateau Pressure
±2 cmH2O or ±10%
Medium pressure
±2 cmH2O or ±10%
Baseline pressure
±2 cmH2O or ±10%
Exhaled tidal volume
±10% if VT < 20 mL; ±2 mL + 10% if VT > 20 mL
Minute volume
±10%
Inhalation flow
±10%
Respiratory frequency
±1 rpm
Inhalation time
±0.06 s
Exhalation time
±0.06 s
I:E Ratio
NA
O2 Concentration
±3%
2.1.9 | Alarm Adjustment
Table 2.1-9 Alarm Adjustment
Alarm
Limits
Increment
Maximum inspiratory pressure
(cmH2O)
10 (or >min - 120)
1
ADL: 40
PED: 30
NEO-INF: 25
Minimum inspiratory pressure
(cmH2O)
1 - 99 (or <max)
1
ADL: 5
PED: 5
NEO-INF: 2
Maximum tidal
volume(2) (L)
ADL: >VTmin - 3,0
PED: >VTmin - 0.500
NEO-INF: >VTmin 0,250
ADL: 0,010(2)
PED: 0,005(1)
NEO-INF: 0,005(1)
ADL: 0,600
PED: 0,075
NEO-INF: 0,015
Minimum tidal
volume(2) (L)
ADL: 0 to <VTmax
PED: 0 to <VTmax
NEO-INF: 0 to <VTmax
ADL: 0,010 (2)
PED: 0,001 (1)
NEO-INF: 0,001 (1)
ADL: 0,150
PED: 0,025
NEO-INF: 0,005
Maximum minute
volume (expired) (4)
(L/min)
ADL: >VMmin - 55
PED: >VMmin - 55
NEO-INF: >VMmin
- 55
0,01/ 0,05/ 0,1/ 0,5/
1,0 according to the
alarm limit value
ADL: 7,23 (9,0 en
MMV+PSV)
PED: 1,91 (6,0 en
MMV+PSV)
NEO-INF: 0,40
Minimum minute
volume (expired)(4)
(L/min)
ADL: 0 to <VMmax
PED: 0 to <VMmax
NEO-INF: 0 to <VMmax
0,01/ 0,05 /0,1 /0,5/
1,0 according to the
alarm limit value
ADL: 2,41 (4,5 in
MMV+PSV)
PED: 0,63 (3,0 in
MMV+PSV)
NEO-INF: 0,13
Concentration of
O2 (%)
High: 25 – 110
Low: 19 – 95
1
Inadequate oxygen
(%)
18 or less (not configurable)
N/A
N/A
Disconnection
N/A (not configurable)
N/A
N/A
Leakage out of
range (L/min)
N/A (not configurable)
N/A
5 - 60
5
15
Apnea (s)
2. 6
Precision
Peak pressure
Initial Value
High: 60
Low: 40
ADL: 50(3)
PED: 30(3)
NEO-INF: 10
Low PEEP (cmH2O)
0-6
2
ADL/PED/NEOINF: 2
Maximum respiratory rate (rpm)
3 - 160
1
ADL/PED: 30
NEO-INF: 40
Technical specifications | GraphNet advance neo ts
ETCO2 (mmHg)
Max: >Min to 150
Min 1 to <Max
Continuous high
pressure
Alarm condition: 5 cmH2O above the configured PEEP level for
over 15 s. Not configurable.
External power
failure
Not configurable. Whatever the cause of the event may be, the
ventilator automatically switches to battery operation.
Dead battery
Null or very low charge level. Replace by an alternative respiratory
method. Not configurable.
Inop. Vent.
When the operation of the ventilator is suspended, replace by an
alternative ventilatory method. Not configurable.
Blower failure
Not configurable. Alarm signals are triggered when excessive
power consumption by the blower is detected (caused by increased resistance at the rotation of the blades).
1
Max: 50
Min: 30
(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.
2.1.10 | Obtaining Control and
Monitoring Data
2.1.11 | Electromagnetic
Compatibility
Table 2.1-10 Obtaining control and monitoring data
Parameter
Method
Variables involved
Precision
Pressure
Relative pressure transducers
Control, support and monitored pressures
±2 cmH2O
Controlled
flow
Mesh pneumotacograph related to differential pressure
transducers.
Continuous flow, controlled
volume generation flow.
±10%
Monitored flow
Variable opening pneumotacograph related to
the differential pressure
transducer (optional fixed
opening pneumotacograph for NEO-INF category).
Graphs and monitored
flows and exhaled volumes.
±10%
Volume
It is derived from the pertinent flow measurements.
Controlled, monitored and
graphed volumes.
±10%
Time
Quartz crystal.
Inhalation and exhalation
times, respiratory frequency and I:E ratio. Internal
clock.
±0.06 s
± 1 rpm
O2 Concentration
Galvanic cell.
O2 Concentration
±3% Vol.
WARNING
• Replacement of equipment cables (main feed or
internal cables) by others who are not approved
by TECME, S.A. may result in a decrease in immunity or an increase in the emissions indicated for
GraphNet advance.
Technical specifications | GraphNet advance neo ts
2. 7
2.1.11.1 | Manufacturer’s
statement: Electromagnetic
emissions
Table 2.1-11 Electromagnetic emission statement
GraphNet advance is intended for use in the specified electromagnetic environment. The
GraphNet advance client and/or user must ensure that it is used in an electromagnetic
environment that is similar to the one indicated in this Table.
Emission test
2.1.11.2 | Manufacturer’s
statement: Electromagnetic
immunity
Compliance
Electromagnetic environment
RF CISPR 11
emissions
Group I
GraphNet advance uses RF energy only for its
internal operation. Therefore, RF emissions are
very low and it is unlikely that they cause any interference in nearby electronic equipment.
RF CISPR 11
emissions
Class A
Harmonic IEC
61000-3-2 emissions
Class A
Voltage fluctuations / non-continuous IEC 610003-3 emissions
Per specifications
Table 2.1-12 Electromagnetic immunity statement
GraphNet advance is intended for use in the specified electromagnetic environment. The
GraphNet advance client and/or user must ensure that it is used in an electromagnetic
environment that is similar to the one indicated in this Table.
Immunity test
IEC 60601-1-2
testing level
Compliance level
Electromagnetic environment
(ESD) IEC
610000-4-4
electrostatic
discharge
Contact: ± 6 kV.
Air: ± 8 kV.
Contact: ± 6 kV.
Air: ± 8 kV.
The floors must be made
out of wood, concrete
or ceramic tile. If the
floors are covered with
a synthetic material, the
relative humidity must be
at least 30%.
Fast power
transients in
IEC 61000-4-4
bursts
± 2 kV for feed lines.
± 1 kV for intake/
outtake lines.
± 2 kV for feed
lines.
± 1 kV for intake/
outtake lines.
The quality of the power
network must be equivalent to that of a typical
commercial or hospital
environment.
IEC 61000-4-5
shock waves
Differential mode:
±1 kV.
Common mode: ±
2 kV.
Differential mode:
±1 kV.
Common mode: ±
2 kV.
The quality of the power
network must be equivalent to that of a typical
commercial or hospital
environment.
< 5% UT (drop >
95% of UT) for 0.5
cycles.
< 5% UT (drop >
95% of UT) for 0.5
cycles.
40% UT (drop of
60% of UT) for 5
cycles.
40% UT (drop of
60% of UT) for 5
cycles.
70% UT (drop of
30% of UT) for 25
cycles.
70% UT (drop of
30% of UT) for 25
cycles.
< 5% UT (drop >
95% of UT) for 5 s.
< 5% UT (drop >
95% of UT) for 5 s.
Voltage holes,
brief interruptions and voltage variations in
IEC 61000-4-11
power intake
lines
2. 8
GraphNet advance can be used in all establishments, except for residential establishments and
those that are directly connected to the low voltage public power network that feeds residential
buildings.
Technical specifications | GraphNet advance neo ts
The quality of the
power network must be
equivalent to that of a
typical commercial or
hospital environment. If
the GraphNet-advance
user needs operation to
continue operation during
power interruptions, it is
recommended that the
system be connected
to an uninterrupted feed
source or to a battery.
(50-60 Hz) IEC
61000-4-8 feed
frequency magnetic field
3 A/m.
3 A/m.
The feed frequency
magnetic field should
be characteristic of the
levels found in a typical
commercial or hospital
environment.
NOTE: UT is the CA network voltage before applying the testing level.
2.1.11.3 | Manufacturer’s
statement: Electromagnetic
immunity
Table 2.1-13 Electromagnetic immunity statement
GraphNet advance is intended for use in the specified electromagnetic environment. The GraphNet user/client must make sure that it is
used in an electromagnetic environment like the one indicated in this Table.
Immunity test
IEC 60601 testing
level
Compliance
level
Electromagnetic environment
No RF mobile and/or portable communication equipment (including cables) must be used at a distance from GraphNet advance that is smaller
than the separation distance calculated with the equation that applies to
the transmitter frequency.
Recommended separation distance
Driven IEC 610004-6 RF
3 Vrms
150 kHz – 80 Mhz
outside of ISM(1)
bands.
10 Vrms
150 kHz – 80 Mhz
within ISM(1) bands.
Radiated IEC
61000-4-3 RF
10 V/m
80 MHz - 2,5 GHz
10 Vrms
d = 0,35 P
10 Vrms
d = 1,2 P
10 V/m
d = 1,2 P
for 80 MHz - 800 MHz
d = 2,3 P
for 800 MHz - 2,5 GHz
Where P is the maximum output of the transmitter in Watts (W) according
to the manufacturer and d is the recommended separation distance in
meters (m) (2).
The intensity of the fields generated by fixed transmitters, determined by
local electromagnetic tests(3) must be lower than the level of compliance
for each frequency range(4).
There may be interference near the equipment marked with the following
symbol:
NONOTE 1
For 80 MHz and 800 MHz, the greater frequency range applies.
NOTE 2
This guide may not apply in all situations. The electromagnetic propagation is affected by absorption and reflexion from structures, objects
and individuals.
Technical specifications | GraphNet advance neo ts
2. 9
(1) ISM (industrial, scientific and medical) bands 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) The levels of compliance in ISM frequency bands between 150 kHz and 80 MHz and in the 80 MHz and 2.5 GHz frequency range have been
established to reduce the possibility that a portable/mobile communications device may cause interference if inadvertently introduced into the
patient’s area. For this reason, an additional factor of 10/3 has been included in the formula used to calculate the recommended separation distance for transmitters in those frequency ranges.
(3) The field intensities of fixed transmitters, such as radio telephone (portable or wireless) base stations and land mobile radios, HAM radios, AM
and FM and TV broadcasts cannot be precisely predicted theoretically. To find the value of the electromagnetic environment generated by fixed
RF transmitters, an onsite test must be conducted. If the measurement of the field intensity in the location where GraphNet-advance is being used
exceeds the above applicable RF compliance limits, GraphNet-advance must be evaluated to make sure that it can operate normally. If abnormal
performance is observed, it may be necessary to take additional measures, such as reorienting or relocating the equipment.
(4) In the 150 kHz and 80 MHz frequency range, the field intensity should be less than 10 V/m.
2.1.11.4 | Manufacturer’s
statement: Separation
distances
Table 2.1-14 Recommended separation distances between the respirator and
mobile/portable communication equipment
GraphNet advance is intended to be used in an electromagnetic environment in which
radiated RF perturbances are controlled. The GraphNet advance client and/or user can
help prevent electromagnetic interferences by maintaining a minimum distance between
RF communications equipment, mobile and portable (transmitters) and GraphNet advance
as recommended in this Table, based on the maximum output of the communications
equipment.
Separation distance based on transmitter frequency (m)
150 kHz – 80
Mhz outside of
ISM bands.
150 kHz – 80
Mhz within ISM
bands.
d = 0,35 P
d = 1,2 P
0,01
0,04
0,1
0,11
Maximum
transmitter
output (W)
80 MHz - 800
MHz
800 MHz 2,5
GHz
d = 1,2 P
d = 1,2 P
0,12
0,12
0.23
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 is not in the above list, the recommended separation distance d in meters (m) can be determined by using the equation that applies to the
transmitter frequency, where P is the maximum transmitter output in Watts (W) according to
the transmitter manufacturer’s statement.
NOTE 1
For 80 MHz and 800 MHz, apply the separation distance for the larger frequency range.
NOTE 2
ISM (industrial, scientific and medical) bands 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 10/3 factor has been included in the formula used to calculate the separation
distance for transmitters that operate in the ISM frequency band between 150 kHz and 80
MHz and in the frequency range of 80 MHz to 2.5 GHz to reduce the likelihood that mobile
and/or portable communication equipment can cause interference if they are inadvertently
introduced in patient areas.
NOTE 4
These guides may not apply in all situations. The electromagnetic propagation is affected
by absorption and reflexion from structures, objects and individuals.
2. 10
Technical specifications | GraphNet advance neo ts
2.1.12 | Basic Respirator
Operation
GraphNet advance has a microprocessed control system that coordinates the
tasks that arise from programming the equipment. All the actions performed by the
respirator are commanded by this system.
The flow of gas received by the patient is administered by two proportional valves,
one for air, the other for oxygen. The valves operate simultaneously, providing the
appropriate oxygen concentration and the necessary flow wave characteristics.
The exhalation valve is controlled by two attached valves. One of them, with ON/
OFF features, tells it to open or close, which determines the end and the beginning
of the inhalation phase, respectively. The other valve is proportional, and is in charge of regulating the PEEP level when it is configured.
The microprocessor is re-fed with signals that come from the sensor system in the respirator. This makes it possible to control and adjust the configured ventilatory program.
Airway pressure is measured with a transducer related to a sensor on the end of the
patient circuit (exhalation set) or, as an option, on the connection to the patient for the
NEO-INF category (on the proximal pneumotacograph). The signal that comes from
this transducer is also used to trigger inhalations when the pressure sensitivity, respiration cycling, alarm levels and others, are enabled. The proximal pressure is measured
with a transducer next to the patient output. The most relevant task of this item is pressure control in pressure controlled or support pressure mode respirations.
Flow information is obtained through two differential pressure transducers related to the internal output pneumotacograph and the exhalation (distal or proximal)
pneumotacographs. The internal pneumotacograph (Silverman mesh type) makes
it possible to control the flows and volumes driven by the respirator in the inhalation
phase. The exhaled flows are measured through the exhalation (distal and, as an
option, proximal) pneumotacographs.
The equipment has a system of valves that allows for a communication route between the pressure transducers and the ambient pressure. This way, the transducers can be zeroed. Simultaneously, a flow of air is pushed through to purge the
exhalation pneumotacograph lines and prevent water and moisture from settling on
the measurement elements.
2.1.13 | Safety Mechanisms
GraphNet advance has a full safety system that includes the operational system
that controls the microprocessor and various components that act independently
from them.
• WATCHDOG: This is a system that monitors the operation of the electronic circuit
and exercises control independently from its integrity. When it detects an anomaly
in the operation of the respirator, it allows it to discontinue and activates an emergency ventilation mode, the Emergency Ventilation.
The Watchdog can activate the Emergency Ventilation in two different situations:
- After 30 s have elapsed since the respirator has been turned on, without selecting
a patient category, on the first initial calibration screen.
- When the microprocessor loses control of the program sequence regulating ventilation.
• EMERGENCY VENTILATION: the Emergency Ventilation is a safety mechanism
Technical specifications | GraphNet advance neo ts
2. 11
that is activated in extreme conditions to provide the patient with temporary ventilation until measures can be taken to replace the respirator with an alternative
ventilation mechanism. It is not a valid operational mode.
The Emergency Ventilation allows delivery of respirations with characteristics that
are similar to controlled pressure (PCV). During this event, only the peak pressure and the respiratory frequency are monitored. The predetermined values of
the ventilation parameters are indicated in Table 2.1-15. The alarm limits are not
enabled for modification. The active alarms are Maximum and minimum pressure, and maximum respiratory frequency, whose limits appear on screen. The only
enabled complementary function is Manual Insp.
Table 2.1-15 Ventilation parameters in Emergency Ventilation
Parameter
Initial value
Range
Observations
Controlled pressure (PCV)
10 cmH2O
2 – 30 cmH2O
The pressure is limited by
maximum alarm pressure
at 30 cmH2O. This limit
cannot be changed.
Ti (inhalation time)
0.70 s
0.10 – 3.00 s
The inhalation time can be
limited by the frequency
value.
Resp. frequency
20 rpm
1 – 100 rpm
The frequency can be limited by the inhalation time.
Inh. Sensitivity
-2 cmH2O
-0.5 – 20 cmH2O
O2 Concentration
50
-
Same value as in
PCV mode
Same range as in
PCV mode
Upload time
Flow sensitivity not
enabled.
This parameter cannot be
modified.
WARNING
• If the Emergency Ventilation is activated, provide
the patient with an alternative ventilation mechanism and find out the cause of this event. If it has
been activated because of a delay in the acceptance of the first initial calibration screen, restart
the equipment to ventilate the patient.
• SAFETY VALVE: it is located immediately before the patient output. It opens when
the pressure in the patient circuit reaches a value of 120 ± 5 cmH2O. The mixture
of gases goes to an internal collector and is expelled.
• INHALATION RELEASE VALVE (ANTI-ASPHYXIATION): this valve makes it possible to bring ambient air to the patient when the equipment is off or when the
respirator is not in operation.
• OPERATIONAL GAS RELEASE: the gases that can seep into the equipment are
recovered in a common collector and expelled.
• LACK OF COMPRESSED AIR PRESSURE: compressed air is used as a pneumatic circuit command gas. When it is missing, it can be replaced with oxygen. In
addition, when the equipment detects a lack of air, it automatically switches to a
100% O2 concentration.
2. 12
Technical specifications | GraphNet advance neo ts
• LACK OF OXYGEN PRESSURE: in this case, air replaces oxygen and the respirations are delivered with a 21% O2 concentration.
• AUTOMATIC ZERO: every 10 minutes or when the operator activates it (by pressing [Ctrl] + [Ctrl]) all pressure sensors are zeroed. This restarts the readings,
preventing possible offset errors in the measured pressures. During the first few
minutes of ventilation, the respirator can zero faster than indicated. For each zeroing, a message appears on the Icon and message bar indicating that this process is in progress.
• CIRCUIT PURGE: to prevent obstructions and moisture from moving into the
pressure sensors, air is injected through the patient circuit while the pressure
sensors are being zeroed.
• ALARM SYSTEM: GraphNet-advance has an alarm system to warn of situations
that involve some degree of risk to the patient or to the equipment itself. Some
make it possible to keep the condition from which it originated from continuing,
others simply trigger signals to report its presence. For further information about
how the alarm system works, see the Alarms chapter.
• PARAMETER ADJUSTMENT: to avoid unnoticed parameter changes, it is necessary to execute sequences established on the respirator controls. This way, pressing a single key or the dial does not result in changes being entered. For this
reason, the operator is always aware of the actions performed on the equipment.
2.1.14 | Pneumatic Circuit
Respirator
Fig. 2.1-1 Simplified respirator pneumatic circuit diagram.
Fig. references 2.1-1
A
High pressure sector
B
Low pressure sector
Technical specifications | GraphNet advance neo ts
2. 13
2. 14
1
Oxygen input.
2
Air input.
3
Filter.
4
High pressure sensors.
5
Pressure regulation stage.
6
Proportional solenoid valves.
7
Flow sensor.
8
O2 sensor.
9
Safety valve.
10
Inhalation release valve (anti-suffocation).
11
Nebulizer (optional).
12
‘Toward Patient’ Output.
13
Low pressure sensor.
14
Exhalation set (valve and pneumotacograph exhalation).
15
Cycling valve.
16
PEEP proportional solenoid valve.
Technical specifications | GraphNet advance neo ts
Chapter contents
2.2 Technical specifications GraphNet neo
2.2.1
Classification
2.2.2
Physical characteristics
2.2.3
Screen
2.2.4
Environmental requirements
2.2.5
Pneumatic specifications
2.2.6
Electrical specifications
2.2.7
Ventilatory parameter adjustment
2.2.8
Monitored parameters
2.2.9
Alarm adjustment
2.2.10
Obtaining control and monitoring data
2.2.11
Electromagnetic compatibility
2.2.12
Basic respirator operation
2.2.13
Safety mechanisms
2.2.14
Pneumatic circuit respirator diagram
Technical specifications | GraphNet advance neo ts
2. 15
Note
• If necessary, TECME will provide technical information
for the equipment (such as descriptions, diagrams, calibration instructions, etc.) to help qualified technical staff
repair parts defined as repairable by the manufacturer.
2.2.1 | Classification
Table 2.2-1 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).
IP Protection
IPX1.
Operational Mode
Continuous Operation (IEC 60601-1).
2.2.2 | Physical Characteristics
Table 2.2-2 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 without including the 9.8 kg (21.6 lb).
pedestal
Weight including the pedestal
23.8 kg (52.5 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).
2.2.3 | Screen
Table 2.2-3 Screen
Type
Resistive touch screen / color TFT-LCD.
Size
12.1”.
Resolution
800x600.
2.2.4 | Environmental
Requirements
Table 2.2-4 Environmental requirements
Temperature
Humidity
Operation
15 °C – 35 °C
560 – 1030 hPa
15 - 95% non-condensing
Storage
-5 °C – 70 °C
500 – 1060 hPa
< 95% non-condensing
2.2.5 | Pneumatic Specifications
2. 16
Ambient pressure
Table 2.2-5 Pneumatic specifications
Supply gases
Medical grade air and oxygen.
Minimum supply pressure
3.5 kg/cm2 (343.2 kPa – 50 psi).
Maximum supply pressure
7.0 kg/cm2 (686.4 kPa – 100 psi).
Maximum limited pressure (release valve)
120 ± 5 cmH2O.
Intake flow (gas source)
60 L/min.
Peak flow supplied by the respirator.
0.2 – 40 L/min.
Maximum resulting minute volume
17 L/min.
(Respirator) internal complacency
0.16 L/cmH2O.
Respirator connectors for gas supply
Air: DISS 3/4” – 16 male connector. Oxygen: DISS 9/16” – 18 male connector.
Hose connectors for gas supply
Air: DISS 3/4” – 16 female connector
(both ends). Oxygen: DISS 9/16” – 18
female connector (both ends).
Technical specifications | GraphNet advance neo ts
2.2.6 | Electrical Specifications
Table 2.2-6 Electrical specifications
Main feed
Voltage: 100 – 240 V (automatic switch).
Frequency: 50 – 60 Hz.
Maximum consumption: 0.5 A to 110 V – 0.3 A to 220 V.
Internal battery
Voltage: 11.1 V (continuous).
Electric charge: 7.8 Ah (automatic recharge).
Autonomy: 2.5 hours (approximately). Data obtained for
ADL category patient, VCV mode, with default parameter
values.
Fuses
F2L250V (250 V / 2 A – 0.5 mm x 20 mm).
Connectivity
RS-232C.
NOTE
• When the respirator is fed from the internal battery, it
has the same operational capacity as when it is fed
from the power grid through the main feed cable.
2.2.7 | Ventilatory Parameter
Adjustment
Table 2.2-7 Ventilatory parameters adjustment
Parameter
Range
Increments(1)
Initial value
Tidal Volume (mL)
2 – 350
1*
9(2)
Controlled pressure (PCV) (cmH2O)
PCV + PEEP = 2 –
100
1
8
Support pressure
(PSV) (cmH2O)
PSV + PEEP = 0 – 100
1
5
PEEP/CPAP (cmH2O)
0 – 50
1
3(3)
Limited pressure
(in TCPL) (cmH2O)
3 – 70
1
10
Continuous TCPL
flow (L/min)
2 – 40
1
8
0.1 – 10
0.01*
0.5(3)
Ti high 0.5 – 30
Ti low 0.2 – 30
0.01*
5.0
1.5
5:1 – 1:599
(in assist/control modes)
150:1 – 1:60 (APRV)
0.1:0.1
Results of the initial
inspiratory time and
rate.
Respiratory rate
(rpm)
1 – 150.
1
30(3)
Oxygen (concentration) (%)
21 – 100
1*
50
Inspiratory sensitivity (Flow = L/
min; Pressure =
cmH2O)
Triggering by flow:
0.2 – 15
Triggering by pressure:
-0.5 a –20
Expiratory sensitivity (for modes
with PSV)
5% – 80% of the peak
flow
5%
25%
Programmable
inspiratory pause
(in VCV) (s)
0–1
0.25
0 (NO)
Manual inspiratory pause (s)
7 (maximum)
N/A
N/A
Inspiratory time (s)
(in assist/control modes)
Inspiratory time (s)
(APRV)
I:E ratio
By flow: 0.1/0.5/1
according to the
sensitivity value.
By pressure: 0.5
Flow=1;
Pressure=-1.5
Technical specifications | GraphNet advance neo ts
2. 17
Manual expiratory
pause (s)
20 (maximum)
N/A
N/A
Inspiratory flow
waveform
Descending and constant ramp (rectangular)
N/A
Descending ramp.
Leakage compensation (L/min)
Non adjustable.
N/A
10
(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 according to the parameter in question.
(2) Initial factory values. By modifying mL/kg in setting IBW-based VT, these values may
change (see chapter Verification and Initial Calibration).
(3) These values are shown as reference, and are to be found in VCV and PCV modes.
In order to know the initial values of each mode see the chapter Operative Modes.
2.2.8 | Monitored Parameters
Table 2.2-8 Monitored parameters
Parameter
±2 cmH2O or ±10%
Plateau Pressure
±2 cmH2O or ±10%
Medium pressure
±2 cmH2O or ±10%
Baseline pressure
±2 cmH2O or ±10%
Exhaled tidal volume
±10% if VT < 20 mL; ±2 mL + 10% if VT > 20 mL
Minute volume
±10%
Inhalation flow
±10%
Respiratory frequency
±1 rpm
Inhalation time
±0.06 s
Exhalation time
±0.06 s
I:E Ratio
NA
O2 Concentration
±3%
2.2.9 | Alarm Adjustment
Table 9-9 Alarm Adjustment
Alarm
2. 18
Precision
Peak pressure
Limits
Increment
Initial Value
Maximum inspiratory pressure
(cmH2O)
10 (or > min) – 120
1
25
Minimum inspiratory pressure
(cmH2O)
1 – 99 (or <max)
1
2
Maximum tidal
volume(2) (mL)
>VTmin – 250
5(1)
50
Minimum tidal
volume(2) (mL)
0 – <VTmax
1(1)
5
Maximum minute
volume (expired)
(L/min)
>VMmin – 55
0.01/0.05/0.1/0.5/1.0
according to the
alarm limit value
0.40
Minimum minute
volume (expired)
(L/min)
0 – <VMmax
0.01/0.05/0.1/0.5/
1.0 according to the
alarm limit value
0.13
Technical specifications | GraphNet advance neo ts
Concentration of
O2 (%)
High: 25 (or >%O2 +
5) – 110
Low: 19 – 95 (or
<%O2 - 5)
1
Inadequate oxygen
(%)
18 or less (not configurable).
N/A
N/A
Disconnection
N/A (not configurable).
N/A
N/A
Leakage out of
range (L/min)
N/A (not configurable).
N/A
10
Apnea (s)
5 – 60
5
15
Low PEEP (cmH2O)
0–6
1
2
Maximum respiratory rate (rpm)
3 – 160
1
40
High: 60
Low: 40
Continuous high
pressure
Alarm status: 5 cmH2O above the configured PEEP level for over
15 s. Not configurable.
External power
outage
Not configurable. Whatever the cause of the event is, the ventilator
automatically switches to battery operation.
Dead battery
Null or very low charge level. Replace with an alternative ventilatory method. Not configurable.
Inop. Vent.
When the operation of the ventilator is suspended, replace with an
alternative ventilatory method. Not configurable.
Blower failure
Not configurable. Alarm signals are triggered when excessive
power consumption by the blower is detected (caused by increased 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.
2.2.10 | Obtaining Control and
Monitoring Data
Table 2.2-10 Obtaining control and monitoring data
Parameter
Method
Variables involved
Precision
Pressure
Relative pressure transducers
Control, support and monitored pressures
±2 cmH2O
Controlled
flow
Mesh pneumotacograph related to differential pressure
transducers.
Continuous flow, controlled
volume generation flow.
±10%
Monitored flow
Variable (distal) opening
or fixed opening (proximal) pneumotacograph
related to the pressure
differential transducer.
Graphs and monitored
flows and exhaled volumes.
±10%
Volume
It is derived from the pertinent flow measurements.
Controlled, monitored and
graphed volumes.
±10%
Time
Quartz crystal.
Inhalation and exhalation
times, respiratory frequency and I:E ratio. Internal
clock.
±0.06 s
± 1 rpm
O2 Concentration
Galvanic cell.
O2 Concentration
±3% Vol.
Technical specifications | GraphNet advance neo ts
2. 19
2.2.11 | Electromagnetic
Compatibility
2.2.11.1 | Manufacturer’s
statement: Electromagnetic
emissions
WARNING
• The replacement of (main feed or internal wired)
equipment cables by others not approved by
TECME S.A. may result in a decrease in immunity or an increase in the emissions indicated for GraphNet neo.
Table 2.2-11 Electromagnetic emission statement
GraphNet neo is intended to be used in the specified electromagnetic environment. The
GraphNet neo user and/or client must make sure that it is used in an electromagnetic environment like the one indicated in this Table.
Emission test
2.2.11.2 | Manufacturer’s
statement: Electromagnetic
immunity
Compliance
Electromagnetic environment
RF CISPR 11
emissions
Group I
GraphNet neo uses RF power only for internal
operation. Therefore, RF emissions are very low
and it is unlikely that they cause any interference
in nearby electronic equipment.
RF CISPR 11
emissions
Class A
Harmonic IEC
61000-3-2 emissions
Class A
Voltage fluctuations / non-continuous IEC 610003-3 emissions
Per specifications
Table 2.2-12 Electromagnetic immunity statement
GraphNet neo is intended to be used in the specified electromagnetic environment. The
GraphNet neo user and/or client must make sure that it is used in an electromagnetic environment like the one indicated in this Table.
Immunity test
2. 20
GraphNet neo can be used in all establishments
except for residential establishments and those
that are directly connected to the low voltage public power supply grid that feeds buildings used
for residential purposes.
IEC 60601-1-2
testing level
Compliance level
Electromagnetic environment
(ESD) IEC
610000-4-4
electrostatic
discharge
Contact: ± 6 kV.
Air: ± 8 kV.
Contact: ± 6 kV.
Air: ± 8 kV.
The floors must be made
out of wood, concrete
or ceramic tile. If the
floors are covered with
a synthetic material, the
relative humidity must be
at least 30%.
Fast power
transients in
IEC 61000-4-4
bursts
± 2 kV for feed lines.
± 1 kV for intake/
outtake lines.
± 2 kV for feed
lines.
± 1 kV for intake/
outtake lines.
The quality of the power
network must be equivalent to that of a typical
commercial or hospital
environment.
IEC 61000-4-5
shock waves
Differential mode:
±1 kV.
Common mode: ±
2 kV.
Differential mode:
±1 kV.
Common mode: ±
2 kV.
The quality of the power
network must be equivalent to that of a typical
commercial or hospital
environment.
Technical specifications | GraphNet advance neo ts
Voltage holes,
brief interruptions and voltage variations in
IEC 61000-4-11
power intake
lines
(50-60 Hz) IEC
61000-4-8 feed
frequency magnetic field
< 5% UT (drop >
95% of UT) for 0.5
cycles.
< 5% UT (drop >
95% of UT) for 0.5
cycles.
40% UT (drop of
60% of UT) for 5
cycles.
40% UT (drop of
60% of UT) for 5
cycles.
70% UT (drop of
30% of UT) for 25
cycles.
70% UT (drop of
30% of UT) for 25
cycles.
< 5% UT (drop >
95% of UT) for 5 s.
< 5% UT (drop >
95% of UT) for 5 s.
3 A/m.
3 A/m.
The quality of the power
network must be equivalent to that of a typical
commercial or hospital
environment. If the
GraphNet-neo user needs
operation to continue
during power interruptions,
it is recommended that
the system be connected
to an uninterrupted feed
source or to a battery.
The feed frequency
magnetic field should
be characteristic of the
levels found in a typical
commercial or hospital
environment.
NOTE: UT is the CA network voltage before applying the testing level.
2.2.11.3 | Manufacturer’s
statement: Electromagnetic
immunity
Table 2.2-13 Electromagnetic immunity statement
GraphNet neo is intended to be used in the specified electromagnetic environment. The GraphNet neo client and/or user must make sure
that it is used in an electromagnetic environment like the one indicated in this Table.
Immunity test
IEC 60601 testing
level
Compliance
level
Electromagnetic environment
No RF mobile and/or portable communication equipment (including
cables) must be used at a distance from GraphNet-neo that is smaller
than the separation distance calculated with the equation that applies to
the transmitter frequency.
Recommended separation distance
Driven IEC 610004-6 RF
3 Vrms
150 kHz – 80 Mhz
outside of ISM(1)
bands.
10 Vrms
150 kHz – 80 Mhz
within ISM(1) bands.
Radiated IEC
61000-4-3 RF
10 V/m
80 MHz – 2.5 GHz.
10 Vrms
d = 0,35 P
10 Vrms
d = 1,2 P
10 V/m
d = 1,2 P
for 80 MHz - 800 MHz
d = 2,3 P
for 800 MHz - 2,5 GHz
Where P is the maximum output of the transmitter in Watts (W) according
to the manufacturer and d is the recommended separation distance in
meters (m) (2).
The intensity of the fields generated by fixed transmitters, determined by
local electromagnetic tests(3) must be lower than the level of compliance
for each frequency range(4).
There may be interference near the equipment marked with the following
symbol:
Technical specifications | GraphNet advance neo ts
2. 21
NOTE 1
For 80 MHz and 800 MHz, the greater frequency range applies.
NOTE 2
This guide may not apply in all situations. The electromagnetic propagation is affected by absorption and reflexion from structures, objects
and individuals.
(1) ISM (industrial, scientific and medical) bands 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) The levels of compliance in ISM frequency bands between 150 kHz and 80 MHz and in the 80 MHz and 2.5 GHz frequency range have been
established to reduce the possibility that a portable/mobile communications device may cause interference if inadvertently introduced into the
patient’s area. For this reason, an additional factor of 10/3 has been included in the formula used to calculate the recommended separation distance for transmitters in those frequency ranges.
(3) The field intensities of fixed transmitters, such as radio telephone (portable or wireless) base stations and land mobile radios, HAM radios, AM
and FM and TV broadcasts cannot be precisely predicted theoretically. To find the value of the electromagnetic environment generated by fixed RF
transmitters, an onsite test must be conducted. If the measurement of the field intensity in the location where GraphNet-neo is being used exceeds
the above applicable RF compliance limits, GraphNet neo must be evaluated to make sure that it can operate normally. If abnormal performance is
observed, it may be necessary to take additional measures, such as reorienting or relocating the equipment.
(4) In the 150 kHz and 80 MHz frequency range, the field intensity should be less than 10 V/m.
2.2.11.4 | Manufacturer’s
statement: Separation
distances
Table 2.2-14 Recommended separation distances between the respirator and
mobile/portable communication equipment
GraphNet neo is intended to be used in an electromagnetic environment where radiated
RF perturbances are controlled. The GraphNet neo client and/or user can help prevent
electromagnetic interferences by maintaining a minimum distance between RF communications equipment, mobile and portable (transmitters) and GraphNet neo as recommended in this Table, based on the maximum output of the communications equipment.
Separation distance based on transmitter frequency (m)
150 kHz - 80
MHz outside of
ISM bands.
150 kHz - 80
MHz within ISM
bands.
d = 0,35 P
d = 1,2 P
0,01
0,04
0,1
0,11
Maximum
transmitter
output (W)
80 MHz - 800
MHz
800 MHz 2,5
GHz
d = 1,2 P
d = 1,2 P
0,12
0,12
0.23
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 is not in the above list, the recommended separation distance d in meters (m) can be determined by using the equation that applies to the
transmitter frequency, where P is the maximum transmitter output in Watts (W) according to
the transmitter manufacturer’s statement.
NOTE 1
For 80 MHz and 800 MHz, apply the separation distance for the larger frequency range.
NOTE 2
ISM (industrial, scientific and medical) bands 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 10/3 factor has been included in the formula used to calculate the separation
distance for transmitters that operate in the ISM frequency band between 150 kHz and 80
MHz and in the frequency range of 80 MHz to 2.5 GHz to reduce the likelihood that mobile
and/or portable communication equipment can cause interference if they are inadvertently
introduced in patient areas.
NOTE 4
These guides may not apply in all situations. The electromagnetic propagation is affected
by absorption and reflexion from structures, objects and individuals.
2. 22
Technical specifications | GraphNet advance neo ts
2.2.12 | Basic Respirator
Operation
GraphNet neo has a microprocessed control system that coordinates the tasks
that arise from programming the equipment. All the actions performed by the respirator are commanded by this system.
The flow of gas received by the patient is administered by two proportional valves,
one for air, the other for oxygen. The valves operate simultaneously, providing the
appropriate oxygen concentration and the necessary flow wave characteristics.
The exhalation valve is controlled by two attached valves. One of them, with ON/
OFF features, tells it to open or close, which determines the end and the beginning of the inhalation phase, respectively. The other valve is proportional, and is in
charge of regulating the PEEP level when it is configured.
The microprocessor is re-fed with signals that come from the sensor system in the
respirator. This makes it possible to control and adjust the configured ventilatory
program. Airway pressure is measured with a transducer related to a sensor on
the end of the patient circuit (distal pneumotacograph) or on the connection to the
patient (proximal pneumotacograph). The signal that comes from this transducer
is also used to trigger inhalations when the pressure sensitivity, respiration cycling,
alarm levels and others, are enabled. The proximal pressure is measured with a
transducer next to the patient output. The most relevant task of this item is pressure control in pressure controlled or support pressure mode respirations.
Flow information is obtained through two differential pressure transducers related
to the internal output pneumotacograph and the exhalation (distal or proximal)
pneumotacographs. The internal pneumotacograph (Silverman mesh type) makes
it possible to control the flows and volumes driven by the respirator in the inhalation phase. The exhaled flows are measured through the exhalation (distal and, as
an option, proximal) pneumotacographs.
The equipment has a system of valves that allows for a communication route between the pressure transducers and the ambient pressure. This way, the transducers can be zeroed. Simultaneously, a flow of air is pushed through to purge the
exhalation pneumotacograph lines and prevent water and moisture from settling
on the measurement elements.
2.2.13 | Safety Mechanisms
GraphNet neo has a full safety system that includes the operational system that
controls the microprocessor and various components that act independently from
them.
• WATCHDOG: This is a system that monitors the operation of the electronic circuit
and exercises control independently from its integrity. When it detects an anomaly in the operation of the respirator, it allows it to discontinue and activates an
emergency ventilation mode, the Emergency Ventilation.
The Watchdog can activate the Emergency Ventilation in two different situations:
- After 30 s have elapsed since the respirator has been turned on, without selecting a patient category, on the first initial calibration screen.
- When the microprocessor loses control of the program sequence regulating ventilation.
Technical specifications | GraphNet advance neo ts
2. 23
• EMERGENCY VENTILATION: the Emergency Ventilation is a safety mechanism
that is activated in extreme conditions to provide the patient with temporary ventilation until measures can be taken to replace the respirator with an alternative
ventilation mechanism. It is not a valid operational mode.
The Emergency Ventilation allows delivery of respirations with characteristics that
are similar to controlled pressure (PCV). During this event, only the peak pressure and the respiratory frequency are monitored. The predetermined values of
the ventilation parameters are indicated in Table 2.2-15. The alarm limits are not
enabled for modification. The active alarms are Maximum and minimum pressure, and maximum respiratory frequency, whose limits appear on screen. The only
enabled complementary function is Manual Insp.
Table 2.2-15 Ventilation parameters in Emergency Ventilation
Parameter
Initial value
Range
Observations
Controlled pressure (PCV)
10 cmH2O
2 – 30 cmH2O
The pressure is limited by
maximum alarm pressure
at 30 cmH2O. This limit
cannot be changed.
Ti (inhalation time)
0.70 s
0.10 – 3.00 s
The inhalation time can be
limited by the frequency
value.
Resp. frequency
20 rpm
1 – 100 rpm
The frequency can be limited by the inhalation time.
Inh. Sensitivity
-2 cmH2O
-0.5 – 20 cmH2O
O2 Concentration
50
-
Same value as in
PCV mode
Same range as in
PCV mode
Upload time
Flow sensitivity not
enabled.
This parameter cannot be
modified.
WARNING
• If the Emergency Ventilation is activated, provide
the patient with an alternative ventilation mechanism and find out the cause of this event. If it has
been activated because of a delay in the acceptance of the first initial calibration screen, restart
the equipment to ventilate the patient.
• SAFETY VALVE: it is located immediately before the patient output. It opens when
the pressure in the patient circuit reaches a value of 120 ± 5 cmH2O. The mixture
of gases goes to an internal collector and is expelled.
• INHALATION RELEASE VALVE (ANTI-ASPHYXIATION): this valve makes it possible to bring ambient air to the patient when the equipment is off or when the
respirator is not in operation.
• OPERATIONAL GAS RELEASE: the gases that can seep into the equipment are
recovered in a common collector and expelled.
• LACK OF COMPRESSED AIR PRESSURE: compressed air is used as a pneumatic circuit command gas. When it is missing, it can be replaced with oxygen. In
addition, when the equipment detects a lack of air, it automatically switches to a
100% O2 concentration.
2. 24
Technical specifications | GraphNet advance neo ts
• LACK OF OXYGEN PRESSURE: in this case, air replaces oxygen and the respirations are delivered with a 21% O2 concentration.
• AUTOMATIC ZERO: every 10 minutes or when the operator activates it (by pressing [Ctrl] + [Ctrl]) all pressure sensors are zeroed. This restarts the readings,
preventing possible offset errors in the measured pressures. During the first few
minutes of ventilation, the respirator can zero faster than indicated. For each zeroing, a message appears on the Icon and message bar indicating that this process is in progress.
• CIRCUIT PURGE: to prevent obstructions and moisture from moving into the
pressure sensors, air is injected through the patient circuit while the pressure
sensors are being zeroed.
• ALARM SYSTEM: GraphNet-neo has an alarm system to warn of situations that
involve some degree of risk to the patient or to the equipment itself. Some make
it possible to keep the condition from which it originated from continuing, others
simply trigger signals to report its presence. For further information about how the
alarm system works, see the Alarms chapter.
• PARAMETER ADJUSTMENT: to avoid unnoticed parameter changes, it is necessary to execute sequences established on the respirator controls. This way,
pressing a single key or the dial does not result in changes being entered. For
this reason, the operator is always aware of the actions performed on the equipment.
2.2.14 | Pneumatic Circuit
Respirator
Fig. 2.2-1 Simplified pneumatic circuit respirator diagram.
Fig. references 2.2-1
A
High pressure sector
Technical specifications | GraphNet advance neo ts
2. 25
2. 26
B
Low pressure sector
1
Oxygen input.
2
Air input.
3
Filter.
4
High pressure sensors.
5
Pressure regulation stage.
6
Proportional solenoid valves.
7
Flow sensor.
8
O2 sensor.
9
Safety valve.
10
Inhalation release valve (anti-suffocation).
11
Nebulizer (optional).
12
‘Toward Patient’ Output.
13
Low pressure sensor.
14
Exhalation set (valve and pneumotacograph exhalation).
15
Cycling valve.
16
PEEP proportional solenoid valve.
Technical specifications | GraphNet advance neo ts
Chapter contents
2.3 Technical specifications GraphNet ts
2.3.1
Classification
2.3.2
Physical characteristics
2.3.3
Screen
2.3.4
Environmental requirements
2.3.5
Pneumatic specifications
2.3.6
Electrical specifications
2.3.7
Ventilatory parameter adjustment
2.3.8
Monitored parameters
2.3.9
Alarm adjustment
2.3.10
Obtaining control and monitoring data
2.3.11
Electromagnetic compatibility
2.3.12
Basic respirator operation
2.3.13
Safety mechanisms
2.3.14
Pneumatic circuit respirator diagram
Technical specifications | GraphNet advance neo ts
2. 27
Note
• If necessary, TECME will provide technical information
for the equipment (such as descriptions, diagrams, calibration instructions, etc.) to help qualified technical staff
repair parts defined as repairable by the manufacturer.
2.3.1 | Classification
Table 2.3-1 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)
IP Protection
IPX1
Operational Mode
Continuous Operation (IEC 60601-1)
2.3.2 | Physical Characteristics
Table 2.3-2 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)
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)
2.3.3 | Screen
Table 2.3-3 Screen
Type
Resistive sensitive touch screen / color TFT-LCD
Size
12.1”
Resolution
800x600
2.3.4 | Environmental
Requirements
2.3.5 | Pneumatic
Specifications
2. 28
Table 2.3-4 Environmental Requirements
Temperature
Ambient pressure
Humidity
Operation
15 °C – 35 °C
560 – 1030 hPa
15 - 95% non-condensing
Storage
-5 °C – 70 °C
500 – 1060 hPa
< 95% non-condensing
Table 2.3-5 Pneumatic specifications
Supply gases
Medical grade air and oxygen.
Minimum supply pressure
3.5 kg/cm2 (343.2 kPa – 50 psi).
Maximum supply pressure
7.0 kg/cm2 (686.4 kPa – 100 psi).
Maximum limited pressure (release valve)
120 ± 5 cmH2O.
Intake flow (gas source)
180 L/min (120 L/min air compressor).
Peak flow supplied by the respirator.
0.2 – 180 L/min.
Maximum resulting minute volume
ADL: 130 L/min.
PED: 40 L/min.
NEO-INF: 17 L/min.
(Respirator) internal complacency
0.16 L/cmH2O.
Respirator connectors for gas supply
Air: DISS 3/4” – 16 male connector. Oxygen:
DISS 9/16” – 18 male connector.
Hose connectors for gas supply
Air: DISS 3/4” – 16 female connector (both
ends). Oxygen: DISS 9/16” – 18 female connector (both ends).
Technical specifications | GraphNet advance neo ts
2.3.6 | Electrical Specifications
Table 2.3-6 Electrical specifications
Main feed
Voltage: 100 – 240 V (automatic switch).
Frequency: 50 – 60 Hz.
Maximum consumption: 0.5 A to 110 V – 0.3 A to 220 V.
Internal battery
Voltage: 11.1 V (continuous).
Electric charge: 7.8 Ah (automatic recharge).
Autonomy: 2.5 hours (approximately) Data obtained for
ADL category patient, VCV mode, with default parameter
values.
Fuses
F2L250V (250 V / 2 A – 0.5 mm x 20 mm).
Connectivity
RS-232C.
NOTE
• When the respirator is fed from the internal battery, it
has the same operational capacity as when it is fed
from the power grid through the main feed cable.
2.3.7 | Ventilatory Parameter
Adjustment
Table 2.3-7 Ventilatory parameters adjustment
Parameter
Range
Tidal Volume (L)
ADL: 0,050 - 2,500
PED: 0,020 - 0,300
NEO-INF: 0,005 0,150
Minute Volume
(MMV + PSV setting)
(4) (L/min)
ADL: 1 - 50
PED: 1 - 50
NEO-INF: N/A
Controlled
pressure (PCV)
(cmH2O)
Support pressure
(PSV) (cmH2O)
Increments(1)
Initial value
ADL: 0,010*
PED: 0,001*
NEO-INF: 0,001*
ADL: 0,402(2)
PED: 0,051(2)
NEO-INF: 0,009(2)
0,100
ADL: 6,0
PED: 4,0
NEO-INF: N/A
PCV + PEEP = 2 - 100
1
ADL: 15
PED: 8
NEO-INF: 8
PSV + PEEP = 0 - 100
1
ADL: 5
PED: 5
NEO-INF: 5
PEEP/CPAP
(cmH2O)
0 - 50
1
ADL: 5(3)
PED: 5(3)
NEO-INF: 3(3)
Limited pressure
(in TCPL – NEOINF) (cmH2O)
3 - 70
1
10
Continuous TCPL
flow (L/min)
2 - 40
1
8
Inspiratory time
(s) (in assist/control
modes)
0,1 - 10
0,01*
Inspiratory time
(s) (APRV)
Ti high 0.5 – 30
Ti low 0.2 – 30
0,01*
5.0
1.5
I:E Ratio
5:1 – 1:599
(in assist/control modes)
150:1 – 1:60 (APRV)
0,1:0,1
Results of the inspiratory time and the
initial rate.
Respiratory rate
(rpm)
ADL: 1 - 100.
PED and NEO-INF:
1 - 150.
1
ADL: 1,0(3)
PED: 0,6(3)
NEO-INF: 0,5(3)
ADL: 12(3)
PED: 25(3)
NEO-INF: 30(3)
Oxygen (concentration) (%)
21 - 100
1*
50
Inspiration Detection (Flow = L/min;
Pressure = cmH2O)
Triggering by flow:
0.2 – 15
Triggering by pressure:
-0.5 a –20
By flow: 0.1/0.5/1
according to the
detection value.
ADL: Flow = 3; Pressure = -1.5 PED: Flow
= 3; Pressure = -1.5
NEO-INF: Flow = 1;
Pressure= -1.5
By pressure: 0.5
Technical specifications | GraphNet advance neo ts
2. 29
Expiratory detection (for modes with
PSV)
5% - 80% of the peak
flow
5%
25%
Programmable
inspiratory pause
(in VCV) (s)
0–1
0,25
0 (NO)
Manual inspiratory pause (s)
7 (maximum)
N/A
N/A
Manual expiratory
pause (s)
20 (maximum)
N/A
N/A
Sighs (in VCV)
Inspiratory flow
waveform
No. of sighs: 1/2/3
No. of sighs: 1.
Rate: 5/10/15/20 per
hour
Rate: 5 per hour
Added volume: +0.1VT
– +1.0VT (The volume
is added to the configured VT)
Added volume:
+30% (+0.3VT).
N/A
Activated: No
Descending and constant ramp (rectangular)
N/A
Leakage compensation in NIV (L/min)
Non adjustable
N/A
Leakage compensation for the rest
of the modes (L/
min)
Non adjustable.
N/A
Descending ramp
ADL: up to 50
PED: up to 30
ADL: up to 15
PED: up to 15
NEO-INF: up to 10
(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 according to the parameter in question.
(2) Initial factory values. By modifying mL/kg in setting IBW-based VT, these values may
change (see chapter Initial Verification and Calibration).
(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.
(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 17-5).
2.3.8 | Monitored Parameters
Table 2.3-8 Monitored parameters
Parameter
2. 30
Precision
Peak pressure
±2 cmH2O or ±10%
Plateau Pressure
±2 cmH2O or ±10%
Medium pressure
±2 cmH2O or ±10%
Baseline pressure
±2 cmH2O or ±10%
Exhaled tidal volume
±10% if VT < 20 mL; ±2 mL + 10% if VT > 20 mL
Minute volume
±10%
Inhalation flow
±10%
Respiratory frequency
±1 rpm
Inhalation time
±0.06 s
Exhalation time
±0.06 s
I:E Ratio
NA
O2 Concentration
±3%
Technical specifications | GraphNet advance neo ts
2.3.9 | Alarm Adjustment
Table 2.3-9 Alarm Adjustment
Alarm
Limits
Increment
Initial Value
Maximum inspiratory pressure
(cmH2O)
10 (or >min - 120)
1
ADL: 40
PED: 30
NEO-INF: 25
Minimum inspiratory pressure
(cmH2O)
1 - 99 (or <max)
1
ADL: 5
PED: 5
NEO-INF: 2
Maximum tidal
volume(2) (L)
ADL: >VTmin - 3,0
PED: >VTmin - 0.500
NEO-INF: >VTmin 0,250
ADL: 0,010(2)
PED: 0,005(1)
NEO-INF: 0,005(1)
ADL: 0,600
PED: 0,075
NEO-INF: 0,015
Minimum tidal
volume(2) (L)
ADL: 0 to <VTmax
PED: 0 to <VTmax
NEO-INF: 0 to <VTmax
ADL: 0,010 (2)
PED: 0,001 (1)
NEO-INF: 0,001 (1)
ADL: 0,150
PED: 0,025
NEO-INF: 0,005
Maximum minute
volume (expired) (4)
(L/min)
ADL: >VMmin - 55
PED: >VMmin - 55
NEO-INF: >VMmin
- 55
0,01/ 0,05/ 0,1/ 0,5/
1,0 according to the
alarm limit value
ADL: 7,23 (9,0 en
MMV+PSV)
PED: 1,91 (6,0 en
MMV+PSV)
NEO-INF: 0,40
Minimum minute
volume (expired)(4)
(L/min)
ADL: 0 to <VMmax
PED: 0 to <VMmax
NEO-INF: 0 to <VMmax
0,01/ 0,05 /0,1 /0,5/
1,0 according to the
alarm limit value
ADL: 2,41 (4,5 in
MMV+PSV)
PED: 0,63 (3,0 in
MMV+PSV)
NEO-INF: 0,13
Concentration of
O2 (%)
High: 25 – 110
Low: 19 – 95
1
Inadequate oxygen
(%)
18 or less (not configurable)
N/A
N/A
Disconnection
N/A (not configurable)
N/A
N/A
Leakage out of
range (L/min)
N/A (not configurable)
N/A
Apnea (s)
5 - 60
5
15
Low PEEP (cmH2O)
0-6
2
ADL/PED/NEOINF: 2
Maximum respiratory rate (rpm)
3 - 160
1
ADL/PED: 30
NEO-INF: 40
High: 60
Low: 40
ADL: 50(3)
PED: 30(3)
NEO-INF: 10
Continuous high
pressure
Alarm condition: 5 cmH2O above the configured PEEP level for
over 15 s. Not configurable.
External power
failure
Not configurable. Whatever the cause of the event may be, the
ventilator automatically switches to battery operation.
Dead battery
Null or very low charge level. Replace by an alternative respiratory
method. Not configurable.
Inop. Vent.
When the operation of the ventilator is suspended, replace by an
alternative ventilatory method. Not configurable.
Blower failure
Not configurable. Alarm signals are triggered when excessive
power consumption by the blower is detected (caused by increased 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.
Technical specifications | GraphNet advance neo ts
2. 31
2.3.10 | Obtaining Control and
Monitoring Data
Table 2.3-10 Obtaining control and monitoring data
Parameter
Method
Variables involved
Precision
Pressure
Relative pressure transducers
Control, support and monitored pressures
±2 cmH2O
Controlled
flow
Mesh pneumotacograph related to differential pressure
transducers.
Continuous flow, controlled
volume generation flow.
±10%
Monitored flow
Variable opening pneumotacograph related to
the pressure differential
transducer.
Graphs and monitored
flows and exhaled volumes.
±10%
Volume
It is derived from the pertinent flow measurements.
Controlled, monitored and
graphed volumes.
±10%
Time
Quartz crystal.
Inhalation and exhalation
times, respiratory frequency and I:E ratio. Internal
clock.
±0.06 s
± 1 rpm
O2 Concentration
Galvanic cell.
O2 Concentration
±3% Vol.
2.3.11 | Electromagnetic
Compatibility
2.3.11.1 | Manufacturer’s
statement: Electromagnetic
emissions
WARNING
• The replacement of (main feed or internal wired)
equipment cables by others not approved by
TECME S.A. may result in a decrease in immunity or an increase in the emissions indicated for
GraphNet ts
Table 2.3-11 Electromagnetic emission statement
GraphNet ts is intended to be used in the specified electromagnetic environment. The
GraphNet ts client and/or user must make sure that it is used in an electromagnetic environment like the one indicated in this Table.
Emission test
2. 32
Compliance
Electromagnetic environment
RF CISPR 11
emissions
Group I
GraphNet ts uses RF power only for internal operation. Therefore, RF emissions are very low and
it is unlikely that they cause any interference in
nearby electronic equipment.
RF CISPR 11
emissions
Class A
Harmonic IEC
61000-3-2 emissions
Class A
Voltage fluctuations / non-continuous IEC 610003-3 emissions
Per specifications
Technical specifications | GraphNet advance neo ts
GraphNet ts can be used in all establishments except for residential establishments and those that
are directly connected to the low voltage public
power supply grid that feeds buildings used for
residential purposes.
2.3.11.2 | Manufacturer’s
statement: Electromagnetic
immunity
Table 2.3-12 Electromagnetic immunity statement
GraphNet ts is intended to be used in the specified electromagnetic environment. The
GraphNet ts client and/or user must make sure that it is used in an electromagnetic environment like the one indicated in this Table.
Immunity test
IEC 60601-1-2
testing level
Compliance level
Electromagnetic environment
(ESD) IEC
610000-4-4
electrostatic
discharge
Contact: ± 6 kV.
Air: ± 8 kV.
Contact: ± 6 kV.
Air: ± 8 kV.
The floors must be made
out of wood, concrete
or ceramic tile. If the
floors are covered with
a synthetic material, the
relative humidity must be
at least 30%.
Fast power
transients in
IEC 61000-4-4
bursts
± 2 kV for feed lines.
± 1 kV for intake/
outtake lines.
± 2 kV for feed
lines.
± 1 kV for intake/
outtake lines.
The quality of the power
network must be equivalent to that of a typical
commercial or hospital
environment.
IEC 61000-4-5
shock waves
Differential mode:
±1 kV.
Common mode: ±
2 kV.
Differential mode:
±1 kV.
Common mode: ±
2 kV.
The quality of the power
network must be equivalent to that of a typical
commercial or hospital
environment.
< 5% UT (drop >
95% of UT) for 0.5
cycles.
< 5% UT (drop >
95% of UT) for 0.5
cycles.
40% UT (drop of
60% of UT) for 5
cycles.
40% UT (drop of
60% of UT) for 5
cycles.
70% UT (drop of
30% of UT) for 25
cycles.
70% UT (drop of
30% of UT) for 25
cycles.
< 5% UT (drop >
95% of UT) for 5 s.
< 5% UT (drop >
95% of UT) for 5 s.
Voltage holes,
brief interruptions and voltage variations in
IEC 61000-4-11
power intake
lines
(50-60 Hz) IEC
61000-4-8 feed
frequency magnetic field
3 A/m.
3 A/m.
The quality of the power
network must be equivalent to that of a typical
commercial or hospital
environment. If the
GraphNet-ts user needs
operation to continue during power interruptions,
it is recommended that
the system be connected
to an uninterrupted feed
source or to a battery.
The feed frequency
magnetic field should
be characteristic of the
levels found in a typical
commercial or hospital
environment.
NOTE: UT is the CA network voltage before applying the testing level.
Technical specifications | GraphNet advance neo ts
2. 33
2.3.11.3 | Manufacturer’s
statement: Electromagnetic
immunity
Table 2.3-13 Electromagnetic immunity statement
GraphNet ts is intended to be used in the specified electromagnetic environment. The GraphNet user/client must make sure that it is used
in an electromagnetic environment like the one indicated in this Table.
Immunity test
IEC 60601 testing
level
Compliance
level
Electromagnetic environment
No RF mobile and/or portable communication equipment (including cables) must be used at a distance from GraphNet ts that is smaller than
the separation distance calculated with the equation that applies to the
transmitter frequency.
Recommended separation distance
Driven IEC 610004-6 RF
3 Vrms
150 kHz – 80 Mhz
outside of ISM(1)
bands.
10 Vrms
150 kHz – 80 Mhz
within ISM(1) bands.
Radiated IEC
61000-4-3 RF
10 V/m
80 MHz - 2,5 GHz
10 Vrms
d = 0,35 P
10 Vrms
d = 1,2 P
d = 1,2 P
for 80 MHz - 800 MHz
10 V/m
d = 2,3 P
for 800 MHz - 2,5 GHz
Where P is the maximum output of the transmitter in Watts (W) according
to the manufacturer and d is the recommended separation distance in
meters (m) (2).
The intensity of the fields generated by fixed transmitters, determined by
local electromagnetic tests(3) must be lower than the level of compliance
for each frequency range(4).
There may be interference near the equipment marked with the following
symbol:
NOTE 1
For 80 MHz and 800 MHz, the greater frequency range applies.
NOTE 2
This guide may not apply in all situations. The electromagnetic propagation is affected by absorption and reflexion from structures, objects
and individuals.
(1) ISM (industrial, scientific and medical) bands 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) The levels of compliance in ISM frequency bands between 150 kHz and 80 MHz and in the 80 MHz and 2.5 GHz frequency range have been
established to reduce the possibility that a portable/mobile communications device may cause interference if inadvertently introduced into the
patient’s area. For this reason, an additional factor of 10/3 has been included in the formula used to calculate the recommended separation distance for transmitters in those frequency ranges.
(3) The field intensities of fixed transmitters, such as radio telephone (portable or wireless) base stations and land mobile radios, HAM radios, AM
and FM and TV broadcasts cannot be precisely predicted theoretically. To find the value of the electromagnetic environment generated by fixed RF
transmitters, an onsite test must be conducted. If the measurement of the field intensity in the location where GraphNet-ts is being used exceeds
the above applicable RF compliance limits, GraphNet-ts must be evaluated to make sure that it can operate normally. If abnormal performance is
observed, it may be necessary to take additional measures, such as reorienting or relocating the equipment.
(4) In the 150 kHz and 80 MHz frequency range, the field intensity should be less than 10 V/m.
2. 34
Technical specifications | GraphNet advance neo ts
2.3.11.4 | Manufacturer’s
statement: Separation
distances
Table 2.3-14 Recommended separation distances between the respirator and
mobile/portable communication equipment
GraphNet ts is intended to be used in an electromagnetic environment where radiated RF
perturbances are controlled. The GraphNet ts client and/or user can help prevent electromagnetic interferences by maintaining a minimum distance between RF communications
equipment, mobile and portable (transmitters) and GraphNet ts as recommended in this
Table, based on the maximum output of the communications equipment.
Separation distance based on transmitter frequency (m)
150 kHz – 80
Mhz outside of
ISM bands.
150 kHz – 80
Mhz within ISM
bands.
d = 0,35 P
d = 1,2 P
0,01
0,04
0,1
0,11
Maximum
transmitter
output (W)
80 MHz - 800
MHz
800 MHz 2,5
GHz
d = 1,2 P
d = 1,2 P
0,12
0,12
0.23
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 is not in the above list, the recommended separation distance d in meters (m) can be determined by using the equation that applies to the
transmitter frequency, where P is the maximum transmitter output in Watts (W) according to
the transmitter manufacturer’s statement.
NOTE 1
For 80 MHz and 800 MHz, apply the separation distance for the larger frequency range.
NOTE 2
ISM (industrial, scientific and medical) bands 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 10/3 factor has been included in the formula used to calculate the separation
distance for transmitters that operate in the ISM frequency band between 150 kHz and 80
MHz and in the frequency range of 80 MHz to 2.5 GHz to reduce the likelihood that mobile
and/or portable communication equipment can cause interference if they are inadvertently
introduced in patient areas.
NOTE 4
These guides may not apply in all situations. The electromagnetic propagation is affected
by absorption and reflexion from structures, objects and individuals.
2.3.12 | Basic Respirator
Operation
GraphNet ts has a microprocessed control system that coordinates the tasks that
arise from programming the equipment. All the actions performed by the respirator
are commanded by this system.
The flow of gas received by the patient is administered by two proportional valves,
one for air, the other for oxygen. The valves operate simultaneously, providing the
appropriate oxygen concentration and the necessary flow wave characteristics.
The exhalation valve is controlled by two attached valves. One of them, with ON/
OFF features, tells it to open or close, which determines the end and the beginning of the inhalation phase, respectively. The other valve is proportional, and is in
charge of regulating the PEEP level when it is configured.
The microprocessor is re-fed with signals that come from the sensor system in the
respirator. This makes it possible to control and adjust the configured ventilatory
program. Airway pressure is measured with a transducer related to a sensor on
the end of the patient circuit (exhalation set). The signal that comes from this transducer is also used to trigger inhalations when the pressure sensitivity, respiration
cycling, alarm levels and others, are enabled. The proximal pressure is measured
Technical specifications | GraphNet advance neo ts
2. 35
with a transducer next to the patient output. The most relevant task of this item is
pressure control in pressure controlled or support pressure mode respirations.
Flow information is obtained through two differential pressure transducers related
to the internal output pneumotacograph and to the exhalation pneumotacograph.
The internal pneumotacograph (Silverman mesh type) makes it possible to control
the flows and volumes driven by the respirator in the inhalation phase. The exhaled
flows are measured through the exhalation pneumotacograph.
The equipment has a system of valves that allows for a communication route between the pressure transducers and the ambient pressure. This way, the transducers can be zeroed. Simultaneously, a flow of air is pushed through to purge the
exhalation pneumotacograph lines and prevent water and moisture from settling on
the measurement elements.
2.3.13 | Safety Mechanisms
GraphNet ts has a full safety system that includes the operational system that
controls the microprocessor and various components that act independently from
them.
• WATCHDOG: This is a system that monitors the operation of the electronic circuit
and exercises control independently from its integrity. When it detects an anomaly
in the operation of the respirator, it allows it to discontinue and activates an emergency ventilation mode, the Emergency Ventilation.
The Watchdog can activate the Emergency Ventilation in two different situations:
- After 30 s have elapsed since the respirator has been turned on, without selecting
a patient category, on the first initial calibration screen.
- When the microprocessor loses control of the program sequence regulating ventilation.
• EMERGENCY VENTILATION: the Emergency Ventilation is a safety mechanism
that is activated in extreme conditions to provide the patient with temporary ventilation until measures can be taken to replace the respirator with an alternative
ventilation mechanism. It is not a valid operational mode.
The Emergency Ventilation allows delivery of respirations with characteristics that
are similar to controlled pressure (PCV). During this event, only the peak pressure and the respiratory frequency are monitored. The predetermined values of
the ventilation parameters are indicated in Table 2.3-15. The alarm limits are not
enabled for modification. The active alarms are Maximum and minimum pressure, and maximum respiratory frequency, whose limits appear on screen. The only
enabled complementary function is Manual Insp.
2. 36
Technical specifications | GraphNet advance neo ts
Table 2.3-15 Ventilation parameters in Emergency Ventilation
Parameter
Initial value
Range
Observations
Controlled pressure (PCV)
10 cmH2O
2 – 30 cmH2O
The pressure is limited by
maximum alarm pressure
at 30 cmH2O. This limit
cannot be changed.
Ti (inhalation time)
0.70 s
0.10 – 3.00 s
The inhalation time can be
limited by the frequency
value.
Resp. frequency
20 rpm
1 – 100 rpm
The frequency can be limited by the inhalation time.
Inh. Sensitivity
-2 cmH2O
-0.5 – 20 cmH2O
O2 Concentration
50
-
Same value as in
PCV mode
Same range as in
PCV mode
Upload time
Flow sensitivity not
enabled.
This parameter cannot be
modified.
WARNING
• If the Emergency Ventilation is activated, provide
the patient with an alternative ventilation mechanism and find out the cause of this event. If it has
been activated because of a delay in the acceptance of the first initial calibration screen, restart
the equipment to ventilate the patient.
• SAFETY VALVE: it is located immediately before the patient output. It opens when
the pressure in the patient circuit reaches a value of 120 ± 5 cmH2O. The mixture
of gases goes to an internal collector and is expelled.
• INHALATION RELEASE VALVE (ANTI-ASPHYXIATION): this valve makes it possible to bring ambient air to the patient when the equipment is off or when the
respirator is not in operation.
• OPERATIONAL GAS RELEASE: the gases that can seep into the equipment are
recovered in a common collector and expelled.
• LACK OF COMPRESSED AIR PRESSURE: compressed air is used as a pneumatic circuit command gas. When it is missing, it can be replaced with oxygen. In
addition, when the equipment detects a lack of air, it automatically switches to a
100% O2 concentration.
• LACK OF OXYGEN PRESSURE: in this case, air replaces oxygen and the respirations are delivered with a 21% O2 concentration.
• AUTOMATIC ZERO: every 10 minutes or when the operator activates it (by pressing [Ctrl] + [Ctrl]) all pressure sensors are zeroed. This restarts the readings,
preventing possible offset errors in the measured pressures. During the first few
minutes of ventilation, the respirator can zero faster than indicated. For each zeroing, a message appears on the Icon and message bar indicating that this process is in progress.
•CIRCUIT PURGE: to prevent obstructions and moisture from moving into the
pressure sensors, air is injected through the patient circuit while the pressure
sensors are being zeroed.
Technical specifications | GraphNet advance neo ts
2. 37
• ALARM SYSTEM: GraphNet-ts has an alarm system to warn of situations that
involve some degree of risk to the patient or to the equipment itself. Some make
it possible to keep the condition from which it originated from continuing, others
simply trigger signals to report its presence. For further information about how the
alarm system works, see the Alarms chapter.
• PARAMETER ADJUSTMENT: to avoid unnoticed parameter changes, it is necessary to execute sequences established on the respirator controls. This way,
pressing a single key or the dial does not result in changes being entered. For
this reason, the operator is always aware of the actions performed on the equipment.
2.3.14 | Pneumatic Circuit
Respirator
Fig. 2.3-1 Simplified pneumatic circuit respirator diagram.
Fig. references Fig. 2.3-1
2. 38
A
High pressure sector
B
Low pressure sector
1
Oxygen input.
2
Air input.
3
Filter.
4
High pressure sensors.
5
Pressure regulation stage.
6
Proportional solenoid valves.
Technical specifications | GraphNet advance neo ts
7
Flow sensor.
8
O2 sensor.
9
Safety valve.
10
Inhalation release valve (anti-suffocation).
11
Nebulizer (optional).
12
‘Toward Patient’ Output.
13
Low pressure sensor.
14
Exhalation set (valve and pneumotacograph exhalation).
15
Cycling valve.
16
PEEP proportional solenoid valve.
Technical specifications | GraphNet advance neo ts
2. 39
This Page Left Intentionally Blank
2. 40
Technical specifications | GraphNet advance neo ts
3 Maintenance instructions
Chapter contents
3.1
Adv maintenance 5000 hours or 1 year.
3.2
Neo maintenance 5000 hours or 1 year.
3.3
Ts maintenance 5000 hours or 1 year.
3.4
Adv maintenance 10000 hours or 2 years.
3.5
Neo maintenance 10000 hours or 2 years.
3.6
Ts maintenance 10000 hours or 2 years.
Maintenance instructions | GraphNet advance neo ts
3. 1
This Page Left Intentionally Blank
3. 2
Maintenance instructions | GraphNet advance neo ts
3.1 | ADV Maintenance 5000
Hours or 1 Year.
Necessary items according to kit 1081 R1V
MAINTENANCE 5000 HOURS OR 1 YEAR.
ITEM
CODE
DESCRIPTION
NUMBER
1
3365A1V
Nv-GraphNet Exhalation Valve
1
2
2391M1V
Lock Joint
1
3
2726C1V
Teledyne Oxygen Sensor
1
Necessary tools
- 1.5 and 4 mm allen wrench.
- Electrical screw driver with 2.5 and 3 mm allen tips; and flat screwdriver tip.
- Electronic use pliers.
- Point tweezer.
- 5.5 mm tube wrench (for base plate bolt and attached source).
- Support wood (for front cabinet with multiple).
- 1/4” tube wrench (for multiple box screw).
- Antistatic strap.
- Precincts.
- 40w solderer (to solder internal oxygen cable ends).
- Tin.
Operation
Description
10
Externally cleaning and disinfecting the respirator with a quaternary
hydroalcoholic/ammonia cleaner (such as benzalconium chloride) with
a base solvent.
20
Evaluating the functional parameters of the equipment when it is brought
into Service, following the procedures outlined in CHAPTER VII.
30
Verifying internal subsystems per CHAPTER IV.
40
Removing the back cover and performing internal cleaning. Removing
dust and dirt. Cleaning the ventilator and electronic plates.
50
Verifying the condition of the auxiliary battery.
60
Verifying the condition of the porous metal filters and cleaning them.
70
Verifying the general condition of the internal tubes (general condition,
bending, pinching, water remnants, etc.)
80
Cleaning CPU plate, sensor plate and key plate internal contacts and
connections (using antistatic wrist strap in the process).
90
Verifying regulator pressure.
100
Verifying the correct operation of the air and oxygen proportional valves.
110
Verifying the correct operation of the antisuffocation valve and the safety valve.
120
Changing the oxygen sensor.
130
Changing the exhalation valve.
140
Changing the lock joint.
150
Completing equipment back cover sign. Completing history record.
Completing related documentation.
160
Calibrating the equipment per CHAPTER VII.
170
Performing a final check on the equipment per CHAPTER VIII.
Maintenance instructions | GraphNet advance neo ts
3. 3
3.2 | NEO Maintenance 5000
Hours or 1 Year.
Necessary items according to kit 1082 R1V
MAINTENANCE 5000 HOURS OR 1 YEAR.
ITEM
CODE
DESCRIPTION
NUMBER
1
3365A1V
Nv-GraphNet Exhalation Valve
1
2
2391M1V
Lock Joint
1
3
2726C1V
Teledyne Oxygen Sensor
1
Necessary tools.
- 1.5 And 4 mm allen wrench.
- Electrical screw driver with 2.5 And 3 mm allen tips; and flat screwdriver tip.
- Electronic use pliers.
- Point tweezer.
- 5.5 Mm tube wrench (for base plate bolt and attached source).
- Support wood (for front cabinet with multiple).
- 1/4” Tube wrench (for multiple box screw).
- Antistatic strap.
- Precincts.
- 40w solderer (to solder internal oxygen cable ends).
- Tin.
3. 4
Operation
Description
10
Externally cleaning and disinfecting the respirator with a quaternary
hydroalcoholic/ammonia cleaner (such as benzalconium chloride) with
a base solvent.
20
Evaluating the functional parameters of the equipment when it is brought
into Service, following the procedures outlined in CHAPTER VIII.
30
Verifying internal subsystems per CHAPTER IV.
40
Removing the back cover and performing internal cleaning. Removing
dust and dirt. Cleaning the ventilator and electronic plates.
50
Verifying the condition of the auxiliary battery.
60
Verifying the condition of the porous metal filters and cleaning them.
70
Verifying the general condition of the internal tubes (general condition,
bending, pinching, water remnants, etc.)
80
Cleaning CPU plate, sensor plate and key plate internal contacts and
connections (using antistatic wrist strap in the process).
90
Verifying regulator pressure.
100
Verifying the correct operation of the air and oxygen proportional valves.
110
Verifying the correct operation of the antisuffocation valve and the safety valve.
120
Changing the oxygen sensor.
130
Changing the exhalation valve.
140
Changing the lock joint.
150
Completing equipment back cover sign. Completing history record.
Completing related documentation.
160
Calibrating the equipment per CHAPTER VII.
170
Performing a final check on the equipment per CHAPTER VIII.
Maintenance instructions | GraphNet advance neo ts
3.3 | TS Maintenance 5000
Hours or 1 Year.
Necessary items according to kit 1083 R1V
MAINTENANCE 5000 HOURS OR 1 YEAR.
ITEM
CODE
DESCRIPTION
NUMBER
1
3365A1V
Nv-GraphNet Exhalation Valve
1
2
2391M1V
Lock Joint
1
3
2726C1V
Teledyne Oxygen Sensor
1
Necessary tools.
- 1.5 And 4 mm allen wrench.
- Electrical screw driver with 2.5 And 3 mm allen tips; and flat screwdriver tip.
- Electronic use pliers.
- Point tweezer.
- 5.5 Mm tube wrench (for base plate bolt and attached source).
- Support wood (for front cabinet with multiple).
- 1/4” Tube wrench (for multiple box screw).
- Antistatic strap.
- Precincts.
- 40w solderer (to solder internal oxygen cable ends).
- Tin.
Operation
Description
10
Externally cleaning and disinfecting the respirator with a quaternary
hydroalcoholic/ammonia cleaner (such as benzalconium chloride) with
a base solvent.
20
Evaluating the functional parameters of the equipment when it is brought
into Service, following the procedures outlined in CHAPTER VII.
30
Verifying internal subsystems per CHAPTER IV.
40
Removing the back cover and performing internal cleaning. Removing
dust and dirt. Cleaning the ventilator and electronic plates.
50
Verifying the condition of the auxiliary battery.
60
Verifying the condition of the porous metal filters and cleaning them.
70
Verifying the general condition of the internal tubes (general condition,
bending, pinching, water remnants, etc.)
80
Cleaning CPU plate, sensor plate and key plate internal contacts and
connections (using antistatic wrist strap in the process).
90
Verifying regulator pressure.
100
Verifying the correct operation of the air and oxygen proportional valves.
110
Verifying the correct operation of the antisuffocation valve and the safety valve.
120
Changing the oxygen sensor.
130
Changing the exhalation valve.
140
Changing the lock joint.
150
Completing equipment back cover sign. Completing history record.
Completing related documentation.
160
Calibrating the equipment per CHAPTER VII.
170
Performing a final check on the equipment per CHAPTER VIII.
Maintenance instructions | GraphNet advance neo ts
3. 5
3.4 | ADV Maintenance 10000
Hours or 2 Years.
Necessary items according to kit 1081R2V
MAINTENANCE 10000 HOURS OR 2 YEARS.
ITEM
CODE
DESCRIPTION
NUMBER
1
1081 R1V
Maintenance Kit for 5000 Hours or 1 year
1
2
3309 E1V
10.8v 4.4ah Lithium-Ion Battery
1
3
2330 A1V
Full Ventilator
1
4
2453 A1V
Full Pneumotacograph Mesh Holder
2
Necessary tools.
- 1.5 And 4 mm allen wrench.
- Electrical screw driver with 2.5 And 3 mm allen tips; and flat screwdriver tip.
- Electronic use pliers.
- Point tweezer.
- 5.5 Mm tube wrench (for base plate bolt and attached source).
- Support wood (for front cabinet with multiple).
- 1/4” Tube wrench (for multiple box screw).
- Antistatic strap.
- Precincts.
- 40w solderer (to solder internal oxygen cable ends).
- Tin.
3. 6
Operation
Description
10
Externally cleaning and disinfecting the respirator with a quaternary
hydroalcoholic/ammonia cleaner (such as benzalconium chloride) with
a base solvent.
20
Evaluating the functional parameters of the equipment when it is brought
into Service, following the procedures outlined in CHAPTER VII.
30
Verifying internal subsystems per CHAPTER IV.
40
Removing the back cover and performing internal cleaning. Removing
dust and dirt. Cleaning electronic plates.
50
Verifying the condition of the porous metal filters and cleaning them.
60
Verifying the general condition of the internal tubes (general condition,
bending, pinching, water remnants, etc.)
70
Cleaning CPU plate, sensor plate and key plate internal contacts and
connections (using antistatic wrist strap in the process).
80
Verifying regulator pressure.
90
Verifying the correct operation of the air and oxygen proportional valves.
100
Verifying the correct operation of the antisuffocation valve and the safety valve.
110
Changing the oxygen sensor.
120
Changing the fan.
130
Changing the battery.
140
Changing the lock joint.
150
Changing the exhalation valve.
160
Changing the pneumotacograph mesh holders.
170
Completing equipment back cover sign. Completing history record.
Completing related documentation.
180
Calibrating the equipment per CHAPTER VII.
190
Performing a final check on the equipment per CHAPTER VIII.
Maintenance instructions | GraphNet advance neo ts
3.5 | NEO Maintenance 10000
Hours or 2 Years.
Necessary items according to kit 1082R2V
FOR 10000 HOURS OR 2 YEAR MAINTENANCE.
ITEM
CODE
DESCRIPTION
NUMBER
1
1082 R1V
Maintenance Kit for 5000 Hours or 1 year
1
2
3309 E1V
10.8v 4.4ah Lithium-Ion Battery
1
3
2330 A1V
Full Ventilator
1
3
3975 A1V
Full Neo Pneumotacograph Mesh Holder
2
Necessary tools.
- 1.5 And 4 mm allen wrench.
- Electrical screw driver with 2.5 And 3 mm allen tips; and flat screwdriver tip.
- Electronic use pliers.
- Point tweezer.
- 5.5 Mm tube wrench (for base plate bolt and attached source).
- Support wood (for front cabinet with multiple).
- 1/4” Tube wrench (for multiple box screw).
- Antistatic strap.
- Precincts.
- 40w solderer (to solder internal oxygen cable ends).
- Tin.
Operation
Description
10
Externally cleaning and disinfecting the respirator with a quaternary
hydroalcoholic/ammonia cleaner (such as benzalconium chloride) with
a base solvent.
20
Evaluating the functional parameters of the equipment when it is brought
into Service, following the procedures outlined in CHAPTER VII.
30
Verifying internal subsystems per CHAPTER IV.
40
Removing the back cover and performing internal cleaning. Removing
dust and dirt. Cleaning electronic plates.
50
Verifying the condition of the porous metal filters and cleaning them.
60
Verifying the general condition of the internal tubes (general condition,
bending, pinching, water remnants, etc.)
70
Cleaning CPU plate, sensor plate and key plate internal contacts and
connections (using antistatic wrist strap in the process).
80
Verifying regulator pressure.
90
Verifying the correct operation of the air and oxygen proportional valves.
100
Verifying the correct operation of the antisuffocation valve and the safety valve.
110
Changing the oxygen sensor.
120
Changing the fan.
130
Changing the battery.
140
Changing the lock joint.
150
Changing the exhalation valve.
160
Changing the pneumotacograph mesh holders.
170
Completing equipment back cover sign. Completing history record.
Completing related documentation.
180
Calibrating the equipment per CHAPTER VII.
190
Performing a final check on the equipment per CHAPTER VIII.
Maintenance instructions | GraphNet advance neo ts
3. 7
3.6 | TS Maintenance 10000
Hours or 2 Years.
Necessary items according to kit 1083R2V
FOR 10000 HOURS OR 2 YEAR MAINTENANCE.
ITEM
CODE
DESCRIPTION
NUMBER
1
1083 R1V
Maintenance Kit for 5000 Hours or 1 year
1
2
3309 E1V
10.8v 4.4ah Lithium-Ion Battery
1
3
2330 A1V
Full Ventilator
1
4
2453 A1V
Full Pneumotacograph Mesh Holder
2
Necessary tools.
- 1.5 And 4 mm allen wrench.
- Electrical screw driver with 2.5 And 3 mm allen tips; and flat screwdriver tip.
- Electronic use pliers.
- Point tweezer.
- 5.5 Mm tube wrench (for base plate bolt and attached source).
- Support wood (for front cabinet with multiple).
- 1/4” Tube wrench (for multiple box screw).
- Antistatic strap.
- Precincts.
- 40w solderer (to solder internal oxygen cable ends).
- Tin.
3. 8
Operation
Description
10
Externally cleaning and disinfecting the respirator with a quaternary
hydroalcoholic/ammonia cleaner (such as benzalconium chloride) with
a base solvent.
20
Evaluating the functional parameters of the equipment when it is brought
into Service, following the procedures outlined in CHAPTER VII.
30
Verifying internal subsystems per CHAPTER IV.
40
Removing the back cover and performing internal cleaning. Removing
dust and dirt. Cleaning electronic plates.
50
Verifying the condition of the porous metal filters and cleaning them.
60
Verifying the general condition of the internal tubes (general condition,
bending, pinching, water remnants, etc.)
70
Cleaning CPU plate, sensor plate and key plate internal contacts and
connections (using antistatic wrist strap in the process).
80
Verifying regulator pressure.
90
Verifying the correct operation of the air and oxygen proportional valves.
100
Verifying the correct operation of the antisuffocation valve and the safety valve.
110
Changing the oxygen sensor.
120
Changing the fan.
130
Changing the battery.
140
Changing the lock joint.
150
Changing the exhalation valve.
160
Changing the pneumotacograph mesh holders.
170
Completing equipment back cover sign. Completing history record.
Completing related documentation.
180
Calibrating the equipment per CHAPTER VII.
190
Performing a final check on the equipment per CHAPTER VIII.
Maintenance instructions | GraphNet advance neo ts
4 Subsystem diagnosis
Chapter contents
4.1
Operations
Subsystem diagnosis | GraphNet advance neo ts
4. 1
This Page Left Intentionally Blank
4. 2
Subsystem diagnosis | GraphNet advance neo ts
4.1 | Operations
Operation
10
Description
With the Equipment off, verify:
1- The equipment must be plugged in and with the “110-220 VAC” on.
2- High pressure gas feed correctly connected.
3-Equipment output (P2, P1, nebulizer, Patient, etc.) must not have connected
hoses.
20
Start of the calibration process:
Keep the “ESC” key pressed and then turn on the equipment.
When the buzzer stops, release the “ESC” key.
The following screen will appear:
Enter the appropriate code. You will have up to three chances to enter the correct
code. Otherwise, the equipment will lock and it will be necessary to turn it off and
on again. Once the correct code has been entered, the following will appear on
the screen:
Press any key to access the CALIBRATION MENU.
Subsystem diagnosis | GraphNet advance neo ts
4. 3
30
Analogical entries
This menu has no data to calibrate.
This screen shows the digital values of the analogical entries (sensors),
Hours of use, condition of the fan, it opens valves and activates LED’s.
This screen performs the following controls:
- Turns on LED’s
Press the “LEDS” key to verify the LED operation. This verification will NOT turn
on the “110 – 220 VAC” and “Vent Inop” LED’s
- Key operation
Press each of the keys and check its sensitivity and on screen key number change.
- Internal Oxygen Sensor detection
Read on row 9:
40~60 (O2 cell typical values Teledyne class R17MED c/3 months of use)
70~90 (O2 cell typical values Analytical.3 PSE-11-917-J c/3 months of use )
4. 4
Subsystem diagnosis | GraphNet advance neo ts
40
- Verification of sensors and power (without gas feed and connected to 220V)
min
typical
max
Row 1
Air flow
200
240
280
Row 2
Oxygen flow
200
240
280
Row 3
Ctrl Pressure
1670
1800
1930
Row 4
Graf Pressure
400
480
550
Row 5
Exhalation flow
2050
2200
2350
Row 6
Air feed pressure
-
32
-
Row 7
Oxygen feed pressure
-
32
-
Check values
Make sure that the Ventilator is connected to the gas feed.
- Valve opening and total closing
-Air Valve:
Completely open and verify the presence of high flow in patient output.
- Oxygen valve:
Same as above
Subsystem diagnosis | GraphNet advance neo ts
4. 5
40 (cont.)
To enable valves, press the Dial and open completely by turning the Dial counterclockwise. “Esc” closes all valves and turns off the LED’s.
Return to the main menu with “Esc.”
- Antisuffocation valve:
Connect hose to patient output, completely CLOSE (Max val) the valve and aspirate. The circuit must remain airtight. Then, OPEN (0) the valve and aspirate
again. The circuit must permit the aspiration.
- PEEP valve:
Completely open and verify the presence of low flow through the exhalation
valve connector.
4. 6
Subsystem diagnosis | GraphNet advance neo ts
40 (cont.)
- Cycling valve:
Press “Cycling” and verify the presence of low flow through the exhalation valve
connector.
- Blowing valves
Press “Zero” and verify the presence of flow through P1 and P2 connectors.
- Safety valve Manually open the Valve. Drive the air from Analogical Entry Menu to 1 l/min
and connect the patient output equipment to the Master pressure Gauge pressure sensor. Check that the value of the pressure, once the circuit has stabilized, is 120 +/- 5 cmH2O. Press “Esc” twice to close the Valve. Drive and verify
that, for a period of 30” the pressure in the circuit is greater than 100 cmH2O.
/ REG /
- Fan failure
Insert a low hardness item and exert soft pressure on the fan through the grill
and make sure that the failure is detected on screen (Fan: Failure).
- Switch to battery
With the 220V feed on, press the “Charger” button and make sure that the “Battery/Charge” LED comes on and off.
Disconnect the 220V feed and verify that the equipment switches to Battery. The
“Battery/Charge” LED must come on Blue. Press “Charge” (Source: Bat), read
Value that does not exceed 10 or 15 pts. /depending on the battery charge when
the charge is enabled.
Subsystem diagnosis | GraphNet advance neo ts
4. 7
50
- Connect capnograph with equipment on
Press CAPNOGRAPH key and see if the sensor changes reading status:
Going from CAPNOGRAPHY ERROR to SENSOR OK
- Disconnect sensor
4. 8
Subsystem diagnosis | GraphNet advance neo ts
5 Disassembly
Chapter contents
5.1
Opening the equipment
Disassembly | GraphNet advance neo ts
5. 1
This Page Left Intentionally Blank
5. 2
Disassembly | GraphNet advance neo ts
5.1 | Opening the Equipment
Remove the back cover of the equipment by removing the eight 2.5 mm Allen
screws shown in the figure.
Back cover cable disconnection.
Lay the equipment down with the front down, on a foam surface.
Lift the back cover to disconnect the cables.
The cables that must be disconnected from the base plate are indicated on the label on the back cover. It must also be checked at the time of connecting the cables
and replacing the cover.
Cable connection information label
• Battery CON 27
• RS-232 CON 19
• Speaker
CON 18
• Fan CON 23
Disassembly | GraphNet advance neo ts
5. 3
Remove the six screws indicated in the figure below to separate the front cabinet
from the back cabinet. The front cabinet Allen screws are 3 mm, and the back cabinet screws are 2.5 mm on the upper part of the cabinet and 4 mm in the lower part,
between the two lower supports. Separate the two cabinets to disconnect power,
remove the lock joint.
Then, disconnect all cables that are plugged into the CPU plate and loosen the
3x0.5 bolts holding it (use antistatic protection). Remove the CPU plate, bringing
the plate toward you and then slide it up. Once out of place, disconnect the rest of
the cables in the lower part of the CPU.
5. 4
Disassembly | GraphNet advance neo ts
Remove the four Allen screws holding the upper part of the pneumatic box and
disconnect all the hoses that come from the multiple connector and the sensor
plate outputs.
Then, remove the source, first removing the shield. Then, disconnect the mass
cable and remove the screw holding it to the source support. Disconnect the plate
and slide it up. Finally, loosen the 4x0.7 bolt holding the support to the Multiple
connector and the front cabinet.
Disassembly | GraphNet advance neo ts
5. 5
Disconnect the Multiple connector set and remove all 4x0.7 bolts holding the lower
cabinet of the box to the cabinet and the Multiple connector. Once this task has
been completed, separate the front cabinet from the lower box cabinet.
Separate the Front Cabinet output Multiple connector by removing the four 4x0.7
holding it in place.
5. 6
Disassembly | GraphNet advance neo ts
Finally, remove the entire front panel of the cabinet, first removing the CPU shield
(disconnecting the upper alarm light cable) and then the ten Parker screws holding
it to the front cabinet.
Disassembly | GraphNet advance neo ts
5. 7
This Page Left Intentionally Blank
5. 8
Disassembly | GraphNet advance neo ts
6 Miscellaneous
Chapter contents
6.1
Air intake
6.2
Oxygen intake
6.3
GraphNet exhalation valve
6.4
Touch 10 PSI 0.7 Kg Regulator
6.5
2.8 Kg cm2 Air/oxygen regulator
6.6
Internal pneumotacograph
6.7
Full proportional valve
6.8
Safety valve
6.9
Anti air backup valve
6.10
Anti oxygen backup valve
6.11
Full antisuffocation valve
6.12
Complete gas control
6.13
Inner box with pneumatic set
6.14
Full touch exit multiple connector
6.15
Full touch panel
Miscellaneous | GraphNet advance neo ts
6. 1
This Page Left Intentionally Blank
6. 2
Miscellaneous | GraphNet advance neo ts
6.1 | Air Intake
Code: 2478 A1 V
Nº
Code
Designation
1
0659 M2 V
2
2206 C1 O
2-214 O-Ring
3
0206 C1 V
Porous Metal Filter
¾” Connector
4
1199 Q1 T
M4x0.7x10 Screw
5
2852 M1 V
Body of Entry of Driving Gas with 6 Openings
6
1781 D1 V
Body of Entry of Driving Gas
6.2 | Oxygen Intake
Code: 2479 A1 V
Nº
Code
1
0319 Q2 V
9/16” Connector
DESIGNATION
2
2206 C1 O
2-214 O-Ring
3
1199 Q1 T
M4x0.7x10 Screw
4
2852 M1 V
Body of Entry of Driving Gas With 6 Openings
5
0206 C1 V
Porous Metal Filter
6
1781 D1 V
Body of Entry of Driving Gas
Miscellaneous | GraphNet advance neo ts
6. 3
6.3 | GraphNet Exhalation
Valve
Code: 3346 A1 V
6. 4
Nº
Code
1
1227 C0 O
2-010 O-Ring
2
3249 M1 V
Exhalation Valve Cover
3
1111 G0 V
Exhalation Valve Diaphragm
4
3345 M1 V
Exhalation Valve Body
Miscellaneous | GraphNet advance neo ts
DESIGNATION
6.4 | 0.7kg Touch 10 PSI
Regulator
Code: 0554 A11V
Nº
Code
DESIGNATION
1
0491 M1 V
Regulator Cover
2
0480 M1 T
Regulator Spring Press Screw
3
0490 M13 V Regulator Body With 3 Sal. Core (1/8”-M5)
4
0226 M1 V
D.5 M5x0.8 Hose Coupling
5
0563 C0 T
M4x0.7x40 Allen Screw
6
0560 C0 O
4x10 mm Aluminum Flat D Washer
7
0253 C0 U
M4x0.7 Round Hexagonal Bolt
8
0217 C0 O
2-020 O-Ring
9
0475 M2 V
Regulator Plug
10
0281 C0 O
2-007 O-Ring
11
1147 M1 V
Spring Stop Guide Plate
12
1325 M1 V
8.2 D. Regulation Spring Conical Support
13
1324 M1 V
8.2 D. Regulation Spring Flat Support
14
0511 G0 V
Diaphragm
15
1141 M1 T
4x0.7x7 Round Head Screw
16
1140 M1 V
Mixing Diaphragm Fixing Plate
17
0476 M1 V
Regulator Mixer 1st Stage Rod
18
2628 M1 V
3.2 M5x0.8x4.5 D. Hose Connector
19
0477 M1 V
Regulator Mixer 1st Stage Seat
20
0483 M1 R
Regulation Spring
21
0484 M1 R
Cell And Regulator Spring
22
3926 1 V
Plastic Box Regulator Support
Miscellaneous | GraphNet advance neo ts
6. 5
6.5 | 2.8 Kg/cm2 Air/Oxygen
Regulator
AIR REGULATOR 2,8 Kg/cm2
OXYGEN REGULATOR 2,8 Kg/cm2
6. 6
Miscellaneous | GraphNet advance neo ts
Code: 0554 A6/A7 V
Nº
Code
DESIGNATION
1
0490 M14 V Regulator Body With Core
2
0491 M1 V
Regulator Cover
3
0480 M1 T
Regulator Spring Press Screw
4
0484 M1 R
Cell And Regulator Spring
5
0217 C0 O
2-020 O-Ring
6
0475 M2 V
Regulator Plug
7
0476 M1 V
Regulator Mixer 1st Stage Rod
8
0281 C0 O
2-007 O-Ring
9
0477 M1 V
Regulator Mixer 1st Stage Seat
10
1141 M1 T
4x0.7x7 Round Head Screw
11
0511 G0 V
Diaphragm
12
1140 M1 V
Mixing Diaphragm Fixing Plate
13
1147 M1 V
Spring Stop Guide Plate
14
0482 M1 V
Regulation Spring Flat Support
15
0483 M1 R
Regulation Spring
16
0481 M1 V
Regulation Spring Conical Support
17
0560 C0 O
4x10 Mm Aluminum Flat D Washer
18
0253 C0 U
M4x0.7 Round Hexagonal Bolt
19
0563 C0 T
M4x0.7x40 Allen Screw
20
2214 C1 V
1/8-6 Qsl Festo Connector
21
2628 M1 V
3.2 M5x0.8x4.5 D. Hose Connector
22
2776 M1 V
Pneumotacograph Connector
23
2722 C1 T
M4x0.7x45 Allen Screw
Miscellaneous | GraphNet advance neo ts
6. 7
6.6 | Internal
Pneumotacograph
Code: 2925 A1 V
Nº
Code
DESIGNATION
1
2772 M1 V
Pneumotacograph Body
2
2773 M1 V
Pneumotacograph Perforated Cover
3
2781 M1 V
Pneumotacograph Blind Cover
4
2770 C1 T
M3x0.5x8 Button Head Allen Screw
6.7 | Full Proportional
Valve
Code: 2545 A1 V
6. 8
Nº
Code
1
2530 M1 V
Proportional Valve Body
2
2538 A2 V
External Reelstand Tube
Miscellaneous | GraphNet advance neo ts
DESIGNATION
6.8 | Safety Valve
Code: 2493 A1 V
Nº
Code
DESIGNATION
1
2487 M1 V
Safety Valve Plug
2
2489 M1 R
Safety Valve Spring
3
2774 M1 V
Safety Valve Body
4
2488 I1 V
Safety Valve Spring Press
5
0515 C0 O
O´Ring 2-013
6.9 | Anti Air Backup Valve
Code: 2306 A1 V
Nº
Code
1
2138 M1 V
Line Directional Valve Body
DESIGNATION
2
2137 M1 V
Line Directional Valve Cover
3
0211 C0 O
2-009 O-Ring
4
2305 G1 V
Line Directional Valve Plug
Miscellaneous | GraphNet advance neo ts
6. 9
6.10 | Anti Oxygen Backup
Valve
Código: 2306 A2 V
Nº
CÓDIGO
DESIGNACIÓN
1
2138 M1 V
Cuerpo Válvula Direccional De Línea
2
2137 M1 V
Tapa Válvula Direccional De Línea
3
0211 C0 O
O´Ring 2-009
4
2305 G1 V
Obturador Válvula Direccional De Línea
5
2465 M1 R
Resorte Grueso Válvula Direccional
Code: 2306 A2 V
Nº
Code
1
2138 M1 V
Line Directional Valve Body
DESIGNATION
2
2137 M1 V
Line Directional Valve Cover
3
0211 C0 O
2-009 O-Ring
4
2305 G1 V
Line Directional Valve Plug
5
2465 M1 R
Directional Valve Thick Spring
6.11 | Full Antisuffocation
Valve
Code: 2454 A1 V
6. 10
Nº
Code
1
2496 I1 V
Antisuffocation Valve Cover
2
2495 A1 V
Antisuffocation Valve Body with Core
3
2710 A1 V
Antilock Valve Body
Miscellaneous | GraphNet advance neo ts
DESIGNATION
6.12 | Full Gas Control
Code: 2457 A1 V
Nº
Code
1
0554 A6 V
2.8 Kg/Cm2 Air Regulator
DESIGNATION
2
0554 A7 V
2.8 Kg/Cm2 Oxygen Regulator
3
2925 A1 V
Internal Pneumotacograph
4
2545 A1 V
Full Proportional Valve
5
2493 A1 V
Safety Valve
6
2454 A1 V
Full Antisuffocation Valve
Miscellaneous | GraphNet advance neo ts
6. 11
6.13 | Lower Box with
Pneumatic Set
Code: 3929 A1 V
6. 12
Nº
Code
1
3843 I1 V
DESIGNATION
Pneumatic Box Lower Casing
2
3403 A1 V
Net Box Proportional Valve Cable
3
2451 A1 V
Antisuffocation Intake
4
2478 A1 V
Air Intake
5
2479 A1 V
Oxygen Intake
6
3927 A1 V
Plastic Box Pneumatic Set
7
3852 A1 V
Proximal Switch Plate
8
1304 C0 T
4x0.7x12 Cc Screw
9
1314 C0 A
4 Mm Star Washer D.
Miscellaneous | GraphNet advance neo ts
6.14 | Full Touch Exit
Multiple Connector
Code: 3899 A2 V
Nº
Code
DESIGNATION
1
3899 M2 V
Touch Exit Multiple Connector
2
3353 M1 V
Exhalation Valve Socket Internal Cover
3
3920 A1 V
Proximal Sensor Tab
4
3172 M1 V
O2 Sensor Protector
5
2167 M1 U
Pneumotacograph Adjustment Bolt
6
2603 A2 V
GraphNet Output Connector W/Pin
7
3331 I1 V
GraphNet O2 Sensor Cable
8
3171 I1 V
O2 Sensor Protector Cover
9
2726 C1 V
Teledyne Oxygen Sensor
10
3352 I1 V
Exhalation Valve Socket Ring
11
2202 Q1 V
Pneumotacograph Fine Hose Connector
12
2204 Q1 V
Nebulizer Hose Connector
Miscellaneous | GraphNet advance neo ts
6. 13
6.15 | Full Touch Panel
Code: 3914 A1 V
6. 14
Nº
Code
1
3837 I1 V
Touch Graphnet Encoder Dial
DESIGNATION
2
3912 M1 U
Touch Keyboard Encoder Nut
3
3838 I1 V
Touch Net Encoder Dial Ring
4
3969 S1 P
English Advance Touch Plate
5
3906 M1 V
Touch Plate Adhesive Label
6
3905 E1 V
Ms50217 Touch Elo Resistant Glass
7
3903 M1 V
Touch Elo Resistant Glass Self-Adhesive Label (Short)
7
3904 M1 V
Touch Elo Resistant Glass Self-Adhesive Label (Long)
8
3917 I1 P
Touch Panel
9
3878 B1 V
Touch Keyboard Plate
10
2927 E1 V
GraphNet 12” Sharp Display
11
0251 C0 U
3x0.5 Hex Nut Red.
12
3907 M1 V
Feed Light Diffuser Mylar
12
3908 M1 V
Alarm Light Diffuser Mylar
13
3909 I1 V
Insertion Key
13
3911 I1 V
Diffuser Insertion Key
Miscellaneous | GraphNet advance neo ts
7 Calibration
Chapter contents
7.1
Necessary item and devices
7.2
Observations
7.3
Operations
Calibration | GraphNet advance neo ts
7. 1
This Page Left Intentionally Blank
7. 2
Calibration | GraphNet advance neo ts
7.1 | Necessary items and
devices
1 - Adult patient circuit, espiratory valve, patient circuit plug and “Y” connector.
Patient circuits assembly
First take two polysulfone connector (0707I3V) and glue them to the single use
patient circuit hoses (30cm x 22mm) using Methylene Chloride to seal the joint.
Then glue a “Y” connector to the other end of the hoses. This patient circuit should
be replaced every 6 months. See figure below:
2 - Adult / pediatric test lung 4138C1V
3 - Manovacuometer (EM).
4 - Standard flow and pressure gauge (EM).
5 - Oxygen sensor O2.
6- Bacteriological filter.
7- Pressure regulator 100 cm. H2O. DS-01
8- Air only inlet hose. DS-02
9- Nebulizer-Standard gauge fitting hose. DS-03
10- Pressure measurement hose. DS-04
11- Capnograph
12- Proximal sensor
7.2 | Observations
DS-01
DS-02
DS-03
DS-04.
- EM devices should be calibrated periodically.
- The air used must be free of oil, moisture and particles larger than 0.3 μm.
Calibration | GraphNet advance neo ts
7. 3
7.3 | Operation
operation
10
DESCRIPTION
With the Equipment off, verify:
1- The equipment must be plugged in and with the “110-220 VAC” on.
2- High pressure gas feed correctly connected.
3- Equipment output (P2, P1, nebulizer, Patient, etc.) must not have connected
hoses.
20
Start of the calibration process:
Keep the “ESC” key pressed and then turn on the equipment.
When the buzzer stops, release the “ESC” key.
The following screen will appear:
Enter the appropriate code. You will have up to three chances to enter the correct
code. Otherwise, the equipment will lock and it will be necessary to turn it off and
on again. Once the correct code has been entered, the following will appear on
the screen:
Press any key to access the CALIBRATION MENU.
7. 4
Calibration | GraphNet advance neo ts
30
Calibration and Configuration Menu:
The calibration and configuration menu shows on screen a list in the following
order:
You can enter each option through the touch screen interface or the encoder dial,
turning and pressing. To go back, press “ESC.”
40
Setting the clock:
To change the date and time values, select the appropriate field by turning the
dial and enable by pressing it.
To be changed, the enabled field turns pink, and the value is changed by turning
the dial.
Pressing the dial enters the values and disables the field.
Calibration | GraphNet advance neo ts
7. 5
40 (cont.)
Once all changes have been made in the date and time fields, press “MENU”
and the following will appear:
Select an appropriate option and confirm by pressing the dial.
Return to the main menu with “ESC.”
50
Ambient Pressure
Follow these steps:
Change the value with the dial: Depends on the area of residence.
7. 6
Calibration | GraphNet advance neo ts
50 (cont.)
Press “MENU” and the following will appear on screen:
Select an option and confirm by pressing the dial.
Return to the main menu with “ESC.”
60
Touch-screen Calibration
Follow these steps:
Then, follow the steps indicated on the screen.
Important: use only your fingers to touch the screen, do NOT use elements with
sharp edges.
Calibration | GraphNet advance neo ts
7. 7
70
Pressure Sensors.
Make sure the equipment has no intake gases.
The screen shows a list that corresponds to the minimum and maximum calibrated values for each sensor. These values correspond to the pressures indicated
in the table below:
80
90
SENSOR
MIN
MAX
Control Sensor
0
100 cmH2O
Graph Sensor
0
100 cmH2O
Air Sensor
0
5 kg/cm2 (71 PSI)
Oxygen Sensor
0
5 kg/cm2 (71 PSI)
Press the “Zero” key to zero the sensors.
The values in the left column (min) correspond to the sensor zero pressure values for low and high pressure.
Select the first field to record (PCtrl/min) and then press the dial to capture the
“0” value of that sensor. Repeat the procedure for the rest of the minimum values
(min).
100
Control sensor maximum value (PCtrl)
1-Connect the feed gases using the DS-02 device
2- Connect the Compound Gauge to the patient output. Generate pressure up to
90 cmH2O and control airtightness. Then record in the Calibration card. Remove
Compound Gauge.
3- Connect DS-01 device to respirator and Pattern pressure Gauge, as indicated
in the figure. Fig. 4. Turn on nebulizer and regulate the dial on the device until
the Pattern pressure analyzer indicates a value of 100 cm H2O.
4-Turning the Dial, select the appropriate field (PCtrl/max)
7. 8
Calibration | GraphNet advance neo ts
100 (cont.)
Fig. 4
5- Capture the value by pressing the Dial
110
Graph sensor maximum value (PGraf)
1- Turning the Dial, select the appropriate field (PGraf/max)
2- Capture the value by pressing the Dial using the 100 cm H2O reference pressure.
120
Maximum High Air Pressure sensor value
1- Turning the Dial clockwise, select the appropriate field (Air/max)
2- Make sure that it is connected to the 5 Kg./cm2 pressure line.( 71 psi ) at both
gas intakes through a “Y” connector (DS-02 device).
3- Capture the value by pressing the Dial.
130
Maximum High Oxygen Pressure sensor value
1- Turning the Dial clockwise, select the appropriate field (Oxygen/max)
2- Capture the value by pressing the Dial.
Calibration | GraphNet advance neo ts
7. 9
140
Connect the nebulizer output to the pattern flow gauge. Set the flow units in LPM
(liters per minute) and the measurement conditions in ATP (measurement at ambient pressure and temperature) with the DS-03 device. Fig. 3
Press the “Nebulizer” key and record the flow value for the instrument. This must
be between 7 and 9 LPM. Then record the value in the Calibration card.
150
Air Flow
To calibrate the air flow, follow these steps:
7. 10
Calibration | GraphNet advance neo ts
150 (cont.)
When you enter this menu for the first time after turning on the equipment, this
will appear on the screen:
Select the gas, Accept, and you will enter the next screen
If you must select the gas and the option of what gas to choose has not come
up, press the “Air” or “Oxygen” key. This will depend on which gas has been
selected before.
160
Connect the patient output equipment to a master flow gauge as shown in Fig.
1. Set the flow units in LPM (liters per minute), gas to be measured based on the
previous operation (OP 150) and the ATP measuring conditions (ambient pressure
and temperature measurement).
Make sure that the Ventilator is connected to the gas feed.
Calibration | GraphNet advance neo ts
7. 11
160 (cont.)
Fig. 1
170
7. 12
Initially, the target value “0” is selected, and, when the dial is pressed, it automatically moves on to the next target value (0, 5, 10 …. Up to 160 lt./min.)
Calibration | GraphNet advance neo ts
170 (cont.)
The valve opening bar becomes yellow, and the valve is opened by turning
the dial clockwise and closed by turning it counterclockwise. The “FINE” and
“THICK” keys change the opening speed
FINE
Slow opening 1 in 1
THICK
A Fast opening 10 in 10
If flow has to be calibrated for a GraphNet Neo Ventilator, the maximum flow tobe
calibrated is 40 LPM.
Curve to be calibrated in Neo:
Calibration | GraphNet advance neo ts
7. 13
180
When the value of the flow indicated by the external gauge is the same as the
selected target value, press the dial to record the value.
The curve changes with the new recorded value, and it automatically moves on
to the next target value.
190
Repeat those operations until all target values have been completed. Maximum
flow must reach 160Lpm for ADV and TS ventilators, and 50 Lpm for Neo ventilators.
200
Verify that the shape of the calibration curve is uniform and no uncalibrated values are left.
Press “MENU” and the following will appear on screen:
Select an option and confirm by pressing the dial.
Return to the main menu with “ESC.”
7. 14
Calibration | GraphNet advance neo ts
210
Oxygen Flow
Go through the same calibration steps as for Air Flow (OP 150 to OP 200).
220
Air Valve
To calibrate the air flow, follow these steps:
Calibration | GraphNet advance neo ts
7. 15
230
If the valve has not been previously calibrated, this curve will say:
If it has been previously calibrated, press “Menu.”
240
250
7. 16
Select calibrate and press the dial to start auto calibration.
Verify that the shape of the calibration curve is uniform and make sure that it has
reached 160 LPM. For GraphNet Neo make sure it has reached 50 Lpm
Calibration | GraphNet advance neo ts
260
Once the auto calibration has been completed, the following will appear:
Select an option and confirm by pressing the dial.
Return to the main menu with “Esc.”
270
Oxygen Valve
Go through the same calibration steps as for Air Flow (OP 220 to OP 260).
280
PEEP Valve
1-Connect full exhalation valve.
2-Connect patient circuit to plug. Fig. 6
3-Make sure that the Ventilator is connected to the gas feed.
Calibration | GraphNet advance neo ts
7. 17
Select the “Calibrate” option and confirm by pressing the Dial to start auto calibration
When auto calibration has been completed, select “Save”
Return to the main menu with “Esc.”
290
Distal
Use the same armed circuit as for the Peep calibration. Then, follow the following
images (NOTE: this calibration must only be performed if there is valve auto
calibration)
7. 18
Calibration | GraphNet advance neo ts
290 (cont.)
Then, if this has not been calibrated, this curve and caption will appear:
Turn the dial and select calibrate. Verify that the curve is uniform and that it reaches
120 LPM for the ADV and TS versions or 30 LPM for the Neo version, as shown in
the figure below.
Zero by pressing “Zero” Press the “menu” key and then select the “Calibrate
K” option. Confirm by pressing the dial; the Kdi value must be between 30 and
100
Calibration | GraphNet advance neo ts
7. 19
300
Proximal (ADV and NEO versions only)
Use the same armed circuit as for the previous calibration. Remove the plug and
position the proximal flow sensor with a 15-15 connector as shown in the figure
(with the proximal Sensor inverted) and connect the other end of the Proximal
Sensor to the Multiple connector of the Ventilator. Then follow the following instructions:
7. 20
Calibration | GraphNet advance neo ts
300 (cont.)
Then, if this has not been calibrated, this curve and caption will appear:
Turn the dial and select calibrate. Verify that the curve is uniform and that it reaches20 LPM, as shown in the figure below.
Calibration | GraphNet advance neo ts
7. 21
300 (cont.)
Zero by pressing “Zero.” Cover the end of the proximal sensor. Press the “Menu”
key and then select the “Calibrate K” option. Confirm by pressing the dial. The Kes.
value must be between 20 and 70.
Return to the main menu with “Esc.”
310
Pneumotacograph Compensation
Use the same calibration device as for PEEP (Fig. 6)
1- Press “Menu” and select “Calibrate”
Select the option and confirm by pressing the Dial to start auto calibration
When auto calibration has been completed, select “Save”
Return to the main menu with “Esc.”
7. 22
Calibration | GraphNet advance neo ts
320
Analogical entries
This menu has no data to calibrate.
This screen shows the digital values of the analogical entries (sensors), Hours of
use, condition of the fan, it opens valves and activates LED’s.
This screen performs the following controls:
-Turns on LED’s
Press the “LEDS” key to verify the LED operation. This verification will NOT turn
on the “110 – 220 VAC” and “Vent Inop” LED’s
- Key operation
Press each of the keys and verify their sensitivity and key number change on
screen.
- Internal Oxygen Sensor detection
Read on row 9:
40~60 (O2 cell typical values Teledyne class R17MED c/3 months of use)
70~90 (O2 cell typical values Analytical.3 PSE-11-917-J c/3 months of use)
Calibration | GraphNet advance neo ts
7. 23
330
- Verification of sensors and power (without gas feed and connected to 220V)
MÍN
TÍPICO
MÁX
Row 1 Air flow
200
240
280
Row 2 Oxygen flow
200
240
280
Row 3 Ctrl Pressure
1670
1800
1930
Row 4 Graf Pressure
400
480
550
Row 5 Exhalation flow
2050
2200
2350
Row 6 Air feed pressure
30
32
34
Row 7 Oxygen feed pressure
30
32
34
Check values
Make sure that the Ventilator is connected to the gas feed.
- Valve opening and total closing
- Air Valve:
Completely open and verify the presence of high flow in patient output.
-Oxygen valve:
Same as above.
7. 24
Calibration | GraphNet advance neo ts
330 (cont.)
To enable valves, press the Dial and open completely by turning the Dial counterclockwise. “Esc” closes all valves and turns off the LED’s.
Return to the main menu with “Esc.”
-Antisuffocation valve:
Connect hose to patient output, completely CLOSE (Max val) the valve and aspirate. The circuit must remain airtight. Then, OPEN (0) the valve and aspirate
again. The circuit must permit the aspiration.
- PEEP valve:
Completely open and verify the presence of low flow through the exhalation
valve connector.
- Cycling valve:
Press “Cycling” and verify the presence of low flow through the exhalation
valve connector.
- Blowing valves
Press “Zero” and verify the presence of flow through P1 and P2 connectors.
Calibration | GraphNet advance neo ts
7. 25
330 (cont.)
- Safety valve
Connect DS-04 with a plug to the circuit like shown in the figure below. Manually
open to 1 Lpm the air proportional valve in the Analogical Entry Menu. Once the
circuit has stabilized check that the value of pressure is 120+/- 5 cmH2O.
- Fan failure
Insert a low hardness element and exert soft pressure on the ventilator through
the grill and verify that the failure is being detected on the screen (Fan:
Failure).
- Switch to battery
With the 220V feed on, press the “Charger” button and make sure that the
“Battery/Charge” LED comes on and off.
Disconnect the 220V feed and verify that the equipment switches to Battery.
The “Battery/Charge” LED must come on Blue. Press “Charge” (Source:
Bat), read Value that does not exceed 10 or 15 pts. /depending on the battery
charge when the charge is enabled.
7. 26
Calibration | GraphNet advance neo ts
340
- Connect capnograph with equipment on
- Press CAPNOGRAPH key and see if the sensor changes reading status:
Going from CAPNOGRAPHY ERROR to SENSOR OK
- Disconnect sensor
350
Turn on the ventilator and set the following parameters for a 24 hour cycling
period:
Vt= 200ml
F= 5
Peep= 5
Sensitivity= 0,5 cmH2O
360
Battery autonomy test
Once the ventilator is running, check the “Charging” led is off and the battery
status indicator shows full.
Disconnect the ventilator from the 220V power supply and check the correct performance with default parameters for 2,5 hours (minimum). If the performance is
correct, reconnect the equipment to the main power supply.
370
Once the battery test is complete, keep the ventilator running for 24hs. Then Final
Control must be done.
Calibration | GraphNet advance neo ts
7. 27
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7. 28
Calibration | GraphNet advance neo ts
8 Final Control
Chapter contents
8.1
Necessary items
8.2
Observations
8.3
Operations
Final Control | GraphNet advance neo ts
8. 1
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8. 2
Final Control | GraphNet advance neo ts
8.1 | Necessary Items
1 - Patient circuits:
Adult/pediatric patient circuit with espiratory valve, “Y” connector and plug.
Neonatal patient circuit with espiratory valve, “Y” connector and plug.
2 - Test lungs:
Adult/pediatric test lung 4138C1V
Neonatal test lung 4139C1V
3 - Standard flow and pressure gauge (EM).
4 - Bacteriological filter
5 - Oxygen sensor.
6 - Capnography sensor (only for Advance)
7 - Proximal sensor (only for Advance and Neo)
8 - Air and oxygen inlet hoses
9 - Pressure measurement hose DS-04
8.2 | Observations
- Pressure measurements must be taken at the patient connection “Y” coupling.
- After changing the respirator parameters and before taking the measurement, a
stabilization period must be of at least 10 respirations.
- The encoding dial is used to select and change parameters. Turning the dial selects and pressing it confirms selection.
- The instructions give details about the values that are expected in the measurements in order to create the final control approval criterion.
- EM devices should be calibrated periodically.
-The air used must be free of oil, moisture and particles larger than 0.3 μm.
Final Control | GraphNet advance neo ts
8. 3
8.3 | Operations
OPERATION
10
DESCRIPTION
- Before Final Control we must check: 24 hour cycling period, battery status and
Tidal volume, respiratory frequency and PEEP trends.
- Cycling hours:
Press Menu and follow these steps:
Time of use should be greater than 24 hours. Press Reset to return to the main
screen.
- Battery:
Battery charging led should be off and battery icon status must show full charge.
- Tidal volume, Respiratory frequency and PEEP trends.
Press Menu and follow these steps:
Check trends curves linearity and selected value average.
8. 4
Final Control | GraphNet advance neo ts
20
30
40
- After the 24 hours cycling period, turn off the ventilator, wait for one hour and turn
on the equipment for the final control.
- On the patient category screen, select adult patient “ADL” and confirm. Select
continue and confirm by pressing the dial. For GraphNet Ts, only “ADL” and
“PED” categories will appear. For GraphNet Neo start at OP 230.
-- Connect the standard flow and pressure gauge to the bacteriological filter at the
patient output, then the oxygen sensor connector. Connect the Adult/pediatric
patient circuit, then the DS-04 device between the +P inlet from the gauge and
the “Y” connector with plug.
Adult/pediatric patient circuit
Adult pediatric test lung 4138C1V
Final Control | GraphNet advance neo ts
8. 5
50
- After selecting the adult category, the calibration screen will appear. Select passive humidifying system.
- Press the dial to start the calibration with air and oxygen
60
8. 6
- After the calibration, the “Operational modes” screen will appear. Select the “VCV”
mode (volume controlled mode), remove the plug, connect the test lung. Then,
accept with the dial and let the equipment start cycling with the default values.
Final Control | GraphNet advance neo ts
60 (cont.)
Final Control | GraphNet advance neo ts
8. 7
70
For GraphNet Advance only, connect capnograph.
- Press the “Graphics” key and select the “CO2” screen. Verify that the capnograph sensor has been detected on the screen.
Disconnect the capnograph and press the “Esc” key twice to jump to the main
screen.
8. 8
Final Control | GraphNet advance neo ts
80
Programming the initial parameters.
To program the value of a certain parameter, proceed as follows:
- Locate the parameter to be programmed on the screen.
- Press on the parameter to select it.
- Change the value with the encoder. The change occurs in increments
of 10 units,
but a smaller increment can be obtained by pressing the “Ctrl” key.
- Confirm by pressing the encoder.
Program the following initial parameters as indicated:
VT= 400 ml.
Oxygen = 50%
f= 12 (per minute)
PEEP=0
Ti= 1 sec.
Pressure sensitivity= -1.5 cm H2O
Flow wave: Decreasing
Confirm the remaining parameters by pressing the dial.
Final Control | GraphNet advance neo ts
8. 9
90
- Press the “Menu” key, select “Ventilation adjuncts” then, select “Volume
compensation” and switch from “Yes “ to “No” then select “Humidifier” and
switch from “Passive” to “None (Service).”
- Press the “Esc” key twice to return to the main screen.
100
Volume Control:
Program the Flow Analyzer in: LPM flow, ATP and reading trigger in volume 1.
Read the exhaled VT (in the Master flow and pressure Analyzer) with a minimum
stabilization period of 10 respiratory cycles.
Expected (correct) value:
VT value = 400 ml ± 10% (360–440)
110
Flow Wave Control:
Control the shape of the flow wave on screen.
Perform the same procedure for the rectangular wave shape (operation 90).
120
PEEP Control:
Program “PEEP = 5 cm H2O”
Perform the Analyzer reading at the end of the exhalation (minimum
value).
Perform the respirator reading at the end of the exhalation.
Record the readings in the form.
Expected (correct) value:
Programmed value ± 2 cm H2O.
- Do the same for the PEEP readings equal to 10 and 15 cm H2O
-Return to “PEEP = 0”
8. 10
Final Control | GraphNet advance neo ts
130
O2 Percentage Control:
With the same operational parameters, supervise the generation and
control of the O2 percentage
Program: “Oxygen %: 21%”
Program the flow Analyzer at the oxygen percentage reading (The Oxymeter of
the flow Analyzer must be calibrated).
Check:
Flow Analyzer reading.
Respirator reading.
Expected (correct) value:
Programmed value ±3 points
- Do the same for the “Oxygen %” values equal to 30%, 90% and 100%.
- Then, return to “Oxygen %: 50%”
140
Trigger Sensitivity Control:
This control operates with the respirator working with initial parameters.
NOTE: At the time of the trigger, a blinking lung appears on the upper left of the
screen.
Pressure trigger check
Program:
PEEP = 5 cm H2O
Pressure sensitivity: -1.5 cm H2O
Check:
The respirator must not autotrigger.
The total frequency reading must be the same as the programmed value.
Trigger through test lung manipulation.
Flow trigger check.
Program:
Flow sensitivity = 1 liters /min.
PEEP = 0
Check:
The respirator must not autotrigger.
The total frequency reading must be the same as the programmed value.
Trigger through test lung manipulation.
Final Control | GraphNet advance neo ts
8. 11
150
PCV Mode (Pressure Control)
Press “Mode” and select PCV mode.
Program:
PCV = 15 cm H2O
Ti= 2 sec.
PEEP = 0
Pressure sensitivity: -1.5 cm H2O
Confirm the remaining parameters by pressing the dial.
Press “Alarm Limits” and select “Tidal Volume.” Select “Max” and change its valueto 1200.
Press “Esc” twice to return to the main screen.
Program the analyzer at the peak pressure reading.
Check:
Reading of the pressure stabilized with the flow Analyzer (reading at the
end of the exhalation).
Respirator Peak Pressure reading.
Expected (correct) value:
Programmed value ± 2 cm H2O%
8. 12
Final Control | GraphNet advance neo ts
160
PSV/CPAP mode:
Press “Mode” and select “PSV/CPAP” mode.
Press the “Menu” key, select “Backup ventilation” and “Accept.”
- Switch from “VCV” to “PCV” and accept with the dial.
Final Control | GraphNet advance neo ts
8. 13
160 (cont.)
The following image will appear on the screen. The “PSV/CPAP” mode will start
after pressing the encoder.
Program:
PSV = 15 cm H2O
Pressure sensitivity = -1.5 cm H2O
PEEP = 0
Confirm the remaining parameters by pressing the dial.
Trigger through test lung manipulation.
Trigger by pressing “Manual Insp” key.
Check:
Verify the operation of the mode with the graphic generated on screen.
Reading of the peak pressure stabilized with the flow Analyzer (reading
at the end of the exhalation).
Respirator peak pressure reading.
Expected (correct) value.
Programmed value ± 2 cm H2O.
8. 14
Final Control | GraphNet advance neo ts
170
Apnea Alarm
Check:
Do not trigger the test lung.
At 15 sec. The apnea alarm must be activated.
The respirator goes to backup ventilation.
Trigger the test lung.
Verify that it returns to PSV mode ventilation (the mode is displayed on
the upper left of the screen)
Record the readings in the form.
180
Accessories:
Press “Mode” and select “VCV” mode.
- Disconnect the test lung.
Check:
Typical audio and quality volume test. Press “Menu,” select tools, sound
level. Change up to 60% and confirm.
Record in the form.
Press “Esc” to exit.
Manual trigger: Operation control with “Manual Insp.”
O2 100% sequence activation: Press the “Suction %O2” and press the
dial to confirm.
Press “Esc” to exit.
Final Control | GraphNet advance neo ts
8. 15
190
Alarms:
- Press the “Alarm Limits” key. Select inhalation pressure.
- Select “Max” and proceed as follows:
Lower alarm limit to the peak pressure level read.
Verify alarm activation.
Return alarm limit to 40 cm H2O
Check and record in the form..
- Select “Min” and proceed as follows:
Raise the minimum pressure alarm limit above the peak pressure read
Verify alarm activation.
Return alarm limit to 5 cm H2O Control and record in the form.
200
Gas feed.
Initially, the testing is conducted individually, and then as a group. The reason is
that the feed system has individual and group alarms.
Check and record in the form:
Oxygen.
Close the main feed key.
Verify alarm activation.
Verify that the equipment switches to 100% of the other valve.
Verify performance of the on-screen graph.
Open the feed key again
Air.
Repeat the procedure used for the air feed
Air and Oxygen.
Repeat the procedure used for air and oxygen, but now simultaneously.
210
Electric feed
Disconnect the ventilator during the operation of the 220 V network.
Check and record in the form:
Verify continuous operation.
On-screen, light and sound alarm activation.
LED battery activation (Blue LED)
Reconnect the equipment to the 220 V network.
Verify normal operation has resumed.
8. 16
Final Control | GraphNet advance neo ts
220
Internal battery charge check:
Verify that when the battery charge indicator is completely green (
green battery charge LED goes off.
230
), the
For GraphNet Advance, GraphNet Neo and GraphNet Ts, this last one
should have Neonatal category activated.
-The final control procedure for the “NEO-INF” category is described below. Turn
on the ventilator and select “NEO-INF” category, confirming by pressing the dial,
select “Continue” and confirm the option. In GraphNet Advance and GraphNet
Ts, the upper screen will appear. And for GraphNet Neo ventilators, the lower
screen will appear.
Final Control | GraphNet advance neo ts
8. 17
240
- Connect patient circuit, proximal sensor, espiratory valve and plug like the image
below.
Neo-Inf final control
Neonatal test lung: Neo: 4139A1V
250
8. 18
- The calibration screen will appear after the Neo category is selected. Select passive
humidifying system.
Final Control | GraphNet advance neo ts
250 (cont.)
260
- Press the dial to start air and oxygen calibration.
- After the calibration, the “Operational modes” screen will appear. Select “Other
operational modes.” Once on that screen, choose the “VCV” mode, remove
theplug, connect the test lung, then accept with the dial and the equipment will
begin
to cycle with the default values. Place the ventilator on standby and connect the
air filter; then the Master flow and pressure Analyzer and then the oxygen sensor
connector. Finally, connect with a silicon hose from the “Y” of the lung to the pressure sensor of the Master pressure and flow Analyzer. Remove the standby and
let the ventilator cycle again.
Final Control | GraphNet advance neo ts
8. 19
260 (cont.)
270
Programming the initial parameters.
To program the value of a certain parameter, proceed as follows:
- Locate the parameter to be programmed on the screen.
- Press on the parameter to select it.
- Change the value with the encoder. The change occurs in increments of 10 units,
but a smaller increment can be obtained by pressing the “Ctrl” key.
- Confirm by pressing the encoder.
Program the following initial parameters as indicated:
VT= 30 ml.
Oxygen = 50%
f= 12 (per minute)
PEEP=0
Ti= 1 sec.
Pressure sensitivity= -1.5 cm H2O (*)
Flow wave: Decreasing
Confirm the remaining parameters by pressing the dial.
Increase maximum pressure alarm limit to 50cm H2O
8. 20
Final Control | GraphNet advance neo ts
270 (cont.)
(*) This parameter is selected with the same key that was used for flow sensitivity
control, alternating between one and the other each time it is pressed.
280
- Press the “Menu” key, select “Ventilation adjuncts” then, select “Volume
compensation” and switch from “Yes “ to “No” then select “Humidifier” and
switch from “Passive” to “None (Service).”
- Press the “Esc” key twice to return to the main screen.
Final Control | GraphNet advance neo ts
8. 21
290
Volume Control:
Program the Flow Analyzer in: LPM flow, ATP and reading trigger in
volume 1.
Read the exhaled VT (in the Master flow and pressure Analyzer) with a
minimum stabilization period of 10 respiratory cycles.
Record the reading in the form.
Expected (correct) value:
VT value = 30 ml ± 10% (27-33)
300
Flow Wave Control:
Control the shape of the flow wave on screen.
Perform the same procedure for the rectangular wave shape (operation
90).
310
PEEP Control:
Program “PEEP = 3 cm H2O”
Perform the Analyzer reading at the end of the exhalation (minimum value).
Perform the respirator reading at the end of the exhalation.
Expected (correct) value:
Programmed value ± 2 cm H2O.
- Do the same for the PEEP values that are equal to 5 and 8 cm H2O
-Return to “PEEP = 0””
320
O2 Percentage Control:
With the same operational parameters, supervise the generation and control of
the O2 percentage.
Program: “Oxygen %: 21%”
Program the flow Analyzer at the oxygen percentage reading (The Oxymeter of
the flow Analyzer must be calibrated).
Check:
Flow Analyzer reading.
Respirator reading.
Expected (correct) value:
Programmed value ±3 points.
- Do the same for the “Oxygen %” values equal to 30%, 90% and 100%.
- Then, return to “Oxygen %: 50%
8. 22
Final Control | GraphNet advance neo ts
330
Trigger Sensitivity Control:
This control operates with the respirator working with initial parameters.
NOTE: At the time of the trigger, a blinking lung appears on the upper left of the
screen.
Pressure trigger check.
Program:
PEEP = 3 cm H2O
Pressure sensitivity: -1.5 cm H2O
Check:
The respirator must not autotrigger.
The total frequency reading must be the same as the programmed value.
Trigger through test lung manipulation.
Flow trigger check:
Program:
Flow sensitivity = 1 liters /min.
PEEP = 0
Check:
The respirator must not autotrigger.
The total frequency reading must be the same as the programmed value.
Trigger through test lung manipulation.
340
Proximal Sensor Check
Place the ventilator on standby and connect the proximal sensor to it, and the
other end of the sensor between the “Y” and the test lung. Remove the standby
and let the ventilator cycle again.
Then, press the “Menu” key, go into “Ventilatory adjuncts,” select “Pneumo”
and change the option from “Distal” to “Proximal.” An icon that says “Prox” (
)
will appear on screen.
Final Control | GraphNet advance neo ts
8. 23
340 (cont.)
Control the “VT” value on the upper part of the screen. This value must be in 30ml
± 10% (27-33).
Then, put the ventilator back on standby, remove the Proximal Sensor and go
back to cycling the equipment. At this point, following the above steps, this time
change “Proximal” to “Distal”
350
PCV Mode (Pressure control)
Press “Mode” and select PCV mode
8. 24
Final Control | GraphNet advance neo ts
350 (cont.)
Program:
PCV = 8 cm H2O
Ti = 2 sec.
PEEP = 0
f=12
Pressure sensitivity: -1.5 cm H2O
Confirm the remaining parameters by pressing the dial.
Press “Alarm Limits” and select “Tidal Volume.” Select “Max” and change its value
to 100.
Press “Esc” twice to return to the main screen.
Program the analyzer at the peak pressure reading.
Check:
Reading of the pressure stabilized with the flow Analyzer (reading at
the end of the exhalation).
Respirator Peak Pressure reading.
Expected (correct) value:
Programmed value ± 2 cm H2O%
360
PSV/CPAP Mode:
Press “Mode” and select “PSV/CPAP” mode.
Final Control | GraphNet advance neo ts
8. 25
360 (cont.)
Press the “Menu” key, select “Backup ventilation” and “Accept.”
- Once in this menu, accept the “TCPL” selection in “Operative Modes” select
“Accept.”
The following image will appear on the screen. The “PSV/CPAP” mode will start
after pressing the encoder.
8. 26
Final Control | GraphNet advance neo ts
360 (cont.)
Program:
PSV = 8 cm H2O
Pressure sensitivity = -1.5 cm H2O
PEEP = 0
Confirm the remaining parameters by pressing the dial.
Trigger pressing the “Manual Insp” key.
Check:
Verify the operation of the mode with the graphic generated on screen.
Respirator peak pressure reading.
Expected (correct) value.
Programmed value ± 2 cm H2O.
370
Apnea Alarm
Check:
Do not trigger the test lung.
At 15 sec. The apnea alarm must be activated.
The respirator goes to backup ventilation.
Trigger the test lung.
Verify that it returns to PSV mode ventilation (the mode is displayed onthe upper left of the screen)
380
Accessories:
Press “Mode” and select “VCV” mode.
Check:
O2 60% sequence activation: Press the “Suction %O2” and press the
dial to confirm.
Press “Esc” to exit.
Final Control | GraphNet advance neo ts
8. 27
390
Gas feed.
Initially, the testing is conducted individually, and then as a group. The reason is
that the feed system has individual and group alarms.
Check and record in the form:
Oxygen.
Close the main feed key.
Verify alarm activation.
Verify that the equipment switches to 100% of the other valve.
Verify performance of the on-screen graph.
Open the feed key again.
Air.
Repeat the procedure used for the air feed
Air and Oxygen.
Repeat the procedure used for air and oxygen, but now simult neously.
400
Electric feed
Disconnect the ventilator during the operation of the 220 V network.
Check and record in the form:
Verify continuous operation.
On-screen, light and sound alarm activation.
LED battery activation (Blue LED)
Reconnect the equipment to the 220 V network.
Verify normal operation has resumed.
410
Internal battery charge check:
Verify that when the battery charge indicator is completely green (
green battery charge LED goes off.
420
8. 28
- Turn off the ventilator
Final Control | GraphNet advance neo ts
), the
Appendix
Chapter contents
A.1
Tools needed
Appendix | GraphNet advance neo ts
A. 1
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A. 2
Appendix | GraphNet advance neo ts
A.1 | Tools Needed
Disassembly-Assembly Kit
● 1.5, 2.5, 3.4 mm Allen Wrench
● Electronic Pliers
● Longnose pliers
● Philips Screwdriver #
● Flat Screwdriver #
● 5.5 mm Spanner Wrench (CPU nuts - Attached)
● Brucela
● Electronic Solderer (Internal terminal O2 cable)
● Support Wood
● ¼ “ Wrench (Base Box – Multiple Connector) Long special
● CI PLCC Extractor
● Antistatic wrist strap
● Precincts - Brackets
● Tin
● Spare Terminals and Hoses
General Diagnosis Instrument Kit
● Respirator Analyzer
● Manometer with Syringe
● High Pressure Manometer
● Calibrated Oxygen
● Test Lung
Appendix | GraphNet advance neo ts
A. 3
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A. 4
Appendix | GraphNet advance neo ts