Technical Specifications

GraphNet ts
Software Version N11-TS-01.15.XX
Intended use
The GraphNet ts ventilator was designed for adult, pediatric, and neonatal patients (optionally with the NEO-INF module) that require
invasive and noninvasive ventilatory support, for a short or long period of time. This device provides effective and safe care for patinets able
or unable to make their own breathing efforts. The GraphNet ts allows to easily monitor and understand the main ventilatory parameters.

Classification

Risk:
• Class IIb (Council Directive 93/42/EEC).
• Class III (MERCOSUR/GMC/RES. N° 40/00).

Electrical Insulation:
• Class I – Type B (according to IEC 60601-1).

IP Protection:
• IP21 (IEC 60529).

Operational mode:
• Continuous Operation (IEC 60601-1).

Standards:

• EN ISO 13485:2016 - Medical devices. Quality management systems. Requirements for regulatory purposes (ISO 13485:2016).
• EN 60601-1:2006 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC
60601-1:2005).
• EN ISO 80601-2-12:2011/AC:2011 - Medical electrical equipment. Part 2-12: Particular requirements for basic safety and essential
performance of critical care ventilators (ISO 80601-2-12:2011/Cor 1: 2011).
• EN 60601-1-2:2007/AC:2010 - Medical electrical equipment. Part 1-2: General requirements for basic safety and essential
performance. Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2007).
• EN 60601-1-6:2010 - Medical electrical equipment. Part 1-6: General requirements for basic safety and essential performance.
Collateral standard: Usability (IEC 60601-1-6:2010).
• EN 60601-1-8:2007/AC:2010 - Medical electrical equipment. Part 1-8: General 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 60601-1-8:2006).
• EN 60601-1-9:2008/AC:2013 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential
performance - Collateral Standard: Requirements for environmentally conscious design (IEC 60601-1-9:2007/A1:2013).
• EN 62304:2006/AC:2008 - Medical device software. Software life cycle processes (IEC 62304:2006).
• EN 62366:2008 - Medical devices. Application of usability engineering to medical devices (IEC 62366:2007).

Physical characteristics

• Height: 33.1 cm (13.03 in).

• Width: 36 cm (14.2 in).
• Depth: 29.5 cm (11.6 in).
• Height including the trolley: 131 cm (51.6 in).
• Weight not including the trolley: 10.35 kg (22.8 lb).
• Weight including the trolley: 23.8 kg (52.5 lb).
• Weight including accesories 29.25 kg (64.5 lb).
• Width of the trolley 51 cm (20.1 in) - 65 cm with lateral wheels (25.6 in).
• Depth of the trolley 52 cm (20.5 in) - 52 cm (23.2 in) - 59 cm in-line wheels (23.2 in).

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Environmental requirements

Temperature Ambient Pressure Humidity

Operation 15 - 35 ºC 560 - 1030 hPa 15% - 95% non-condensing

Storage/Transport - 10 ºC - 55 ºC 500 - 1060 hPa < 95% non-condensing

Screen
• Type: Resistive sensitive Touch Screen / color TFT-LED.
• Size: 12.1”.
• Resolution: 800x600.

Graphics
GraphNet ts has 6 different screens to organize different curves and patient information.
• Five Curves: Pressure, volume and flow; and pressure/volume and flow/volume loops.
• Two Curves: Pressure and flow.
• Three Curves: Pressure, flow and volume.
• Loops: Pressure/volume, flow/volume and flow/pressure loops.
• Patient’s Data: Pressure, volume and flow curves with patient data sheet.
• Numerical data: Numerical control of the following ventilation parameters: Peak pressure, PEEP, volume per minute, tidal
volume, respiratory rate, oxygen concentration.

Operative modes
ADULT AND PEDIATRIC NEONATES-INFANTS (Optional category)
• VCV – Volume Control (Assisted/Controlled). • VCV – Volume Control (Assisted/Controlled).
• PCV – Pressure Control (Assisted/Controlled). • PCV – Pressure Control (Assisted/Controlled).
• PSV – Pressure Support. • PSV – Pressure Support.
• CPAP – Continuous Positive Airway Pressure. • CPAP – Continuous Positive Airway Pressure.
• SIMV (VCV) + PSV – Synchronized Intermittent Mandatory Ventilation. • TCPL – Time Cycled Pressure Limited.
• SIMV (PCV) + PSV – Synchronized Intermittent Mandatory Ventilation. • SIMV (VCV) + PSV – Synchronized Intermittent Mandatory Ventilation.
• MMV + PSV – Mandatory Minute Ventilation. • SIMV (PCV) + PSV – Synchronized Intermittent Mandatory Ventilation.
• PSV + Tidal Volume Assured. • SIMV (TCPL) + PSV – Synchronized Intermittent Mandatory Ventilation.
• APRV – Airway Pressure Release Ventilation. • CPAP with Continuous Flow (with leak compensation for NIV).
• NIV – Non-Invasive Ventilation. • APRV – Airway Pressure Release Ventilation.
• HFOT - High flow oxygen therapy (Optional). • NIV – Non-Invasive Ventilation.
• VSV – Volume Support (Optional). • HFOT - High flow oxygen therapy (Optional).
• PRVC – Pressure Regulated Volume Control (Optional). • VSV – Volume Support (Optional).
• SIMV (PRVC) + PSV – Synchronized Intermittent Mandatory • PRVC – Pressure Regulated Volume Control (Optional).
Ventilation (Optional). • SIMV (PRVC) + PSV – Synchronized Intermittent
• AVA - Adaptative Ventilatory Assist (Optional). Mandatory Ventilation (Optional).

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Parameter selection (according to the operative mode and patient category)
Parameter Range

ADL: 0.050 – 4.000

Tidal volume [L] PED: 0.020 – 0.300
NEO-INF: 0.002 – 0.150 (with the option of neonatal category)
ADL: 1.0 – 50
Programable minute volume (MMV + PSV) [L/min] PED: 1.0 – 50
NEO-INF: N/A

ADL: 130
Maximum resulting minute volume [L/min] PED: 40
NEO-INF: 17

Inspiratory time [s] (in assist-control modes) 0.1 – 10

Inspiratory time [s] (APRV) Low time: 0.2 – 30
High time: 0.5 – 30
I:E ratio 5:1 – 1:599 (in assist/control modes)
150:1 – 1:60 (APRV)

Respiratory rate [bpm] ADL: 1 - 100

PED/NEO-INF: 1 - 150

Oxygen concentration [%] 21 - 100

Inspiratory sensitivity Triggering by flow [L/min]: 0.2 – 15

Triggering by pressure [cmH2O]: 0.2 – 20 below the PEEP

Expiratory sensitivity (for modes with PSV) 5% – 80% of the peak flow in steps of 5%.
PEEP/CPAP [cmH2O] 0 - 50
Controlled pressure (PCV) [cmH2O] 2 - 100
Support pressure (PSV) [cmH2O] 0 - 100
Modifications to rise time can be seen graphically as a rise
Rise time or decline in the tracing of the initial segment of the
inspiratory pressure curve
Programmable inspiratory pause (in VCV) [s] or [%] 0-2 or 0 - 80% of Ti
Inspiratory flow waveform Descending and constant ramp (rectangular)
Inspiratory flow [L/min] 0.2 - 180
Continuous flow (NEO-INF) [L/min] 2 - 40
Limited pressure in TCPL (NEO-INF) [cmH2O] 3 - 70
Maximum pressure limited (safety limits) [cmH2O] Up to 120
ADL: 1 - 80
Continuous flow in oxygen therapy [L/min] (with HFOT option) PED: 1 - 60
NEO-INF: 1 - 20
Oxygen concentration in oxygen therapy [%] (with HFOT option) 21 - 100

Monitored Parameter Reference

Parameters
Peak pressure [cmH2O] Peak
Plateau pressure [cmH2O] Plateau
Mean pressure [cmH2O] Mean
PEEP [cmH2O] PEEP
Inspiratory peak flow [L/min] Peak Flow
Expiratory peak flow [L/min] Exp. peak flow
Inspiratory time [s] Ti
Expiratory time [s] Te
I:E ratio I:E
Total rate [bpm] ftotal
Expired tidal volume [L] for ADL/PED - [mL] for NEO/INF VT
Inspired tidal volume [L] for ADL/PED - [mL] for NEO/INF VTi
Expired minute volume [L/min] VE
Inspired minute volume [L/min] VEi
Oxygen monitor [%] Oxygen
Ideal body weight [kg] IBW
Tidal volume per kg of patient weight [mL/kg] Vt/kg
Mandatory minute volume [L/min] VE Mandat
Spontaneous minute volume [L/min] VE Spont
Spontaneous respiratory rate [bpm] F spont
Expiratory time constant [s] TCexp
Dynamic compliance [ml/cmH2O] Cdyn
Static compliance [ml/cmH2O] Cest
Inspiratory resistance [cmH2O/L/s] Ri
Expiratory resistance [cmH2O/L/s] Re
Leak [L/min] Leak
Percentage of leak [%] % Leak
F/VT index (Tobin index) [bpm/L] F/VT
Ratio between the inspiration time and
Ti/Ttot
the time needed for a full breath
Imposed work of breathing [mL/min] WOBi
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Stress index (with neonatal optional) Stress Index
Ratio C20/C for NEO/INF C20/C
F/VT per kg [bpm/L/kg] for NEO/INF (with neonatal optional) F/VT/Kg
Alarms
Light and audible signals according to different priorities and messages on the screen. The system keeps a record of the occurred events
with name, date, and time. This record is printable and cannot be deleted.

Alarm adjustment Non-configurable alarms

Parameter Range Emergency ventilation

High inspiratory pressure [cmH2O] 10 (or > min – 120) Continuous high pressure
Low air and oxygen pressure
Low inspiratory pressure [cmH2O] 1 – 99 (or < max)
Low oxygen (or air) pressure
ADL: >VTmin - 3,0 High oxygen pressure (or air)
High tidal volume [L] PED: >VTmin – 0,500 Defective battery
NEO-INF: >VTmin - 0,250 Low battery
Power loss
ADL: 0 - <VTmax Fan failure
Low tidal volume [L] PED: 0 - <VTmax Target volume not reached
NEO-INF: 0 - <VTmax Nebulization interrupted
ADL: >VMmin - 55 Transporting
High minute volume (exhaled) [L/min] PED: >VMmin - 55 Standby
NEO-INF: >VMmin - 55 Oxygen concentration below 18%
ADL: 0 – <VMmax Disconnection
Low minute volume (exhaled) [L/min] PED: 0 – <VMmax Non-compensable leak
NEO-INF: 0 – <VMmax Sound controller failure
High: 25 – 110 Oxygen therapy disabled (with HFOT optional)
High/Low O2 concentration [%]
Low: 19 – 95 SBT aborted (with measurements optional)
Apnea condition [s] 5 – 60 AVA target unreacheable (with AVA optional)
High PEEP [cmH2O] 1 - 6 above PEEP set AVA out of limits (with AVA optional)
Low PEEP [cmH2O] 0 - 6 below PEEP set
High rate [bpm] 3 – 160
SBT finalized [min] (with measurements optional) 10 – 120
High f/Vt [bpm/L] 65 – 900
(with measurements optional)

Complementary functions

Function Comments

Altitude compensation for volume correction

Body temperature volume correction (BTPS) Volume correction according to the selected
type of humidifier

Pressure correction according to patient circuit

resistance

Tidal volume setting based on Ideal Body Weight (IBW) ml/kg of patient weight

Possibility to set the VCV mode as tidal volume +

inspiratory time or tidal volume + peak flow

Intra-hospital transport Facilitates the mobilization when the ventilator can

only be supplied with oxygen tubes

Tube compensation (endotracheal o tracheostomy tube) Compensation of 10%-100% for Ø 4 -12 mm (from 2.5 mm
(Optional) with the option of neonatal category)

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 Record up to 5000 events of the following:
• Alarms / warnings: activated alarms during the ventilation
and warnings shown during the self-test
• Adjustments: including device configuration changes such as
Extended event log patient category, ventilatory mode, parameter adjustment,
ventilatory complements, among other adjustments
• States: Including states in which the device is (power on,
calibration, during ventilation, Stand-By, Intra hospital
transportation, Power off, recalibrations, battery charge level),
as well as some complementary functions accessed
through quick access

Manual inspiration The ventilator should initiate a mandatory breath.

Manual inspiratory / expiratory pause Inspiratory pause: 0 - 10 s

Expiratory pause: 0 - 20 s

Nebulization 30 min - synchronized with the inspiration / deactivated

Enabled by default
Leak compensation:
Leak compensation in NIV ADL: up to 60 L/min
PED: up to 30 L/min
NEO-INF: up to 10L/min

Activated / Deactivated
Leak compensation:
Leak compensation – remaining modes ADL: up to 15 L/min
PED: up to 15 L/min
NEO-INF: up to 10 L/min

Volume compensation (based on the compliance of the patient circuit) Activated/deactivated

Trends Up to 72 hours

Mandatory Settings:
Rangos

ADL/PED PSV/CPAP – MMV + PSV -

PSV + Assured VT – VSV

NEO/INF PSV/CPAP - VSV

Backup ventilation Optional Settings:

PSV/CPAP – VSV
ADL/PED SIMV(VCV)+PSV – SIMV(PCV)+PSV –
SIMV(PRVC) + PSV - APRV
SIMV(VCV)+PSV
SIMV(PSV)+PSV
NEO/INF SIMV(TCPL)+PSV
SIMV(PRVC)+PSV
CPAP continuous flow
APRV

Sighs In VCV mode

Sound volume 40% - 100%

Sequence for aspiration with variable

Suction %O2 O2 concentration and time,
greater than 2 minutes

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Safety mechanisms

Mechanisms Comments

If the screen is locked when an alarm is triggered,

Screen lock it is automatically unlocked

Standby

Mechanism that is activated in conditions of extreme

necessity to provide temporary ventilation to the patient
Emergency ventilation until measures are taken to replace the ventilator with an
alternative ventilatory mechanism

This valve allows the patient to breathe ambient air,

under the following conditions:
• When the device is de-energized
Pressure relief valve • When the ventilator is out of order
• When air pressure and oxygen pressure are simultaneously low
• On standby
• When the oxygen therapy mode is disabled

Operating gas leakage The gas that can seep into the unit is collected in a
common manifold and directed towards the outside

Auto-zeroing Every 10 minutes or when the operator enables it, the

pressure sensors are zeroed

Circuit purge To avoid obstruction and humidity leakage

in the pressure sensors

Safety valve 120 cmH2O (±5)

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Measurements

Parameters Comments

AutoPEEP or intrinsic PEEP Dynamic pulmonary hyperinflation

Static and dynamic compliance
Inspiratory and expiratory resistance
Slow vital capacity Amount of air that can be expired after a maximal inspiration
P0.1 Occlusion Pressure during the first 100 ms

Insufflations with low flow (4L/min) in order to determine

P/V flex (Inflection Points) the lower inflection point (Lip) and upper inflection point (Uip).
This tool can be used to assess recruitability and to set PEEP based
on respiratory mechanics

Pi max Negative inspiratory effort

Trapped volume Air remaining within the lungs due to dynamic

pulmonary hyperinflation

Spontaneous breathing trial (SBT) (with measurements optional) Tool to assess patient tolerance of breath with minimal
ventilatory support, prior to extubation procedure

PaFi and Oxygenation index (with measurements optional) Used to determine the oxygenation status of the patient

Conectivity
• RS-232C with DB-9 connector.
• VGA output for an external monitor connection.
• HL7 compatible.

Electrical requirements
• Main Power: 100 - 240 V / 50-60 Hz. Automatic voltage switching.
• Internal Battery: 11.1 V / 7.8 Ah. Automatic recharge. Estimated duration: 2.5 hours when fully charged.
attery level indicator on screen.

Pneumatic requirements
• Working pressure: 2.0 bar (approx. 29 psi).
• Gases supply:
• Oxygen: Pressure 2.8-6 bar (approx. 41-87 psi). Connector: DISS 9/16"-18.
• Air: Pressure 2.8-6 bar (approx. 41-87 psi). Connector: DISS 3/4"-16.
• Automatic gas switching when one of them is absent in order to allow patient ventilation with the remaining gas.

Optionals
• Module 1: High flow oxygen therapy (HFOT).
• Module 2: PRVC: Pressure Regulated Volume Control, VSV: Volume Support, SIMV(PRVC)+PSV.
• Module 3: Stress Index, Spontaneous Breathing Trial (SBT), PaFi and Oxygenation Index.
• Module 4: Neonatal Category.
• Module 5: AVA ventilatory mode: Adaptative Ventilatory Assist
• Module 6: Tube compensation

Accessories
• Two expiratory ensembles.
• Water filter for compressed air inlet.
• Air supply high pressure hose (3 meters) with 3/4”-16H connectors.
• O2 supply high pressure hose (3 meters) with 9/16”-18H DISS connectors.
• Nebulizer (complete kit).
• Adult test lung.
• Power cord.

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Optional accesories

• Reusable patient circuit: Reusable circuits for adult, pediatric and neonatal patients.
• Four-wheel trolley (with brakes).
• Flexible arm with tubes holder.
• Heater-Humidifier.
• Compressor: Allows to use the ventilator 24 hours, in the case of absence of air from the central source.

4798L2V Rev. 03

50 years of innovation and development in mechanical ventilators.

www.tecmeglobal.com / [email protected]

Córdoba Buenos Aires Atlanta

Av. Circunvalación (N-O) - Agustín Tosco 3040 Trole 557 - 2º Piso, Nueva Pompeya,C.A.B.A., 2825 Pacific Drive. Suite B
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P: +54 351 4144600 – F: +54 351 4144605 P: +54 11 1561387326 P: +1 770 409 9172 - F: +1 770 729 8176