INTENDED USE

The GraphNet ts ventilator was designed to be used with all types of patients: adult, pediatric, and neonatal infants (optionally with the NEO-INF
module) requiring invasive and noninvasive ventilatory support, for a short or long period, allowing monitoring of the main ventilatory parameters.
The equipment provides care for patients able or unable to make their own breathing efforts.

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 13485:2012/AC:2012 - Medical devices. Quality management systems. Requirements for regulatory
purposes (ISO 13485:2003).
• EN 60601-1:2006 - Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance (IEC 60601-1:2005).
• EN ISO 80601-2-12:2011/AC:2011 - Medical electrical equipment. Part 2-12: 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: 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)
 OPERATING CONDITIONS

Temperature Ambient Pressure Humidity

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

Storage - 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
ADULTS AND PEDIATRICS 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. • SIMV (VCV) + PSV.
• SIMV (PCV) + PSV. • SIMV (PCV) + PSV.
• MMV + PSV – Mandatory Minute Ventilation. • TCPL – Time Cycled Pressure Limited.
• PSV + Tidal Volume Assured. • SIMV (TCPL) + PSV.
• APRV – Airway Pressure Release Ventilation. • CPAP with Continuous Flow (with leak compensation for NIV).
• NIV – Non-Invasive Ventilation. • APRV – Airway Pressure Release Ventilation.
• High Flow Oxygen Therapy (Optional). • High Flow Oxygen Therapy (Optional).
• VSV – Volume Support (Optional). • VSV – Volume Support (Optional).
• PRVC – Pressure Regulated Volume Control (Optional). • PRVC – Pressure Regulated Volume Control (Optional).
• SIMV (PRVC) + PSV (Optional). • SIMV (PRVC) + PSV (Optional).
PARAMETER SELECTION (according to operative mode and patient category)

Parameter Range

Tidal Volume [ml] 20-2500 mL (from 5 ml with the option of neonatal category)

Minute Volume (MMV + PSV setting) [L/min] 1.0-50

Maximum resulting minute volume [L/min] 130 (Not a direct user setting)

Inspiratory Time [s] 0.1 - 10 (in assist/controlled modes)

0.2 - 30 (Low Time in APRV)
0.5 - 30 (High time in APRV)

I:E Ratio 5:1 - 1:599 (in assist/control modes)

150:1-1:60 (APRV)

Respiratory Rate [rpm] ADL: 1 - 100

PED/NEO-INF: 1 - 150

FIO2 [%] 21 - 100

Inspiratory Sensitivity Flow Triggered [L/min]: 0.2 - 15

Pressure Triggered [cmH2O]: 0.5 - 20 below the PEEP value

Expiratory Sensitivity for PSV [% of Peak Flow] 5-80 of the initial peak flow, in steps of 5%.

PEEP/CPAP [cmH2O] 0-50

Controlled Pressure (PCV) [cmH2O] 2-100

Support Pressure (PSV) [cmH2O] 0-100

Rise Time Modifications to rise time can be seen graphically as a rise

or decline in the tracing of the initial segment of the inspiratory pressure curve

Inspiratory Pause (programmable in VCV) [s] 0-2

Inspiratory Flow Waveform (VCV) Rectangular – Descending Ramp

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] (*) PED: 1 - 60
NEO-INF: 1 - 20 (*)

Oxygen concentration in oxygen therapy [%] 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
Inspiratory Time [s] Ti
Expiratory Time [s] Te
I:E Ratio I:E
Total Rate [rpm] ftotal
Expired Tidal Volume [L] for ADL/PED - [mL] for NEO/INF VT
Inspired Tidal Volume VTi
Expired Minute Volume [L/min] VE
FIO2 [%] %Oxygen
Ideal body weight IBW
Tidal volume per kg of patient weight Vt/kg
Mandatory Minute Volume [L/min] VE Mandat
Spontaneous Minute Volume [L/min] VE Spont
Spontaneous Respiratory Rate [rpm] Fspont
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 [rpm/L] F/VT
Ratio between the inspiration time and the time needed for a full breath Ti/Ttot
Imposed Work of Breathing [mL/min] WOBi
Stress Index (*) Stress Index
ALARMS
Light and audible signals according to priority 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. The system allows the deactivation of Tidal Volume and Minute Volume alarms in NIV.

Alarm Non-Configurable
Adjustment Alarms

Parameter Range Emergency Ventilation

Continuous high pressure
Maximum Inspiratory Pressure [cmH2O] 10 (or > min – 120)
Low air and oxygen pressure
Minimum Inspiratory Pressure [cmH2O] 1-99 (or < max)
Low oxygen (or air) pressure
Maximum Tidal Volume [L] ADL: >VTmín - 3,0
Defective Battery
PED: >VTmín - 0.500
Low Battery
NEO-INF: >VTmín -
Power loss
0,250
Fan failure
Minimum Tidal Volume [L] ADL: 0 - <VTmáx
Target volume not reached
PED: 0 - <VTmáx
Nebulization interrupted
NEO-INF: 0 - <VTmáx
Transporting
Maximum Minute Volume (Expired) [L/min] ADL: >VMmín - 55
Standby
PED: >VMmín - 55
Inadequate oxygen [%]
NEO-INF: >VMmín- 55
Disconnection
Minimum Minute Volume (Expired) [L/min] ADL: 0 – <VMmáx
Leakage out of range
PED: 0 – <VMmáx
Sound controller failure
NEO-INF: 0 – <VMmáx
Maximum proximal flow
High/Low O2 concentration [%] Alta: 25 - 110
SBT aborted (*)
Baja: 19 - 95
Apnea Condition [s] 5-60
PEEP loss [cmH2O] 0-6
High rate [rpm] 3-160
SBT finalized [min] (*) 10 - 120
High f/Vt [bpm/L] (*) 65 - 200

OTHER FEATURES AND CONTROLS

Function Clarifications

Manual Inspiration The ventilator should initiate a mandatory breath

Manual Inspiratory / Expiratory Pause Inspiratory Pause: 0-7 s

Expiratory Pause: 0-20 s

Nebulization 30 min - Synchronized with the Inspiration / Deactivated

Enabled by default
Leak Compensation:
Leak Compensation – NIV and Continuous Flow CPAP ADL: up to 50 L/min
PED: up to 30 L/min
NEO: up to 10 L/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
OTHER FEATURES AND CONTROLS

Function Clarifications

Mandatory Setting:
Rangos

ADL/PED PSV/CPAP – VSV – MMV + PSV

– PSV + Assured VT

NEO/INF PSV/CPAP – VSV

Backup Ventilation
Optional Setting:

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

Sighs In VCV mode

Sound Volume 40 % - 100%

Sequence for aspiration with variable O2

Suction %O2 concentration and time,
greater than or equal to 2 minutes

Inspired Oxygen Sensor

SAFETY MECHANISMS

Mechanisms Clarifications

Screen Lock If the screen is locked when an alarm is triggered,

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 equipment is
Pressure Relief Valve de-energized, when the ventilator is out of order, when air
pressure and oxygen pressure are simultaneously low,
on standby.

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

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

pressure sensors are zeroed

To avoid obstruction and humidity leakage

Circuit Purge in the pressure sensors

Safety Valve 120 cmH2O (±5)

COMPLEMENTARY FUNCTIONS

Function Clarifications

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 bottles

• Record up to 5000 events

• Alarms / warnings: activated alarms during the ventilation and warnings

shown during the self-test
Extended event log • Adjustments: operative mode, settings and ventilatory adjuncts.

• States: Turn on, turn off, Standby, transport, calibrations

and battery charge.
RESPIRATORY MECHANICS
Parameters Clarifications

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

Air remaining within the lungs due to dynamic

Trapped Volume pulmonary hyperinflation

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

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

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.
Charge 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.
• Module 2: PRVC: Pressure Regulated Volume Control, VSV: Volume Support, SIMV(PRVC)+PSV.
• Module 3: Stress Index and Spontaneous Breathing Trial (SBT).
• Module 4: Neonatal Category.

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.
• O2 Sensor.
OPTIONAL ACCESORIES

• Reusable Patient Circuit: Reusable circuits (Hytrel and Silicone) for ADL (22 mm), PED (15 mm)
and NEO-INF (10mm) patient categories.
• Heater-Humidifier.
• Compressor: Allows using the ventilator 24 hours, supplying the absence of air of the central source.
• Neonatal test lung.
• Flexible arm with tubes holder.
• Four-wheel cart (with brakes).

Manufactured by

Tecme Corporation: 2825 Pacific Drive. Suite B - Norcross, GA 30071

Phone: +1 770 409 9172 - Fax: +1 770 729 8176. [email protected]

www.tecmeusa.com