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