Taema

eXtend High end critical care ventilator

eXtend, spcifications techniques.xls

Supplier
Name of the supplier Address Phone Fax Supplier origin Manufacturing location Certification Taema (AIR LIQUIDE Sant International subsidiary) 6, rue Georges Besse, CE 80 92182 Antony cedex France + 33 (0) 1 40 96 66 00 + 33 (0) 1 40 96 67 00 France Antony, France ISO 9001 and EN 46001 by G-MED

Equipment definition
Brand Model Type Patient category Software language Software language (under development) Taema eXtend ICU ventilator Adult, Child, Infant French, English, Italian

Standards and approvals

Standards EC certificate EC certificate date Medical class Date of the 1st unit sold in France EN 60601-1, EN 794-1, EN 60601-1-1, IEC 60601-2-12 CE 0459 03/01/2005 2b December 2004

General features
Size (l x w x h) without stand Size (l x w x h) with stand Total weight without stand Number of wheels Wheels with brake 50 x 45 x 28 cm 60 x 65 x 155 cm 27 kg 4 2

Environment
Operating temperature Storage temperature Relative humidity (operating) Relative humidity (storage) Atmospheric pressure (operating) Atmospheric pressure (storage) 10 to 40C -40 to 70C 30 to 75% 10 to 100% 700 to 1060 mbar 500 to 1060 mbar

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Technology specification
Ventilator Display

eXtend, spcifications techniques.xls

Electronic, 2 microprocessors Colour touch screen Analogic resistive technology 1024 x 768 pixels Mechanical Accuracy: < 3 % of the set value Delivered flow: 0 to 200 L/min Delivered pressure: 0 to 90 cmH2O One proportional valve hot wire (x2), differential pressure (x1) 6 piezo electric Electro-chemical

Mixer

Inspiratory valve Flow sensor Pressure sensor O2 sensor

Power supply
Voltage Frequency Electrical consumption Electrical class Type Power failure alarm Available electricity plugs Internal battery autonomy Plug for external DC supply 100 to 240 V 50 to 60 Hz 90 W I B Yes EU; soon available: UK, US 30 min 24 V

Gas supply
Pneumatic supply (O2, air) Autonomy Gas connectors type Minimum request Gas consumption Medical air compressor 2.5 to 6 bar (250 to 600 kPa) Cylinders NF; under developpement: DISS, NIST O2 = patient volume minute + 10 L/min (internal consumption) Option

Automatic self-test
Calibration Leak Test Circuit compliance Safety Sensors (flow, pressure, FiO2) - Proportional valve 3 different levels of leak for more flexibility Measurement and compensation Alarms system test, safety valve test, electronic and software test

Ventilation modes
Volume controlled ventilation (Assist./Cont.) Pressure controlled ventilation (Assist./Cont.) Synchronized intermittent mandatory ventilation Pressure support ventilation (Spont., CPAP, PEEP) Non invasive ventilation Apnea ventilation VCV PCV SIMV PSV VCV, PCV, SIMV, PSV VCV (adjustable VT and RR, Decel flow, TI/Ttot 33 %)

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Advanced ventilation modes (optional)
Volume assured pressure support Mandatory rate ventilation (PS regulated to reach a target RR) Airway pressure release ventilation Pressure regulated volume control

eXtend, spcifications techniques.xls

VAPS MRV (Patented feature) APRV PRVC

Ventilation settings
Tidal volume (VTi) 20 to 2000 mL: Adults: 200 to 2000 mL Paediatrics: 50 to 500 mL Infants: 20 to 75 mL 0 to 200 L/min > 200 L/min (depending on gaz supply pressures) 5 to 80 bpm: Adults: 5 to 50 bpm Paediatrics: 9 to 70 bpm Infants: 15 to 80 bpm 90 bpm 1 to 60 bpm: Adults: 1 to 40 bpm Paediatrics: 1 to 40 bpm Infants: 1 to 60 bpm 0 to 60 % of TI 0,3 to 4,9 s: Adults: 0,3 s to 80 % of Ttot Pediatrics: 0,3 s to 60 % of Ttot Infants: 0,3 s to 60 % of Ttot 0 to 40 cmH2O: Adults: 0 to 40 cmH2O Paediatrics: 0 to 40 cmH2O Infants: 0 to 40 cmH2O 0 to 35 cmH2O: Adults: 0 to 35 cmH2O Paediatrics: 0 to 35 cmH2O Infants: 0 to 30 cmH2O 2 to 60 cmH2O: Adults: 2 to 60 cmH2O Paediatrics: 2 to 60 cmH2O Infants: 2 to 40 cmH2O 90 cmH2O 50 to 150 cmH2O/s Constant, decelerating, sinusoidal 21 to 100 % 1 to 20 L/min 0.1 to 5 cmH2O 60 ms (typical) 0 (OFF) to 70 % of peak flow 0 to 5 s 0 to 12 s 0 to 2 min OFF, 1/9 to 1/200 cycles 1 to 2 x VT 1 to 2 x PI

Inspiratory peak flow Maximum inspiratory peak flow Respiratory rate (RR)

Spontaneous max RR SIMV respiratory rate (RR SIMV)

Inspiratory plateau (Tplat) Inspiratory time (TI)

Positive end expi. pressure (PEEP)

Pressure support (PS)

Insufflation pressure (PI)

Maximum insufflation pressure Pressure slope (Slope) Flow wave shape FiO2 Inspiratory flow trigger (in NIV) Inspiratory pressure trigger (other modes and NIV with PEEP =0) Inspiratory trigger response time Expiratory trigger Inspiratory pause Expiratory pause Sustained exhalation Sigh rate Sigh in VCP Sigh in PCV

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Specific features
System compliance Nebulization: nebulizer supply pressure Adjustable nebulization parameters

eXtend, spcifications techniques.xls

Non Invasive Ventilation

External pressure measurement Remote alarm Range settings depending on patient category Standard settings Customized user configuration Possibility to change the expiratory flow sensor during ventilation Possibility to inhibit FiO2 monitoring in case of sensor failure Possibility to inhibit expiratory flow measurement in case of sensor failure

Measured and compensated 1.5 bar (150 kPa) Duration of nebulization session: 1 to 59 min Frequency of sessions: 0 to 24 h Nebulization flow: 5 to 20 L/min Leak index Leaks compensation to maintain PEEP Triggers adapted to the leaks 0 to 80 cmH2O (under development) Yes Yes Adjustable by the user Yes Yes Yes Yes

Monitoring
Static compliance and resistance (Rstat Cstat) Total PEEP Plateau pressure (Pplat) Curves Loops FiO2 Digital values Automatic measurement in the ACMV Automatic measurement in the ACMV Automatic measurement in the ACMV Flow (t), Pressure (t) P/V, V/F, F/P 15 to 100 % MVe, VTe, MVi, VTi, RR, Ppeak, Pmean, PEEP, RR/VT (RSB), (MVi-MVe)/MVi (leak index), TI/Ttot, PEEP tot, Pplat, Cstat, Rstat, FiO2, Inspi. peak flow, Expi. peak flow, Trig. insp. (% cycles triggered by the patient) Yes, all parameters during 48 h 10000 events

Trends Events log (ventilation and alarms settings, activated alarms, suction, pauses)

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Advanced monitoring
Adjustable low inflation flow

eXtend, spcifications techniques.xls

Inflation flow: 2 to 10 L/min, PImax: 35 to 60 cmH20, VTi max: 500 to 2000 mL

Alarms Parameter
Visual and audio Power failure alarm Low batterie level Apnea PI high VTi low VTi high MVe low MVe high RR low RR high FiO2 low FiO2 high Automatic thresholds Mute function 3 different priority levels, with specific tunes and colors Yes Yes 15 s 10 to 90 cmH2O 10 to 1990 mL 20 to 3000 mL (or 5000 mL in NIV) 0,5 to 39,5 L/min 1 to 40 L/min 4 to 86 bpm 8 to 90 bpm 18 to 94 % 24 to 100 % On demand after the stabilisation of the parameters during 4 cycles 2 minutes

Sterilization
Parts to be sterilized Sterilization process Patient circuit assembly, humidifier chamber (if used), expiratory valve, water trap, expiratory flow sensor Autoclave (134 C, 18 min // 121C 30 min); cold (with ethylenoxide, gaseous formaldehyde)

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