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Ventilator-Medical-Device
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Ventilator – Medical Device

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Pediatric through adult (20 ml Tidal volume)

12’’ color touch screen

Ergonomic design helps to do better

Use for invasive and non-invasive

Automatic set-out raspiratory parameters by IBW determination

Categories: Hospital Equipment, Medical Device
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Description

72 hours trend storage

Smart alarm system

Capability to stay on for 2 hours with internal Battery

Automatic leak compensation

Automatic tube compensation

Modern pressure and flow trigger

 

Technical Specification
Ventilation Modes Assisted Control Mandatory Ventilation CMV
Synchronized Intermittent Mandatory Ventilation SIMV
Spontaneous Ventilation SPONT
Breath Types Volume–controlled breaths V–CMV, V–SIMV
Pressure–controlled breaths P–CMV, P–SIMV, PS
Volume Targeted Pressure–controlled breaths (Pressure Regulated Volume Control) & (Volume Support) PRVC–CMV,PRVC–SIMV,VS
Dual Level PEEP breaths (Spontaneous Positive Airway Pressure) SPAP
Patient Height 42 – 250 cm
IBW  (Ideal Body Weight ) 5–200 Kg
Gender Male, Female
VBS (Ventilator Breathing System) Acceptable Compliance range 0.5 – 5 ml/cmH2O
Acceptable Inspiratory Resistance range 0 – 2.5 cmH2O.s/l
Acceptable Expiratory Resistance range 0 – 2.5 cmH2O.s/l
Apnea Backup Settings On (Rate, Pcontrol,Ti);  OFF
Breath triggering Pressure triggering (-2) – (-20) cmH2O
Flow triggering 2 – 20 l/min
Additional Setting Respiratory Rate

Accuracy:±1 b/min or 4% wig

2– 120 b/min
Tidal Volume

Accuracy:

For 50–2000 ml:  ± (4 ml + 15% Actual reading)

For 20–49 ml:      ± (7 ml + 15% Actual reading)

20 – 2000 ml

(Compliance & BTPS compensated)

PEEP / CPAP

Accuracy:±12% or ±(2cmH2O +4% Actual reading)  wig

0 – 40 cmH2O
Pcontrol

Accuracy: ±12% or ±(2cmH2O +4% Actual reading)  wig

2 – 80 cmH2O
Psupport

Accuracy: ±12% or ±(2cmH2O +4% Actual reading)  wig

0 –60cmH2O
Peak Flow

Accuracy: ±12% or ±(3 l/min +4% Actual reading) wig

Mandatory

3– 120 l/min

Spontaneous

1 –200l/min

Leak Comp

Automatic Leak Compensation

On or Off
Base Flow 4.5 – 25 l/min
Flow Patterns Square, Dec, Dec 50%
NIV On or Off

Non–Invasive ventilation can be enabled in all modes.

I–Time (Ti)

Accuracy: ± 0.02 sec

0.2 – 5.0 sec
Pause (insp plateau)

Accuracy:  ±0.02 sec

0.0 – 2.0 sec
Rise time Fast, Med, Slow
Exhalation sensitivity

Accuracy: ±12% or ±(3 l/min +4% Actual reading) wig

10–80 % of peak flow
Oxygen (FiO2)

Accuracy (Delivery): ± (3 %) full scale

21 – 100 %
Nebulizer

Accuracy:  ±10 s

On or Off;

User selected duration (1–480 minutes)

User selected interval (1–480 minutes)

Sigh On or Off; 0 – 50% of volume or pressure setting

Interval; 20 – 200 breaths

Sighs per time: 1 – 6

Humidification Type None, HME, Warm Humidified
Compliance Comp On or Off
Graph Settings Waveforms; up to 3 (flow, pressure, volume)

Loops; 1 or 2

Trend Data Settings Up to 3 trends
Displayed Measurements 6
Compliance Compensation On or Off
Audio/Display Settings Audio Level

LCD Brightness

SPAP Mode Settings Phigh

Accuracy:±12% or ±(2cmH2O +4% Actual reading)  wig

5 to 50 cmH2O
Plow

Accuracy: ±12% or ±(2cmH2O +4% Actual reading)  wig

0 to 50 cmH2O
Psup High

Accuracy: ±12% or ±(2cmH2O +4% Actual reading)  wig

Phigh + Psup High will not exceed 80 cmH2O

0 to 75cmH2O
Psup Low

Accuracy: ±12% or ±(2cmH2O +4% Actual reading)  wig

Plow + Psup Low will not exceed 80 cmH2O

0 to 80 cmH2O
Thigh

Accuracy:  ±0.02 sec

(Thigh+Tlow ≤ 60 sec)

0.1 to 59.8 sec
Tlow

Accuracy:  ±0.02 sec

(Thigh+Tlow ≤ 60 sec)

0.2 to 59.9 sec
Monitored / Displayed Patient Values Pressure Values
Ppeak (peak pressure during a breath)

Accuracy: ±12% or ±(2cmH2O +4% Actual reading)  wig

0 – 100 cmH2O
PEEP (pressure at end exhalation)

Accuracy: ±12% or ±(2cmH2O +4% Actual reading)  wig

0 –100cmH2O
Pmean (averaged mean pressure)

Accuracy: ±12% or ±(2cmH2O +4% Actual reading)  wig

0 – 100 cmH2O
PendInsp

Accuracy: ±12% or ±(2cmH2O +4% Actual reading)  wig

0 – 100 cmH2O
Volume / Flow Values
Vte (expiratory tidal volume)

Accuracy: ±(4 ml + 15% Actual reading)

0 – 3000 ml
Vti

Accuracy: ±(4 ml + 15% Actual reading)

0 – 3000 ml
Ve (exhaled minute volume)

Accuracy: ±12 % or ±(2 L+ 4% Actual reading)  wig

0 –99l/min
VeSpont (spontaneous exhaled minute volume)Accuracy: ±12 % or ±(2 L+ 4% Actual reading)  wig 0 –99l/min
Leak

Accuracy: ±12 %  or ±(3% + 4% Actual reading)  wig

0 – 100%
PF (peak inspiratory flow)

Accuracy: ±12% or ±(3 l/min +4% Actual reading) wig

0 – 200 l/min
PFe (peak expiratory  flow)

Accuracy: ±12% or ±(3 l/min +4% Actual reading) wig

0 – 160  l/min
Time Values
Rate (measured mandatory and spontaneous breaths per minute)

Accuracy: ±1 b/min or 4% wig

0 – 150 b/min
Rate Sp.

Accuracy: ±1 b/min or 4% wig

0 – 150 b/min
Inspiration Time (Ti)

Accuracy: ± 0.2 sec

0.1   99.9 sec
Expiratory Time (Te)

Accuracy: ± 0.2 sec

0.1   99.9 sec
I:E, calculated only 1:99 – 99:1
H:L 1:599 – 299:1
Ti/Ttot

Accuracy: ±5% or ±1 wig

1 – 99.9%
Respiratory Mechanics
Cstat

(static compliance, lung stiffness)

Accuracy: ±10% or ±4 ml/cmH2O wig

0 – 250ml/cmH2O
Cdyn

(Dynamic compliance)

0 – 250 ml/cmH2O
Rinsp

(resistance of airways and tubes)

0 – 1000 cmH2O/l/sec
Rexp

(Expiratory resistance)

0 – 1000 cmH2O/l/sec
Auto PEEP (Actual PEEP – set PEEP)

Accuracy: ±12% or ±(2cmH2O +4% Actual reading)  wig

0 – 100 cmH2O
Pplateau

Accuracy: ±12% or ±(2cmH2O +4% Actual reading)  wig

0 – 100 cmH2O
RSBI

(Measured breathing rate divided by Insp tidal volume) (RR/Vt = RSBI)

Accuracy: ±10% or ±40 b/min/l   wig

0 – 3000 b/min/l
O2

Accuracy (Delivery): ±3 %

Response time < 30 s

15 – 103%
P0.1

(The maximal slope of the airway pressure drop during the first 100 ms when the airway is occluded.)

Accuracy: ± (2 cmH20 + 4%)

-30 – 0 cmH2O
NIF

(The maximum negative pressure generated during inspiration against an occluded airway)

Accuracy: ± (2 cmH20 + 4%)

-60 – 0 cmH2O
P0.1/NIF 0 – 100 %
WOBimp

(Work of breathing)

Accuracy: ± 10% Actual reading

0 – 20 j/l
RCe

(Expiratory time constant)

0 – 99.9 Sec
C20/C

(Compliance ratio)

0.00 – 5.00
Real Time Curves
Pressure + Time , Flow + Time , Volume + Time Pressure over time, Flow over time, Volume over time
P–V Loop, F–V Loop Pressure–volume loop, Flow–volume loop
Performing Procedures Inspiration-Hold Pause the ventilator at end inspiration

Maximum allowable duration shall be 20 sec

Expiration-Hold Pause the ventilator in expiration

Maximum allowable duration shall be 20 sec

Manual Breathing Delivery a mandatory breath during the next expiratory breath in all mode
P0.1 The maximal slope of the airway pressure drop during the first 100 ms when the airway is occluded
NIF The maximum negative pressure generated during inspiration against an occluded airway
Suction This function allows breaths to be delivered with a 100% O2 concentration, before and after a tracheal suction maneuver.

20 – 120 s; Resolution: 10

O2 100% Delivers O2 100% for 2 minutes
Standby Places ventilator in standby mode
Sigh Breaths delivered at a regular interval, with a higher than normal volume or pressure.
Nebulizer During the nebulization time, the nebulizer valve opens synchronous to inspiration to provide pressure for an external medication nebulizer
Configuration setting Sigh On or off,

0 – 50% of volume or pressure setting, Resolution: 1%

Interval: 20 – 200 breaths, Resolution: 1

Sigh per time: 1 – 6 breaths, Duration: 1

Nebulizer On or off, Duration: 1- 480 min, Resolution: 1

Accuracy: ±10 s

Humidification Type None, HME, Warm Humidified
Compliance Comp On or Off;
Power and Gas Supply AC input 100 to 240 VAC (47 – 63 Hz)
Battery Backup  (with fully charged battery) ≥120 min
High pressure oxygen inlet supply 29 – 87  psi clean, dry, and oil–free medical grade
Battery specification Type Two Li-Ion
Voltage, Energy 14.4 V, totally >80Wh
Alarm System Auditory alarm Internal speakers
Visual alarm In the TFT display
Indicator LED
Types Technical, Physiological, Messages
Priorities High, Medium, Low
Environmental Data Operating temperature 5 – 40 °C
Storage temperature (-10) – 60 °C
Operating Humidity 15% – 95% non condensing
Storage Humidity 5% – 95% non condensing
Operating altitude 11,000 ft (3,500 m) above sea level
Physical Data Width x depth x height (main case) 45 x 35 x 29 cm
Weight ≈12 Kg
Noise Level TBD
Display TFT Size 12.1” wide, with Touch screen
Pressure Safety Maximum limited pressure 110 ±10  cmH2O
Maximum operating pressure 80 cmH2O
Compliance and Approvals Classifications Class I equipment, Type BF, internally powered, drip–proof equipment for continuous operation

EMC related group and classification: I-B

Meets International Standards EN 60601-1: 2006

EN 60601-1-2: 2007

EN 60601-1-8: 2007

EN 60601-2-12: 2006

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