Ventilation Beyond Limits

Technical Data Sheet

Product: fabian HFO with SW 4.0 File: 7200.i TDS fabian HFO 1.0.8.pdf

Part No.: 7200.i Rev.: 1.0.8

Functionality
The fabian HFO is intended for premature infants, newborn’s as well as children weighing from
300 g to 30 kg.

Intended Use
The fabian HFO is intended for “in-patient use” in hospitals, medically-used rooms and intra-hospital
patient transport.
The fabian HFO is an electronically microprocessor controlled ventilator.
The fabian HFO ventilates with excess pressure based on the continuous-flow principle.
(Time cycled, pressure / volume limited / volume guaranteed )
Oxygen is metered by the integrated Air/O2 blender.
The oxygen concentration is measured internally with a galvanic oxygen sensor.

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Ventilation Beyond Limits

Ventilation modes

• HFO
High frequency oscillation ( piston, membrane principle ) – internal HFO connection
• IPPV
Intermittent Positive Pressure Ventilation
• SIMV
Synchronised Intermittent Mandatory Ventilation
• SIPPV
Synchronised Intermittent Positive Pressure Ventilation
• CPAP
Continuous Positive Airway Pressure
• PSV
Pressure Support Ventilation
• SIMV + PSV
Synchronised Intermittent Mandatory Ventilation combined with PSV
• NIV ventilation
nCPAP/duoPAP with variable flow generators
( Infant Flow®, Infant Flow LP®, InspireTM, Medijet® ) optional
• HFNC O2 Therapy
High and Low flow oxygen therapy optional

Enhancements

• Apnea ventilation
• Backup ventilation
• Combined SIMV + PSV ventilation
• Flow trigger
• Volume trigger
• Adjustable PSV termination criteria
• NIV with leak compensation
• Volume Guaranteed ventilation in conventional and HFO mode
• Volume Limit
• Demand flow in CPAP
• External bias flow
• PRICO enabled

Special procedures

• Manual inspiration / hold ( Sustained Lung Inflation / SLI )

• Lung recruitment ( sigh ) in HFO mode optional
• O2 flush

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Ventilation Beyond Limits

Ventilation parameter settings

Alarm delay 0 – 30 seconds

Automatic O2 calibration 21 Vol.%

21 Vol. % and 100 Vol. %

I-time settings Frequency / I-time

I-time / E-time

O2 Flush time OFF

30 seconds
60 seconds
120 seconds

Tubing set nCPAP MediJet ®

Infant Flow ® / Inspire™
Infantflow LP ®

Manual breath time 2 – 30 seconds

Manual breath HFO ON

OFF

Patient area Neonatal

Pediatric

Ppsv Parameter Absolute value

Above PEEP ( Delta p)

Restored settings Hospital settings

Factory defaults

Trigger mode Volume trigger

Flow trigger

Termination criteria PSV 5 – 35%

Unit for pressure mbar

cmH2O

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Ventilation Beyond Limits

Setting Ranges and Parameters

I-Flow [l/min] 1 – 32

E-Flow [l/min] 3 – 20

Rise Time [s] 0.1 - 2

I-time [sec] 0.1 – 2

E-time [sec] 0.2 – 30

Flow in O2 therapy mode [l/min] 0 - 19

Flow min. in CPAP mode [l/min] 4 - 16

Frequency[1/min] 2 – 200

PEEP [mbar] 0 – 30

Backup breath in CPAP mode 0–5

Pinsp [mbar] 4 – 80

P insp ( backup ) [mbar] 4 - 80

P manual [mbar] 4 - 100

P PSV [mbar] 2 - 80

Trigger (Volume) 10 – 25% from Vte in 10 steps

Trigger ( Flow ) 0.120 – 1.2 l/min in 10 steps

V limit [ml] 1 – 500

Pmax [mbar] 4 – 80

V guarantee [ml] 0.8 – 300

O2 [Vol. %] 21 – 100

O2 Flush [Vol. %] 23 – 100

Leakage compensation

Conventional modes Up to 100 %

HFO mode Up to 100 %

NIV ( nCPAP / duoPAP ) Up to 25 % (when enabled)

CPAP Up to 100 %

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Ventilation Beyond Limits

HFO Driver

Membrane technology.
Loudspeaker / Piston principle.
Active inspiration and expiration.
Very low power consumption.
No cooling needed.

HFO mode
Setting Ranges and Parameters

AMPmax [mbar] 5 – 100

Vguarant [ml] 0.3 – 100

O2 [Vol %] 21 – 100

O2 Flush [Vol.%] 23 – 100

Pmanual [mbar] 4 – 80

80 *
Hfamp [mbar] 100 *

HfFreq [Hz] 5 - 20

40 *
Pmean 50 *

1:1
1:2
I:E 1:3

Flow [l/min] 5 - 20

Freqrecruitment [1/hr] 1 - 60

Pmean recruitment [mbar] 7 - 50

I-Timerecruitment [s] 2 - 60

* country - specific

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Ventilation Beyond Limits

NIV ( nCPAP / duoPAP )

Setting Ranges and Parameters
I-time [sec] 0.15 - 15

E-time [sec] 0.2 - 30

Frequency [1/min] 2 - 60

O2 [Vol. %] 21 - 100

O2 flush [%] 23 - 100

Flow min [l/min] 0 - 19

CPAP [mbar] 2 - 13

P manual [mbar] 5 - 15

P duo [mbar] 5 - 15

Monitoring
Acoustic pressure of alarm tones A weighted sound pressure level in 1m distance : 46dB

Respiratory Rate High and adjustable

Minute Volume (MV) High / Low and adjustable

CPAP pressure Low (automatic)

Airway Pressure High / Low and adjustable

DCO2 High / Low and adjustable

ET Tube High Leakage / Tube obstructed (automatic)

Apnea Alarm Time 2 to 20 sec (adjustable)

O2 concentration (FiO2) Set value ± 5 Vol.% for > 1 minute at 21 Vol% below threshold value 18 Vol%

End-expiratory CO2 concentration (etCO2) High / Low (optional) and adjustable

Pmin in CPAP and HFO Disconnection alarm (automatic)

Integrated Battery Low / empty battery and reaming time in h:min

Power failure Alarm Acoustic and visual message

Gas supply failure Acoustic and visual message for O2 and Air
Automatic switch over

Ventilator (System)failure Acoustic and visual message with ID Code

Logbook Alarms and Warnings Up to 1000 events

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Ventilation Beyond Limits

Measuring
Airway measurement Range: -60 – 130 mbar
Precision: ±4%
Resolution 0.1 – 1 mbar

Breath volume measurement Range: 0 – 9.99 l ( BTPS ) (inspiratory and expiratory)

Precision: ±8%
Resolution 0.1 – 100 ml

Volume Controlled max. bias error: 0.5 ml

max. linearity error: 10% (1ml at 10ml)
max. error delivered vs. set volume: 0.5 mbar < 10 mbar
1 mbar > 10 mbar

Pressure Controlled Breaths max. bias error: 0.5 mbar

max. linearity error: 3%
max. error of airway pressure (Paw): 1 mbar or 3 %
max. error in delivered vs set PEEP: 0.5 mbar < 10 mbar
1 mbar > 10 mbar

Inspiratory Oxygen Concentration max. error delivered vs. set FiO2: 3 Vol. %
Response time to change in FiO2:
Conventional Ventilation blender delay is 1 breath.
HFO mode blender delay is 500ms.
Total Delay = Blender Delay + Pneumatic Delay

Tube leak Range: 0 – 50 %

Precision: ± 10 %
Resolution 1%

Dynamic compliance Range: 0-500 ml/mbar

Precision: ±8%
Resolution: 0.1 – 1 ml/mbar

Time constant R*C

Rapid shallow breathing index RSBI

Overdistension index C20 / C Range: 0-5

Resolution: 0.1

Inspiratory O2 concentration Range Range: 18 – 100 Vol. %

Precision: ± 3%
Drift: < 1 Vol% per month. < 15% rel. over entire
service life
Pressure influence: Proportional to change in partial pressure
Warm – up time: max. 3 minutes
< 30 minutes with new O2 sensor

etCO2 ( side stream ) Range: 0 – 150 mmHg

0 – 150 bpm
Precision: 0 – 38 mmHg ± 2 mmHg
39 – 150 mmHg ± 5% of reading + 0.08
Resolution: 0.1 mmHg
Response time: max. 4.3 s
Power up time: max. 10 s
Sampling flow: 50 ml/min
Airway adapter: Dead space: < 0.5 ml

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Ventilation Beyond Limits

etCO2 ( main stream ) Range: 0 – 150 mmHg

0 – 150 bpm
Precision: 0 – 40 mmHg ± 2 mmHg
41 – 70 mmHg ± 5% of reading
71 – 100 mmHg ± 8% of reading
101 – 150 mmHg ± 10% of reading
Resolution: 0.1 mmHg ( 0 – 69 mmHg )
0.25 mmHG ( 70 – 150 mmHg )
Rise time: 60 ms
Power up time: max. 15 s
Airway adapter: Dead space: < 1 ml

SpO2 Range: 1 – 100 %

25 – 240 bpm
Precision: SpO2: ± 3% ( neo and pediatric )
Pulse rate: ± 3 ( no patient motion )
Perfusion Index: PI

Measured values displayed

Airway pressure measurement (proximal) Positive End-Expiratory Pressure (PEEP)
Peak inspiratory pressure (PIP)
Mean airway pressure MAP (Pmean )
Lower pressure level in DuoPAP (Plow)
Upper pressure level in DuoPAP (Phigh)
Pressure amplitude (peak-to-peak) in HFO

Flow measurement Total minute volume (MV)

(proximal) Mandatory minute volume (MVmand)
Spontaneous minute volume (MVspon)

Tidal volume measurement Inspiratory Tidal volume (VTi) of mandatory breaths (VTimand)
Expiratory Tidal volume (VTe) of mandatory breaths (VTemand)
Inspiratory tidal volume of spontaneous breaths (VTispon)

Respiratory rate measurement Respiratory rate (RR)

Mandatory respiratory rate (RRmand)
Spontaneous respiratory rate (RRspon)

O2 measurement (FiO2) Inspiratory O2 concentration (FiO2)

CO2 measurement in side-stream flow, mainstream End-expiratory CO2 concentration (etCO2)

flow, microstream®

Displayed curves and Loops Flow / Volume / Pressure

Pressure / Volume Loop ( also in HFO mode )
Volume / Flow Loop ( also in HFO mode )
3 Waves at a glance

Trends Up to 5 days

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Ventilation Beyond Limits

Resistance Values
System resistance at 30 l/min < 20 mbar/l/s

Inspiratory resistance < 12 mbar/l/s

Expiratory resistance < 8 mbar/l/s

Physical Specifications
Dimension 30 cm x 37 cm x 40 cm
WxHxD

Weight approx. 20 kg with HFO module

Screen Diagonal screen size 10.4 “

TFT colour touch screen with LED Backlight
Keypad with 10 buttons

Input / output ports Input and output ports:

- 1 USB port ( SpO2 / SW update )
- 1 RS 232 ( 9 pin ) port for PDMS / HIS
- 1 RJ 45 Ethernet port for PDMS / HIS
- 1 Nurse call connector
- External trigger connector

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Ventilation Beyond Limits

Ratings
Air pressure supply 2.0-6.5 bar / 200 to 650 kPa / 29 to 94 psi
max. 40 l/ min.
Connection thread: NIST ( DISS adapter available )

O2 pressure supply 2.0-6.5 bar / 200 to 650 kPa / 29 to 94 psi

max. 40 l/min.
Connection thread: NIST ( DISS adapter available )

Power supply 100-240 VAC

0.9 – 0.5 A
50/60Hz
external 24 VDC 5 A
(no charging when connected via external battery connector)

Power consumption max. 100 W

Standby , fabian connected to mains: max 35 W

Internal Battery 16.8 V

4500 mAh
max. charging time: 5 hours
NIMH Battery
battery charge is continuously monitored
Battery run in HFO mode: 1 hour
Battery run in conventional mode (IPPV): 2.5 hour

Sound pressure Max. 52 dB (A)

Device fuse T 1.25 A L

Safety class Type B ≙ EN 60601-1

Certification IEC 60601-1

IEC 60601-1-2
IEC 60601-1-8
IEC 6060601-2-12

Classification according to EC directive 93/42/EEC Class II b

IP Protection IPX1, Protected against falling water Equivalent to 3-5mm rainfall per
minute for duration of 10 minutes. Unit is placed in its normal operating
position.

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