Sophie

Sophie
Pediatrics
Sophie
The innovative ventilaton system
for neonatology
+ Dead space free ventilation control with
external respiration sensor
+ Synchronized, non-invasive ventilation
+ Integrated respiratory gas humidifier
+ High Frequency Oscillation (HFO)
+ Ergonomic design
Sophie The flexible neonatology ventilaton system
In intensive cooperation with renowned physicians, Fritz Stephan GmbH has succeeded in
developing SOPHIE as a neonatology ventilator system based on the proven cutting-edge
technology of STEPHANIE thus ensuring highest levels of efficiency, design and operability.
With its flexibility and performance, SOPHIE can be adapted easily and reliably to the individually required ventilation situation for premature and newborn infants.
In addition to conventional and high frequency ventilation strategies it also allows non-invasive
ventilation. This system sets new standards of non-invasive ventilation of premature and newborn
infants by combining the innovative patient interface „EasyFlow nCPAP“ with dead space free
ventilation control via external respiration sensor.
Ventilation modes
SOPHIE offers all established conventional pressure
controlled ventilation forms. Convenient undelayed
change between various ventilation modes are
possible by simple menu selection.
As a matter of course, our well proven volume
guarantee is included in the range of features.
It controls ventilation pressure of the subsequent
inspiration according to the previously measured
expiratory tidal volume.
High Frequency Ventilation HFOV
SOPHIE is a ventilator that combines highfrequency oscillation and conventional ventilation
strategies in one unit. The HFOV, which is
available by pressing a button, can be carried out
without any delay or need to change the patient tubes.
The integration of the heated humidifier avoids any
additional compressible volumes that would reduce
the HFOV performance.
Optimum respiratory gas conditioning
The integrated respiratory gas humidifier provides
the patient simply and safely with ideally heated and
humidified respiratory gas through molecular humidification. The intelligent control system prevents any
condensation in the heated, temperature-monitored
patient tubes. SOPHIE thus needs absolutely no
additional equipment to condition the respiratory gas.
Pediatrics
Non-invasive Ventilation (NIV)
The benefits of a non-invasive ventilation therapy
for newborn or prematurely born babies have been
established by several scientific studies (e.g. COIN
study). The application of NIV permits lung-protective ventilation strategies thus helping reduce the
occurrence of air leak syndromes and BPD.
The use of NIPPV reduces the danger of ventilation
failure after extubation and therefore significantly
reduces the incidence of reintubation. A newly
developed system of Fritz Stephan GmbH detects
the abdominal movement of patients by means of
an external respiration sensor. This is then converted
into a stable, fast-reacting (<30ms) trigger signal, thus
allowing SNIPPV which can further improve the
efficiency of ventilation.
Although the BPD rate has the tendency to be
lowered by an early application of NIV, the risk of
pneumothorax may increase (especially in very
prematurely born babies) since exogenous surfactants
can only be safely applied to an intubated patient.
Due to its innovative control system, SOPHIE allows
swift changes between invasive and non-invasive
ventilation thus allowing the optimal support of the
so-called INSURE method
(INtubation-SURfactant-Extubation).
Innovative design
SOPHIE's innovative design combines top quality
aluminium and glass surfaces to produce an aesthetic
whole.
SOPHIE's compatibility with STEPHANIE is
another advantage: patient components, tubes and
sensors are identical thus allowing an easy exchange
between the two units.
Intuitive operation concept
All settings can be adjusted with just one single
knob. The user is guided systematically through the
ventilation menu, with the display only showing the
relevant parameters for the chosen ventilation form.
The parameters can be adapted easily to the patient's
needs even before starting ventilation. Efficient monitoring permits safe control at all times. Clearly allocated buttons make it much easier to separately adapt
the relevant parameters during ventilation.
Fritz Stephan GmbH
Medizintechnik
Kirchstraße 19
56412 Gackenbach
Germany
Phone +49 +6439-91 25-0
Fax +49 +6439-91 25-111
info@stephan-gmbh.com
www.stephan-gmbh.com
General specification
Patient range
Neonates and pediatric patients
up to 25 kg bodyweight
Class according to
93/42 ECC
II b
Dimensions
470 x 342 x 332 mm (WxHxD)
Weight
26 / 42 kg (w/o /with trolley)
Function principle
Time cycled, pressure controlled
Operational specification
Power supply
100 - 240 V AC, 50 - 60 Hz,
210 VA, 24V DC (opt.)
Battery backup
min. 60 min. (with internal,
rechargeable Li-Ion-Battery)
Gas supply
AIR
2.7 - 6.5 bar
O2
2.7 - 6.5 bar
Ventilation parameters
Ventilation modes
PC-IMV, PC-Ass./Cont., PC-SIMV, PC-HFO (opt.),
PC-IMV-HFO (opt.), PC-Ass./Con.-ITT,
PC-SIMV-ITT, nCPAP, NIPPV, SNIPPV (opt.)
Modifications
Volume guarantee (VtLim/VtTar)
Inspiratory Time Termination
ITT (PSV)
Maneuver functions Inspiration Hold / Manual
Medication nebulization
Preoxygenation
Ventilation settings
Frequency
1 - 300/min
Inspiration time
0.1 - 2 s
Expiration time
0.1 - 60 s
Tidal volume
2 - 150 ml (VtTar/VtLim)
Pmax
5 - 60 cmH2O
PEEP
0 - 30 cmH2O
Pmin
PEEP-Pmax
Inspiration pattern
Rectangle, sinusoidal, linear
Trigger sensitivity
Flow
0.2 - 2.9 l/min
Pressure
0.2 - 2.9 cmH2O
Abdominal movem. 0.2 - 2.9 Arbs
NIV MaxFlow
Off/20 - 6 l/min
Breathing gas temp. 33 - 39 °C
FiO2
21 - 99 %
Inspiratory Time Termination (ITT) PSV
Exp.-Trigger KV% 5 - 40 % V‘ Peak
High Frequenzy Oscillation HFO
Frequency
5 - 15 Hz
Inspiration
33 - 50%
MAP
0 - 30 cmH2O
Amplitude Vosc
max. 24 ml @ 10 Hz
Inspiration Hold / manual
Max. Hold Time
Tinsp./1 - 7 s
Ventilation settings
Medication nebulization
Aerosol time
30 - 420 s
Preoxygenation
FiO2
FiO2 - 100%
Preoxy time
0 - 420 s
Measured values
Pressure measurement
Insp. press.
-20 - 99 cmH2O (Pmax)
End-Expir. press. -20 - 99 cmH2O (PEEP)
Mean airway press. -20 - 99 cmH2O (Pmean)
Osc.-amplitude
0 - 120 cmH2O (Posc)
Volume measurement
Insp. tidal volume 0 - 999 l (VTins)
Exp. tidal volume 0 - 999 l (VTexp)
Leak volume
0 - 999 l (VTleak)
Exp. minute volume 0 - 999 l/min (MV)
Osc. minute volume 0 - 999 l/min (MVo)
Ventilation time parameters
Breathing frequency 0 - 999/min (F)
Inspiration
0,1 - 100% (Insp%)
O2 measurement
FiO2
0 - 100%
Breathing gas temperature
Proximal measurem. 12 - 60 °C
Lung mechanics
Resistance (R)
0 - 999 H2O/l/s
Compliance (C)
0 - 999 ml/cmH2O
Curve display
Paw(t), V‘(t), V(t), P(V), P(V‘),
V(V‘), Arbs(t)
Trend display
Pmean(t), MV(t), VT(t)
Trend duration
0,5, 1, 2, 4, 12, 24 (h)
Alarms/Monitoring
Airway pressure
high/low (Pmax)
Exp. minute volume
high/low (MV)
Exp. tidal volume
low (VT)
Insp.O2-Concentr. FiO2 high/low
Breathing gas temp. high/low
End-Exp. pressure
high (PEEP)
Mean airway pressure high/low (Pmean)
Oscillatory amplitude high/low (Posc)
Osc. tidal volume
high/low (Vo)
Osc. minute volume high/low (MVo)
Disconnection
Water level humidifier bottle
Apnea
Interface
RS232: VueLink/PDMS
User interface
Display screen
10,4" Color-TFT
Color-Schemes
Day view / Night view
Input devices
Buttons + Turn-Push-Button
Technical changes without notice. Fritz Stephan GmbH 10/2011
Technical Specifications
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