Pediatrics

Sophie The innovative Ventilation System

for Neonatology
inside + SpO2-Controller "SPOC"
controlled Oxygen Saturation
automatic FiO2 Adjustment
adaptive Increase of Ventilation
+ Synchronized, non-invasive Ventilation
through external Respiration Sensor
+ Integrated Respiratory Gas Humidification
+ High Frequency Oscillation
Sophie The flexible Neonatology Ventilation System

The requirements for sensitive ventilation units in neonatology are growing continuously.
To meet those requirements, Fritz Stephan GmbH has developed the SOPHIE ventilation
system based on state-of-the-art ventilation technology. By using SOPHIE, the individual
ventilation strategy for the premature and newborn infant can be implemented easily and reliably.
Modern trigger technology permits flexible synchronization of invasive and non-invasive venti-
lation. With SPOC, Fritz Stephan GmbH offers an adaptive controller SpO2 controller which,
for the first time, incorporates additional non-invasive ventilation into oxygen saturation control
strategy.

Oxygen Saturation Control SPOC

In cooperation with Ulm University Hospital/Germany, Fritz Stephan GmbH has developed an automatic
SpO2 control system for stabilizing oxygen saturation (SpO2). By combining the existing pulse oximetry of
your clinic with SOPHIE, double measurement can be avoided.

How does SPOC react to desaturation?

+ under NIV, the synchronized mechanical ventilation
is intensified and helps to positively influence
oxygen uptake (VO2).
+ Increase of FiO2 is not uniform, previous and
current events are taken into account.
+ In case of hyperoxia SPOC reduces FiO2 to below
25% within a very short time.

SPOC operates independently of the selected

ventilation form.

SPOC helps to:

+ prevent hyperoxia, to reduce oxidative stress
+ prevent hypoxia, to avoid hemorrhage and damage
to brain tissue
+ reduce SpO2 fluctuation
+ increase the period within the SpO2 target range
 Pediatrics

Ventilation forms Non-invasive Ventilation (NIV)

Easy accelerated change between all established, NIV allows lung protective ventilation strategies thus
conventional and pressure controlled ventilation forms reducing the occurrence of air leak syndromes and BPD.
is possible with just a single menu selection. NIPPV minimizes both the risk of respiratory failure
Also included is the volume guarantee feature, after extubation and the frequency of reintubation
which controls respiratory pressure of the subsequent significantly. By using an external respiration sensor,
inspiration corresponding to the previously measured patient abdominal movements are converted to a stable,
expiratory tidal volume. responsive (<30ms) trigger signal. This synchronized
non-invasive ventilation (SnIPPV) increases effective-
High Frequency Oscillation HFOV ness and reduces reintubation rates.
SOPHIE combines High Frequency Oscillation and
conventional ventilation forms in one device. HFOV Intuitive Operation Concept
can be activated immediately without replacing the Relevant ventilation parameters can easily be adjusted
patient tube by the push of just a single button. to the patient requirements prior to commencing
The application of an integrated, active respiratory ventilation. Effective monitoring allows safe supervision
humidifier does not create any additional compress- at all times.
ible volumes which may affect HFOV performance. Seperate adjustment of relevant parameters during ven-
tilation is simplified by clearly assigned buttons.
Optimum respiratory gas conditioning
The integrated active respiratory humidification
system supplies the patient by nebulizing optimally
warmed and humidified respiratory gas.
The intelligent control system prevents the formation
of condensate in the heated, temperature controlled
patient tubes. SOPHIE thus conditions respiratory
gas independently of auxiliary devices.
 Fritz Stephan GmbH
Medizintechnik Tel. +49 +6439-91 25-0
Kirchstraße 19 Fax +49 +6439-91 25-111
56412 Gackenbach [email protected]
Germany www.stephan-gmbh.com

General specifications Measured values

Patient range Neonates and pediatric patients up to 25 kg Pressure measurement
Classification II b (according to 93/42 ECC) Insp. pressure -20 - 99 mbar (Pmax)
Dimensions 470 x 342 x 332 mm (WxHxD) End expiration pressure -20 - 99 mbar (PEEP)
Weight 26 / 42 kg (without/with trolley) Mean airway pressure -20 - 99 mbar (Pmean)
Function principle Time cycled, pressure controlled Osc. amplitude 0 - 120 mbar (Posz)
Operational specifications Volume measurement
Power supply 100-240 V AC, 50-60 Hz, 210 VA, 24 V DC (opt.) Insp. tidal volume 0 - 999 l (VTins)
Battery backup min. 90 min. (with internal, rechargeable Exp. tidal volume 0 - 999 l (VTexsp)
Li-Ion-Battery) Leck volume 0 - 999 l (VTleck)
Gas supply Exp. minute volume 0 - 999 l/min (MV)
AIR 2.7 - 6.5 bar Osc. minute volume 0 - 999 l/min (MVo)
O2 2.7 - 6.5 bar Ventilation time parameters
Ventilation parameters Breathing frequency (F) 0 - 999 l/min
Ventilation modes Inspiration 0 - 100% (Insp%)
PC-IMV, PC-Ass./Cont., PC-SIMV, PC-HFO (opt.), PC-IMV-HFO O2 measurement
(opt.), PC-Ass./Con.-ITT, PC-SIMV-ITT, nCAP, NIPPV, SNIPPV (opt.) FiO2 0 - 100%
Modifications Volume guarantee (VtLim/VtTar) Breathing gas temperature
Inspiratory Time Termination (ITT) PSV Proximal measurement 12 - 60˚ C
Maneuver functions Inspiration Hold / Manual, Pre-oxygenation, Lung mechanics
Medication nebulization Resistance (R) 0 - 999 mbar/l/s
Ventilation settings Compliance (C) 0 - 999 ml/mbar
Frequency 1 - 300/min SpO2 0 - 100%
Inspiration time 0.1 - 2 s Base FiO2 0 - 100%
Expiration time 0.1 - 60 s Curve display Paw(t), V'(t), V(t), V(P), V'(V), V'(P), Arbs(t)
Tidal volume 2 - 150 ml (VtTar/VtLim) Trend display Pmitt(t), MV(t), VT(t), FiO2(t),
Pmax 5 - 60 mbar BaseFiO2(t), SpO2(t)
PEEP 0 - 30 mbar Trend duration 0,5; 1; 2; 4; 12; 24 (h)
Inspiration pattern Rectangle, sinusoidal, linear Alarms/Monitoring
Trigger sensitivity Airway pressure high/low (Pmax)
Flow 0.2 - 2.9 l/min Exp. minute volume high/low (MV)
Pressure 0.2 - 2.9 mbar Exp. tidal volume high/low (VT)
Abdominal movement 0.2 - 2.9 Arbs Insp. O2Concentr. FiO2 high/low
NIV MaxFlow Off/20 - 6 l/min Breathing gas temperature high/low
Breathing gas temp. 30 - 40˚ C End exp. pressure high (PEEP)
FiO2 21 - 100% Mean airway pressure high/low (Pmean)
Inspiratory Time Termination (ITT) PSV Osc. amplitude high/low (Posc)
Exsp.-Trigger KV% 5 - 40% V' Peak Osc. tidal volume high/low (Vosc)
Technical changes without notice. Fritz Stephan GmbH 03/2020

High frequency oscillation HFO Osc. minute volume high/low (MVosc)

Frequency 5 - 15 Hz BasisFiO2 high
Inspiration 33 - 50% FiO2 limit
MAP 0 - 30 mbar Disconnection
Amplitude Posz 5 - 100% Water level humidifier bottle
Amplitude Vosz max. 24 ml @ 10 Hz Apnea
Base FiO2 21 - 100% Interfaces / Monitors
Backup FiO2 Basis, 21 - 100% RS232: Vue Link, PDMS, IntelliBridge
SpO2 UL 84 - 100% GE Healthcare Patient monitor DASH 2000/3000/4000/5000
SpO2 LL 80 - 96% Patient monitor SOLAR 8000i/8000M/9500
Inspiration Hold / Manual Unity Network Interface Device in connection
Max. Hold time Tinsp 1 - 7 s with pulse oxymeter option
Medication nebulization Masimo Radical 7 Signal Extraction pulse CO oximeter
Aerosol time 30 - 420 s Philips IntelliVue X2, MP series, MX series
Pre-oxygenation Dräger Infinity series
FiO2 FiO2 - 100% Operating unit
Preoxy time 0 - 420 s Screen 10,4" color TFT
Color scheme Day view / Night view
Input devices Buttons + Turn-Push-Button