NO-A nitric oxide delivery system

In June 2010 EKU Elektronik received the outpout orientated innovation award "Success" by the Investitions- und Strukturbank Rheinland-Pfalz (ISB) GmbH for the successful development of the NO-application device NO-A. EKU Elektronik received the award for the NO-A, a therapy device for the application of nitric oxide (NO) therapy gas in the ventilation flow of an intensive care patient in connection with different ventilators.

The inhaled nitric oxide (iNO) therapy shall reduce the clinical necessity of a left-to-right shunt and contribute to cardiac relief. In order to improve the oxygenation of ventilated patients nitric oxide (NO) is added to the respiratory gas.

It is applied for the treatment of newborns, children and adults with pulmonary hypertension, oxygen deficiency, neonatal pulmonary failure, persistent pulmonary hypertension of neonates, pulmonary fibrosis, chronic obstructive pulmonary disease (COPD) and acute respiratory distress syndrome (ARDS). Furthermore the device is used in cardiac surgery (cardiac valve diseases and cardiac transplantation) to treat an increased pulmonary pressure, as inhaled NO has a dilating effect on the blood vessels in the lung and therefore significantly improves the haemodynamics of the patient. Please refer to the relevant details listed in the information accompanying the finished medicinal product.


Features:

  • neonatal, paediatric or adult application
  • direct connection by ventilator interface
  • optional flow sensor for support of external ventilators of different brands
  • convenient design and comprehensive power supply for intrahospital transport (mains, 12V, battery)
  • dual cylinder management: operation with one or two cylinders with automatic flush and cylinder switching
  • wide-ranging cylinder compatibility (50 – 1000 ppm)
  • fail-safe dosing by secondary dosing system
  • wide dosing range by clocked dosing (13 µl/min – 17 l/min)
  • extended concentration range (0.1 – 99.9 ppm)
  • triggered or continuous dosing mode
  • dosing trend (1 h / 24 h)
  • timer (for non-responder-test or weaning)
  • integrated gas monitoring
  • optional oxygen monitoring
  • ambient air monitoring
  • interface connection to PDMS (e.g. via Philips VueLink/IntelliVue, EKU-PDMS and others)

Ventilator Compatibility NO-A

The NO-A has different operating and dosing modes which enable a combination with almost any ventilator. Besides the manual operation, which enables the user to adapt the therapy to a wide spectrum of ventilation situations by adjusting the ventilation flow independently, the NO-A offers two other operating modes which automatically adjust to the conditions in the ventilation circuit with the ventilator interface and a flow sensor.

The dosing modes differ from continuous and triggered dosing mode. An optional third mode even allows the operation in semi-closed systems of anaesthesia units by a dosimetric procedure (currently only available in Germany).


Operating modes

via ventilator coupling

EKU Elektronik is the only manufacturer of nitric oxide delivery systems with electronic connection (interface) to different ventilators of well-known manufacturers. By the connection to the ventilator the required volume is automatically dosed close to the patient corresponding to the adjusted target concentration.

This direct coupling to the ventilator enables:

  • economy in consumption of the therapy gas
  • continuous adjustment to a wide-ranged therapeutic application frame
  • automatic adjustment for therapeutic maneuvers
  • short NO standing times in the breathing gas and consequently minimization of risks caused by conversion products

Currently available ventilator interfaces:

Getinge (MAQUET) 



SERVO-i
(from V4.00):
triggered*

SERVO-s
(from V4.00):
triggered*

SERVO-U
(from V1.02):
triggered,
V2 only*

SERVO-n
(n/a):
triggered

SERVO300
(n/a)
:
continuous

Flow-i
(from V4.04.00):
bolus/dosimetry, V2 only * (Germany only)

 

Dräger

Evita 2 dura
(from V 3.5)
:
triggered*
Evita 4
(from V4.25)
:
triggered*

Evita XL
(from V7.05)
:
triggered*

Evita V300
(from V2.40)
:
triggered*
Evita V500
(from V2.40)
:
triggered*

Babylog 8000
(from V5.0)
:
continuous*

Babylog VN500
(from V2.40):
triggered,
continuous*, **

Primus
(from V04.53.00)
:
bolus/dosimetry, V2
only * (Germany only)
Perseus
(from V2.01):
bolus/dosimetry, V2
only *(Germany only)

 

Hamilton Medical


HAMILTON-T1/C1
(from V2.0.0/P 1.0.4)
:
continuous,
V2 only*

HAMILTON-C3
(from V2.0.0)
:
continuous,
V2 only*
HAMILTON-S1/G5
(from V2.6.0/P 1.0.6):
continuous,
V2 only*


HAMILTON-C6
(from V1.1.1):
continuous,
V2 only*

Löwenstein Medical


Leoni plus
(from V2.3.30/HULBUS 0.0.4):
continuous,
V2 only **

 

 






*  Compatibility depends on ventilator SW / HW version.

** Dosing mode depends on ventilator mode.

via flow sensor

Furthermore the NO-A offers optional compatibility to almost any ventilator by using the external flow sensor.

The NO-A flow sensor is installed in the ventilation circuit, measures the real flow in the inspiratory way and enables automatic dosing of the required volume.

Already known settings with flow sensor:

Getinge (MAQUET)


SERVO-i: triggered
SERVO-s: triggered
SERVO-U: triggered

Löwenstein Medical

Leoni plus: triggered

Hamilton Medical

HAMILTON-S1/G5: triggered

ACUTRONIC Medical Systems

fabian HFO: triggered, V2 only 

HFO mode with EKU flow sensor max. 14 Hz

Dräger

Evita 2 dura: triggered
Evita 4: triggered
Evita XL: triggered
Evita V300: triggered
Evita V500: triggered
Babylog 8000: triggered
Babylog VN500: triggered

GE Healthcare

Engström Workstation
: triggered
Centiva /5: triggered

 

Covidien 


Puritan Bennett 840: triggered

CareFusion 


SensorMedics 3100A/B HFOV: triggered
Avea: triggered
Infant Flow SiPAP: triggered

Air Liquide Medical Systems


eXtend XT: triggered

 

SLE 


SLE5000
: 
triggered

SLE6000: triggered

Novalung


ALPHA100 (HFVO): triggered

Dosing modes:

continuous dosing

With this dosing method the therapy gas is supplied in continuously clocked cycles to the ventilation by knowing the MVi-value and a "quasi-continuous" dosing is achieved by the time in the inspiratory path of the breathing circuit. This dosing method is also found in the NO-A's secondary dosing system.

triggered dosing

The triggered dosing of NO-A applies the corresponding amount of therapy gas by analysing the available flow curves with the approach to achieve a "flow-proportional" NO-dosing and thus to receive a constant NO-concentration in the inspiratory tube even with varying flows.

dosimetric application

Performances of iNO-therapy are based on the continuous availability of the drug in the inspiratory breathing flow/respiratory gas stream. The effect of the drug is linked to the NO-molecule in the interaction of the muscle cell, not to the concentration at the patient tube. A bolus-wise dosing is therefore a dosimetric procedure which doses a proportional volume of nitric oxice (iNO) referring to the tidal volume at the beginning of each breath.

dosimetric application

For this the nitric oxide has to be led in at the Y-piece close to the patient. Compared to the conventional dosing methods the dosimetric application in a bolus offers the advantage of transporting the drug to the target cells in a more controlled way with simultaneous minimisation of the contact time between nitric oxide and the oxygen existing in the respiratory gas. The shorter the contact time, the less nitrogen dioxide is produced as toxic conversion product. Furthermore this dosing method enables to reduce the consumption of therapy gas significantly, as only actually applied respiratory volume has to be enriched with nitric oxide.


For any questions regarding ventilator compatibility of a system applied by you, please contact us or any of our authorised cooperation partners.

NO-A variations

In Germany and Europe the nitric oxide delivery system NO-A can also be found in the following variations and is distributed, calibrated and serviced by the below mentioned cooperation partners:

NO-A with front foil blue

NO-A with front foil blue 
exclusively distributed by MAQUET Vertrieb und Service Deutschland GmbH

countries: Germany, Austria, Switzerland, BeNeLux

CARDINO

CARDINO 
exclusively distributed by Linde Gas Therapeutics GmbH

countries: Germany only

EZ-KINOX

EZ-KINOX 
exclusively distributed by Air Liquide Santé Services, France

countries: Europe

Cooperation Partners

Distribution and service of the NO-A or of the different NO-A variations are exclusively performed by our authorised cooperation partners from the field of ventilation and gas supply such as:

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