3.2      Technical Data of the DIBTA 16 Port Analyser 

3.2.1     General Data

Type DIBTA 16 PORT DA8106 and Type:  DAN-HP-4 Port  DA8124 

3.2.1.1    Unit construction

Table top unit with screwed casing. The analyser unit is hermetically sealed 

3.2.1.2    Casing

Sheet aluminum housing with plastic case. 

3.2.1.3    Dimensions approx.

Width:  45      cm      

Height: 27,5     cm      

Depth:  53       cm (50 cm without tubes)) 

3.2.1.4    Weight:

Approx.20 kg 

3.2.1.5    Gas processing:

All gases are transported within the analyser by the integrated feed pump. The surrounding air destined for rinsing is lead across a  filter (optional Nafion, soda lime) for processing and protecting the analyser. CO2-free air (zero gas) is produced by piping surrounding air through a absorber containing soda lime. 

3.2.1.6    Gas ports:

4  to 16 sample ports for breath bags from which measuring gas is pumped into the analyser; inlet port for rinsing gas and extra gas each; gas outlet.  

3.2.1.7    Protection classification

24VDC max. 4A, typ. 1,5A - the device has been tested according to EN 60601-1-2: 12.2007 for Electromagnetic Compatibility and therefore exceeds the requirements of the EN 61326. 

3.2.1.8    Degree of protection

           In accordance with EEC low voltage directive 2006/95/EG   

3.2.1.9    Operating System:

Windows standard 7, 10 

3.2.1.10 Data System

Laptop minimum quad core I5 or I7 or equivalent recommended 

3.2.1.11 Software

DIBTA Software from Delta Analytics ( Version: 15, 16)

Multitasking on specified operation systems

Database system

                H2 –Database             Report Interfaces pdf-Report (implemented)  

Optional: Excel-Report

Optional: Interfaces for Hospital Management Software f. ex.  HL7 Interface 

3.2.1.12 Electric connections:

           Measuring output, signal output and input respectively:  

Standard Ethernet adapter (RJ45).   

3.2.1.13 Power supply:

           Mains voltage:  

90 … 264 VAC (Auto Range/external medical power supply) 47 … 63 Hz

Power consumption:

max. 100 VA (during warm up) / 50VA standard operation mode. 

3.2.1.14 Climatic conditions

Ambient temperature:

+15 °C to +30 °C 

3.2.1.15 Storage and transport temperature:

+5 °C to +45 °C 

3.2.1.16 Operations range for relative humidity:

< 75 % rh yearly mean value 

3.2.1.17 Operating altitude:

-400 to 2200 meter MSL 

3.2.2     Measuring Data

3.2.2.1    Time behaviour

Tempering analyser to 50 °C:

0.5 h  / warm up

8 h to reach maximal stability   

Measuring time per sample:

maximum 2 minutes (typical 1.6 minutes) 

3.2.2.2    Sample gas consumption (minimum required sample volume)

Standard: Breath bag: 25 ml to 50 ml (minimum required sample volume)   

optional: Sample container: 12 ml 

3.2.2.3    Measurement span

0.5 % CO2 up to 8 % CO2 

clinical relevant: 0,5 % CO2  .. 5 % CO2 

3.2.2.4    Linearity

max. deviation of the 12CO2-value:

r = 0,98

max. deviation of the isotope ratio:

r = 0,98 ( clinical relevant range; = -40 ... +250 ‰ for NDIR) 

3.2.2.5    Precision of a single measurement:

           standard deviation of Delta value: +/- 0.2 ‰  

(with 30 data acquisitions > 1 vol-% CO2 sample from large gas bag)  

3.2.2.6    Repeatability of Delta value

+/- 0.36 ‰

(intraindividual, 10 measurements, concentration > 1.5 vol-% CO2 

3.2.2.7    Reproducibility of Delta value:

+/- 0.41 ‰

(extraindividual, concentration > 1.5 vol-% CO2) 

3.2.2.8    Stability

Semi-automatic drift compensation by integrated comparision media.

Zero point adjustment:

by internal generated CO2-free air

End point adjustment:

built-in calibration cells (to be checked once a year)

3.2.2.9    Influence effects  

Associated gas / transverse sensitivity:

                    compensated by filtering and internal electronic correction  

Temperature influence:                                                                                      

<= 1% of the measured value per 10 K ambient temperature

Atmospheric pressure influence:

zero point: no influence

sensitivity: <= 0.2 % of the measured value per 1 % change of pressure 

3.2.2.10 Gas inlet conditions

Temperature:

clinical relevant range: 5 °C to + 35 °C

Pressure inside the measuring chambers:

1 atm (1013 hPa)  max. 1200 hPa ( 200 hpa overpressure)

Flow rate:

given by the internal gas feed pump (typical value 10 l/h)