1. Performance comes from innovation
Measurement accuracy requirements for Reference Meters used in the calibration of dialysis machines
This slide shows the IBP‘s products.
Rigth: HDM99XP
Middle: HDM97Pocket
Left: Heat Exchanger for Dialysis Machines
100508

2. Recommendations
If no manufacturer recommendation is available, a risk analysis must be carried out by the dialysis provider.
B.Braun IBP Meters
FMC UMED and IBP Meters
Gambro Mesalab meters and IBP Meters
Nikkiso IBP Meters

3. What accuracy do we need?
This is the most important question in a risk analysis.
The Guidance Section of the international standard ISO "General Quality Assurance Requirements for Measuring Equipment" gives detailed information on this question:
 "The error attributable to calibration should be as small as possible. In most areas of measurement, it should be no more than one third and preferably one tenth of the permissible error of the confirmed equipment when in use.“
This means that the measuring equipment for the calibration of dialysis machines must have a measuring accuracy which is at least three times higher than the measuring accuracy of the dialysis machines.

4. References to calibrate
The goal of calibration is …
… to connect the dialysis machine to the national standard.
Chain of accuracy
Dialysis Machine
Referenc meters
References to calibrate
National
Primary Standard
Fresenius
B.Braun
Gambro
Nikkiso
IBP
Mesalabs
Temperature
Conductivity
Pressure
NIST
PTB
etc.
To be connected to the national standard the accuracy of each step in the chain must be at least 3 time higher.

5. References to calibrate
Conductivity chain of accuracy
Dialysis Machine
Referenc meters
References to calibrate
National
Primary Standard
0.1 mS/cm
0.03 mS/cm
0.01 mS/cm
mS/cm
0.01 mS/cm is already the technical border for meteorological reference institutes like NIST and PTB.
This shows already the technical border for conductivity measurement.

6. Conductivity Measurement Accuracy Temperature Measurement Accuracy
Measuring Accuracy of Dialysis Machines
Machine
Conductivity Measurement Accuracy
Temperature Measurement Accuracy
FMC S
±0.1 mS/cm
±0.5°C
Gambro AK200
+0.5/-1.5°C
Gambro Phoenix
±0.2 mS/cm
B.Braun Dialog
±0.5°C*
Machine
* Not available, value estimated

7. Temperature to compensate
Influence of Temperature Measurement Accuracy
Conductivity mS/cm
Temperature °C Reference Temperature 25 °C
TPC 2,07 %/°C
As the typical dialysate temperature is 37°C the meter needs to compensate 12 °C.
Meter Temp. Accuracy
Temperature to compensate
Possible Error
With correct TPC
0.05 °C
12 °C
0.017 mS/cm
0.5 °C
0.17 mS/cm
0.1 °C
0.35 ms/cm
0.2 °C
0.70 ms/cm
Meter Accuracy
at 37°C
HDM97 – HDM99
90XL
90DX - NEO2
This example illustrates how important the accuracy of the temperature measurement is.

8. Dialysis Machine Manufacturer Temperature Coefficient
Conductivity Temperature Compensation
To make technicians life interesting, different manufacturers of dialysing machines use different temperature coefficients.
The following values are used:  
Dialysis Machine Manufacturer
Temperature Coefficient
Baxter (European Machine)
2.20%/°C
B.Braun
2.10%/°C
Fresenius
Gambro (not the US Phoenix Machine)
1.80%/°C
Hospal
2.07%/°C
Nikkiso Bicarbonate conductivity Total conductivity
2.02%/°C 2.05%/°C

9. Conductivity of Solution Temperature of Solution
Conductivity Temperature Coefficient - Differences
As the typical dialysate temperature ist 37°C the temperature compensation coefficient becomes very important.
Conductivity of Solution
Temperature of Solution
Temp. Coefficient
Machine
Instrument
Reading
Difference
14.00 mS/cm
37.0 °C
2.07 %/°C
0.00 %
1.97 %/°C
14.17 mS/cm
1.21 %
Thus, this example illustrates that the user must set the temperature coefficient correctly in order to ensure accurate conductivity measurements.
The temperature coefficient must be selectable!

10. Temperature coefficient
Conductivity Temperature Coefficient Selection
Display
To use for
Temperature coefficient
at 25°C
at 37°C
BAXTER
Baxter (Europe Dialysis-Machine)
2.000 %/K
2,200 %/K
BELLCO
Bellco
2,000 %/K
2,100 %/K
B.BRAUN
B.Braun
FRESENI
Fresenius
GAMBRO
Gambro
AK-Type and Phoenix Machines
2,070 %/K
HOSPAL
Hospal
NIK ALL
Nikkiso Overall Conductivity
2,050 %/K
NIK BIC
Nikkiso Bicarbonate Conductivity
STANDARD
Other Dialysis Machines
USER TC
Adjustable
0 … 5,000 %/K
nLF-ISO
Non Linear Function for
tap, purified and waste water.
According Standard ISO7888 – DIN EN27888 Reference temperature 25°C
RO-DWA
Reverse Osmosis DWA DWA GmbH & Co. KG
Ubstadter Straße 28
76698 Ubstadt-Weiher
0,00 %/K
RO-HERCO
Reverse Osmosis Herco
Herco Wassertechnik GmbH
Planckstraße 26
71691 Freiberg
Reference temperature 25°C
RO-LAUER
Reverse Osmosis Lauer
LAUER MEMBRAN WASSERTECHNIK GmbH
Industriegebiet Speichermatt
79599 Wittlingen
nLF-ISO according Standard ISO7888 – DIN EN27888 Reference temperature 25°C
RO-PPW
Reverse Osmosis PPW
Phoenix Pure Water GmbH
Siemens Technopark
Werner-von-Siemens-Str. 2-6
D Bruchsal - Germany
2,200 %/K Reference temperature 25°C

11. Accuracy Dialysis Machine 1/3 accuracy according to the Standard
Machines vs. the Standard vs. Reference Meters
Accuracy Dialysis Machine
±0.2 mS/cm
±0.1 mS/cm
±0.5°C
1/3 accuracy according to the Standard
±0.07 mS/cm
±0.03mS/cm
±0.17°C
Accuracy IBP
Meters
±0.03 mS/cm
±0.05°C
Accuracy MESA
90XL
±0.03 mS/cm
±0.1°C
Accuracy MESA
NEO-2
±0.05 mS/cm
±0.1°C
Accuracy MESA
90DX
±0.1 mS/cm
±0.2°C
The displayed accuracy values apply to 14 mS/cm and 37°C.

12. Which meter can be used with which machine
IBP Meters
MESA
90XL
NEO-2
MESA 90DX
B.Braun
FMC
Gambro AK200
Gambro Phoenix
Water Treatment
Suitable - accuracy level of all channels higher than required
Suitable for temperature but for conductivity only if temperature reading is be better than technical data
Not suitable - accuracy below level required

13. Features comes from innovation
Dialysis Reference Meter
This slide shows the IBP‘s products.
Rigth: HDM99XP
Middle: HDM97Pocket
Left: Heat Exchanger for Dialysis Machines
Heat Exchanger for Dialysis Machines
100508

14. Ask now Any question? werner.pfingstmann@ibpmedical.com
or at any time:

15. www.ibpmedical.com Thank you for your attention! IBP Medical GmbH
Ikarusallee 15
30179Hannover
Germany
Phone:
Fax:
IBP Medical Inc.
4113 W. St. Charles Ave.
PHOENIX AZ 85041
USA
Phone
Fax