SOMNOmedics SOMNOtouch RESP User manual

I
NSTRUCTION MANUAL
Miniaturized
Pneumotachograph for
SOMNOtouch™ RESP
SOMNOmedics GmbH –Am Sonnenstuhl 63 –D-97236 Randersacker
Tel. (+49) 931 / 35 90 94-0 –Fax (+49) 931 / 35 90 94-49
E-Mail [e-mail] –Internet www.somnomedics.de

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SOMNOmedics GmbH –Am Sonnenstuhl 63 –D-97236 Randersacker
Tel.: (+49) 931 / 35 90 94 - 0 –Fax: (+49) 931 / 35 90 94 - 49
E-Mail: [e-mail] - Internet: www.somnomedics.de
Rev. 1
01.08.2014

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1. Contents
2. Intended use.................................................................................................................................... 4
3. Functionality.................................................................................................................................... 4
4. Safety note ...................................................................................................................................... 4
5. Initializing the measurement .......................................................................................................... 5
6. Attaching the senor......................................................................................................................... 7
7. Calibration procedure ..................................................................................................................... 8
8. Adjusting the analysis.................................................................................................................... 11
9. Cleaning and disinfection .............................................................................................................. 12
10. Contact ...................................................................................................................................... 13

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2. Intended use
The miniaturized pneumotachrograph in combination with the differential pressure sensor, the SOMNOtouch™
RESP and the breathing volume analysis of the DOMINO light software offers the capability of measuring and
analysing:
Flow rate of the respiratory signal
Breathing frequency
Tidal volume
Minute volume
Leakage flow
Leakage
3. Functionality
The Pneumotachograph is a flow resistance with a well-defined relationship between flow rate and pressure
drop. Depending on the ex- or inhalation flow rate of the patient, a different pressure drop occurs across the
pneumotachograph. That is, the air pressure upstream of the pneumotachograph is higher than the air pressure
downstream. By measuring this pressure drop with a differential pressure sensor, the respiratory flow can be
determined.
4. Safety note
This device is NOT designed to be used in a Life Support situation, surgical rooms, intensive care units,
or in emergency vehicles.
The unit should be used by doctors or other qualified medical personnel who have been trained in the
intended use.
Position the cables or hoses NOT in a way that leads to entanglement or strangulation.
Avoid excessive tension on any cable.
Read the manual before using this device and follow the manufacturer’s instructions.
Use only SOMNOmedics accessories which are recommended in this instruction manual.
Opening the casing, repairing or modifying the device in any way will void the guarantee.

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5. Initializing the measurement
Follow the usual steps for initializing a measurement with the SOMNOtouch™ RESP. If you have any questions,
you will find a detailed description of the necessary steps in the manual for the DOMINO light Software.
For the study setup described above, a montage is already included in the DOMINO light Software installation.
To use it, change to the advanced mode in the Initializing window. Now, go to the “Montage” tab and select
the “SOT RESP+Pneumo“ entry in the list of existing montages. You will get the following view in the montage
selection:
Figure 1: montage selection in the advanced mode
By clicking the “Application plans” button, which is at the bottom of the window, a document will open. This
document includes one page descriptions of the correct application of the different sensors, which are
available for the SOMNOtouch™ RESP. If you scroll down, you will find an instruction for using the
pneumotachograph. You can print off this document and pass it to the patient.
If you want to add the pneumotachograph to an existing montage, add the sensors depicted below to the
montage.
These should now appear in the signal overview at the right hand side of the window.
Figure 2: sensor selection for adapting an existing montage

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Figure 3: signal overview when selecting the two necessary sensors

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6. Attaching the senor
1. Use the corresponding belt to fit SOMNOtouch -1- on the patient’s thorax. Attach SOMNOtouch
over a pajama and not directly on the skin! Patients with pacemaker should consult their
physician before attaching SOMNOtouch to the body.
2. Fit the effort belt -2- around the patient’s abdomen and connect the plug to the one of the two
lateral AUX connectors of the SOMNOtouch.
3. Attach the SpO2 sensor -3- on one finger and connect the plug to the SpO2 connector on the
bottom of the device.
4. Connect the pneumotachograph -4- side with the white Luer-Lock connector to the CPAP device
-6- using the CPAP tube -5-.
5. Connect the opposite end of the pneumotachograph -4- (black Luer-lock) to the mask via the
CPAP oxygen adapter -7-.
6. Use the CPAP pressure tubes -8- to connect pneumotachograph -4- and the differential pressure
sensor -9-.
Please make sure that the white Luer-Lock connector of the pneumotachograph -4- is the one
adjacent to the CPAP device and attached to the colour matched, positive pole of the
differential pressure sensor -9-!
7. Connect the differential pressure sensor -9- to SOMNOtouch -1- and attach it to the thorax belt.
8. Connect the SOMNOtouch -1- pressure input to the CPAP oxygen adapter -7- using a CPAP
pressure tube -10-.
If the mask has a suitable pressure outlet, the pressure tube can be connected directly to the
mask and the adapter can be omitted.
9. Fit the mask.
Figure 4: Measurement with the pneumotachograph

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7. Calibration procedure
As part of the production and testing of the differential pressure sensors, SOMNOmedics performs a calibration
procedure. Because of changing environmental conditions it is possible that there are zero shifts - so called
offsets. Therefore, in each measurement it must be examined whether there is an offset. If that is the case, a
zero-point calibration is necessary.
Proceed as described below:
As part of the measurement, allow for a period of at least 1 minute, in which the sensor is connected
correctly and there is no airflow through the pneumotachograph. It is possible to do this at the
beginning or at the end of the measurement. Don´t use the mask and don´t turn on the ventilation
during this period!
After the end of the recording, when you have transferred the recording to your computer, look for
the period for which you know that no airflow was present through the pneumotachograph. Select the
relevant area by left-clicking and dragging the cursor. It is possible that a non-zero average value is
displayed –the mentioned offset.
To eliminate this offset, click with the right mouse button on the channel description PT flow to open
the context menu. (Figure 5)
Confirm “Zero Point Calibration” with the left mouse button in the context menu. The PT curve flow is
shifted according to the defined zero point (Figure 6). The analyzes will also be automatically adjusted
and corrected.
Figure 5: selected period in the PT Flow
channel and opened context menu
Figure 6: PT Flow after offset removal
Volume calibration with calibration pump
If you reserve the right to make a recalibration, you can do this via another software function. You
need an additional calibration pump- a pump that displaces a defined volume per pump stroke. You
can use it to simulate a respiratory signal and record it with the SOMNOtouch. Figure 7 shows such a
measurement with a calibration pump. In order to adjust the calibration of the pneumotachograph,
the known volume of the calibration pump can be entered manually and the analysis will be adjusted
accordingly. Mark the breaths/surges, which you want to use for the calibration, as shown in Figure
8. Click with the right mouse button on the channel description PT Flow to open the context menu. In

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the following input window (Figure 9) please enter the volume of the used calibration pump and
confirm with OK. The PT flow curve is rescaled according to the defined tidal volume.
Figure 7: Meassurement with a 500ml calibration pump
Figure 8: Re-calibration of the pneumotachograph

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Figure 9: Entering the calibration volume
Confirm the reanalysis with the new calibration values in the input window (Figure 10). Then the tidal
volume analysis data are updated and displayed according to the adjusted calibration, as shown in
Figure 11.
Figure 10: confirmation of the re-analysis
Figure 11: view of the new calibrated data

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8. Adjusting the analysis
In the global settings you can select the entry breathing volume analysis under the Analysis tab. There, the
following parameters can be set:
Breath Threshold for definition of the beginning and the end of the breath
Min. Breath Strength
Average Window
Hypo- and Hyperventilation
Max leakage; specify for the report
mask selection
Edit mask parameters
set back to default mask
change the unit of the leakage indicator
flow Source
pressure Source
Figure 12: Settings for the breathing volume analysis

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9. Cleaning and disinfection
Regularly clean the device, accessories, cables and sensors to ensure trouble free operation.
Article
Disinfectant (trade
mark)
Concentration
Duration
Interval
Other
Pneumotachograph
Use either of the
following:
Sekusept aktiv or
Sekusept plus or
Gigasept AF or
Lysetol AF
We recommend the use
of Sekusept aktiv.
1,0%
1,5%
2,0%
2,0%
1h
After use
Prepare the disinfectant
solution in the given
concentration. Use only cold
water. Place the used
pneumotachographen in the
solution. Make sure that it is
fully immersed. There must
be no air trapped in the
cavities. Leave the
pneumotachographen in the
solution for one hour. Then
rinse it with water (drinking
water quality) and dry it.
differential pressure
sensor TOS150
Wipe disinfection: For
example:
Terralin Liquid
Mikrozid AF Tuch
Ready to use
Ready to use
5 min
5 min
After use
Remove adhesives if
necessary
Follow manufacturer´s
instructions!
Silicon tubes for
connecting
pneumotachograph
and differential
pressure sensor
Wipe disinfection: For
example:
Terralin Liquid
Mikrozid AF Tuch
Ready to use
Ready to use
5 min
5 min
After use
Remove adhesives if
necessary
Follow manufacturer’s
instructions!
The miniaturized pneumotachograph can be treated with Washers/Disinfectors (WD), as well as steam
autoclaves, if necessary. Please take care to remove the silicon tubes that connect the pneumotachograph with
the differential pressure sensor prior to the cleaning.
Use protective gloves when using aggressive disinfectants!
Follow the manufacturer’s instructions when using disinfectants. Keep to the prescribed dose and
contact time!
Use cold water to prepare disinfection solvents!

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10.Contact
For all questions, problems and suggestions please contact us via telephone or fax. We assure a quick
and qualified advice and handling of all your enquiries.
*If due to technical difficulties our staff is not available, you will be redirected to our mail box. If that
is the case, please leave your name and telephone number so that we can call you back as soon as
possible.
@
You can send us important information any time by fax:
+49 (0) 9 31 / 35 90 94 49
Our telephone hotline assures you professional help and advice during the day:
9:00 –17:00 +49 (0) 9 31 / 35 90 94 0
Our mobile phone hotline provides a high level of support with urgent technical
problems*:
7:00 –9:00 +49 (0) 1 72 / 6 75 69 90
17:00 –24:00 +49 (0) 1 72 / 6 75 69 90
With the Service-Login on our website www.somnomedics.de you get free access to
the latest software updates.
We also provide service and support via E-Mail:
[e-mail]