SOMNOmedics SOMNOtouch RESP eco User manual

SOMNOmedics America Inc. –815 Ponce de Leon Blvd., Suite
P-209 –Coral Gables, FL 33134
Toll free: 866 361 9937
[e-mail]
www.somnomedics-diagnostics.com
I
NSTRUCTION MANUAL
SOMNOtouchTM RESP eco

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SOMNOmedics America Inc. –815 Ponce de Leon Blvd., Suite
P-209 –Coral Gables, FL 33134
Toll free: 866 361 9937
[e-mail]
www.somnomedics-diagnostics.com
Rev. 0
14.08.2019
All proper names marked with TM are
copyright protected by SOMNOmedics.

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Index
1Introduction .................................................................................................................................... 5
1.1 Intended Use.............................................................................................................................. 5
1.2 Patients....................................................................................................................................... 5
2About the SOMNOtouch™ RESP eco ......................................................................................... 6
2.1 Model and Device Number......................................................................................................... 6
2.2 Elements of keyboard................................................................................................................. 7
3Safety instructions......................................................................................................................... 7
4Installing the DOMINO light Software .......................................................................................... 9
5Operating Instructions................................................................................................................. 13
5.1 Initialising the SOMNOtouch™ RESP eco ............................................................................... 13
5.1.1 Starting the SOMNOtouchTM RESP eco at the device.......................................................... 15
5.1.2 Attaching the sensors............................................................................................................ 15
5.2 Manual abortion of the recording.............................................................................................. 17
5.3 Data Transfer from SOMNOtouch™ to computer .................................................................... 17
5.4 Firmware Update.................................................................Fehler! Textmarke nicht definiert.
5.5 Open a Recorded Measurement.............................................................................................. 19
5.6 Analysis .................................................................................................................................... 20
5.6.1 Define the Begin and the End of the measurement.............................................................. 20
5.6.2 Define TIB (Time in Bed)....................................................................................................... 21
5.7 Enter the Findings and the Diagnosis ...................................................................................... 21
5.8 Open the Report....................................................................................................................... 21
6DOMINO light Software................................................................................................................ 25
6.1 DOMINO light Panel................................................................................................................. 25
6.2 Global Preferences................................................................................................................... 26
6.2.1 Menu –Folders ..................................................................................................................... 26
6.2.2 Menu –Channels.................................................................................................................. 27
6.2.3 Menu –Analysis.................................................................................................................... 28
6.2.3.1 Sleep Wake Analysis .............................................................................................. 28
6.2.3.2 Classification of Arousals........................................................................................ 29
6.2.3.3 Activity Analysis ...................................................................................................... 29
6.2.3.4 Flow Analysis .......................................................................................................... 30
6.2.3.5 Snore Analysis ........................................................................................................ 32
6.2.3.6 Position Analysis..................................................................................................... 33
6.2.3.7 Effort Analysis ......................................................................................................... 33
6.2.3.8 SpO2 Analysis.......................................................................................................... 33
6.2.3.9 CPAP Analysis........................................................................................................ 34
6.2.4 Menu - Analysis Channels .................................................................................................... 34
6.2.5 Menu –Filter ......................................................................................................................... 35
6.2.6 Menu –Keys ......................................................................................................................... 36
6.2.7 Menu –Markers .................................................................................................................... 36

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6.2.8 Menu –Area Definition.......................................................................................................... 37
6.2.9 Menu –User Data................................................................................................................. 37
6.2.10 Menu –Report .................................................................................................................... 38
6.2.10.1 Standard Report...................................................................................................... 38
6.3 Analysis .................................................................................................................................... 38
6.3.1 Setting Analysis and Channels ............................................................................................. 38
6.3.2 Functions of the Pop-up Window.......................................................................................... 39
6.3.2.1 Functions of the Analysis Pop-up Window.............................................................. 39
6.3.2.2 Function of the Raw Data Pop-up Window............................................................. 41
6.3.3 Inserting Markers .................................................................................................................. 42
6.3.4 Deleting, Editing, Adding Markers......................................................................................... 43
6.3.5 Creating and Editing Samples............................................................................................... 43
6.3.6 The Event List ....................................................................................................................... 44
6.3.7 Edit Modes ............................................................................................................................ 44
6.3.7.1 Edit Mode................................................................................................................ 45
6.3.7.2 Quick Edit Mode...................................................................................................... 46
6.3.7.3 Select Edit Mode..................................................................................................... 46
6.3.7.4 Repeat Mode........................................................................................................... 46
6.4 Reports..................................................................................................................................... 46
7Troubleshooting........................................................................................................................... 47
8Maintenance of the SOMNOtouch™........................................................................................... 47
8.1 Maintenance rate...................................................................................................................... 47
8.2 Cleaning and disinfection ......................................................................................................... 47
8.3 Use and Maintenance of the Rechargeable Battery ................................................................ 48
8.4 Functional Testing of the integrated Pulse Oximeter ............................................................... 48
9Service........................................................................................................................................... 48
9.1 Technical specification ............................................................................................................. 48
9.2 Lifetime..................................................................................................................................... 49
9.3 Storage..................................................................................................................................... 49
9.4 Transport .................................................................................................................................. 49
9.5 Operating and Storage/Transport conditions ........................................................................... 49
9.6 Warranty................................................................................................................................... 49
9.7 Disposal of Parts and the SOMNOtouchTM Device .................................................................. 49
9.8 Advice on the electromagnetic compatibility ............................................................................ 49
9.9 Accessories and Spare Parts................................................................................................... 52
9.10 Contact ..................................................................................................................................... 53
9.11 Notes ........................................................................................................................................ 54

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1 Introduction
The SOMNOmedics team would like to thank you for purchasing this product. We are confident that
you will enjoy using the SOMNOtouch™ RESP eco for many years. The SOMNOtouch™ has been
developed by SOMNOmedics to meet the highest quality control standards available.
Caution: Federal law restricts this device to sale by or on the order of a physician.
In order to obtain the best results from your system, we recommend that you carefully read this
instruction manual before connecting the SOMNOtouch™ RESP eco to a patient.
Advice and suggestions to improve the functionality of the device and this manual we will be gratefully
accepted.
Warning: Take care in arranging patient and sensor cables to avoid risk of patient entanglement or
strangulation. To minimize the risk of patient strangulation, the sensor and electrode cables
must be carefully placed and secured.
Technical Specifications are subject to change without notice.
The Initialisation of the System and Analysis of the Data must be performed by Trained Operators.
Measurements can be performed in professional healthcare facilities or at the Patients’ home. When
used at the Patients’ home, the Patient should be carefully instructed on how to use and care for the
system.
Please also hand out to the patient a copy of the enclosed Patient Instruction Manual. The initialized
device will automatically start recording the measurement at the pre-set time. The data transfer and
the analysis must be performed by the doctor or qualified physiologist.
The SOMNOtouch™ RESP eco may not be worn during swimming and showering.
Please refer to the safety instructions in chapter 0.
1.1 Intended Use
The SOMNOtouchTM RESP eco is a portable physiological signal recorder. It is indicated for use in the
recording, displaying, monitoring, printing, and storage of biophysical parameters for the purpose of
assisting in the diagnosis of sleep disorders and sleep related respiratory disorders of adult patients.
The device is intended to be prescribed for use by a physician in the office, sleep laboratory or
patient’s home.
This device is NOT designed to be used in life support situations.
1.2 Patients
The SOMNOtouch™RESP eco and its components may only be used as follows:
- For adults only
- Excluded are monitored and intensive care patients

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2 About the SOMNOtouch™ RESP eco
Fig. 2.1: SOMNOtouch RESP eco
2.1 Model and Device Number
When unpacking the SOMNOtouch™, check to make sure that all items are in good condition and that
all accessories correspond to the delivery note. Also compare the Model on the delivery note with the
label on the back of the SOMNOtouch™.
Fig. 2.1: Type Label
Information, Symbols, Icons and Classifications on the Type Label of SOMNOtouch™RESP
eco
Read the instruction manual very carefully before you start working with the
SOMNOtouch™.
Protection Class: BF
The CE icon and the correlating number show that the SOMNOtouch™ complies
with the regulations for Medical Products.
IP22
This device complies with the IP-Protection-Class “22”.
On/Off Button
Internal Effort
Sensor
Marker Button
SpO2Connector
Luer Lock Connector
Interface/Charger
Connector
External Signal
Input (AUX)
Body Position Sensor
+
Acceleration Sensor (X,Y & Z direction)
Power/Status LED (green)

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2.2 Elements of keyboard
Picture
Description
Function
Status LED 1
Recording
Green LED
Yellow LED
Idle Mode
off
off
Waiting Mode
1x /4s
off
Recording Mode
1x /s
off
Initialisation / data transfer
on
off
Status LED 2
Charging
When this LED is Yellow, the battery
is being charged
When this LED is off, the battery is
fully charged
When this LED is off, no charge is
taking place.
Patient Marker
The patient uses the button as a
Marker during the measurement. To
place a marker for denoting an
event, (going to bed, getting up,
taking medication, etc.) the patient
pushes this button.
On/Off
This button switches the device on.
The device switches off again after
30 secs.
If pressing this button together with
the marker button a recording can
be terminated manually
3 Safety instructions
This instruction manual is regarded as part of the instrument and should always be
kept on hand.
The SOMNOtouch™ is NOT designed to be used in a Life Support situation,
surgical rooms, intensive care units, or in emergency vehicles.
The SOMNOtouch™ must be applied only under instruction of a physician.
The SOMNOtouch™ has no audible alarms for monitoring Pulse and SpO2.
The SOMNOtouch™ must be able to measure the pulse properly to obtain accurate
SpO2measurement. Verify that nothing is hindering the pulse measurement before
relying on the SpO2measurement.
Fingernail polish may reduce light transmission and thereby affect SpO2accuracy.
The pulse oximetry device integrated in SOMNOtouch™ is calibrated to determine
the percentage of arterial oxygen saturation of functional haemoglobin. Significant
levels of dysfunctional haemoglobin such as carboxyhemoglobin or
methemoglobin may affect the accuracy of the measurement.
Cardiogreen and other intravascular dyes, depending on the concentration, may
affect the accuracy of the SpO2measurement.
Check all cables and connections for damage before using this device.

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Damaged parts must be replaced immediately. Please contact SOMNOmedics or
your SOMNOmedics Distributor.
If the device is damaged (e.g. broken case) it has to be taken out of service.
Misuse of the pulse oximeter sensor with an increased pressure over a prolonged
period can lead to a barotrauma.
For patients with pacemakers we recommend placing the SOMNOtouch™ RESP
eco on the abdominal region rather than the thoracic region. We recommend
placing the device at least 7 inches away from the pacemaker. Following these
placement guidelines, there is no indication for complications in patients with a
pacemaker.
Avoid the use of Radio Transmitters and Receivers, High Frequency Devices, CB-
Radio Systems, Cellular Phones, Microwave Ovens, etc. where the electrical field
strength exceeds 10 V/m (correlating to IEC 60601-1-2).
Only sensors designed and supplied by SOMNOmedics may be used with this unit.
All sensors are provided unsterile and should never be sterilized.
This device is not to be used on broken skin. If this device comes in contact with
broken skin/blood, do not reuse this device and discard.
Only accessories recommended by SOMNOmedics are allowed to be connected to
the SOMNOtouch™.
This device is not designed for usage in Explosive Environmental Conditions.
It is very important to protect the SOMNOtouch™ from temperatures below 0°C and
above 50°C. Furthermore the SOMNOtouch™ may not be worn during swimming
and showering.
Operate the device in an environment with the humidity between 15 and 93% non-
condensing.
This device complies with the IP Protection Class “IP22”.
Do not use an autoclave for disinfection and sterilization of the SOMNOtouch™ or
any of its accessories, cables and sensors.
Follow the manufactures instructions when using disinfectants. Keep to the
prescribed dose and contact time. Use protective gloves when using aggressive
disinfectant agents.
There was no testing conducted to demonstrate the moisture retention filter for
nasal cannula (SEN123) used is effective in preventing cross-contamination.
Chemicals which are used for cleaning the unit should be stored, prepared and
kept ready in their own marked containers to avoid confusions.
Long-term storage of this device should only be in a closed and dry room to avoid
condensation caused by thermal fluctuations. Do not store the SOMNOtouch™ in
places of high temperature exceeding 35° C or under direct sunlight or in front of a
stove. Be sure not to store it under frozen condition. Please also avoid the areas of
high humidity.
Opening the case, repairing or modifying the SOMNOtouch™ in any way will void
the guarantee and might affect the safety of the device. Only SOMNOmedics and its
authorised distributors may repair the unit.

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Always use the charging cable that is delivered with your device to charge the
internal battery.
The device is not to be used while the battery is being charged.
The body strap is made of material commonly used in clothing and non-medical
watchbands, however if redness or swelling of the skin occurs where the band is in
contact, please discontinue use immediately and consult your physician.
4 Installing the DOMINO light Software
Please note the System Requirements for running DOMINO light Software.
Please also note that the Software must be activated by entering a Registration Code.
You will find the file on the installation CD.
Double click on this file to start the installation.
Choose your language and click on the button Next >.
Accept the Welcome Information by clicking the Next button.

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Select an installation folder and click the Next button.
Accept the selection “New Installation”by clicking the Next button.
Start the installation process by clicking “Next”.
The installation progress will be displayed by a blue running bar.

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When the installation is complete the software will ask if you want to install the USB driver. If you
choose to “Install SOMNOtouch USB Driver”,the later manual driver installation will not be
necessary (exception: Windows XP).
If “Run DOMINO light”is chosen, the software will start immediately after clicking the “Finish”button.
For the driver installation a window of the device installation assistant will open. Confirm each with
“Next”.
If you skipped the driver installation, you can do it later manually. In chapter 5 the way how to do it is
explained for windows 7 and windows 10.

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Updating the Software
To update your software version please install the new version in the same directory as the original
version. During the installation you will be asked to choose one of the following installation types.
New analysis, channels and features of the software are updated. The settings of analysis and
analysis templates remain as before.
You can choose which components shall be installed.
All existing settings are overwritten with the new standard settings of the software.

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5 Operating Instructions
Note:
The SOMNOtouch™ automatically switches to idle mode when no measurement is running. Start and
end of a recording are programmed via the DOMINO light Software or the initialisation procedure on
the device.
The date and time of the PC system clock are transferred to the SOMNOtouch™ during
initialisation. Therefore, it is important to have the correct date and time set.
Please note that measurements running during the change of Summer/Winter time will have a
time shift.
5.1 Initialising the SOMNOtouch™ RESP eco
For Initialisation and Transfer the device needs to be connected via USB cable to the computer. Then,
initialisation and transfer can be performed either with the the virtual docking station or the DOMINO
light panel.
Fig.5.1: DOMINO light virtual Docking station.
Connect the SOMNOtouch™ RESP eco to the USB cable. As soon as the device is recognized, click
“Initialise”.
After a successful connection, the serial number, firmware version, hardware ID and the battery
capacity are shown beneath the initialisation window (see Fig. 6-2).

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Fig. 5.1: Easystart DOMINOlight
Patient Data Input:
▪Enter the data into the corresponding fields. Type carefully as this information will be saved for later
use. It is important to enter a Patient ID number. This number is used to store the Patient Data in
the optional Patient Database.
▪It is also possible to use an existing Patients’ Data from the Database using the button “DB”. Select
the Patient from the selection window and confirm with the button “OK”. To speed up the database
search, it is possible to sort the columns Patient ID, First/ Last Name and Date of Birth by
clicking on the column heading.
▪If you click on “Add to DB”, the patient data will be stored in the Patient Database (*optional
purchase).

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5.1.1 Starting the SOMNOtouchTM RESP eco at the device
Press the ON button to activate the device. The green LED is turned on.
A recording can be started by pressing the marker button three times. During recording the green LES
is flashing once every second.
Please make sure all sensor are connected before the recording starts!
In case a not-transferred recording is on the device it is not possible to start the recording at the
device. The recording must be transferred to the PC first.
If you start the device directly an automatic patient ID is generated. This ID you can change later
during transfer of the data to the PC. There you can set name/surname and other patient data.
5.1.2 Attaching the sensors
The main device should be placed on top of light clothes (nightshirt, pyjamas) and should not be in
direct contact with the skin.
Be careful while attaching the belts and sensors to the patient to prevent strangulation. Fix the cables
with adhesive tape if necessary.
Please note: The sensors must be plugged in and out without turning them.
Fig.5.3: Plug in the sensors
a) Fit the SOMNOtouch™ to the effort belt and attach the belt to the patient’s chest..

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b) Attach the nasal oral cannula and connect its plug together with the filter to the Luer-Lock® Adaptor
Unit.
c) Attach the SpO2sensor to a finger of the left hand and connect the plug to the SOMNOtouchTM.
The upper side of the sensor is marked by the embossing of a finger as shown in the following image.
Create a strain relief for the sensor cable with adhesive tape.
Then connect the sensor to the SOMNOtouch™ (red arrow).
CPAP:
Attach the open end of the supplied tube to the CPAP mask
or an O2adaptor (not supplied), and connect its plug to the
Luer-Lock® Adaptor Unit (in place of the nasal cannula).
or

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5.2 Manual abortion of the recording
To abort the recording, you have to press the on/off button and the patient marker
simultaneously for approximately one second. Then, the termination process must be confirmed by
pressing the marker button again. If the recording was terminated successfully the green LED is
flashing fast for 4 seconds.
5.3 Data Transfer from SOMNOtouch™ to computer
Once there is a measurement on the SOMNOtouch™ RESP eco it is possible to transfer it to the
computer via the virtual Docking Station or the DOMINO light panel. Please proceed as follows:
Connect the SOMNOtouch™ RESP eco to the PC via the USB cable. Click “Transfer” at the docking
station-program (or the DOMINO light panel):
Fig. 5.4: Transfer through the docking station
The parameters of the measurement will be displayed in the transfer window. Please check all patient
data and if necessary correct them.
NIBP 0012
RESP 0024

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Fig. 5.5: Transfer window DOMINO light
(1) It is possible to instruct the software to automatically execute an analysis, to display a report, to
print and export a report, to close the recording, and to move the recorded data to the Archive Folder
set in “Global Preferences”. To configure these settings, click the button. Select the options
required and click the “OK” Button.
(2) The recording can be continued after the data transfer is complete (if you transfer a recording
before its programmed end).
(3) Before transferring the data, additional observations or comments can be entered into the
“Description”field. This information appears in the “Open Recording”window.
Click “Transfer” to start the data transfer.
All recorded measurements are saved in the default directory set in the “Global Preferences”.
This folder is displayed at “Transfer to”.

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5.4 Open a Recorded Measurement
To open a recording, click on the Analysis symbol of the DOMINO light panel. The following
window will open:
Fig. 5.6: Open Recording
The above window will display all the measurements saved in the folder which was defined as the
Default Folder in the Global Preferences. It is possible to open a Recording saved in a different
folder by clicking on the button Select Folder and selecting the directory from the dropdown list.
From this window, it is also possible to Delete (1) or Rename (2) recordings of measurements or Print
(3) the list. If a recording is renamed, the original recording will be saved and the data copied and
saved under the New Name entered.
It is also possible to Reset and Re-analyse (4) a recording. This function will remove all manual
editing and completely re-analyse the study using the predefined parameters in the Global
Preferences.
The software shows the last displayed recording. Easily open the last displayed recording by double-
clicking on the link (5).
Processing status:
...Recorded measurement has not been opened (only Raw Data stored).
...Recorded measurement has been automatically analysed.
...Recorded measurement has been edited, completed and released for archiving.
...Recorded measurement cannot be opened.
After having archived a recording it will be marked with the symbol in the column Archived.
Additionally, the name of the CD/DVD used for archiving will be indicated.
If you open a measurement, which has not previously been analysed, the Preferences Window will
open. The measurement is automatically analysed according to the predefined parameters in the
Global Preferences .The DOMINO light software marks analysed events in the Raw Data window by
placing a coloured frame around each event.
Search
Options
2
1
Saved
measure
-ments
Click on the name of the column to
sort measurements alphabetically or
chronologically
Processing Status
3
4
5

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fig. 5.7: Analysis
A double-click on a particular position in the Analysis Data window will synchronize to the
corresponding Raw Data in the window below.
5.5 Analysis
5.5.1 Define the Begin and the End of the measurement
- Set Start Marker: Right click on the Raw Data area where you wish the Recording to Begin →
left click on “Define Start”
- Set End Marker: Right click in the Raw Data area where you wish the Recording to End →
left click on “Define End”
All data before the Start Marker and all data after the End Marker will be hidden from view.
Parameter
Indicates position of the data
in the Raw Data Window
Time Bar
Index/h
Time-base of Analysis
(Change with right mouse button)
Analysis
Raw Data
Marker
Time base of Raw Data
(Change with right
mouse button)
Automatically marked events
Interactive Scroll Bar
Signal Scaling