SOMNOmedics SOMNOtouch RESP User manual

SOMNOmedics GmbH –Am Sonnenstuhl 63 –D-97236 Randersacker
Phone: (+49) 931 / 35 90 94-0 –Fax: (+49) 931 / 35 90 94-49
E-Mail: [e-mail] –Internet: www.somnomedics.eu
I
NSTRUCTION MANUAL
SOMNOtouchTM RESP

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SOMNOmedics GmbH –Am Sonnenstuhl 63 –D-97236 Randersacker
Phone: (+49) 931 / 35 90 94 - 0 –Fax: (+49) 931 / 35 90 94 - 49
E-Mail: [e-mail] - Internet: www.somnomedics.eu
Rev. 8
14.11.2019
All proper names marked with TM are
copyright protected by SOMNOmedics.

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Index
1Introduction .................................................................................................................................... 6
1.1 Intended Use.............................................................................................................................. 6
1.2 About this instruction manual ..................................................................................................... 6
1.3 Explanation of Symbols used in this Manual.............................................................................. 7
1.4 Patients....................................................................................................................................... 7
2About the SOMNOtouch™ RESP.................................................................................................. 7
2.1 Model and Device Number......................................................................................................... 8
2.2 Elements of keyboard............................................................................................................... 10
2.3 Configuration ............................................................................................................................ 11
3Safety instructions....................................................................................................................... 12
4Installing the DOMINO light Software ........................................................................................ 14
5Manual Docking Station Driver Installation............................................................................... 19
5.1 Windows 7................................................................................................................................ 19
5.2 Windows 10.............................................................................................................................. 22
6Operating Instructions................................................................................................................. 26
6.1 Initialising the SOMNOtouch™ RESP...................................................................................... 26
6.1.1 Easy Start.............................................................................................................................. 27
6.1.2 Advanced Mode .................................................................................................................... 29
6.1.3 Starting the SOMNOtouchTM RESP at the display................................................................ 32
6.1.4 Programmed start of the SOMNOtouch™ RESP ................................................................. 34
6.2 Attaching the sensors............................................................................................................... 35
6.3 Display during recording........................................................................................................... 39
6.4 Settings..................................................................................................................................... 41
6.5 Manual abortion of the recording.............................................................................................. 44
6.6 Data Transfer from SOMNOtouch™ to computer .................................................................... 44
6.7 Firmware Update...................................................................................................................... 45
6.8 Open a Recorded Measurement.............................................................................................. 46
6.9 Analysis .................................................................................................................................... 49
6.9.1 Define the Begin and the End of the measurement.............................................................. 49
6.9.2 Define TIB (Time in Bed)....................................................................................................... 49
6.10 Enter the Findings and the Diagnosis ...................................................................................... 50
6.11 Open the Report....................................................................................................................... 50
7DOMINO light Software................................................................................................................ 57
7.1 System Requirements.............................................................................................................. 57
7.2 DOMINO light Panel................................................................................................................. 58

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7.3 Global Preferences................................................................................................................... 59
7.3.1 Menu –Folders ..................................................................................................................... 59
7.3.2 Menu –Channels.................................................................................................................. 60
7.3.3 Menu –Analysis.................................................................................................................... 61
7.3.3.1 Sleep Wake Analysis .............................................................................................. 62
7.3.3.2 Classification of Arousals........................................................................................ 63
7.3.3.3 Activity Analysis ...................................................................................................... 63
7.3.3.4 Flow Analysis .......................................................................................................... 65
7.3.3.5 Snore Analysis ........................................................................................................ 67
7.3.3.6 LM-Analysis (LM: Leg Movements) ........................................................................ 67
7.3.3.7 Heart Rate Analysis ................................................................................................ 70
7.3.3.8 Position Analysis..................................................................................................... 72
7.3.3.9 Effort Analysis ......................................................................................................... 72
7.3.3.10 SpO2 Analysis.......................................................................................................... 73
7.3.3.11 CPAP Analysis........................................................................................................ 73
7.3.3.12 Classification systolic.............................................................................................. 74
7.3.4 Menu - Analysis Channels .................................................................................................... 74
7.3.5 Menu –Filter ......................................................................................................................... 75
7.3.6 Menu –Keys ......................................................................................................................... 76
7.3.7 Menu –Markers .................................................................................................................... 76
7.3.8 Menu –Area Definition.......................................................................................................... 77
7.3.9 Menu –User Data................................................................................................................. 77
7.3.10 Menu –Report .................................................................................................................... 78
7.3.10.1 Standard Report...................................................................................................... 78
7.3.10.2 User defined Report................................................................................................ 79
7.4 Analysis .................................................................................................................................... 86
7.4.1 Setting Analysis and Channels ............................................................................................. 86
7.4.2 Functions of the Pop-up Window.......................................................................................... 87
7.4.2.1 Functions of the Analysis Pop-up Window.............................................................. 87
7.4.2.2 Function of the Raw Data Pop-up Window............................................................. 88
7.4.3 Layouts for Data Display in Analysis Mode........................................................................... 90
7.4.4 Inserting Markers .................................................................................................................. 90
7.4.5 Deleting, Editing, Adding Markers......................................................................................... 91
7.4.6 Creating and Editing Samples............................................................................................... 92
7.4.7 The Event List ....................................................................................................................... 93
7.4.8 Edit Modes ............................................................................................................................ 93
7.4.8.1 Edit Mode................................................................................................................ 94
7.4.8.2 Quick Edit Mode...................................................................................................... 95
7.4.8.3 Select Edit Mode..................................................................................................... 95
7.4.8.4 Repeat Mode........................................................................................................... 95
7.5 Reports..................................................................................................................................... 95
7.5.1 Reports using the DOMINO light Report Generator ............................................................. 95
7.5.2 Export Result List to MS Excel.............................................................................................. 95
7.6 Form Letters ............................................................................................................................. 96
7.6.1 Creating a Form letter ........................................................................................................... 96
7.6.2 Opening a Form Letter.......................................................................................................... 97
7.6.3 Save Form Letter in MS Word 2007 ..................................................................................... 97
7.7 Data Exchange......................................................................................................................... 98
7.7.1 Data Export as Picture, in RIFF or ASCII Format ................................................................. 98
7.7.2 EDF+ Export.......................................................................................................................... 98

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7.8 Archiving................................................................................................................................. 100
7.8.1 Archiving data ..................................................................................................................... 100
7.8.2 Archiving database.............................................................................................................. 102
7.9 Patient Database (Option)...................................................................................................... 103
7.9.1 Registration......................................................................................................................... 103
7.9.2 Search Function.................................................................................................................. 104
7.9.3 Menu –History.................................................................................................................... 104
7.9.4 Menu –Recording............................................................................................................... 107
7.9.5 Menu - Summary Picture .................................................................................................... 108
8Flowchart menu navigation....................................................................................................... 109
9Troubleshooting......................................................................................................................... 110
10 Maintenance of the SOMNOtouch™......................................................................................... 111
10.1 Maintenance rate.................................................................................................................... 111
10.2 Cleaning and disinfection ....................................................................................................... 111
10.3 Use and Maintenance of the Rechargeable Battery .............................................................. 112
11 Service......................................................................................................................................... 112
11.1 Technical specification ........................................................................................................... 112
11.2 Lifetime................................................................................................................................... 113
11.3 Storage................................................................................................................................... 113
11.4 Transport ................................................................................................................................ 113
11.5 Operating and Storage/Transport conditions ......................................................................... 113
11.6 Malfunctions ........................................................................................................................... 113
11.7 Warranty................................................................................................................................. 113
11.8 Disposal of Parts and the SOMNOtouchTM Device ................................................................ 113
11.9 Advice on the electromagnetic compatibility .......................................................................... 114
11.10Accessories and Spare Parts................................................................................................. 117
11.11Contact ................................................................................................................................... 119
11.12Notes ...................................................................................................................................... 120

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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 for many years. The SOMNOtouch™ has been
developed by SOMNOmedics to meet the highest quality control standards available.
The SOMNOtouch™ is available in two configurations allowing it to be used for Basic Respiratory
Screening and Long-term Blood Pressure Recording.
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™ 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 the surgery 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.
It may also be useful to give 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.
It is very important to protect the SOMNOtouch™ from temperatures below 5 °C and above
40 °C. Furthermore, the SOMNOtouch™ may not be worn during swimming and showering.
Please refer to the safety instructions in chapter 3.
1.1 Intended Use
The SOMNOtouchTM RESP is intended to be used as a cardiorespiratory screener (polygraph).
Beneath the diagnosis of breathing related sleep disorders, the device can also be used to control a
CPAP-therapy, for example an obstructive sleeping apnoea.
While using different additional sensors, the application can be spread to areas like EEG-long-term-
observation, occupational medicine, sports medicine and many more. Please refer that the system is
only designed for diagnostic application. It’s not intended for the use in life-sustaining or observing
systems.
1.2 About this instruction manual
It is essential that you read each paragraph carefully when you see this icon on the left of that
paragraph. This icon indicates potential danger to Patients, Property, Data Loss or in
connection with external devices. This icon also appears on the label on the bottom of the
SOMNOtouch™. This instruction manual is a part of the device and it must be available at all
times.
A strict compliance of the manual is required for the intended use of the SOMNOmedics
device.

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1.3 Explanation of Symbols used in this Manual
Indicates a hint or tip. This Symbol provides assistance with possible problems
when working with the SOMNOtouch™.
This Warning Symbol indicates potential danger to Patients, Property or Data
Loss.
1.4 Patients
The SOMNOtouch™RESP and its components may only be used as follows:
- At patients as of the first month of life, no premature infants
- Excluded are monitored and intensive care patients
2 About the SOMNOtouch™ RESP
Fig. 2.1: About the SOMNOtouch™ RESP
Marker Button
External Signal
Input (AUX)
Interface/Charger
Connector
External Signal
Input (AUX)
Status LEDs
Body Position Sensor
+
Acceleration Sensor
(X,Y & Z direction)
Internal Buzzer
On/Off Button
Input for SpO2Sensor
Luer Lock® for Nasal cannula
Internal Effort Sensor
External signal port
(AUX)
Interface/Charging-
port
External signal-
port (AUX)
Pressuresensorconnector
SpO2Sensorport

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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™. The label shown is an example. Individual icons on the label
may differ from country to country.
Fig. 2.2: Type Label
Information, Symbols, Icons and Classifications on the Type Label of SOMNOtouch™RESP
HF-Transmitter with Bluetooth-Protocol integrated.
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”.
Information, Symbols, Icons and Classifications on the Type Label of the power supply
Used or replaced parts and devices must be disposed of according to local
regulations for environmental protection.
The power supply meets the requirements of protection class II and does not need
any additional protective conductor connection.
The power supply is intended for indoor use only.
The CE icon shows that the SOMNOtouch™RESP complies with the applicable
regulations of the EU and that the conformity was declared by the manufacturer.
Follow instructions for use
Regulatory Compliance Mark (Australia)

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Additionally, you receive the device information of the serial number, current firmware and Bluetooth
pin when you press the SOMNOmedics logo in the start display (1). To the left of the SOMNOmedics
logo are the available licenses displayed, that are saved on the device (2).
Fig. 2.3: Logo information
There you will also find our Hotline number and the link to our homepage.

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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
flashes 1x /3s
off
Recording Mode
flashes 16x /s
off
Initialisation / data transfer
on
off
Error during initialisation
2s on
+ buzzer
Status LED 2
Charging
When this LED is Yellow, the battery
is being charged
When this LED gets 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
If this button is pressed when the
device is connected to the computer
via the docking station, it will switch
into initialisation mode.
This button switches the device On.
A longer press on the button when in
menu display will turn the device off.
During a measurement the display
can be switched on or off by
pressing this button.

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2.3 Configuration
The configuration includes a SOMNOtouch™ RESP and body strap, an SpO2sensor, one effort
sensor and belt, the Docking Station and Battery Charger, a USB adapter cable, a Carry Bag for
housing the SOMNOtouch™, the Instruction Manual and the DOMINO light software for Initialization,
Data Transfer and Analysis.
Channels:
- 3 Acceleration Sensors (X,Y & Z direction)
- Body Position
- Marker Button
- Pulse Rate
- SpO2
- Nasal/Oral Flow
- Snore
- Thoracic Effort
- Abdominal Effort
- CPAP/BiPAP pressure

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3 Safety instructions
This instruction manual is regarded as part of the instrument and should always be
kept on hand.
This device 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.
Because the SOMNOtouch™ has no audible alarms for monitoring Pulse and SpO2,
international labelling requirements dictate it to be labelled “Not for continuous
monitoring”.
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 carboxyhaemoglobin or
methaemoglobin may affect the accuracy of the measurement.
Cardiogreen and other intravascular dyes, depending on the concentration, may
affect the accuracy of the SpO2measurement.
If any sensor cable or the device housing itself is damaged, a low risk of injury to
the patient may occur through a direct connection to the ground lead. The
maximum voltage generated by the device is 3.3 V. Check the device housing, all
cables and connections for damage before using this device.
Damaged parts should not be used and 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 with an increased pressure over a prolonged period
can lead to a barotrauma.
For patients with pacemakers we recommend placing the SOMNOtouch™ on the
abdominal region rather than the thoracic region. We recommend placing the
device at least 6 inch away from the pacemaker. Following these placement
guidelines, there is no indication for complications in patients with a pacemaker.
On patients with cardiac pacemakers or other implanted stimulators, the active
impedance analysis of all EXG channels may be affected and MUST be turned off in
the Montage Settings of DOMINO light.
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.

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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 5 °C
and above 40 °C. Furthermore the SOMNOtouch™ may not be worn during
swimming and showering.
Operate the device in an environment with the humidity between 15 and 90% non-
condensing.
This device complies with the IP-Protection-Class “22”.
Should any liquids enter the device, the device must be cleaned immediately by
SOMNOmedics customer service personnel. Following this, the device will undergo
a safety-related examination. Do not switch on the device if any liquids have
entered.
Do not use an autoclave for cleaning 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.
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 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. Only SOMNOmedics and its authorised distributors may repair the
unit.
Any damage of the warranty seal “Warranty void, if seal is broken”, located at the
sides of the device case, will lead to immediate loss of warranty.
Always use the Docking Station to charge the internal battery.
The Docking Station should only be used with the supplied power supply XP-
Power VEP15US12 from SOMNOmedics.
Connect the Docking Station to a freely accessible socket. In case of a fault it
should be possible to unplug it easily.
When recharging a partly-charged Li-Ion battery, this counts as one whole
recharging cycle and shortens the durability of the battery.
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.
When using the 4-channel analogue optocoupler to record signals from several
external devices, medical devices and non-medical devices should not be
connected at the same time as there is no galvanic separation between the 4 signal
inputs.

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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.
Select an installation folder and click the Next button.

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Accept the selection “New Installation”by clicking the Next button.
Click “Next”.
Start the installation process by clicking “Next”.
Select your device/s and confirm with “OK”.

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The installation progress will be displayed by a blue running bar.
When the installation is complete the software will ask if you want to install the USB driver for the
Docking Station. 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.

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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.
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.

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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 Manual Docking Station Driver Installation
5.1 Windows 7
1. Connecting the Docking Station
First, connect the Docking Station to a free USB-Slot of your Computer.
After connecting the device with the USB-Port there are two possible options:
Option 1
A dialog window “Update driver software…”appears. In this case continue at #3,
“Automatic driver software installation”.
Option 2
Nothing happens after you have connected the device. In this case move on with #2 “Manual
driver installation”.
2. Manual driver installation
In the Start menu right click „Computer“, then in the context menu left click “Properties”:
The window “System”is opened.
Left click the entry “Device Manager”.

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In the window “Device Manager”you will find an entry “Other devices”, underneath this entry
there is a point “SOMNOtouch RESP”:
Right click this entry, then a context menu appears. In this context menu left click on “Update
Driver Software”.
Move on at #3 “Automatic driver installation”.