SOMNOmedics SOMNOwatch plus R 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.de
SOMNOwatch™ plus R&K
I
NSTRUCTION MANUAL
Caution: Federal law restricts this device to sale by or on the order of a physician.

-2-
MedicalDevicesforSleepDiagnosticsandTherapy
All proper names marked with TM are protected copyright by SOMNOmedics.
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.de
Rev. 2
29.10.2019

-3-
MedicalDevicesforSleepDiagnosticsandTherapy
Index
1Introduction .................................................................................................................................... 6
1.1 About this instruction manual ..................................................................................................... 6
1.2 Explanation of Symbols used in this Manual.............................................................................. 6
2About the SOMNOwatch™ plus.................................................................................................... 7
2.1 Model and Device Number......................................................................................................... 7
2.2 Elements of keyboard................................................................................................................. 8
2.3 Configuration .............................................................................................................................. 9
3Safety instructions....................................................................................................................... 10
4Docking Station Driver Installation ............................................................................................ 11
4.1 WinXP....................................................................................................................................... 11
5Operating Instructions................................................................................................................. 12
5.1 Initializing the SOMNOwatch™ plus ........................................................................................ 12
5.2 Attaching the Sensors .............................................................................................................. 16
5.3 Data Transfer from SOMNOwatch™ plus to PC ...................................................................... 18
5.4 Open a Recorded Measurement.............................................................................................. 19
5.5 Analysis .................................................................................................................................... 21
5.5.1 Define the Begin and the End of the measurement......................................................... 21
5.5.2 Define TIB (Time In Bed)................................................................................................. 21
5.5.3 Editing Events.................................................................................................................. 21
5.5.3.1 Edit Mode (Events).................................................................................................. 22
5.5.3.2 Quick Edit Mode...................................................................................................... 22
5.5.3.3 Select Edit Mode..................................................................................................... 22
5.5.3.4 Repeat Mode........................................................................................................... 22
5.5.4 Editing Sleep Stages ....................................................................................................... 23
5.5.4.1 Edit Mode (Sleep Stages)....................................................................................... 23
5.5.4.2 Advanced Sleep Edit Mode..................................................................................... 25
5.5.5 Define Artefact Areas....................................................................................................... 26
5.5.6 Enter the Findings and the Diagnosis.............................................................................. 26
5.6 Open the Report....................................................................................................................... 27
6DOMINO light Software................................................................................................................ 32
6.1 System Requirements.............................................................................................................. 32
6.2 DOMINO light Panel................................................................................................................. 33
6.3 Global Preferences................................................................................................................... 34
6.3.1 Menu –Folders................................................................................................................ 34
6.3.2 Menu –Channels............................................................................................................. 35
6.3.3 Menu –Analysis............................................................................................................... 36
6.3.3.1 Sleep Profile............................................................................................................ 37
6.3.3.2 Sleep FFT Analysis................................................................................................. 39
6.3.3.3 Spindle and K-Complex Analysis............................................................................ 41

-4-
MedicalDevicesforSleepDiagnosticsandTherapy
6.3.3.4 EOG Analysis.......................................................................................................... 42
6.3.3.5 Activity Analysis ...................................................................................................... 44
6.3.3.6 Position Analysis..................................................................................................... 45
6.3.4 Menu - Analysis Channels............................................................................................... 46
6.3.5 Menu –Filter.................................................................................................................... 46
6.3.6 Menu - Keys..................................................................................................................... 47
6.3.7 Menu - Markers................................................................................................................ 47
6.3.8 Menu –Area Definition .................................................................................................... 48
6.3.9 Menu –User Data............................................................................................................ 48
6.3.10 Menu –Report................................................................................................................. 49
6.3.10.1 Standard Report ................................................................................................. 49
6.3.10.2 User defined Report............................................................................................ 50
6.4 Analysis .................................................................................................................................... 54
6.4.1 Setting Analysis and Channels........................................................................................ 54
6.4.2 Functions of the Pop-up Window..................................................................................... 55
6.4.2.1 Functions of the Analysis Pop-up Window.............................................................. 55
6.4.2.2 Function of the Raw Data Pop-up Window............................................................. 57
6.4.3 Layouts for Data Display in Analysis Mode ..................................................................... 59
6.4.4 Inserting Markers............................................................................................................. 59
6.4.5 Deleting, Editing, Adding Markers ................................................................................... 59
6.4.6 Creating and Editing Samples......................................................................................... 60
6.4.7 The Event List.................................................................................................................. 61
6.4.8 Edit Modes....................................................................................................................... 62
6.4.8.1 Edit Mode................................................................................................................ 62
6.4.8.2 Quick Edit Mode...................................................................................................... 63
6.4.8.3 Select Edit Mode..................................................................................................... 63
6.4.8.4 Repeat Mode........................................................................................................... 63
6.5 Reports..................................................................................................................................... 64
6.5.1 Reports using the DOMINO light Report Generator........................................................ 64
6.5.2 Export Result List to MS Excel ........................................................................................ 64
6.6 Form Letters ............................................................................................................................. 65
6.6.1 Creating a Form Letter..................................................................................................... 65
6.6.2 Opening a Form Letter..................................................................................................... 66
6.6.3 Save Form Letter in MS Word 2007................................................................................ 66
6.7 Data Exchange......................................................................................................................... 67
6.7.1 Data Export as Picture, in RIFF or ASCII Format............................................................ 67
6.7.2 EDF+ Export .................................................................................................................... 67
6.8 Archiving................................................................................................................................... 70
6.8.1 Archiving data.................................................................................................................. 70
6.8.2 Archiving database .......................................................................................................... 71
6.9 Patient Database (Option)........................................................................................................ 72
6.9.1 Registration...................................................................................................................... 72
6.9.2 Search Function............................................................................................................... 73
6.9.3 Menu –History................................................................................................................. 74
6.9.4 Menu –Recording ........................................................................................................... 77
6.9.5 Menu - Summary Picture................................................................................................. 78
7Troubleshooting........................................................................................................................... 79

-5-
MedicalDevicesforSleepDiagnosticsandTherapy
8Maintenance of SOMNOwatch™ plus ........................................................................................ 80
8.1 Cleaning and disinfection ......................................................................................................... 80
8.2 Use and Maintenance of the Rechargeable Battery ................................................................ 80
9Service........................................................................................................................................... 81
9.1 Technical specification ............................................................................................................. 81
9.2 Lifetime..................................................................................................................................... 82
9.3 Malfunctions ............................................................................................................................. 82
9.1 Storage..................................................................................................................................... 82
9.2 Advice to the electromagnetic compatibility ............................................................................. 82
9.3 Warranty................................................................................................................................... 82
9.4 Accessories and Spare Parts................................................................................................... 82
9.5 Disposal of Parts and the SOMNOwatchTM plus Device.......................................................... 83
9.6 Contact ..................................................................................................................................... 84
9.7 Notes ........................................................................................................................................ 85

-6-
MedicalDevicesforSleepDiagnosticsandTherapy
1 Introduction
The SOMNOmedics team would like to thank you for purchasing this product. We are confident that
you will enjoy using the SOMNOwatch™ plus for many years. The SOMNOwatch™ plus has been
developed by SOMNOmedics to meet the highest quality control standards available.
Indication for Use:
The SOMNOwatch™ plus is a non-life-supporting portable physiological signal recording device
intended to be used for Sleep Recording on adult patients.
The SOMNOwatch™ plus is not intended to be used alone or in combination with another product as
a life support device, a life support system, or as a critical component to a life support device or
system. There is no claim of compatibility with diagnostic imaging equipment.
Caution: Federal law restricts this device to sale by or on the order of a physician.
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.
In order to obtain the best results from your system, we recommend that you carefully read this
instruction manual before connecting the SOMNOwatch™ plus to a patient.
Technical Specifications are subject to change without notice.
The SOMNOwatch™ plus is available in three configurations allowing it to be used for Basic
Respiratory Screening, Sleep Recording and Long-term blood pressure Recording.
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
initialised device will automatically start recording the measurement at the preset time. The data
transfer and the analysis must be performed by the doctor.
It is very important to protect the SOMNOwatch™ plus from temperatures below 0°C and above
50°C. Furthermore the SOMNOwatch™ plus should not be worn during swimming and
showering. Please refer to the safety instructions in chapter 3.
1.1 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
SOMNOwatch™ plus. This instruction manual is a part of the device and it must be available at
all times.
1.2 Explanation of Symbols used in this Manual
Indicates a hint or tip. This Symbol provides assistance with possible problems
when working with the SOMNOwatch™ plus.

-7-
MedicalDevicesforSleepDiagnosticsandTherapy
This Warning Symbol indicates potential danger to Patients, Property or Data
Loss.
2 About the SOMNOwatch™ plus
fig. 2-1: About the SOMNOwatch™ plus
2.1 Model and Device Number
When unpacking the SOMNOwatch™ plus, 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 bottom of SOMNOwatch™ plus.
fig. 2-2: Type Label
Information, Symbols, Icons and Classifications on the Type Label
Read the instruction manual very carefully before you start working with the
SOMNOwatch™ plus.
Protection Class: BF
The CE icon and the correlating number show that the SOMNOwatch™ plus
complies with the regulations for Medical Products.
IP54
This device complies with the IP-Protection-Class "54". This Classification states
that the SOMNOwatch™ plus is dust and splash proof.
Marker Button
External Signal
Input (AUX)
Interface/Charger
Connector
Light Sensor
Status LED’s
Body Position Sensor
+
Acceleration Sensor
(x,y &z direction)
Internal Buzzer

-8-
MedicalDevicesforSleepDiagnosticsandTherapy
2.2 Elements of keyboard
Picture
Description
Function
Status LED’s
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
Recording with programmed
sampling of external signal:
sampling on
sampling off
Recording with manual
sampling of external signal*:
sampling on
sampling off
*Sampling will be started the
next minute. During this period
the green and yellow LED is
alternately flashing 16x /s.
flashes 16x /s
off
flashes 16x /s
off
off
flashes 16x /s
off
flashes 16x /s
Patient Marker
Pressing this button during the
connection to a PC switches
on the Initialization Mode.
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 must push this button.
Manual start by pressing this
button quickly 6 times
consecutively during Idle
Mode.
Manual activation or
deactivation of sampling of
external signal by holding the
button pressed more then 3
seconds.
Light Sensor
This sensor measuring the
intensity of the ambient light.

-9-
MedicalDevicesforSleepDiagnosticsandTherapy
2.3 Configuration
The configuration includes a SOMNOwatch™ plus with EXG-Headbox (R&K Module) and body strap,
a shoulder belt, the Docking Station and Battery Charger, a USB adapter cable, a Carry Bag for
housing the SOMNOwatch™ plus, the Instruction Manual and the DOMINO light software for
Initialisation, Data Transfer and Analysis.
Channels:
- 3 Acceleration Sensors (x,y &z direction)
- Ambient Light
- Body Position
- Marker Button
- 1x EEG
- 2x EOG
- 1x EMG

-10-
MedicalDevicesforSleepDiagnosticsandTherapy
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 SOMNOwatch™ plus has to be applied only under instruction of a physician.
Check all cables and connections for damage before using this device.
Damaged parts must be replaced immediately. Please contact SOMNOmedics or your
SOMNOmedics Distributor.
Only sensors designed and supplied by SOMNOmedics may be used with this unit.
All sensors are provided unsterile nor are they intended to 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
SOMNOwatch™ plus.
This device is not designed for usage in Explosive Environmental Conditions.
It is very important to protect the SOMNOwatch™ plus from temperatures below 0°C and
above 50°C. Furthermore the SOMNOwatch™ plus should not be worn during swimming
and showering. Operate the device in an environment with the humidity between 10 and
90% Non Condensing.
This device complies with the IP-Protection-Class "54". This Classification states that the
SOMNOwatch™ plus is dust and splash proof.
Do not use an autoclave for cleaning the SOMNOwatch™ plus 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 SOMNOwatch™ plus in
places of the high temperature exceeding 35 deg. C or under direct sunlight or in front of
a stove. Be sure not to store it under frozen condition. Please also avoid the places of
high humidity.
Opening the case, repairing or modifying the SOMNOwatch™ plus in any way will void
the guarantee. Only SOMNOmedics and its authorised distributors may repair the unit.
Always use the Docking Station (SOW106) to charge the internal battery.

-11-
MedicalDevicesforSleepDiagnosticsandTherapy
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 Docking Station Driver Installation
4.1 WinXP
Click on Continue Anyway to start the
installation of the driver.
Click on Finish to complete the installation.
The first time you connect the
SOMNOwatch™ plus Docking Station to a
USB-port the following window will occur:
Please choose the option No, not this time
and click on the Next button
Make sure you have the CD-ROM with the
Driver in the CD-ROM-Drive.
Now confirm the recommended option Install
the software automatically by clicking Next.
In the following window you must choose the
CD-ROM and click on Next.

-12-
MedicalDevicesforSleepDiagnosticsandTherapy
5 Operating Instructions
Note: The SOMNOwatch™ plus automatically switches in idle mode when no measurement is
running.
The date and time of the PC system clock is transferred to the SOMNOwatch™ plus
during initialisation. Therefore it is important to have preset the right date and
time.
Please note that measurements running during the change of Summer/Winter time
will have a time shift.
5.1 Initializing the SOMNOwatch™ plus
fig. 5-1: DOMINO light Panel.
After a successful connection, the serial number, the firmware version, the hardware ID and the
battery capacity are shown in the initialization window (see fig. 5-2).
-Connect the SOMNOwatch™ plus to the Docking Station
Note: It is necessary to disconnect the battery charger to displayed the correct capacity
of the battery!
-Press the Marker Button .
-Select Initialisation on the DOMINO light Panel (marked red in fig. 5-1).

-13-
MedicalDevicesforSleepDiagnosticsandTherapy
fig. 5-2: Patient Data Input.
You can add more details to the patient in the database (see fig. 5-3).
fig. 5-3: Add details to the patient.
Now, click on the Next button or on the tab sheet Montage.
Patient Data Input:
▪Enter the data into the corresponding fields
(see fig. 5-2). 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’s, first/ last names 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).
Patient Data: Here you can edit the patient data.
Questionnaire: Here you can add a questionnaire
for daytime sleepiness (ESS) or
Restless Legs Syndrom (RLS).
Notes: Add special information to the patient with
date and time.

-14-
MedicalDevicesforSleepDiagnosticsandTherapy
Now select the sleep R&K montage. The channels which will be recorded are defined here.
fig. 5-4: Menu - Montage
→Used to create a new montage
→An existing montage may be saved with a different name after modification.
Template: It is possible to change these analysis templates in the Global Settings.
Magnitude: Quantitative determination of activity by
summing all X-Y-Z movements within one
storage cycle.
Now, click on the Next button or on the tab sheet Recording.

-15-
MedicalDevicesforSleepDiagnosticsandTherapy
fig. 5-5: Menu - Recording
Special function “Enable Battery to charge”(4) →Allows the battery of the SOMNOwatch™ plus to
charge while a recording is running.
The recording duration will only be limited by the
storage capacity of the SOMNOwatch™ plus.
Ext. channel not continuously recorded (5) →This allows all signals connected to the External Signal
Input (AUX) to be turned On and Off as required.
Note: This is only possible for recordings with
programmed Auto Start (3).
Manual Start →Push Marker Button at least 5 seconds to switch on/off.
Programmed Start →Click sign and program start date, start time and duration.
Now you could enter an observation or comment in the Description window (6). This information
appears in the Open Recording window. When you click on Initialise the internal memory will be
deleted and the message Initialisation successful appears.
2
Start options:
Manual start (1) →Measurement is started manually by
pressing the marker button quickly 6
times consecutively.
start immediately (2)→Type in the recording duration.
The measurement will be started
immediately after initialisation.
Auto Start (3)→This option is used when the patient uses
the SOMNOwatch™ plus unattended. The
unit will switch to Waiting Mode (green
LED flashes 1x per second) until the
programmed time is reached. Recording
will start automatically at this pre-programmed
Date and Time and record the data for the
duration programmed.
3
4
5
1
6

-16-
MedicalDevicesforSleepDiagnosticsandTherapy
5.2 Attaching the Sensors
a) Fit the SOMNOwatch™ plus to the Body Strap.
b) Apply the shoulder belt and stick the EXG-Headbox onto it. Connect the EXG-Headbox to the
SOMNOwatch™ plus.

-17-
MedicalDevicesforSleepDiagnosticsandTherapy
c) It is necessary to make sure that the skin, where the electrodes (gold or snap electrodes) are to be
applied, are clean. Use an abrasive skin prepping gel (suitable for bio-electrical measurements) to
prepare the patients skin.
GND: Centre it in the middle of the forehead
EOG l: Top left of the left eye
EOG r: Bottom right of the right eye
(Diagonal to EOG l)
C4: Top right on the forehead (as near as possible to
the hair line)
A1: Behind the left ear
EMG: Place these two electrodes underneath the
chin. The electrodes should be placed 1 cm apart

-18-
MedicalDevicesforSleepDiagnosticsandTherapy
5.3 Data Transfer from SOMNOwatch™ plus to PC
Once there are one or more measurements on the SOMNOwatch™ plus, it is possible to transfer
these with the DOMINO light software and the Docking Station.
Please proceed as follows:
Connect the SOMNOwatch™ plus to the Docking Station.
Press the Marker Button .
Start the data transfer by clicking the Transfer icon on the DOMINO light Panel.
The parameters of the measurement will be displayed.
fig. 5-6: Transfer
(1) It is possible to instruct the software to automatically produce an analysis, to display a report, to
print and export a report, to close the recording, and to move the recording 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.
Before transferring the data, you may enter an observation or comment in the Description window
(3). This information appears in the Open Recording window.
Click on the Transfer Button to start the data transfer.
All recorded measurements are saved in the default directory set in “Global Preferences”.
1
2
3

-19-
MedicalDevicesforSleepDiagnosticsandTherapy
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. 5-7: Opening 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.
Search
Options
1
2
Saved
measurements
Click on Name or Start to sort
measurements alphabetically
or chronologically
Processing Status
3
4
5

-20-
MedicalDevicesforSleepDiagnosticsandTherapy
If you open a measurement, which has not previously been analysed, the Preferences Window will
open. Please choose the sleep R&K template at the tab Analysis.
fig. 5-8: Analysis template “sleep R&K”
The measurement is automatically analysed according to the predefined parameters in the Global
Preferences (see Chapter 6.3.3).
The DOMINO light software marks analysed events in the Raw Data window by placing a coloured
frames around each event.
fig. 5-9: Analysis
A double-click on a particular position in the Analysis Data window will synchronize to the
corresponding Raw Data in the window below.
Indicates position of
the data in the Raw
Data Window
Time Bar
Index/h
Analysis
Raw Data
Cursor
Time base of Raw
Data (Change with
right mouse button)
Automatically marked
events
Marker
Signal Scaling
Time-base of Analysis
(Change with right mouse button)
Selection
Information
Interactive
Scroll Bar
Time
Signal value
(in µV, mV, lm, % or text)
Epochs coming
up
Current Epoch
Epochs before
Sleep
stages