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

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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. 5
29.10.2019

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Index
1Introduction .................................................................................................................................... 6
1.1 About this instruction manual ..................................................................................................... 6
1.2 Explanation of Symbols used in this Manual.............................................................................. 7
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
4Installing the DOMINO light Software ........................................................................................ 12
5Docking Station Driver Installation ............................................................................................ 17
5.1 WinXP....................................................................................................................................... 17
6Operating Instructions................................................................................................................. 18
6.1 Initializing the SOMNOwatch™ plus ........................................................................................ 18
6.2 Attaching the Sensors .............................................................................................................. 22
6.3 Manual Blood Pressure Measurement..................................................................................... 24
6.4 Data Transfer from SOMNOwatch™ plus to PC ...................................................................... 25
6.5 Open a Recorded Measurement.............................................................................................. 26
6.6 Analysis .................................................................................................................................... 28
6.7 Open the Report....................................................................................................................... 29
Pulse Transit Time ......................................................................................................................... 32
7DOMINO light Software................................................................................................................ 40
7.1 System Requirements.............................................................................................................. 40
7.2 DOMINO light Panel................................................................................................................. 41
7.3Global Preferences................................................................................................................... 42
7.3.1 Menu –Folders................................................................................................................ 42
7.3.2 Menu –Channels............................................................................................................. 43
7.3.3 Menu –Analysis............................................................................................................... 44
7.3.3.1 Sleep Wake Analysis .............................................................................................. 44
7.3.3.2 Activity Analysis ...................................................................................................... 46
7.3.3.3 Heart Rate Analysis ................................................................................................ 47
7.3.3.4 Position Analysis..................................................................................................... 49
7.3.3.5 SpO2 Analysis.......................................................................................................... 49
7.3.3.6 Pleth Analyis ........................................................................................................... 50
7.3.3.7 PTT Analysis / Blood Pressure ............................................................................... 50
7.3.4 Menu - Analysis Channels............................................................................................... 53
7.3.5 Menu - Filter..................................................................................................................... 53
7.3.6 Menu - Keys..................................................................................................................... 54
7.3.7 Menu - Markers................................................................................................................ 54

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7.3.8 Menu –Area Definition .................................................................................................... 55
7.3.9 Menu –User Data............................................................................................................ 55
7.3.10 Menu –Report................................................................................................................. 56
7.3.10.1 Standard Report...................................................................................................... 56
7.3.10.2 User defined Report................................................................................................ 57
Creating Tables .................................................................................................................................... 61
Editing of Text Fields ........................................................................................................................... 62
Using Items from the Standard Report in the Custom Report.................................................................... 62
7.4 Analysis .................................................................................................................................... 64
7.4.1 Setting Analysis and Channels........................................................................................ 64
7.4.2 Functions of the Pop-up Window..................................................................................... 65
7.4.2.1 Functions of the Analysis Pop-up Window.............................................................. 65
7.4.2.2 Function of the Raw Data Pop-up Window............................................................. 67
7.4.3 Layouts for Data Display in Analysis Mode ..................................................................... 69
7.4.4 Inserting Markers............................................................................................................. 69
7.4.5 Deleting, Editing, Adding Markers ................................................................................... 69
7.4.6 Creating and Editing Samples......................................................................................... 70
7.4.7 The Event List.................................................................................................................. 71
7.4.8 Edit Modes....................................................................................................................... 72
7.4.8.1 Edit Mode................................................................................................................ 72
7.4.8.2 Quick Edit Mode...................................................................................................... 73
7.4.8.3 Select Edit Mode..................................................................................................... 73
7.4.8.4 Repeat Mode........................................................................................................... 73
7.5 Reports..................................................................................................................................... 74
7.5.1 Reports using the DOMINO light Report Generator........................................................ 74
7.5.2 Export Result List............................................................................................................. 74
7.6 Form Letters ............................................................................................................................. 75
7.6.1 Creating a Form letter...................................................................................................... 75
7.6.2 Opening a Form Letter..................................................................................................... 76
7.6.3 Save Form Letter in MS Word 2007................................................................................ 76
7.7 Data Exchange......................................................................................................................... 77
7.7.1 Data Export as Picture, in RIFF or ASCII Format............................................................ 77
7.7.2 EDF+ Export .................................................................................................................... 77
7.8 Archiving................................................................................................................................... 80
7.8.1 Archiving data.................................................................................................................. 80
7.8.2 Archiving database .......................................................................................................... 81
7.9 Patient Database (Option)........................................................................................................ 82
7.9.1 Registration...................................................................................................................... 82
7.9.2 Search Function............................................................................................................... 83
7.9.3 Menu –History................................................................................................................. 83
7.9.4 Menu –Recording ........................................................................................................... 86
7.9.5 Menu - Summary Picture................................................................................................. 87
8Troubleshooting........................................................................................................................... 88
9Maintenance of SOMNOwatch™ plus ........................................................................................ 89
9.1 Maintenance rate...................................................................................................................... 89

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9.2 Cleaning and disinfection ......................................................................................................... 89
9.3 Use and Maintenance of the Rechargeable Battery ................................................................ 90
10 Service........................................................................................................................................... 90
10.1 Technical specification......................................................................................................... 90
10.2 Lifetime................................................................................................................................. 91
10.3 Malfunctions......................................................................................................................... 91
10.4 Storage................................................................................................................................. 91
10.5 Advice to the electromagnetic compatibility......................................................................... 91
10.6 Warranty............................................................................................................................... 91
10.7 Accessories and Spare Parts............................................................................................... 91
10.8 Disposal of Parts and the SOMNOwatchTM plus Device...................................................... 91
10.9 Contact................................................................................................................................. 92
10.10 Notes.................................................................................................................................... 93

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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 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 long-term blood pressure recordings 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.
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.

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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.
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.
This device complies with the IP-Protection-Class "54". This Classification states
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

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IP54
that the SOMNOwatch™ plus is dust and splash proof.
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.

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Light Sensor
This sensor measuring the
intensity of the ambient light.
2.3 Configuration
The configuration includes a SOMNOwatch™ plus with BP Module, a belt, an SpO2sensor, 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
- Pulse
- Pulse Waveform
- 3 Channel ECG

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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 SOMNOwatch™ plus has to be applied only under instruction of a physician.
Because the SOMNOwatch™ plus has no audible alarms for monitoring Pulse and SpO2,
international labelling requirements dictate it to be labelled “Not for continuous
monitoring”.
The SOMNOwatch™ plus 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 SOMNOwatch™ plus 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.
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.

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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.
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.

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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 button Weiter.
Accept the Welcome Information by clicking the Next button.
Select an installation folder and click the Next button.
Accept the selection New Installation by clicking the Next button.

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Choose SomnoWatch Plus at Montage and click on the Next button.
Start the installation process by clicking the Next button.
The installation progress will be displayed by a running green bar.

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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 SOMNOmedics USB Driver now, the manual selection of
the driver file location will not be required in Chapter 5.
If Run Somno Panel is chosen the DOMINO software will immediately be started after clicking the
Finish button.

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Updating the Software
To update your software version please install the new version in the same directory as the basic
version. During the installation you will be asked to choose one of the following installation types.

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After the installation of the update you have to confirm your registration ID in the global preferences.
Confirm the Code in the Tab “folder” by clicking on “Save and Exit”

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5 Docking Station Driver Installation
5.1 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.

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6 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.
6.1 Initializing the SOMNOwatch™ plus
fig. 6-1: 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. 6-2).
-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. 6-1).

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fig. 6-2: Patient Data Input.
You can add more details to the patient in the database (see fig. 6-3).
fig. 6-3: 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. 6-2). 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.

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Now select the blood pressure montage. The channels which will be recorded are defined here.
fig. 6-4: 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.