SOMNOmedics SOMNOwatch User manual

I
NSTRUCTION MANUAL
VERSION 07.11.2012
Caution: Federal law restricts this device to sale by or on the order o a physician.
SOMNOwatch
SOMNOmedics GmbH – Am Sonnenstuhl 3 – D-9723 Randersacker
Phone.: +49 (0) 931 / 35 90 94-0 – Fax: +49 (0) 931 / 35 90 94-49
E-Mail: [e-mail] – Internet: www.somnomedics.eu

2
Medical Devices for Sleep Diagnostics and Therapy
All proper names marked with TM are protected copyright by SOMNOmedics.
SOMNOmedics GmbH – Am Sonnenstuhl 3 – D-9723 Randersacker
Phone: +49 (0) 931 / 35 90 94-0 – Fax: +49 (0) 931 / 35 90 94-49
E-Mail: [e-mail] - Internet: www.somnomedics.eu
Rev. 3
07.11.2012

3
Medic al Devices for Sleep Diagnostics and Therapy
Index
1 Introduction .................................................................................................................................... 5
1.1 About this instruction manual ..................................................................................................... 5
1.2 Explanation of Symbols used in this Manual .............................................................................. 5
2 About the SOMNOwatch ................................................................................................................ 6
2.1 Fields of use ...............................................................................................................................
2.2 Model and Device Number .........................................................................................................
2.3 Elements of keyboard ................................................................................................................. 7
2.4 Configurations ............................................................................................................................ 7
3 Sa ety instructions ......................................................................................................................... 9
4 Docking Station Driver Installation ............................................................................................ 10
4.1 WinXP ....................................................................................................................................... 10
5 Operating Instructions ................................................................................................................. 11
5.1 How to switch the SOMNOwatch On ....................................................................................... 11
5.2 Recording Measurements ........................................................................................................ 11
5.2.1 Safety Instructions ........................................................................................................... 11
5.2.2 Initializing the SOMNOwatch ........................................................................................... 11
5.2.3 Readout of measurement ................................................................................................ 14
6 Attachment o external Sensors ................................................................................................. 15
.1 PLM Sensor .............................................................................................................................. 15
.2 Respiratory Pressure Sensor for Flow and Snore (blue) ......................................................... 1
.3 CPAP Pressure Sensor (green) ............................................................................................... 1
.3.1 ECG Sensor ..................................................................................................................... 17
.3.2 EEG Sensor ..................................................................................................................... 18
7 Troubleshooting ........................................................................................................................... 19
7.1 Review ...................................................................................................................................... 19
8 Maintenance .................................................................................................................................. 20
8.1 Cleaning and disinfection ......................................................................................................... 20
8.2 Use and Maintenance of the Rechargeable Battery ................................................................ 22
9 Service ........................................................................................................................................... 23
9.1 Technical specification ............................................................................................................. 23
9.2 Malfunctions ............................................................................................................................. 24
9.3 Warranty ................................................................................................................................... 24
9.4 Accessories and Spare Parts ................................................................................................... 24
9.5 Disposal of Parts and the SOMNOscreen Device .................................................................... 24

4
Medic al Devices for Sleep Diagnostics and Therapy
9. Contact ..................................................................................................................................... 25
10 Notes ............................................................................................................................................. 26

5
Medic al Devices for Sleep Diagnostics and Therapy
1 Introduction
SOMNOmedics thanks you for purchasing this product. We are confident that you enjoy using the
SOMNOwatch for many years. The SOMNOwatch has been developed by SOMNOmedics to meet
the highest quality control standards available.
Indications For Use: The SOMNOwatch is indicated for use in the recording, displaying, monitoring,
printing, and storage of biophysical parameters for the purpose of assisting in the diagnosis of
Neurological and Sleep Disorders.
Caution: Federal law restricts this device to sale by or on the order o 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 to a patient.
Any comments and suggestions you wish to make regarding the improvement of this Instruction
Manual will be much appreciated.
Unfortunately it is sometimes possible that our hotline may be busy when you call and you will be
redirected to our mailbox. When this happens, please leave your name and telephone number so that
we can call you back promptly.
1.1 About this instruction manual
It is essential that you read each paragraph care ully when you see this icon on the le t
o that paragraph. This icon also appears on the label on the bottom o the
SOMNOscreen. This instruction manual is a part o the device and it has to be kept
available at all times.
1.2 Explanation o Symbols used in this Manual
Indicates a hint or tip. This Symbol provides assistance with possible problems
when working with the SOMNOwatch.
This
Warning
Symbol indicates potential danger to Patients, Property or Data
Loss.
Our telephone hotline provides a high level of support:
9:00 – 17:00 +49 (0) 9 31 / 35 90 94 0
Our handy hotline promises competent and immediate help to answer urgent technical
problems*:
7:00 – 9:00 +49 (0) 1 72 / 6 75 69 90
17:00 – 24:00
*

Medic al Devices for Sleep Diagnostics and Therapy
It is very
important to protect the SOMNO
watch
rom temperatures
below 0°C and
above 50°C. Furthermore the SOMNOwatch should not be worn during swimming
and showering.
Please re er to the sa ety instructions in chapter 3.
2 About the SOMNOwatch
ig. 2-1: Abbout the SOMNOwatch.
2.1 Fields o use
The SOMNOwatch is available with several different sensors allowing it to be used for Actigraphy,
PLM/RLS Recorder, Respiratory Screener, Sleep Recorder, Movement Analyser, Long-term ECG and
EEG Recorder. Additional fields of application are not only monitoring training, sport and rehabilitation,
but also e.g. the detection of Sleep Walking.
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.
2.2 Model and Device Number
When unpacking the SOMNOwatch, 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 (see fig. 2-2).
ig. 2-2: Type Label.
patient marker
external signal
input (AUX)
Interface/charge
connector
light sensor
status LED
body position sensor
+
activity sensors
(X,Y,Z – axis)

ꍆ ｮ
 J
7
Medic al Devices for Sleep Diagnostics and Therapy
In ormation, Symbols, Icons and Classi ications on the Type Label
Read the instruction manual very carefully before you start working with the
SOMNOwatch.
Protection Class: BF
IP54
This device complies with the
IP
-
Protection
-
Class "54
".
This Classification states
that the SOMNOwatch is dust and water resistant.
2.3 Elements o keyboard
Picture
Description
Func
tion
Status LED
Neutral Mode: Green LED blinking 1x all 4 seconds.
Waiting Mode: Green LED blinking 1x per second.
Recording Mode: Green LED blinking 1 x per second.
Initialisation: Green LED lights permanently.
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 must
push this button.
Light Sensor
This sensor measuring the intensity of the ambient light.
2.4 Con igurations
The SOMNOwatch is available in 5 different configurations. All configurations include a SOMNOwatch
with Docking Station and Battery Charger, a USB adapter cable, a Carry Bag for housing the
SOMNOwatch and Sensors, Instruction Manuals and the DOMINO light software for Initialisation,
Data Transfer and Analysis.

8
Medic al Devices for Sleep Diagnostics and Therapy
Set
MODULES,
CHANNELS,
ACCESSORIES
Actigraphy
Actigraphy/
PLM-
Analysis
Actigraphy/
Respiratory
Screening
Actigraphy /
Long-Term
ECG
Actigraphy/
Long-Term
EEG
Actigraphy/
Temperature
Integrated Channels
3 Activity Sensors
(X,Y,Z – Axis)
● ● ● ● ● ●
Ambient Light ● ● ● ● ● ●
Body Position ● ● ● ● ● ●
Patient Marker ● ● ● ● ● ●
Modules
Movement Analyser ○ ● ○ ○ ○ ○
Respiratory Analyser ○ ○ ● ○ ○ ○
ECG Analyser ○ ○ ○ ● ○ ○
EEG Analyser
( 1 x Referential )
○ ○ ○ ○ ● ○
Temperature Analyser ○ ○ ○ ○ ○ ●
Sensors
PLM external ○ ○ ○ ○ ○ ○
Pressure Sensor
(Flow/Snore)
○ ○ ● ○ ○ ○
Pressure Sensor
(CPAP)
○ ○ ○ ○ ○ ○
ECG Electrode ○ ○ ○ ● ○ ○
EEG Electrode ○ ○ ○ ○ ● ○
Temperature Probe ○ ○ ○ ○ ○ ●
Acc
essories
Interface
(Docking Station with
Battery Charger)
● ● ● ● ● ●
Software ● ● ● ● ● ●
Carry Bag ● ● ● ● ● ●
Instruction Manuals ● ● ● ● ● ●
● = standard, ○ = optional

ђ
9
Medic al Devices for Sleep Diagnostics and Therapy
3 Sa ety instructions
This device is NOT designed to be used in a Li e Support situation.
A minimal risk o injury through electric voltage (limited to 3.6 volts) may occur due
to the use o De ective cables when a ground lead is contacted to the patient.
Check all cables and connections or damage be ore using this device. Damaged
parts must be replaced immediately. Please contact SOMNOmedics or your
SOMNOmedics Distributor.
This device is not designed or usage in Explosive Environmental Conditions.
It is very important to protect the SOMNOwatch rom temperatures below 0°C and
above 50°C. Furthermore the SOMNOwatch should not be worn during swimming
and showering.
This device complies with the IP-Protection-Class "54". This Classi ication states
that the SOMNOwatch is dust and splash proo .
Do not use an autoclave or cleaning the SOMNOwatch or any o its accessories,
cables and sensors.
Follow the manu actures instructions when using disin ectants. Keep to the
prescribed dose and contact time.
Use protective gloves when using aggressive disin ectant agents.
Long-term storage o this device should only be in a closed and dry room to avoid
condensation caused by thermal luctuations. Do not store the SOMNOwatch in
places o the high temperature exceeding 35 deg. C or under direct sunlight or in
ront o a stove. Be sure not to store it under rozen condition. Please also avoid
the places o high humidity.
Chemicals which are used or cleaning the unit should be stored, prepared and
kept ready in their own marked containers to avoid con usions.
Opening the case, repairing or modi ying the SOMNOwatch in any way will void the
guarantee. Only SOMNOmedics and its authorised distributors may repair the unit.
Damaging the Guarantee Seal “Warranty void, i seal is broken” will immediately
void the guarantee o this SOMNOmedics product.
Only sensors designed and supplied by SOMNOmedics may be used with this unit.
Always use the Docking Station (SOW106) to charge the internal battery.

10
Medic al Devices for Sleep Diagnostics and Therapy
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
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 con irm the recommended option Install
the so tware automatically by clicking Next.
In the following window you must choose the
CD-ROM and click on Next.

녆 躠
 ц
11
Medic al Devices for Sleep Diagnostics and Therapy
5 Operating Instructions
5.1 How to switch the SOMNOwatch On
The SOMNOwatch automatically switch in a neutral mode when no measurement is running.
The start and end of a measurement is programmed with the delivered software.
5.2 Recording Measurements
5.2.1 Sa ety Instructions
The date and time o the PC system clock is delivered to the SOMNOwatch during
the initialisation. There ore it is important to have preset the right date and time.
Please note that measuremets running during the change o Summer/Winter time
will have a time shi t.
5.2.2 Initializing the SOMNOwatch
ig. 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 initialisation window (see fig. 5-2).
- Connect the SOMNOwatch to the Docking
Station
- Press the patient marker .
- Select Initialisation at the DOMINO panel
(marked red in fig. 5-1).

12
Medic al Devices for Sleep Diagnostics and Therapy
ig. 5-2: Patient Data Input.
You could add more details to the patient in the database (see fig. 5-3).
ig. 5-3: Add details to the patient.
Now, click on the Next button or on the tab sheet Montage.
Patient Data Inp
ut:
 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, irst/ last names and
date o 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, only when you buy the Patient
Database).
Patient Data: Here you can edit the patient data.
Questionnaire: Here you can add a questionnaire
for the daytime sleepiness (ESS) or
the Restless Legs Syndrom (RLS).
Notes: Add special informations to the patient with
date and time.

롆 紀
 ы
13
Medic al Devices for Sleep Diagnostics and Therapy
Now you have to choose a montage. The channels which will be recorded are defined here.
ig. 5-4: Menu - Montage
ig. 5-5: Register „Messung”
When you click on Initialise the internal memory will be deleted and the message Initialisation
success ul appears.
2
3
1
Descriptions (see
fig. 5-4
and
fig. 5-5
)
Montages: (1)
Select an already existing montage or define a new one
with the button Save as  .
Power-Saving Mode:(2)
The activity sensor for the Z-Axis, the body position sensor
and the AUX input for external sensors are deactivated. A
longer recording duration is possible thereby.
Settings of recording channels: (3)
Please activate the checkboxes of the channels that have
to be recorded and select the sample and storage rate.
The maximum recording duration is immediately
determined and displayed according to the selected
settings.
Magnitude: Quantitative determination of activity by
adding up all X-Y-Z movements within one
storage cycle.
Template: (4)
Select a analysis template consistent with the
measurement.
Example: Detection of PLM’s -> Template PLM
It is possible to change these templates in the Global
Settings.
Recording duration: (5)
If you want to start the measurement immediately after the
initialisation, then select start immediately. Behind it you
can now type in the recording duration.
Please deselect start immediately for a multiple recording.
The line beneath for the programmed start will be activated
automatically. Here you can type in the date, the start time
and the duration of the programmed recording.
Now you could enter a description for the measurement.
This description will be shown in the Open Recording
window.
4

졆 紀
˴ ы
14
Medic al Devices for Sleep Diagnostics and Therapy
5.2.3 Readout o measurement
Once there are one or more measurements on the SOMNOwatch, it is possible to readout these with
the DOMINO light Software and the Docking Station.
Please proceed as follows:
What to do?
Connect the SOMNOwatch to the Docking Station.
Press the patient marker .
Please start the data transfer by clicking this icon at the DOMINO light panel.
The parameters of the measurement will be displayed.
It is possible to instruct the software to produce a analysis, a Screen Report and/or a Printed Report
fully automatically. To configure these settings, click on this button . Select the options required
and click on OK.
Click on the Trans er Button to start the data transfer.

15
Medic al Devices for Sleep Diagnostics and Therapy
6 Attachment o external Sensors
External sensors have to be plugged just into the auxiliary input (AUX). Important for the operator is,
that he selects a corresponding montage for the used sensor to avoid confusion.
6.1 PLM Sensor
In order to measure leg movements simultaneous on both legs to detect periodic limb movement
(PLM) or the restless legs syndrome (RLS) an external PLM sensor can be used to measure the
second leg. For this application the PLM sensor has to be prepared and applied as shown in fig. -1
and fig. -2.
The active sensor has to be placed on Musculus Tibialis Anterior (centered between the knee and the
ankle) of the leg. Use the 3-packed snap electrodes to fit the sensor on the correct position. Additional
it is necessary to fix the cable with an extra tape, to avoid interferences during the measurements and
to have a strain relief.
ig. 6-1: Connecting the sensor with the triple-electrode
ig. 6-2: Application o the external PLM sensor
Strain relief

콆 紀
˴ ы
1
Medic al Devices for Sleep Diagnostics and Therapy
6.2 Respiratory Pressure Sensor or Flow and Snore (blue)
To use the SOMNOwatch as a respiratory screener an external pressure sensor has to be connected
to the AUX input. The nasal or naso/oral canula, which leads the air to the sensor, is applied to the
patient by putting the tube behind the ears and fixing the canula by pushing the sleeve (fig. -3). It is
connected by a standard Luer fitting.
ig. 6-3: Application o the nasal canula and the respiratory pressure sensor
6.3 CPAP Pressure Sensor (green)
For CPAP control the SOMNOwatch needs to have the external CPAP pressure sensor. The
application can be done in two ways. Possibility one is to connect the pressure sensor to the mask by
a small tube to an existing output.
ig. 6-4: Connecting the CPAP pressure sensor to the mask

ժ쵆
 p
17
Medic al Devices for Sleep Diagnostics and Therapy
The second possibility is to connect the pressure sensor to the CPAP device. If the CPAP mask does
not contain an interface for the supplied tube, follow the next steps below: Connect the supplied tube
(outside-Ø: 5 mm, inside-Ø: 2 mm) via Luer-Lock to the pressure interface of the CPAP sensor.
Connect the other end of these tube with the T-adaptor. Connect another tube of 20 cm in length
(outside-Ø: 5 mm, inside-Ø: 2 mm) with T-adaptor and the interface of the CPAP device. The out
coming tube (outside-Ø: 5 mm, inside-Ø: 2 mm) of the air supplying tube has to be fitted on the free
end of the T-adaptor.
ig. 6-5: Connecting the CPAP pressure sensor to the CPAP device
6.3.1 ECG Sensor
If the SOMNOwatch should record an ECG the sensor has to be plugged in the AUX input. The ECG
sensor has three fittings for snap electrodes. One is on the back of the blue disc and the others are
green and yellow. Snap in the proper electrodes. To obtain the best results the skin where the
electrodes are placed should be cleaned before applying the electrodes. Use a peeling paste (suitable
for bio-electrical measurements) to prepare the patients skin.
The blue disc (GROUND) should be applied under the patients left clavicle. Apply the green and
yellow electrode in extension to the heart axis. Loose cables should be fixed with an adhesive tape.
ig. 6-6: Application o the ECG sensor

ｮ
˴JJ
18
Medic al Devices for Sleep Diagnostics and Therapy
6.3.2 EEG Sensor
To record an EEG with the SOMNOwatch the EEG sensor has to be plugged into the AUX input. The
EEG sensor has three fittings for snap electrodes. One is on the back of the blue disc and the others
are red and marine blue. Snap in the proper electrodes. To obtain the best results the skin where the
electrodes are placed should be cleaned before applying the electrodes. Use a peeling paste (suitable
for bio-electrical measurements) to prepare the patients skin.
The blue disc should be applied on the center of the forehead. The red electrode should be placed on
the patients right forehead as near as possible to the hair line (F3-F4 spot). The marine blue electrode
should be applied behind the patients left ear (A1 spot). Loose cables should be fixed with an
adhesive tape.
ig. 6-7: Application o the EEG sensor

19
Medic al Devices for Sleep Diagnostics and Therapy
7 Troubleshooting
7.1 Review
Problem
Possible Reason
What to do?
Analysis
Unable to start Display
Programme.
Registration code
not entered.
Contact SOMNOmedics Support and request the
registration code. Enter the registration code into the
Global Pre erences in the Folders menu. After
entering the code, click on the Save and Exit button.
Trans er
A Recording cannot be
transferred from the
SOMNOwatch.
Hard disc reports
Insu icient
memory available.
Archive all recordings and then delete them from the
hard disk.
Check to ensure that you have the correct rights to
save data from your System Administrator.
Measurement does not start
Pre-programmed
measurement does not
start.
Date or Time of the
programmed
measurement is
false.
Check Date and Time on the PC. Correct if necessary.
Sign
als
One channel was not
recorded.
Montage not
programmed
correctly.
Please check the montage and make sure the channel
is selected.
Noisy EEG/EOG
signals, not suitable for
analysis.
Incorrect filter
settings.
Check filters. Recommended filter for EEG: 0,3-30Hz
and EOG: 0,3-10Hz
Contact sites not
properly cleaned.
Clean the contact site with paste (Nuprep).
Timing
It is not possible to
change the time base
in the Analysis or Raw
Data menu.
Wrong mode
selected. Please activate the mode Display (Mode → Display).
The Time base for the Raw Data can’t be longer than
the programmed time of the whole analysis!

20
Medic al Devices for Sleep Diagnostics and Therapy
8 Maintenance
8.1 Cleaning and disin ection
Regularly clean the device to ensure trouble free operation.
Cleaning the device:
Wipe the case using only mild detergents. DO NOT use a wet or fluffy cloth.
Other disinfectants, approved by DGHM, may be used after testing that they do not damage the
surface of the device or the sensors.
Do not use an autoclave for cleaning the SOMNOwatch or any of its accessories, cables and sensors.