SOMNOmedics SOMNOwatch User manual

SOMNOmedics America, Inc. –815 Ponce de Leon Boulevard –FL33134 Coral Gables
Toll free number: 866-361-9937
E-Mail: [e-mail] –Internet: www.somnomedics-diagnostics.com
VERSION 2013/07/01
Caution: Federal law restricts this
device to sale by or on the order of a
physician.
SOMNOwatch™
I
NSTRUCTION MANUAL
USA
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.
Rev. 4
Head Office:
SOMNOmedics America, Inc.
815 Ponce de Leon Boulevard
FL33134 Coral Gables
Toll free number: 866-361-9937
Fax: [phone]
E-Mail: [e-mail]
Internet: www.somnomedics-diagnostics.com

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Index
1Introduction .................................................................................................................................... 4
1.1 About this instruction manual ..................................................................................................... 4
1.2 Explanation of Symbols used in this Manual.............................................................................. 4
2About the SOMNOwatch™ ............................................................................................................ 5
2.1 Fields of use ............................................................................................................................... 5
2.2 Model and Device Number......................................................................................................... 5
2.3 Elements of keyboard................................................................................................................. 6
2.4 Configurations ............................................................................................................................ 6
3Safety instructions......................................................................................................................... 8
4Docking Station Driver Installation .............................................................................................. 9
4.1 WinXP......................................................................................................................................... 9
5Operating Instructions................................................................................................................. 10
5.1 How to switch the SOMNOwatch™ On.................................................................................... 10
5.2 Recording Measurements ........................................................................................................ 10
5.2.1 Safety Instructions ........................................................................................................... 10
5.2.2 Initializing the SOMNOwatch™ ....................................................................................... 10
5.2.3 Readout of measurement................................................................................................ 13
6Attachment of the SOMNOwatch™ ............................................................................................ 14
6.1 Actigraphy recording................................................................................................................. 14
6.2 PLM recording .......................................................................................................................... 15
7Troubleshooting........................................................................................................................... 16
7.1 Review...................................................................................................................................... 16
8Maintenance.................................................................................................................................. 17
8.1 Cleaning and disinfection ......................................................................................................... 17
8.2 Use and Maintenance of the Rechargeable Battery ................................................................ 17
9Service........................................................................................................................................... 18
9.1 Technical specification ............................................................................................................. 18
9.2 Malfunctions ............................................................................................................................. 19
9.3 Warranty................................................................................................................................... 19
9.4 Accessories and Spare Parts................................................................................................... 19
9.5 Disposal of Parts and the SOMNOwatchTM Device.................................................................. 19
9.6 Contact ..................................................................................................................................... 20
10 Notes ............................................................................................................................................. 21

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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 SOMNOwatch™ for many years. The SOMNOwatch™ has been developed
by SOMNOmedics to meet the highest quality control standards available.
Indication for Use:
The SOMNOwatch™is a non-life-supporting portable physiological signal recording device intended
to be used for testing adult patients suspected of having movement-correlated sleep disturbances.
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 SOMNOwatch™ to a patient.
Technical Specifications are subject to change without notice
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™. This instruction manual is a part of the device and it
must 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™.
This Warning Symbol indicates potential danger to Patients, Property or Data
Loss.

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It is very important to protect the SOMNOwatch™ from temperatures below 0°C
and above 50°C. Furthermore the SOMNOwatch™ may not be worn during
swimming and showering.
Please refer to the safety instructions in chapter 3.
2 About the SOMNOwatch™
fig. 2-1: Abbout the SOMNOwatch™.
2.1 Fields of use
The SOMNOwatch™ is used for Actigraphy and PLM/RLS Recorder.
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).
fig. 2-2: Type Label.
patient marker
Interface/Recharging
light sensor
status LED
Body Position Sensor
+
Acceleration Sensor
(X,Y and Z direction)

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Information, Symbols, Icons and Classifications 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 of keyboard
Picture
Description
Function
Status LED
Neutral Mode: Green LED blinking 1x all 4 seconds.
Waiting Mode: Green LED blinking 1x per second.
Recording Mode: Green LED blinking 16x 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 Configurations
The SOMNOwatch™ is available in 2 different configurations. All configurations include a
SOMNOwatch™ with Docking Station and Battery Charger, a USB adapter cable, a Carry Bag for
housing the SOMNOwatch™, Instruction Manuals and the DOMINOlight Link US software for
Initialisation, Data Transfer and Analysis.

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Set
MODULES,
CHANNELS,
ACCESSORIES
Actigraphy
Actigraphy/
PLM-
Analysis
Integrated Channels
3 Activity Sensors
(X,Y,Z –Axis)
●
●
Ambient Light
●
●
Patient Marker
●
●
Body Position
●
●
Modules
PLM Analyser
○
●
Accessories
Watch Strap (Size M)
●
●
Foot Strap
○
●
Interface
(Docking Station with
Battery Charger)
●
●
Software
●
●
Carry Bag
●
●
Instruction Manuals
●
●
● = standard, ○ = optional

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3 Safety instructions
This instruction manual is regarded to be a 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™ has to be applied only under instruction of a physician.
Damaged parts must be replaced immediately. Please contact SOMNOmedics or
your SOMNOmedics Distributor.
Only accessories recommended by SOMNOmedics are allowed to be connected to
the SOMNOwatch™.
This device is not designed for usage in Explosive Environmental Conditions.
It is very important to protect the SOMNOwatch™ from temperatures below 0°C
and above 50°C. Furthermore the SOMNOwatch™ may 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™ is dust and splash proof.
Do not use an autoclave for cleaning the SOMNOwatch™ or any of its accessories.
Follow the manufactures instructions when using disinfectants. Keep to the
prescribed dose and contact time.
Use protective gloves when using aggressive disinfectant agents.
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™ 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.
Chemicals which are used for cleaning the unit should be stored, prepared and
kept ready in their own marked containers to avoid confusions.
Opening the case, repairing or modifying the SOMNOwatch™ 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.

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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 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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5 Operating Instructions
5.1 How to switch the SOMNOwatch™ On
The SOMNOwatch™ automatically switches 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 Safety Instructions
The date and time of the PC system clock is delivered to the SOMNOwatch™
during the 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.
5.2.2 Initializing the SOMNOwatch™
fig. 5-1: DOMINOlight 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™ to the Docking
Station
-Press the patient marker .
-Select Initialization at the DOMINOlight Panel
(marked red in fig. 5-1).

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fig. 5-2: Patient Data Input.
You could 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, 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.

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Now you have to choose a montage. The channels which will be recorded are defined here.
fig. 5-4: Menu - Montage
fig. 5-5: Register „Messung”
When you click on Initialise the internal memory will be deleted and the message Initialisation
successful 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 is 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 an 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
8
5

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5.2.3 Readout of measurement
Once there are one or more measurements on the SOMNOwatch™, it is possible to readout these
with the DOMINOlight Link US 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 DOMINOlight Panel.
The parameters of the measurement will be displayed.
It is possible to instruct the software to produce an analysis, a Screen Report and/or a Printed Report
fully automatically. To configure these settings, click the button. Select the options required and
click on OK.
Click on the Transfer Button to start the data transfer.

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6 Attachment of the SOMNOwatch™
6.1 Actigraphy recording
Wrist Belt:
Apply SOMNOwatchTM at the non dominant wrist.
fig. 6-1: Applying SOMNOwatchTM for Activity recording
Repeat at other side
Step 1
Step 2
Step 3

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6.2 PLM recording
Foot Strap:
Apply SOMNOwatchTM to one ankle with the AUX input facing up.
fig. 6-2: Applying SOMNOwatchTM for PLM recording
Step 1
Step 2
Sideview
Final

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7 Troubleshooting
7.1 Review
Problem
Possible Reason
What to do?
Analysis
Unable to start Display
Program.
Registration code
not entered.
Contact SOMNOmedics Support and request the
registration code. Enter the registration code into the
Global Preferences in the Folders menu. After
entering the code, click on the Save and Exit button.
Transfer
A Recording cannot be
transferred from the
SOMNOwatch™.
Hard disc reports
Insufficient
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.
Signals
One channel was not
recorded.
Montage not
programmed
correctly.
Please check the montage and make sure the channel
is selected.
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!

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8 Maintenance
8.1 Cleaning and disinfection
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.
Do not use an autoclave for cleaning the SOMNOwatch™ or any of its accessories.
Disinfection of Straps:
Article
Disinfectant
(trade mark)
Concentration
Duration
Intervals
Other
Elastic Wrist Belt
or Foot Strap
Quick
disinfection on
alcohol basis:
For example:
Mikrozid AF
Liquid
Mikrozid AF
Cloth
Isopropanol-
Spray
Ready to use
Ready to use
70%
5 min
5 min
5–10 min
After use
Remove adhesives if
necessary. Follow
manufacturers
instructions!
Use protective gloves when using aggressive disinfectants!
Follow the manufactures instructions when using disinfectants. Keep to the
prescribed dose and contact time!
Use cold water to prepare disinfection solvents!
8.2 Use and Maintenance of the Rechargeable Battery
The internal battery is a Lithium-Ion (Li ION) rechargeable battery. The battery offers a long life
(approximately 500 charges), is not susceptible to memory effects and is ecologically friendly.
It takes approximately 1.75 h to charge a fully flat battery. The Battery is fully charged when the
yellow Charging LED on the charger turns off.
Always use the Docking Station (SOW106) to charge the internal battery. Otherwise
the battery could be damaged.

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9 Service
9.1 Technical specification
6 CHANNELS
6 Internal Channels:
3 Activity Sensors for X-Y-Z Axis, Body Positon,
Ambient Light, Patient Marker)
DATA PROCESSING
12 Bit ADC
Different Sampling Rates Adjustable ( 1/120s - 128/s )
Different Storage Rates Adjustable ( 1/120s - 128/s )
Internal Data Storage 8 MB
POWER SUPPLY
Rechargeable Li ION battery (630mAh)
DIMENSIONS AND WEIGHT
57mm x 48mm x 17mm
Weight: 29g including battery
TEMPERATURE
During operation: 5°C to 40°C
Storage: 0°C to 50 °C
Humidity
Operation: 10 to 90% Non Condensing
Storage: 10 to 95% Non Condensing

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9.2 Malfunctions
In the event of a problem with the SOMNOwatchTM, switch it off and ensure that it is removed from use
and clearly labelled.
The following are examples where this may be necessary:
- The device is visibly damaged (broken case)
- The device is not working correctly (poor measurements)
- Components are loose or fit poorly
- Connectors are damaged (crushed or cut cables)
Please contact your local distributor for a fast response or contact SOMNOmedics for a fast and
efficient response. Please see chapter 9.6.
9.3 Warranty
SOMNOmedics will only guarantee the Safety, Reliability and Operation of the SOMNOwatch™ under
the following conditions:
- Updates, modifications or repairs are only executed by authorized distributors or SOMNOmedics.
- The device is operated only by trained and qualified personnel.
- The device is transported in original packaging only.
- The device is stored in a suitable environment.
- The device is used according to the instruction manual and all safety instructions are followed.
The Warranty only covers the SOMNOwatch™ Unit. The System is guaranteed for 24 months.
9.4 Accessories and Spare Parts
Please request our latest catalogue from your local Distributor or contact SOMNOmedics.
9.5 Disposal of Parts and the SOMNOwatchTM Device
Used or replaced parts and devices must be disposed of according to local regulations for
environmental protection.

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9.6 Contact
Our telephone and fax customer service line is available 24 hours a day 7 days a week! We provide
fast and qualified advice for all your queries.
Our 24 hour telephone hotline provides a high level of support at all times:
Hotline: [phone]
You can send us important information by fax on:
415 373 4443
We also provide service and support via e-mail on:
[e-mail]
@