SOMNOmedics SOMNOwatch plus Manual de usuario

SOMNOwatch™ plus

NSTRUCTION MANUAL

SOMNOmedics GmbH –Am Sonnenstuhl 63 –D-97236 Randersacker

Tel. +49 (0) 931 / 35 90 94 0 –Fax +49 (0) 931 / 35 90 94 49

E-Mail info@somnomedics.de

Internet www.somnomedics.de

Caution-- Investigational device. Limited by Federal (or

United States) law to investigational use.

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All proper names marked with TM are protected copyright by SOMNOmedics.

Rev. 4

14.11.2019

SOMNOmedics GmbH –Am Sonnenstuhl 63 –D-97236 Randersacker

Tel. +49 (0) 931 / 35 90 94 0 –Fax +49 (0) 931 / 35 90 94 49

E-Mail info@somnomedics.de - Internet www.somnomedics.de

 
 
 
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Index 
1Introduction .................................................................................................................................... 7 
1 About this instruction manual ..................................................................................................... 7 
2 Explanation of Symbols used in this Manual.............................................................................. 7 
2About the SOMNOwatch™ plus.................................................................................................... 8 
1 Indication for Use:....................................................................................................................... 8 
2 Model and Device Number......................................................................................................... 9 
3 Elements of keyboard............................................................................................................... 10 
4 Configuration ............................................................................................................................ 11 
3Safety instructions....................................................................................................................... 12 
4Installing the DOMINO light Software ........................................................................................ 14 
5Docking Station Driver Installation ............................................................................................ 19 
6Operating Instructions................................................................................................................. 20 
1 Initializing the SOMNOwatch™ plus ........................................................................................ 20 
2 Attaching the Sensors .............................................................................................................. 29 
2.1 Activity Analysis / Sleep Wake Analysis / Tremor Analysis............................................. 29 
2.2 PLM/RLS Analysis........................................................................................................... 30 
2.2.1 Recording with external EMG Sensor..................................................................... 30 
2.2.2 Recording with external Activity Sensor.................................................................. 31 
2.3 Body Temperature........................................................................................................... 32 
2.4 EDA.................................................................................................................................. 33 
2.5 Sleep Profile..................................................................................................................... 34 
2.6 ECG Analysis / Training Control / Rehab ........................................................................ 35 
2.7 Flow/Snore....................................................................................................................... 36 
2.8 CPAP............................................................................................................................... 37 
3 Data Transfer from SOMNOwatch™ plus to PC...................................................................... 38 
4 Open a Recorded Measurement.............................................................................................. 39 
5 Analysis .................................................................................................................................... 47 
5.1 Define the Begin and the End of the measurement......................................................... 47 
5.2 Use-oriented Analysis Steps............................................................................................ 47 
5.2.1 Activity Analysis ...................................................................................................... 47 
5.2.2 Sleep Wake Analysis .............................................................................................. 48 
5.2.3 Rasterviw ................................................................................................................ 49 
5.2.4 PLM/RLS Analysis .................................................................................................. 52 
5.2.5 Body Temperature .................................................................................................. 53 
5.2.6 Flow/Snore.............................................................................................................. 54 
5.2.7 Heart rate analysis .................................................................................................. 54 
5.2.8 Sleep Profile............................................................................................................ 56 
6 Enter the Findings and the Diagnosis ...................................................................................... 61 
7 Open the Report....................................................................................................................... 61 
7.1 Activity Analysis............................................................................................................... 61 

 
 
 
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7.2 Sleep Wake Analysis....................................................................................................... 64 
7.3 Tremor Analysis............................................................................................................... 68 
7.4 PLM/RLS Analysis........................................................................................................... 69 
7.5 Body Temperature........................................................................................................... 73 
7.6 EDA.................................................................................................................................. 75 
7.7 Sleep Profile..................................................................................................................... 76 
7.8 ECG Analysis................................................................................................................... 80 
7.9 Training/Rehab ................................................................................................................ 82 
7.10 Flow/Snore....................................................................................................................... 83 
7.11 CPAP Control................................................................................................................... 86 
7DOMINO light Software................................................................................................................ 87 
1 System Requirements.............................................................................................................. 87 
2 DOMINO light Panel................................................................................................................. 88 
3 Global Preferences................................................................................................................... 89 
3.1 Selection of device type................................................................................................... 89 
3.2 Menu –Folders............................................................................................................... 90 
3.3 Menu –Channels............................................................................................................. 91 
3.4 Menu - Analysis ............................................................................................................... 92 
3.4.1 Sleep Wake Analysis .............................................................................................. 93 
3.4.2 Sleep Profile............................................................................................................ 94 
3.4.3 Spindle and K-Complex Analysis............................................................................ 97 
3.4.4 Sleep FFT Analysis................................................................................................. 99 
3.4.5 Activity Analysis .................................................................................................... 101 
3.4.6 Light Analysis........................................................................................................ 102 
3.4.7 Flow Analysis ........................................................................................................ 103 
3.4.8 Snore Analysis ...................................................................................................... 104 
3.4.9 Leg Movements (LM) Analysis.............................................................................. 105 
3.4.10 Heart Rate Analysis .............................................................................................. 107 
3.4.11 FFT Analysis ......................................................................................................... 108 
3.4.12 HR-Movement Analysis......................................................................................... 109 
3.4.13 Position Analysis................................................................................................... 109 
3.4.14 Temperature Analysis........................................................................................... 110 
3.4.15 CPAP Analysis...................................................................................................... 110 
3.4.16 EDA-Analysis (EDA: Electro Dermal Activity)....................................................... 111 
3.5 Menu - Analysis Channels............................................................................................. 112 
3.6 Menu –Filter.................................................................................................................. 112 
3.7 Menu - Raw Data Profiles.............................................................................................. 113 
3.8 Menu - Analysis Profiles ................................................................................................ 114 
3.9 Menu - Keys................................................................................................................... 115 
3.10 Menu - Markers.............................................................................................................. 115 
3.11 Menu –Area Definition ................................................................................................. 116 
3.12 Menu –User Data......................................................................................................... 116 
3.13 Menu –Report............................................................................................................... 117 
3.13.1 Standard Report.................................................................................................... 117 
3.13.2 User defined Report.............................................................................................. 118 
4 Analysis .................................................................................................................................. 125 
4.1 The quick start toolbar ................................................................................................... 125 
4.2 Setting Analysis and Channels...................................................................................... 126 
4.2.1 Functions of the Analysis Pop-up Window............................................................ 127 

 
 
 
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4.2.2 Function of the Raw Data Pop-up Window........................................................... 129 
4.3 Layouts for Data Display in Analysis Mode ................................................................... 131 
4.4 Inserting and Editing Markers....................................................................................... 131 
4.5 Creating and Editing Samples....................................................................................... 132 
4.6 Creating, Deleting and Editing User areas .................................................................... 133 
4.7 The Event List................................................................................................................ 133 
4.8 Averaging....................................................................................................................... 134 
5 Manual Editing........................................................................................................................ 135 
5.1.1 Edit Mode.............................................................................................................. 135 
5.1.2 Quick Edit Mode.................................................................................................... 136 
5.1.3 Select Edit Mode................................................................................................... 136 
5.1.4 Repeat Mode......................................................................................................... 136 
5.1.5 Define a Global Artefact........................................................................................ 137 
6 Reports................................................................................................................................... 138 
6.1 Reports using the DOMINO light Report Generator...................................................... 138 
6.2 Export Result List to MS Excel ...................................................................................... 138 
7 Form Letters ........................................................................................................................... 139 
7.1 Creating a Form Letter................................................................................................... 139 
7.2 Opening a Form Letter................................................................................................... 140 
7.3 Save Form Letter in MS Word 2007.............................................................................. 140 
8 Data Exchange....................................................................................................................... 141 
8.1 Data Export as Picture, in RIFF or ASCII Format.......................................................... 141 
8.2 EDF+ Export .................................................................................................................. 141 
9 Archiving................................................................................................................................. 144 
9.1 Archiving Data................................................................................................................ 144 
9.2 Archiving database ........................................................................................................ 146 
10 Patient Database (Option).................................................................................................. 147 
10.1 Registration.................................................................................................................... 147 
10.2 Search Function............................................................................................................. 148 
10.3 Menu –History............................................................................................................... 149 
10.4 Menu –Recording ......................................................................................................... 150 
10.5 Menu –Summary Picture .............................................................................................. 152 
10.6 Trend Function............................................................................................................... 153 
10.7 Compare Sleep Stages.................................................................................................. 154 
8Troubleshooting......................................................................................................................... 155 
9Maintenance of SOMNOwatch™ plus ...................................................................................... 156 
1 Cleaning and disinfection ....................................................................................................... 156 
2 Use and Maintenance of the Rechargeable Battery (internal)............................................... 157 
Service......................................................................................................................................... 158 
1 Technical specification....................................................................................................... 158 
2 Lifetime............................................................................................................................... 159 
3 Malfunctions....................................................................................................................... 159 
4 Storage and Transport....................................................................................................... 159 

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10.5 Warranty............................................................................................................................. 159

10.6 Disposal of Parts and/or the SOMNOwatchTM plus............................................................ 159

10.7 Accessories and Spare Parts............................................................................................. 160

10.8 Contact............................................................................................................................... 161

10.9 Notes.................................................................................................................................. 162

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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™ plus for many years. The SOMNOwatch™ plus has been

developed by SOMNOmedics to meet the highest quality control standards available.

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.

Advice and suggestions to improve the functional properties of the device and this manual we will be

gratefully accepted.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Technical Specifications are subject to change without notice.

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 case accessories are used which do not come from SOMNOmedics, a bill

will be issued for any repairs.

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.

Careful attention of the manual is premise for the intended use of this SOMNOmedics device.

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.

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2 About the SOMNOwatch™ plus

fig. 2-1: About the SOMNOwatch™ plus

2.1 Indication for Use:

The SOMNOwatchTM plus is an Actigraph with the possibility to record Bio-Signals via the external

signal input. It can be used for Activity Analysis, PLM/RLS detection, estimation of Sleep Wake

Rhythm, detection of Body Position and as Movement Analyser for Tremor diagnose.

Additional sensors can be connected to the external signal input:

1 channel EEG, 1 channel ECG, Temperature Probe, Skin Resistance Sensor (Electro dermal Activity)

and a Pressure Sensor to measure Flow and Snore (alternatively for CPAP Therapy Control).

The indication for use of the SOMNOwatchTM plus is:

Sleep Disorders, Parkinson’s disease, Attention Deficit Hyperactivity Disorder (ADHD), Therapy

Control during Rehabilitation e.g. after stroke, PLM/RLS, Heart Rhythm Disturbance, Autonomic

Nervous System Dysfunctions, Circadian Rhythm Disturbances and Breathing Disorders during sleep.

The SOMNOwatch™ plus is a non-life-supporting, portable physiological signal recording device.

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.

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.

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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2.2 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: Typenschild.

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.

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2.3 Elements of keyboard

Picture

Description

Function

Status LED’s

green LED

yellow LED

Idle Mode

off

Waiting Mode

flashes 1x /3s

off

Recording Mode

flashes 16x /s

off

Initialisation / data transfer

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

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 than 3

seconds.

Light Sensor

This sensor measuring the

intensity of the ambient light.

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