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Summary of Contents for SOMNOmedics SOMNOtouch RESP eco
- Page 1 NSTRUCTION MANUAL SOMNOtouch RESP eco SOMNOmedics America Inc. – 815 Ponce de Leon Blvd., Suite P-209 – Coral Gables, FL 33134 Toll free: 866 361 9937 info@somnomedics-diagnostics.com www.somnomedics-diagnostics.com...
- Page 2 SOMNOmedics America Inc. – 815 Ponce de Leon Blvd., Suite P-209 – Coral Gables, FL 33134 Toll free: 866 361 9937 info@somnomedics-diagnostics.com www.somnomedics-diagnostics.com Rev. 0 14.08.2019 All proper names marked with TM are copyright protected by SOMNOmedics. - 2 -...
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Page 3: Table Of Contents
Index Introduction ............................ 5 Intended Use ..........................5 Patients ............................5 About the SOMNOtouch™ RESP eco ..................6 Model and Device Number ......................6 Elements of keyboard ......................... 7 Safety instructions ......................... 7 Installing the DOMINO light Software ..................9 Operating Instructions ......................... - Page 4 6.2.8 Menu – Area Definition ......................37 6.2.9 Menu – User Data ......................... 37 6.2.10 Menu – Report ........................38 6.2.10.1 Standard Report ...................... 38 Analysis ............................ 38 6.3.1 Setting Analysis and Channels ..................... 38 6.3.2 Functions of the Pop-up Window ..................39 6.3.2.1 Functions of the Analysis Pop-up Window..............
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Page 5: Introduction
1 Introduction The SOMNOmedics team would like to thank you for purchasing this product. We are confident that you will enjoy using the SOMNOtouch™ RESP eco for many years. The SOMNOtouch™ has been developed by SOMNOmedics to meet the highest quality control standards available. -
Page 6: About The Somnotouch™ Resp Eco
Marker Button Connector Luer Lock Connector Fig. 2.1: SOMNOtouch RESP eco 2.1 Model and Device Number When unpacking the SOMNOtouch™, 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 back of the SOMNOtouch™. -
Page 7: Elements Of Keyboard
Elements of keyboard Picture Description Function Green LED Yellow LED Idle Mode Status LED 1 Waiting Mode 1x /4s Recording Mode 1x /s Recording Initialisation / data transfer When this LED is Yellow, the battery is being charged Status LED 2 When this LED is off, the battery is fully charged Charging... - Page 8 Be sure not to store it under frozen condition. Please also avoid the areas of high humidity. Opening the case, repairing or modifying the SOMNOtouch™ in any way will void the guarantee and might affect the safety of the device. Only SOMNOmedics and its authorised distributors may repair the unit. - 8 -...
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Page 9: Installing The Domino Light Software
Always use the charging cable that is delivered with your device to charge the internal battery. The device is not to be used while the battery is being charged. 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. - Page 10 Select an installation folder and click the Next button. Accept the selection “New Installation” by clicking the Next button. Start the installation process by clicking “Next”. The installation progress will be displayed by a blue running bar. - 10 -...
- Page 11 When the installation is complete the software will ask if you want to install the USB driver. If you choose to “Install SOMNOtouch USB Driver”, the later manual driver installation will not be necessary (exception: Windows XP). If “Run DOMINO light” is chosen, the software will start immediately after clicking the “Finish” button. For the driver installation a window of the device installation assistant will open.
- Page 12 Updating the Software To update your software version please install the new version in the same directory as the original version. During the installation you will be asked to choose one of the following installation types. New analysis, channels and features of the software are updated. The settings of analysis and analysis templates remain as before.
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Page 13: Operating Instructions
5 Operating Instructions Note: The SOMNOtouch™ automatically switches to idle mode when no measurement is running. Start and end of a recording are programmed via the DOMINO light Software or the initialisation procedure on the device. The date and time of the PC system clock are transferred to the SOMNOtouch™ during initialisation. - Page 14 Fig. 5.1: Easystart DOMINOlight Patient Data Input: ▪ Enter the data into the corresponding fields. 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.
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Page 15: Starting The Somnotouch
5.1.1 Starting the SOMNOtouch RESP eco at the device Press the ON button to activate the device. The green LED is turned on. A recording can be started by pressing the marker button three times. During recording the green LES is flashing once every second. - Page 16 b) Attach the nasal oral cannula and connect its plug together with the filter to the Luer-Lock® Adaptor Unit. CPAP: Attach the open end of the supplied tube to the CPAP mask or an O adaptor (not supplied), and connect its plug to the Luer-Lock®...
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Page 17: Manual Abortion Of The Recording
5.2 Manual abortion of the recording To abort the recording, you have to press the on/off button and the patient marker simultaneously for approximately one second. Then, the termination process must be confirmed by pressing the marker button again. If the recording was terminated successfully the green LED is flashing fast for 4 seconds. - Page 18 Fig. 5.5: Transfer window DOMINO light (1) It is possible to instruct the software to automatically execute an analysis, to display a report, to print and export a report, to close the recording, and to move the recorded data to the Archive Folder set in “Global Preferences”.
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Page 19: Open A Recorded Measurement
5.4 Open a Recorded Measurement To open a recording, click on the Analysis symbol of the DOMINO light panel. The following window will open: Click on the name of the column to sort measurements alphabetically or Processing Status chronologically Saved measure -ments Search... -
Page 20: Analysis
Parameter Indicates position of the data in the Raw Data Window Time Bar Index/h Marker Analysis Time-base of Analysis (Change with right mouse button) Raw Data Signal Scaling Automatically marked events Time base of Raw Data Interactive Scroll Bar (Change with right mouse button) fig. -
Page 21: Define Tib (Time In Bed)
5.5.2 Define TIB (Time in Bed) Set the Lights OFF and Lights ON Markers The markers “Lights OFF” (patient in bed) and “Lights ON“ (patient out of bed) define the relevant analysis data. Set Lights OFF: Right click on the raw data area at the time the patient goes to bed (check body position, activity or marker) →... - Page 22 User Data / Patient Data It is possible to edit this data by clicking on Patient Info in the Report Preview window. Recorded Time Complete recording time. Time in Bed (TIB) Period of time between the Lights off and Lights on marker s. Respiratory Report Obstructive Number (Index): Number of Obstructive Apnoea (index: per h of TIB).
- Page 23 Limitation Number (Index): Number of Flow Limitations. Number (Index): Respiratory Disturbance Index = “A + H” + “Limitations” Apnoea (Index) Number of Apnoea (index: per h of TIB). Hypopnoea (Index) Number of Hypopnoea. Number apn Number hy popnoea AHI (/h) TIB (h.) Flow Limitations (Index) Number of Flow Limitations.
- Page 24 Average SpO2 Average value of the complete SpO curve. Number of Desaturations occurring under 90% with indication of its Number < 90% percentage against TIB. Number of Desaturations occurring under 80% with indication of its Number < 80% percentage to TIB. Biggest Desaturation Indication of the moment of the Biggest Desaturation event.
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Page 25: Domino Light Software
Before starting to use the Analysis Section of the software, it is necessary to activate it with a Registration Code. Please contact SOMNOmedics by fax, e-mail or telephone to obtain this. Please refer to Fig. 6.2 for instructions on how to obtain and enter the Registration Code. -
Page 26: Global Preferences
Preferences imported: will be saved to a file. Computer-ID – phone SOMNOmedics support. Quote this number and you will be given the Registration Code to enter here. Fig. 6.2: Global Preferences – Menu - Folders The default folder can be chosen from the Recordings Directory using the symbol. -
Page 27: Menu - Channels
6.2.2 Menu – Channels In the Channels Menu the characteristics of the Raw Data Signal can be adjusted. Colour, Signal Scaling, Signal Direction and Channel Order can all be configured. The Channel Order can be changed by using the Drag & Drop function. Auto size of Limit values for Signal Invert signals... -
Page 28: Menu - Analysis
6.2.3 Menu – Analysis In this menu, all variables of the built-in algorithms can be changed. It is also possible to set the display colour for each analysis trace and set the colour of the classification box for each event. See red box marked in the figures below. -
Page 29: Classification Of Arousals
6.2.3.2 Classification of Arousals Fig. 6.6: Classification of arousals Arousals are labelled in the selected source channel. As soon as an arousal is detected, the analysis “Arousal Classification” will check if an event occurred in any of the other channels within the delay time set here. -
Page 30: Flow Analysis
Illustration Line: Bar: Threshold low and high activity [mg] This value is used for the detection of times with high, median and low activity. Those values will be displayed for the user defined areas in the report. The activity values calculated in the pre-set Timeframe are compared with this value. - Page 31 2) Min. Signal Minimum value of the signal. An artefact will be detected as soon as the signal falls below this value. 3) Min. Duration [s] Minimum duration for an Apnoea or Hypopnoea. 4) Max. Duration [s] Maximum acceptable duration for an Apnoea or Hypopnoea. 5) Apnoea Ratio [%] The Apnoea ratio states the fractional flow relative to the baseline.
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Page 32: Snore Analysis
Flow Desaturation Fig. 6.11: Correlation Flow Analysis It is possible to select multiple parameters using the “and”/ “or” function for each parameter. The link and means that the correlating desaturation must occur within the set delay time for an apnoea or hypopnoea to be detected. -
Page 33: Position Analysis
6.2.3.6 Position Analysis Fig. 6.13: Position Analysis Analysis Window [s] The size of the time window, in which the dominant body position is determined. It is possible to change the classification of body position dependent on the attachment of the SOMNOtouch™. -
Page 34: Cpap Analysis
3) Desaturation [% SpO The minimum decrease in SpO for a desaturation event to be detected. 4) Max. Drop (Artefact) [% SpO per s] An artefact will be detected if desaturation decreases faster than this predefined value. 5) Oscillation Range [% SpO A new desaturation will be scored if this predefined value is exceeded. -
Page 35: Menu - Filter
Full Chart: Upon activating this option the respective curve will be displayed in full chart mode. Event Box: Upon activating this option coloured frames will mark the events of the respective signals in the Raw Data window. Auto Size: This option will scale the amplitude of the curve automatically. -
Page 36: Menu - Keys
6.2.6 Menu – Keys The Keys menu allows you set the keyboard keys to be used during manual editing. Define and add events: Within the Keys Menu, predefined events can be associated to the programmed keys. These defined keys are available in the Edit mode of the Raw Data display to edit, add or delete events. -
Page 37: Menu - Area Definition
6.2.8 Menu – Area Definition It is possible to define own area definitions in the Analysis window. The detected events within the defined areas will be shown itemised in the report. The default areas shown in Fig. 6.22 are predefined at programme installation. Adding areas: Enter the name of the area in the field and click the button “Add Area”. -
Page 38: Menu - Report
6.2.10 Menu – Report 6.2.10.1 Standard Report In the Reports Menu, it is possible to configure Standard Report Templates to your specific needs. You can set the contents, the format and the order of the report items. As many reports as are required can be created by clicking on the symbol A template may be renamed by clicking on the symbol... -
Page 39: Functions Of The Pop-Up Window
The current filter settings may be changed for the epoch displayed on the screen. Fig. 6.25: Menu Selection If the button Display Filter Settings is selected, the following window will open up: Fig. 6.26: Changing Filter Settings If you activate the take over for analysis checkbox, all the analysis channels which use this channel as a source, will be reanalysed using these settings. - Page 40 Fig. 6.27: Selecting Channels for Analysis Display (2) None or All will remove either all analysis channels or none of them. (3) Add Raw Data will add a selected raw data channel to the analysis window. (4) Print Analysis will print the current analysis display window. Mark a section within the analysis section to have access to the following functions (hold and drag the left mouse button): (5) Define artefact will define the marked area as either a Global Artefact (artefact on all channels)
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Page 41: Function Of The Raw Data Pop-Up Window
6.3.2.2 Function of the Raw Data Pop-up Window Fig. 6.28: Pop-up Window Raw Data (1) Select channel… offers a comfortable method to manually select analysis channels to be displayed. Select all channels Delete all channels Invert selection All Raw Data channels will have the same height Fig. -
Page 42: Inserting Markers
(2) None or All will remove either all analysis channels or none of them. (3) Add Anaylsis Channel will add a selected analysis channel to the raw data window. (4) Set marker will open the Markers window (see chapter 6.2.7). (5) Set Info-marker allows you to add markers with several text lines (free text comments). -
Page 43: Deleting, Editing, Adding Markers
6.3.4 Deleting, Editing, Adding Markers From the Tools menu, select the sub menu Edit Markers. The list (Fehler! Verweisquelle konnte nicht gefunden werden.) containing all set markers will be displayed. You may add additional User defined Markers 2), edit existing Markers (3) delete existing Markers (4) or hide Markers (remove check marks from the check boxes 5). -
Page 44: The Event List
Delete samples: To delete saved samples, select Edit Samples from the Tools menu. The window shows the complete list of all saved samples. Mark all the samples to be deleted (click on the corresponding text line) and click on the Delete button. Print samples: To print the saved Samples, select Edit Samples from the Tools menu. -
Page 45: Edit Mode
6.3.7.1 Edit Mode To mark an event in the Raw Data window, use the Keys on the keyboard that were assigned in the Keys menu in Global Preferences (see chapter 6.2.6). These keys or key combinations are used to edit the study in this mode. It is also possible to change these Keys while analysing a study in Tools →... -
Page 46: Quick Edit Mode
6.3.7.2 Quick Edit Mode The Quick Edit Mode allows an event to be marked without using the keyboard. For example, to mark a Desaturation, define the Event Source in the Keys menu in Global Preferences or, with an open study, in Tools → Preferences. (Set the Desaturation Event Source to the SpO2 Signal for example) and then drag the cursor over the event to be marked. -
Page 47: Troubleshooting
8 Maintenance of the SOMNOtouch™ 8.1 Maintenance rate Return the SOMNOtouch™ to SOMNOmedics after 3 years of usage for inspection. The inspection includes calibration of all recording channels and visual inspection for any external damage. -
Page 48: Use And Maintenance Of The Rechargeable Battery
Follow the manufactures instructions when using disinfectants. Keep to the prescribed dose and contact time! Use cold water to prepare disinfection solvents! 8.3 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. -
Page 49: Lifetime
While storage and transportation the temperature has to be between – 25 °C and 70 °C and the humidity up to 90 %, not condensing. 9.6 Warranty SOMNOmedics will only guarantee the Safety, Reliability and Operation of the SOMNOtouch™ under the following conditions: Updates, modifications or repairs are only executed by authorized distributors or SOMNOmedics. - Page 50 The use of accessories, sensors, and cables other than those provided by SOMNOmedics GmbH may result in increased emission and/or decrease immunity of this device.
- Page 51 Voltage dips, short Mains power quality should be <5% U <5% U interruptions and that of a typical commercial or for ½ cycle for ½ cycle voltage variations hospital environment. (>95% dip) (>95% dip) on power supply 40% U 40% U ...
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Page 52: Accessories And Spare Parts
9.9 Accessories and Spare Parts Please request our latest catalogue from your local Distributor or contact SOMNOmedics. APPLICATION PARTS (*), SENSORS, ACCESSORY SOT RESP Article Description Item No. ● SOMNOmedics SOW080 ● USB charging cable TOE001 ● DOMINO light Software (1 licence) SOW105 ●... -
Page 53: Contact
Send us a message by fax at any time. +49 (0) 9 31 / 35 90 94 49 Send us your query by email any time. service@somnomedics.de Get free access to current software updates via service login on our website www.somnomedics-diagnostics.com. -
Page 54: Notes
9.11 Notes - 54 -...
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