SOMNOmedics SOMNOwatch plus BP Instruction Manual Download Page 1

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SOMNOmedics GmbH

– Am Sonnenstuhl 63 – D-97236 Randersacker

Phone.: (+49) 931 / 35 90 94-0

– Fax: (+49) 931 / 35 90 94-49

E-Mail: [email protected]

– Internet: www.somnomedics.de

SOMNOwatch

™ plus BP

NSTRUCTION MANUAL

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

Summary of Contents for SOMNOwatch plus BP

Page 1: ...36 Randersacker Phone 49 931 35 90 94 0 Fax 49 931 35 90 94 49 E Mail info somnomedics de Internet www somnomedics de SOMNOwatch plus BP I NSTRUCTION MANUAL Caution Federal law restricts this device t...

Page 2: ...s a n d T h e r a p y All proper names marked with TM are protected copyright by SOMNOmedics SOMNOmedics GmbH Am Sonnenstuhl 63 D 97236 Randersacker Phone 49 931 35 90 94 0 Fax 49 931 35 90 94 49 E Ma...

Page 3: ...6 2 Attaching the Sensors 22 6 3 Manual Blood Pressure Measurement 24 6 4 Data Transfer from SOMNOwatch plus to PC 25 6 5 Open a Recorded Measurement 26 6 6 Analysis 28 6 7 Open the Report 29 Pulse T...

Page 4: ...g Adding Markers 69 7 4 6 Creating and Editing Samples 70 7 4 7 The Event List 71 7 4 8 Edit Modes 72 7 4 8 1 Edit Mode 72 7 4 8 2 Quick Edit Mode 73 7 4 8 3 Select Edit Mode 73 7 4 8 4 Repeat Mode 73...

Page 5: ...intenance of the Rechargeable Battery 90 10 Service 90 10 1 Technical specification 90 10 2 Lifetime 91 10 3 Malfunctions 91 10 4 Storage 91 10 5 Advice to the electromagnetic compatibility 91 10 6 Wa...

Page 6: ...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...

Page 7: ...n and that all accessories correspond to the delivery note Also compare the Model on the delivery note with the label on the bottom of SOMNOwatch plus fig 2 2 Type Label Information Symbols Icons and...

Page 8: ...rnal signal sampling on sampling off Sampling will be started the next minute During this period the green and yellow LED is alternately flashing 16x s flashes 16x s off flashes 16x s off off flashes...

Page 9: ...n includes a SOMNOwatch plus with BP Module a belt an SpO2 sensor the Docking Station and Battery Charger a USB adapter cable a Carry Bag for housing the SOMNOwatch plus the Instruction Manual and the...

Page 10: ...dyes depending on the concentration may affect the accuracy of the SpO2 measurement Check all cables and connections for damage before using this device Damaged parts must be replaced immediately Ple...

Page 11: ...exceeding 35 deg C or under direct sunlight or in front of a stove Be sure not to store it under frozen condition Please also avoid the places of high humidity Opening the case repairing or modifying...

Page 12: ...also note that the Software must be activated by entering a Registration Code You will find the file on the installation CD Double click on this file to start the installation Choose your language an...

Page 13: ...l e e p D i a g n o s t i c s a n d T h e r a p y Choose SomnoWatch Plus at Montage and click on the Next button Start the installation process by clicking the Next button The installation progress w...

Page 14: ...e software will ask if you want to install the USB driver for the Docking Station If you choose to Install SOMNOmedics USB Driver now the manual selection of the driver file location will not be requi...

Page 15: ...n o s t i c s a n d T h e r a p y Updating the Software To update your software version please install the new version in the same directory as the basic version During the installation you will be a...

Page 16: ...s f o r S l e e p D i a g n o s t i c s a n d T h e r a p y After the installation of the update you have to confirm your registration ID in the global preferences Confirm the Code in the Tab folder...

Page 17: ...plete the installation The first time you connect the SOMNOwatch plus Docking Station to a USB port the following window will occur Please choose the option No not this time and click on the Next butt...

Page 18: ...lease note that measurements running during the change of Summer Winter time will have a time shift 6 1 Initializing the SOMNOwatch plus fig 6 1 DOMINO light Panel After a successful connection the se...

Page 19: ...tore 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 confi...

Page 20: ...here fig 6 4 Menu Montage Used to create a new montage An existing montage may be saved with a different name after modification Template It is possible to change these analysis templates in the Glob...

Page 21: ...program start date start time and duration Now you could enter an observation or comment in the Description window This information appears in the Open Recording window When you click on Initialise th...

Page 22: ...h e r a p y 6 2 Attaching the Sensors a Fit the SOMNOwatch plus and the BP Adaptor Unit to the belt b Connect the BP Adaptor Unit to the SOMNOwatch plus c Clean and dry all skin areas carefully with...

Page 23: ...e s f o r S l e e p D i a g n o s t i c s a n d T h e r a p y d Attach the SpO2 sensor to the finger of the right hand and connect the plug to the BP Adaptor Unit Create a strain relief with adhesive...

Page 24: ...thod is the determination of the relative blood pressure changes caused by other sleep related events It is necessary to perform a single Manual Blood Pressure Measurement The SpO2 Sensor and the ECG...

Page 25: ...e displayed 1 It is possible to instruct the software to automatically produce an analysis to display a report to print and export a report to close the recording and to move the recording data to the...

Page 26: ...and the data copied and saved under the New Name entered It is also possible to Reset and Re analyse 4 a recording This function will remove all manual editing and completely re analyse the study usin...

Page 27: ...rks analysed events in the Raw Data window by placing a coloured frames around each event fig 6 7 Analysis template blood pressure fig 6 8 Analysis A double click on a particular position in the Analy...

Page 28: ...IB 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 d...

Page 29: ...Report menu Select the blood pressure template and click on the View Button Note Only events during TIB will be evaluated in the report User Data Patient Data It is possible to edit this data by clic...

Page 30: ...ime TotalSleep Sustained sleep efficiency in cy SleepLaten TIB Time TotalSleep Sleep Latency Period of time between the Lights off marker and the beginning of sleep Total Sleep Period SPT Period of ti...

Page 31: ...on of its percentage against Sleep Time Number 80 Number of Desaturations occurring under 80 with indication of its percentage to Sleep Time Biggest Desaturation Indication of the moment of the Bigges...

Page 32: ...ication of exact time Maximum PTT ms Maximum value of PTT and indication of exact time Minimum PTT ms Minimum value of PTT and indication of exact time Average PTT ms Average value of all PTT values A...

Page 33: ...imum Heart Rate during TST with indication of the moment of the event Minimum HR bpm Minimum Heart Rate during TST with indication of the moment of the event Average HR bpm Average value of all Heart...

Page 34: ...ximum value of the Systolic Blood Pressure and indication of the exact moment Min Systol mm Hg Minimum value of the Systolic Blood Pressure and indication of the exact moment Average Systol mm Hg Aver...

Page 35: ...layed in the column Limit red boxes in picture below In order to make this report most flexible the limits for the Blood Pressure report can be defined by the user Limits for calculation of Systolic D...

Page 36: ...s a n d T h e r a p y To edit the limits for the calculation of the Pulse select Heart Rate Analysis or Heart Rate Analysis AASM from the Analysis tab of the Global Preferences Select the button Limi...

Page 37: ...of Single Body Positions Prone Supine Left Right and Upright during TST Duration during sleep Time which the patient spent in each respective Body Position during sleep Duration awake Time which the...

Page 38: ...aphics displayed in the report Tilting table report In order to analyze the occurrence of syncope in regard to dysfunction of the circulatory system tilting table check ups are performed To have a com...

Page 39: ...d T h e r a p y In the tilting table report a graphic overview of Systolic Diastolic and Mean Arterial Pressure related to the recording time is displayed Additionally the values of Blood Pressure Pu...

Page 40: ...s Any comments and suggestions you wish to make regarding the improvement of this Instruction Manual will be much appreciated Technical Specifications are subject to change without notice 7 1 System R...

Page 41: ...n of measurement enter Patient Data selection of channels to record and determination of start time and duration Transfer Select this icon to transfer a Recording from the SOMNOwatch plus to the PC An...

Page 42: ...Folders fig 7 2 Global Preferences Menu Folders The default folder can be chosen from the Recordings Directory using the symbol Other symbols Add folder Edit folder Delete folder Select language Engl...

Page 43: ...Signal Scaling Signal Direction and Channel Order can all be configured The Channel Order can be changed by using the Drag Drop function fig 7 3 Menu Channels Select individual colours for each chann...

Page 44: ...e classification box for each event See red box marked on fig 7 5 below It is also possible to set the Source Signal to be used for analysing the study See blue box marked on fig 7 5 below Select or c...

Page 45: ...hs before and after The calculated value must be above the Activity Threshold to be scored as WAKE 3 Extension of wake phase epoch If an epoch of WAKE is detected the WAKE phase will be extended by th...

Page 46: ...ctivity Analysis fig 7 7 Activity Analysis Time frame s Size of the Analysis Timeframe in detection of Activity Max value Activity is equal to the maximal value within the timeframe Average value Acti...

Page 47: ...ated 3 HRV Averaging The averaging factor can be determined fort he HRV curve in the analysis 4 Asystole ms It is determined by the distance between two R points following each other If this distance...

Page 48: ...on of the QRS complexes is bigger than the registered value a tachycardia with wide QRS complexes is recognised from the raw data channel 4 Narrow complex QRS max ms If the duration of the QRS complex...

Page 49: ...pO2 Analysis 1 Max Desaturation Time s Maximum duration of a desaturation event 2 Min Desaturation Time s Minimum duration of a desaturation event 3 Desaturation SpO2 The minimum decrease in SpO2 for...

Page 50: ...e Pleth Analysis will detect an artefact too If the absolute value of the Pleth signal drop below the Min Pleth Ampliute value the Pleth Analysis will also detect an artefact 7 3 3 7 PTT Analysis Bloo...

Page 51: ...efact will be detected Adjust both values to each individual patient child adult and to the measurement site finger toe fig 7 15 Determining Artefact Limits 2 Min Change mmHg Change of the Systolic Bl...

Page 52: ...5 Max Blood press mmHg Blood Pressure values above this threshold will be detected as artefact 6 Reference press mmHg This value is used to calculate the nocturnal Blood Pressure lowering in the repo...

Page 53: ...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 amplit...

Page 54: ...activate the Edit Mode before using the keys menu Mode Edit Mode in the analysis window You will need the Event Source ringed in red in order to use the Quick Edit Mode see chapter 7 4 8 2 This mode a...

Page 55: ...field marked 1 and click the button Add Area Renaming markers Please select an existing area from the list and click the button Edit Area It is possible to enter a new name for the current area and y...

Page 56: ...an choose in the Graphics Selection Box between TIB or the complete recording shown in the overview graph In the Reports Menu it is possible to configure Standard Report Templates to your specific nee...

Page 57: ...you click on a symbol you first have to choose the right position of the desired object by left clicking on the draft Opens the Standard Report Here you can select and copy the desired object and past...

Page 58: ...JPG or BMP format Diagrams used in the Standard Report could be pasted Placeholders could be generated for the import of Samples Type in a specific name for the placeholder If you now save a Sample wi...

Page 59: ...r complete night or only during TIB Abb 7 5 Analysis Channels selection Zoom In Zoom Out Additional functions full short only legend without Activates Deactivates the timeline The graphic can be rotat...

Page 60: ...tion menu will appear Abb 7 7 Selection table 1 Edit opens the window to edit the properties of an object 2 Send to back places the selected object in the background This is used to display object in...

Page 61: ...in the Global Preferences and then click the button New Custom Template After defining a name for the new Custom Template generate or edit the new custom report using the Edit button that is available...

Page 62: ...is activated the text can be edited A user friendly method of editing text fields in the custom report is provided Here items like the font size Text Alignment Bold Italic Underline etc can be define...

Page 63: ...ard Report to the Custom Template Click on the individual components required and they will be marked with little grey squares in their corners Multiple items can be selected by holding down the Shift...

Page 64: ...ault settings for all studies To cancel all manual editing made to a recording select Reset and re analyse when opening the recording Additionally it is possible to change the Channel Settings and the...

Page 65: ...hem 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...

Page 66: ...splay all correlating Raw Data for the section selected in the bottom chart 9 Save Sample will save the marked area for addition to the reports see chapter 7 4 6 10 Define area as offers the possibili...

Page 67: ...ow see chapter 7 3 7 5 Set Info marker allows you to add markers with several text lines free text comments 6 Define start and Define end will set the predefined markers and remove all data located ou...

Page 68: ...n d T h e r a p y Marking a section in the Raw Data window opens up the following additional functions 11 Zoom Selection will display the marked area over the complete Raw Data window 12 Save Sample...

Page 69: ...aced Now either open the Markers menu from the Tools menu or by right clicking on the Raw Data window chapter 7 4 2 2 Select the Marker from the list as follows Double click to select the desired mark...

Page 70: ...ndow by clicking on the required window with the right mouse button Select Save Sample and enter a descriptive name for this sample and click on OK The sample will be saved and added to the report and...

Page 71: ...ent list by clicking Show analysis events in the Tools menu fig 7 33 Event List Choose e g the PTT Analysis to get a list with all the systolic blood pressure events Double Click on an event to jump d...

Page 72: ...nts will be marked with a hashed box 7 4 8 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 7 3 6...

Page 73: ...released The marked Event will be scored without having to use the keyboard 7 4 8 3 Select Edit Mode The Select Edit Mode also allows an event to be marked without using the keyboard Drag the cursor...

Page 74: ...port in the Reports menu to open the report selection The settings for the Report Templates are made in the Global Preferences Standard Report Template see chapter 7 3 10 1 User Defined Template see c...

Page 75: ...eded using the function Insert Print Field MS Word 2007 Insert Merge Field Additionally it is also possible to use the Insert Word Field to request information from the operator To create a new Form L...

Page 76: ...d Patients Study Now select Open Form Letter from the Reports menu Double click on the required Form Letter and it will be opened in MS Word automatically 7 6 3 Save Form Letter in MS Word 2007 Click...

Page 77: ...t make it possible to exchange data between different Sleep Labs and or different manufacturers devices This feature is useful for international studies and clinical trials The DOMINO light software e...

Page 78: ...ll open the following window see fig 7 39 fig 7 39 EDF Export Settings for Channel ECG The settings of the chosen channel Name Dimension Physical and Digital Minimum Maximum as well as Pre filtering a...

Page 79: ...on the button Add to add a new channel to the translation table To enter the EDF Label or the Transducer Type it is necessary to double click in one of the fields next to the Channel name Click on the...

Page 80: ...nto your CD writer or a DVD R into your DVD writer NOTE Double Layer DVD s are supported and it is possible to burn multisession CD s Click on the button Analysis on the DOMINO light panel and select...

Page 81: ...Archived Recording Please copy the complete folder folder name patient name from the CD DVD to the default recordings directory you defined in the global preferences see chapter 7 3 1 and remove the w...

Page 82: ...patient The database allows you to search for patients according to different criteria and to sort and display them in any order The File menu includes the Import feature which makes it possible to i...

Page 83: ...the data and parameters of the patients recording or recordings will be displayed in the bottom part of the window Multiple recordings can be sorted by clicking the columns heading name and select th...

Page 84: ...of multiple recordings from one patient Define a Template which includes all the required measurement results Use the menu Tools Result templates The following window will open fig 7 45 Define a Temp...

Page 85: ...s select Compare Sleep Stages in the main menu as well as the Trend of specific values select Trend Create Trend Display can be displayed fig 7 46 List of Results from Measurement From this window res...

Page 86: ...ll as all Analysed Results and all edited entries including Anamnesis Findings Diagnosis and Comments All results are selected from the menu Tools Result Templates see fig 7 45 The Report button is us...

Page 87: ...i c a l D e v i c e s f o r S l e e p D i a g n o s t i c s a n d T h e r a p y 7 9 5 Menu Summary Picture fig 7 48 Menu Summary Picture This Menu shows the Summary Graphics from the Patients Analyse...

Page 88: ...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...

Page 89: ...isinfection Article Disinfectant trade mark Concentration Duration Intervals Other BP Adaptor Unit Wipe disinfection For example Terralin Liquid Mikrozid AF Cloth Ready to use Ready to use 5min 5 min...

Page 90: ...ging LED on the charger turns off Always use the Docking Station SOW106 to charge the internal battery Otherwise the battery could be damaged 10 Service 10 1 Technical specification 11 Channels Name M...

Page 91: ...iged by law to provide on request information about the electromagnetic compatibility For this information please directly contact SOMNOmedics 10 6 Warranty SOMNOmedics will only guarantee the Safety...

Page 92: ...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 You can send us important information by fax on 49 0 9 31...

Page 93: ...93 M e d i c a l D e v i c e s f o r S l e e p D i a g n o s t i c s a n d T h e r a p y 10 10 Notes...

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