seca 115 Instructions for Use for Physicians and Assistants from software version 1.
English CONTENTS 1. System description . . . . . . . . . . . . 4 1.1 Congratulations! . . . . . . . . . . . . 4 1.2 Intended use . . . . . . . . . . . . . . . 4 1.3 Description of function. . . . . . . . 5 Installation options . . . . . . . . . . . 5 seca mBCA data transmission . . 5 Transmission of data by seca scales and stadiometers . . . . . . 6 Managing seca patient files . . . . 6 Recording weight and height . . . 6 Determining body composition . 6 Evaluation . . . . . . . . . . . . . . . . .
English Cardiometabolic risk . . . . . . . Development/growth . . . . . . . Energy . . . . . . . . . . . . . . . . . Function/rehabilitation . . . . . . Fluid . . . . . . . . . . . . . . . . . . . . Health risk . . . . . . . . . . . . . . . Raw data for impedance . . . . 61 64 66 68 70 72 74 6.2 References . . . . . . . . . . . . . . . 77 7. Technical information . . . . . . . . . 78 7.1 Technical modifications. . . . . . 78 7.2 Display of weight values . . . . . 79 8. Warranty . . . . . . . . . . . . . .
1. SYSTEM DESCRIPTION 1.1 Congratulations! With the seca seca 115 PC software, you have acquired a product from the seca 360° system which will assist you with the analysis and interpretation of weight, height and bioimpedance measurements. For more than 170 years, seca has used its experience in the service of health care and, as a market leader, it has always set standards in many countries of the world with innovative developments for weighing and measuring. 1.
English 1.3 Description of function Installation options The seca 115 PC software can be installed in the form of a client/server solution or a standalone solution. The seca 115 PC software consists of the application software and a seca patient database, together with communication and evaluation modules. For client/server operation, the application software is installed on PC workstations (clients).
Transmission of data by seca scales and stadiometers seca scales and stadiometers from the seca 360° system can communicate with one another wirelessly and transmit data to the seca 115 PC software. For this to happen, the seca 360° wireless USB adapter 456 must be connected to a PC on which at least the seca 115 application software is installed. seca scales with an RS232 interface can transmit data to the PC software by wired connection.
English The seca 115 PC software can only administer bioimpedance measurements determined using a seca mBCA. Evaluation Measured results are evaluated in graphical form based on scientifically-established formulas. In-house studies by seca established formulas for determining the parameters total body water (TBW), extracellular water (ECW), fat-free mass (FFM) and skeletal muscle mass (SMM) for arms, legs, torso and the whole body.
1.4 User qualification Installation and administration Measuring mode The seca 115 PC software may only be installed and administered by experienced administrators or hospital technicians. The seca 115 PC software may only be used by persons with sufficient expertise. 2. SAFETY INFORMATION 2.1 Safety rules in the instructions for use DANGER! Identifies an exceptionally hazardous situation. If you fail to take note of this information, serious irreversible or fatal injury will result.
English ► Only install the seca 115 PC software on PCs equipped with an antivirus program. Always keep your antivirus program up to date to protect your computer system from current and future malware. The seca 115 PC software is protected from manipulation and was checked for malware at the time the software was created. ► Use the seca 115 PC software only for the specified intended use. ► Use only seca mBCAs, scales and stadiometers in conjunction with the seca 115 PC software.
too, have the option of displaying measured results in different units. This is purely an additional function. ► Only use measured results in SI units. ► The user takes sole responsibility for the use of measured results in non-SI units. ATTENTION! Loss of data • Before you save and re-use measured results in the seca 115 PC software (e.g. in a hospital information system), make sure that the measured values are plausible and that they correspond to the display on the measuring device.
English 3. OVERVIEW 3.1 seca patient list 1 2 3 4 7 5 9 8 10 11 12 14 13 15 6 16 17 18 19 20 22 No.
No.
English No. Control 19 Show/hide patient list from the USB memory stick 20 Drive selection window 21 Search window 22 delete 23 select all deselect all Function • seca patient list on the USB memory stick is automatically shown at system start • List can be hidden in order to display more entries in the main patient list For selecting the USB memory stick Search seca patient files on the USB memory stick. • “Asterisk search” - e.g.
3.
English Symbol J save K close L Date/time Meaning Save changes and additions to the seca patient file Close the seca patient file and return to the seca patient list Settings are adopted from the operating system 3.
Control/display Symbol Meaning Empty: function deactivated Checkboxes Cross: function activated 3.4 Identification on the packaging Text/symbol Mod S/N Meaning Model number Serial number Follow instructions for use 0123 Product complies with EC directives Name of manufacturer Packaging material can be disposed of through recycling programs Protect from moisture Permitted min. and max. temperature for transport and storage Permitted min. and max. moisture for transport and storage 4.
English ATTENTION! Loss of data Incorrect installation or incorrect changes to the installation can lead to loss of data and, as a result, to misdiagnoses. ► Make sure the installation or changes to the installation are carried out by an experienced administrator or hospital technician. 5. OPERATION 5.1 Starting/exiting program Opening the program 1. Click “Start Î Programs Î seca Î seca medical software”. The login dialog opens. 2. Enter your user name. 3. Enter your password.
4. Confirm your entries with ok. The seca patient list opens. Logging off / switching user Exiting program ► Click on Log off. The login dialog opens. Another user can log in. ► Click on the cross symbol. The program will close. 5.2 “Extras” menu Changing references The seca 115 PC software evaluates measured results using references. References are formulas and comparison values determined in clinical studies.
English The References dialog window opens. 2. Click on the arrow of the parameter for which you want to select the reference. A pull-down menu with all the selection options for the reference opens. 3. Click the desired reference. The pull-down menu closes. The selected reference appears in the selection field. 4. Repeat steps 2. and 3. for all parameters whose references you would like to change. 5. To save the settings, click ok. The dialog window closes.
Creating user-specific modules A number of evaluation modules have already been set up to assess your patient's state of health (see “Evaluation modules” on page 60). In the User-specific modules dialog, you can compile two further modules. You can view and evaluate these in the seca patient file under the examination results tab, just like the preset evaluation modules.
English 2. In the Module name field, enter the name you want to give the module. 3. Click a maximum of 4 parameters you want displayed in your module. 4. Click on ok. The user-specific module is saved. NOTE: • With Cancel selection, you can deselect all selected items with a mouse-click. • With Cancel, you can exit the dialog window without saving settings. • To delete a saved module, click on Cancel selection, delete the module name in the Module name field and click on ok. 5.
The Measuring device administration window appears. NOTE: You cannot make any changes in this window. If changes are to be made, please contact your administrator. 2. To exit the Measuring device administration window, click on close.
English 5.3 Working with the seca patient list Adjusting column width 1. Position the mouse pointer in the title line on the line between two columns. The pointer turns into a double arrow. 2. Hold down the left mouse button and drag to make the column wider or narrower. 3. Release the left mouse button once the required column width is reached. Sorting column content in ascending or descending order 1. Click in the title line of the desired column.
Showing and hiding columns 1. Position the mouse pointer in the seca patient list. 2. Right-click. A context menu with the titles of all columns appears. 3. Click on the title of the column you want to hide. The checkmark in front of the column title is no longer displayed. The corresponding column is hidden in the seca patient list. 4. Click on the title of the column again to show it again. The checkmark in front of the column title is displayed again.
English Showing and hiding the seca patient list from the USB memory stick The patient list from the USB memory stick is shown each time the program starts. You can hide the patient list from the USB memory stick to obtain more space for the entries of the main patient list. 1. Click on the “-” symbol above the patient list from the USB memory stick. The patient list from the USB memory stick is no longer shown. 2. To show the patient list from the USB memory stick again, click on the “-” symbol again.
Searching for a seca patient file 1. Enter a search term in the search field. NOTE: If you do not know exactly how to spell a name, you can carry out a so-called “asterisk search” e.g. “Mi*” to find “Miller”. 2. Click the arrow next to the search field. The search process starts. The search results are displayed. 3. In order to return to the complete seca patient list, delete the search term in the search field. 4. Click the arrow next to the search field. The complete seca patient list is shown again.
English Creating a new seca patient file If you create a new seca patient file, you must fill in at least the following fields (each marked “*” in the file): • • • • date of birth gender ethnicity attending physician (if the current user is a physician, this field will be filled in automatically) If the patient ID has to comply with a specified structure in your institution, you can enter it manually.
NOTE: If you are logged in as a physician, you will automatically be entered in the Attending physician field. The field can be edited. 3. Click on save. If no manual ID was assigned, the ID created automatically by the seca 115 software is displayed. 4. Click on close. The seca patient list is shown again. Additional seca patient files can be created.
English Sending seca patient file to a seca mBCA Use this function to send a seca patient file to a seca mBCA to determine a patient's body composition on that device. NOTE: This function is only available if you have an Ethernet network connection available. 1. Ensure that the desired seca mBCA is switched on. 2. In the patient list of the PC software, select the desired seca patient file. 3. Click on send to mBCA. The Measuring device selection dialog window appears. 4.
Copying seca patient files to USB memory stick If you want to work with seca patient files on a seca mBCA and there is no wireless or Ethernet connection to this device, you can use an initialized USB memory stick. NOTE: If you are uncertain of whether the USB memory stick has been initialized, please contact your administrator. In order to copy data to a USB memory stick, proceed as outlined below. 1. Insert the USB memory stick in a free USB port on the PC. The message USB stick detected appears. 2.
English 5. Eject the USB memory stick in accordance with the procedure of your PC's operating system. 6. Extract the USB memory stick from the USB port of the PC. NOTE: In order to be able to access seca patient files on a seca mBCA , you need your user PIN (generated automatically when your administrator sets up your user account for the seca 115 PC software) or the USB PIN (generated when your administrator initializes the USB memory stick).
Importing seca patient files from the USB memory stick If you have created or updated seca patient files on a USB memory stick, e.g. during a measurement on a seca mBCA, you can import these data to the patient database of the seca 115 PC software. To do so, proceed as outlined below. 1. Insert the USB memory stick in a free USB port on the PC. The message USB stick detected appears. 2. Click on ok. The dialog window closes.
English of the seca 115 PC software. Your administrator can provide the seca patient file with a unique ID and transfer it to the main patient list. 3. Eject the USB memory stick in accordance with the procedure of your PC's operating system. 4. Extract the USB memory stick from the USB port of the PC. Exporting seca patient files to .csv format If you would like to re-use a patient's examination results outside this program, you can export them to the .csv format.
7. Select the directory to which you want to export the patient data. 8. Click on save. The data is exported. NOTE: If an interface to your PDMS is configured, then weight and height, as well as a PDF document with all the measured results and evaluations, will be exported to the PDMS automatically. If you are uncertain of whether an interface has been configured, please contact your administrator.
English Deleting individual seca patient files You can delete seca patient files both in the main patient list and in the patient list of the USB memory stick. To do so, proceed as outlined below. 1. Select the seca patient file to be deleted (in this case, in the main patient list). 2. Click the appropriate checkbox. A cross appears in the checkbox. The seca patient file is selected. 3. Repeat steps 1. and 2. for all seca patient files to be deleted. 4. Click on delete. The seca patient file is deleted.
Deleting all seca patient files You can delete seca patient files both in the main patient list and in the patient list of the USB memory stick. To do so, proceed as outlined below. 1. Click on select all (in this case, in the main patient list). NOTE: If you want to undo the selection, click on deselect all. 2. Click on delete. All seca patient files are deleted. ATTENTION! Loss of data If you delete data on the USB memory stick, you cannot restore them.
English 5.4 Working with the seca patient file Opening the seca patient file 1. Click on the checkbox of the seca patient file you want to open. A cross appears in the checkbox. The seca patient file is selected. 2. Click on open or double-click on the entry in the seca patient list. The seca patient file opens.
3. Change or add to the patient data where necessary: – supplement data manually. – mark entries and use the Cut, Copy and Paste functions. These functions are accessible via the Edit menu element or by rightclicking on the context menu. 4. Click on save. 5. To close the seca patient file, click close. The seca patient list is shown again. Entering a medical history 38 • On the medical history tab, you can enter previous illnesses or therapies already started.
English 1. Click on medical history. The medical history tab is active. 2. Click on the checkboxes for the relevant previous illnesses and therapies. A cross appears in the corresponding checkboxes. 3. Click on save. NOTE: Use Cancel selection to undo the entire selection. Then click on save again.
Entering laboratory data In the laboratory data tab, you can enter the patient's current laboratory data and waist circumference and track the history. If an interface to your patient data management system (PDMS) has been configured for this program, patient and laboratory data can be transferred from the PDMS. NOTE: If you are uncertain of whether an interface has been configured, please contact your administrator. To enter laboratory data manually, proceed as outlined below. 1. Click on laboratory data.
English 4. Repeat steps 2. and 3. for all values you want to enter. 5. Click on save. Viewing history for individual values You can view the history for individual values. To do so, proceed as outlined below. 1. Click on the » symbol next to the desired value. The history field for that value opens. 2. To close the history view, click «. 3. To return to the seca patient list, click close.
Deleting values in the history field You can delete individual values in the history field. To do so, proceed as outlined below. 1. Right-click on the value you want to delete. The delete button appears. 2. Left-click on the delete button. The value is deleted 3. To return to the seca patient list, click close. Determining weight and height To determine a patient's weight and height, proceed as outlined below. 1.
English ATTENTION! Incorrect measurement if incorrect device selected If the incorrect device is selected, measured results may be assigned to an incorrect patient or no measurement may be performed at all. ► Use the name of each device to check you have selected the right devices. ► For selecting devices logged on to the same USB wireless adapter: make sure that the selected measuring devices are logged on to the same wireless group.
5. Perform the measurements as described in the instructions for use for the selected devices. 6. Ensure that the measured values are shown in the Measured values dialog window: – If you are using seca 360° devices on which automatic data transmission is activated, the measured values are automatically sent to the PC.
English 8. If you want to determine the patient's total energy expenditure (TEE), enter the patient's Physical Activity Level (PAL) in the Measured values dialog window. NOTE: • If you do not enter waist circumference and PAL, the following modules will not be displayed in the examination results tab: Cardiometabolic risk, Energy. • If waist circumference is not yet available, you have the option of entering waist circumference in the laboratory data tab later.
9. In the measured values window, click on ok. The measuring procedure is complete. The examination results tab is active. The results of the examination can be evaluated. Determining body composition with a seca mBCA If you would like to determine a patient's body composition using a seca mBCA (bioimpedance measurement), you can send an open seca patient file to the desired seca mBCA. To do so, proceed as outlined below.
English 4. In the Measuring device selection dialog window, select the desired seca mBCA in the Body composition line. 5. In the Measuring device selection dialog window, click on Send patient file. The seca patient file is passed to the selected seca mBCA where it appears in the patient tab. 6. Perform the bioimpedance measurement as described in the “Instructions for Use for Physicians and Assistants” for the seca mBCA. 7.
NOTE: This section describes how to use the seca 115 PC software For basic information about the medical content of the evaluation modules, see the section entitled “Medical basis” from page 60. The following evaluation modules can be considered if weight, height, PAL and waist circumference are available for a patient.
English 3. Click on the measurement you want displayed. The evaluation of the measurement is displayed. For some evaluations, a graphical display is provided.
Adding a comment to an evaluation parameter You can add a comment to every evaluation parameter shown. 1. Right-click in a results graph. A context menu appears. 2. Click on New comment. The comments window opens. The date and time are entered automatically. 3. Enter a subject. 4. Enter your comment in the comments field. 5. Click on ok in the comments field. The comments field closes. The comment symbol appears in the results graph.
English Viewing comments on an evaluation parameter If the comment symbol is shown in the results graph of an evaluation parameter, there is at least one comment. 1. Right-click in a results graph. A context menu appears. 2. Click on Display comments. The comments list opens. All the comments on that evaluation parameter are displayed. 3. To exit the comments list, click on close. Deleting comments on evaluation parameters You can delete comments on the evaluation parameters. 1.
The delete button appears. 3. Click on the delete button. The measurement is deleted. Displaying results graphs enlarged The results graphs can be displayed enlarged if the window symbol appears in the graph. The enlarged displays contain additional details which enable you to assess your patient's state of health better. 1. Click on a graph to have it displayed enlarged and with details (in this case, BMI). 2. Click on the graph again to shrink it back to its original size.
English Viewing the history You can view a patient's history by selecting several measurements. Measured results and evaluations are then displayed in progression graphs. NOTE: This function is not available in the Cardiometabolic risk and Raw data for impedance modules, as in these modules, a progression display is not relevant for assessing a patient's state of health. Proceed as outlined below to select measurements for the history. 1. Click on the examination results tab. 2.
5. Click on a graph to have it displayed enlarged and with details (in this case, BMI). 6. Click on the graph again to shrink it back to its original size. Using the therapy planner (Energy module only) If the patient's resting energy expenditure and total energy expenditure are known, you can calculate the recommended daily energy intake for the patient in order to achieve a target weight within a defined time (duration of therapy).
English The seca 115 PC software can calculate resting energy expenditure (REE) if the following parameters are entered or have been measured: age, gender, weight and height. Total energy expenditure (TEE) can be calculated if the physical activity level (PAL) has also been entered. 1. In the Energy module, click on Therapy planner. 2. Enter the value and type of the therapy objective. 3. Enter the therapy duration in days. The recommended daily energy intake is calculated. 4.
Writing comments On the comments tab, you can add comments to the seca patient file. 1. Click on comments. The comments tab is active. 2. Click on Writing comments. The comments window opens.
English The date and time are entered automatically. NOTE: Comments can be neither deleted nor subsequently edited in the comments tab. 3. Enter a subject. 4. Enter your comment in the comments field. 5. Click on ok in the comments field. The comments field closes. The comment appears as the top entry in the comments list. 5.5 Managing a seca patient file Printing a seca patient file In the print dialog, you can save all the results of a measurement in the form of a PDF file.
3. Specify the scope of the printout: – no selection: results graphs for all parameters without further explanations – patient: results graphs for all parameters with explanations for the patient – table: all parameters in tabular form 4. Click on ok to save the evaluation in the form of a PDF file. The PDF file created is automatically displayed in the PDF viewer. 5. Use the print dialog of the PDF viewer to print out the PDF file.
English 2. In the Patient ID field, enter the ID under which the patient file is managed in your PDMS. 3. Click on import. The patient data are imported.
6. MEDICAL BASIS This section briefly describes the content of the preset evaluation modules in this seca 115 PC software, together with their medical objectives. The references on which the evaluations are based will also be introduced. For additional information, we refer you to the appropriate professional literature. 6.1 Evaluation modules The evaluation modules described below are preset in this seca 115 PC software and will assist you in assessing your patients' state of health.
English Cardiometabolic risk This module indicates whether metabolic syndrome is present and the level of the 10-year risk for coronary heart disease. NOTE: The Cardiometabolic risk module is only available if a seca patient file has been created for a patient and the laboratory data and waist circumference have been entered no later than the day weight and height were measured (see “Entering laboratory data” on page 40). No bioimpedance analysis is required for this module.
Detail view, body mass index Detail view, visceral adipose tissue (VAT) Detail view, metabolic syndrome 62 •
English Detail view, 10-year risk of coronary heart disease for the age group 30-74 years Medical basis • 63
Development/growth This module indicates both the weight and height of a person and automatically calculates the BMI. This allows weight changes to be monitored in both children and adults. In children, this module assists with regular checks to assess growth and development. No bioimpedance analysis is required for this module.
English A detail view is available for the BMI: Medical basis • 65
Energy The aim of this module is to determine a person's energy expenditure and energy reserves. The following parameters are displayed: • • • • • fat mass (FM) fat mass index (FMI) energy stored in the body (Ebody) resting energy expenditure (REE) total energy expenditure (TEE) The parameter resting energy expenditure (REE) is available without bioimpedance analysis. REE is determined with the aid of the parameters height and weight, and with the aid of automatic BMI calculation.
English Fat mass Therapy planner The Energy module serves as a basis for dietary advice. The therapy planner of the module assists you in this. You can use the therapy planner to specify the following values: • treatment objective: weight change or BMI change • duration of treatment in days From these values, the planner calculates recommended daily energy intake. No detail views are available in this module.
Function/rehabilitation This module is for determining a person's level of fitness. This allows the success of a training regime to be assessed. The parameters height and weight, as well as a bioimpedance analysis, are required for this module.
English Display of normal fat mass range for adults Skeletal muscle mass For this parameter, you can have the following additional information displayed for each part of the body: • skeletal muscle mass (SMM) in kg • skeletal muscle mass (SMM) in percent • height and gender as a reference for the limit values used 1. Click on the drop-down menu The drop-down menu opens. 2. Click on the desired part of the body.
The additional information for the selected part of the body is displayed. Body composition chart (mass indices) Fluid This module allows a person's fluids status to be determined. The parameters height and weight, as well as a bioimpedance analysis, are required for this module.
English The following detail view is available for this module: Bioimpedance vector analysis Medical basis • 71
Health risk The aim of this module is to provide an overview of body composition and to compare the results with values for healthy people. A body composition which deviates from the normal range is an indicator which can be used to assess the risk to health. The goal is to determine the general state of health or, in the case of a previously known disease, assess its severity. The parameters height and weight, as well as a bioimpedance analysis, are required for this module.
English Bioimpedance vector analysis Body composition chart (mass indices) Medical basis • 73
Raw data for impedance This module shows detailed raw data for resistance (R), reactance (Xc), impedance (Z) and phase angle (φ) for information purposes. You can also view impedance (Z), reactance (Xc), resistance (R) and phase angle (φ) for individual parts of the body and frequencies.
English Selecting the part of the body 1. Click on the drop-down menu to select the part of the body. The drop-down menu opens. 2. Click on the desired part of the body. 3. The values for the selected part of the body are displayed.
Selecting frequency 1. Click on the drop-down menu to select the frequency. The drop-down menu opens. 2. Click on the desired frequency. NOTE: If the Raw data for impedance module on the mBCA was not activated, only four frequencies will be available to choose from. 3. The values for the selected frequency are displayed.
English 6.2 References Bioimpedance analysis using a seca medical Body Composition Analyzer is scientifically based on clinical studies. The results of the clinical studies are stored as references in the seca mBCA and in the seca 115 PC software and form the basis for assessing your patients' state of health For some evaluation parameters (e.g. waist circumference for children), the reference used depends on the patient's ethnicity.
7. TECHNICAL INFORMATION 7.1 Technical modifications Combination of seca mBCA seca 515/514 (SW version 1.1) and seca 115 (SW version 1.
English 7.2 Display of weight values The seca 115 PC software displays the weight values it receives only in the unit set in the PC software. If the setting on the transmitting device is different, the weight values will be converted automatically. Details are in the table below. seca 115 PC software setting seca device setting seca 115 display Weight ≤ 20 kg Weight > 20 kg kg kg lbs kkk.ggg kkk.gg sts kkk.gg1) kg lbs lbs ppp:oo.o ppp.p sts ppp.p1) kg sts lbs ss:pp.p sts - 1) s:pp:oo.
Konformitätserklärung Declaration of conformity Certificat de conformité Dichiarazione di conformità Declaratión de conformidad Overensstemmelsesattest Försäkran om överensstämmelse Konformitetserklæring Vaatimuksenmukaisuusvakuutus Verklaring van overeenkomst Declaração de conformidade Δήλωση Συμβατότητας Prohlášení o shodĕ Vastavusdeklaratsioon Megfelelőségi nyilatkozat Atitikties patvirtinimas Atbilstības apliecinājums Oświadczenie o zgodności Izjava o skladnosti Vyhlásenie o zhode Onay belgesi
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D GB F … erfüllt die geltenden Anforderungen folgender Richtlinien: 93/42/EWG über Medizinprodukte. … complies with the requirements of the following Directives: 93/42/EEC governing medical devices. … satisfait aux exigences en vigueur figurant dans les directives suivantes : 93/42/CEE relatives aux dispositifs médicaux. I … risponde ai requisiti prescritti dalle direttive seguenti: 93/42/CEE in materia di prodotti medicali.
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