seca 105 Instruction for Use Jan 2011

English TABLE OF CONTENTS 1. System description... 3 1.1 Congratulations!... 3 1.2 Intended use... 3 1.3 User qualification... 3 1.4 Data transmission measuring devices... 3 2. Safety information... 4 2.1 Basic safety information... 4 Handling of the software... 4 Handling measured results... 4 2.2 Safety information in these instructions for use... 5 3. Overview... 6 3.1 Patient list... 6 3.2 Patient file... 8 3.3 Identification on the type plate . . 9 4. Installation... 10 5. Operation... 11 5.1 Starting/exiting the program . . 11 Opening the program... 11 Logging off/changing the user 12 Exiting the program... 12 5.2 "Extras" menu... 12 Changing references... 12 Creating user-specific modules 13 Viewing measuring device administration... 15 5.3 Working with the patient list. . . 16 Setting the column width... 16 Sorting the column content in ascending or descending order... 17 Showing and hiding columns . 17 Searching a patient file... 18 Creating a patient file... 19 Exporting patient files in CSV format... 20 Deleting individual patient files. 22 Deleting all patient files... 23 5.4 Working with the patient file. . . 24 Opening the patient file... 24 Editing patient data... 24 2•

Entering a medical history . . . 26 Entering laboratory data... 27 Measuring... 29 Evaluating results... 32 Writing comments... 38 5.5 Managing patient files... 39 Printing patient files... 39 Importing patient files... 41 6. Medical basis... 42 6.1 Evaluation modules... 42 Cardiometabolic risk... 42 Development / growth... 45 Energy... 46 6.2 References... 47 Percentile curves for children . 47 Waist circumference for children... 48 Resting energy expenditure children... 48 10-year risk for coronary heart disease... 49 Energy expenditure, adults. . . 50 Metabolic syndrome... 50 7. Display of weights... 51 8. Warranty... 53

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1. SYSTEM DESCRIPTION 1.1 Congratulations! With the seca seca 105 software you have acquired a product from the seca 360° wireless system that assists you with the analysis and interpretation of weight and length 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.

1.2 Intended use The seca 105 software is used according to the national regulations, primarily in hospitals, physicians' practices, and inpatient care institutions. The seca 105 software handles the administration of weight and length measurements as well as their automatic evaluation. Results are displayed graphically and assist the treating doctor with the following medical aspects: • Monitoring of growth processes and weight changes • Determination of the energy expenditure for the assessment of weight changes, the course of illnesses, and the general state of health, and for nutrition advising. • Estimation of the cardiometabolic risk. The seca 105 software is not diagnostic software.

1.3 User qualification The seca 105 software may only be used by people with sufficient professional knowledge.

1.4 Data transmission measuring devices Weight and length measuring devices from the seca 360° wireless system can transmit measured results wirelessly to the PC. As an accessory, the seca 360° wireless USB adapter 456 is required for this.

System description • 3

Scales and length measuring devices with RS232 interface can transmit measurements through a wire to the PC.

2. SAFETY INFORMATION 2.1 Basic safety information Handling of the software

• Note the warnings in the instructions for use. • Keep these instructions for use and the declaration of conformity that they contain in a safe place. • The seca 105 software is not diagnostic software. The software assists the treating doctor with creating a diagnosis. For the creation of a precise diagnosis and for the initiation of therapies, in addition to the use of the seca 105 software, careful examinations must be conducted by the treating doctor and the results of these taken into consideration. The responsibility for diagnoses and the therapies derived from them lies with the treating doctor. • Use seca 105 only for the prescribed purpose. • Use only scales and length measuring devices from seca together with the seca 105 software. • Keep HF devices such as mobile telephones and TVs at least 1 meter away in order to prevent mistaken measurements and disturbances during the wireless transmission.

Handling measured results

• Before you save and re-use measured values in the seca 105 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. • If measured values have been transmitted from the seca 105 software to a hospital information system, make sure before re-use that the measured values are plausible and assigned to the correct patient.

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2.2 Safety information in these instructions for use DANGER! Indicates an exceptionally dangerous situation. If you do not heed this warning, severe irreversible or life-threatening injuries may result. WARNING! Indicates an exceptionally dangerous situation. If you do not heed this warning, severe irreversible or life-threatening injuries may result. CAUTION! Indicates a dangerous situation. If you do not heed this warning, slight to medium injuries may result. WARNING! Indicates a possible mistaken operation of the product. If you do not heed this warning, device damage or incorrect measured results may result. NOTE: Contains additional information about the application of this product.

Safety information • 5

3. OVERVIEW 3.1 Patient list 1

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No.

Operating element

1

File

2

Edit

Function The following functions can be accessed using this menu element: • CSV export • Exit The following functions can be accessed using this menu element (only with an open patient file): • Cut • Copy • Paste Also as a context menu via right mouse-click

English No.

Operating element

3

Extras

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?

5

Registered user [role]

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Log off

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Create Open

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Column sorting

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Search window

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Selection bar

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Checkbox

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Delete

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Select all Unselect all

Function The following functions can be accessed using this menu element: • References • User-specific modules • Measuring device administration The following functions can be accessed using this menu element: • Product information • Instructions for use • Administrator manual The following roles are provided in the software: • Administrator • Doctor • Assistant • Open the login dialog (input the user name and password) in order to log in another user Create a new patient file Open a patient file • Up arrow: ascending sorting • Down arrow: descending sorting Search patient files. • "Asterisk search," e.g. "Mi*" for Miller possible • Back to the complete list with empty search Indicates which patient file is currently selected. Activate a patient file. Clicking buttons in the patient list affects all "activated" patient files. Delete patient file (patient files can be restored by users with the role Administrator.) • Select all patient files in order to carry out actions for all. • Deselect all patient files if action has been carried out for all or if no action should be carried out.

Overview • 7

3.2 Patient file A

B

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D

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F G

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A B C D

Meaning Summary of the most important patient data Patient data Enter, edit, and view the patient's main data Medical history Enter, edit, and view the patient's medical history Enter, edit, and view the patient's laboratory data Laboratory Data can be imported if an interface to the hospital data information system is programmed.

F G

Results of examination Comments Measure

H

Import

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Print

E

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Symbol Patient info

View results of examination. Add and view comments about the patient file Start measurement procedure Import patient data Configuration or programming of an interface for the hospital information system (HIS) required Print patient data and save as PDF

English Symbol

J K L

Save Close

Date/time

Meaning Save changes and additions to the patient file Close the patient file and return to the patient list Settings are taken over from the operating system

3.3 Identification on the type plate Text/symbol Model Ser. no.

Meaning Model number Serial number Heed instructions for use Device conforms with the standards and guidelines of the EU

Overview • 9

4. INSTALLATION The seca 105 software may only be installed by experienced PC administrators. For information about installation and configuration options, check the menu bar of the software under ?Administrator manual. In case of questions and requests for changes to the system currently installed on your PC, please contact your administrator. WARNING! Misdiagnosis due to data loss

The improper installation of or improper changes to the installation can cause data loss and, as a result, misdiagnoses. – Have the installation or changes to the installation made by an experienced PC administrator.

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5. OPERATION 5.1 Starting/exiting the program Opening the program

1. Click "StartProgramssecaseca medical software.

The login dialog is opened.

2. Enter your user name. 3. Enter your password. NOTE: User name and password are created by the administrator. If you want to change the user name or password, please contact your administrator. 4. Confirm your entries with OK. The patient list is opened.

Operation • 11

Logging off/changing the user

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Click on Log off. The login dialog is opened. Another user can log on.

Exiting the program

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Click the "x" symbol. The program exits.

5.2 "Extras" menu Changing references

The seca 105 software evaluates measured results using references. During the installation and configuration of the software, your administrator sets in which country you are operating your software. With this setting, the references that are normally used in your country are pre-set automatically. According to the regulations that apply in your institution and your personal preferences, you can change the pre-set references. To do this, proceed as follows: NOTE: This section describes the handling of the software. For basic information about the medical content, see chapter “Medical basis” starting on page 42.

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English 1. From the Extras menu, select the References element.

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 selection possibilities for the reference opens. 3. Click the desired reference. The pull-down menu closes. The selected reference appears in the selection field. 4. Repeat the steps 2. and 3. for all parameters whose references you would like to change. 5. In order to save the settings, click OK. The dialog window closes. NOTE: If you click on "Cancel," the settings are not saved.

Creating user-specific modules

For the evaluation of your patient's state of health, the evaluation modules Cardiometabolic risk, Development / growth, and Energy have already been created. On the User-specific modules dialog, you can compile two additional modules. You can view and evaluate these in the patient file under Results of examination, just like the pre-set evaluation modules.

Operation • 13

NOTE: This section describes the handling of the software. For basic information about the medical content, see chapter “Medical basis” starting on page 42. In order to compile a user-specific module, proceed as follows: 1. Click in the Extras menu on User-specific modules.

The User-specific modules dialog window appears. The Module 1 is pre-selected.

2. In the Module name field, enter the name that you want to assign the module. 3. Click a maximum of 4 parameters that you want to display in your module.

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English 4. Click on OK. The user-specific module is saved. NOTE: • With Cancel selection you can de-select all selected points with a mouse-click. • With Cancel you can exit the dialog window without saving settings. • In order to delete a saved module, click on Cancel selection, delete the module name in the Module name field, and click on OK. 5. If desired, repeat the process for the Module 2.

Viewing measuring device administration

You can see which scales and length measuring devices are connected to your PC. The following information is displayed for each connected measuring device: • Device name if entered by the administrator (recommended) • Model • Setup location if entered by the administrator (recommended) • Serial number • Connection properties: – seca 360° wireless: [PC name : channel; device type] – RS232 devices: [PC name : COM port] In order to display the measuring device configuration, proceed as follows: 1. From the Extras menu, select the Measuring device administration element.

Operation • 15

The Measuring device administration window appears.

NOTE: You cannot make any changes on this window. If changes should be made, please contact your administrator. 2. In order to exit the Measuring device administration window, click on Close.

5.3 Working with the patient list Setting the column width

1. Position the mouse pointer in the title line on the line between two columns.

The mouse pointer becomes a double arrow. 2. Hold the left mouse button down and drag the column wider or narrower with the mouse. 3. Release the left mouse button when the desired column width has been reached.

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Sorting the column content in ascending or descending order

1. Click in the title line of the desired column.

An arrow appears next to the column title, which shows the current sorting direction. 2. Click the arrow in order to re-sort the column content. 3. In order to reverse the sorting direction, click the arrow again.

Showing and hiding columns

1. Position the mouse pointer in the patient list. 2. Click the right mouse button. A context menu with the titles of all columns appears.

3. Click on the title of the column that you want to hide. The checkmark in front of the column title is no longer displayed. The corresponding column is hidden in the patient list.

Operation • 17

4. Click on the title of the column again in order to show it. The checkmark in front of the column title is displayed again. The corresponding column is shown in the patient list again.

Searching a patient file

1. Enter a search term in the search field.

Screenshot

NOTE: If you do not know exactly how to write a name, you can carry out a so-called "asterisk search," e.g. "Mi*" for "Miller." 2. Click the arrow next to the search field. The search procedure starts. The search results are displayed. 3. In order to return to the complete patient list, delete the search term in the search field. 4. Click the arrow next to the search field. The complete patient list is shown again.

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Creating a patient file

If you create a new patient file, you must fill out at least the following fields (in the file, each marked with "*"): • • • •

Date of birth Gender Ethnicity Doctor supervising treatment (if the current user is a doctor, this field is filled out automatically)

If the patient ID must fulfill a prescribed structure in your institution, you can enter it manually. If you do not enter a "manual" ID, then an ID is assigned automatically when the patient file is saved. 1. Click on Create.

An empty patient file appears. The Patient data tab is active.

Operation • 19

2. Enter the patient data: NOTE: If you are logged in as a doctor, you are entered automatically in the Doctor supervising field. The field can be edited. 3. Click on Save. If no manual ID was assigned, the ID created automatically by the software is displayed. WARNING! Data loss due to incomplete saving

If you do not close a patient file after saving it and you enter another patient file, the data of the first patient will be overwritten. – Close a newly-created patient file before you create another patient file. 4. Click on Close. The patient list is shown again. Additional patient files can be created.

Exporting patient files in CSV format

If you would like to re-use results of examinations of a patient outside of this program, you can export them in the .csv format. This data format can be imported into common spreadsheet programs. NOTE: Person-related data such as name and address of the patient will not be exported. 1. Position the red selection bar on the patient file that should be exported. 2. Click the appropriate checkbox A cross appears in the checkbox. The patient file is selected. 3. Repeat the steps 1. and 2. for all patient files that should be exported. NOTE: If you want to export all patient files, use the Select all function. 4. Click in the "File" menu on "Export." The export window appears.

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