seca 101 Instructions for Use for Doctors and Assistants from software version 1.
CONTENTS 1. System description . . . . . . . . . . . . 3 1.1 Intended use . . . . . . . . . . . . . . . . 3 1.2 Description of function. . . . . . . . . 3 Transmission of data by seca scales and stadiometers . . . . . . . 3 Printing. . . . . . . . . . . . . . . . . . . . 3 Transmitting data to a PDMS . . . 4 Managing patient data . . . . . . . . 4 Access rights . . . . . . . . . . . . . . . 4 1.3 User qualification . . . . . . . . . . . . . 4 Installation and administration. . . 4 Measuring mode . . . . . .
English English 1. SYSTEM DESCRIPTION 1.1 Intended use The seca 101 PC software is mainly used at hospitals, medical practices and inpatient care facilities in accordance with national regulations. The seca 101 PC software is for managing weight and height measurements and for automatically calculating parameters which can be deduced from them, for example body mass index (BMI). Measured results can be transmitted to a patient data management system or printed out on a standard PC printer.
Transmitting data to a PDMS The following EMR modules for data transmission to a patient data management system (PDMS) (file ending: "*.sem" = seca EMR Integration Module) are available for downloading from www.seca.com: • seca GDT module • seca HL7 module • seca keyboard module EMR modules for other protocols are in preparation and will continuously be made available for download on the seca website. Managing patient data Access rights The seca 101 PC software does not contain its own patient database.
English 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. WARNING! Identifies an exceptionally hazardous situation. If you fail to take note of this information, serious irreversible or fatal injury may result. CAUTION! Identifies a hazardous situation. If you fail to take note of this information, minor to moderate injury may result.
Using measured results WARNING! Hazard to patient The seca 101 PC software is not diagnostic software. The PC software assists the attending physician in producing a diagnosis. ► To produce an accurate diagnosis and instigate therapies, the attending physician must commission specific examinations and take account of their results in addition to using the seca 101 PC software. ► The responsibility for diagnoses and the ther- apies derived from them lies with the attending physician.
English 3. OVERVIEW 1 2 9 3 4 5 8 No. Control 1 Patient data 7 6 Function Values are entered on measurement: • Weight • Height Data are transmitted from the PDMS to the seca 101 PC software: • Patient ID • First name • Surname • Date of birth • Gender Fields containing data transmitted by the PDMS can be displayed or hidden. Contact your administrator.
No. Control 2 Devices 3 Available stadiometers 4 Selection bar 5 settings 6 cancel 7 send to EMR 8 help 9 Available scales Function Show/hide list of devices • « : hide list of devices • » : show list of devices Shows which seca stadiometers and seca scales with a BMI function are connected to the seca 101 PC software. Shows which devices are selected for measurements.
English 4. INSTALLATION 4.1 General The seca 101 PC software should only be installed by experienced administrators. Information about configuration options can be found in the Administrator's manual. If you have any queries or requests for changes, please contact your administrator or hospital technician. WARNING! Misdiagnosis through loss of data Improper installation or incorrect changes to installation may cause loss of data and result in misdiagnosis.
5. OPERATION 5.1 Starting/exiting the PC software Starting the PC software ► Click on "start\Programme\seca\seca emr flash 101". The PC software starts. NOTE: • The seca 101 PC software can be set up so that it starts automatically whenever a user logs on in Windows. Contact your administrator for this. • Some PDMS can be set up so that they start the seca 101 PC software automatically as soon as patient data in the PDMS start being transmitted to the seca 101 interface.
English Opening a software window If the seca 101 PC software is set up to start automatically, it appears in the notification area of the taskbar in the form of a program icon. ► Right-click on the program icon in the notification area of the taskbar and select the item Open. Exiting the PC software ► Click on the cross symbol at the top right. The PC software will close. 5.2 Selecting measuring devices 1. In the seca 101 PC software, click on the » symbol next to the Devices entry.
NOTE: • Measuring devices which appear in both the Available scales and the Available stadiometers fields are seca scales with a BMI function or seca measuring stations. • If you want to receive both weight and height from a measuring device, click on the device in both the Available scales and Available stadiometers fields. 3. Click on the « symbol. The device list closes. NOTE: You cannot edit the device list. If devices need adding or removing, contact your administrator. 4.
English 5.3 Measuring operation with the seca directprint module NOTE: The seca directprint function is not available for devices with an RS232 interface. 1. Check that the seca 360° wireless USB adapter 456 is inserted in a USB port of the PC and that the LED on the USB adapter is red. seca 101 2. Ensure that all the measuring devices you have selected in the seca 101 PC software (see "Selecting measuring devices" on page 11) are selected.
5.4 Measuring operation with the HL7 or GDT protocol NOTICE! Faulty data transmission seca 101 PDMS The operation described in this section applies only to PDMS connected to the seca 101 PC software via standardized protocols (e. g. HL7 or GTD). ► If the seca keyboard module is set up for data transmission to the PDMS, proceed as described in the section entitled "5.5 Measuring operation with the seca keyboard module".
English NOTICE! Incorrect measurement if wrong devices selected If the wrong devices are selected, measured results may be assigned to the wrong patient or measurements may not be received at all. ► Use the name of each device to check you have selected the correct devices. 4. Perform the measurement(s) on the patient. send print 5. On the measuring devices, press the send button (if button has two functions, press button briefly). The measurements are transmitted to the seca 101 PC software.
Saving the measured results 1. Click on send to EMR. The measured results are transmitted to the patient record in the PDMS. 2. Check in the PDMS that the measurements have been correctly transmitted and assigned to the right patient record. NOTE: • Some PDMS can be set up so that the measurements are transmitted straight to the PDMS when transmitted via the interface without this being displayed in the main window of the seca 101 PC software (Autosend to PDMS/suppress GUI).
English 5.5 Measuring operation with the seca keyboard module The seca keyboard module allows measured results to be inserted directly at the cursor position in any target software, e.g. a word-processing program or a PDMS, which does not support common transmission protocols (HL7, GDT).
send print 4. On the measuring devices, press the send button (if button has two functions, press button briefly). The measurements are transmitted to the target software and inserted directly at the cursor position. The measurements are not displayed in the software window of the seca 101 PC software. NOTICE! Loss of data If there is no input for approx. 10 minutes, partial results are discarded. ► Measure one patient's weight and height immediately consecutively. 5.
English Navigating in a downsized window If you have significantly down-sized the software window, it will no longer be possible to show all the patient data in the software window. A scroll bar will be shown instead. To view all the patient data, proceed as outlined below. ► Move the scrollbar thumb to the left or right. The patient data will appear depending on the direction of movement. ► Click on one of the arrow keys of the scrollbar.
Minimizing/restoring window If you wish to close the software window without exiting the PC software, proceed as outlined below. ► Click on the Minimize icon. The PC software will behave differently depending on the default settings made by the administrator: – : the PC software appears in the taskbar in the form of a button.
English 6. WARRANTY Please note that this PC software is subject to restrictions on the warranty which may arise in conjunction with the license, for example. The warranty restrictions can be called up at www.seca.com.
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 Deklarajca zgodoności Izjava o skladnosti Vyhlásenie o zhode Onay belgesi
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D … erfüllt die geltenden Anforderungen folgender Richtlinien: 93/42/EWG über Medizinprodukte. GB … complies with the requirements of the following standard: 93/42/EEC on medical products. F … satisfait les exigences en vigueur de la norme suivante : 93/42/CEE sur les produits et appareils médicaux I … soddisfa i requisiti vigenti della seguente norma: 93/42/CEE sui prodotti medicali. E … cumple las exigencias vigentes de la siguiente norma: 93/42/CEE sobre productos médicos. DK ...
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