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Summary of Contents for Seca 515
- Page 1 515/514 Instructions for use doctors and assistants Software version 1.1...
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Page 2: Table Of Contents
Recording weight and height ....4 seca 360° wireless network ....29 Bioimpedance measurement . - Page 3 9. Function check ......65 12.5 Printing ....... 70 10.
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Page 4: Device Description
515/514 purchased a highly precise and simultaneously robust device. 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. -
Page 5: Analysis
The device can only be configured with administrator rights. An initial adminis- trator PIN for the device is provided. It can only be changed on the device. The creation and management of user data is thus only necessary if the seca patient database of the... -
Page 6: User Qualification
The device may only be set up and connected to a network by experienced administrators or hospital technicians. Measuring mode The device and the PC software may only be operated by persons seca 115 with sufficient specialist expertise. 1.5 Contraindications Bioimpedance measurements may be performed on persons exhibiting the following characteristics: •... -
Page 7: Safety Information
• The device does not contain any parts for servicing by the user. Please only have maintenance, technical checks and repairs per- formed by an authorized service partner. You can find the service partner in your area at www.seca.com or by sending an e-mail to service@seca.com. Safety information • 7... -
Page 8: Preventing Electric Shock
• Use only original accessories and spare parts from seca, otherwise seca will not grant any warranty. CAUTION! Hazard to patient, malfunction • Keep other medical devices, e.g. high-frequency surgical devices, at a minimum distance of approx. 1 meter to prevent incorrect measurements or faults with wireless transmission. -
Page 9: Dealing With Measuring Results
Measurements from third-party devices not compatible Bioimpedance measurements taken with devices from different manu- facturers are not compatible. Follow-up measurements performed on a device other than a seca Medical Body Composition Analyzer may lead to inconsistent data and to misinterpretations of the measured results. -
Page 10: Dealing With Packaging
Dealing with packaging WARNING! Danger of suffocation Packaging made of plastic film (bags) presents a danger of suffocation. ► Store packaging out of the reach of children. ► If the original packaging is no longer available, only use plastic bags with safety holes to reduce the danger of suffocation. -
Page 11: Overview
English 3. OVERVIEW 3.1 Controls Rear Front Rear of weighing platform Control Function To switch on the device: press button briefly ON/OFF button To switch the device to standby: press button briefly To switch off the device: press button and hold Touchscreen display Central control and display element, can be swiveled 180°... - Page 12 Control Function For connecting a USB memory stick (contained in the scope of delivery) for managing the following data: • creating seca patient files on the device USB interface • loading seca patient files from the PC software supplied onto seca 115 the USB memory stick;...
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Page 13: Symbols In The Start Display
- height - BMI • data connections • date/time Login symbol: shows whether the user is logged in to a seca patient database (user PIN required) Printer symbol: indicates whether the print function of the PC software is seca 115 available. - Page 14 Symbol Meaning Data connection symbol: shows the current connection type to the seca patient database (in this case: Ethernet connection to PC using seca 115 Additional possible connection types: • wireless connection to PC using seca 360° seca 115 •...
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Page 15: Color Symbols And Other Controls
PC with seca 115 Gray: connection not available White: user is logged in Login symbol: log in to a seca patient database Gray: no user logged in White: tab not selected Red: tab selected Light gray: function available... -
Page 16: Identification On The Device And The Type Plate
3.4 Identification on the device and the type plate Text/symbol Meaning Model number Approval type Type designation of design approval (only seca 515 Serial number, consecutive ProdID Product identification number, consecutive Follow instructions for use Medical electrical device, type BF... -
Page 17: Identification On The Packaging
English Text/symbol Meaning 12 V Operate device only with an original seca power pack min. 1,25 A use compatible seca adapter only USB interface Do not dispose of device with household waste 3.5 Identification on the packaging Protect from wet... -
Page 18: Before You Really Get Started
• administrator manual • additional information Instructions for use for doctors and assistants, printed seca 360° wireless USB adapter 456 seca USB memory stick, 2 GB, initialized (USB PIN: 0000) Ethernet cable (1.5 m) for connecting to a TCP/IP network 18 •... -
Page 19: Establishing Power Supply
► Use only the original seca power pack as contained in the scope of delivery and listed in the section entitled “Spare parts” on page 74. The connection for the power pack is located on the underside of the weigh- ing platform. -
Page 20: Configuring The Device
4.5 Operating the device in a PC network The device does not have “on-board” patient and user management. If you wish to manage seca patient files and user accounts, the device must be connected to a PC on which the PC software is installed. -
Page 21: Printing
USB memory stick memory stick supplied. The seca USB memory stick is supplied initialized, meaning it contains a seca patient database and is secured with an initial USB PIN (0000). If you wish to use additional USB memory sticks (seca original accessories recommended), these must also be initialized before seca patient files can be saved on them. -
Page 22: Operation Using A Seca 360° Length Measuring Device
PC software. seca 115 NOTE: • Information on creating and saving seca patient files can be found in the section entitled “Assigning a measurement to a patient file” from page 36. • Also follow the instructions for use for the length measur- seca 360°... -
Page 23: Operation
English 5. OPERATION 5.1 Operating concept Swiveling the touchscreen display The touchscreen display of the device can be swiveled. As a result, it can be perfectly positioned for every application. ► Swivel the touchscreen display so that is convenient for you to operate max.180°! max. -
Page 24: Selecting Extended Functions
Selecting extended functions Functions commonly used in a certain context are accessible in the primary menu. Additional functions are accessible in the secondary menu. NOTE: The assignment of functions to the primary and secondary menus is specified at the factory and cannot be changed. 1. -
Page 25: Display Special Characters
English Display special characters Special characters can also be displayed with the computer keyboard. 1. Press and hold down any key on the computer keyboard (in this case “u” key) . All special characters are displayed in a context menu that is accessible via the selected key (in this case four special characters available). -
Page 26: Measuring Procedure
• Measure weight and height • Perform a bioimpedance measurement • Assign measurements to a seca patient file • Evaluate measured results • Save measuring procedure The order of the tabs on the touchscreen display follows this sequence. It is possible to operate in a different order. -
Page 27: Determining Weight And Height
English 5.2 Determining weight and height NOTICE! Incorrect measurement due to force shunt All the controls of the device are in the so-called weight-sensitive area. If you touch or lean on the device when measuring a patient, this will affect the measured results. ►... -
Page 28: Manually Determining Hold Value (Hold)
Manually determining hold value The device is equipped with an autohold function. During the measuring pro- (hold) cedure, the weight is automatically frozen and the message “HOLD” is dis- played in the window. It is possible that you will have to determine the hold value manually, e.g. -
Page 29: Activating/Deactivating Pre-Tare Function
The numerical keypad appears. 3. Enter the patient's height. 4. Press the Enter key on the numerical keypad. The entry is accepted. Transmitting height via seca 360° If the device is connected to a length measuring device, you can seca 360°... -
Page 30: Calculating Bmi Automatically
– Via the wireless network (see “Transmitting height via seca 360° seca 360° wireless network” on page 29) The BMI is calculated and displayed automatically. Switching weighing range The scale has 2 weighing ranges. In weighing range 1, there is a low maxi- mum capacity and the increments of the weight display are more precise. -
Page 31: Performing A Bioimpedance Measurement
English 5.3 Performing a bioimpedance measurement Switching on the device 1. Ensure that the device has no load. 2. Press the ON/OFF button. The start screen appears. tab is active. weight/height Determining weight and height ► Determine weight and height as described in the section entitled “Determining weight and height”... -
Page 32: Starting Measurement
3. Deactivate the modules for which you do not require evaluation. 4. Press the button. continue Starting measurement 1. State whether the patient belongs to a group of people for whom a bioimpedance measurement may not be performed. – : the measurement is not performed. The tab is weight/height active again. - Page 33 English Test point Characteristics • Hands must be clean • Same pair of hand electrodes on left and right • Select the pair of hand electrodes such that arms are Hands extended but not under strain • Finger spacers of the hand electrodes between the middle finger and ring finger on both sides •...
- Page 34 Remaining measurement time is displayed. As soon as the measurement ends, the message End of measurement appears. Screen still missing. 5. Press the button. continue 34 •...
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Page 35: Entering Pal Value And Waist Circumference
– If you have not yet measured weight and height, the weight/height tab is active. – If you have not yet assigned a seca patient file, the tab is patient active. – If all data are available, the tab is active. -
Page 36: Printing Partial Results
Logging on to a seca patient If you wish to search for or create seca patient files for the first time after database switching on the device, the device will require you to authenticate yourself using your user PIN. -
Page 37: Searching For A Seca Patient File
Search NOTE: If you are not logged in to a seca patient database, a dialog window appears for user PIN entry. Enter your user PIN as described in the section entitled “Logging on to a seca patient database” on page 36. - Page 38 6. Press the button. confirm The current measurement is assigned to the selected seca patient file. The name of the patient appears in the header of the touchscreen display. 38 •...
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Page 39: Providing A Seca Patient File From The Pc Software
– select seca patient file – click on send to mBCA – select the seca mBCA to which the seca patient file is to be sent – click send patient file The seca patient file is transmitted to the seca mBCA by the PC software and appears in the tab. -
Page 40: Creating A New Seca Patient File
Create NOTE: If you are not logged in to a seca patient database, the dialog window for entering your user PIN appears. Enter your user PIN as described in the section entitled “Logging on to a seca patient database” on page 36. -
Page 41: Editing Patient Data
You cannot make changes to patient data directly on the device. If you dis- cover that patient data need to be changed, make the changes using the PC software. For further information, see the user documentation for seca 115 PC software. seca 115... -
Page 42: Viewing Analyses
5.5 Viewing analyses NOTE: This section describes navigation in the tab. For information analysis about the medical content of the evaluation modules, see the section entitled “Medical basis” from page 45. 1. Press the tab. analysis dialog window appears. Examination results The results for the first evaluation module (in this case: Function/ ) are displayed. -
Page 43: Closing The Measuring Procedure
– If you are logged in to a seca patient database, the measured results will be saved. The corresponding data connection symbol is red. – If you are not logged in to a seca patient database, the dialog win- dow for user PIN entry appears. Enter your user PIN as described in the section entitled “Logging on to a seca patient database”... -
Page 44: Printing Results Report
(see “Saving the measured results” on page 43). 1. Press the button. switch menu The secondary menu appears. 2. Press the button. log off The login symbol is grayed out. You have been logged off from the seca patient database. 44 •... -
Page 45: Medical Basis
English 6. MEDICAL BASIS This section briefly describes the principles of bioimpedance analysis, as well as the content and medical objectives of the evaluation modules pre-set in this device. For additional information, we refer you to the appropriate professional literature. 6.1 Bioimpedance analysis (BIA) Classic body composition analysis The current “gold standard”... -
Page 46: Functional Principle Of Bioimpedance Analysis
2 and 5 kHz are used. Alternating current at these frequencies is hardly able to penetrate cell walls. Cell walls and intracellular water therefore have a very seca 515/514 minor impact on impedance. measurement of total body impedance... -
Page 47: Evaluation Parameters
Institute for Human Nutrition and Food Studies at the University of Kiel and joint representative studies were conducted. In contrast to all formulas published to date, the seca formulas are popula- tion-specific. The formulas developed in Kiel apply solely to Caucasian population groups. - Page 48 (FMI) • Absolute in degrees Phase angle • “Health risk” from page 57 • Normal range display according to seca (φ) • “Raw data for impedance” from page 59 reference values with percentile curves • “Fluid” from page 56...
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Page 49: Seca Specialty: Co-Ordinate System With Tolerance Ellipses
The transfer of this principle to the display and interpretation of fat mass indi- ces, on the other hand, is a new development by seca in collaboration with the Institute for Human Nutrition and Food Studies at the University of Kiel. -
Page 50: Evaluation Modules
6.3 Evaluation modules The evaluation modules described below are pre-set in this device and assist you in assessing your patients' state of health. The evaluation modules offer the option of only viewing those evaluation parameters (see “Evaluation parameters” on page 47) relevant to a specific objective. - Page 51 English Weight percentile curves for children Height percentile curves for children Medical basis • 51...
- Page 52 BMI percentile curves for children WHO reference values for adults 52 •...
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Page 53: Energy
English 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 (E body • resting energy expenditure (REE) •... -
Page 54: Function/Rehabilitation
Function/rehabilitation This module is for determining a person's level of fitness. This allows the suc- cess of a training regime to be assessed. For this module, the parameters height and weight are required, as well as a bioimpedance measurement. The following parameters are displayed: •... - Page 55 English Body Compostion Chart (mass indices) Skeletal muscle mass Medical basis • 55...
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Page 56: Fluid
Fluid This module allows a person's fluids status to be determined. For this mod- ule, the parameters height and weight are required, as well as a bioimped- ance measurement. The following parameters are displayed: • total body water (TBW) • extracellular water (ECW) •... -
Page 57: Health Risk
English 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. - Page 58 Bioimpedance vector analysis Body Compostion Chart (mass indices) 58 •...
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Page 59: Raw Data For Impedance
(ö) for the frequencies 50 Hz and 5 Hz. NOTE: In the PC software, you can view the raw data for impedance seca 115 for individual body parts and for additional frequencies. For further information, see the “Instructions for use for doctors and assistants” of the PC software. -
Page 60: References
The device automati- cally uses ethnicity-dependent references to suit the corresponding entry in the seca patient file (see “Creating a new seca patient file” on page 40). The evaluation module in question indicates which clinical study is being used as a reference for determining and assessing an evaluation parameter, e. -
Page 61: Configuring The Device
English 7. CONFIGURING THE DEVICE 7.1 Adapting default module selection for bioimpedance analysis The default module selection determines which evaluation modules are considered during a bioimpedance analysis. The device is factory set, so that when the tab is activated, the Default dialog window appears and all evaluation modules are acti- module selection... -
Page 62: Creating Default Module Selection
Creating default module selection In order to create an in-house default module selection, proceed as outlined below. 1. Press the button. switch menu The secondary menu is displayed. 2. Press the button. settings menu appears. User 3. Press the drop-down menu. The drop-down menu opens. -
Page 63: Saving Settings
English 6. Press the button. apply The module selection is saved and available from the next bioimpedance analysis. NOTE: To exit the dialog window without saving, press the button or cancel the most recently active tab (red, in this case: ). -
Page 64: Hygiene Treatment
8. HYGIENE TREATMENT WARNING! Electric shock The device is not de-energized when the on/off button is pressed and the display goes out. Use of fluids on the device may cause electric shock. ► Before each hygiene treatment, ensure that the device is switched off. -
Page 65: Function Check
Please only have servicing and repairs performed by an authorized service partner. ► You can find a service partner in your area at www.seca.com or by sending an e-mail to service@seca.com. Have an authorized technician perform subsequent verification according to national legal regulations. -
Page 66: Maintenance (Unverified Model)
The verification counter sticker can be ordered from seca service. 11.MAINTENANCE (UNVERIFIED MODEL) On leaving the factory, your seca device has an accuracy of ±0.15% or bet- ter. To preserve this level of accuracy, the product must be set up with care and maintained on a regular basis. -
Page 67: Troubleshooting
Switch on device dark No power supply Check whether power is being supplied Touchscreen display faulty Inform seca service • Switch off the device (hold the on/off Device in undefined state following Touchscreen display not button for approx. 3 seconds) -
Page 68: Bioimpedance Analysis
After a different tab has been Re-assign seca patient file and press the called up temporarily, the seca patient file selected, but selection button (see “Assigning a... -
Page 69: Data Transmission
Windows firewall • Provide the seca patient file from the PC software (see “Providing a seca patient file Patient name cannot be No keypad available for set dialog from the PC software”... -
Page 70: Printing
115 printer Call up tab and assign seca patient patient On repeat measurement: no seca file (see “Searching for a seca patient file” patient file assigned on page 37) No personal data in results report Call up tab and create seca patient... -
Page 71: Technical Data
Medical device in accordance with Directive 93/42/EEC Class IIa EN 60601-1: • Insulated device, protection class II • Medical electrical device, type BF wireless network: seca 360° • frequency band 2.433 GHz - 2.480 GHz • transmission power < 10 mW Interfaces: •... -
Page 72: Technical Data, Bioimpedance Analysis
In the USA, a study was conducted with 130 healthy adults of different ethnicities. The aim of the study was to validate the parameters determined using seca formulas against clinically established reference methods. The results of this comparative study are shown in the table above. The table shows the degree of certainty (R ) and standard deviation (SEE) for the param- eters determined using seca's formulas by ethnicity. -
Page 73: Weighing Data (Verified Model)
English 13.3 Weighing data (verified model) seca 515 Accuracy class in accordance with Directive 2009/23/EC Measuring method 4 load cells Maximum load • Partial weighing range 1 150 kg • Partial weighing range 2 300 kg Minimum load • Partial weighing range 1 1 kg •... -
Page 74: Technical Modifications
New: • skeletal muscle mass (SMM) parameter in the evaluation Function/rehabilitation module • send individual seca patient file from the PC software to mBCA seca 115 • start printing out results reports directly on device ( seca 515/514 graphical representation: phase angle (φ), bioimpedance vector analysis (BIVA), body... -
Page 75: Warranty
Additional claims cannot be considered. Costs of trans- port to and from seca are the responsibility of the customer if the device is located somewhere other than the customer's headquarters. In the event of... - Page 76 NOTE: Changes or modifications made to this equipment not expressly approved by seca may void the FCC authorization to operate this equipment. NOTE: Radiofrequency radiation exposure Information: This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
- Page 77 Declaration of conformity seca 515 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...
- Page 78 … entspricht dem in der Bescheinigung über die Bauartzulassung ... er i samsvar med mønsteret som er beskrevet i sertifikatet over konstruks- beschriebenen Baumuster. jonstype-godkjennelsen. Das Gerät erfüllt die geltenden Anforderungen folgender Richtlinien: Apparatet oppfyller gjeldende krav i følgende direktiver: 2009/23/EG über nichtselbsttätige Waagen, 93/42/EWG über Medizinpro- 2009/23/EF om ikke-automatiske vekter;...
- Page 79 EN 300 328, EN 301 489-1 i -17 dotyczących kompatybilności elektromagnetycznej i zagadnień widma radiowego. Hamburg, July 2015 Frederik Vogel CEO Development and Manufacturing seca gmbh & co. kg Hammer Steindamm 9-25 22089 Hamburg Germany Phone: +49 40 20 00 00 0...
- Page 80 NOTE: Changes or modifications made to this equipment not expressly approved by seca may void the FCC authorization to operate this equipment. NOTE: Radiofrequency radiation exposure Information: This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
- Page 81 Declaration of conformity seca 514 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...
- Page 82 EN 300 328, EN 301 489-1 és -17 az elektromágneses összeférhetőségi- és ... erfüllt die geltenden Anforderungen folgender Richtlinien: rádióspektrum ügyekről. 93/42/EWG über Medizinprodukte, 2011/65/EU zur Beschränkung der Ver- ... išpildo galiojančius tokių direktyvų reikalavimus: wendung bestimmter gefährlicher Stoffe in Elektro- und Elektronikgeräten, 1999/5/EG über Funkanlagen und Telekkommunikationsendeinrichtungen 93/42/EEB ir medicinos prietaisų, 2011/65/ES dėl tam tikrų...
- Page 83 EN 300 328, záležitostiach rádiového spektra. EN 301 489-1 ve -17. Hamburg, July 2015 Frederik Vogel CEO Development and Manufacturing seca gmbh & co. kg Hammer Steindamm 9-25 22089 Hamburg Germany Phone: +49 40 20 00 00 0...
- Page 84 Präzision für die Gesundheit deutschland <fett>seca Medizinische Waagen und Messsysteme seca gmbh & co. kg. Hammer Steindamm 9-25 22089 Hamburg · Germany Telefon · +49 (0)40 20 00 00 0 Fax · +49 (0)40 20 00 00 50 E-mail · info@seca.com...
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