seca 515/514 Instructions for Use for Doctors and Assistants
TABLE OF CONTENTS Fr s of quality (515) . . . . . . . . . . . . . . . . . . . . . . . 4 1. ançai Seals 2. Seals of quality (514) . . . . . . . . . . . . . . . . . . . . . . . 5 3. Device description . . . . . . . . . . . . . . . . . . . . . . . . . 3.1 Congratulations! . . . . . . . . . . . . . . . . . . . . . . . . 3.2 Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3 Functional description . . . . . . . . . . . . . . . . . . . Calculating weight and height . . . . . . . . . . .
English Phase angle (φ) . . . . . . . . . . . . . . . . . . . . . . Fat mass (FM) . . . . . . . . . . . . . . . . . . . . . . . Skeletal muscle mass (SMM) . . . . . . . . . . . Energy/energy equivalent stored in body . . 59 60 60 60 9. Configuring device . . . . . . . . . . . . . . . . . . . . . . . . 9.1 Adapting standard module selection for BIA . Showing/hiding standard module selection Creating standard module selection . . . . . 9.2 Saving settings . . . . . . . . . . . . . . . . . . . . . . . .
1. SEALS OF QUALITY (515) With seca products, you are not only purchasing technology that has been perfected for more than 100 years, but a quality that has been officially and legally certified that also bears the quality seals from many institutions. seca products meet European directives, standards and national laws. When you buy seca, you buy the future. Scales that bear this symbol conform to the European Directive 2009/23/ EC on non-automatic weighing instruments.
English 2. SEALS OF QUALITY (514) With seca products, you are not only purchasing technology that has been perfected for more than 100 years, but a quality that has been officially and legally certified that also bears the quality seals from many institutions. seca products meet European directives, standards and national laws. When you buy seca, you buy the future.
3. DEVICE DESCRIPTION 3.1 Congratulations! With the Medical Body Composition Analyzer seca 515/514, you have just purchased a highly precise and simultaneously robust weighing instrument. 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. 3.
English Analysis User data management The analysis of BIA measurements takes place in graphic form and is based on scientifically established formulas. An in-house study by seca has established formulas for determining the parameters of total body water (TBW), extracellular water (ECW), fat-free mass (FFM), and lean soft tissue (LST) for arms and legs.
3.5 Contraindications Impedance measurements may not be performed on patients who exhibit the following characteristics: • Electronic implants, e.g. cardiac pacemaker • Active prostheses Impedance measurements may not be performed on patients who are connected to one of the following devices: • Life-support electronic systems, e.g. artificial heart, artificial lungs • Portable electronic medical devices, e.g.
English 4. SAFETY INFORMATION 4.1 Safety rules in these 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.
CAUTION! Patient hazard, malfunction • Keep other medical devices, e.g. high-frequency surgical devices, at a minimum distance of approx. 1 meter to prevent incorrect measurement or faults with wireless transmission. • Keep HF devices such as cell phones at a minimum distance of approx. 1 meter to prevent incorrect measurement or faults with wireless transmission. Preventing electric shock WARNING! Electric shock • Never touch the power supply with wet hands.
English • Strong cleaning agents can ruin the scale's surfaces. Use only a soft cloth that you can dip in ethyl alcohol, if necessary. Use of measured results WARNING! Patient hazard The seca 515/514 is not a diagnostic device. The device assists the attending physician with creating a diagnosis.
5. OVERVIEW 5.1 Operating elements 1 2 8 3 4 5 Rear side 7 Front side 6 Rear side of weighing platform 9 No.
English No. Operating element 3 Function USB interface For connecting a USB memory stick (contained in the scope of delivery) for managing the following data: • Creating patient data on the device • Load patient data from the supplied PC software seca 115 onto the memory stick; call up data on device • Save measured results on the memory stick • Reading log files from the device (administrator function) Pair of hand electrodes, right 3 pcs.
5.2 Symbols in the Start display A B C D E F G H Q P O I N M J K L Symbol 14 • Meaning A Header, remains unchanged in all menu levels and tabs.
English Symbol E Meaning Data connection symbol: Shows the current connection type to the seca patient database (here: Ethernet connection to PC using seca 115.
5.
English Operating element/ display Symbol Meaning Selected function Drop-down menu Drop-down menu opened Red text: Value outside normal range Text color Gray text: Value within normal range 5.4 Identification on the device and the type plate Text/symbol Model Approval type Ser. no.
6. BEFORE YOU REALLY GET STARTED... 6.1 Scope of delivery b a c User Docs seca 115 g No. a b c d e f g 18 • d f e Components Medical Body Composition Analyzer Power pack DVD with PC software seca 115 and license for a specific workplace DVD “User Documentation” with user documentation in PDF format: • Instructions for use for doctors and assistants • Administrator manual • Quick guide • Additional information material Pcs.
English 6.2 Establishing power supply WARNING! Using the wrong power supply may cause bodily injury or damage to the equipment Conventional power supplies may provide a higher voltage than is indicated on them. The device may overheat, catch fire, melt, or short circuit. − Use only the original seca plug-in power supply as contained in the scope of delivery and listed in section ”Spare parts” on page 73. The connection for the power pack is located on the underside of the weighing platform.
6.4 Configuring device Sections 6.5 to 6.7 show the data transmission options provided by the device. Your administrator or hospital technician decides which data connection types are set up for your device. Additional configuration options can be found in the administrator manual on the supplied DVD “User Documentation”. If you have any requests for changes, please contact your administrator.
English Indirect connection via USB memory stick If the device is not to be directly integrated in a PC network, you can create patient data and save measurements on the supplied seca USB memory stick. The seca USB memory stick is supplied in an initialized state, meaning it contains a seca patient database and is secured with an initial USB PIN (0000).
6.7 Operation using a seca 360° length measuring device As an alternative to manual entry, you can use a seca 360° length measuring device to determine the height and transfer this to the seca 515/ 514 via the seca wireless network. The seca 360° length measuring device can be used as a supplement to the following accessories: • seca 360° wireless printer • PC with PC software seca 115 NOTE: • Information on creating and saving patient data can be found in section „Assigning patient“ from page 35.
English 7. OPERATION 7.1 Operating concept Swiveling the touchscreen display The touchscreen display of the device can be swiveled. As a result, it can be optimally positioned for every application. ♦ Swivel the touchscreen display for comfortable operation and reading. max. 180°! ATTENTION! Damage to device The swivel mechanism of the touchscreen display has an end stop. Do not attempt to swivel the touchscreen display by more than 180°.
Selecting extended functions Functions that are 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 into the primary and secondary menu is specified at the factory and cannot be changed. 1. Press the change menu button. The secondary menu is displayed. 2. Press the change menu button. The functions in the primary menu are shown again.
English Displaying special characters With the computer keyboard, special characters can also be displayed. 1. Press and hold a button on the computer keyboard. All special characters are displayed in a context menu that is accessible via the selected key. 2. In the context menu, press the desired special character. The special character appears in the input field. 3. Enter further text as usual. Entering numbers Numbers are entered via a computer number keypad that is shown on the touchscreen display.
Measurement procedure The operating concept is based on the following typical measurement procedure: • • • • • Measure weight and height Perform bioelectric impedance analysis Assign measurements to a patient Evaluate measured results Save measurement procedure The order of the tabs on the touchscreen display follows this sequence. It is possible to operate in a different order. ATTENTION! Data loss If there is no new entry for approx. 5 minutes, the current measurement is discarded.
English 7.2 Determining the weight and height ATTENTION! Incorrect measurement due to force shunts All operating elements of the device are in the so-called weightsensitive area. If you touch or support yourself on the device when measuring a patient, this influences the measured results. − During the measurement process, ensure that the device is only touched by the patient who is currently being measured. Starting the weighing procedure 1. Ensure that the device has no load. 2. Switch on the device.
Manually determining the hold value (hold) The device is equipped with an autohold function. During the measurement procedure, the weight is automatically frozen and displayed in the HOLD window. It is possible that you will have to manually determine the hold value, e.g. if the patient removes an item of clothing after the initial weighing without stepping off the scale. For this purpose, proceed as follows: 1. Press the hold button. The display flashes until a stable weight is measured.
English Activating/deactivating the pre-tare function If you wish to have a permanently saved additional weight automatically subtracted from the measurement result during the current weighing procedure, proceed as follows. 1. Switch on the device. 2. Ask the patient to position themselves on the device. 3. Press the pre-tare button. The number keypad appears. The last additional weight saved is displayed. 4. In the number keypad, press the Enter key. The entry is accepted.
Automatic BMI calculation To determine the BMI, you have to record the patient's height and weight. ♦ After weighing, manually enter the height of the patient. – Manually (see “Manually entering body size” on page 29) – Via the seca wireless network (see “Transmitting body size via seca wireless network” on page 29) The BMI is automatically calculated and displayed. Automatic switchover of weighing range The scale has 2 weighing ranges.
English 7.3 Performing bioelectric impedance analysis (BIA) Switching on the device 1. Ensure that the device has no load. 2. Press the ON/OFF button. The start screen appears. The weight/height tab is active. Determining the weight and height ♦ Determine the weight and height as described in section „Determining the weight and height“ from page 27. Checking the module selection 1. Activate the bia tab.
Starting measurement 1. Make an entry stating whether the patient belongs to a group of people for whom a BIA measurement may not be performed. – yes: The measurement is not performed. The weight/height tab is active again. – no: The procedure starts. A dialog window for positioning the patient appears. WARNING! Patient hazard Illnesses can be transmitted due to poor hygiene. − Ensure that the patient does not have any contagious diseases. − Ensure that the patient’s hands and feet are clean.
English If the patient is not in correct contact with an electrode pair, the corresponding electrode indicator on the touchscreen display is red. If the patient is in correct contact with an electrode pair, the corresponding electrode indicator on the touchscreen display is green. Note: • The hand electrode selection influences the measurement result. Note the pair of hand electrodes selected by the patient.
As soon as the measurement ends, the message End of measurement appears. Screen stillm issing. 5. Press the continue button. Entering the PAL value The Module-specific entries dialog window appears following a completed BIA measurement. Enter the PAL value (PAL = Physical Activity Level) here.
English 2. Press the suitable PAL value for your patient. The list is closed. The value appears in the input field. 3. Press the confirm button. – If you have not yet measured the weight and height, the weight/ height tab is active. – If you have not yet assigned a patient, the patient tab is active. – If all data are available, the analysis tab is active. ATTENTION! Data loss If there is no new entry for approx. 5 minutes, the current measurement is discarded.
NOTE: • If you have connected a USB memory stick containing a seca patient database to the device, you will not be able to access the seca patient database of the PC software seca 115 via Ethernet or seca wireless network. • If you are uncertain as to how a seca patient database can be accessed, contact your administrator or hospital technician.
English Searching for patient data To search patient data, proceed as follows: 1. Press the patient tab. The input screen for the patient search appears. 2. Enter at least the one of the following items of data: – Patient ID – Date of birth – Name NOTE: It is possible to perform a wildcard search for patient names (e.g. Br* for Brown). 3. Press the search button. NOTE: If you are not logged in to a seca patient database, a dialog window appears for user PIN entry.
The patient details are displayed. 5. Make sure that you have selected the correct patient. NOTE: • If you wish to perform a new patient search, press the new patient button. • If you wish to return to the results list, press the cancel button. If the results list has only one entry, the search screen appears. 6. Press the confirm button. The current measurement is assigned to the selected patient. The name of the patient appears in the header of the touchscreen display.
English Creating new patients 1. Press the patient tab. The input screen for the patient search appears. 2. Press the create button. 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 section ”Logging in to a seca patient database” on page 36. The device accesses the seca patient database (here: In the PC software seca 115 via Ethernet) The initial input screen for patient data (mandatory fields) appears. 3.
The second input screen for patient data (optional fields) appears. 5. Enter the following patient data: – First name – Name – Patient ID NOTE: You only need to enter a patient ID if this has to follow a specific structure in your institution. If you do not enter an ID, then an ID is assigned automatically when the data are saved. 6. Press the confirm button. A summary of the patient data is shown. The patient data are stored.
English 7.5 Viewing analyses NOTE: This section describes the navigation in the analysis tab. For information about the medical content of the evaluation modules, see chapter „Medical basis“ from page 44. 1. Press the analysis tab. The Examination results dialog window appears. The results for the first evaluation module (here: Function/ rehabilitation) are displayed. 2. For graphic analysis of individual results, press the drop-down triangle in the corresponding line. The graphic analysis appears: 3.
The drop-down menu is opened. 5. Select the evaluation module that you wish to view. 7.6 Closing the measurement procedure Saving the measured results 1. Ensure that you can access the seca patient database in one of the following ways: – The PC with PC software seca 115 is switched on and connected to the device via the seca wireless network or Ethernet. The corresponding data connection symbol turns white.
English Logging off from a seca patient database In order to log off from a seca patient database, proceed as follows: ATTENTION! Data loss If you log off without saving the measurement procedure, all data in the current measurement procedure will be lost. − Save the current measurement procedure before logging off from a patient database (see “Saving the measured results” on page 42). 1. Press the change menu button. The secondary menu appears. 2. Press the log out button. The login symbol is grayed out.
8. MEDICAL BASIS This section briefly describes the basis for bioelectric impedance analysis, as well as the contents and medical goals of the evaluation modules that have been pre-set in this device. The references on which the evaluations rest will also be presented. For additional information, we refer to the appropriate professional literature. 8.
English Functional principle of bioelectric impedance analysis Bioelectric impedance analysis (BIA) is a method for rapid, simple, and non-invasive assessment of body composition. Only one measurement procedure is required on an individual device. In the BIA method, the human body is regarded as an electrical conductor in an alternating current circuit and its alternating current resistance (impedance) is measured.
Therefore, seca has developed in-house prediction formulas for calculating the following parameters for the arms and legs: • • • • Total body water (TBW) Extracellular water (ECW) Fat-free mass (FFM) Lean soft tissue (LST) for the arms and legs In-house reference values were determined for the following parameters in order to be able to show normal ranges: • Bioelectric impedance vector analysis (BIVA) • Mass indices (FMI, FMMI) • Phase angle (Φ) In order to calculate the formulas and reference values, th
English Evaluation module Display Diagnostic relevance Total energy expenditure (TEE) Absolut in MJ/d or kcal/d • Energy balancing within the context of nutrition advising • Using the seca 115 software therapy planner Total body water (TBW) Absolute in l Study of changes in the quantity of fluid in the human body.
seca specialty: Coordinate system with tolerance ellipses In addition to the classic display of evaluation modules in numerical values, bar graphs, and percentile curves, the seca 515/514 uses coordinate systems with tolerance ellipses for the graphic display of body impedance and fat-mass indices. This form of graphic display was developed by Professor A. Piccoli for the interpretation of body impedance under the name Bioelectric Impedance Vector Analysis (BIVA).
English 8.3 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 modules (see “Evaluation modules” on page 46) that are relevant to a specific objective. For information about how you can access the evaluation modules and navigate within them, see „Viewing analyses“ from page 41.
Height percentile curves for children BMI percentile curves for children WHO reference values for adults 50 •
English Energy The goal of this module is the quantitative determination of energy expenditure and energy reserves of the body for the assessment of weight changes, the course of illnesses, and of the general nutritional state of a patient. The following parameters are displayed: • • • • • Fat mass (FM) in kg Fat mass (FM) in % Energy stored in body (Ebody) Resting energy expenditure (REE) Total energy expenditure (TEE) The energy module serves as the basis of nutrition advising.
Function/rehabilitation This module serves to determine the fitness level and to assess metabolic activity and success for a training program e.g. within the framework of rehabilitation or physiotherapy.
English Skeletal muscle mass and lean soft tissue per extremity Medical basis • 53
Fluid The fluid module makes it possible to determine the fluid status of a patient and to monitor changes in fluids as the result of medical treatment.
English Health risk The goal is to determine the general state of health or, in the case of a previously known disease, assessing the severity.
Bioelectric impedance vector analysis Fat mass index (body composition chart) Raw data for impedance The raw data for impedance module provides the results of the bioelectric impedance analysis as raw data so that it can be used for medical studies. You can also view the impedance (Z), reactance (Xc), resistance (R), and phase angle (Φ) for the frequencies 50 Hz and 5 Hz. NOTE: In the PC software seca 115, you can view the raw data for impedance for individual body parts and for additional frequencies.
English 8.4 References The following references constitute the scientific basis for bioelectric impedance analysis using the Medical Body Composition Analyzer seca 515/514. These references are stored in the device software and form the basis for the assessment of the state of health of your patient. The references used by the device depend on the country in which you are active. For some evaluation modules (e.g. waist circumference for children), the reference used also depends on the patient's ethnicity.
Resting energy expenditure (REE) for adults The following references are permanently set: Reference Origin a Setup location Müller et. al. 2004 Germany Germany Liu et al. 1995b China China International Austria Switzerland USA Hong Kong Other FAO/WHO/UNU 2004c a.Müller MJ, Bosy-Westphal A, Klaus S,Kreymann G, Lührmann PM, Neuhäuser-Berthold M, Noack R, Pirke KM, Platte P, Selberg O, Steininger J.
English Extracellular water (ECW) The following reference is permanently set: Reference seca 2011a Origin Germany USA Characteristics • Considers 4 ethnicities: Caucasian, African, South/Central American, Asiatic • Age group 18 to 65 years • BMI range 18.5 to 35 kg/m2 a..Reference values: seca gmbh & co.
a.Reference values: seca gmbh & co. kg, Generation of normal ranges to analyze body composition of adults base on Bioelectrical Impedance Analysis (BIA), 2011 Fat mass (FM) The following reference is permanently set: Reference Gallagher et al. 2000a Origin USA Characteristics • Considers 3 ethnicities: Caucasian, Afro-American, Asiatic • Age group: 20+ a.
English 9. CONFIGURING DEVICE 9.1 Adapting standard module selection for BIA The standard module selection determines which evaluation modules are considered during a BIA. The device is factory set, so that when activating the bia tab, the standard module selection dialog window appears and all evaluation modules are activated. This way, the module selection can be verified before each measurement and, if necessary, adapted for the individual measurement.
Creating standard module selection In order to create an in-house standard module selection, proceed as follows: 1. Press the change menu button. The secondary menu is displayed. 2. Press the settings button. The user menu appears. 3. Press the drop-down menu. The drop-down menu is opened. 4. Press the standard module selection menu element. The current module selection is displayed. Factory setting: All modules selected (exception: Raw data for impedance).
English 9.2 Saving settings Applying settings 1. Press the apply button. The Save operation successful dialog window appears. 2. Press the continue button. The settings\user menu appears on the display again. You can implement additional settings in the settings\user menu or exit the menu as described in the section “Exit Settings\user menu”. Exit Settings\user menu 1. Press the exit button. The Unsaved changes dialog window appears. 2. Press the desired button yes. – yes: The changes are saved.
10. HYGIENIC PREPARATION WARNING! Electric shock The device has not been put out of operation if the on/standby button is pressed and the touchscreen display goes out. The use of fluids on the device can lead to electric shock. − Before each hygienic treatment, remove the mains cable to ensure that the device is out of operation. 10.1 Cleaning Clean the surfaces of the device with a soft cloth as required, dipped in ethyl alcohol if necessary. 10.
English 11. MAINTENANCE/RECALIBRATION (515) 11.1 Information on maintenance and recalibration We recommend having your device maintained prior to recalibration. The device’s measurement technology for bioelectric impedance analysis (BIA) must be checked every two years. ATTENTION! Incorrect measurements may be taken as the result of improper maintenance −Please only have maintenance and repairs performed by an authorized service partner. −You can find service partners in your area at www.seca.
12. MAINTENANCE (514) On leaving the factory, your seca device has an accuracy of ± 0.15 % or better. To preserve this level of accuracy, the product must be set up with care and maintained on a regular basis. The device’s measurement technology for bioelectric impedance analysis (BIA) must be checked every two years. We recommend performing maintenance of the whole device as part of this check.
English 13. TROUBLESHOOTING 13.1 Power supply and display Problem Device cannot be switched on Touchscreen stays dark Cause Remedy The device has no power supply. Check whether power is being supplied Power pack faulty Replace power pack with original part Device in standby • Touch the touchscreen display • Press the on/off switch • Place a load on the device Device not switched on Switch on the device The device has no power supply.
13.3 Bioelectric impedance analysis Problem The tab bia has been activated, but no module selection appears Cause Module selection has been deactivated. A standard module selection has been Not all modules are activated in specified, whereby some modules the module selection have been deactivated.
English 13.4 Data connection Problem A measurement procedure/ patient has been overwritten from the USB memory stick to the PC software seca 115 and the patient appears there as “not assigned” Cause For access to the seca patient database, the USB memory stick is used instead of the User PIN. Manually assign the measurement procedure/patient in the seca 115 to an attending physician.
13.5 seca 360°wireless printer Problem No printout No patient data on the printout No BIA results on the printout Cause The seca 360°wireless printer is not switched on. Switch on seca 360°wireless printer No seca wireless network has been established between the device and the seca 360° wireless printer.
English 14. TECHNICAL DATA 14.1 General technical data General technical data Measurements • Depth • Width • Height 828 mm 976 mm 1251 mm Net weight approx.
14.
English 14.4 Weighing data (uncalibrated model) seca 514 Measuring method 4 load cells Maximum load • Partial weighing range 1 • Partial weighing range 2 150 kg / 330 lbs / 24 sts 300 kg / 660 lbs / 47 sts Minimum load Partial weighing range 1 Partial weighing range 2 1,0 kg 2,0 kg Scale division • Partial weighing range 1 • Partial weighing range 2 50 g / 0.1 lbs 100 g / 0.2 lbs Tare range 300 kg Accuracy • 0 to 35 kg • 35 kg to maximum load • 0 to 75 lbs • 75 lbs to maximum load • 0 to 5.
17. DISPOSAL Do not dispose of the scale with your household waste. It must be properly disposed of as electronic waste. Follow your respective national regulations. For further information, please contact our service representative: service@seca.com 18. WARRANTY There is a two-year warranty period from delivery for defects that are due to material or fabrication errors. All moving parts, including batteries, cables, network devices, rechargeable batteries, etc. are exempted from this.
FOR USA AND CANADA: seca seca 515 FCC ID: X6T172A01 IC: 8898A-172A01 This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada. Operation is subject to the following two conditions. (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. NOTE: This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada.
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 Der medic
D GB F I E DK S N FIN … entspricht dem in der Bescheinigung über die Bauartzulassung beschriebenen Baumuster. Die Waage erfüllt die geltenden Anforderungen folgender Richtlinien: 2009/23/EG über nichtselbsttätige Waagen, 93/42/EWG über Medizinprodukte. Darüberhinaus sind unter anderem folgende Normen anwendbar: EN 45501 über metrologische Aspekte nichtselbsttätiger Waagen; EN 300 328, EN 301 489-1 und -17 über elektromagnetische Verträglichkeit und Funkspektrumangelegenheiten.
SLO SK ...ustreza potrjenemu modelu vrste izdelave. Tehtnica izpolnjuje veljavne zahteve naslednjih direktiv: 2009/23/ES o neavtomatskih tehtnicah; 93/42/EGS o medicinskih pripomočkih. Poleg tega veljajo naslednje norme: EN 45501 o metroloških vidikih neavtomatskih tehtnic; EN 300 328, EN 301 489-1 in -17 o elektromagnetni združljivosti in zadevah v zvezi z radijskim spektrom. TR ...onay belgesinde ü retim türü ile ilgili açıklanan üretim örneğine uygundur.
FOR USA AND CANADA: seca seca 514 FCC ID: X6T172A01 IC: 8898A-172A01 This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada. Operation is subject to the following two conditions. (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. NOTE: This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada.
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 Der medic
D Die Waage erfüllt die geltenden Anforderungen folgender Richtlinien: 93/42/EWG über Medizinprodukte. Darüberhinaus sind unter anderem folgende Normen anwendbar: EN 45501 über metrologische Aspekte nichtselbsttätiger Waagen; EN 300 328, EN 301 489-1 und -17 über elektromagnetische Verträglichkeit und Funkspektrumangelegenheiten. GB F I E The scales comply with the applicable requirements of the following directives: 93/42/EEC governing medical devices.
17-10-07-600-002 /11 G Medical scales and measuring systems since 1840 seca gmbh & co. kg Hammer Steindamm 9-25 22089 Hamburg - Germany Telephone - +49 40 20 00 00 0 Fax: +49 40 20 00 00 50 e-mail - info@seca.com All contact information can be found at www.seca.
