Seca mBCA 525 c Instructions For Use Manual

Seca mBCA 525 c Instructions For Use Manual

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seca mBCA 525 c
Instructions for use
Software version: 2.0.101
17-10-05-409-002_2024-10S

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  • Page 1 525 c Instructions for use Software version: 2.0.101 17-10-05-409-002_2024-10S...
  • Page 2: Table Of Contents

    Creating the "Planned measurements" list on the device ..........30 3 Safety information ..........Editing the "Planned measurements" list in the seca analytics 125 software .... 31 Safety information in these instructions for Calling up patient data from the "Planned use ..............
  • Page 3 125 software ......67 11 Servicing ..............68 12 Technical data............69 12.1 Technical data: Device ........69 Technical data: seca mBCA 525 c – Monitor ............69 Technical data: seca mBCA 525 c – Measuring mat........... 71 Technical data: seca mBCA 525 c –...
  • Page 4: About This Document

    Correct result of action Incorrect action Incorrect result of action Points to the next step of a procedure Points to an element the user is clicking End of a procedure, e.g. the installation of a part 4 • seca mBCA 525 c...
  • Page 5: Description Of Device

    English DESCRIPTION OF DEVICE ž Intended use ž Clinical benefit ž Contraindications ž Patient target group ž User qualification ž Functional description Intended use The device supports physicians in making a diagnosis or deciding on a course of treatment based on bioimpedance measurement. To calculate further parameters, the device can be combined with cloud-based software.
  • Page 6: User Qualification

    Weight, height and waist circumference are required to analyze the body com- position. The parameters can be entered on the device in the seca analytics circumference software following bioimpedance measurement or at a later date. 6 • seca mBCA 525 c...
  • Page 7: Network Functions

    The device can be integrated into a PC network via a LAN interface or via WiFi in Network functions order to set up a connection to the software. seca analytics 125 software receives measurement data and processes seca analytics 125 them in graphical form. The software thus assists the attending physician in ana- lyzing measured results and making a diagnosis.
  • Page 8: Basic Safety Information

    Only have servicing and repairs performed by an authorized seca service partner. You can find a service partner in your vicinity at www.seca.com or by emailing service@seca.com. ► Use only seca original accessories and spare parts, otherwise seca will not grant any warranty.
  • Page 9: Handling A Wheeled Stand

    1 meter to prevent faulty measurements or wireless transmis- sion interference. ► The actual transmission output of HF devices may require minimum distances of more than 1 meter. For details, go to www.seca.com. Handling a wheeled stand WARNING! Injury from falling, damage to device ►...
  • Page 10: Preventing Injuries And Infections

    ► Use the device only in the intended ambient conditions. ► Store the device only in the intended storage conditions. ► Use only cleaning agents and disinfectants which match the details in the section entitled "Hygiene treatment". 10 • seca mBCA 525 c...
  • Page 11: Handling Rechargeable Batteries

    (e.g. in seca software or in an EMR system), en- sure that the measured values are plausible. ► If measured values have been sent to seca software or to an EMR system, ensure before continuing to use them that the measured values are plausible and assigned to the correct patient.
  • Page 12: Handling Packaging Material

    Store the original packaging material for future use (e.g. returning for servicing). OVERVIEW ž Monitor controls ž Measuring mat controls ž Fields in the display ž Buttons and symbols in the display: Navigation ž Symbols in the display: Operating state ž Labels Monitor controls 12 • seca mBCA 525 c...
  • Page 13 • For updating the monitor and the measuring mat (USB memory stick) • For exporting logfiles (USB memory stick) USB WiFi adapter Data transmission to the software with mobile use seca analytics 125 (under protective cap) ISIS interface (under Advance feature for system upgrade (currently no function) protective cap)
  • Page 14: Measuring Mat Controls

    For connecting to adhesive electrodes Infrared interface Data transmission between monitor and measuring mat Inductive charging in- • For charging measuring mat battery pack terface • Is suspended in the magnetic catch of the monitor with magnetic catch 14 • seca mBCA 525 c...
  • Page 15: Fields In The Display

    • Active function (in this case: Planned measurements • Status display for network and battery pack charging status (in this case: Connection Header seca analytics 125 software active, rechargeable battery for the monitor fully charged, network connection via WiFi) See also: ž Symbols in the display: Operating state...
  • Page 16: Symbols In The Display: Operating State

    Searching for WiFi network WiFi connection: • WiFi active, signal optimal • WiFi active, signal weak • WiFi, active, signal very weak • WiFi deactivated or not set up Connection to software: Active/not active seca analytics 125 16 • seca mBCA 525 c...
  • Page 17: Labels

    English Symbol Meaning Electrode status: • Permanently lit up: Electrode OK • Electrode not OK or implausible measured values • Skin contact error Measurement procedure running Data transfer running Labels Markings on the device and on the type plate Symbol Meaning Name and address of manufacturer, date of manufacture Unique Device Identifier (product identification number)
  • Page 18 Device license number from the US Federal Communications Commission (FCC) IC ID Device license number from Industry Canada Type plate on the power supply connection socket: xxx-yyy V Permitted supply voltage Permitted power supply frequency min xx-yy Hz Current consumption xx A 18 • seca mBCA 525 c...
  • Page 19 English Markings on the device and on the type plate Symbol Meaning Inductive charging interface LAN interface USB interface Do not dispose of device in household waste Markings on the packaging Symbol Meaning Protect from moisture Arrows indicate top of product Transport and store in an upright position Fragile, do not throw or drop Permitted min.
  • Page 20: Starting Up Device

    Calling up the instructions for use The device is supplied without any printed instructions for use. In addition to the PDF version available on the www.seca.com website, you can view the instruc- tions for use directly on the device. 1. Press the key.
  • Page 21: Scope Of Delivery

    English Scope of delivery seca mBCA 525 c QUICK START Item Component Pcs. Measuring mat with electrode cables and battery pack Monitor with USB WiFi adapter (under protective cap) and battery pack Power supply cable (country-specific) Push-button electrodes for single use, for affixing to patient, pack of 100.
  • Page 22 NOTE ► Observe the maximum permitted current consumption of the bar- code scanner. ► Use only barcode scanners recommended by seca. ► The device is compatible with NFC/RFID scanners. For details, contact seca Service. To connect a barcode scanner, proceed as follows: 1.
  • Page 23: Establishing Power Supply

    English 3. Hang the barcode scanner in a suitable holder. ž Establishing power 4. Establish the power supply supply. Establishing power supply 1. Insert the device connector of the power supply unit into the power supply connection socket of the device. 2.
  • Page 24: Network And Device Settings

    ► Set up a PIN code on initial commissioning. ► Only pass the PIN code on to users who are entitled to operate or configure the device. 2. Once set up on the device, enter the four-digit PIN code: 24 • seca mBCA 525 c...
  • Page 25: Saving Energy

    English ð The main screen is displayed (in this case: three planned measurements): 3. Then proceed as follows: ž Calling up patient data ► Call up patient data ► Measure bioimpedance ž Measuring If the device is not operated for an extended period, it will automatically switch to Saving energy ž Setting the standby standby mode after a set period of time...
  • Page 26: Switching Off The Device

    Searching for patient data seca analytics 125 entering the patient’s name on the device. ✓ Connection to software is active seca analytics 125 ✓ Main screen is displayed 1. Press the key. New patient 26 • seca mBCA 525 c...
  • Page 27 English 2. Press the input field. ð A screen keypad is displayed 3. Begin making the entry. ð The search for patient data starts automatically. ð If you complete the entry or interrupt it for more than three seconds, hits will displayed.
  • Page 28: Scanning Patient Id

    125 ► Only create patient data on the device if you are sure that they do not yet exist in the seca analytics 125 software. 1. Press the key. New patient 28 • seca mBCA 525 c...
  • Page 29 English 2. Press the key: Create 3. Enter the patient's last and first name, followed by the date of birth (in this case: last name): 4. Confirm each entry with the key. 5. Enter the patient's gender and ethnicity. NOTE Bioimpedance analysis is based on comparison with reference popula- tions.
  • Page 30: Using The "Planned Measurements" List

    Using the "Planned measurements" list ž Creating the "Planned measurements" list on the device ž Editing the "Planned measurements" list in the seca analytics 125 software ž Calling up patient data from the "Planned measurements" list ž Removing patient data from the "Planned measurements" list...
  • Page 31: Editing The "Planned Measurements" List In The Seca Analytics 125 Software

    Planned measurements list in the seca analytics software. In this case the software will directly access seca analytics 125 measurements" list in the seca the list on the device. analytics 125 software ✓ Device is switched on and online ✓...
  • Page 32: Removing Patient Data From The "Planned Measurements" List

    Remove from list ð The entry is no longer displayed. NOTE The patient data have only been deleted from the device; you can call them up again in the software at any time. seca analytics 125 32 • seca mBCA 525 c...
  • Page 33: Measuring

    English Measuring ž Connecting the measuring mat (measuring whole body) ž Connecting the measuring mat (measuring right half of body) ž Perform a measurement ž Adding weight, height, waist circumference (optional) ž Ending measurement ž Viewing the bioimpedance measurement analysis WARNING! Patient hazard, malfunction, damage to device ►...
  • Page 34 ► The side with the writing on it should be facing upwards ► The keypad should be facing the user 4. Ensure that the checkbox is deactivated. Only right half of body 5. Connect the measuring mat to the electrodes: 34 • seca mBCA 525 c...
  • Page 35 English ► Place the push-button adapters on the electrodes (black: proximal; red: distal) ► Arrange the electrode cables so that they do not cross over one another ► Do not route electrode cables over or underneath the patient 6. Ask the patient to do the following during the measurement: ►...
  • Page 36: Connecting The Measuring Mat

    3. Lay the measuring mat on the patient's knees. ► The side with the writing on it should be facing upwards ► The keypad should be facing the user 4. Ensure that the checkbox is activated. Only right half of body 36 • seca mBCA 525 c...
  • Page 37 English 5. Connect the measuring mat to the electrodes: ► Place the push-button adapters on the electrodes (black: proximal; red: distal) ► Arrange the electrode cables so that they do not cross over one another ► Do not route electrode cables over or underneath the patient 6.
  • Page 38: Perform A Measurement

    ð The measuring progress is displayed. 2. Wait until the measurement has finished. ð The measuring results are displayed: ð You have the following options for continuing: ž Adding weight, height, waist circumference (optional) ► 38 • seca mBCA 525 c...
  • Page 39: Adding Weight, Height, Waist Circumference (Optional)

    English ► Save measurement in the software: Press the seca analytics 125 Submit 3. If set up on the device, enter your user-ID (depending on configuration). NOTE The device performs a quality check on every bioimpedance measure- ment. If the bioimpedance measurement does not satisfy the quality requirements, this will be displayed on the monitor.
  • Page 40: Ending Measurement

    3. Carefully detach the push-button electrodes from the patient's skin. ž Disposing of 4. Dispose of the push-button electrodes consumables. Viewing the bioimpedance seca analytics 125 software is required to display bioimpedance measured ž Compatible seca results and analyses products. measurement analysis 40 • seca mBCA 525 c...
  • Page 41: Configuration

    Setting up a network connection ž Managing WiFi connections ž Setting up a LAN connection ž Setting up a connection to the seca analytics 125 software ž Changing workflow settings Managing WiFi connections Setting up a WiFi connection seca analytics 125 For mobile use you can integrate the device in a WiFi network or connect it to a mobile WiFi hotspot.
  • Page 42 To be able to use the full functional scope, the device must then be connected ž Setting up a connection to the seca ana- to the software seca analytics 125 lytics 125 software. ✓ WiFi access data are available ✓ ž Dis-...
  • Page 43 English 5. Press the key. Connect ð The WiFi network is displayed in the list. My networks 6. If wished, connect the device to further networks in the Available networks list. ð These WiFi networks are also added to the My networks list.
  • Page 44: Setting Up A Lan Connection

    For stationary use, e.g. in a specific treatment room of your practice, you can in- tegrate the device in a LAN network. To be able to use the full functional scope, the device must then be connected ž Setting up a connection to the seca ana- to the seca analytics 125...
  • Page 45: Setting Up A Connection To The Seca Analytics 125 Software

    Data loss, access to data by unauthorized persons ► Note the instructions on IT security in our White Paper entitled "Cy- ber Security". The document can be found as a download in the Support area at www.seca.com. 1. Press the key.
  • Page 46 ð A certificate is generated in the software. seca analytics 125 ð If a validity date for the certificate is displayed on the device, the connec- tion is set up. 46 • seca mBCA 525 c...
  • Page 47: Changing Workflow Settings

    NOTE The connection data are retained when network connections (WiFi/ LAN) are deactivated. When the network connections reactivated, the connection to the seca analytics 125 software thus does not need to be set up again. Changing workflow settings Selecting the language style Selection of the language style influences the texts of the user interface of the device.
  • Page 48: Device Settings

    ž Changing regional settings ž Changing units of measurement ž View history ž Viewing system information ž Factory settings ž Performing software updates ž Enabling/locking device for external access (VNC) ž Exporting logfiles/audit trail 48 • seca mBCA 525 c...
  • Page 49: Setting Up/Changing The Pin Code

    ► Note the instructions on IT security in our White Paper entitled "Cy- ber Security". The document can be found as a download in the Support area at www.seca.com. You can set up the device so that a PIN code is queried during the switch-on procedure.
  • Page 50: Adjusting The Display Settings

    You can specify the time period after which the device switches to standby. 1. Press the key. 2. Select the menu item Device Display settings 3. Under press the key until you reach the desired set- Standby timer ting. 50 • seca mBCA 525 c...
  • Page 51 English ð If no entry is made during the time period selected here, the device will switch to standby. 4. Press the key. Save ð The change is saved. Calibrating the display 1. Press the key. 2. Select the menu item Device Display settings 3.
  • Page 52: Changing The Audio Settings

    ð The active language is identified with the symbol. 3. Press the key until the desired language is visible. 4. Press the desired language. 5. Confirm that you wish to proceed. ð The selected language is active. 52 • seca mBCA 525 c...
  • Page 53: Changing Regional Settings

    The date and time cannot be set on this device. The settings are adopted from the software ž Setting up a con- seca analytics 125 nection to the seca analytics 125 software. 1. Press the key. 2. Select the menu item...
  • Page 54 4. Press the desired setting in the dropdown menu. 5. In the Height field press the key. 6. Press the desired setting in the dropdown menu. 7. Press the key. Save ð The change is saved. 54 • seca mBCA 525 c...
  • Page 55: View History

    You can check in the menu whether all measurements were submitted View history History to the seca analytics 125 software. The list contains up to 50 measurements. Older measurements are overwritten. NOTE You can view details and analyses for the measurements in the seca software.
  • Page 56: Factory Settings

    Key sounds 70 % Units • Weight • Height Activated DHCP WiFi Connection seca analytics 125 None Server address (IPv4/DNS) 22020 Server port Battery capacity, ≤ 20 % Automatic switch-off at Language English [Serial number] Device name 56 • seca mBCA 525 c...
  • Page 57: Performing Software Updates

    The measuring mat is suspended in the magnetic catch of the monitor ž Suspending the measuring mat in the magnetic catch ✓ All measurements were submitted to the software seca analytics 125 ž View history ✓ The USB memory stick (format: FAT 32) contains only the currently down- loaded software package 1.
  • Page 58 ð After successful checking, the software version contained on the USB memory stick is displayed. 4. Press the Install key. ð The software update starts. 5. Wait until installation is complete. 58 • seca mBCA 525 c...
  • Page 59: Enabling/Locking Device For External Access (Vnc)

    NOTE As an alternative to the USB memory stick, software updates can also be carried out via a network connection. If you have any questions about this function, please contact seca Service. Enabling/locking device for NOTICE! Data loss, access to data by unauthorized persons external access (VNC) ►...
  • Page 60: Exporting Logfiles/Audit Trail

    ð The data is exported. 5. Wait until the export has finished. 6. Remove the USB memory stick from the device and manage the data ac- cording to the regulations of your institution. 60 • seca mBCA 525 c...
  • Page 61: Hygiene Treatment

    English HYGIENE TREATMENT ž Cleaning ž Disinfecting ž Sterilizing 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 an electric shock. ► Before each hygiene treatment, ensure that the device is switched off.
  • Page 62: Disinfecting

    • A function check of the optional accessories If you find faults or deviations during the function check, first try to remedy the fault with the aid of the “Troubleshooting” section in this document. 62 • seca mBCA 525 c...
  • Page 63: Troubleshooting

    “Troubleshooting” section in this document, you must not use the device. ► Have the device repaired by seca Service or an authorized service partner. ► Follow the section entitled “Servicing” in this document.
  • Page 64: Troubleshooting: Bioimpedance Measurement

    • Repeat measurement Plausibility check of • Cannula, drainage, intravenous ac- bioimpedance measurement cess, etc. • Evaluate and comment measuring result failed in the seca analytics 125 software • Pronounced edema • Severe cachexia 64 • seca mBCA 525 c...
  • Page 65 English Fault Cause Remedy Ensure that patient adopts the following position: • Arms held far enough away from the torso so that there is also sufficient dis- Patient not correctly positioned tance from the torso with the hands opened • Legs held far enough away so that the thighs are not touching •...
  • Page 66: Plausibility Check

    (see also: measurement\ž Measuring mat and measuring sequence). 3. Press the key. Repeat ð Bioimpedance measurement starts. ð Should bioimpedance measurement fail again, you have the following op- tions for continuing: 66 • seca mBCA 525 c...
  • Page 67: Troubleshooting: Data Transmission To The Seca Analytics 125 Software

    125 mends evaluating and commenting this measurement directly after submission to the software. seca analytics 125 10.3 Troubleshooting: Data transmission to the seca analytics 125 software Fault Cause Remedy ž Setting up a WiFi connection WiFi function of device deactivated •...
  • Page 68: Servicing

    CAUTION! Faulty measurements as a result of poor servicing ► Have servicing and repairs carried out exclusively by seca Service or an authorized service partner. ► You can find your local service partner at www.seca.com.
  • Page 69: Technical Data

    English TECHNICAL DATA ž Technical data: Device ž Technical data: Network 12.1 Technical data: Device Technical data: seca mBCA 525 c – Monitor Dimensions: 230 millimeters • Depth • Width 252 millimeters • Height 262 millimeters Net weight Approx. 2 kg Ambient conditions, operation: +10 °C to +40 °C (50 °F to 104 °F) •...
  • Page 70 Technical data: seca mBCA 525 c – Monitor Power supply, input: Internal power supply unit, connector type in accor- dance with IEC 60320: C13 • Type • Mains voltage 100 V ~ - 240 V ~ • Power supply frequency 50 Hz –...
  • Page 71: Technical Data: Seca Mbca 525 C - Measuring Mat

    English Technical data: seca mBCA 525 c – Measuring mat Dimensions: 783 millimeters • Depth • Width 120 millimeters • Height 20 millimeters Net weight Approx. 1 kg Ambient conditions, operation: +10 °C to +40 °C (50 °F to 104 °F) • Temperature • Air pressure 700 hPa –...
  • Page 72: Technical Data: Seca Mbca 525 C - Bioimpedance Measurement

    Technical data: seca mBCA 525 c – Measuring mat IEC 60601-1 Medical electrical equipment: General requirements for basic safety and essential performance IEC 60601-1-2 Medical electrical equipment: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic dis-...
  • Page 73: Technical Data: Network

    English 12.2 Technical data: Network seca mBCA 525 c – Interfaces and ports Data transmis- Interface Protocol Factory setting sion rate 2.4 GHz, IEEE 802.11 b/g/n WiFi, internal Encryption: up to WPA, WPA2 adapter 72.2 Mbit/s PSK, WPA2 Enterprise PEAP RADIUS) 2.4 GHz, IEEE 802.11 b/g/n...
  • Page 74: Optional Accessories And Spare Parts

    525 c – Recommended WiFi settings Consequences in the Recommended set- Parameter event of different set- tings tings No special Separate VLAN – requirements No special – requirements No special VoiP – requirements No special WiFi multimedia –...
  • Page 75: Disposal

    The warranty will be voided if the device is opened by persons not expressly au- thorized by seca to do so. In the event of a warranty issue, please contact your local seca office or the dealer from whom you ordered the product.
  • Page 76: Declarations Of Conformity

    USA and Canada 17.1 Declaration of conformity 0123 seca gmbh & co. kg hereby declares that the product complies with the terms of the applicable European directives and regulations. The unabridged declaration of conformity can be found at www.seca.com. 17.2...
  • Page 78 Medical Measuring Systems and Scales since 1840 seca gmbh & co. kg Hammer Steindamm 3  ̶   2 5 22089 Hamburg . Germany T +49 40 20 00 00 0 F +49 40 20 00 00 50 E info@seca.com seca operates worldwide with headquarters...

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