Seca mVSA 535 Instructions For Use Manual
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Seca mVSA 535 Instructions For Use Manual

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seca mVSA 535
seca mBCA 525
Instructions for use
Software version 1.0 from build 1043
Art no: 17-10-05-353-002f_02-2020 B

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Summary of Contents for Seca mVSA 535

  • Page 1 535 seca mBCA 525 Instructions for use Software version 1.0 from build 1043 Art no: 17-10-05-353-002f_02-2020 B...

  • Page 2: Table Of Contents

    Connecting the SmartBucket ... . 30 seca mBCA 525 ......5 Connecting the blood pressure cuff .
  • Page 3 Deactivating the WiFi connection ..134 10.8 seca 360° wireless system....103 4.3 Setting up a data connection to the seca analytics 115 PC software .
  • Page 4 4.5 Data export and backup ....141 (seca mVSA 535 only) ....150 Exporting patient and user data manually .

  • Page 5: Seca Mbca 525

    English INSTRUCTIONS FOR USE FOR seca mVSA 535/seca mBCA 525 English ➔ ➔ Description of device What do I do if ...? ➔ ➔ Safety precautions Technical data ➔ ➔ Device overview Optional accessories and spare parts ➔ ➔ Starting up the device...

  • Page 6: Intended Use For Seca Mbca 525

    535 dren 3 years and older and adults. The “Bioimpedance analysis” function is not intended for use on children. 1.2 Intended use for seca mBCA 525 The medical Body Composition Analyzer is mainly used in seca mBCA 525 inpatient facilities (hospitals, medical practices and care facilities) in accor- dance with national regulations.

  • Page 7: Power Supply

    The device can be configured so that the seca patient files of the device are automatically synchronized with the seca patient files of the PC software.

  • Page 8: Data Transmission And Network Functions

    The device can be integrated in a network via a LAN interface or via WiFi in order to use the following functions: functions • Communication with the databases of the seca analytics 115 software and use of the function seca directprint •...

  • Page 9: Contraindications

    English 1.5 Contraindications The device is not intended for permanent monitoring of patients. The device is not intended for patient monitoring during transport (for example, in ambulances or helicopters) or a transfer within an institution. The device is not intended for operation in the vicinity of an MRT device or in a pressurized chamber.

  • Page 10: Basic Safety Precautions

    Only have ser- vicing and repairs performed by an authorized seca Service partner. ► Only use original seca accessories and spare parts, otherwise seca will not grant any warranty. 10 •...

  • Page 11: Handling A Wheeled Stand

    English CAUTION! Patient hazard, malfunction ► Keep other electrical medical devices, e.g. high-frequency surgical devices, a minimum distance of approx. 1 meter away to prevent in- correct measurements or wireless transmission interference. ► Keep HF devices such as cell phones a minimum distance of ap- prox.

  • Page 12: Prevent Damage To Device

    This is only an additional func- tion. ► Use the results exclusively in SI units. ► The use of measuring results in non-SI units is the sole responsibility of the user. 12 • seca mVSA 535 seca mBCA 525...

  • Page 13: Handling Packaging Material

    Inconsistent measuring results ► Before you electronically save measured values determined using this device and use them further (e.g. in seca PC software or in an EMR system), make sure that the measured values are plausible. ► If measured values are transmitted to seca PC software or an EMR system, make sure prior to further use that the measured values are plausible and are assigned to the correct patient.

  • Page 14: Device Overview

    ➔ Markings on the blood pressure cuff ➔ Markings on the packaging 3.1 Monitor controls for seca mVSA 535/seca mBCA 525 NOTE This section shows product variants. The functional scope of your device may deviate from this. seca mBCA 525...
  • Page 15 Depending on version, to fit: Connection for SpO • Masimo SET ® patient cables and sensors (no illustration) measurement • seca patient cables and sensors (shown in illustration) Connection for blood pressure For seca blood pressure cuffs measurement Device overview • 15...

  • Page 16: Measuring Mat Controls (Bioimpedance Analysis)

    LEDs, electrodes on left LED green, flashing: Measurement in progress LED red: Electrode contact poor Enter patient position LED green: seca patient file loaded, patient position selected Button with LED, patient position left LED green, flashing: Measurement stopped LED red: No seca patient file loaded...

  • Page 17: In-Ear Thermometer Controls

    Measuring temperature in ear “Discard” button For discarding probe cover In-ear thermometer display Serves as a secondary display. display takes priority seca mVSA 535 “Switch unit” button Switch between °C and °F “Measure” button Press button to start measurement Not relevant for .

  • Page 18: Login/Navigation: Buttons And Symbols In The Touchscreen Display

    No input or input faulty Select user account Enter password • Navigation: Confirm entry • Measuring: Save measurement procedure Process running Button available Button pressed Button not available Navigate to the left/right Navigate up/down 18 • seca mVSA 535 seca mBCA 525...

  • Page 19: Operating State: Symbols

    Monitor: Rechargeable battery discharged Measuring mat: Controls permanently on: Rechargeable battery full Controls flashing consecutively: Rechargeable battery charging Measuring mat: Rechargeable battery discharged LAN available WiFi available Device is connected to the seca analytics 115 seca connect 103 software Device overview • 19...

  • Page 20: Operating State: Symbols On The Measuring

    Symbol Operating state No connection to the seca analytics 115 software or to the seca connect 103 software Device synchronizing with the software seca analytics 115 Measuring mat detected Measuring mat not detected Popup window: Information for the user Popup window:...

  • Page 21: Mat

    Export seca patient file Delete seca patient file Weight (W) Height (H) Waist circumference (WC) Physical Activity Level (PAL) Adopt value seca 360° wireless Adopt value from previous measurement Close seca patient file, changes will not be saved Device overview • 21...

  • Page 22: Vital Signs " Tab

    (min: 0.02 %, max: 20 %) ® Devices with Masimo SET measuring equipment, oxygen saturation measuring mode: Normal, APOD, maximum Devices with seca measuring equipment, oxygen saturation measuring mode: Stable, default, sensitive Save measuring procedure Discard measurement 22 • seca mVSA 535...

  • Page 23: Bia " Tab

    Save measurement procedure Discard measurement Measuring mat Button/symbol Meaning Enter patient position LED green: seca patient file loaded, patient position selected LED green, flashing: Measurement stopped LED red: No seca patient file loaded Start measurement Electrode LEDs: LED green: Electrode OK...

  • Page 24: Analysis " Tab

    Print results report ( : Function seca directprint of the PC software) seca analytics 115 Position indicator for analysis modules, Here: 2nd module of 5 Position indicator for analysis parameters, Here: 2nd analysis parameter of 4 Detail view available for analysis parameter:...

  • Page 25: Markings On The Device And On The Type Plate

    English 3.8 Markings on the device and on the type plate Text/symbol Meaning Name and address of manufacturer, date of manufacture Model number Serial number, consecutive Product identification number, consecutive ProdID Variant number Mat.No. Follow Instructions for Use Do not use device on individuals with cardiac pacemakers or implanted defibrillators Medical electrical device, type BF...
  • Page 26 • Power consumption ON/OFF key Inductive charging interface LAN interface USB interface NIBP Connection of blood pressure cuff TEMP Connection of temperature sensor Connection of SpO sensor Do not dispose of device with household waste 26 • seca mVSA 535 seca mBCA 525...

  • Page 27: Markings On The Blood Pressure Cuff

    English 3.9 Markings on the blood pressure cuff Text/symbol Meaning Follow instructions for use Cuff size (here: L) Cuff suitable for specified arm size Artery position: These arrows must be on the brachial or femoral artery when blood pressure cuff is put on. Cuff end: These markings must be within the adjustment range when closing the blood pressure cuff.

  • Page 28: Markings On The Packaging

    Permitted min. and max. temperature for transport and storage Permitted min. and max. moisture for transport and storage Not sterile Do not reuse Open packaging here Packaging material can be disposed of through recycling programs 28 • seca mVSA 535 seca mBCA 525...

  • Page 29: Starting Up The Device

    Accessories to suit the version ordered Accessory for the version shown Pcs. DVD with PC software and license for seca analytics 115 one permanent workstation seca blood pressure cuff, size M ® • SpO sensor (Masimo SET or seca) ® • Patient cable (Masimo SET...

  • Page 30: Setting Up Device

    ► Always keep the SmartBucket connected to the USB interface. ► Only connect accessories, for example a USB memory stick, to the other USB interface. ► Connect the USB cable of the SmartBucket to a free USB port of the monitor. 30 • seca mVSA 535 seca mBCA 525...

  • Page 31: Connecting The Blood Pressure Cuff

    English Connecting the blood pressure cuff 1. Connect the tube coupling for the blood pressure cuff to the compressed air connection of the device until you hear the tube coupling engage. => => Click! 2. Stow the blood pressure cuff in the SmartBucketas shown in the illustration below.

  • Page 32: Connecting The In-Ear Thermometer

    Device damage, malfunction The SpO sensor must be compatible with the SpO measuring ® equipment (Masimo SET or seca) fitted. ► Ensure that the SpO sensor is compatible with the SpO measuring equipment fitted in your device ➔ Optional accessories and spare parts.

  • Page 33: Suspending The Measuring Mat In The Magnetic Catch

    SmartBucket until you feel the connector engage. ® Masimo SET => => Press! seca: NOTE The holder above the SpO connection is for storing the SpO sensor. Suspending the measuring mat in NOTICE!

  • Page 34: Establishing A Power Supply

    4.3 Establishing a power supply 1. Plug the device connector of the power supply cable into the connecting socket of the device. 2. Plug the power supply connector into a power supply socket. 34 • seca mVSA 535 seca mBCA 525...

  • Page 35: Charging Rechargeable Batteries

    English 4.4 Charging rechargeable batteries Before starting up the device for the first time, the rechargeable batteries for the monitor and the measuring mat - if there is a measuring mat - must be fully charged. 1. Ensure that the measuring mat is correctly suspended in the magnetic catch of the monitor ➔...

  • Page 36: Initial Login

    ► Perform measurements using the power supply: ➔ Operation ► Configure device using the power supply: ➔ For administrators: Configuring seca mVSA 535/seca mBCA 525 4.6 Initial login The following user accounts are available on the device initially: • “admin”: (Configure and administer device) •...

  • Page 37: Configuration Options

    535/seca mBCA User accounts 4.7 Configuration options The device can only be configured by users with administrator rights. Further information is available here: ➔ For administrators: Configuring seca mVSA 535/seca mBCA 525 Starting up the device • 37...

  • Page 38: Operation

    5. OPERATION ➔ Switching the system on/off ➔ Managing seca patient files ➔ Preparing a seca patient file ➔ Measuring bioimpedance ➔ Measuring vital signs ➔ Analyzing measurement ➔ Operation when connected to a hospital information system 5.1 Switching the system on/off ➔...

  • Page 39: Logging In

    English Logging in You must log in to the device if you want to do one of the following: • Assign a vital signs measurement to a seca patient file • Analyze measuring results • Manage the system 1. Press the Login button.

  • Page 40: Saving Energy

    2. Keep the ON/OFF button of the monitor depressed until the touchscreen display and the LED of the ON/OFF button go off. The device is switched off. The measuring mat switches off automatically. 40 • seca mVSA 535 seca mBCA 525...

  • Page 41: Managing Seca Patient Files

    PC software, check the synchronization settings➔ Activating automatic synchronization. ► Only create a new seca patient file on the device if you are sure that there is no seca patient file for the patient in the seca analytics 115 PC software.

  • Page 42: Creating A Seca Patient File

    If you create seca patient files several times, this can lead to incorrect assignment of measuring results and falsify the analysis. ► If there is no seca patient file on the device for the current patient, check whether there is already a seca patient file in the PC software.
  • Page 43 Confirm your entry by pressing the button 8. Enter the appropriate gender. 9. Enter the appropriate ethnicity. 10. Press the save button. The seca patient file has been created and is displayed. NOTE You can amend patient data subsequently ➔ Editing a seca patient file.

  • Page 44: Editing A Seca Patient File

    1. Call up a seca patient file ➔ Editing a seca patient file Calling up a seca patient file. 2. Press the button. 3. Edit the entries on the first page. 4. Press the button. 5. Edit the entries on the second page.

  • Page 45: Preparing A Seca Patient File

    Introduction Measuring bioimpedance, you have to prepare a seca patient file in the patient tab. The prepared seca patient file is transmitted to the measuring mat. You do not initially need to prepare a patient file for vital signs measurement ➔...
  • Page 46 3. Confirm the entry with the button. 4. Repeat Steps 2. and 3. for the remaining basic parameters. 5. Press the button. The seca patient file is prepared and is displayed. You have the following options for continuing: ► ➔ Measuring bioimpedance ► ➔...

  • Page 47: Measuring Bioimpedance

    2. Prepare the seca patient file ➔ Preparing a seca patient file. The seca patient file is transmitted to the measuring mat. 3. Press the bia tab. 4. Wait until the position buttons on the monitor are active. Operation • 47...
  • Page 48 Electrodes being tested Measurement in progress Measuring results will be stored on the measuring mat Measuring results will be transmitted to the monitor Measurement end: Measuring results have been transmitted to the monitor 48 • seca mVSA 535 seca mBCA 525...
  • Page 49 ➔ Suspending the measuring mat in the magnetic catch. symbol is displayed on the monitor. 3. Prepare the seca patient file ➔ Preparing a seca patient file. The seca patient file is transmitted to the measuring mat. Operation • 49...
  • Page 50 • Electrodes being tested • Measurement in progress • Measuring results will be stored Flashing on the measuring mat Measurement end: Measuring results are stored on the Flashing measuring mat, waiting for transmission to the monitor 50 • seca mVSA 535 seca mBCA 525...

  • Page 51: Connecting The Measuring Mat

    12. Suspend the measuring mat in the magnetic catch of the monitor ➔ Suspending the measuring mat in the magnetic catch. The updated seca patient file is transmitted to the monitor. The measurement procedure is complete when the Measurement successful message appears. You have the following options for continuing: ►...

  • Page 52: Canceling A Measurement Procedure

    ► Step 8. of the measurement without active WiFi direct connection Canceling a measurement You can cancel the measurement procedure at any time. procedure 1. Press the logout button. The measurement procedure will be discarded. 2. Log in again ➔ Logging 52 • seca mVSA 535 seca mBCA 525...

  • Page 53: Measuring Vital Signs

    Displaying weight and height ➔ Stopping a measurement procedure ➔ Assigning anonymous measurement procedure to a seca patient file WARNING! Hazard to patient, malfunction, damage to device ► Set up the device so that it cannot fall on patients. ► Route the cables and tubes of the measurement accessory so that the patient cannot become entangled or be strangled.

  • Page 54: Measuring Blood Pressure

    ► Do not apply the blood pressure cuffs on spots that have weak cir- culation or on extremities on which intravenous routes lie. ► High cuff pressures may be unpleasant for sensitive patients. Keep the patient’s general condition under observation during the mea- surement. 54 • seca mVSA 535 seca mBCA 525...
  • Page 55 ► Inflating the blood pressure cuff may lead to occasional malfunc- tions of other medical electrical devices used on the same limb. ► Use only blood pressure cuffs from seca. ► Before every measurement, ensure that the blood pressure mea- surement tubes and connections are free of damage and airtight.
  • Page 56 (re-pumping: Increasing cuff pressure by approx. 50 mmHg and releasing it in increments). If no measured value is delivered even after several re-pumping steps, the process is canceled and an error message is issued. 56 • seca mVSA 535 seca mBCA 525...
  • Page 57 English Modifying presets NOTE Your settings apply only to the current measurement procedure. If you stop the measurement procedure ➔ Stopping a measurement proce- dure, the presets defined by the administrator become active again. 1. Ensure that the blood pressure cuff is not applied. 2.

  • Page 58: Measuring Temperature, Oral/Axillary (Covidien Tm Filac Tm 3000, Blue)

    ► For axillary temperature measurements, ensure that the tempera- ture probe, with probe cover, makes direct contact with the skin of the patient and does not come into contact with clothing or other objects. 58 • seca mVSA 535 seca mBCA 525...
  • Page 59 English Starting an oral/axillary temperature measurement 1. Remove the temperature probe (blue) from the probe holder (blue). 2. Pick up a probe cover: Click! a) Insert the probe in a probe cover in the pack b) Allow the probe cover to engage audibly with the probe c) Remove probe and probe cover from the pack d) Ensure that the probe cover is undamaged 3.
  • Page 60 5. Press the confirm button. The dialog window closes. Changed settings are used for the current measurement. 6. Perform a temperature measurement as described in the section entitled ➔ Starting an oral/axillary temperature measurement. 60 • seca mVSA 535 seca mBCA 525...

  • Page 61: Measuring Temperature, Rectal (Covidien Tm Filac Tm 3000 Red)

    English Measuring temperature, rectal ➔ Starting a rectal temperature measurement (COVIDIEN FILAC 3000 red) ➔ Modifying presets WARNING! Patient hazard, incorrect measurement ► The decision to use this device with children, pregnant or lactating patients is the responsibility of the user. ►...
  • Page 62 5. Discard the probe cover and dispose of it in line with your institution’s policy. Press! NOTE You can only perform a further temperature measurement if you dis- card the probe cover and push the temperature probe completely back into the probe holder. 62 • seca mVSA 535 seca mBCA 525...
  • Page 63 English 6. Push the temperature probe completely into the probe holder. => You have the following options for continuing: ► Measure further vital signs ➔ Measuring vital signs ► Measure bioimpedance ➔ Measuring bioimpedance ► Stop the measurement procedure ➔ Stopping a measurement procedure Modifying presets...

  • Page 64: Measuring In-Ear Temperature (Covidien Tm Genius ® 2)

    ► Temperature measurements on the left or right ear can lead to dif- ferent results. Always perform follow-up measurements on the same ear. ► Wait at least two minutes before performing a follow-up measure- ment on the same ear. 64 • seca mVSA 535 seca mBCA 525...
  • Page 65 English 1. Take the in-ear thermometer out of the SmartBucket. 2. Make sure that the lens of the measuring head is clean. 3. Press the button to switch on the in-ear thermometer. 4. Pick up a probe cover: a) Push the measuring head firmly into a probe cover in the magazine b) Ensure that the probe cover engages audibly with the measuring head c) Remove the probe cover and thermometer from the magazine...
  • Page 66 => You have the following options for continuing: ► Measure further vital signs ➔ Measuring vital signs ► Measure bioimpedance ➔ Measuring bioimpedance ► Stop the measurement procedure ➔ Stopping a measurement procedure 66 • seca mVSA 535 seca mBCA 525...

  • Page 67: Reading Off Pulse Rate

    English Reading off pulse rate ➔ Interrogate pulse rate source ➔ Modifying presets (seca measuring equipment only) WARNING! Patient hazard, incorrect measurement A pulse rate determined on the basis of blood pressure or oxygen sat- uration is susceptible to artifacts.
  • Page 68 3. Press the desired measuring mode: seca measuring equipment Mode Measuring range Motion tolerance Default 0 - 240 bpm High Sensitive 20 - 300 bpm 4. Press the confirm button. The dialog window closes. Changed settings are used for the current measurement.

  • Page 69: Measuring Oxygen Saturation (Spo 2 )

    English Measuring oxygen saturation (SpO ➔ Starting an SpO measurement ➔ Modifying presets WARNING! Patient hazard, incorrect measurement ► The device has no alarm function. Never leave the patient unobserved during a measurement. ► The pulse oximeter is not an apnea monitoring device. ►...
  • Page 70 Patient hazard, damage to device ► For devices equipped with Masimo SET ® measurement equipment, only use Masimo sensors and patient cables. ► For devices equipped with seca SpO measurement equipment, only use seca sensors and patient cables. 70 • seca mVSA 535...
  • Page 71 English CAUTION! Patient hazard, incorrect measurement ► Do not use damaged sensors or damaged patient cables, for example with exposed optics. ► Do not place the pulse oximeter where the controls can be changed by the patient. ► Electrical shock and flammability hazard: Before cleaning, always turn off the device and disconnect from any power source.
  • Page 72 If your device is equipped with Masimo SET pulse oximetry, perfu- sion index (PI) is displayed in addition to oxygen saturation. This helps you assess perfusion at the measurement point and to find a better measurement point if necessary. 72 • seca mVSA 535 seca mBCA 525...
  • Page 73 • Mild perfusion disorders Adaptive Probe Off Detection Vigorous patient movements (APOD) • Poor perfusion • Severely disrupted signal, for Maximum example due to indoor lighting or direct sunlight seca SpO module Mode Motion tolerance Stable High Normal Normal Sensitive 4.

  • Page 74: Displaying Weight And Height

    1. Open a secapatient file or create a new one ➔ Calling up a seca patient file, ➔ Creating a seca patient file. 2. Enter the values for weight and height in the seca patient file ➔ Entering basic parameters. 74 •...

  • Page 75: Stopping A Measurement Procedure

    You have the following options: ► Save measurement procedure: Press the button ► Assign anonymous measurement to a seca patient file: ➔ Assigning anonymous measurement procedure to a seca patient file ► Discard measurement procedure: Press the...

  • Page 76: Analyzing Measurement

    In order to be able to view analyses, you must assign the current mea- surement to a seca patient file ➔ Stopping a measurement procedure or call up a seca patient file ➔ Calling up a seca patient file. Viewing an analysis The device determines a series of analysis parameters and groups these in analysis modules.
  • Page 77 English You have the following navigation options: ► Press the buttons: View more analysis modules ► Press the button: Return to module summary ► To view details of an analysis parameter: Continue at Step 3. 3. Press an analysis parameter. The detail view is displayed, in this case: Body Composition Chart.

  • Page 78: Viewing The History Of An Analysis Parameter

    Add a comment ► Press the button: Return to the analysis of the current measurement NOTE Just a single comment can be added to each measuring result. Existing comments will be overwritten. 78 • seca mVSA 535 seca mBCA 525...

  • Page 79: Operation When Connected To A Hospital Information System

    English 3. Press the checkboxes for all the values you want to look at in the history. 4. Press the button. The history will be displayed. 5.7 Operation when connected to a hospital information system If the device is connected to a hospital information system, then depending on the hospital information system in question, in measuring mode it may behave differently and may require different operating steps to those described in this document.

  • Page 80: Hygiene Treatment

    Interval Cleaning 1. Remove all the measuring accessories (measuring devices and consumables) from the device (depending on version): Monitor with storage seca mBCA 525 ➔ compartment Removing the probe holder As required ➔ Monitor with SmartBucket Removing the magazine holder seca mVSA 535...

  • Page 81: Disinfecting

    Interval Disinfecting 1. Remove all the measuring accessories (measuring devices and consumables) from the device (depending on version): Monitor with storage seca mBCA 525 ➔ Removing the probe holder compartment ➔ As required Removing the magazine holder Monitor with SmartBucket 2.

  • Page 82: Sterilizing

    ► Ensure that the probe holder is fitted back in the device from which it was removed following a hygiene treatment. Removing the probe holder 1. Open the covering cap. 2. Remove the probe holder. Press! 82 • seca mVSA 535 seca mBCA 525...

  • Page 83: Fitting The Probe Holder

    English Fitting the probe holder 1. Insert the probe holder in the SmartBucket as shown in the illustration below. Click! 2. Close the cover cap until you hear it engage. 6.5 Removing/fitting the magazine holder (devices with in-ear thermometer) Removing the magazine holder 1.

  • Page 84: Function Check

    “Troubleshooting” in this document, you may not use the device. ► Have the device repaired by seca Service or by an authorized ser- vice partner. ► Follow the section entitled “Servicing” in this document.

  • Page 85: What Do I Do If

    ➔ Bioimpedance measurement ➔ Vital signs measurement ➔ Network connection ➔ Data connection to the seca analytics 115 software ➔ Data connection to the seca connect 103 software ➔ Data connection via the seca 360° wireless connection ➔ Print 9.1 Monitor...

  • Page 86: Measuring Mat

    Fault Cause Remedy Prepare seca patient file ➔ Preparing a No seca patient file prepared seca patient file Administrator: Activate measuring mat: ➔ Managing Measuring mat not activated system components in the administrator bia tab not active menu Administrator, if desired: •...

  • Page 87: Bioimpedance Measurement

    • Suspend the measuring mat in the stor- age compartment of the device seca patient files cannot No WiFi connection • Call up seca patient file again, data will be be transmitted to the transmitted via the infrared interface measuring mat...

  • Page 88: Vital Signs Measurement

    Administrator menu is being seca mVSA 535 operated on a wheeled • Original seca USB connecting cable • Use original seca USB connecting cable stand: Measured results not being used (in scope of supply for wheeled stand) for vital signs are •...

  • Page 89: Measurement

    No temperature Temperature module of the ➔ measurement possible SmartBucket not activated Retrofitting the SmartBucket (seca mBCA 525 only) • Assess patient vital signs using alternative Special patient condition, such as means hypothermia • Switch from predictive measurement mode to direct mode...

  • Page 90: Spo 2 Measurement

    Activate temperature module (administrator rights required): Temperature module of the ➔ SmartBucket not activated Retrofitting the in-ear thermometer (seca mVSA 535 only) Measured result Dispose of damaged probe cover and use Probe cover damaged unexpectedly high new one • Lens of measuring head blocked •...

  • Page 91: Network Connection

    PC software via LAN Transmit measuring results to WiFi not available in your institution seca analytics 115 seca connect 103 software via LAN 9.6 Data connection to the seca analytics 115 software Fault Cause Remedy Use a compatible version of Data transmission cannot...

  • Page 92: Data Connection To The Seca Connect 103 Software

    9.7 Data connection to the seca connect 103 software Information about the data connection to the software can seca connect 103 be found in the following documents: • Integration instructions for seca mVSA 535 • System instructions for use for (version 2.0 or higher)

  • Page 93: Technical Data

    Measuring mat Analysis modules ➔ ➔ Bioimpedance measurement Standards and directives 10.1 Monitor Dimensions, weights Monitor with storage compartment ( seca mBCA 525 Dimensions ( seca mBCA 525 • Depth 230 mm • Width 252 mm • Height 262 mm Weight of scale ( approx.

  • Page 94: Monitor Interfaces And Network Ports

    Medical device in accordance with Directive 93/42/EEC Class IIa IEC 60601-1: Insulated device, protection class: Type of protection IP20 seca mBCA 525 Type of protection IP21 seca mVSA 535 Duty cycle Continuous duty seca 360° wireless 2 x USB 2.0 (max 500 mA)

  • Page 95: Measuring Mat

    English 10.3 Measuring mat Measuring mat Dimensions • Depth 783 mm • Width 170 mm • Height 20 mm Net weight approx. 1 kg Ambient conditions, operation • Temperature +10 °C to +40 °C (50 °F to 104 °F) • Air pressure 700 hPa –...

  • Page 96: Clinical Studies

    In the USA, a study was conducted on 130 healthy adults of different ethnicities. The aim of the study was to validate the param- eters 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 standard deviation (SEE) by ethnicity for the parameters determined using seca's in-house formulas.

  • Page 97: Measurement

    English seca blood pressure module Measuring range for blood pressure Upward measurement: • Systolic BP 77 mmHg - 200 mmHg • Diastolic BP 45 mmHg - 190 mmHg • Mean arterial pressure 56 mmHg - 193 mmHg Downward measurement: • Systolic BP 25 mmHg - 280 mmHg •...

  • Page 98: Covidien Filac 3000 Temperature

    Type of protection against ingress of liquids IPX0 Masimo SET ® measurement General technical data a b c d e f g ® Masimo SET module Measurement Functional oxygen saturation Measuring method Spectrophotometry (red/infrared) 98 • seca mVSA 535 seca mBCA 525...
  • Page 99 English a b c d e f g Masimo SET ® module LED wavelength: 660 nm Infrared 905 nm Maximum light output 15 mW This information may be of particular interest to clinicians Measuring time: • Device switched on, sensor not applied ≤...
  • Page 100 100 • seca mVSA 535 seca mBCA 525...

  • Page 101: Spo Measurement Seca

    English measurement seca seca SpO module Measurement Functional oxygen saturation Measuring method Spectrophotometry (red/infrared) LED wavelength: 660 nm Infrared 905 nm Maximum light output 5 mW This information may be of particular interest to clinicians Measuring range: • SpO 0% - 100 %...

  • Page 102: Analysis Parameters

    Absolute in mmHg Vital signs (NIBP) Body temperature (TEMP) Absolute in °C Vital signs Pulse rate (PR) Absolute in min (based on NIBP or SpO Vital signs Oxygen saturation (SpO Relative in % Vital signs 102 • seca mVSA 535 seca mBCA 525...

  • Page 103: Analysis Modules

    1 measuring station (or 1 personal scale and 1 stadiometer) Maximum configuration per wireless group 1 mVSA/1mBCA 1 PC with seca 360° wireless USB adapter 456 PC software seca analytics 115 Number of channels per wireless group Automatic (recommended) Type of channel assignment...

  • Page 104: Standards And Directives

    Requirements For Basic Safety And Essential Performance Of Pulse Oximeter Equipment) 11.OPTIONAL ACCESSORIES AND SPARE PARTS Optional accessories and spare parts Article number SmartBucket Version overview seca mVSA 526 (mBCA compatible from serial number 10000000090505) seca mBCA 525 Bioimpedance measurement: measuring mat 531-20-00-001...

  • Page 105: Compatible Seca Measuring Devices

    Only discard (rechargeable) batteries when fully discharged. 13.3 Consumables Do not dispose single-use items such as probe covers with household waste. Comply with facility requirements and the national provisions applicable in your country. Compatible seca measuring devices • 105...

  • Page 106: Warranty

    The warranty shall become null and void where the device is opened by per- sons not expressly authorised to do so by seca. In the event of a warranty issue, please contact your local seca office or the dealer from whom you ordered the product.

  • Page 107: Declarations Of Conformity

    ➔ For Europe ➔ For USA and Canada 15.1 For Europe seca gmbh & co. kg hereby declares that the product meets the terms of the applicable European directives 15.2 For USA and Canada seca mVSA 535 seca mBCA 525...

  • Page 108: For Administrators: Configuring Seca Mvsa 535/Seca Mbca 525

    FOR ADMINISTRATORS: CONFIGURING seca mVSA 535/ seca mBCA 525 English ➔ ➔ Preparing configuration Managing system components ➔ ➔ User accounts Factory settings ➔ ➔ Making settings for measuring Instructions for use for mode seca mVSA 535/seca mBCA 525 ➔...

  • Page 109: Configuration Options

    7. Enter your password using the keypad The administrator area is displayed. 1.2 Configuration options ➔ Network functions ➔ User role model Network functions Function WiFi seca 360° Infrared Transmit weight • to monitor Transmit height • to monitor Preparing configuration • 109...

  • Page 110: User Role Model

    User role model • = possible, - = not possible Function Administrator User Create seca patient files • Call up seca patient files • Enter basic parameters (weight, height, • waist circumference, PAL) Edit seca patient files • Delete seca patient files •...

  • Page 111: User Accounts

    English 2. USER ACCOUNTS ➔ Activating initial user accounts ➔ Working with user accounts 2.1 Activating initial user accounts The following user accounts are available on the device initially: • “admin”: (Configure and administer device) • “user”: (Perform measurements and manage them). The user accounts have to be activated in order to be able to use the device: •...

  • Page 112: Assigning The Password For The "User" User Account

    6. Press the save button. The password has been stored. The “user” user account can be used. 7. Configure the device as required for your specific situation ➔ administrators: Configuring seca mVSA 535/seca mBCA 525. 112 • seca mVSA 535 seca mBCA 525...

  • Page 113: Working With User Accounts

    Deleting user accounts Setting up user accounts User accounts can be created only in the PC software. seca analytics 115 To make new user accounts available on the device, it must be synchronized with the PC software ➔ Activating automatic synchronization.

  • Page 114: Deleting User Accounts

    ► Select a password to satisfy your institution's security requirements. ► Use the user accounts without password protection only for special applications (e.g. configuring interfaces with practice or hospital in- formation systems). seca Service will be pleased to assist if you have any questions relating to “interface configuration”. NOTE •...

  • Page 115: Making Settings For Measuring Mode

    ► Standalone operation: Ensure that the date and time information on the device is correct. ► Network operation: Ensure that the date and time information in the seca PC software is correct. These settings are adopted by the device. 1. Press the Settings tab.

  • Page 116: Setting Display Brightness And Volume

    • Settings you make in this tab are active directly. You do not need to save or confirm them. 3.2 Setting display brightness and volume 1. Press the Settings tab. 2. Press the Display and volume button. 116 • seca mVSA 535 seca mBCA 525...

  • Page 117: Calibrating The Touchscreen Display

    English 3. Press the buttons as appropriate: ► Set display brightness ► Set volume for warning and information sounds ► Set volume for button sounds NOTE Amended settings can immediately be seen/heard each time a button is pressed. You do not need to save or confirm them. 3.3 Calibrating the touchscreen display 1.

  • Page 118: Setting Units Of Measurement

    This is only an additional func- tion. ► Use the results exclusively in SI units. ► The use of measuring results in non-SI units is the sole responsibility of the user. 118 • seca mVSA 535 seca mBCA 525...
  • Page 119 English 1. Press the Settings tab. 2. Press the units button. 3. Make the desired settings: ► Reference for resting energy expenditure ► Unit for energy ► Unit for weight ► Unit for height ► Unit for temperature ► Unit for blood pressure NOTE Settings you make in this tab are active directly.

  • Page 120: Deactivating Analysis Modules

    • If the analysis modules Energy and Health risk are deactivated, the basic parameters Waist Circumference and Physical Activity Level will not be interrogated ➔ Preparing a seca patient file. • Settings you make in this tab are active directly. You do not need to save or confirm them.

  • Page 121: Making Presets For Vital Signs Measurement

    English 3.6 Making presets for vital signs measurement ➔ Presets for blood pressure ➔ Presets for pulse rate (seca measuring equipment only) ➔ Presets for SpO ➔ Presets for temperature (COVIDIEN FILAC 3000 only) ➔ Selecting color mode for “vital signs” tab...
  • Page 122 5. Adapt initial pressure if necessary. 6. Press the desired number of measurements. • Single measurement • Multiple measurement 7. Press the confirm button. The dialog window closes. The modified settings are adopted. 122 • seca mVSA 535 seca mBCA 525...

  • Page 123: Presets For Pulse Rate (Seca Measuring Equipment Only)

    Presets for pulse rate (seca 1. Press the Settings tab. measuring equipment only) 2. Press the Measurement vital signs button. 3. Press the PR button. 4. Press the desired measuring mode (seca measuring equipment only): seca measuring equipment Mode Measuring range Motion tolerance...

  • Page 124: Presets For Spo

    1. Press the Settings tab. 2. Press the Measurement vital signs button. 3. Press the SpO button. ® The presets are displayed (in this case: Masimo SET pulse oximetry): 4. Press the desired sensitivity: 124 • seca mVSA 535 seca mBCA 525...

  • Page 125: Presets For Temperature

    • Mild perfusion disorders Adaptive Probe Off Detection Vigorous patient movements (APOD) • Poor perfusion • Severely disrupted signal, for Maximum example due to indoor lighting or direct sunlight seca SpO module Mode Motion tolerance Stable High Normal Normal Sensitive 5.
  • Page 126 • Predictive • Direct 6. Press the desired measuring position (COVIDIEN FILAC 3000 blue only). • Oral • Axillary 7. Press the confirm button. The dialog window closes. The modified settings are adopted. 126 • seca mVSA 535 seca mBCA 525...

  • Page 127: Selecting Color Mode For "Vital Signs" Tab

    English Selecting color mode for “vital 1. Press the Settings tab. signs” tab 2. Press the Measurement vital signs button. 3. Press the Color mode input field. 4. Select a color mode. • Standard • Color, day • Color, night 5.

  • Page 128: Setting Up Peripherals

    Setting up LAN connection to the network (stationary operation) ➔ Setting up WiFi connection (mobile operation) ➔ Setting up a data connection to the seca analytics 115 PC software ➔ Setting up a data connection to the seca connect 103 software ➔...

  • Page 129: Activating The Lan Connection

    ► To set up connection manually, continue at Step 5. ► To set up automatic connection: Press the DHCP button and con- tinue with ➔ Setting up a data connection to the seca analytics 115 PC software Setting up peripherals • 129...
  • Page 130 ► WiFi direct (BIA mat): The monitor and the measuring mat communicate with one another via a direct WiFi connection ► WiFi off: The monitor and the measuring mat communicate with one another via the infrared interface 130 • seca mVSA 535 seca mBCA 525...

  • Page 131: Deactivating The Lan Connection

    11. You have the following options for continuing: ► ➔ Setting up a data connection to the seca analytics 115 PC software ► ➔ Setting up a data connection to the seca connect 103 software Deactivating the LAN connection 1.

  • Page 132: Setting Up Wifi Connection (Mobile Operation)

    Measuring mat Infrared WiFi WiFi seca mBCA 525/ seca mVSA 535 Server/Stand-Alone-PC WiFi-Router Monitor If you connect the device to your network as a WiFi client, the measuring mat, if present, can only communicate with the monitor via the infrared interface.
  • Page 133 The device is connected to your network via WiFi. 10. You have the following options for continuing: ► ➔ Setting up a data connection to the seca analytics 115 PC software ► ➔ Setting up a data connection to the seca connect 103 software...

  • Page 134: Deactivating The Wifi Connection

    2. Press the WiFi button. 3. In the WiFi Mode drop-down menu, press the WiFi off setting. 4. Press the button to confirm your entry. The WiFi function is deactivated. The connection data are deleted. 134 • seca mVSA 535 seca mBCA 525...

  • Page 135: Setting Up A Data Connection To The Seca Analytics 115 Pc Software

    English 4.3 Setting up a data connection to the seca analytics 115 PC software ➔ Introduction ➔ Connecting the device automatically (UDP) ➔ Connecting the device manually (TCP) ➔ Exporting patient and user data manually ➔ Setting up automatic export...

  • Page 136: Connecting The Device Manually (Tcp)

    3. In the Connect mode dropdown menu, select the seca analytics 115 UDP option. The recommended presets are displayed. 4. Adapt the default settings if necessary. 5. Ensure that these settings match those in the seca analytics 115 software (menu: Extras\Settings\Synchronization).

  • Page 137: Activating Automatic Synchronization

    English 3. In the Connect mode dropdown menu, select the seca analytics 115 TCP option. The recommended presets are displayed. 4. Adapt the default settings if necessary. 5. In the Connect Server IP line, enter the appropriate IP address. Configuration...
  • Page 138 1. Press the Peripherals tab. 2. Press the seca connect button. 3. In the Connect mode dropdown menu, select the seca analytics 115 TCP or seca analytics 115 UDP option. 4. Press the button to reach the seca analytics 115 configuration page.

  • Page 139: Setting Up Automatic Export

    1. Establish which data format your practice or hospital information system accepts. 2. Press the Peripherals tab. 3. Press the seca connect button. 4. In the Connect mode dropdown menu, select the seca analytics 115 TCP or seca analytics 115 UDP option. 5. Press the button The seca analytics 115 configuration page is displayed.

  • Page 140: Setting Up A Data Connection To The Seca Connect 103 Software

    • Note the user documentation for the practice or hospital information system used. • seca Service will be pleased to assist if you have any questions relating to “interface configuration”. 4.4 Setting up a data connection to the seca connect 103 software...

  • Page 141: Data Export And Backup

    Exporting patient and user data manually ➔ Restore patient and user data manually Exporting patient and user data This function allows you to export seca patient files and user accounts in order to create a backup copy, for example. manually 1. Press the System tab.

  • Page 142: Restore Patient And User Data Manually

    115 (operate with PC software). seca analytics 115 1. Load the archived seca patient files and user accounts onto a USB memory stick. 2. Press the System tab. 3. Press the Data management button. 4. Connect the USB memory stick to the monitor.

  • Page 143: Setting Up Seca 360° Wireless The Network

    English 4.6 Setting up seca 360° wireless the network ➔ Introduction ➔ Activating/deactivating the seca 360° wireless module ➔ Setting up a seca 360° wireless connection Introduction If you use devices from the system in your institution, e.g. seca 360° wireless a measuring station, you can link them to the mVSA/mBCA.

  • Page 144: Activating/Deactivating The Seca 360° Wireless Module

    Activating/deactivating the 1. Press the Peripherals tab. seca 360° wireless module 2. Press the seca 360° button. 3. Press the Send/receive on checkbox. seca 360° wireless module is activated. 4. To deactivate the seca 360° wireless module, press the Send/receive on checkbox again.
  • Page 145 English 4. Press the seca 360° button. 5. Press the set up button. 6. Press one of the three wireless groups. The device searches for seca 360° wireless devices which are switched The device will suggest three wireless channels. NOTICE! Incorrect device assignment Only one example of a device category (e.g.

  • Page 146: Managing System Components

    Updating the monitor software ➔ Updating the measuring mat software ➔ Retrofitting the SmartBucket (seca mBCA 525 only) ➔ Retrofitting the measuring mat (seca mVSA 535 only) ➔ Retrofitting the in-ear thermometer (seca mVSA 535 only) ➔ Power management 5.1 Viewing system information 1.

  • Page 147: Updating The Monitor Software

    5.2 Updating the monitor software This function allows you to update the software of the device. NOTICE! Data loss ► Export seca patient files and user accounts manually before updat- ing the software (operate without PC software). seca analytics 115 ►...

  • Page 148: Updating The Measuring Mat Software

    Updating the monitor software • System has had a measuring mat added ( seca mVSA 535 ➔ Retrofitting the measuring mat (seca mVSA 535 only) • Measuring mat has been replaced with a new one ( seca mVSA 535 seca mBCA 525 If the measuring mat software is out of date, the corresponding message will appear on the monitor.

  • Page 149: Retrofitting The Smartbucket (Seca Mbca 525 Only)

    English 5.4 Retrofitting the SmartBucket (seca mBCA 525 only) medical Body Composition Analyzer seca mBCA 525 from serial number 10000000090505 can be retrofitted with the SmartBucket seca mVSA 526 to measure vital signs ➔ Optional accessories and spare parts. 1. Retrofit the SmartBucket as described in the relevant assembly instructions.

  • Page 150: Retrofitting The Measuring Mat (Seca Mvsa 535 Only)

    5.5 Retrofitting the measuring mat (seca mVSA 535 only) can be retrofitted with the measuring mat seca mVSA 535 seca mBCA 531 to perform bioimpedance measurements ➔ Optional accessories and spare parts. 1. Retrofit the measuring mat as described in the relevant assembly instructions.

  • Page 151: Retrofitting The In-Ear Thermometer (Seca Mvsa 535 Only)

    English 5.6 Retrofitting the in-ear thermometer (seca mVSA 535 only) seca mVSA 535 without temperature measurement can be retrofitted with 2 in-ear thermometer ➔ ® the COVIDIEN GENIUS Optional accessories and spare parts. 1. Connect the in-ear thermometer as described in the section entitled ➔...

  • Page 152: Power Management

    ► Press the button to switch off the device when battery charge status is low (minimum: 10 %). ► Press to switch off the device at a higher battery charge status (maximum: 100 %). 152 • seca mVSA 535 seca mBCA 525...

  • Page 153: Factory Settings

    Temperature: Unit °C COVIDIEN FILAC 3000 Oral measurement, predictive Blue measurement Predictive measurement Pulse rate: Unit Preset (seca measuring equipment only) Default setting Oxygen saturation: Unit Mode Normal Decimal separator: International Decimal point Energy: Reference resting energy FAO/WHO/UNU expenditure: Connection data None Factory settings •...

  • Page 154: Resetting The Device

    Factory settings. seca patient files and user accounts are deleted from the device by this process. NOTE If seca patient files and user accounts are to be retained, proceed as described in the section entitled ➔ Resetting the user interface.

  • Page 155: Resetting The User Interface

    Factory settings. seca patient files and user accounts are retained by this process. NOTE If all seca patient files and user accounts are to be removed from the device, proceed as described in the section entitled ➔ Resetting the device.

  • Page 156: Enabling Vnc Access

    NOTE If you have selected “Network” as the export destination, the system log in the installation directory of the PC software seca analytics 115 (server or standalone PC) will be exported to the “Program- Data\seca\LogExports” folder. 6.5 Enabling VNC access With a VNC connection, you can reproduce the user interface of the device on a PC screen and remotely control the device from the PC.

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