English INSTRUCTIONS FOR USE FOR seca mVSA 535/seca mBCA 525 English ➔ ➔ About this document Servicing ➔ ➔ Description of device Troubleshooting ➔ ➔ Safety precautions Technical data ➔ ➔ Device overview Optional accessories and spare parts ➔ ➔...
Description of function ➔ User qualification ➔ Contraindications 2.1 Intended use for the seca mVSA 535 The medical Vital Signs Analyzer is mainly used in inpatient seca mVSA 535 facilities (hospitals, medical practices and care facilities) in accordance with national regulations.
The electrodes are affixed to the patient's hands and feet. Vital signs measurement Blood pressure is measured non-invasively with seca measuring equipment and seca blood pressure cuffs. Temperature is measured with COVIDIEN...
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.
USB connection. The device has a module and can receive measuring seca 360° wireless results from compatible seca scales and measuring rods. Compatibility PC software seca analytics 115 This device (software version 1.0, Build 1163 or higher) is only compatible with version 1.4 (Build 6657 or higher) of the...
• portable electronic medical devices, e.g. ECG devices or infusion pumps Impedance measurements may only be performed on persons exhibiting the following characteristics after discussion with the attending physician: • cardiac arrhythmias • pregnancy 10 • seca mVSA 535 seca mBCA 525...
English 3. SAFETY PRECAUTIONS ➔ Safety precautions in these instructions for use ➔ Basic safety precautions 3.1 Safety precautions in these instructions for use DANGER! Used to identify an extremely hazardous situation. If you fail to take note of this information, serious irreversible or fatal injuries will occur. WARNING! Used to identify an extremely hazardous situation.
Only have ser- vicing and repairs performed by an authorized seca Service partner. You can find service partners in your area at www.seca.com or by sending an e-mail to service@seca.com.
English Preventing electric shock WARNING! Electric shock ► Set up devices which can be operated with the electricity supply so that the power supply socket is within easy reach and the power supply can be disconnected quickly. ► Ensure that your local power supply matches the details on the device.
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.
Follow-up measurements not performed on a seca device may lead to inconsistent data and to misinterpreted measuring results. ► Ensure that follow-up measurements are also performed on a seca device. NOTE For an overview of the parameters which can be determined using this device, see the section entitled “Technical data\analysis parameters”.
➔ Markings on the blood pressure cuff ➔ Markings on the packaging 4.1 Monitor controls for seca mVSA 535/seca mBCA 525 NOTE This section shows product versions. The functional scope of your device may deviate from this. seca mBCA 525...
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Depending on version, to fit: Connection for SpO • Masimo SET patient cables and sensors (not illustrated) ® measurement • seca patient cables and sensors (shown in illustration) Connection for blood pressure For seca blood pressure cuffs measurement Device overview • 17...
For measuring temperature in ear Discard button Discard 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 .
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...
Patient tab Vital signs tab BIA tab Analysis tab Open instructions for use Instructions for use: Return to section summary Enter text or numbers No input or input faulty Select user account Enter password 20 • seca mVSA 535 seca mBCA 525...
English Button/symbol Meaning • Navigation: Confirm entry • Measuring: Save measurement procedure Process running Button available Button pressed Button not available Navigate to the left/right Navigate up/down One or more items from list selected/not selected Alternative from list selected/not selected Return to previous screen Login Log in user...
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Rechargeable battery charging Measuring mat: Rechargeable battery discharged LAN connection set up: on/off WiFi connection set up: on/off (EMR)/ seca connect 103 seca analytics 115 connection active (EMR)/ seca connect 103 seca analytics 115 connection interrupted Connection to seca analytics 115...
Button/symbol Meaning Adopt value from previous measurement Close seca patient file, changes will not be saved Vital signs tab Button/symbol Meaning NIBP Blood pressure measured non-invasively Start blood pressure measurement Blood pressure measurement in progress Blood pressure: Multiple measurement: First measurement will be discarded...
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 LED green, flashing: Measurement in...
English Button/symbol Meaning Blue marking: Mean value Male Female 4.8 Unsubmitted measurements list: Symbols Button/symbol Meaning Weight (W) Height (H) Waist circumference (WC) Physical Activity Level (PAL) Body mass index (BMI) Pulse rate (PR) Blood pressure (NIBP) Oxygen saturation (SpO Temperature (Temp) Blue marking: Mean value Yellow marking (when connected to EMR...
• Protection against access with wires • Protection against splashes from all directions Li-ion Lithium-ion rechargeable battery Device complies with EU directives • 0123: appointed office for medical devices: 0123 TÜV SÜD Product Service 28 • seca mVSA 535 seca mBCA 525...
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English Text/symbol Meaning Symbol of the US Federal Communications Commission (FCC) Device license number from the Federal FCC ID Communications Commission (FCC) Device license number from Industry Canada Type plate for power supply socket: xxx-yyy V ~ • Permitted supply voltage min xx-yy Hz •...
(here: L). This side facing the patient Latex-free Name and address of manufacturer Date of manufacture Name and address of distributor Model number Lot number The blood pressure cuff complies with EU directives 30 • seca mVSA 535 seca mBCA 525...
English 4.11 Markings on the packaging Text/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. and max. temperature for transport and storage Permitted min. and max. humidity for transport and storage Open packaging here Packaging material can be disposed of through...
5.1 Scope of delivery NOTE This section shows version 535-3110-001 by way of an example. The scope of delivery of your device may deviate from this. An overview of versions can be found at www.seca.com. seca mVSA QUICK START seca 115 Standard scope of delivery Pcs.
Connecting the SmartBucket ➔ Connecting the blood pressure cuff ➔ Connecting the temperature probe ➔ Connecting the in-ear thermometer ➔ Connecting the seca SpO sensor ® ➔ Connecting the Masimo SET sensor ➔ Suspending the measuring mat in the magnetic catch...
3. Close the cover cap of the connection compartment. Click! Press! => => 4. Push the temperature probe into the probe holder completely as shown in the illustration below. => 34 • seca mVSA 535 seca mBCA 525...
=> Connecting the seca SpO sensor NOTICE! Damage to device, malfunction The SpO sensor must be compatible with the seca SpO measuring equipment fitted. ► Ensure that the SpO sensor is compatible with the SpO measuring equipment fitted in your device ➔...
2. Put the connector for the SpO sensor/the patient cable in the socket on the SmartBucket until you feel the connector engage. => => Press! NOTE The holder above the SpO connection is for storing the SpO sensor. 36 • seca mVSA 535 seca mBCA 525...
English Suspending the measuring mat in NOTICE! the magnetic catch Malfunction The measuring mat rechargeable battery is only charged via the inductive charging interface of the monitor. ► Ensure that the inductive charging interface is not covered by other measuring accessories such as a blood pressure cuff, for example. ►...
Leave the device connected to the power supply for approx. 4 hours when starting it up for the first time. This ensures that the recharge- able batteries for the monitor and the measuring mat are fully charged. 38 • seca mVSA 535 seca mBCA 525...
► Leave device switched on (recommended): ➔ Charging rechargeable batteries ► Perform measurements using the power supply: ➔ Operation ► Configure device using the power supply: ➔ For administrators: Configuring seca mVSA 535 /seca mBCA 525 Starting up the device • 39...
535 /seca mBCA User accounts 5.7 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 40 • seca mVSA 535 seca mBCA 525...
English 6. OPERATION ➔ Switching the system on/off ➔ Managing seca patient files ➔ Measuring vital signs ➔ Measuring bioimpedance ➔ Adding weight and height ➔ Analyzing measurement 6.1 Switching the system on/off ➔ Switching on ➔ Logging in ➔...
Logging in You must log in to the device if you want to do one of the following: • Assign vital signs measurement to a seca patient file • Perform a bioimpedance measurement • Analyze measuring results • Manage the system 1.
English Logging out/switching user ► Press the Logout button. You will be logged out. The login window is displayed. Another user can log in ➔ Logging Saving power/switching off 1. Briefly press the ON/OFF button of the monitor. 2. The Save energy dialog window appears. 3.
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.
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English 3. Press the Create patient file button. NOTICE! Restricted function If you press the Anonymous patient field, the first input screen is skipped and an anonymous patient file is created. It is not possible to display any measured value graphs (histories) in anonymous patient files.
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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. You have the following options for continuing: ► Measure vital signs: ➔ Measuring vital signs ►...
3. Select a seca patient file: ► Desired entry not visible: Continue at step 4. ► Desired entry visible: Continue at step 5. 4. Search for the desired seca patient file in the list: a) Press the input field b) Use the keypad...
Exporting a seca patient file 1. Connect a USB memory stick to the monitor. 2. Call up a seca patient file ➔ Calling up a seca patient file. 3. Press the button. A confirmation dialog opens. 4. Press the Confirm button.
(exception: blood pressure measurement and in-ear temperature measurement). Depending on device configuration, pulse rate is determined using either oxygen saturation or blood pressure. Weight and height can be recorded by compatible seca measuring devices or entered manually: ➔ Adding weight and height.
► Do not apply the blood pressure cuffs on spots that have weak circulation 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 measurement. 50 • seca mVSA 535 seca mBCA 525...
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► 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.
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Results from multiple measurements cannot be transmitted to EMR systems or the PC software. seca analytics 115 ► Switch to Single measurement, if necessary, if you want to transmit blood pressure values to an EMR system or the seca analytics 115 PC software ➔...
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English • If inflation fails to deliver a measured value, the device automatically switches to deflation. If necessary, the device re-pumps several times during the deflation (re-pumping: Increasing cuff pressure by approx. 50 mmHg followed by incremental releasing of that pres- sure).
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6. Press the Confirm button. The dialog window closes. Changed settings are adopted for the current measurement. 7. Start the blood pressure measurement as described in the section entitled ➔ Preparing the blood pressure measurement. 54 • seca mVSA 535 seca mBCA 525...
English Measuring temperature, oral/ ➔ axillary (COVIDIEN FILAC 3000, Starting an oral/axillary temperature measurement blue) ➔ 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. ►...
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Predictive) flash until a valid measured value is obtained. The temperature value is displayed until you stop the measurement procedure ➔ Stopping a measurement procedure. 4. Discard the probe cover and dispose of it in line with your institution’s policy. Press! 56 • seca mVSA 535 seca mBCA 525...
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English NOTE You can only perform a further temperature measurement if you dis- card the probe cover and push the temperature probe back into the probe holder completely. 5. Push the temperature probe into the probe holder completely. => You have the following options for continuing: ►...
Too much lubricant can distort the measure- ment result. ► For rectal temperature measurements, do not insert the tempera- ture probes deeper than about 19 mm (3/4 inch) for adults and about 13 mm (1/2 inch) for children. 58 • seca mVSA 535 seca mBCA 525...
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English Starting a rectal temperature measurement 1. Remove the temperature probe (red) from the probe holder (red). 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.
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• Direct 4. Press the Confirm button. The dialog window closes. The modified settings are adopted. 5. Start the temperature measurement as described in the section entitled ➔ Starting a rectal temperature measurement. 60 • seca mVSA 535 seca mBCA 525...
English Measuring in-ear temperature DANGER! (COVIDIEN GENIUS Patient hazard ® ► Choking on probe covers can lead to serious injury. WARNING! Patient hazard, incorrect measurement ► The decision to use this device with children, pregnant or lactating patients is the responsibility of the user. ►...
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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. 62 • seca mVSA 535 seca mBCA 525...
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English 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 d) Ensure that the probe cover is undamaged Click! The system is ready to measure when the displays of both the monitor...
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=> 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 64 • seca mVSA 535 seca mBCA 525...
English Entering temperature manually NOTICE! Faulty operation, missing measuring results Manual temperature entries cannot be transmitted to the PC software. seca analytics 115 ► Enter these values manually in the PC software seca analytics 115 as well. NOTE • The option of entering temperatures manually is available on device versions delivered without integrated temperature measuring equipment.
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 saturation is susceptible to artifacts. ► To obtain an exact value, determine pulse rate by means of ECG or palpation.
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English Modifying presets (seca measuring equipment only) NOTE These settings apply 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 neither the blood pressure cuff nor the SpO sensor are applied.
SpO . When elevated levels of COHb or MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed. – Elevated levels of bilirubin – Elevated levels of dyshemoglobin 68 • seca mVSA 535 seca mBCA 525...
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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. Operation • 69...
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SIQ message is consistently displayed while monitoring consecutive patients after completing troubleshooting steps listed in this manual. NOTE: • A functional tester cannot be used to assess the accuracy of the pulse oximeter. 70 • seca mVSA 535 seca mBCA 525...
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English • High-intensity extreme lights (such as pulsating strobe lights) directed on the sensor, may not allow the pulse oximeter to obtain vital sign readings. • When using the Maximum Sensitivity setting, performance of the "Sensor Off" detection may be compromised. If the device is in this setting and the sensor becomes dislodged from the patient, the potential for false readings may occur due to environmental "noise"...
Weight and height The device provides several options for adding the parameters weight and height. Your administrator specifies which of the options you can use. Further information is available here: ➔ Adding weight and height. 72 • seca mVSA 535 seca mBCA 525...
► Stop the current measurement procedure before you start a new one. You have the following options: ► Press the button: Save measurement procedure ► Assign anonymous measurement to a seca patient file: ➔ Assigning anonymous measurement procedure to a seca patient file ► Press the...
3. Log yourself in: ➔ Logging in 4. Call up a patient file ➔ Calling up a seca patient file. 5. Add the basic parameters in the seca patient file by pressing the relevant button: ► Weight: ➔ Adding weight and height ►...
English Once all the basic parameters have been added, the device submits the updated seca patient file to the measuring mat. You have the following options for continuing: ► ➔ Performing a measurement (with WiFi direct connection to the measuring mat) ►...
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Measuring results will be submitted to the monitor Measurement end: Measuring results have been submitted to the monitor The measurement procedure is complete when the Measurement successful message appears. 76 • seca mVSA 535 seca mBCA 525...
English You have the following options for continuing: ► Press the button: Add comment ► Press the button: Save measurement ► Press the Analysis tab: ➔ Analyzing measurement ► Press the Vital signs tab: ➔ Measuring vital signs ► Press the button: Discard measurement 9.
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10. 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: ►...
English Connecting the measuring mat The measuring mat is intended for bioimpedance measurement by the 8- point method (measurement of the whole body) with the patient in a lying position. Measurement by the 4-point method (right half of the body) is like- wise possible.
6.5 Adding weight and height ➔ Receiving weight and height (seca 360° proximity) ➔ Receiving weight and height (seca 360° wireless) ➔ Entering weight and height manually You can add the parameters weight and height as follows: • In the Patient tab •...
Example display: Beispiel-Darstellung: seca 285 measuring station with seca 452 interface module and Messstation seca 285 mit Interface-Modul seca 452 und seca mVSA 535 seca mVSA 535 1. If you have not yet done so, call up a patient file: ➔...
Receiving weight and height If your seca scale or your seca length measuring device is equipped with a module you can transmit weight and height wirelessly. seca 360° wireless seca 360° wireless 3. Receive 1. Measure 3. Empfangen 1. Messen 4.
English Entering weight and height You can enter weight and height manually or adopt the values from the manually previous measurement. 1. Press the Patient tab. 2. If you have not yet done so, select a patient file. 3. Press the Weight or Height field. A numerical keypad appears (in this case: Weight): You have the following options for entering a value: ►...
• In order to be able to view analyses, you must assign the current measurement to a seca patient file ➔ Stopping a measurement pro- or call up a seca patient file ➔ cedure Calling up a seca patient file.
English 2. Press an analysis module. A parameter overview of the current measuring results is displayed: You have the following options for continuing: ► ➔ Analyzing vital signs (history) ► ➔ Analyzing a bioimpedance measurement ► Press the buttons: View more analysis modules ►...
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Existing comments will be overwritten. 3. Press the checkboxes for all the measurements you want to look at in the history. 4. Press the button. The history is displayed (in this case three measurements) 86 • seca mVSA 535 seca mBCA 525...
English You have the following navigation options: ► Press the button: Select other values for history ► Press the buttons: View more analysis parameters ► Press the button: Return to the previous view Analyzing a bioimpedance ➔ Calling up detail view measurement ➔...
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To view the history of an analysis parameter, proceed as follows: 1. Call up a parameter overview ➔ Viewing current measuring results. 2. Press the parameter whose history you wish to view. The detail view of the parameter is displayed: 88 • seca mVSA 535 seca mBCA 525...
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English 3. Press the button. All measurements for the selected analysis parameter are displayed. The latest measurement is selected automatically. You have the following options for continuing: ► Press the drop-down menu: Filter measuring results by period (a maximum of 5 measuring results are displayed). Then continue at step 5.
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You have the following options for continuing: ► Press the button: select other values for the history ► Press the buttons: View more analysis parameters ► Press the button: Return to the previous view 90 • seca mVSA 535 seca mBCA 525...
English 7. OPERATION WHEN CONNECTED TO AN EMR SYSTEM ➔ Switching on the device ➔ Measuring ➔ Logging in with EMR user ID ➔ Calling up patient data from the EMR system ➔ Saving measurements in the EMR system Your administrator can set up the device so that it communicates with your EMR system.
EMR system is active again. NOTE If you are not sure if this function is enabled, contact your administrator. 92 • seca mVSA 535 seca mBCA 525...
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English To perform a measurement with an interrupted connection to an EMR system, proceed as follows: 1. Log yourself in: a) Scan EMR user ID b) Confirm status message The User ID not verfied message appears. 2. Call up a patient file: a) Scan patient ID b) Confirm status message The patient ID is displayed:...
Your EMR user ID is displayed in the input field: 3. Enter your EMR system password. The Patient tab is displayed. You can call up patient data from the EMR system ➔ Calling up patient data from the EMR system. 94 • seca mVSA 535 seca mBCA 525...
English 7.4 Calling up patient data from the EMR system You have the following options for calling up patient data from the EMR system: ➔ Scanning patient ID (recommended) ➔ Manually entering patient ID Scanning patient ID (recommended) If you logged in from the Vital signs tab using a scanner (➔ Logging in with EMR user ID), the Vital signs tab continues to be shown after login:...
The patient data are shown in the Patient information dialog window. 3. Ensure that the patient data displayed are correct. 4. Press the button. The patient data is transmitted to the device and displayed in the Vital signs tab. 96 • seca mVSA 535 seca mBCA 525...
English 7.5 Saving measurements in the EMR system ➔ Submitting the measurement directly to the EMR system ➔ Saving measurement temporarily and submitting it later ➔ Using the Unsubmitted measurements list Submitting the measurement To submit a measurement directly to the EMR system, proceed as follows: directly to the EMR system 1.
3. Press the button. The Unsubmitted measurements list is displayed: NOTE Measurements marked yellow (offline measurement) contain uncon- firmed patient data – because the connection to the EMR system was interrupted, for example. 98 • seca mVSA 535 seca mBCA 525...
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English Confirm offline measurement (EMR system connection) Measurements marked yellow (offline measurement) contain unconfirmed patient data – because the connection to the EMR system was interrupted, for example. These measurements have to be confirmed before you can view details or submit the measurement to your EMR system. 1.
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The measurements are deleted from the list. NOTE In the EMR system, measurements from the Unsubmitted measure- ments list are not assigned to the user who performed the measure- ments, but to the user who submitted them. 100 • seca mVSA 535 seca mBCA 525...
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English Deleting a measurement 1. Press the checkboxes of the measurements to be deleted: 2. Press the button. The selected measurements are deleted. Operation when connected to an EMR system • 101...
Component (depending on version) 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 • ➔...
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English Component (depending on version) Interval Cleaning 1. Discard probe cover and dispose of it 2. Moisten a soft cloth with a mild soap solution 3. Clean temperature probe Temperature probe (red/blue) with cable As required 4. Shake out temperature probe so that no liquid remains in it 5.
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 seca mVSA 535...
English 8.4 Removing/fitting probe holder (devices with temperature probe) WARNING! Patient hazard The color of the probe holder indicates whether a device is intended for oral/axillary or rectal temperature measurement. This distinction can no longer be made once the probe holder has been removed. Confusing the probe holders can lead to cross-contamination.
2. Remove the magazine holder. Fitting the magazine holder 1. Insert the magazine holder in the SmartBucket as shown in the illustration below. 2. Push down the magazine holder until you hear it engage. Click! 106 • seca mVSA 535 seca mBCA 525...
“Troubleshoot- ing” 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.
CardinalHealth recommends calibrating regularly every 12 months. The COVIDIEN Genius Checker/Calibrator is required for calibration. If you do not have a COVIDIEN Genius Checker/Calibrator available, get in touch with your contact at CardinalHealth 108 • seca mVSA 535 seca mBCA 525...
Bioimpedance measurement ➔ Vital signs measurement ➔ Network connection ➔ Connection to the seca analytics 115 software ➔ EMR system connection via seca connect 103 software ➔ seca 360° proximity connection 11.1 Monitor Fault Cause Remedy No power supply Provide power supply...
Fault Cause Remedy Prepare seca patient file ➔ Preparing a No seca patient file prepared bioimpedance measurement Administrator: Activate measuring mat: ➔ Managing Measuring mat not activated system components in the administrator BIA tab not active menu Administrator, if desired: •...
• Suspend the measuring mat in the storage 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...
535 operated on a wheeled • Original seca USB connecting cable • Use original seca USB connecting cable stand: Measuring results not being used (in scope of delivery for the wheeled stand) for vital signs are •...
English COVIDIEN FILAC 3000 temperature measurement Fault Cause Remedy Administrator: No temperature Temperature module of the Activate temperature module: measurement possible SmartBucket not activated System\SmartBucket tab • Assess patient vital signs using alternative Special patient condition, such as means hypothermia •...
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(administrator rights required) automatically. • Put on a new probe cover and repeat measurement. Internal memory: Checksum error • If the error occurs again, contact seca Service • Do not continue using device Thermometer no longer calibrated • Contact seca Service 114 •...
System\SmartBucket tab Manual temperature Manual temperature entries are not Not a malfunction entries do not appear in synchronized with the • Enter values in the seca analytics 115 seca analytics 115 PC software software manually seca analytics 115 software measurement...
Distance between monitor and WiFi • Transmit measuring results to No WiFi connection router is too big PC software or seca analytics 115 via LAN seca connect 103 Transmit measuring results to WiFi not available in your institution PC software or...
English 11.6 Connection to the seca analytics 115 software Fault Cause Remedy Use a compatible version of Data transmission cannot be set up between device Software versions not compatible seca analytics 115 ➔ seca analytics 115 Compatibility Create seca patient file ➔...
11.7 EMR system connection via seca connect 103 software For more information on using the software, see the seca connect 103 seca 103/452 system instructions for use. Fault Cause Remedy Administrator: Use a compatible version of the Software versions not compatible software ➔...
103 (default: 22020) ➔ Setting up a connec- tion to the seca analytics 115 PC software • Follow seca 103/452 system instructions for use No measurement has yet been Perform measurement as described in the...
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)
10 Ω to 1000 Ω Right arm, left arm, right leg, left leg, Measuring segments right half of body, torso Measuring current 100 μA (+20 %, -50 %) Measuring time max. 30 s 122 • seca mVSA 535 seca mBCA 525...
In the USA, a study was conducted on 130 healthy adults of different ethnicities. The aim of the study was to validate the para- meters 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.
➔ Masimo SET measurement ➔ seca SpO measurement Blood pressure measurement seca blood pressure module • Oscillometric • Possible to switch between inflation and deflation Measuring method • Single measurement • Multiple measurement can be config- ured: Max. 6 measurements in max.
English seca blood pressure module Pulse rate: 45 min – 200 min • Measuring range for inflation • Measuring range for deflation 30 min – 240 min • Accuracy (under laboratory conditions, verified with CuffLink patient max. ± 3 min...
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English a b c d e f g Masimo SET module ® IEC 60601-1: Medical electrical device, type BF ® a.The accuracy of the Masimo SET technology with Masimo sensors was validated with no movement in human blood studies with induced hypoxia on healthy adult male and female volunteers with light to dark skin pigmentation in the range from 70 –...
± A (accuracy root mean square) of the value measured by CO oximeters. c.Tested with a Fluke Index II Oximeter Tester (all movement patterns). 128 • seca mVSA 535 seca mBCA 525...
English 12.6 Analysis parameters NOTE These instructions for use describe the maximal available functional scope of the device. The actual functional scope of your device may be less than this. Analysis parameter Display Analysis module • Normal range display of R and X in coordinate Bioimpedance vector analysis Fluid...
1 measuring station (or 1 personal scale and 1 measuring rod) Maximum configuration per wireless group 1 mVSA/1 mBCA 1 PC with seca 360° wireless USB adapter 456 PC software seca analytics 115 Number of channels per wireless group Automatic (recommended)
Requirements For Basic Safety And Essential Performance Of Pulse Oximeter Equipment) 13.OPTIONAL ACCESSORIES AND SPARE PARTS Optional accessories and spare parts Article number SmartBucket Version overview at seca mVSA 526 (mBCA compatible from serial number 10000000090505) www.seca.com seca mBCA 525 Bioimpedance measurement: measuring mat...
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.
17.DECLARATION OF CONFORMITY 0123 seca gmbh & co. kg hereby declares that the product meets the terms of the applicable European directives. The unabridged declaration of conformity can be found at: www.seca.com. 134 • seca mVSA 535 seca mBCA 525...
English FOR ADMINISTRATORS: CONFIGURING seca mVSA 535 / seca mBCA 525 English ➔ ➔ Preparing configuration Setting up peripherals ➔ ➔ User accounts Connecting to an EMR system ➔ ➔ Making settings for measuring Factory settings mode ➔ ➔ Managing system components...
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The list of user accounts is displayed. 5. Press your user account. Your user account is displayed in the input field. 6. Press the input field. 7. Enter your password using the keypad The administrator area is displayed. 136 • seca mVSA 535 seca mBCA 525...
Connecting to the EMR system via • • software seca connect 103 seca 360° proximity connection: Available for seca measuring devices with an seca 452 internal interface module or external interface module (firmware version Q2_2020_Build_615 or higher) Overview of access rights •...
► Select a password to satisfy your institution's security requirements. 7. Enter the password again. The login window is displayed. 8. Activate the User user account ➔ Assigning a password to the User user account. 138 • seca mVSA 535 seca mBCA 525...
6. Press the Save button. The password has been saved. 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. User accounts • 139...
➔ Deleting user accounts Setting up user accounts User accounts can be created only in the seca analytics 115 PC software. To make new user accounts available on the device, it must be synchronized with the PC software ➔ Activating automatic synchronization.
► 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 EMR systems). seca Service will be pleased to assist if you have any questions relating to interface configuration.
► 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.
English 3. Specify the regional settings by pressing the relevant input field: ► Select system language ► Select decimal separator ► Enter date ► Select date format ► Enter time ► Select time format ► Select naming convention ► Activate/deactivate name separator The measuring mat –...
1. Press the Settings tab. 2. Press the Display and volume button. 3. Press the Calibrate touchscreen button. 4. Confirm that you wish to proceed. The calibration display appears: 5. Press the symbol. The symbol changes position. 144 • seca mVSA 535 seca mBCA 525...
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English 6. Press the symbol again. The symbol changes its position again. 7. Repeat step 6. until you get a request to confirm calibration. 8. Confirm calibration. The touchscreen display is calibrated. NOTE If calibration is not confirmed, the procedure re-starts after a few seconds.
► Unit for weight ► Unit for height ► Unit for temperature ► Unit for blood pressure NOTE Settings you make in this tab are active directly. You do not need to save or confirm them. 146 • seca mVSA 535 seca mBCA 525...
English 3.5 Deactivating analysis modules 1. Press the Settings tab. 2. Press the Analysis modules button. All analysis modules are activated at the factory. 3. Press the checkboxes of all the analysis modules you would like to deactivate. The deactivated analysis modules are no longer displayed in the analysis ➔...
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...
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Results from multiple measurements cannot be transmitted to EMR systems or the PC software. seca analytics 115 ► Specify Single measurement as a preset if blood pressure values are to be transmitted to an EMR system or the seca analytics 115 PC software.
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Configuring multiple measurement NOTE Settings you make here cannot be changed by the user. 1. Press the Settings tab. 2. Press the Vital signs button. 3. Press the NIBP button. The presets are displayed. 150 • seca mVSA 535 seca mBCA 525...
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English 4. Press the button. The Configure multiple measurement dialog window appears: 5. Specify the number of part-measurements: • Maximum six part-measurements • Deactivated part measurements at the start and during the measuring sequence are performed but not used for forming the mean value •...
The measuring profile is saved. The name of the measuring profile appears in the NIBP settings dialog window instead of the text Multiple measurement. Presets for pulse rate (seca 1. Press the Settings tab. measuring equipment only) 2. Press the Vital signs button.
English 3. Press the PR button. 4. Press the desired measuring mode (seca measuring equipment only): seca measuring equipment Mode Measuring range Motion tolerance Standard High 0 - 240 min Sensitive 20 - 300 min 5. Press the Confirm button.
Motion tolerance Stable High Normal Normal Sensitive 5. Press the Confirm button. The dialog window closes. The modified settings are adopted. Presets for temperature 1. Press the Settings tab. (COVIDIEN FILAC 3000 only) 154 • seca mVSA 535 seca mBCA 525...
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English 2. Press the Vital signs button. 3. Ensure that the temperature probe is pushed into the probe holder completely. 4. Press the TEMP field. The presets are displayed (in this case: COVIDIEN FILAC 3000 blue): 5. Press the desired measurement method. •...
4. Select a color mode. • Standard • Color, day • Color, night 5. Log off. 6. Press the Vital signs tab. The Vital signs tab is displayed in the selected color mode. 156 • seca mVSA 535 seca mBCA 525...
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) ➔ Data export and backup ➔...
This function allows you to update the software of the device. Current software packages can be found at www.seca.com. NOTICE! Data loss ► Export seca patient files and user accounts manually before updat- ing the software (for operation without seca analytics 115 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.
4.4 Retrofitting the SmartBucket ( only) seca mBCA 525 medical Body Composition Analyzer from serial number seca mBCA 525 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.
English 4.5 Retrofitting the measuring mat ( only) seca mVSA 535 NOTICE! Malfunction If your device is connected to an EMR system, the Measure bioimpedance function cannot be used. ► Do not retrofit a measuring mat. ► Ensure that the Measuring mat active checkbox is deactivated.
4.6 Retrofitting the in-ear thermometer ( only) seca mVSA 535 without temperature measurement can be retrofitted with seca mVSA 535 ® 3 in-ear thermometer ➔ the COVIDIEN GENIUS Optional accessories and spare parts. 1. Connect the in-ear thermometer as described in the section entitled ➔...
Exporting patient and user data manually ➔ Restoring patient and user data manually Exporting patient and user data This function allows you to export seca patient files and user accounts in manually order to create a backup copy, for example. 1. Press the System tab.
115 (operation 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.
English 4.8 Power management You can specify from which battery charge status (in %) the device shuts down and switches off. 1. Press the System tab. 2. Press the Power management button. The current setting is displayed (default setting: 50 %). 3.
Setting up a LAN connection to the network (stationary operation) ➔ Setting up a WiFi connection (mobile operation) ➔ Setting up a connection to the seca analytics 115 PC software ➔ Setting up a connection to the seca connect 103 software ➔...
► 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 connection to the seca analytics 115 PC software Setting up peripherals • 167...
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► 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 168 • seca mVSA 535 seca mBCA 525...
11. You have the following options for continuing: ► ➔ Setting up a connection to the seca analytics 115 PC software ► ➔ Setting up a connection to the seca connect 103 software Deactivating the LAN connection 1.
531 Measuring mat Infrared WiFi WiFi seca mBCA 525/ seca mVSA 535 Server/Stand-Alone-PC WiFi-Router Monitor For devices with bioimpedance measurement: If you integrate the device in your network via WiFi, the measuring mat can only communicate with the monitor via the infrared interface.
English Activating the WiFi connection 1. Ensure that the measuring mat – if present – is correctly suspended in the magnetic catch of the monitor. 2. Press the Peripherals tab. 3. Make sure that the LAN connection to the network is not active ➔...
The device is connected to your network via WiFi. 10. You have the following options for continuing: ► ➔ Setting up a connection to the seca analytics 115 PC software ► ➔ Setting up a connection to the seca connect 103 software Deactivating the WiFi connection 1.
English 5.3 Setting up a 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 Introduction...
English 3. In the Connect Mode drop-down menu, select the option seca analytics 115 TCP. The recommended presets are displayed. 4. Adapt the presets if necessary. 5. In the Connect Server IP line, enter the appropriate IP address. Configuration IP address...
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1. Press the Peripherals tab. 2. Press the seca connect button. 3. In the Connect Mode drop-down menu, select the option seca analytics 115 TCP or seca analytics 115 UDP. 4. Press the button to reach the seca analytics 115 configuration page.
2. Press the Peripherals tab. 3. Press the seca connect button. 4. In the Connect Mode drop-down menu, select the option seca analytics 115 TCP or seca analytics 115 UDP. 5. Press the button. The seca analytics 115 configuration page is displayed.
115 manually. • Note the user documentation for the EMR system used. • seca Service will be pleased to assist if you have any questions relating to interface configuration. 5.4 Setting up a seca 360° proximity connection Use a connection to adopt measured values from com- seca 360°...
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English 1. Press the Peripherals tab. 2. Press the button. seca 360° proximity The seca 360° proximity dialog window opens 3. Search for available devices: ► Press the button: Search for devices on the network ► Press the button: Enter the IP address of a device Available devices are displayed.
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The device is shown blue in the list. The connection is set up. In measuring mode, the seca measuring device is reserved as soon as a patient file is called up. The device is released again once the measure- ment is stopped ➔...
535 seca mBCA 525 . You can submit the parameters height and weight directly to the device and adopt them in a seca patient file. On the seca mVSA 535 , the values also appear in the Vital signs tab.
360° wireless 4. To deactivate the module, press the Send/receive seca 360° wireless on checkbox again. Setting up a seca 360° wireless 1. Ensure that the modules of the seca 360° wireless seca mVSA 535 connection and of all devices you want to connect to the seca mBCA 525 are activated.
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English 4. Press the button. seca 360° wireless 5. Press the Set up button. 6. Press one of the three wireless groups. The device searches for devices which are switched seca 360° wireless The device will suggest three wireless channels.
6. CONNECTING TO AN EMR SYSTEM ➔ Information about user and patient data ➔ Assigning a clear device name ➔ Setting up a connection to the seca connect 103 software ➔ Configuring data transfer to the EMR system ➔ Use of certificates ➔...
English 6.2 Assigning a clear device name For the device to be connected to an EMR system, it needs to be assigned a clear device name. Under this device name, the device transmits a heartbeat to the network every 30 seconds. To assign a device name, proceed as follows: 1.
6.3 Setting up a connection to the seca connect 103 software ➔ Setting up a seca 360° proximity connection ➔ Making workflow settings The device must be connected to the software in order to seca connect 103 be able to communicate with your EMR system.
• Enter an organization ID – to assign the device to a department in your institution, for example 1. Press the Peripherals tab. 2. Press the seca connect button. 3. Ensure that in the Connect Mode drop-down menu the option is selected.
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4. Press the button. The seca connect 103: Workflow page is displayed. 5. Specify the settings for the scan sequence for user and patient ID: ► Sequence for ID scan fixed: 1. User, 2. Patient ► Sequence for ID scan flexible 6.
English 6.4 Configuring data transfer to the EMR system seca recommends performing the data transfer to the EMR system only in collaboration with seca Service and the manufacturer of your EMR system. NOTE More information on this can be found in the...
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 Comma Energy: Reference resting energy FAO/WHO/UNU expenditure: Connection data None 190 •...
Overview of factory settings). seca patient files and user accounts are deleted from the device in 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.
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.
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. 7.5 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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