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

Vital signs analyzer
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seca mVSA 535
Instructions for Use
Software version 2.1 from Build 1522
Art. no.: 17-10-05-395-002b_2022_09B

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Summary of Contents for Seca mVSA 535

  • Page 1 535 Instructions for Use Software version 2.1 from Build 1522 Art. no.: 17-10-05-395-002b_2022_09B...

  • Page 2: Table Of Contents

    Logging in......35 seca patient files ..... . . 7 Logging out/switching user.
  • Page 3 Submitting the measurement directly to the 14. Compatible seca products ....116 EMR system ......84 Saving measurement temporarily and 15.
  • Page 4 6.6 Summary: Device behavior when connected to seca mVSA 535 ......119 an EMR system ..... . . 161 1.

  • Page 5: Instructions For Use For Seca Mvsa 535 • 5

    Indicates areas on the display which require particular attention Indicates directions in overview graphics Correct handling method Correct handling result Incorrect handling method Incorrect handling result Instructions for use for seca mVSA 535 • 5...

  • Page 6: Description Of Device

    ➔ Functional description ➔ User qualification ➔ Contraindications 2.1 Intended use for seca mVSA 535 The medical Vital Signs Analyzer is used in inpatient facilities seca mVSA 535 (hospitals, medical practices and care facilities) in accordance with national regulations. The medical Vital Signs Analyzer is used for non-invasive, seca mVSA 535...

  • Page 7: Device Components

    In stand-alone mode, measured results are managed in seca patient files. seca patient files can be set up, edited, exported and deleted directly on the device. Patient data from EMR systems...

  • Page 8: Data Transmission And Network Functions

    • Connection of the device to the software available as seca connect 103 an option: Using the user and patient data of an EMR system and submitting measured results to the EMR system •...

  • Page 9: Safety Precautions

    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.

  • Page 10: Handling A Wheeled Stand

    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.

  • Page 11: Handling A Wall Bracket

    ► The wall bracket and the adapter plate must only be fitted by ade- quately qualified individuals (e.g. specialist dealers, hospital techni- cians or seca Service). ► The wall bracket and the adapter plate must be fitted in line with the relevant assembly instructions.

  • Page 12: Preventing Damage To Device

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

  • Page 13: Handling Packaging Material

    ► If you do not use the device for a long period of time, remove the (rechargeable) batteries. This prevents acid from leaking into the device. ► If acid leaked into the device, discontinue use. Have the device checked by an authorised seca service partner and repaired if necessary. Safety precautions • 13...

  • Page 14: Device Overview

    4. DEVICE OVERVIEW ➔ Monitor controls for seca mVSA 535 ➔ In-ear thermometer controls ➔ Fields in the touchscreen display ➔ Login/navigation: Keys and symbols in the touchscreen display ➔ Operating state: Symbols ➔ Measuring: Keys and symbols ➔ Unsubmitted measurements list: Symbols ➔...

  • Page 15: Monitor Controls For Seca Mvsa 535

    English 4.1 Monitor controls for seca mVSA 535 NOTE This section shows product versions. The functional scope of your device may deviate from this. Controls Function Handle Transporting the device Touchscreen display Central control/display element LED white: Device on ON/OFF key with LED...

  • Page 16: In-Ear Thermometer Controls

    For SpO sensor 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 Power supply connection For connecting the power supply cable...

  • Page 17: Fields In The Touchscreen Display

    English 4.3 Fields in the touchscreen display Login/logout Status/error field messages Side navigation Tab contents Battery charge status/ connection status Bottom navigation bar 4.4 Login/navigation: Keys and symbols in the touchscreen display Key/symbol Meaning Patient tab Vital signs tab Clinical observations tab Analysis tab Open instructions for use Instructions for use: Return to section...

  • Page 18: Operating State: Symbols

    Symbol Operating state Monitor: Controls permanently on: Rechargeable battery charge status (%) Controls flashing: Rechargeable battery charging Monitor: Controls permanently on: Rechargeable battery full Controls flashing consecutively: Rechargeable battery charging Monitor: Rechargeable battery discharged 18 • seca mVSA 535...
  • Page 19 English Symbol Operating state LAN connection set up: on/off WiFi connection set up: on/off ()EMR: seca connect 103 connection active (EMR): seca connect 103 connection interrupted Pop-up window: Information for the user Pop-up window: Error message Pop-up window: Setting option for the user...

  • Page 20: Measuring: Keys And Symbols

    Search for seca patient file Switch sorting direction Edit seca patient file Export seca patient file Delete seca patient file Adopt value from previous measurement Close seca patient file, changes will not be saved Vital signs tab Key/symbol Meaning NIBP...
  • Page 21 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 Write comment Call up list of unsubmitted measurements Adopt value from previous measurement Save measurement Discard measurement Device overview •...

  • Page 22: Clinical Observations Tab

    Detail view available for analysis parameter: Percentile curve Blue marking: Mean value 4.7 Unsubmitted measurements list: Symbols Key/symbol Meaning Clinical observations Weight (W) Height (H) Body mass index (BMI) Pulse rate (PR) Blood pressure (NIBP) Oxygen saturation (SpO Temperature (Temp) 22 • seca mVSA 535...

  • Page 23: Markings On The Device And On The Type Plate

    English Key/symbol Meaning Blue marking: Mean value Yellow marking (when connected to EMR system): Unconfirmed offline measurement 4.8 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 ProdID Product identification number, consecutive Variant number...
  • Page 24 A • 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 24 • seca mVSA 535...

  • Page 25: Markings On The Blood Pressure Cuff

    English 4.9 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 26: Markings On The Packaging

    Small parts present a danger of suffocation if swallowed. Keep out of sunlight Only use indoors Non-ionizing radiation DEHP-free Latex-free Not resistant to magnetic resonance Do not use if packaging damaged Lot number Person with authority in the EU 26 • seca mVSA 535...

  • Page 27: Starting Up The Device

    5.1 Scope of delivery NOTE This section shows version 535-1110-001 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 Standard scope of delivery Pcs.

  • Page 28: Setting Up Device

    ➔ Connecting the blood pressure cuff ➔ Connecting the temperature probe ➔ Connecting the in-ear thermometer ➔ Connecting the seca SpO sensor ® ➔ Connecting the Masimo SET sensor NOTE This section shows how to assemble all of the measuring accessories available for this device.

  • Page 29: Connecting The Blood Pressure Cuff

    English Connecting the blood pressure cuff 1. Variant-dependent: Connect the tube coupling for the blood pressure cuff to the connector of the extension tube until you hear the tube coupling engage. Click! => => 2. Connect the tube coupling for the extension tube to the compressed air connection of the device until you hear the tube coupling engage.

  • Page 30: Connecting The In-Ear Thermometer

    SmartBucket until you feel the connector engage. NOTE The magazine holder in the thermometer compartment provides space for two probe cover magazines. 2. Place the in-ear thermometer in the thermometer compartment as shown in the illustration below. Press! => 30 • seca mVSA 535...

  • Page 31: Connecting The Seca Spo Sensor

    English 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 ➔...

  • Page 32: Establishing A Power Supply

    The LED of the ON/OFF key goes off. 5.5 Setting the date and time When you start up the device for the first time, you first need to set date and time. 1. Connect the device to the power supply. 32 • seca mVSA 535...

  • Page 33: Initial Login

    ► Perform measurements using the power supply: ➔ Operation ► Configure device using the power supply: ➔ For administrators: Configuring seca mVSA 535 5.6 Initial login The following user accounts are available on the device initially: • admin: Configure and manage device •...

  • Page 34: Configuration Options

    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 34 • seca mVSA 535...

  • Page 35: Operation

    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 • Analyze measured results • Manage the system Operation • 35...

  • Page 36: Logging Out/Switching User

    4. Press the input field. 5. Enter your password using the keypad The Patient tab is displayed. 6. Continue with ➔ Managing seca patient files. Logging out/switching user ► Press the Logout key. You will be logged out. The login window is displayed.

  • Page 37: Saving Power/Switching Off

    English Saving power/switching off 1. Briefly press the ON/OFF key of the monitor. 2. The Save energy dialog window appears. 3. Select an option in accordance with the table: NOTE The device automatically switches to standby/shuts down if it is not used for an extended period (phased by idle time) Idle time key Device behavior...

  • Page 38: Managing Seca Patient Files

    6.2 Managing seca patient files ➔ Creating a seca patient file ➔ Calling up a seca patient file ➔ Editing a seca patient file ➔ Exporting a seca patient file ➔ Deleting a seca patient file Creating a seca patient file 1.
  • Page 39 If you do not edit the ID input field, the device saves the automatically-generated patient ID. 8. Press the Save key. The seca patient file has been created and is displayed. You have the following options for continuing: ► Measure vital signs: ➔...

  • Page 40: Calling Up A Seca Patient File

    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...

  • Page 41: Exporting A Seca Patient File

    English 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 key. A confirmation dialog opens. 4. Press the Confirm key.

  • Page 42: Measuring Vital Signs

    Alternatively, a patient’s vital signs can also be entered manually ➔ Entering vital signs manually. Weight and height can be recorded by compatible seca measuring devices or entered manually: ➔ Adding weight and height. 42 •...

  • Page 43: Measuring Blood Pressure

    English Measuring blood pressure ➔ Preparing the blood pressure measurement ➔ Starting a single measurement ➔ Performing a multiple measurement ➔ Modifying presets WARNING! Hazard to patient ► Do not use luer lock adapter on the blood pressure measurement tubes. The use of luer lock adapters can lead to accidental connec- tion of the blood pressure tubes to intravenous lines and thus lead to an infusion of air into the bloodstream of the patient.
  • Page 44 ► 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 45 English 2. Apply the blood pressure cuff to the patient’s non-dominant arm as shown in the illustration below: a) Note the labeling on the blood pressure cuff ➔ Markings on the blood pressure cuff b) Use correct size of blood pressure cuff: End of cuff inside the adjustment range when put on c) Position the blood pressure cuff at the level of the right atrium d) Ensure correct fit of the blood pressure cuff...
  • Page 46 (re-pumping: Increasing cuff pressure by approx. 50 mmHg followed by incremental releasing of that pressure). If no measured value is delivered even after several re-pumping steps, the proce- dure is canceled. 46 • seca mVSA 535...
  • Page 47 English Performing a multiple measurement 1. Press the key on the monitor. The first part-measurement starts (here: 6 part-measurements). Current cuff pressure is displayed. The symbols for measurement method and measuring mode flash (here: Upward measurement). The part-measurement stops automatically as soon as valid blood pressure values are detected.
  • Page 48 5. Press the Confirm key. The dialog window closes. Changed settings are adopted for the current measurement. 6. Start the blood pressure measurement as described in the section entitled ➔ Preparing the blood pressure measurement. 48 • seca mVSA 535...

  • Page 49: Measuring Temperature, Oral/Axillary (Covidien Tm Filac Tm 3000, Blue)

    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. ►...
  • Page 50 Predictive) flash until a valid measured value is obtained. The temperature value is displayed until you stop the measurement ➔ Stopping a measurement. 4. Discard the probe cover and dispose of it in line with your institution’s policy. Press! 50 • seca mVSA 535...
  • Page 51 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: ►...

  • Page 52: Measuring Temperature, Rectal (Covidien Tm Filac Tm 3000 Red)

    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. 52 • seca mVSA 535...
  • Page 53 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.
  • Page 54 3. Press the desired measurement method. • Predictive • Direct 4. Press the Confirm key. 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. 54 • seca mVSA 535...

  • Page 55: Measuring In-Ear Temperature (Covidien Tm Genius ® 3)

    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. ►...
  • Page 56 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 key to switch on the in-ear thermometer. 56 • seca mVSA 535...
  • Page 57 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...

  • Page 58: Reading Off Pulse Rate

    Stopping a measurement Reading off pulse rate ➔ Interrogating 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 59 English Modifying presets (seca measuring equipment only) NOTE These settings apply to the current measurement procedure. If you stop the measurement ➔ Stopping a measurement, the presets defined by the administrator become active again. 1. Ensure that neither the blood pressure cuff nor the SpO sensor are applied.

  • Page 60: Measuring Oxygen Saturation (Spo )

    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 60 • seca mVSA 535...
  • Page 61 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 • 61...
  • Page 62 ► Replace the cable or sensor when a replace sensor or when a low 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. 62 • seca mVSA 535...
  • Page 63 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"...

  • Page 64: Weight And Height

    ➔ Adding weight and height. Adding a comment In stand-alone mode, you have the option of adding a comment to every measurement. 1. Press the key. 2. Enter the comment. 3. ➔ Stopping a measurement 64 • seca mVSA 535...

  • Page 65: Stopping A Measurement

    ► Stop the current measurement before you start a new one. You have the following options: ► Press the key: Save measurement ► Assign anonymous measurement to a seca patient file: ➔ Assigning anonymous measurement to a seca patient file ► Press the...

  • Page 66: Adding Weight And Height

    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: ➔...

  • Page 67: Entering Weight And Height Manually

    3. Submit the measured values as described in the instructions for use for the measuring device. The values appear on in the Weight and Height fields seca mVSA 535 (here: Vital signs tab): You have the following options for continuing: ► Measure more vital signs ➔...

  • Page 68: Entering Vital Signs Manually

    1. Measure blood pressure as described in the instructions for use for your blood pressure measuring device. 2. Call up a patient file ➔ Calling up a seca patient file. 3. In the Vital signs tab, keep the NIBP field depressed for at least three...

  • Page 69: Entering Temperature Manually

    1. Measure body temperature as described in the instructions for use for your thermometer. 2. Call up a patient file ➔ Calling up a seca patient file. 3. In the Vital signs tab, keep the TEMP field depressed for at least three...

  • Page 70: Entering Pulse Rate Manually

    1. Measure pulse rate as described in the instructions for use for your pulse rate measuring device. 2. Call up a patient file ➔ Calling up a seca patient file. 3. In the Vital signs tab, keep the PR field depressed for at least three seconds: 70 •...

  • Page 71: Entering Oxygen Saturation Manually

    1. Measure oxygen saturation as described in the instructions for use for your oxygen saturation measuring device. 2. Call up a patient file ➔ Calling up a seca patient file. 3. In the Vital signs tab, keep the SpO field depressed for at least three seconds: Operation •...
  • Page 72 You have the following options for continuing: ► Measure more vital signs ➔ Measuring vital signs ► Enter more vital signs manually ➔ Entering vital signs manually ► Stop the measurement ➔ Stopping a measurement 72 • seca mVSA 535...

  • Page 73: Analyzing Measurement

    Analyzing vital signs (history) NOTE • In order to be able to view analyses, you must assign the current measurement to a seca patient file ➔ Stopping a measurement call up a seca patient file ➔ Calling up a seca patient file.

  • Page 74: Analyzing Vital Signs (History)

    Return to the previous view NOTE Just a single comment can be added to each measured result. Existing comments will be overwritten. 3. Press the checkboxes for all the measurements you want to look at in the history. 74 • seca mVSA 535...
  • Page 75 English 4. Press the key. The history is displayed (in this case three measurements) You have the following navigation options: ► Press the key: Select other values for history ► Press the keys: View more analysis parameters ► Press the key: Return to the previous view Operation •...

  • Page 76: Operation When Connected To An Emr System

    3. Wait until the Vital signs tab is displayed: You have the following options for continuing: ► ➔ Measuring with an active connection to an EMR system ► ➔ Measuring with an interrupted connection to an EMR system 76 • seca mVSA 535...

  • Page 77: Measuring

    English 7.2 Measuring ➔ Measuring with an active connection to an EMR system ➔ Measuring with an interrupted connection to an EMR system Measuring with an active connection to an EMR system If the device has an active connection to the EMR system, proceed as described in the following sections: 1.
  • Page 78 The measurement is saved in the Unsubmitted measurements list. 4. Log in again when the connection to the EMR system is active again. 5. Proceed as described in this section: ➔ Using the Unsubmitted measurements list. 78 • seca mVSA 535...

  • Page 79: Logging In With Emr System User Id

    English 7.3 Logging in with EMR system user ID If the device is connected to your EMR system, you must log in to the device using your EMR system user ID. You have the following options: ➔ Scanning EMR system user ID (recommended) ➔...

  • Page 80: Calling Up Patient Data From The Emr System

    ID. The two search functions (patient name and patient ID) are not available simultaneously. This is set in the software. For more infor- seca connect 103 mation, contact your administrator ➔ Information about user and patient data.
  • Page 81 English • Enter at least the first letter of the name. Refine your search if neces- sary by entering more letters or the whole name. c) Press the key: Confirm entry A hit list is displayed (example): 4. Use the scroll bar if necessary to display more patient data. 5.

  • Page 82: Scanning Patient Id

    We recommend scanning the patient ID (➔ Scanning patient ID). If you logged in using a keypad (➔ Entering EMR system user ID manually), the Patient tab is shown after login: 1. Press the Find patient file key. 82 • seca mVSA 535...
  • Page 83 English 2. Enter patient ID using the keypad The patient data are shown in the Patient information dialog window. 3. Ensure that the patient data displayed are correct. 4. Press the key. The patient data are transmitted to the device and displayed in the Vital signs tab.

  • Page 84: Saving Measurements In The Emr System

    The measurement is assigned to the patient ID and saved temporarily on the device. The measurement procedure is complete. The measurement can be assessed in the Unsubmitted measurements list and submitted to the EMR system ➔ Using the Unsubmitted measurements list. 84 • seca mVSA 535...

  • Page 85: Using The Unsubmitted Measurements List

    English Using the Unsubmitted ➔ measurements list Confirming offline measurement (EMR system connection) ➔ Viewing details ➔ Submitting the measurement ➔ Deleting a measurement In the Unsubmitted measurements list, you can view and assess the details of a measurement before submitting the measurement to the EMR system.
  • Page 86 3. Ensure that the patient data displayed are correct. 4. Press the key. The measurement is confirmed. The yellow marking is no longer displayed in the Unsubmitted measurements list. The details of the measurement are displayed ➔ Viewing details. 86 • seca mVSA 535...
  • Page 87 English Viewing details 1. Press a measurement. The details of the measurement are displayed: NOTE Measurements marked blue contain mean values. If you press the measurement, you can view the individual results. 2. Press the key to close Detail view. Submitting the measurement 1.
  • Page 88 Deleting a measurement 1. Press the checkboxes of the measurements to be deleted: 2. Press the key. The selected measurements are deleted. 88 • seca mVSA 535...

  • Page 89: Recording Clinical Observations

    You can enter clinical observations without login and without patient identifi- cation. We recommend calling up a patient file ➔ Calling up a seca patient file before making your entry. Clinical observations can be submitted to the EMR system together with other vital signs in the Vital signs tab.
  • Page 90 3. Press the parameter for which you would like to enter or amend an observation. You have the following options for input depending on configuration: ► Enter free text (example): ► Enter a numerical value (example): ► Select a value from the option field (example): 90 • seca mVSA 535...
  • Page 91 English 4. Enter the observation. You have the following options for continuing: ► Enter more observations ➔ Recording clinical observations ► Press the key: Adopt observations ► Press the key: Delete observations ► Submit all observations to the EMR system: ➔ Saving measurements in the EMR system Operation when connected to an EMR system •...

  • Page 92: Hygiene Treatment

    ► Do not use caustic or abrasive detergents. ► Do not use organic solvents (e.g. white spirit or petroleum spirit). ► Use disinfectants including the active ingredient 70 % isopropanol only for measuring accessories for measuring vital signs. 92 • seca mVSA 535...

  • Page 93: Cleaning

    1. Remove all the measuring accessories (measuring devices and consumables) from the device (depending on version) • ➔ : Monitor with Removing the probe holder seca mVSA 535 As required SmartBucket • ➔ Removing the magazine holder 2. Moisten a soft cloth with a soap solution 3.

  • Page 94: Disinfecting

    1. Remove all the measuring accessories (measuring devices and consumables) from the device (depending on version): • ➔ Removing the probe holder : Monitor with seca mVSA 535 As required • ➔ Removing the magazine holder SmartBucket 2. Moisten a soft cloth with disinfectant (active ingredient: quaternary ammonium compounds) 3.

  • Page 95: Removing/Fitting Probe Holder (Devices With Temperature Probe)

    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.

  • Page 96: Removing/Fitting The Magazine Holder (Devices With In-Ear Thermometer)

    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! 96 • seca mVSA 535...

  • Page 97: Function Check

    “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.

  • Page 98: Covidien Tm Genius

    Incorrect measurements as a result of poor servicing ► Have servicing and repairs carried out exclusively by seca Service or by an authorized service partner. ► You can find service partners in your area at www.seca.com or by sending an e-mail to service@seca.com. 10.2 COVIDIEN...

  • Page 99: Troubleshooting

    English 11.TROUBLESHOOTING ➔ Monitor ➔ Vital signs measurement ➔ Network connection ➔ EMR system connection via seca connect 103 software ➔ Clinical observations ➔ seca 360°proximity connection 11.1 Monitor Fault Cause Remedy No power supply Provide power supply Monitor cannot be...

  • Page 100: Vital Signs Measurement

    • Restart the device 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 delivery for the wheeled stand) for vital signs are •...

  • Page 101: Covidien Tm Filac Tm 3000 Temperature Measurement

    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 •...
  • Page 102 • 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 102 •...

  • Page 103: Spo 2 Measurement

    Distance between monitor and WiFi No WiFi connection • Transmit measured results to router is too big software via LAN seca connect 103 Transmit measured results to WiFi not available in your institution software via LAN seca connect 103 Administrator: Enable required ports in firewall ➔...

  • Page 104: Emr System Connection Via Seca Connect 103 Software

    11.4 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: Data transmission cannot Use a compatible version of the...

  • Page 105: Clinical Observations

    103 (default: 22020) ➔ Setting up a connec- tion to the seca connect 103 software • Follow seca 103/452 system instructions for use No measurement has yet been Perform measurement as described in the...

  • Page 106: Technical Data

    ➔ Analysis parameters ➔ Analysis modules ➔ Standards and directives 12.1 Monitor Dimensions, weights Monitor with SmartBucket ( seca mVSA 535 Dimensions, empty ( for temperature probe) seca mVSA 535 • Depth 278 mm • Width 254 mm • Height 262 mm...

  • Page 107: Monitor Interfaces And Network Ports

    English Further technical data (all models) IEC 60601-1: Insulated device, protection class: seca mVSA 535 Type of protection IP21 seca mVSA 535 Duty cycle Continious duty 2 x USB 2.0 (max 500 mA) LAN: Ethernet (10/100 Base-T) Interfaces WiFi: 2.4 GHz (WPA, WPA2 PSK,...

  • Page 108: Vital Signs Measurement

    ➔ seca SpO measurement ➔ Manual input of vital signs Blood pressure measurement seca blood pressure module • Oscillometric • Possible to switch between upward and downward measurement Measuring method • Single measurement • Multiple measurement can be config- ured: Max.

  • Page 109: Covidien Tm Filac Tm 3000 Temperature Measurement

    English seca blood pressure module Pulse rate: 45 min - 200 min • Measuring range for upward measurement • Measuring range for downward measurement 30 min - 240 min • Accuracy (under laboratory conditions, verified with CuffLink patient max. ± 3 min...

  • Page 110: Covidien Tm Genius ® 3 Temperature

    70 - 100 % for SpO compared to a laboratory CO oximeter and ECG monitor. This fluctuation corresponds to ± 1 standard deviation. Plus or minus one standard deviation covers 68 % of the population. 110 • seca mVSA 535...
  • Page 111 English ® b.The accuracy of the Masimo SET technology with Masimo sensors was validated with movement in human blood studies with induced hypoxia on healthy adult male and female volunteers with light to dark skin pigmentation, 2 to 4 Hz rubbing and tapping movements being performed at an amplitude of 1 to 2 cm and a non-repetitive movement being performed at 1 to 5 Hz at an amplitude of 2 to 3 cm in the range from 70 - 100 % for SpO compared to a laboratory CO oximeter and ECG...

  • Page 112: Seca Spo Measurement

    25 mmHg - 280 mmHg • Diastolic BP 10 mmHg - 220 mmHg Pulse rate 25 min - 240 min Temperature 32 °C - 44 °C (89,6 °F - 111,2 °F) 0 % - 100 % 112 • seca mVSA 535...

  • Page 113: Analysis Parameters

    English 12.4 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 Body mass index (BMI) Absolute in kg/m Development/growth Weight (W) Absolute in kg...

  • Page 114: Analysis Modules

    Supports the monitoring of weight changes • Height • Body mass index (BMI) • Blood pressure (NIBP) • Body temperature (TEMP) Vital signs Overview of vital signs to support a diagnosis • Pulse rate (PR) • Oxygen saturation (SpO 114 • seca mVSA 535...

  • Page 115: Standards And Directives

    Probe covers for COVIDIEN GENIUS ® 490-0016-001 22 packs, pack of 6 magazines (16 probe covers per magazine) Software: For details of application-specific licence packages seca connect 103 go to www.seca.com wheeled stand for 475-05-35-009 seca 475 seca mVSA 535 carry case 432-00-00-009 seca 432 Optional accessories and spare parts •...

  • Page 116: Compatible Seca Products

    959 Yes, with accessories (7021092) www.seca.com seca 959 seca 963 a.seca 452 external interface module (firmware version R1.3 Build 79 or higher) required b.seca 452 external interface module can only be retrofitted by authorized service technicians 116 • seca mVSA 535...

  • Page 117: Saving Measurement Temporarily And 15. Disposal

    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 118: Declaration Of Conformity

    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. 118 • seca mVSA 535...

  • Page 119: For Administrators: Configuring

    ➔ Configuration options 1.1 Administrator login 1. Switch on the device. 2. Log in as the administrator: ► Initial login: ➔ Activating initial user accounts ► Routine login: continue at step 3. For administrators: Configuring seca mVSA 535 • 119...
  • Page 120 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. 120 • seca mVSA 535...

  • Page 121: Configuration Options

    Connecting to the EMR system via the • • 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 R1.3 Build 79 or higher) Overview of access rights •...

  • Page 122: User Accounts

    ► Select a password which satisfies 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. 122 • seca mVSA 535...

  • Page 123: Assigning A Password To The "User" User Account

    5. Enter the password again. 6. Press the Save key. 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. User accounts • 123...

  • Page 124: Working With User Accounts

    ► Select a password which satisfies 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.
  • Page 125 English NOTE The display language is specified for each user individually. If no user is logged in, the user interface is displayed in the system language ➔ Making regional settings. 5. Ensure that the Password protected field is activated (default setting). 6.

  • Page 126: Making Settings For Measuring Mode

    ► Stand-alone 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 software is correct. These settings are adopted by the device. 1. Press the Settings tab. 2. Press the Regional settings key.

  • Page 127: Setting Display Brightness And Volume

    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 hyphen NOTE •...

  • Page 128: Calibrating The Touchscreen Display

    We recommend using a stylus (touchpen) for calibration. 1. Press the Settings tab. 2. Press the Display and volume key. 3. Press the Calibrate touchscreen key. 4. Confirm that you wish to proceed. The calibration display appears: 128 • seca mVSA 535...
  • Page 129 English 5. Press the symbol with a stylus. The symbol changes position. 6. Press the symbol with a stylus 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.

  • Page 130: Setting Units Of Measurement

    ► 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. 130 • seca mVSA 535...

  • Page 131: Deactivating Analysis Modules

    English 3.5 Deactivating analysis modules 1. Press the Settings tab. 2. Press the Analysis modules key. 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 ➔...

  • Page 132: Making Presets For Vital Signs Measurement

    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 133 English 2. Press the Vital signs key. 3. Press the NIBP key. The presets are displayed. 4. Press the desired measurement method. ► Upward measurement: Adapt maximum pressure if necessary ► Downward measurement: Adapt starting pressure if necessary 5. Press the desired measuring sequence. ►...
  • Page 134 Configuring multiple measurement NOTE Settings you make here cannot be changed by the user. 1. Press the Settings tab. 2. Press the Vital signs key. 3. Press the NIBP key. The presets are displayed. 134 • seca mVSA 535...
  • Page 135 English 4. Press the key. 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 to form the mean value •...

  • Page 136: Presets For Pulse Rate (Seca Measuring Equipment Only)

    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 key.

  • Page 137: Presets For Spo 2

    English 3. Press the PR key. 4. Press the desired measuring mode (seca measuring equipment only): seca measuring equipment Mode Measuring range Motion tolerance Default High 0 - 240 min Sensitive 20 - 300 min 5. Press the Confirm key.

  • Page 138: Presets For Temperature (Covidien Tm Filac Tm 3000 Only)

    SpO module Mode Motion tolerance Stable High Normal Normal Sensitive 5. Press the Confirm key. The dialog window closes. The modified settings are adopted. Presets for temperature 1. Press the Settings tab. (COVIDIEN FILAC 3000 only) 138 • seca mVSA 535...
  • Page 139 English 2. Press the Vital signs key. 3. Ensure that the temperature probe is pushed into the probe holder completely. 4. Press the TEMP field. The presets are displayed (here: COVIDIEN FILAC 3000 blue): 5. Press the desired measurement method. •...

  • Page 140: Selecting Color Mode For Vital Signs Tab

    3. Press the Color mode input field. 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. 140 • seca mVSA 535...

  • Page 141: Managing System Components

    English 4. MANAGING SYSTEM COMPONENTS ➔ Viewing system information ➔ Updating the monitor software ➔ Updating the firmware of the blood pressure module ➔ Retrofitting the in-ear thermometer ➔ Data export and backup ➔ Power management 4.1 Viewing system information 1.

  • Page 142: Updating The Monitor Software

    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 updating the software. 1. Press the System tab. 2. Press the Monitor key.

  • Page 143: Updating The Firmware Of The Blood Pressure Module

    English 4.3 Updating the firmware of the blood pressure module This function allows you to update the firmware of the blood pressure mod- ule. Current firmware packages are automatically announced in the GUI of the device. The firmware package is available for installation on the device after the monitor software has been updated (from software version 2.1) ➔...

  • Page 144: Retrofitting The In-Ear Thermometer

    4.4 Retrofitting the in-ear thermometer 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 ➔ Connecting the in-ear thermometer.

  • Page 145: Data Export And Backup

    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.

  • Page 146: Restoring Patient And User Data Manually

    ► Export seca patient files and user accounts manually before restoring older data manually. 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 key.

  • Page 147: Power Management

    English 4.6 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 key. The current setting is displayed (default setting: 50 %). 3.

  • Page 148: Setting Up Peripherals

    Setting up a LAN connection to the network (stationary operation) ➔ Setting up a WiFi connection (mobile operation) ➔ Setting up a connection to the seca connect 103 software ➔ Setting up a seca 360° proximity connection 5.1 Setting up a LAN connection to the network (stationary operation) ➔...
  • Page 149 4. Make the setting applicable to your network: ► To set up connection manually, continue at step 5. ► To set up automatic connection: Press the DHCP key and continue with ➔ Setting up a connection to the seca connect 103 software Setting up peripherals • 149...

  • Page 150: Deactivating The Lan Connection

    ➔ 7. Set up the connection to the Setting up a seca connect 103 connection to the seca connect 103 software Deactivating the LAN connection 1. Press the Peripherals tab. 150 • seca mVSA 535...
  • Page 151 English 2. Press the LAN key. 3. Press the LAN active checkbox. The LAN function is deactivated. The connection data are deleted. 4. To reactivate the LAN function, proceed as outlined below: a) Press the LAN active checkbox b) ➔ Activating the LAN connection Setting up peripherals •...

  • Page 152: Setting Up A Wifi Connection (Mobile Operation)

    103 tion of the software (server IP and connect port) is known. seca connect 103 WiFi WiFi seca mVSA 535 seca Software Monitor Server/Stand-Alone-PC WiFi-Router Activating the WiFi connection 1. Press the Peripherals tab.

  • Page 153: Deactivating The Wifi Connection

    ➔ 9. Set up the connection to the Setting up a seca connect 103 connection to the seca connect 103 software Deactivating the WiFi connection 1. Press the Peripherals tab. 2. Press the WiFi key. 3. In the WiFi mode drop-down menu, press the WiFi off setting.
  • Page 154 4. Press the key to confirm your entry. The WiFi function is deactivated. The connection data are deleted. 154 • seca mVSA 535...

  • Page 155: Setting Up A Seca 360° Proximity Connection

    (in each case firmware version R1.3 Build 79 or higher). • The seca measuring device is connected to your LAN or WiFi network. • The seca measuring device is configured as follows: –...
  • Page 156 2. Press the key. seca 360° proximity The seca 360° proximity (seca 360° proximity) dialog window opens 3. Search for available devices: ► Press the key: Search for devices on the network ► Press the key: Enter the IP address of a device ►...
  • Page 157 The device is marked 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 ➔...

  • Page 158: Connecting To An Emr System

    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 ➔...

  • Page 159: Assigning A Clear Device Name

    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. The device transmits a heartbeat to the network under this device name every 30 seconds. To assign a device name, proceed as follows: 1.

  • Page 160: Setting Up A Connection To The Seca Connect 103 Software

    • The EMR system is connected to the software. In- seca connect 103 formation on this can be found in the seca 103/452 system instructions for use (from version 2.0 or higher) NOTE • Follow the information in this section of the document ➔...

  • Page 161: Configuring Data Transfer To The Emr System

    The settings are saved. The connection is set up. 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 seca 103/452 system instructions for use (from version 2.0 or higher).

  • Page 162: Clinical Observations

    EMR system. The configuration file is not part of the scope of delivery. You create the con- figuration file for the overall integration solution in consultation with seca Ser- vice. If you wish to use this function, please contact seca Service.

  • Page 163: Loading The Configuration File Onto The Device And Updating It

    The configuration file for clinical observations is loaded onto the device via the connection to the software. Further information is available seca connect 103 in the seca 103/452 system instructions for use. The configuration can be changed by loading another configuration file onto the device. NOTE •...

  • Page 164: Factory Settings

    Unit °C COVIDIEN FILAC 3000 Oral measurement, predictive Blue measurement Predictive measurement Pulse rate: Unit Preset (seca measuring equipment only) Default Oxygen saturation: Unit Mode Normal Decimal separator: International Comma Connection data None WiFi client (device <-> network): Connection data...

  • Page 165: Resetting The Device

    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 166: Exporting The System Log/Audit Trail

    Overview of factory settings). seca patient files and user accounts will be retained. 8.4 Exporting the system log/audit trail This function allows you to export the system log/audit trail and make it available to seca Service for support purposes, for example.

  • Page 167: Enabling Vnc Access

    English 8.5 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. The require- ment is that a VNC viewer is installed on the PC. NOTE This function is intended purely for demonstration purposes.

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