Seca mBCA 525 Instructions For Use Manual Download Page 2

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Instructions for use for seca mVSA 535/

seca mBCA 525 . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1. About this document . . . . . . . . . . . . . . . . . . . . . . . . 5
2. Description of device . . . . . . . . . . . . . . . . . . . . . . . 6

2.1 Intended use for the seca mVSA 535. . . . . . . . .   6
2.2 Intended use for the seca mBCA 525  . . . . . . . .   6
2.3 Description of function . . . . . . . . . . . . . . . . . . . .   7

2.4 User qualification . . . . . . . . . . . . . . . . . . . . . . . 10

Administration/network connection . . . . . . . 10
Measuring mode . . . . . . . . . . . . . . . . . . . . . 10

2.5 Contraindications. . . . . . . . . . . . . . . . . . . . . . . 10

3. Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . 11

3.1 Safety precautions in these instructions for

use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

3.2 Basic safety precautions . . . . . . . . . . . . . . . . . 11

4. Device overview . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

4.1 Monitor controls for seca mVSA 535/

seca mBCA 525 . . . . . . . . . . . . . . . . . . . . . . . 16

4.2 In-ear thermometer controls. . . . . . . . . . . . . . . 18
4.3 Measuring mat controls (bioimpedance

analysis). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

4.4 Fields in the touchscreen display . . . . . . . . . . . 20
4.5 Login/navigation: Buttons and symbols in the

touchscreen display. . . . . . . . . . . . . . . . . . . . . 20

4.6 Operating state: Symbols. . . . . . . . . . . . . . . . . 21

Operating state: Symbols in the touchscreen
display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Operating state: Symbols on the measuring
mat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

4.7 Measuring: Buttons and symbols. . . . . . . . . . . 23

Patient tab  . . . . . . . . . . . . . . . . . . . . . . . . . .   23
Vital signs tab   . . . . . . . . . . . . . . . . . . . . . . .   24
BIA tab   . . . . . . . . . . . . . . . . . . . . . . . . . . . .   25
Measuring mat . . . . . . . . . . . . . . . . . . . . . . .   26
Analysis tab  . . . . . . . . . . . . . . . . . . . . . . . . .   26

4.8 Unsubmitted measurements list: Symbols . . . . 27
4.9 Markings on the device and on the type

plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

4.10 Markings on the blood pressure cuff  . . . . . . .   30
4.11 Markings on the packaging . . . . . . . . . . . . . .   31
4.12 Other symbols . . . . . . . . . . . . . . . . . . . . . . . .   31

5. Starting up the device . . . . . . . . . . . . . . . . . . . . . . 32

5.1 Scope of delivery . . . . . . . . . . . . . . . . . . . . . . . 32
5.2 Setting up device. . . . . . . . . . . . . . . . . . . . . . . 33

Connecting the SmartBucket . . . . . . . . . . . .   33
Connecting the blood pressure cuff  . . . . . . .   34
Connecting the temperature probe   . . . . . . .   34
Connecting the in-ear thermometer  . . . . . . .   35
Connecting the seca SpO

sensor . . . . . . . . 35

Connecting the Masimo SET

SpO

sensor . . . . . . . . . . . . . . . . . . . . . . . . 36

Suspending the measuring mat in the
magnetic catch . . . . . . . . . . . . . . . . . . . . . . 37

5.3 Establishing a power supply. . . . . . . . . . . . . . .   38
5.4 Charging rechargeable batteries  . . . . . . . . . . .   38
5.5 Setting the date and time. . . . . . . . . . . . . . . . .   39
5.6 Initial login . . . . . . . . . . . . . . . . . . . . . . . . . . . .   40
5.7 Configuration options. . . . . . . . . . . . . . . . . . . .   40

6. Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

6.1 Switching the system on/off. . . . . . . . . . . . . . . 41

Switching on  . . . . . . . . . . . . . . . . . . . . . . . .   41
Logging in  . . . . . . . . . . . . . . . . . . . . . . . . . .   42
Logging out/switching user  . . . . . . . . . . . . .   43
Saving power/switching off   . . . . . . . . . . . . .   43

6.2 Managing seca patient files . . . . . . . . . . . . . . . 44

Creating a seca patient file . . . . . . . . . . . . . .   44
Calling up a seca patient file   . . . . . . . . . . . .   47
Editing a seca patient file  . . . . . . . . . . . . . . .   47
Exporting a seca patient file  . . . . . . . . . . . . .   48
Deleting a seca patient file  . . . . . . . . . . . . . .   48

6.3 Measuring vital signs . . . . . . . . . . . . . . . . . . . . 49

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 49
Measuring blood pressure . . . . . . . . . . . . . . 50
Measuring temperature, oral/axillary
(COVIDIEN

FILAC

3000, blue) . . . . . . . 55

Measuring temperature, rectal
(COVIDIEN

FILAC

3000 red) . . . . . . . . 58

Measuring in-ear temperature
(COVIDIEN

GENIUS

3) . . . . . . . . . . . . . . 61

Entering temperature manually . . . . . . . . . . 65
Reading off pulse rate . . . . . . . . . . . . . . . . . 66
Measuring oxygen saturation (SpO

) . . . . . . 68

Weight and height  . . . . . . . . . . . . . . . . . . . .   72
Stopping a measurement procedure  . . . . . .   73
Assigning anonymous measurement
procedure to a seca patient file  . . . . . . . . . .   73

6.4 Measuring bioimpedance. . . . . . . . . . . . . . . . . 73

Preparing a bioimpedance measurement . . .   74
Performing a measurement (with WiFi
direct connection to the measuring mat)  . . .   75
Performing a measurement (without WiFi
direct connection to the measuring mat)  . . .   77
Connecting the measuring mat   . . . . . . . . . .   79

6.5 Adding weight and height . . . . . . . . . . . . . . . . 80

Receiving weight and height
(seca 360° proximity)  . . . . . . . . . . . . . . . . . .   81
Receiving weight and height
(seca 360° wireless) . . . . . . . . . . . . . . . . . . .   82
Entering weight and height manually  . . . . . .   83

CONTENTS

Summary of Contents for mBCA 525

Page 1: ...3UHFLVLRQ IRU KHDOWK VHFD FRP Software version 1 0 from Build 1163 Art no 17 10 05 353 002g_10 2020 B seca mVSA 535 seca mBCA 525 Instructions for use...

Page 2: ...lood pressure cuff 30 4 11 Markings on the packaging 31 4 12 Other symbols 31 5 Starting up the device 32 5 1 Scope of delivery 32 5 2 Setting up device 33 Connecting the SmartBucket 33 Connecting the...

Page 3: ...NIUS 3 in ear thermometer 108 11 Troubleshooting 109 11 1 Monitor 109 11 2 Measuring mat 110 11 3 Bioimpedance measurement 111 11 4 Vital signs measurement 112 General 112 Blood pressure measurement 1...

Page 4: ...export and backup 163 Exporting patient and user data manually 163 Restoring patient and user data manually 164 4 8 Power management 165 5 Setting up peripherals 166 5 1 Setting up a LAN connection t...

Page 5: ...recautions Technical data Device overview Optional accessories and spare parts Starting up the device Compatible seca products Operation Disposal Operation when connected to an EMR system Warranty Hyg...

Page 6: ...f a training program e g within the framework of rehabilitation or physiotherapy Determining a patient s fluids status The medical Vital Signs Analyzer seca mVSA 535 is intended for use in chil dren 3...

Page 7: ...impedance measurement is performed with a measuring mat developed by seca Bioimpedance measurement is carried out with the patient lying down using the 8 point method The 4 point method measuring the...

Page 8: ...measuring results are managed in seca patient files seca patient files can be set up edited exported and deleted directly on the device The device can be configured so that the seca patient files of t...

Page 9: ...e This device software version 1 0 Build 1163 or higher is only compatible with version 1 4 Build 6657 or higher of the seca analytics 115 PC software There is no downward compatibility with older ver...

Page 10: ...operation in the vicinity of an MRI device or in a pressurized chamber The SpO2 measuring function of the device is not intended for monitoring apneas detecting arrhythmias or for use during defibril...

Page 11: ...tion about use of the device 3 2 Basic safety precautions Handling the device Please take note of the information in these instructions for use Keep the instructions for use in a safe place The instru...

Page 12: ...any parts for servicing by the user 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...

Page 13: ...the power supply cable with wet hands Do not use extension cables or power strips Make sure that cables are not pinched or damaged by sharp edges Make sure that cables do not come into contact with h...

Page 14: ...turned on again Otherwise condensation water will form which can damage the electronics Use the device only in the intended ambient conditions Store the device only in the intended storage conditions...

Page 15: ...order to reduce the risk of suffocation Use recyclable materials if possible NOTE Keep the original packing material for future use e g returning for servicing Handling batteries and rechargeable bat...

Page 16: ...thermometer controls Measuring mat controls bioimpedance analysis Fields in the touchscreen display Login navigation Buttons and symbols in the touchscreen display Operating state Symbols Measuring B...

Page 17: ...cales and length measuring devices from the seca 360 wireless system 13 Internal WiFi module For integrating the device in a network using with the seca analytics 115 PC software or with the seca conn...

Page 18: ...hermometer II Connection for temperature measurement For COVIDIENTM GENIUS 3 in ear thermometer III Measuring head For measuring temperature in ear IV Discard button Discard probe cover V In ear therm...

Page 19: ...le loaded patient position selected LED green flashing Measurement stopped LED red No seca patient file loaded F LEDs electrodes on right LED green Electrode contact good LED green flashing Measuremen...

Page 20: ...y Status error messages Battery charge status connection status Login logout field Tab contents Side navigation bar Bottom navigation bar Button symbol Meaning Patient tab Vital signs tab BIA tab Anal...

Page 21: ...s from list selected not selected Alternative from list selected not selected Return to previous screen Log in user Log out switch user Button symbol Meaning Login Logout Operating state Symbols in th...

Page 22: ...attery charging Measuring mat Rechargeable battery discharged LAN connection set up on off WiFi connection set up on off seca connect 103 EMR seca analytics 115 connection active seca connect 103 EMR...

Page 23: ...LED red Rechargeable battery discharged LED green WiFi available Green flashing WiFi connection being set up LED red WiFi not available LED off WiFi deactivated Patient tab Vital signs tab BIA tab Mea...

Page 24: ...Waiting time until next part measurement running Blood pressure Systolic diastolic pressure Blood pressure Mean arterial pressure Blood pressure Inflation deflation Blood pressure Single measurement m...

Page 25: ...ng equipment oxygen saturation measuring mode Normal APOD maximum Devices with seca measuring equipment oxygen saturation measuring mode Stable standard sensitive Save measurement procedure Discard me...

Page 26: ...eca directprint Function of the seca analytics 115 PC software Position indicator for analysis modules in this case Second module of 5 Position indicator for analysis parameters in this case Second an...

Page 27: ...Male Female Button symbol Meaning 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 Sp...

Page 28: ...th fingers No protection against water IP21 Type of protection in accordance with DIN EN 60 529 Protection against ingress of solid foreign bodies with a diameter of over 12 5 mm Protection against ac...

Page 29: ...mber from Industry Canada xxx yyy V min xx yy Hz xx A Type plate for power supply socket Permitted supply voltage Permitted power supply frequency Power consumption ON OFF key Inductive charging inter...

Page 30: ...hen blood pressure cuff is put on Cuff end These markings must be within the adjustment range when closing the blood pressure cuff Adjustment range The marking Cuff end must be in this range when clos...

Page 31: ...ion 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 disp...

Page 32: ...and time Initial login Configuration options seca 115 QUICK START seca mVSA 535 a b c d e f g h i j No Standard scope of delivery Pcs a Monitor to suit the version ordered 1 b Quick Start brief instru...

Page 33: ...he SmartBucket NOTICE Malfunction The SmartBucket needs one of the USB interfaces for communication and power supply If the USB connection is removed no vital signs can be measured Always keep the Sma...

Page 34: ...he blood pressure cuff in the SmartBucketas shown in the illustration below Connecting the temperature probe 1 Open the cover cap of the connection compartment 2 Insert the connector for the temperatu...

Page 35: ...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...

Page 36: ...th the SpO2 measuring equipment fitted Ensure that the SpO2 sensor is compatible with the SpO2 measuring equipment fitted in your device Optional accessories and spare parts Follow the user documentat...

Page 37: ...measuring accessories such as a blood pressure cuff for example After every measurement suspend the measuring mat back in the magnetic catch This ensures that the measuring mat rechargeable battery i...

Page 38: ...etic catch of the monitor Suspending the measuring mat in the magnetic catch 2 Connect the device to the power supply Establishing a power supply 3 Press the ON OFF button of the monitor The LED of th...

Page 39: ...of the monitor The LED of the button is white The initial start screen appears 4 Enter the current date a Press the input field b Use the keypad Enter current date c Press the button Confirm entry 5 E...

Page 40: ...ese user accounts must be activated and configured Additional user accounts can only be set up in the seca analytics 115 PC software and must be synchronized with the device Further information is ava...

Page 41: ...ON OFF button is white The device starts up This takes a few seconds The Vital signs tab is displayed The measuring mat if there is one switches on automatically You have the following options Measur...

Page 42: ...e measuring results Manage the system 1 Press the Login button The login window is displayed 2 Press the input field The list of user accounts is displayed NOTE If you have no user account please cont...

Page 43: ...standby shuts down if it is not used for an extended period phased by idle time Idle time button Device characteristics To remove setting Screen off Display switches off The LED of the ON OFF button i...

Page 44: ...is patient exists in the seca analytics 115 PC software check the synchronization settings Activating automatic synchronization Only create a new seca patient file on the device if you are sure that t...

Page 45: ...horized persons If you do not enter an attending physician the patient file is accessible to all physicians with access to the device Enter an attending physician to prevent access by unauthorized per...

Page 46: ...h a Press the input field b Use the keypad Enter date c Press the button Confirm entry 8 Enter the appropriate gender 9 Enter the appropriate ethnicity 10 Press the Save button The seca patient file h...

Page 47: ...the button Confirm entry A hit list is displayed 5 Press the desired entry The selected seca patient file appears in the Patient information dialog field 6 Press the Confirm button The seca patient fi...

Page 48: ...seca patient file Calling up a seca patient file 3 Press the button A confirmation dialog opens 4 Press the Confirm button The patient file is exported Deleting a seca patient file 1 Call up a seca p...

Page 49: ...a seca patient file a patient file before the measurement This applies in particular when repeat measurements for a patient are likely You can measure one or more vital signs in one measurement proce...

Page 50: ...d pressure cuff For patients with moderate to severe cardiac arrhythmias inaccu rate measurements may result with the blood pressure measure ment The following factors may affect the measurement resul...

Page 51: ...oo high If the blood pressure cuff is too large the measured blood pressure values will be too small Always use a blood pressure cuff that is the correct size Preparing the blood pressure measurement...

Page 52: ...t is available when the device starts up You can modify this and other presets for the current measurement procedure Modifying presets After this the settings specified by the adminis trator will be a...

Page 53: ...pressure SYS DIA and mean arterial pressure MAP are displayed The waiting time until the next part measurement starts The next part measurement starts automatically Once all part measurements are pre...

Page 54: ...desired measurement method Inflation continue at step 5 Deflation continue at step 4 4 Adapt initial pressure if necessary 5 Press the desired measuring sequence Single measurement Multiple measuremen...

Page 55: ...he regulations of your institute Only use properly functioning thermometers If you find damage do not use the thermometer Use a suitable replacement When not in use store the thermometer in the corres...

Page 56: ...pack d Ensure that the probe cover is undamaged 3 Position the temperature probe as shown in the illustration Measurement starts automatically The measured value and the symbol for the measurement pr...

Page 57: ...r 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...

Page 58: ...gulations of your institute Only use properly functioning thermometers If you find damage do not use the thermometer Use a suitable replacement When not in use store the thermometer in the correspondi...

Page 59: ...e the temperature probe into the patient s rectum For adults 12 19 mm For children 6 13 mm Measurement starts automatically The symbol for the measurement procedure in this case Predictive flashes unt...

Page 60: ...easurement procedure If you stop the measurement procedure Stopping a measurement proce dure the presets defined by the administrator become active again 1 Ensure that the temperature probe is pushed...

Page 61: ...ometers If you find damage do not use the thermometer Use a suitable replacement When not in use store the thermometer in the corresponding holder on the machine If the measurements seem implausible c...

Page 62: ...he ear at least 10 minutes before the measurement Implants do not generally have any effect on in ear temperature At low outdoor temperatures the patient should wait at room tem perature for a while b...

Page 63: ...w 5 Introduce the measuring head into the patient s auditory canal as shown in the illustration 6 Measure the patient s temperature a Press the button on the in ear thermometer b Wait until you hear a...

Page 64: ...in line with your institution s policy 9 Press the in ear thermometer into the SmartBucket holder until you feel it engage You have the following options for continuing Measure further vital signs Me...

Page 65: ...ithout integrated temperature measuring equipment On other device versions your administrator can deacti vate the integrated temperature measuring equipment in order to allow manual temperature input...

Page 66: ...ement 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 Depending on de...

Page 67: ...ensor are applied 2 Press the PR field The PR settings dialog window opens The preset is displayed in this case Standard 3 Press the desired measuring mode 4 Press the Confirm button The dialog window...

Page 68: ...nance imaging MRI or in an MRI environment Do not use the pulse oximeter if it appears or is suspected to be damaged Explosion hazard Do not use the pulse oximeter in the presence of flammable anesthe...

Page 69: ...mal fingers etc Skin color disorders Interfering substances Dyes or any substance containing dyes that change usual blood pigmentation may cause erroneous readings The pulse oximeter should not be use...

Page 70: ...might be inaccurate or the device might read zero for the duration of the active irradiation period Variation in measurements may be profound and may be affected by sampling technique as well as the...

Page 71: ...echnology to mini mize the risk of inaccurate readings and unanticipated loss of patient monitoring Refer to the Cable or Sensor DFU for the specified dura tion of the patient monitoring time Starting...

Page 72: ...log window closes The changed settings are used for the current measurement 5 Start the SpO2 measurement as described in the section entitled Starting an SpO2 measurement Weight and height The device...

Page 73: ...atient file To assign an anonymous measurement procedure to a patient file proceed as follows 1 Log in Logging in 2 Press the Patient tab You have the following options for continuing Calling up a sec...

Page 74: ...btain meaningful and comparable bioimpedance measurements Amount of time patient should lie before each measurement Approx 10 minutes If possible arrange follow up measurements at the same time of day...

Page 75: ...As a result some operating steps can be performed on both the monitor and the measuring mat NOTE If you are unsure whether the WiFi direct connection between the monitor and the measuring mat is activ...

Page 76: ...hen the Measurement successful message appears Monitor Measurement progress Electrode symbol Progress symbol 1 Electrodes being tested 2 Measurement in progress Measuring results will be saved on the...

Page 77: ...t on the measuring mat Measuring mat and monitor communicate via an infrared connection The measuring mat must be suspended in the magnetic catch of the monitor before and after a measurement to enabl...

Page 78: ...ca 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 Press the button Add c...

Page 79: ...sh to measure using the 4 point method attach the electrode cables on the keypad for the measuring mat to the hand and foot electrodes of the right half of the body 2 Connect the measuring mat to the...

Page 80: ...height can be received by compatible seca measuring devices Receiving weight and height seca 360 proximity Receiving weight and height seca 360 wireless NOTE If you are uncertain of which options you...

Page 81: ...t the measured values as described in the instructions for use for the measuring device The values appear on the seca mVSA 535 seca mBCA 525 in the Weight and Height fields in this case Vital signs ta...

Page 82: ...the Weight or Height field A numerical keypad appears in this case Weight The value received appears in the field 4 Adopt the value a Press the field b Press the button The adopted values appear in t...

Page 83: ...al keypad appears in this case Weight You have the following options for entering a value Use the keypad Enter current value Press the button Adopt the value from the previous measurement of patient 4...

Page 84: ...ules see the sections entitled Analysis parameters and Analysis modules Viewing current measuring results In order to view a summary of the current measuring results proceed as follows 1 Press the Ana...

Page 85: ...the following options for continuing Analyzing vital signs history Analyzing a bioimpedance measurement Press the buttons View more analysis modules Press the button Return to the previous view Analyz...

Page 86: ...e drop down menu Filter measuring results by period Then continue at step 5 To select values for the history individually continue at step 4 Press the button Add a comment Press the button Return to t...

Page 87: ...ns View more analysis parameters Press the button Return to the previous view Analyzing a bioimpedance measurement Calling up detail view 1 Call up a parameter overview Viewing current measuring resul...

Page 88: ...ress the buttons View more analysis parameters Press the button Return to the previous view Viewing the history of an analysis parameter To view the history of an analysis parameter proceed as follows...

Page 89: ...od a maximum of 5 measuring results are displayed Then continue at step 5 To select values for the history individually continue at step 4 Press the button Add a comment Press the button Return to the...

Page 90: ...A 525 17 10 05 353 002g_10 2020 B 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 Re...

Page 91: ...use If you have any questions con tact your administrator The Measure bioimpedance function is not available if the device is connected to an EMR system 7 1 Switching on the device NOTE To prevent fau...

Page 92: ...nd height 5 Saving measurements in the EMR system Measuring with an interrupted connection to an EMR system The device provides the option of performing measurements with an inter rupted connection to...

Page 93: ...age appears 2 Call up a patient file a Scan patient ID b Confirm status message The patient ID is displayed 3 Perform the measurement as described in the following sections Measuring vital signs Addin...

Page 94: ...ter your EMR system password The Vital signs tab is displayed You can call up patient data from the EMR system Calling up patient data from the EMR system Entering EMR user ID manually 1 Press the Log...

Page 95: ...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 1 Scan the patient ID The patient data are shown in the Patient...

Page 96: ...manually the Patient tab is shown after login 1 Press the Find patient file button 2 Enter patient ID using the keypad The patient data are shown in the Patient information dialog window 3 Ensure that...

Page 97: ...er You can temporarily save a measurement on the device for example to have the measuring results assessed by a third party The measurement can then be submitted to the EMR system This ensures that on...

Page 98: ...rement temporarily and submitting it later The measurement cannot be submitted because the connection to the EMR system is interrupted To open the Unsubmitted measurements list proceed as follows 1 Lo...

Page 99: ...to be confirmed before you can view details or submit the measurement to your EMR system 1 Ensure that the connection to the EMR system is active 2 Press an offline measurement marked yellow The patie...

Page 100: ...ess the button to close Detail view Submitting the measurement 1 Ensure that the connection to the EMR system is active 2 Press the checkboxes of the measurements to be submitted 3 Press the button Th...

Page 101: ...when connected to an EMR system 101 English 17 10 05 353 002g_10 2020 B Deleting a measurement 1 Press the checkboxes of the measurements to be deleted 2 Press the button The selected measurements ar...

Page 102: ...ants including the active ingredient 70 isopropanol only for measuring accessories for measuring vital signs 8 1 Cleaning Clean the device and its accessories as described in the table Cleaning Removi...

Page 103: ...4 Wipe over in ear thermometer and cable 5 Dry the in ear thermometer and cable using a lint free cloth 6 Discard probe cover As required Measuring head and lens 1 Carefully remove all foreign particl...

Page 104: ...ater 4 Allow to dry at room temperature Temperature probes red blue with cable As required 1 Discard probe cover and dispose of it 2 Moisten a soft cloth with disinfectant active ingredient 70 isoprop...

Page 105: ...tion can no longer be made once the probe holder has been removed Confusing the probe holders can lead to cross contamination Ensure that the probe holder is fitted back in the device from which it wa...

Page 106: ...meter Removing the magazine holder 1 Lift the magazine holder with a finger until the magazine holder comes out of its catch 2 Remove the magazine holder Fitting the magazine holder 1 Insert the magaz...

Page 107: ...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 9 2 COVIDIENTM GENIUS 3 in...

Page 108: ...COVIDIENTM GENIUS 3 in ear thermometer the manufacturer CardinalHealthTM recommends calibrating regularly every 12 months The COVIDIENTM Genius Checker Calibrator is required for calibration If you d...

Page 109: ...off the device press and hold the ON OFF button for approx 15 seconds Switch the device back on Image on touchscreen display faulty Touchscreen display faulty Inform seca Service Password not accepte...

Page 110: ...data manually Resetting the device Restoring patient and user data manually If necessary make previous device settings for example WiFi connection manually Fault Cause Remedy Fault Cause Remedy Measur...

Page 111: ...lts Patient position set on device does not match actual patient position Ensure that the patient position set on the device and the actual position match Patient moved during the measurement Request...

Page 112: ...orrect blood pressure cuff used Use correct size of blood pressure cuff Only use seca blood pressure cuffs Blood pressure cuff not applied correctly Correctly apply blood pressure cuff see instruction...

Page 113: ...cal exertion Eating drinking Brushing teeth Smoking Only perform oral temperature measurement about 20 minutes after any of these activities Set measuring position does not match actual measuring posi...

Page 114: ...xpectedly low Lens of measuring head blocked Opening in probe cover blocked Clean measuring head Dispose of probe cover use new one Patient s auditory canal blocked Clean auditory canal Implausible me...

Page 115: ...ensor Use dry sensor Sensor not applied correctly Apply sensor correctly see instructions for use for sensor Strong ambient light Cover application site with opaque material Electromagnetic interferen...

Page 116: ...seca analytics 115 PC software or seca connect 103 via LAN WiFi not available in your institution Transmit measuring results to seca analytics 115 PC software or seca connect 103 via LAN No network co...

Page 117: ...which the seca analytics 115 PC software is installed is not switched on Switch on PC Automatic synchronization is deactivated on the device Administrator Exporting patient and user data manually Prin...

Page 118: ...diately Not a malfunction The device connection to the EMR system has been configured so that no password needs to be entered Administrator Modify configuration if necessary Making workflow settings U...

Page 119: ...r use No measurement has yet been performed using the seca scale measuring rod Perform measurement as described in the instructions for use for the seca scale seca measuring rod seca scale measuring r...

Page 120: ...l models Ambient conditions operation Temperature with COVIDIENTM FILACTM 3000 Temperature with COVIDIENTM GENIUS 3 Air pressure Humidity 10 C to 40 C 50 F to 104 F 16 C to 33 C 60 8 F to 91 4 F 700 h...

Page 121: ...ftware Further technical data all models Interfaces Protocol Data transmission rate Factory setting WiFi IEEE 802 11 b g n Up to 72 2 Mbps Off LAN IEEE 802 3u 100 Mbit s On TCP port Transmission Contr...

Page 122: ...00 hPa 1060 hPa 0 95 non condensing Setup location maximum altitude above mean sea level 3000 m Power supply Range measurements Lithium ion battery approx 5 h Medical device in accordance with Directi...

Page 123: ...5 0 5 Measuring method Standard deviation SEE for predictive formulas in this devicea Ethnicity Caucasian Afro American Asian South and Central American Other Parameter SEE SEE SEE SEE SEE FFM 2 50 kg...

Page 124: ...mmHg 200 mmHg 45 mmHg 190 mmHg 56 mmHg 193 mmHg 25 mmHg 280 mmHg 10 mmHg 220 mmHg 15 mmHg 260 mmHg Accuracy under laboratory conditions verified with CuffLink patient simulator from Fluke max 3 mmHg 2...

Page 125: ...ver time from predictive mode to direct mode Measuring position not detected following removal from probe cover No stable temperature value obtained following application 60 sec 70 sec Accuracy water...

Page 126: ...perature range 32 C 44 C 89 6 F 111 2 F Masimo SET SpO2 modulea b c d e f g Measurement Measuring method Functional oxygen saturation Spectrophotometry red infrared LED wavelength Red Infrared Maximum...

Page 127: ...the test bench for the range 25 240 min 1 compared to a Biotek Index 2 simulator This fluctuation corresponds to 1 standard deviation Plus or minus one standard deviation covers 68 of the population e...

Page 128: ...e rate enhanced 0 100 30 min 1 240 min 1 20 min 1 300 min 1 Measuring accuracy SpO2 no patient movement SpO2 patient movement Pulse rate no patient movement Pulse rate patient movement 60 70 3 Arms 60...

Page 129: ...Absolute in kg Development growth Height H Absolute in m Development growth Extracellular water ECW total body water TBW Relative in Fluid international Energy stored in the body Ebody Absolute in MJ...

Page 130: ...mass SMM Fluid Determination of fluid status Required Weight height Total body water TBW Extracellular water ECW ECW TBW Bioimpedance vector analysis BIVA Health risk Summary of body composition Esti...

Page 131: ...n overview at www seca com Bioimpedance measurement seca mBCA 531 measuring mat 531 20 00 001 Blood pressure measurement Cuff size XS Cuff size S Cuff size M Cuff size L Cuff size XL Cuff size XXL Ext...

Page 132: ...try specific versions go to www seca com seca 655 seca 654 No restriction Yes seca 635 seca 634 10000000026211 10000000027487 Yes with accessories a seca 645 seca 644 10000000027015 10000000027016 sec...

Page 133: ...wo year warranty from the date of delivery for defects attributable to faulty material or poor workmanship This excludes all moveable parts such as rechargeable batteries cables power supply units etc...

Page 134: ...7 10 05 353 002g_10 2020 B 17 DECLARATION OF CONFORMITY seca gmbh co kg hereby declares that the product meets the terms of the applicable European directives The unabridged declaration of conformity...

Page 135: ...this part of the user documentation are accessible only to users with administrator rights Follow the information in the instructions for use Instructions for use for seca mVSA 535 seca mBCA 525 1 PRE...

Page 136: ...n button The login window is displayed 4 Press the input field 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 fiel...

Page 137: ...an internal interface module or seca 452 external interface module firmware version Q2_2020_Build_615 or higher Function Administrator User Creating seca patient files Calling up seca patient files E...

Page 138: ...window is displayed 2 Press the input field The list of user accounts is displayed 3 Press the Admin user account The account is displayed in the input field 4 Press the input field 5 Enter the initi...

Page 139: ...ss by unauthorized persons An insecure password may allow unauthorized persons to access patient data or device settings Select a password to satisfy your institution s security requirements 5 Enter t...

Page 140: ...d as follows 1 Press the Users tab You have the following navigation options Desired entry visible Continue at step 3 Desired entry not visible Continue at step 2 2 Search for the desired user account...

Page 141: ...nd in the administrator manual for the seca analytics 115 PC software The display language is specified for each user individually If no user is logged in the user interface is displayed in the system...

Page 142: ...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 b...

Page 143: ...ate deactivate name separator The measuring mat if there is one switches on automatically NOTE The user interface is shown in the system language if no user is logged in to the device If a user is log...

Page 144: ...sounds NOTE Amended settings can immediately be seen heard each time a button is pressed You do not need to save or confirm them 3 3 Calibrating the touchscreen display 1 Press the Settings tab 2 Pres...

Page 145: ...0 B 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 ca...

Page 146: ...ay measuring results in other units This is only an additional function Use the results exclusively in SI units The use of measuring results in non SI units is the sole responsibility of the user 1 Pr...

Page 147: ...es are no longer displayed in the analysis Analyzing measurement 4 To reactivate analysis modules press the checkboxes of the deactivated analysis modules again The reactivated analysis modules will a...

Page 148: ...be read perfectly whatever the illumination conditions This function is not avail able for other tabs This setting cannot be changed during a measurement procedure Presets for blood pressure NOTE Thi...

Page 149: ...ress the desired measuring sequence Single measurement Multiple measurement Configuring multiple measurement NOTICE Faulty operation missing measuring results Results from multiple measurements cannot...

Page 150: ...525 17 10 05 353 002g_10 2020 B 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 butt...

Page 151: ...ements at the end of the measuring sequence are not completed The running time of the measurement is reduced 6 Specify a start delay waiting time before part measurement 1 Format mm ss Min 00 00 Max 1...

Page 152: ...ing profile 9 Press the button 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 ra...

Page 153: ...easuring mode seca measuring equipment only 5 Press the Confirm button The dialog window closes The modified settings are adopted Presets for SpO2 1 Press the Settings tab 2 Press the Vital signs butt...

Page 154: ...g oxygen saturation SpO2 5 Press the Confirm button The dialog window closes The modified settings are adopted Presets for temperature COVIDIENTM FILACTM 3000 only 1 Press the Settings tab Masimo SET...

Page 155: ...nto the probe holder completely 4 Press the TEMP field The presets are displayed in this case COVIDIENTM FILACTM 3000 blue 5 Press the desired measurement method Predictive Direct 6 Press the desired...

Page 156: ...olor mode for Vital signs tab 1 Press the Settings tab 2 Press the Vital signs button 3 Press the Color mode input field 4 Select a color mode Standard Color day Color night 5 Log off 6 Press the Vita...

Page 157: ...displayed in this case SmartBucket You have the following options View details Perform software update not for SmartBucket Updating the monitor software Viewing system information Updating the monitor...

Page 158: ...n synchronized with the seca analytics 115 PC software for operation with seca analytics 115 PC software 1 Press the System tab 2 Press the Monitor button 3 Press the Software update Monitor button 4...

Page 159: ...oftware of the measuring mat Monitor software has been updated seca mVSA 535 seca mBCA 525 Updating the monitor software System has had a measuring mat added seca mVSA 535 Retrofitting the measuring m...

Page 160: ...artBucket seca mVSA 526 to measure vital signs Optional accessories and spare parts 1 Retrofit the SmartBucket as described in the relevant assembly instructions 2 Activate the SmartBucket in the devi...

Page 161: ...sure that the Measuring mat active checkbox is deactivated seca mVSA 535 can be retrofitted with the seca mBCA 531 measuring mat to perform bioimpedance measurements Optional accessories and spare par...

Page 162: ...fitted with the COVIDIENTM GENIUS 3 in ear thermometer Optional accessories and spare parts 1 Connect the in ear thermometer as described in the section entitled Connecting the in ear thermometer 2 Ac...

Page 163: ...ct a USB memory stick to the monitor 4 Press the Backup button 5 Enter a password to encrypt the data NOTICE Data access by unauthorized persons An insecure password may allow unauthorized persons to...

Page 164: ...fore restor ing older data manually operation without seca analytics 115 PC software Before restoring manually ensure that all the data on the device have been synchronized with the seca analytics 115...

Page 165: ...s off 1 Press the System tab 2 Press the Power management button The current setting is displayed default setting 50 3 Set the desired battery charge status from which the device is to shut down and s...

Page 166: ...the configura tion of the seca connect 103 software server IP and connect port is known For devices with bioimpedance measurement If you connect the device to your network via LAN cable the measuring...

Page 167: ...tab 2 Press the LAN button 3 Press the LAN active checkbox The LAN function is activated 4 Make the setting applicable to your network To set up connection manually continue at step 5 To set up automa...

Page 168: ...You do not need to save or confirm them 6 Continue based on your device variant For devices with bioimpedance measurement continue at step 7 For devices without bioimpedance measurement continue at st...

Page 169: ...N connection is available for connection to the network 10 Press the button to confirm your entry 11 You have the following options for continuing Setting up a connection to the seca analytics 115 PC...

Page 170: ...seca connect 103 software is installed on a server and the configura tion of the seca connect 103 software server IP and connect port is known For devices with bioimpedance measurement If you integra...

Page 171: ...AN connection 4 Press the WiFi button 5 In the WiFi mode drop down menu press the WiFi client network setting 6 Make the setting applicable to your WiFi network Visible network Press the Scan WiFi but...

Page 172: ...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 conn...

Page 173: ...ion NOTE You specify the network printer for the seca directprint function directly in the seca analytics 115 PC software You should also follow the administrator manual for the seca analytics 115 PC...

Page 174: ...sary 5 Ensure these settings match those in the seca analytics 115 PC software menu Extras Settings Synchronization 6 Press the button to confirm the settings Press the button Activating automatic syn...

Page 175: ...115 PC software you should activate automatic synchronization The following data are then synchronized as soon as they are changed either on the device or in the PC software seca patient files User ac...

Page 176: ...ation page 5 Press the Automatic synchronisation checkbox Automatic synchronization is activated 6 To adopt the settings proceed as follows a Press the button b Press the button The settings are adopt...

Page 177: ...format your EMR system accepts 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 Pre...

Page 178: ...rm ware version Q2_2020_Build_615 or higher The seca measuring device is connected to your LAN or WiFi network The seca measuring device is configured as follows Scan user ID Required Scan patient ID...

Page 179: ...ss the Peripherals tab 2 Press the seca 360 proximity button The seca 360 proximity dialog window opens 3 Search for available devices Press the button Search for devices on the network Press the butt...

Page 180: ...bout how to assign organization IDs can be found in the seca 103 452 system instructions for use 4 Press the desired device in the list The device is shown blue in the list The connection is set up In...

Page 181: ...the seca mVSA 535 seca mBCA 525 must be activated and a wireless group set up NOTE The device can only receive data not transmit it via the seca 360 wireless connection Follow the instructions in this...

Page 182: ...less module is activated 4 To deactivate the seca 360 wireless module press the Send receive on checkbox again Setting up a seca 360 wireless connection 1 Ensure that the seca 360 wireless modules of...

Page 183: ...ce The proposed channel numbers can be edited This function is intended purely for special reception situations Devices may be assigned to the wrong wireless groups or unreliable wireless connections...

Page 184: ...you connect to an EMR system can be found here Operation when connected to an EMR system 6 1 Information about user and patient data When connecting to an EMR system the following changes apply to the...

Page 185: ...me the device transmits a heartbeat to the network every 30 seconds To assign a device name proceed as follows 1 Log in as administrator 2 Press the System tab 3 Press the Monitor button The Monitor d...

Page 186: ...seca connect 103 are known The EMR system is connected to the seca connect 103 software In formation on this can be found in the seca 103 452 system instructions for use from version 2 0 or higher NO...

Page 187: ...tings Press the button Adopt settings Making workflow settings You can specify the following settings for the measuring sequence and communication with the EMR system Password settings for the user ID...

Page 188: ...fline measurement Allow offline measurements NOTE Offline measurements are temporarily saved in the Unsubmitted measurements list When the connection to the EMR system is active again the measurements...

Page 189: ...ristics when connected to EMR system Function Standalone mode factory setting connection to seca analytics 115 Connection to EMR system via seca connect 103 User identification measure seca user accou...

Page 190: ...on International Surname first name Name separator Decimal point Display brightness 100 Volume for warning and information sounds Volume for button sounds 70 70 Rechargeable battery capacity automatic...

Page 191: ...sing the seca analytics 115 PC software 3 Press the Reset device button seca patient files and user accounts will be deleted The device will be reset to factory settings Overview of factory settings W...

Page 192: ...as described in the section entitled Resetting the device 1 Press the Reset tab 2 Press the Reset GUI button The user interface will be reset to factory settings Overview of factory settings seca pati...

Page 193: ...cs 115 PC software 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...

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Seca mBCA 525, Instructions For Use Manual

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