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Seca mBCA 525, Инструкция по эксплуатации

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seca mVSA 535

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seca mBCA 525

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2. DESCRIPTION OF DEVICE

2.1 Intended use for the seca mVSA 535

The medical Vital Signs Analyzer 

seca mVSA 535

 is mainly used in inpatient 

facilities (hospitals, medical practices and care facilities) in accordance with 
national regulations.
The medical Vital Signs Analyzer 

seca mVSA 535

 is used for non-invasive, dis

-

continuous determination of arterial blood pressure and/or non-invasive 
determination of oxygen saturation of arterial hemoglobin and/or determina

-

tion of body temperature and pulse rate and determination of weight and 
height.
When the Bioimpedance analysis function is included, the medical device is 
also used to record bioelectric impedance measurements and to calculate 
automatically parameters such as fat-free mass (FFM) which can be derived 
from these measurements. The results are displayed in graphical form and 
assist the attending physician with the following medical issues:

• Determining energy expenditure and energy reserves as a basis for 

nutritional advice

• Assessing metabolic activity and the success of 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 years and older and adults. The Bioimpedance analysis function is not 
intended for use on children.

2.2 Intended use for the seca mBCA 525

The medical Body Composition Analyzer 

seca mBCA 525

 is mainly used in 

inpatient facilities (hospitals, medical practices and care facilities) in accor

-

dance with national regulations. 
The medical Body Composition Analyzer 

seca mBCA 525

 records weight, 

height and bioelectric impedance measurements and automatically calculates 
parameters such as fat-free mass (FFM) which can be derived from these 
measurements. The results are displayed in graphical form and assist the 
attending physician with the following medical issues:

• Determining energy expenditure and energy reserves as a basis for 

nutritional advice

• Assessing metabolic activity and the success of a training program, e.g. 

within the framework of rehabilitation or physiotherapy

• Determining a patient's fluids status

The device is 

not

 intended for use on children.

➔

Intended use for the seca mVSA 535

➔

Intended use for the seca mBCA 525

➔

Description of function

➔

User qualification

➔

Contraindications

Содержание mBCA 525

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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