IEM agedio B500 Operating Manual
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IEM agedio B500 Operating Manual

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Operating manual
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B500 + agedio
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Summary of Contents for IEM agedio B500

  • Page 1 Operating manual ® ® agedio B500 + agedio K520...
  • Page 2 E-Mail: info@iem.de Website: www.iem.de The copyright for the firmware in this product remains with the manufacturer of this device. All usage and ownership rights to the software remain with IEM GmbH. © 2019 IEM GmbH Rev. D - 30.08.2019 - EN...

  • Page 3: Table Of Contents

    Table of contents Introduction ..............................5 About this operating manual ........................5 CE Marking ............................. 6 Contents ..............................7 Instructions for use ........................... 8 Intended use ............................8 Improper use ............................9 Essential performance features ......................10 Definition of terms used ........................11 Safety instructions ..........................
  • Page 4 Applying a cuff ............................45 Performing a measurement ........................49 Measurement process .......................... 52 Aborting a measurement ........................54 Measurement was not successful ......................54 Quality of the measurement ......................... 54 Measurement result report ........................55 Measurement result report for the person who has been measured........... 55 Measurement result report for the doctor ....................

  • Page 5: Introduction

    Introduction Introduction About this operating manual ® This operating manual is intended to quickly and simply familiarise you with using the agedio B500 and its ® ® accessories. The software application agedio K520 is used to perform the analysis for the agedio B500.

  • Page 6: Ce Marking

    K520 satisfies the requirements of the following directives: • Directive 93/42/EEC (MDD ® ® The agedio B500 and the application agedio K520 carry the CE mark. HINWEIS The complete text of the EU declaration of conformity is available at the following website address: www.iem.de.

  • Page 7: Contents

    Introduction Contents Basis-Set Optional accessories Blood pressure cuff “XL” ® • agedio B500 (arm circumference: 38-55 cm (15.0-21.7 Blood pressure cuff “S” inches)) (arm circumference: 20-24 cm (7.9-9.5 inches)) Blood pressure cuff “M” (arm circumference: 24-32 cm (9.5-12.6 inches))) Blood pressure cuff “L” (arm circumference: 32-38 cm (12.6-15.0 inches)) ®...

  • Page 8: Instructions For Use

    Instructions for use Instructions for use Intended use ® The intended use of the agedio B500 is to perform blood pressure measurement and pulse wave analysis (PWA) in one. The measurement is to be carried out on adults by trained personnel at pharmacies and by other persons employed in the health sector.

  • Page 9: Improper Use

    Instructions for use Improper use • ® The agedio B500 must not be used for any purpose other than the blood pressure measurement procedure described herein. • ® The agedio B500 must not be used on babies or children. • ®...

  • Page 10: Essential Performance Features

    Instructions for use Essential performance features The essential performance features are blood pressure measurement with: • error tolerances for the manometer and the measurement results within the required limits according to IEC 80601-2-30 • maximum change value in blood pressure determination as specified in IEC 80601-2-30 •...

  • Page 11: Definition Of Terms Used

    Instructions for use Definition of terms used The following signal words, symbols and pictograms are used in this manual to indicate dangers and important information: Warnings WARNING Short description of the danger This warning symbol together with the signal word WARNING indicates a possible or immediately imminent danger.

  • Page 12: Safety Instructions

    Instructions for use Safety instructions Read the safety instructions carefully before using the product and discuss them with the person to be measured! It is important that you understand the information in this operating manual. If you have any questions, please do not hesitate to contact technical support. WARNING Danger of tissue bleeding, petechiae or haematoma! •...
  • Page 13 Instructions for use WARNING Danger of injury as a result of allergic reactions to the cuff material! • Remove the cuff in the event of pain or allergic reaction. • Do not use the cuff on persons with a known hypersensitivity to epoxy resin. WARNING Danger of blood flow interruptions as a result of applying and inflating a cuff on limbs with an intravascular drip or intravascular treatment or with an arteriovenous (AV) shunt or fistula!
  • Page 14 Instructions for use WARNING Danger as a result of self-diagnosis! • Inform the person to be measured that they must not make any changes to their healthcare based on the measured values without consulting their doctor. • Inform the person to be measured that they must never change the dosage of prescribed medication without consulting their doctor! •...
  • Page 15 Instructions for use WARNING Danger of blood flow interruptions as a result of constant cuff pressure or taking measurements too frequently! • Inform the person to be measured about this danger. • Observe the person being measured carefully during the measurement. •...
  • Page 16 Instructions for use WARNING Danger of injury and danger of prolonged impairment of blood circulation in the person to be measured or the affected limb due to the operation and use of the automated non-invasive blood pressure monitor! • Inform the person to be measured about this danger. •...
  • Page 17 Instructions for use WARNING Danger of strangulation due to the cuff tube! • Ensure that children are not left unsupervised with the blood pressure monitor! • Persons with limited mental capabilities may only use this device under direct supervision. (Keep out of reach.) •...
  • Page 18 Instructions for use WARNING Danger of injury as a result of using non-approved accessories! • Only use accessories approved by the manufacturer and sold by the distributor or manufacturer. • Read the respective information provided by the manufacturer before using the accessories for the first time.
  • Page 19 • The use of components not included in the scope of delivery may lead to measurement errors. Therefore, only accessories offered by IEM may be used. • The cuffs and the tube are made from non-conducting material. They therefore protect the monitor against the effects of a defibrillator discharge.
  • Page 20 The use of components not included in the scope of delivery may lead to measurement errors because alternative transformers and cables, for example, may result in increased electromagnetic interference emissions or reduced electromagnetic immunity. Therefore, only accessories offered by IEM may be used. • ®...
  • Page 21 Instructions for use CAUTION Warranty • ® Do not open the casing of the agedio B500, otherwise all warranties lapse. Non-adherence may lead to damage to the product or its accessories. CAUTION Batteries • Remove the batteries/rechargeable batteries from the battery compartment when they are discharged or if you do not expect to use the blood pressure monitor for a longer period of time.

  • Page 22: Blood Pressure Monitor Agedio B500

    Blood pressure monitor agedio® B500 ® Blood pressure monitor agedio B500 Description ® The agedio B500 is a fully automatic blood pressure and pulse monitor, which also records pulse waves. ® The measured values are transmitted together to the software application agedio K520.
  • Page 23 Blood pressure monitor agedio® B500 The display When shown: battery empty Pulse rate per minute Displays systolic value (top number) Pulse detected Data transmission Number of measured values ® Bluetooth Displays diastolic value (bottom number) Infrared communication...
  • Page 24 Blood pressure monitor agedio® B500 The blood pressure cuff Blood pressure cuff Air tube connector Air tube ® The agedio B500 is connected to the cuff using the air tube connector...

  • Page 25: Technical Data

    Blood pressure monitor agedio® B500 Technical data Specification Value Unit Measuring method Oscillometric Systolic 60 to 290 Blood pressure measurement range mmHg Diastolic 30 to 195 Pulse measurement range 30 to 240 1/min Pressure accuracy +/- 3 mmHg Pulse accuracy +2% or +3 BPM (whichever is greater) Memory Measurements...
  • Page 26 Blood pressure monitor agedio® B500 Specification Value Unit Storage temperature -25 to +70 ° C Humidity, non-condensing (operation, 15 to 93 transport and storage) Battery capacity approx. 500* Measurements Data connection Bluetooth Data transmission Bluetooth Class 1 *based on 2 measurements per day using quality batteries (alkaline))

  • Page 27: Symbols On The Device

    Blood pressure monitor agedio® B500 Symbols on the device Symbol Meaning 4 x LR6 or HR6, AA with 1.5 V Manufacturer Date of manufacture YYYY-MM-DD FCC label for approved communications equipment CE 0044: Marking for a medical device in accordance with Directive 93/42/EEC The device may not be freely usable everywhere in Europe.
  • Page 28 Blood pressure monitor agedio® B500 Symbol Meaning The symbol on the product or packaging indicates that this product should not be treated as normal domestic waste but must be disposed of at a recycling point for electric and electronic devices. You can obtain further information about this from your local authority, local waste disposal companies or the shop in which you bought the product.

  • Page 29: Operating Conditions

    Blood pressure monitor agedio® B500 Operating conditions CAUTION Operating conditions • Extreme temperatures, humidity or air pressures can affect measurement accuracy. Do not store the blood pressure monitor outside a temperature range of -25 ° C to +70 ° C. Do not use the blood pressure monitor outside a temperature range of +5 °...

  • Page 30: The Ios App Agedio K520

    K520 app. Processing serves to evaluate blood pressure values and vessel condition. Furthermore, IEM GmbH anonymously analyzes your data and measurement results as well as device data (model, serial number, crash information, etc.) in order to improve the measurement devices and for research purposes.

  • Page 31: Configuring The Ios App Agedio K520

    The iOS app agedio® K520 NOTE ® The iOS app agedio K520 also works offline. No internet connection is required. ® Configuring the iOS app agedio K520 NOTE ® The iOS app agedio K520 language settings comply with the global iOS settings. ®...

  • Page 32: Customising The App

    The iOS app agedio® K520 NOTE You need an AirPrint printer to be able to operate the software application effectively. This is not included in the basic set. If you have any questions, please contact the manufacturer. In this iOS app you can choose between two different pysical units. Tap on the physical units to select one: This app allows you to choose between different physical units.
  • Page 33 The iOS app agedio® K520 NOTE The maximum length for the slogan is approximately 40 characters. Since the length of each letter differs (e.g. “I” vs. “W”), the length of each individual slogan should be tested. The main thing to check is the length of the slogan on the report print-out Inserting a customer logo NOTE...
  • Page 34 The iOS app agedio® K520 ® Imprint for the app agedio K520 NOTE The imprint contains all of the formal information and contact details for support and servicing To view the imprint, tap on in the top right corner of the home screen. ®...

  • Page 35: Initial Operation Of The Blood Pressure Monitor Agedio B500

    Initial operation of the blood pressure monitor agedio® B500 ® Initial operation of the blood pressure monitor agedio B500 Unpacking All parts included in delivery package have been properly packed and checked for completeness and functionality. Should the product be incomplete, damaged or defect, please inform your healthcare provider immediately.

  • Page 36: Inserting Rechargeable Batteries/Batteries

    Initial operation of the blood pressure monitor agedio® B500 Inserting rechargeable batteries/batteries Check the supplied batteries for any visible damage. Never use damaged batteries. NOTE • Hold the monitor in your hand and insert the batteries. • Make sure that the button on the front is not pressed! •...
  • Page 37 Initial operation of the blood pressure monitor agedio® B500 ® The agedio B500 is ready for operation. CAUTION Warranty • Make sure that all segments of the screen are displayed. Inform your specialist supplier or the manufacturer if the display screen is damaged.

  • Page 38: Switching On/Off The Blood Pressure Monitor

    Initial operation of the blood pressure monitor agedio® B500 Switching on/off the blood pressure monitor Switching on Press the - button.  The display shows the start screen. Switching off The blood pressure monitor switches off automatically after approximately 5 minutes.

  • Page 39: Setting Up The Bluetooth

    Initial operation of the blood pressure monitor agedio® B500 ® Setting up the Bluetooth connection ® ® ® Before using the agedio B500 with the iOS app agedio K520, you must first pair the agedio B500 with your iPad. Open the iOS settings on your iPad and select the setting Bluetooth. ®...
  • Page 40 Initial operation of the blood pressure monitor agedio® B500 NOTE After 3 seconds, the display shows bt, ignore it and press the button for another 3 seconds. After 6 seconds, you automatically enter the menu and the display automatically shows the next menu entry.
  • Page 41 Initial operation of the blood pressure monitor agedio® B500...
  • Page 42 Initial operation of the blood pressure monitor agedio® B500 NOTE ® ® If the agedio B500 was previously paired with a different Bluetooth device (e.g. iPad), the pairing must be renewed before pairing again with the “old” iPad, because the agedio ®...

  • Page 43: Preparing For A Measurement

    Preparing for a measurement Preparing for a measurement Interviewing the person to be measured Interviewing the person to be measured at the initial stage of preparing for the measurement is an important step in order to avoid any possible dangers and risks for that person. Ask the person to be measured the following questions: •...
  • Page 44 Preparing for a measurement WARNING In very rare cases materials used for and on the cuff may cause allergic reactions! • Ask the person to be measured if they have any known allergies. • Do not use the cuff on persons with a known hypersensitivity to epoxy resin. Selecting a suitable upper arm cuff is very important for a correct blood pressure measurement and pulse wave analysis.

  • Page 45: Applying A Cuff

    Preparing for a measurement Applying a cuff WARNING Strangulation risk due to blood pressure cuff and blood pressure cuff tube • Persons with limited mental capabilities may only use this device under direct supervision. (Keep out of reach.) • ® Do not use the agedio B500 on babies or children.
  • Page 46 Preparing for a measurement Insert the air tube connector into the air tube socket on the left-hand side of the blood pressure monitor. Apply the cuff to the bare upper arm by guiding the left arm of the person to be measured through the blood pressure cuff.
  • Page 47 Preparing for a measurement NOTE • The tube must run down the middle of the inside of the lower arm towards the middle finger. • The bottom edge of the cuff must be about 2 cm (0.8 inches) above the elbow. •...
  • Page 48 Preparing for a measurement Positioning the person to be measured The person being measured should remain in the following position during measurement: • seated comfortably • legs not crossed • feet flat on the ground • back and arm supported •...

  • Page 49: Performing A Measurement

    Performing a measurement Performing a measurement ® Place the agedio B500 on a table. ® ® Start the iOS app agedio K520 by tapping on the agedio icon On the start screen of the iOS app, tap on the Vascular Age icon Enter the details for the person to be measured into the relevant fields and select the sex.
  • Page 50 Performing a measurement ® Ensure that the agedio B500 is switched on. Press and hold the button on the blood pressure monitor for approximately 3 seconds and wait until the display flashes [bt]. ® A signal tone sounds and the display shows the Bluetooth and the data transmission symbols.
  • Page 51 Performing a measurement NOTE After 6 seconds, the menu automatically opens. The menu sequence is: • infrared transmission (Ir) • ® Bluetooth transmission (bt) • active pairing (PAI A) • passive pairing (PAI P) • delete measured values (C lr) ®...

  • Page 52: Measurement Process

    Performing a measurement appears in the iOS app and the note: Device ready In the iOS app tap on Next >. The measurement starts automatically. Measurement process The measurement consists of several phases: • First, the calibration measurement is performed. •...
  • Page 53 Performing a measurement NOTE • The person being measured should not speak during measurement. • The measurement can be aborted at any time by pressing the button. • After the measurement, all of the air is released from the blood pressure cuff. The display shows your blood pressure and your pulse rate.

  • Page 54: Aborting A Measurement

    Performing a measurement Aborting a measurement Press the button to abort the current measurement. “Abr” then appears in the agedio ® B500 display and a signal tone sounds. Measurement was not successful If the display shows an “error”, recheck the correct procedure for setting up and applying the device.

  • Page 55: Measurement Result Report

    Measurement result report Measurement result report Measurement result report for the person who has been measured Vascular age measurement: At the top, you will find the manually entered data for the person being measured. NOTE If you entered a logo in the app settings, this will be shown on the right next to the data for the person being measured.
  • Page 56 Measurement result report Measurement result You will find the result of your vascular age measurement at the end of the report. The pulse wave velocity (PWV) for the person being measured is displayed as an absolute value in meters per second (m/s).

  • Page 57: Measurement Result Report For The Doctor

    Measurement result report Measurement result report for the doctor ® The iOS app agedio K520 also compiles a blood pressure measurement report for the doctor. This report contains additional information and measurement values for medical professionals. NOTE • The medical report is only intended for medical professionals. Therefore, no further explanation of the details is provided here.
  • Page 58 Measurement result report Completing the vascular age measurement Tap the icon to complete the process. You can now continue with the next measurement.

  • Page 59: Care And Maintenance

    Care and maintenance Care and maintenance ® Regular maintenance and care of the device is required to maintain the correct functioning of your agedio B500 in the long term. WARNING Intolerance! • Some people have intolerances (e.g. allergies) to disinfectants or their components! •...

  • Page 60: Cleaning

    Care and maintenance Cleaning ® For hygiene reasons, the user should clean the agedio B500 and the cuff after every use. Cleaning the agedio ® B500 : ® Only use a moistened cotton cloth with a mild detergent to clean the agedio B500.
  • Page 61 Care and maintenance CAUTION Damage caused by cleaning! • Only use a mild detergent without fabric softener and lukewarm water to clean the bladder and tube. • Ensure that no water enters the bladder or tube! When the cuff, bladder and tube are completely dry, lie the cuff sleeve out fully with the Velcro side facing downwards.
  • Page 62 Care and maintenance CAUTION Damage due to incorrect bladder size! • Ensure that the correct bladder size is used for the cuff sleeve. • The cuff sleeve size is indicated on the outside. CAUTION Damage during cleaning! • To clean, use lukewarm water up to 30° C max., to which you can add a mild detergent if necessary.

  • Page 63: Disinfection

    Ensure that any disinfectants used are washed off, leaving no residue, before the blood pressure cuff is worn. When using other disinfectants that were not checked by IEM GmbH, the user is responsible for obtaining proof that they can be used safely.

  • Page 64: Maintenance Plan

    In certain countries, this requirement may be regulated by national laws or regulations. The calibration check comes at an additional cost and can be carried out either in Germany either by IEM GmbH, a relevant authority or by authorised maintenance services in accordance with the "Medizinprodukte- Betreiber-Verordnung"...

  • Page 65: Disposal

    Disposal Disposal Blood pressure monitor The symbol on the product or packaging indicates that this product should not be treated as normal domestic waste but must be disposed of at a recycling point for electric and electronic devices. You can obtain further information about this from your local authority, local waste disposal companies or the shop in which you bought the product.

  • Page 66: Fault Management

    Fault management Fault management Main sources of error The following can cause measurement errors or unwanted results: • arm movement of the person being measured during the measurement. • incorrect cuff size applied. • the cuff slipping while being worn. •...
  • Page 67 Fault management ® Error description for the agedio B500 Error description Cause Solution Err 1 The arm moved during the Keep the arm still during the measurement measurement. Insufficient valid pulse rate Apply the blood pressure cuff detected again. The arm moved during the Keep the arm still during the Err 2 measurement...
  • Page 68 Fault management Error description Cause Solution Err 6 Air blockage Check the blood pressure cuff for an air blockage or a kink in the air tube. If there is a kink in the air tube, unkink it or send the blood pressure monitor to your healthcare provider or the manufacturer.
  • Page 69 Fault management ® ® Communication errors agedio B500 Bluetooth interface Error description Cause Solution Cod 1 Error during pairing Pair the blood pressure monitor again. If this error occurs repeatedly, contact the manufacturer or your specialist supplier. Transmission device is switched Switch on the transmission device.
  • Page 70 Fault management Error description Cause Solution Cod 6 Hardware communication error If this error occurs repeatedly, contact your distributor or specialist supplier. Cod 7 Memory empty Perform a measurement. If this error occurs repeatedly, contact the manufacturer or your specialist supplier.

  • Page 71: Warranty And Repair Conditions

    IEM GmbH has no influence or control.
  • Page 72 Liability clause: In all cases in which IEM GmbH is liable for compensation of damages on the basis of contractual or legal liability, IEM GmbH shall only be held liable if the company’s managerial staff and agents are guilty of intent or gross negligence.

  • Page 73: Emc Guidelines And Manufacturer's Declaration

    EMC guidelines and manufacturer's declaration EMC guidelines and manufacturer's declaration Electromagnetic interference emissions ® The agedio B500 is intended to be operated in the electromagnetic environment specified below. Only use the ® agedio B500 in such an environment. Measurement of –...
  • Page 74 EMC guidelines and manufacturer's declaration Electromagnetic immunity ® The agedio B500 is intended to be operated in the electromagnetic environment specified below. Only use the ® agedio B500 in such an environment. – Measurement of IEC 60601-1 test Electromagnetic environment Compliance level interference emissions level...
  • Page 75 EMC guidelines and manufacturer's declaration – Measurement of IEC 60601-1 test Electromagnetic environment Compliance level interference emissions level guidelines IEC 61000-4-5 Not applicable IEC 61000-4-6 Not applicable Magnetic field at supply Magnet fields at mains frequency should frequency (50/60 Hz) in 30 A/m 30 A/m match the typical values found in...
  • Page 76 EMC guidelines and manufacturer's declaration ® The agedio B500 has been tested with the following frequencies: Measurement of interference IEC 60601-1 test level Compliance level emissions RF interference emissions 380 - 390 MHz 380 - 390 MHz according to 27 V/m; PM 50%; 18 Hz 27 V/m;...

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