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IEM agedio B500 Operating Manual

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  • Page 2 Fax: +49 2402 9500-11 Email: 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. © 2020 IEM GmbH...

  • Page 3: Table Of Contents

    Table of contents Introduction ................................5 Clinical validation ................................6 CE mark ..................................6 Contents ..................................7 Instructions for use ............................... 8 Intended use .................................. 8 Contraindications ................................. 9 Essential performance features ..........................10 Safety & security ..............................11 Explanation of safety symbols ..........................11 Important patient information ..........................
  • Page 4 Performing a measurement ............................ 41 Aborting a measurement ............................45 Measurement not successful ..........................47 ® Transferring the measurement values via Bluetooth ..................48 Active pairing (Bluetooth ® modem) ........................48 Passive pairing (iPad) ............................... 49 Memory ................................50 Saving readings ................................. 50 Deleting readings from the device .........................

  • Page 5: Introduction

    Introduction Introduction Thank you for choosing the agedio ® B500 upper arm blood pressure monitor with integrated pulse wave analysis. Read this operating manual carefully before use and keep it in a suitable place so that the information is available when required. The agedio ®...

  • Page 6: Clinical Validation

    • and bears the CE mark. ® GmbH hereby declares that the agedio ® B500 is compliant with the directive 2014/53/EU (RED). NOTE The complete text of the EU Declaration of Conformity is available at the following internet address: www.iem.de.

  • Page 7: Contents

    Introduction Contents Basic set Optional accessories agedio ® B500 Arm cuff “XL” (Arm circumference: • 38-55 cm [15.0-21.7 inches]) Arm cuff “S” (Arm circumference: 20-24 cm [7.9-9.5 inches]) Arm cuff “M” (Arm circumference: 24-32 cm [9.5-12.6 inches]) Arm cuff “L” (Arm circumference: 32-38 cm [12.6-15.0 inches]) 4 AA batteries Tape measure...

  • 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. It is used by trained pharmacy staff and other healthcare workers to measure blood pressure and pulse wave velocity in adults.

  • Page 9: Contraindications

    Instructions for use Contraindications The blood pressure monitor must not be used for newborn infants or children under the age of 12, must not be used for surgery, must not be used near a magnetic resonance imaging scanner or other strong magnetic field, and must not be used for monitoring patients within a clinical context or during their transport.

  • Page 10: Essential Performance Features

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

  • Page 11: Safety & Security

    Safety & security Safety & security This section provides all of the safety information relating to the device. Read this section carefully before using the blood pressure monitor, and discuss it with the patient! 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.

  • Page 12: Important Patient Information

    Safety & security NOTE The signal word NOTE indicates further information about the agedio ® B500 or its accessories. INTERNAL REFERENCE Indicates references within the document for further information.
  • Page 13 Safety & security Important patient information Read the safety information carefully before using the product and discuss it with the patient! 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.
  • Page 14 Safety & security WARNING Risk of impaired blood circulation as a result of applying and inflating a cuff on limbs with an intravascular drip or intravascular treatment or with an arteriovenous (AV) shunt! Do not apply the agedio® B500 if there is an intravascular drip or arteriovenous (AV) shunt in the •...
  • Page 15 Safety & security WARNING Risk of injury as a result of allergic reactions to the cuff material! Remove the cuff if pain is experienced or an allergic reaction develops. • Do not use the cuff on persons with a known hypersensitivity to epoxy resin. •...
  • Page 16 Safety & security WARNING Risk of impaired blood circulation as a result of constant cuff pressure or taking measurements too frequently! Inform the patient about this danger. • Observe the patient carefully during the measurement. • Ask the patient when the last blood pressure measurement was taken and how they tolerated the •...
  • Page 17 Safety & security WARNING Risk of injury and risk of prolonged impairment of blood circulation in the patient or the affected limb due to the operation and use of the automated non-invasive blood pressure monitor! Inform the patient about this danger. •...
  • Page 18 Safety & security WARNING Risk of strangulation due to the cuff tube! Ensure that children are not left unsupervised with the blood pressure monitor! • Persons who are deemed legally incompetent may only use this device under direct supervision. • (Keep out of reach.) Do not wrap the cuff or the cuff tube around the neck! •...
  • Page 19 Safety & security WARNING Risk 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 •...

  • Page 20: Important Device Information

    The use of components not included in the delivered package may result in measurement errors. • You should therefore only use genuine IEM ® GmbH accessories. The cuffs and the tube are made from non-conducting material. They therefore protect the •...
  • Page 21 The use of components not included in the shipped package may result in measurement errors • because the use of alternative transformers or cables (for example) may result in increased electromagnetic interference emissions or reduced immunity to electromagnetic interference. You should therefore only use genuine IEM ® GmbH accessories. The agedio ®...
  • Page 22 Safety & security CAUTION Damage to the device due to liquid Liquid must not enter the device! If you suspect that liquid has entered the monitor during • cleaning or using it, the monitor must no longer be used. If the monitor is exposed to moisture, switch off the monitor and remove the batteries. •...
  • Page 23 Safety & security CAUTION Batteries Remove the (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. The (rechargeable) batteries should not be exposed to fire or high temperatures! •...

  • Page 24: Description Of Device

    Description of device Description of device Blood pressure monitor Fig. 1: Blood pressure monitor Display Battery cover Infrared interface (for service) Air tube socket button...

  • Page 25: Blood Pressure Cuff

    Description of device Blood pressure cuff Blood pressure cuff Fig. Blood pressure cuff Air tube connector Air tube...

  • Page 26: Display

    Description of device Display Fig. 3: 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 27: Operating Conditions

    Description of device Operating conditions CAUTION Extreme temperature, air humidity or air pressure values can affect measurement accuracy. Please observe the operating conditions. 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 °C to +40 °C.

  • Page 28: Preparing For Measurement

    Preparing for measurement Preparing for measurement Unpacking NOTE All of the products included in the package as shipped were properly packaged upon shipment and checked to ensure that they were complete and functional. Should the products be incomplete, damaged or non-functional, please inform your healthcare provider immediately. WARNING Risk of strangulation by the cuff tube and cuff! Keep the cuff out of the reach of children.

  • Page 29: Inserting The Batteries

    Preparing for measurement Inserting the batteries Fig. 4: Opening the battery cover NOTE Hold the monitor in your hand and insert the batteries. • Make sure that the button on the front is not pressed! • If the button is accidentally pressed while inserting the batteries, the device goes into the •...
  • Page 30 Preparing for measurement WARNING Make sure that all segments of the screen are displayed. Inform your healthcare provider if the display is damaged. Fig. 5: Test screen...

  • Page 31: Switching On/Off The Blood Pressure Monitor

    Preparing for measurement Switching on/off the blood pressure monitor Switching on Fig. 6: Start screen Press the button.  The start screen will be displayed (see Fig. 6). Switching off The blood pressure monitor switches off automatically after approximately 5 minutes.

  • Page 32: Performing A Measurement

    Performing a measurement Performing a measurement Patient interview Interviewing the patient at the initial stage of preparing for the measurement is an important step in order to avoid any possible dangers and risks for the patient. Ask the patient the following questions: Do you have any other electrical medical devices on your body? •...

  • Page 33: Applying The Cuff

    Performing a measurement Before measuring The patient should refrain from eating, smoking or engaging in any strenuous activity directly before the measurement. All these factors affect the results. Before blood pressure is measured, the patient should relax in a quiet environment for five minutes. Always measure on the same arm (normally your left).
  • Page 34 Performing a measurement Applying the cuff WARNING Strangulation risk due to blood pressure cuff and blood pressure cuff tube Do not use the agedio® B500 on newborn babies or children. • Ensure that children are not left unsupervised with the blood pressure monitor! •...
  • Page 35 Performing a measurement WARNING Risk of injury as a result of allergic reactions to the cuff material! Remove the cuff if pain is experienced or an allergic reaction develops. • Observe the information regarding cleaning and disinfection. • WARNING Risk of injury as a result of using non-approved accessories! Only use accessories approved by the manufacturer and sold by the distributor or manufacturer.
  • Page 36 Performing a measurement Fig. 7: Inserting the air tube Insert the air tube connector into the air tube socket on the left side of the blood pressure monitor and place the blood pressure monitor on the table (see Fig. 7). Select the correct cuff size.
  • Page 37 Performing a measurement NOTE To obtain accurate blood pressure and pulse wave readings, it is very important that the correct cuff is used. Uncover your left upper arm. NOTE The blood pressure cuff must be applied directly on the skin. Insert your left arm into the cuff.
  • Page 38 Performing a measurement Fig. 8: Correct position of cuff Position the cuff correctly (see Fig. 8): 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 39: Correct Posture

    Performing a measurement NOTE Place the cuff so that there is enough room to insert your index and middle fingers between the skin and the cuff’s material.
  • Page 40 Performing a measurement Correct posture Once the cuff is applied, the patient should assume the correct posture for measurement (Fig. 9): Sit down comfortably on a chair to measure your blood pressure. Place your elbow on a table or a solid surface. Lean back with your back against the backrest of the chair.

  • Page 41: Performing A Measurement

    Performing a measurement NOTE During the measurement, the patient must relax as much as possible and may not speak unless • to express discomfort. Allow 5 minutes’ rest before the first measured value is recorded. • The measurement result can be affected by the position of the cuff, posture and position of the •...
  • Page 42 Performing a measurement Performing a measurement INTERNAL REFERENCE The agedio® K520 is not described in detail in this operating manual; please refer to the agedio® K520 operating manual for this purpose. Pre-requisites: The agedio ® K520 must be installed on an iPad. •...
  • Page 43 Performing a measurement Tap on the corresponding icon. Enter the corresponding parameters and follow the instructions in the agedio® K520 iOS app. To active Bluetooth ® : Press and hold the button on the blood pressure monitor for approximately 3 seconds and wait until the display flashes [bt]. An audible signal sounds and the display shows the Bluetooth ®...
  • Page 44 Performing a measurement NOTE The patient 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 •...

  • Page 45: Aborting A Measurement

    Performing a measurement WARNING Taking measurements too frequently can result in impaired blood circulation! Wait for at least 2 or 3 minutes before performing another measurement to give your arteries time • to return to their initial state.
  • Page 46 Performing a measurement Aborting a measurement If the measurement causes you pain, press the button during the measurement. [Abr] then appears on the agedio ® B500 display and an audible signal will sound.  The air is let out of the cuff and the measurement is aborted. Remove the blood pressure cuff.

  • Page 47: Measurement Not Successful

    Performing a measurement Measurement not successful If the display shows “error”, recheck the correct procedure for setting up and applying the device. Repeat the measurement. If the display still shows “error”, please repeat the initial setup process. INTERNAL REFERENCE For further troubleshooting and fault correction measures, please refer to the chapter “Fault management”.

  • Page 48: Transferring The Measurement Values Via Bluetooth

    Transferring the measurement values via Bluetooth® Transferring the measurement values via Bluetooth ® If the blood pressure monitor is configured to transfer readings via Bluetooth ® , readings will be sent to the agedio® K520 iOS app automatically. NOTE In the event of problems with data transmission, please refer to the chapter “fault management”. •...

  • Page 49: Passive Pairing (Ipad)

    Transferring the measurement values via Bluetooth® Passive pairing (iPad) NOTE Pairing requires some basic familiarity with Bluetooth ® . If you are not familiar with Bluetooth, • please contact your healthcare provider. Switch on the agedio ® B500. Press and hold the button for around 6 seconds.

  • Page 50: Memory

    Memory Memory Saving readings Fig. 10: Number of readings The blood pressure monitor can save 15 blood pressure readings and 15 pulse rate readings. NOTE Only readings that have not yet been transferred to the database are saved. If there are more than 15 readings, the oldest data is overwritten by the new readings.

  • Page 51: Deleting Readings From The Device

    Memory NOTE Data loss To avoid data loss, contact your healthcare provider, certainly no later than when the display • already shows 15 measurements. Previously transmitted data is retained in the database and is not overwritten. • When performing a new measurement with the agedio ®...
  • Page 52 Memory Deleting readings from the device To clear the memory on your blood pressure monitor, proceed as follows: Fig. 11: Deleting measurements Press and hold the button on the blood pressure monitor for approximately 6 seconds.  The display shows [PAI P]. NOTE After 3 seconds, the display will show [bt];...
  • Page 53 Memory ® Bluetooth transmission (bt) • Delete measured values (C lr) • NOTE The Infrared transmission [Ir] menu option is intended for service personnel only. Wait until [c lr] flashes on the display (see Fig. 11). Press the button.  You will hear an audible signal and the display will show [c lr] without flashing. Press and hold the button for at least 3 seconds.

  • Page 54: Cleaning And Disinfection

    Cleaning and disinfection Cleaning and disinfection WARNING Intolerance! When applying the device, there must be no disinfectant residue present on the blood pressure • cuff! There are patients who have intolerances (e.g. allergies) to disinfectants or their components! • CAUTION Damage during cleaning! Do not immerse the cuff and its bladder or the blood pressure monitor in disinfectant, water or •...

  • Page 55: Cleaning

    Cleaning and disinfection Cleaning For hygiene reasons, the user should clean the agedio ® B500 and the cuff after every use. CAUTION Damage during cleaning! To clean, use lukewarm water up to 30°C max., to which you can add a mild detergent if •...
  • Page 56 Cleaning and disinfection Cleaning the bladder and tube: To clean the bladder, remove it from the cuff. To do this, pull the one side of the cuff out of the clasp and fully open out the cuff. Remove the bladder with the tube from the bladder pouch by pulling it out through the slit on the inside of the cuff, see Fig.
  • Page 57 Cleaning and disinfection When the cuff, bladder and tube are completely dry, lay the cuff sleeve out fully with the hook-and-loop side facing downwards. Insert the bladder into the bladder pouch via the slit provided and thread the tube through the small opening on the inside of the cuff (Fig. 13). Ensure that no folds occur when inserting the bladder! Fig.

  • Page 58: Disinfection

    It is important to ensure that the disinfectant is washed off completely before the cuff is applied to a patient’s arm. When using other disinfectants that are not recommended by IEM ® GmbH the burden of proof that these can be used without causing damage lies with the user.

  • Page 59: Maintenance

    In certain countries, this requirement may be regulated by national laws or regulations. The metrological check is subject to a charge and can be carried out by IEM ® GmbH, by a competent public authority or by an authorised maintenance service in accordance with the “Medical Devices Operator Ordinance”.

  • Page 60: 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. Further information about this is available from your local authority, local waste disposal institutions or the supplier from which the product was purchased.

  • Page 61: Fault Management

    Fault management Fault management Main sources of error The following can cause measurement errors or unwanted results: Arm movement of the patient during the measurement • Incorrect cuff size applied • The cuff slipping while being worn • Using not fully charged, incorrectly charged or out-of-date rechargeable batteries •...

  • Page 62: Blood Pressure Measurement Errors

    Fault management 12.1 Blood pressure measurement errors 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 again. detected. Err 2 The arm moved during the Keep the arm still during the measurement.
  • Page 63 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 64: Communication Errors

    Fault management 12.2 Communication errors 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. The data transmission device Switch on the transmission device. is switched off.
  • Page 65 Fault management Error description Cause Solution Cod 7 Memory empty Perform a measurement. If this error occurs repeatedly, contact the manufacturer or your specialist supplier.

  • Page 66: Technical Data And Symbols

    Technical data and symbols Technical data and symbols 13.1 Technical data The blood pressure monitor complies with EMC directives. The cuff and air tube are made of a non-conductive material. This makes the device defibrillator-safe. Specification Value Unit Measuring method Oscillometric Systolic 60 to 290 Blood pressure measurement range...
  • Page 67 Technical data and symbols Specification Value Unit Transport temperature -25 to +70 °C Storage temperature -25 to +70 °C Rel. humidity, non-condensing (operation, 15 to 93 transport and storage) Battery capacity approx. 500* Measurements Data connection Bluetooth® Data transmission Class 1 Bluetooth ®...

  • Page 68: Symbols On The Device

    Technical data and symbols 13.2 Symbols on the device Symbol Meaning 4 x NiMH or LR6, AA 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 69 Technical data and symbols Symbol Meaning Comply with the operating manual! The symbol on the product or packaging means that this product should not be treated as normal domestic waste, but should be returned to a recycling point for electric and electronic devices. Further information about this is available from your local authority, local waste disposal institutions or the supplier from which the product was purchased.

  • Page 70: Warranty And Repair Conditions

    Warranty and repair conditions Warranty and repair conditions 14.1 Warranty: ® GmbH provides a two-year warranty on the blood pressure monitor from the date of sale. Proof of • the date of sale must be provided in the form of a properly completed warranty card or an invoice. Faults due to material or production defects will be remedied free of charge within the warranty period.

  • Page 71: Repairs

    Liability clause Wherever IEM ® GmbH is liable for compensation of damages on the basis of contractual or legal liability, IEM ® GmbH may only be held liable if the company’s managerial staff or agents are guilty of intent or gross negligence.

  • Page 72: 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 designed to be operated in the electromagnetic environment specified below. Only use the agedio ® B500 in such an environment. Measurement of Compliance Electromagnetic environment –...
  • Page 73 EMC guidelines and manufacturer's declaration Electromagnetic immunity The agedio ® B500 is designed to be operated in the electromagnetic environment specified below. Only use the agedio ® B500 in such an environment. Emitted interference IEC 60601-1 Electromagnetic environment – Compliance level measurement test levels guidelines...
  • Page 74 EMC guidelines and manufacturer's declaration Emitted interference IEC 60601-1 Electromagnetic environment – Compliance level measurement test levels guidelines Power frequency Power frequency magnetic fields (50/60 Hz) magnetic should be at levels characteristic of a 30 A/m 30 A/m field according to IEC typical commercial or hospital 61000-4-8 environment.
  • Page 75 EMC guidelines and manufacturer's declaration ® The agedio B500 has been tested in relation to the following frequencies: Emitted interference IEC 60601-1 test levels Compliance levels measurement Radiated RF 380–390 MHz 380–390 MHz disturbance according 27 V/m; PM 50 %; 18 Hz 27 V/m;...
  • Page 76 EMC guidelines and manufacturer's declaration Measurement of IEC 60601-1 test levels Compliance levels interference emissions Radiated RF 380–390 MHz 380–390 MHz disturbance according 27 V/m; PM 50%; 18 Hz 27 V/m; PM 50%; 18 Hz to IEC 61000-4-3 430–470 MHz 430–470 MHz 28 V/m;...

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