IEM agedio B500 Operating Manual Download

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Operating manual

agedio

B500 + agedio

K520

Summary of Contents for agedio B500

Page 1: ...EN Operating manual agedio B500 agedio K520 ...

Page 2: ...erillstr 69 52222 Stolberg Germany Telehone 49 2402 9500 0 Telefax 49 2402 9500 11 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: ...3 3 Symbols on the device 27 3 4 Operating conditions 29 4 The iOS app agedio K520 30 4 1 Data protection 30 4 2 Installing the iOS app agedio K520 30 4 3 Configuring the iOS app agedio K520 31 4 4 Customising the app 32 5 Initial operation of the blood pressure monitor agedio B500 35 5 1 Unpacking 35 5 2 Inserting rechargeable batteries batteries 36 5 3 Switching on off the blood pressure monitor...

Page 4: ...4 8 Measurement result report 55 8 1 Measurement result report for the person who has been measured 55 8 2 Measurement result report for the doctor 57 8 3 Report output 57 9 Care and maintenance 59 9 1 Cleaning 60 9 2 Disinfection 63 9 3 Maintenance plan 64 10 Disposal 65 11 Fault management 66 12 Warranty and repair conditions 71 13 EMC guidelines and manufacturer s declaration 73 ...

Page 5: ...can be used together with the applicable software application to perform arterial age monitoring It is suitable for home healthcare settings and professional facilities such as pharmacies first aid facilities care homes or for home use Read this operating manual carefully before the initial operation and keep it in a suitable place so that the information is available when required NOTE The iOS ap...

Page 6: ...14 53 EU RED Directive 2011 65 EU RoHS The software application agedio 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: ...od pressure cuff L arm circumference 32 38 cm 12 6 15 0 inches 5 Operating manual agedio B500 and K520 6 4AA batteries Optional accessories Blood pressure cuff XL arm circumference 38 55 cm 15 0 21 7 inches 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 ...

Page 8: ...rm circumference of 20 55 cm 7 9 21 7 inches using the corresponding blood pressure cuff size 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 consul...

Page 9: ...The agedio B500 must not be used for blood pressure monitoring during operations The agedio B500 is not intended for alarm triggering monitoring on intensive care units The agedio B500 must not be used near an MRI scanner or other strong magnetic fields The agedio B500 must not be used in vehicles or aircraft WARNING The agedio B500 has not been tested for use on pregnant women or those suffering ...

Page 10: ...cessful blood pressure measurement is not possible Recording the pulse wave at 100 Hz The device does not emit an alarm pursuant to IEC 60601 1 8 The blood pressure monitor is not intended for use in conjunction with HF surgical equipment or for the clinical monitoring of patients such as in an intensive care unit Basic safety means that the patient cannot be endangered by automatic operation of t...

Page 11: ...ble or immediately imminent danger Non adherence may lead to minor moderate or severe injuries or death Directions for use CAUTION Short description of the danger This warning symbol together with the signal word CAUTION indicates possible material damage Non adherence may lead to damage to the device or its accessories NOTE The signal word Note indicates further information about the agedio B500 ...

Page 12: ...measured has sensitive body tissue tissue bleeding or haematomas can occur despite correctly fitting the cuff If the person to be measured takes medication to alter blood coagulation or suffers from coagulation disorders please do not perform the measurement If the person being measured experiences pain swelling redness or numbness in the arm on which the cuff is placed remove the device and conta...

Page 13: ...se 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 Do not apply the agedio B500 if there is an intravascular drip or arteriovenous AV shunt or fistula in the arm ...

Page 14: ... person to be measured that they should follow the doctor s instructions Advise the person to discuss the measurement results with a doctor because only a doctor can assess the measurement results in detail or make a diagnosis Self diagnosis and self treatment based on the measurement results is dangerous WARNING Danger of injury as a result of applying and inflating a cuff on an arm on the same s...

Page 15: ... Make sure that the cuff tube is in the correct position and ensure that the cuff tube is not knotted pinched kinked or stretched Do not bend the cuff tube If the person being measured experiences pain swelling redness or numbness in the arm on which the cuff is placed abort the measurement and contact a doctor if necessary It is expected that some mild to moderate discomfort may be experienced du...

Page 16: ... the correct position and ensure that the cuff tube is not knotted pinched kinked or stretched Check that it does not result in a prolonged impairment of the blood circulation If the person being measured experiences pain swelling redness or numbness in the arm on which the cuff is placed abort the measurement and contact a doctor if necessary It is expected that some mild to moderate discomfort m...

Page 17: ... cuff If the person being measured experiences pain swelling redness or numbness in the arm on which the cuff is placed remove the device and contact a doctor if necessary It is expected that some mild to moderate discomfort may be experienced during a blood pressure measurement The measuring process can be aborted at any time by pressing the button This causes the cuff to deflate and the cuff can...

Page 18: ...rom the batteries due to improper use can cause skin irritation If you come into contact with the liquid rinse the affected area thoroughly with plenty of water If the liquid comes into contact with your eyes do not rub your eyes but instead immediately flush your eyes with water for 10 minutes and seek medical attention immediately WARNING Danger of a temporary loss of function of an existing ele...

Page 19: ...cribed above then this monitor and the other devices should be monitored to ensure that they are functioning correctly 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 d...

Page 20: ...ered by IEM may be used The agedio B500 meets all the requirements of the EMC standards however the agedio B500 should not be exposed to strong electromagnetic fields because outside of the limits this may result in malfunction You should therefore ensure that the distance between the agedio B500 and any portable RF communications equipment is at least 30 cm 12 inches CAUTION Damage to the device ...

Page 21: ... or if you do not expect to use the blood pressure monitor for a longer period of time The batteries rechargeable batteries should not be exposed to fire or high temperatures Do not attempt to recharge batteries Do not attempt to open or short circuit the batteries rechargeable batteries Danger of explosion Remove the batteries or rechargeable batteries from the battery compartment as soon as they...

Page 22: ...cords pulse waves The measured values are transmitted together to the software application agedio K520 The agedio B500 is suitable for use in pharmacies home healthcare settings and professional facilities such as first aid facilities care homes or for home use Blood pressure monitor 1 Display 4 Battery cover 2 Infrared interface for connectivity 5 Air tube socket 3 Button ...

Page 23: ...The display 1 When shown battery empty 6 Pulse rate per minute 2 Displays systolic value top number 7 Pulse detected 3 Data transmission 8 Number of measured values 4 Bluetooth 9 Displays diastolic value bottom number 5 Infrared communication ...

Page 24: ...Blood pressure monitor agedio B500 24 The blood pressure cuff 1 2 Blood pressure cuff Air tube 3 Air tube connector The agedio B500 is connected to the cuff using the air tube connector ...

Page 25: ...ge 30 to 240 1 min Pressure accuracy 3 mmHg Pulse accuracy 2 or 3 BPM whichever is greater Memory 15 Measurements Power supply 6V 4x AA 1 5V alkaline Dimensions l x w x h 152 x 110 x 57 mm Weight without batteries 325 g Material casing ABS acrylnitrile butadiene styrene Material cuff Polyester IP protection class 21 Operating temperature 5 to 40 C Ambient pressure 700 to 1060 hPa Transport tempera...

Page 26: ... Storage temperature 25 to 70 C Humidity non condensing operation transport and storage 15 to 93 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: ... 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 Protect from rain and moisture Comply with the operating manual ...

Page 28: ...c 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 The device is defibrillation proof The device emits electromagnetic waves The product has a Bluetooth interface Serial number ...

Page 29: ...uracy 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 Only store or use the blood pressure monitor at a humidity non condensing of 15 to 93 Extreme temperatures humidity non condensing or altitude can affect the performance of the blood pressure monitor ...

Page 30: ...prove the measurement devices and for research purposes As correlating measured data to your person is not possible the data is considered anonymous In case of using agedio in conjunction with an activated special feature storing your data along with a customer ID whereby an assignment of the data to your person is given your consent to the storage of the data will be explicitly requested before t...

Page 31: ...ing the iOS app agedio K520 you will need to change a few settings on your iPad in order to adapt the iOS app agedio K520 to your environment and prepare it for use NOTE Activated iOS settings are indicated with a green background 10 Open the iOS settings on your iPad 11 Check that the Bluetooth interface is activated in the Bluetooth settings If Bluetooth is not switched on activate this function...

Page 32: ...centimeters cm weight in kilograms kg Imperial feet inches or pounds Metric or imperial you can change the units on the input page NOTE The app s language settings comply with the iOS settings 4 4 Customising the app Inserting a customer slogan To customise your agedio K520 app you can insert your slogan and include your logo Both appear on the home screen and on the printed reports 14 Select the ...

Page 33: ...p to load your logo from this location Ideally this is located on your server or your home page The URL must be in the following format http example com image jpg Alternative file formats JPG TIFF BMP PNG and GIF 18 Test the logo s position quality and size in the app and on print outs NOTE Some servers require that you observe case sensitivity to load the logo If you do not insert a logo the app ...

Page 34: ...vation code 22 Using the navigation bar on the right the following information can be displayed Information about the manufacturer of the app and contact details for servicing purposes EULA and privacy policy Operating manual 23 Press to return to the home screen Special features In the section Special features additional features for the iOS app agedio K520 can be activated In addition special fe...

Page 35: ...please inform your healthcare provider immediately 24 Unpack the entire delivery package and check that everything is present 25 Inspect the products to ensure there is no visible damage 26 Should the products be incomplete or damaged please inform the suppliers immediately 27 Keep the packaging so that it can be used to safely package the products at a later date 28 When returning goods it is obl...

Page 36: ... pressed If the button is accidentally pressed while inserting the batteries the device goes into the manometer mode used for servicing purposes Remove the batteries and insert the batteries again 30 Open the battery cover on the underside of the blood pressure monitor 31 Insert four batteries AA alkaline with the correct polarity 32 Close the battery compartment with the battery compartment lid 3...

Page 37: ...ressure monitor agedio B500 37 EN 34 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: ...ure monitor agedio B500 38 5 3 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: ... B500 with the iOS app agedio K520 you must first pair the agedio B500 with your iPad 35 Open the iOS settings on your iPad and select the setting Bluetooth 36 Switch on the agedio B500 by pressing the button until the start screen is displayed 37 Press and hold the button on the blood pressure monitor for approximately 3 seconds ...

Page 40: ...it until PAI P flashes on the display 39 Press the button 40 A signal tone sounds and the display continuously shows PAI P 41 After a few seconds the iPad displays the serial number of the agedio B500 see rating plate 42 Click on the serial number of the agedio B500 on the iPad touchscreen The iPad is now connected with the agedio B500 and Connected briefly appears on the iPad touchscreen 43 The B...

Page 41: ...Initial operation of the blood pressure monitor agedio B500 41 EN ...

Page 42: ...t a time However if the iOS does not recognise the status and continues to show Not Connected a connection to the app will not be established Solution Press the small blue i on the right next to the status Not Connected and select the option Forget This Device Then they can be paired again as described above NOTE If any problems occur during the installation initial operation servicing or if any u...

Page 43: ...tula Do you suffer from circulation disorders in the arm being used for the measurement Are you allergic to epoxy resin or any disinfectants Do you take anticoagulant medication anticoagulants or do you suffer from blood coagulation disorders If the above points can be ruled out for the person to be measured then you can continue to prepare for measurement Also note the warnings in the correspondi...

Page 44: ...known hypersensitivity to epoxy resin Selecting a suitable upper arm cuff is very important for a correct blood pressure measurement and pulse wave analysis Select the cuff size according to the upper arm circumference of the person to be measured Upper arm circumference of the person to be measured Arm cuff size 20 24 cm 7 9 9 5 inches S 24 32 cm 9 5 12 6 inches M 32 38 cm 12 6 15 0 inches L 38 5...

Page 45: ...ed mental capabilities must not be put at risk Keep out of reach Do not put the blood pressure cuff or the blood pressure cuff tube around the neck of the person to be measured The measuring process can be aborted at any time by pressing any button This deflates the cuff and the device can then be removed If the person being measured experiences pain swelling redness or numbness in the arm on whic...

Page 46: ...rough the blood pressure cuff NOTE The blood pressure cuffs are supplied pre assembled In case the cuff is not pre assembled proceed as follows Lay out the cuff fully with the Velcro side facing downwards A loop is located at one end of the cuff thread the other end of the cuff through and fold the end of the cuff over the loop so that the hook side of the Velcro attaches to the soft pile side 46 ...

Page 47: ... sure that the artery symbol on the cuff is positioned on the brachial artery Align the cuff so that no part of the cuff tube can be kinked When the blood pressure cuff is correctly positioned the metal loop is on the outside of the upper arm on the elbow side and is covered by the cuff strap fabric The blood pressure cuff must be applied directly on the skin 47 Fasten the Velcro on the blood pres...

Page 48: ...k and arm supported centre of the cuff at the same height as the right atrium NOTE During the measurement the person being measured 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 person being measured stress o...

Page 49: ...he person to be measured into the relevant fields and select the sex Permissible values Parameter Min Max Unit Age 20 100 years Height 45 17 7 250 98 4 cm inches Weight 30 200 kg You can correct incorrect entries by tapping on the entry field again 52 When all parameters are complete marked with a tick tap on Next The Preparation window is displayed NOTE If you have previously used the agedio B900...

Page 50: ...he agedio B500 is switched on 54 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: ...d transmission Ir Bluetooth transmission bt active pairing PAI A passive pairing PAI P delete measured values C lr Bluetooth can also be activated using the menu Wait until bt flashes on the display Press the button An acoustic signal sounds and the display shows the Bluetooth and the data transmission symbols ...

Page 52: ... the vascular age measurement is performed Eine abgeschlossene Phase erkennen Sie an diesem Icon A completed phase can be recognised by this icon Ensure that the person being measured does not change their position during the whole measurement process After the measurement is complete the agedio K520 app displays the report Remove the blood pressure cuff WARNING Taking measurements too frequently ...

Page 53: ...ion Severe malfunctions are indicated by a continuous beep NOTE After the blood pressure measurement the blood pressure monitor pumps for approximately 10 seconds at the same rate as the diastolic blood pressure reading to record the pulse wave The pulse wave analysis provides additional indicators of potential risks but it is not a sufficiently reliable indicator for individual illnesses or treat...

Page 54: ... the device 60 Repeat the measurement 61 If the display still shows error please repeat the initial operation process INTERNAL REFERENCE For further troubleshooting and fault correction measures please refer to chapter Fault management 7 4 Quality of the measurement In the header of the report you will see the quality of the measurement iOS app agedio K520 distinguishes between three levels Excell...

Page 55: ... on the right next to the data for the person being measured Blood pressure reading In accordance with the World Health Organisation WHO the blood pressure reading is classified as shown Blood pressure Systolic mmHg Diastolic mmHg Colour normal 130 85 Green high normal 130 139 85 89 Yellow high 139 89 Red The heart rate HR shows the number of heartbeats per minute It is shown as 1 min beats per mi...

Page 56: ...to the age of the person being measured to determine the difference The vessels may be the same age older or younger specified in years The colour coding provides a visual decision aid It is based on the PWV column and helps suggest the best way to interpret the results Green The measured values are OK Your PWV is the same or better than the average for your age group Yellow The measured values ar...

Page 57: ...ports can be obtained from the app in various ways Processing the report The report is provided as a PDF accessible via the available or installed services on the Apple operating system iOS One option is to send the report via e mail Sending the report outside of the app is not subject to the privacy policy and EULA of this app To send it via e mail tap the icon on the top right Printing the repor...

Page 58: ...Measurement result report 58 Completing the vascular age measurement Tap the icon to complete the process You can now continue with the next measurement ...

Page 59: ...allergies to disinfectants or their components When applying the device no disinfectant residue may be present on the blood pressure cuff CAUTION Loss of warranty Do not open the casing If the device is opened all warranties expire Do not immerse the cuff with bladder or the blood pressure monitor in disinfectant water or other liquids If liquid enters the monitor switch it off immediately and sen...

Page 60: ... Cleaning the cuff sleeve Only use a mild detergent without fabric softener and lukewarm water to clean the cuff sleeve Cleaning the bladder and tube 65 To clean the bladder remove it from the cuff To do this pull the one side of the cuff out of the loop and fully open out the cuff 66 Remove the bladder with tube from the bladder pouch by pulling them out through the slit on the inside of the cuff...

Page 61: ...ure that no water enters the bladder or tube 68 When the cuff bladder and tube are completely dry lie the cuff sleeve out fully with the Velcro side facing downwards Slide the bladder through the slit in the bladder pouch and thread the tube through the small opening from the inside of the cuff to the outside Ensure that no folds occur when inserting the bladder ...

Page 62: ...ent if necessary Never use abrasive or solvent based detergents because these can damage the surface of the blood pressure monitor and the cuff Do not use fabric softeners or other additives e g hygiene rinses textile deodorants These agents can leave behind residue and damage the material The cuff sleeve can be machine washed at max 30 C with a mild detergent Do not spin The cuff sleeve is not su...

Page 63: ...ctants are recommended for disinfecting the cuff sleeve Isopropanol 70 percent Terralin liquid manufacturer Schülke Mayr For the best result moisten the cuff sleeve with disinfectant for at least 5 minutes Always allow the disinfectant to completely dry Ensure that any disinfectants used are washed off leaving no residue before the blood pressure cuff is worn When using other disinfectants that we...

Page 64: ... 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 Medical Product Operator Regulations To ensure continued compliance with the essential requirements pursuant to the Direc...

Page 65: ...n about this from your local authority local waste disposal companies or the shop in which you bought the product Batteries Rechargeable batteries Batteries must not be disposed of with domestic waste As a consumer you are legally bound to return used batteries You can dispose of your old batteries at official collection points in your local area or anywhere that sells this type of battery Li Batt...

Page 66: ...ied the cuff slipping while being worn using not fully charged incorrectly charged or out of date rechargeable batteries kinks or knots in the cuff tube Checklist Please read the following checklist if any errors occur when using the agedio B500 Check that the agedio B500 and the iPad are switched on and that the app agedio K520 is started on the iPad Check that the rechargeable batteries are suff...

Page 67: ...ll during the measurement Err 3 Blood pressure is outside of the measurement range If this notification is consistently or repeatedly shown then this blood pressure monitor might not be suitable for you Contact a doctor Strong arm movement Keep the arm still during the measurement Err 4 IR communication error If this notification is consistently or repeatedly shown contact your healthcare provider...

Page 68: ...blood pressure cuff to the blood pressure monitor Leak in the blood pressure cuff or in the air tube Replace the blood pressure cuff with air tube Abr aborted Measurement aborted by pushing a button Do not push the buttons during a measurement except if you want to stop the measurement Err 9 Residual pressure in the blood pressure cuff Wait until the blood pressure cuff has fully deflated Err 10 I...

Page 69: ...on Check that your transmission device is switched on If this error occurs repeatedly contact the manufacturer or your specialist supplier Cod 3 Measured values could not be transmitted Take another measurement and check that the measured values are transmitted If this error occurs repeatedly contact the manufacturer Cod 4 Communication error If this error occurs repeatedly contact the manufacture...

Page 70: ...lution 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: ...nly the NiMH rechargeable batteries can be replaced by the operator If the defect is due to non observance of the operating manual incorrect operation moisture humidity or extreme temperatures or climatic conditions or short term fluctuations of these factors corrosion oxidation unauthorised interventions or connection attempts unauthorised opening or repairs repair attempts with unauthorised spar...

Page 72: ...ntent or gross negligence Strict liability according to the Product Liability Act remains unaffected regardless of culpability Liability for the culpable breach of fundamental contractual obligations also remains unaffected however except in the cases specified in clauses 1 and 2 liability is limited to foreseeable damage typical for the contract A change in the burden of proof to the disadvantage...

Page 73: ...cording to CISPR 11 Group 1 The agedio B500 uses RF power exclusively for its internal function Its RF emission is therefore very low and it is unlikely that any neighbouring electronic device will experience any interference RF interference emissions according to CISPR 11 Class B The agedio B500 is suitable for use in facilities other than residential areas and those directly connected to the pub...

Page 74: ...kV air discharge Floors should consist of wood or cement or ceramic tiles If the floor consists of synthetic materials relative humidity must be at least 30 RF radiated disturbances in accordance with IEC 61000 4 3 10 V m 80 MHz to 2 7 GHz 10 V m Do not use wearable or portable radio equipment closer to the Tel O Graph GSM or its cables than the recommended safe distance The field strength of stat...

Page 75: ...el Electromagnetic environment guidelines IEC 61000 4 5 Not applicable IEC 61000 4 6 Not applicable Magnetic field at supply frequency 50 60 Hz in accordance with IEC 61000 4 8 30 A m 30 A m Magnet fields at mains frequency should match the typical values found in business and hospital environments IEC 61000 4 11 Not applicable ...

Page 76: ...M 50 18 Hz 430 470 MHz 28 V m FM 5 kHz 1 kHz Sinus PM 18 Hz 704 787 MHz 9 V m PM 50 217 Hz 800 960 MHz 28 V m PM 50 18 Hz 1700 1990 MHz 28 V m PM 50 217 Hz 2400 2570 MHz 28 V m PM 50 217 Hz 5100 5800 MHz 9 V m PM 50 217 Hz 380 390 MHz 27 V m PM 50 18 Hz 430 470 MHz 28 V m FM 5 kHz 1 kHz Sinus PM 18 Hz 704 787 MHz 9 V m PM 50 217 Hz 800 960 MHz 28 V m PM 50 18 Hz 1700 1990 MHz 28 V m PM 50 217 Hz 2...

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