IEM agedio B500 User manual

EN

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0044
Operating manual: agedio®B500
Blood pressure monitor: agedio®B500
Analysis unit: agedio®K520
Manufacturer
IEM®GmbH
Cockerillstrasse 69
52222 Stolberg
Germany
Telephone: [phone]
Fax: [phone]
Email: [e-mail]
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
Rev. E –07.04.2020 - EN

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Table of contents
1Introduction ........................................................................................................................................................... 5
1.1 Clinical validation..........................................................................................................................................................6
1.2 CE mark ..........................................................................................................................................................................6
1.3 Contents .........................................................................................................................................................................7
2Instructions for use............................................................................................................................................... 8
2.1 Intended use ..................................................................................................................................................................8
2.2 Contraindications .........................................................................................................................................................9
2.3 Essential performance features ............................................................................................................................. 10
3Safety & security ................................................................................................................................................. 11
3.1 Explanation of safety symbols................................................................................................................................ 11
3.2 Important patient information ................................................................................................................................ 12
3.3 Important device information ................................................................................................................................. 20
4Description of device .......................................................................................................................................... 24
4.1 Blood pressure monitor............................................................................................................................................ 24
4.2 Blood pressure cuff ................................................................................................................................................... 25
4.3 Display ......................................................................................................................................................................... 26
4.4 Operating conditions................................................................................................................................................. 27
5Preparing for measurement ............................................................................................................................... 28
5.1 Unpacking ................................................................................................................................................................... 28
5.2 Inserting the batteries............................................................................................................................................... 29
5.3 Switching on/off the blood pressure monitor...................................................................................................... 31
6Performing a measurement ............................................................................................................................... 32
6.1 Patient interview ........................................................................................................................................................ 32
6.2 Before measuring ...................................................................................................................................................... 32
6.3 Applying the cuff........................................................................................................................................................ 33
6.4 Correct posture .......................................................................................................................................................... 39

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6.5 Performing a measurement .................................................................................................................................... 41
6.6 Aborting a measurement ......................................................................................................................................... 45
6.7 Measurement not successful ................................................................................................................................. 47
7Transferring the measurement values via Bluetooth®.................................................................................... 48
7.1 Active pairing (Bluetooth®modem) ....................................................................................................................... 48
7.2 Passive pairing (iPad) ............................................................................................................................................... 49
8Memory................................................................................................................................................................ 50
8.1 Saving readings ......................................................................................................................................................... 50
8.2 Deleting readings from the device ......................................................................................................................... 51
9Cleaning and disinfection ................................................................................................................................... 54
9.1 Cleaning....................................................................................................................................................................... 55
9.2 Disinfection ................................................................................................................................................................. 58
10 Maintenance........................................................................................................................................................ 59
11 Disposal ............................................................................................................................................................... 60
12 Fault management.............................................................................................................................................. 61
12.1 Blood pressure measurement errors..................................................................................................................... 62
12.2 Communication errors ............................................................................................................................................. 64
13 Technical data and symbols .............................................................................................................................. 66
13.1 Technical data............................................................................................................................................................ 66
13.2 Symbols on the device ............................................................................................................................................. 68
14 Warranty and repair conditions ......................................................................................................................... 70
14.1 Warranty: ..................................................................................................................................................................... 70
14.2 Repairs......................................................................................................................................................................... 71
14.3 Liability clause............................................................................................................................................................ 71
15 EMC guidelines and manufacturer's declaration ............................................................................................. 72

Introduction
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EN
1Introduction
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®B500 is a fully automated blood pressure monitor that allows for automated transmission via
Bluetooth®. The agedio® B500 also records the pulse waveform of the pulse, which is transferred together with
the blood pressure reading. The agedio®K520 iOS app is used to perform the analysis for the agedio® B500. The
agedio®K520 iOS app can be downloaded via the Apple App Store.
This operating manual explains the agedio® B500 blood pressure monitor and its accessories in the order you
will follow when preparing the device for use and using it later on.
If you have any questions about services or products, feel free to contact us.
INTERNAL REFERENCE
agedio® K520 is not described in this operating manual; please refer to the agedio® K520 operating
manual for this purpose.

Introduction
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1.1 Clinical validation
The accuracy of the device's measurements has been certified in accordance with ISO 81060-2:2013.
1.2 CE mark
The agedio®B500 satisfies the requirements of the following directives:
•Directive 2017/745 (MDR)
•Directive 2014/53/EU (RED)
•Directive 2011/65/EU (RoHS)
and bears the CE mark.
IEM®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.

Introduction
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1.3 Contents
Basic set
1. agedio®B500
2. Arm cuff “S” (Arm circumference:
20-24 cm [7.9-9.5 inches])
3. Arm cuff “M” (Arm circumference:
24-32 cm [9.5-12.6 inches])
4. Arm cuff “L” (Arm circumference:
32-38 cm [12.6-15.0 inches])
5. 4 AA batteries
6. Tape measure
7. agedio®B500 operating manual
Optional accessories
•Arm 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. Please contact the manufacturer or your specialist supplier if you have any
questions.

Instructions for use
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2Instructions for use
2.1 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. Measurements are performed in conjunction with the agedio K520®iOS app.
The agedio®B500 is suitable for people with an arm circumference of 20-55 cm (7.9-21.7 inches) using the
corresponding blood pressure cuff size.
WARNING
Self-diagnosis and self-treatment on the basis of the results is dangerous!
•Inform the patient that they must not make any changes to their treatments based on the
measured values without consulting their doctor.
•Inform the patient that they must never change the dosage of prescribed medication without
consulting their doctor!
•Advise the patient 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!
NOTE
The agedio®K520 iOS app is used to perform analysis for the agedio®B500.

Instructions for use
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2.2 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.
The blood pressure monitor must be kept out of the reach of unsupervised children and must not be used on
people deemed legally incompetent.
It must not be used for any other purpose than the blood pressure measurement procedure described here and
must not be used in vehicles or aircraft!
The agedio® B500 is not designed to be used on pregnant women or in cases of pre-eclampsia.
NOTE
•There are as yet no clinical studies available on the use of pulse wave analysis on children,
meaning that there is no confidence interval available for persons under the age of 20.
•If you are taking medication to alter blood clotting, consult your doctor before using the blood
pressure monitor.

Instructions for use
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2.3 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
•energy output (cuff pressurisation) within specified limits according to IEC 80601-2-30, EN 1060-3
•An error message is displayed if it is not possible to successfully perform a blood pressure
measurement.
•The pulse wave is recorded at 100 Hz.
The device does not emit an alarm as described by IEC 60601-1-8. The blood pressure monitor is not designed to
be used in conjunction with RF 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 the device.
If the status or condition of the device is in any way unclear, the device is compelled to switch to safe standby
mode by releasing the air from the cuff. The cuff is not automatically pressurised; the device must be started
manually to pressurise the cuff.

Safety & security
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EN
3Safety & 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.
A doctor must be consulted before using the device if the patient is pregnant, is taking medication to alter blood
clotting or if the patient has been diagnosed with cardiac arrhythmia, a coagulation disorder or arteriosclerosis.
3.1 Explanation of safety symbols
WARNING
Short description of the danger
This warning symbol together with the signal word WARNING indicates a possible or immediately
imminent danger.
Failure to comply may result in minor, moderate or severe injuries or death.
CAUTION
This warning symbol together with the signal word CAUTION, indicates possible property damage.
Failure to comply may result in damage to the device or its accessories.

Safety & security
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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.

Safety & security
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3.2 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.
WARNING
Risk of injury if used by patient groups for whom the device is not designed
•The device is not designed for use on pregnant women or those suffering from pre-eclampsia.
WARNING
Self-diagnosis can be dangerous!
•Inform the patient that they must not make any changes to their treatments based on the
measured values without consulting their doctor.
•Inform the patient that they must never change the dosage of prescribed medication without
consulting their doctor!
•Inform the patient that they should follow the doctor’s instructions.
•Advise the patient 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.

Safety & security
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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
arm.
WARNING
Risk of tissue bleeding, petechiae or haematoma!
•Inform the patient about this danger.
•Make sure that the blood circulation in the arm is not impaired when using the device!
•If the patient has sensitive body tissue, contusions or haematomas can occur despite the cuff
being fitted correctly.
•Ask the patient if they take anticoagulants or suffer from coagulation disorders.
•If the patient takes medication to alter blood coagulation or suffers from coagulation disorders,
please do not perform the measurement.
•If the patient 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.)

Safety & security
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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.
WARNING
Risk of injury as a result of applying and inflating a cuff on an arm on the same side of the body where a
mastectomy has been performed!
•Do not apply the agedio® B500 to an arm on the same side of the body where a mastectomy has
been performed.

Safety & security
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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
measurement.
•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 patient 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 during a blood pressure measurement.)
•The measuring process can be aborted at any time by pressing any button. This causes the cuff
to deflate and the cuff can then be removed.

Safety & security
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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.
•Observe the patient carefully during the measurement.
•Make sure that the cuff tube is in 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 patient 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 during a blood pressure measurement.)
•The measuring process can be aborted at any time by pressing any button. This causes the cuff
to deflate and the cuff can then be removed.

Safety & security
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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!
•The cuff must only be applied on the upper arm!
•Check that the cuff has been correctly fitted.
•If the patient 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 then be removed.
WARNING
Risk of injury from applying and inflating a cuff over a wound!
•Ask the patient if they have any injuries.
•Do not apply the agedio® B500 over a wound or bandage.

Safety & security
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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
the first time.
•Make sure to check the accessories with regard to the manufacturer’s specifications before use.
WARNING
Risk of fluid leakage due to improper battery usage!
•Battery fluid leakage 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 rinse your eyes with water for
10 minutes and seek medical attention immediately.
WARNING
Risk of a temporary loss of function of an existing electrical medical device as a result of applying or
inflating a cuff if you are wearing another electrical medical monitoring device on the same arm!
•Only apply the agedio® B500 if the patient is not wearing any other electrical medical device on
that arm.

Safety & security
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3.3 Important device information
CAUTION
Damage to the device
•The device must not be operated in the vicinity of an MRI scanner or in close proximity to other
electrical medical devices.
•The device is not suitable for simultaneous use with high-frequency surgical equipment.
•Do not drop the device and do not place objects on top of it.
•Do not use the device in close proximity to other devices or stacked with other devices because
this may result in malfunction. If it nevertheless becomes necessary to use the monitor in the
manner described 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 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
monitor against the effects of a defibrillator discharge. In the event of discharging a defibrillator,
the monitor itself must not come into contact with the patient. Such a discharge may damage the
monitor and cause it to display incorrect values.
•Extreme temperatures, humidity or air pressures can affect measurement accuracy. Please
observe the operating conditions.