beurer ME 90 Mobile ECG Device Instruction Manual

beurer ME 90 Mobile ECG Device

Dear customer, Thank you for choosing one of our products. Our name stands for high-quality, thoroughly tested products for applications in the areas of heat, weight, blood pressure, body tempera-ture, pulse, gentle therapy, massage and air. Please read these instructions for use carefully and keep them for later use, be sure to make them accessible to other users and observe the information they contain. With kind regards, Your Beurer team

Getting to know your device

The mobile ECG ME 90 is used to monitor heart rhythm at home and on the move. The de-vice provides information about your average pulse value as well as any divergence from a normal ECG. To accurately assess the data measured and to display it in more detail, the de-vice can be connected to the PC via the integrated USB port. The results can be presented as images using the “beurer CardioExpert” software that comes with the device, and it can be printed out so you can pass it on to your doctor. You can also transfer the data onto your smartphone using Bluetooth® low energy technology.

Important notes

Signs and symbols
The following symbols are used in these instructions for use, on the packaging and on the type plate for the device and the accessories:

• Attention
• Note on important information
• Observe the instructions for use
• Application part, type CF
• Direct current
• Please dispose of the device in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equipment).
• Manufacturer
• Dispose of packaging in an environmentally friendly manner
• Application part, type CF
• Direct current Please dispose of the device in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equipment). Manufacturer

General notes

• The ME 90 device is a single-channel electrocardiogram (ECG) device that you can use to rapidly record an electrocardiogram (ECG) when you are on the move. In addition, the device provides a clear evaluation of the recording, particularly as regards any disruption of the heart rhythm

• The ME 90 device displays changes in the heart rhythm, which may have various different causes. These may be harmless, but may also be triggered by illnesses or diseases of differing degrees of severity. Please consult a medical specialist if you believe you may have an illness or disease.

• Electrocardiograms recorded using the ME 90 reflect heart activity at the time of measure-ment. As such, any changes occurring before or after the measurement is taken may not necessarily be detected.

• The ECG measurements, such as those taken with the ME 90, cannot detect all heart dis-orders. Regardless of the measurement taken using the ME 90, you should consult your doctor immediately if you experience symptoms that could indicate acute heart disease. Such symptoms could include, but are not limited to:

  • pain or pressure felt on the left of the chest area or abdomen,
  • radiating pain in the mouth/jaw/facial area, in the shoulder, arm or hand,
  • back pain,
  • nausea,
  • burning sensation in the chest,
  • tendency to collapse,
  • breathlessness,
  • rapid heartbeat or irregular heart rhythm ,
  • especially in combination with these symptoms.
    ALWAYS consult a doctor IMMEDIATELY if you experience any of these symptoms. If you have any doubts, seek an emergency medical examination.

• Do not self-diagnose or self-medicate on the basis of the ME 90 measurement without consulting your doctor. In particular, do not start taking any new medication or change the type and/or dosage of any existing medication without prior approval.

• The ME 90 device is not a substitute for a medical examination of your heart function or for medical electrocardiogram recordings, which require more complex measurements.

• It is not possible to use the ME 90 device to diagnose illnesses or diseases that may be causing an ECG change. This is exclusively the responsibility of your doctor.

• We recommend that you record the ECG curves obtained and that you show these to your doctor if required. This is particularly important when the status messages of the ME 90 do not display the “OK” symbol.

Important safety notes
We recommend against using the device if you have a pacemaker or other implanted de-vices. Follow the advice given by your doctor, if applicable.

• Do not use the device with a defibrillator.
• Do not use the device during an MRI scan.
• Do not expose the device to any static electricity. Always ensure that you are free of stat-ic electricity before operating the device. *
• Do not place the device in water or liquids. Do not clean the device with acetone or other volatile solutions. Clean the device with a cloth dampened with water or a mild cleaning liquid. Then dry the device using a dry cloth.
• Do not place the device in pressure containers or gas sterilisation devices.
• Avoid dropping the device, stepping on the device or shaking it.
• Do not dismantle the device as this may result in damage, defects or malfunctions.
• Do not use the device on people with sensitive skin or allergies.
• This device is not intended for use by people (including children) with restricted physical, sensory or mental skills or a lack of experience and/or a lack of knowledge, unless they are supervised by a person who has responsibility for their safety or they receive instructions from this person on how to use the device. Supervise children around the device to ensure they do not play with it.
• This device must not be used on children weighing less than 10 kg.
• Do not allow the electrodes of the device to come into contact with other conductive parts (including earth).
• Do not store the device in the following locations: locations in which the device is ex-posed to direct sunlight, high temperatures or levels of moisture, or heavy contamination; locations near to sources of water or fire; or locations that are subject to strong electro-magnetic influences.

Static electricity can damage electronic components. To prevent electrostatic damage to the device, ensure that your body is free of static electricity before using the device. Contact with earthedobjects or devices will discharge the energy that has built up and cause electrostatic discharge.

Instructions for storage and maintenance

• Protect the device from impacts, humidity, dirt, marked temperature fluctuations and direct sunlight.
• Do not drop the device.
• Do not use the device in the vicinity of strong electromagnetic fields and keep it away from radio systems or mobile telephones.

Notes on handling batteries

• If your skin or eyes come into contact with battery fluid, rinse the affected areas with water and seek medical assistance.
• Choking hazard! Small children may swallow and choke on batteries. Store the batteries out of the reach of small children.
• Observe the plus (+) and minus (-) polarity signs.
• If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.
• Protect the batteries from excessive heat.
• Risk of explosion! Never throw batteries into a fire.
• Do not charge or short-circuit batteries.
• If the device is not to be used for a relatively long period, take the batteries out of the battery compartment.
• Use identical or equivalent battery types only.
• Always replace all batteries at the same time.
• Do not use rechargeable batteries!
• Do not disassemble, open or crush the batteries.

Battery disposal

• The empty, completely flat batteries must be disposed of through specially designated collection boxes, recycling points or electronics retailers. You are legally required to dispose of the batteries.
• The codes below are printed on batteries containing harmful substances:
  • Pb = Battery contains lead,
  • Cd = Battery contains cadmium,
  • Hg = Battery contains mercury.

General disposal
For environmental reasons, do not dispose of the device in the household waste at the end of its useful life. Dispose of the unit at a suitable local collection or recycling point. Dispose of the device in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equipment). If you have any questions, please contact the local authorities responsible for waste disposal

Device description

Main functions

• The device takes about 30 seconds to produce the cardiogram measurement.
• The device performs an automatic analysis using the data and provides the corresponding results.
• The ME 90 allows a maximum of 36 measurement data records to be stored on the device itself. After that, the old measurement records are overwritten.
• The “beurer CardioExpert” software and app can be used for the following processes:
  • Downloading ECG data
  • Configuring your ECG device
  • Saving your measurements in chronological order
  • Independently monitoring your health
  • Displaying ECG waveforms as reference data for medical specialists
  • Printing the ECG as a useful means of providing important information to your doctor

Included in delivery

• 1 mobile ECG device
• Docking Station (USB cable)
• CD-ROM with “beurer CardioExpert”
• 4 x 3 V CR2032 button cells
• These instructions for use
• Annex for attending doctor

Mobile ECG device

1. Heartbeat LED

2. On/Off button
3. USB connection
4. Activation switch
5. Upper electrodes
6. Lower electrodes
7. Battery cover
8. Docking Station (USB cable)

Display symbols

1. Heartbeat display : flashes in synch with your heartbeat during the
2. Heart rate : shows the average heart rate during the recording ***
3. Battery status indicator : shows the current batte- ry charge status
4. USB connection : shows the status of the USB connection with the
5. Number display : shows the sequential number of the measurements recorded in the Shows the 30-second countdown during the measurement.
6. Date and TIME
7. Display of results
8. Bluetooth

The heart rate, measured in beats per minute, is determined by dividing the heartbeat interval into 60 seconds

Before initial use

Inserting the batteries

• Open the battery compartment lid.
• Insert the two CR2032 batteries. Make sure that the batteries are inserted the correct way round. Do not use rechargeable batteries.
• Subsequently close the battery compartment lid carefully.

Setting the date and time
It is essential to set the date and time. This is the only way the measurements can be saved with the correct date and time to be recalled at a later date. Open the app and go into the settings. This is where you can synchronise the ME 90 with your smartphone. The date and time are carried over from your smartphone. Alternatively, you can also set the date and time using the PC software. To do this, go to the settings menu.

Important information for obtaining accurate measurements

• The electrodes must be laid directly on the skin.
• If your skin or hands are dry, wet them using a damp cloth before you take the measurement.
• If the electrodes are dirty, remove the dirt using a soft cloth or cotton bud dampened with disinfectant alcohol.
• During the measurement, do not touch your body with the hand with which you are taking the measurement.
• Make sure there is no skin contact between your right and left hand (measuring method C), or between your hand and chest (measuring methods A/B). Otherwise, the measurement cannot be taken correctly.
• Do not move during the measurement, do not speak and hold the device still. Movements of any kind will falsify the measurements.
• Ideally perform the measurement either sitting down or lying down, and not standing up

Taking measurements

1. There are three different methods of taking the measurement. Start with measurement method A, “right index finger–chest”. If this method does not deliver measurements, or delivers only unstable measurements (“EE” is frequently displayed), switch to method B “left index finger–chest” and, if necessary, to method C “left hand–right hand”. The most suitable method/procedure depends on the heart configuration (shape of theheart) of each individual user. If it is not possible to take stable measurements using a given measurement method, this could have a harmless cause such as the shape of the heart. However, the cause may also be an illness or disease.
   Note : measurement method C offers maximum comfort, but offers a much lower measurement stability than methods A or B.

2. Press the on/off button for about three seconds to turn the device on. The device shows
   the full display.
   Warning
   If segments are missing, stop using the device and immediately contact customer services. To test whether the full display is completely displayed, hold the On/Off button when switching on the device.
   Note : Please note that there must be no skin contact between your right and left hand (measurement method C) or hand and chest (measurement methods A/B). Otherwise, the measurement cannot be taken correctly. Do not move during the measurement, do not speak and hold the device still. Movements of any kind will falsify the measurements.

3. The device will start beeping (if the beep is enabled) and the number indicator will flash for a few seconds. This indicates that the measurement is about to begin.

4. The measurement is completed, and the results are displayed at the end of the 30-second countdown.
   Note : If the bottom electrode is removed within the space of three seconds after the measurement starts, the measurement will be displayed

Common reasons for imprecise measurements

Display of results

Once you have taken the measurement, the following results may appear on the LCD display.

Note : If the heart rate display is flashing, this means that the ECG signals are unstable or weak. In this case, please repeat the measurement. You can find background information and medical parameters that you may potentially submit to your doctor in the “Annex for the attending doctor”, which comes with your Vdevice.

Displaying the measurements
When the device is switched on, you can display previously recorded measurements by pressing the button

beurer CardioExpert

To obtain a detailed representation of your recorded data, you can use the PC version of “beurer CardioExpert” from the supplied CD, or the app, which is available as a free download from the Apple App Store and Google Play. The data can be transferred via USB interface or Bluetooth® low energy technology

System requirements

PC version

• from Windows 8.1
• from USB 2.0 (Type A)

App requirements

• iOS at least version 10.0
• Android™ devices at least Version 5.0
• Bluetooth® at least 4.0

Problems/solutions

click.
The measurements are no longer displayed in the devices memory.| The memory capacity of 36 measurements has been reached. As a result, old data records are re- placed with new ones.| Download data to your com- puter on a regular basis to save them.
When starting the pro- gramme, the message “Verification error” is displayed.| The device is not con- nected to a PC or the “beurer CardioExpert” did not install correctly.| Make sure the ME 90 is con- nected to your computer and restart the programme.
The Bluetooth ® connection has failed.| Fundamental communi- cation problem between the device and the smart- phone.| Switch off the device, the “beurer CardioExpert” app, and the Bluetooth ® function on your device. Next, follow the instructions for “transfer via Bluetooth ® ” to re-estab- lish the connection.
The device ID is not shown in the field of the settings function of the “beurer CardioExpert” PC software.| Problems when transfer- ring data for the first time.| If the device is successfully recognised, an empty field is displayed. Click the empty field to connect the device to the app manually and to display the device ID.
Problem| Possible cause| Solution
---|---|---
The battery drains very| During data transfer via| It is highly recommended
quickly during the data| USB, the device con-| that the device is discon-
transfer to the PC via USB| sumes more energy. This| nected from the USB inter-
cable.| means that the battery drains faster.| face immediately after data transfer has been carried out successfully.

Technical data

ECG signal ground (earth) referenced.
Bandwidth| 0.05 to 40 Hz
Sample rate| 256 Hz
Measurement range for heart rate| 5 to 199 beats per min
Memory| 36 measurements
Power supply| 4 x 3V CR2032
Battery lifetime| approx. 50 measurements
Transport conditions| -20°C to +60°C, 10%–95% humidity
Storage conditions| -20°C to +60°C, 10%–95% humidity
Operating conditions| +5°C to +40°C, 30%–85% humidity
Weight| 42 g (incl. Batteries)
Dimensions| 95.5 mm x 38 mm x 9 mm

The serial number is located on the device or in the battery compartment.

• This device complies with European Standard EN60601-1-2 (In accordance with CISPR 11, IEC 61000-4-2, IEC 61000-4-3 und IEC 61000-4-8) and is subject to special precautionary measures regarding electromagnetic compatibility. Please note that portable and mobile HF communication systems may interfere with this unit.
• The device complies with the EU Medical Devices Directive 93/42/EEC, the German Medical Devices Act and the standards IEC 60601-2-25 (Medical electrical devices – part 2-25: Particular requirements for the safety of electrocardiographs) and IEC 60601-2-47 (Medical devices – part 2-47: Particular requirements for the safety, including essential performance characteristics of ambulatory electrocardiographic systems).
• The safety class of the device is CF.
• We hereby confirm that this product complies with the European RED Directive 2014/53/EU. The CE Declaration of Conformity for this product can be found under: https://www.beurer.com/web/we-landingpages/de/cedeclarationofconformity.php.

Notes on electromagnetic compatibility

• The device is suitable for use in all environments listed in these instructions for use, including domestic environments.
• The use of the device may be limited in the presence of electromagnetic disturbances. This could result in issues such as error messages or the failure of the display/device.
• Avoid using this device directly next to other devices or stacked on top of other devices, as this could lead to faulty operation. If, however, it is necessary to use the device in the manner stated, this device as well as the other devices must be monitored to ensure they are working properly.
• The use of accessories other than those specified or provided by the manufacturer of this device can lead to an increase in electromagnetic emissions or a decrease in the device’s electromagnetic immunity; this can result in faulty operation.
• Failure to comply with the above can impair the performance of the device

Warranty / service

Beurer GmbH, Söflinger Straße 218, 89077 Ulm, Germany (hereinafter referred to as “Beurer”) provides a warranty for this product, subject to the requirements below and to the extent described as follows.  The warranty conditions below shall not affect the seller’s statutory warranty obligations which ensue from the sales agreement with the buyer. The warranty shall apply without prejudice to any mandatory statutory provisions on liability. Beurer guarantees the perfect functionality and completeness of this product. The worldwide warranty period is 5 years, commencing from the purchase of the new, unused product from the seller. The warranty only applies to products purchased by the buyer as a consumer and used exclusively for personal purposes in the context of domestic use. German law shall apply. During the warranty period, should this product prove to be incomplete or defective in functionality in accordance with the following provisions, Beurer shall carry out a repair or a replacement delivery free of charge, in accordance with these warranty conditions. If the buyer wishes to make a warranty claim, they should approach their local retailer in the first instance: see the attached “International Service” list of service addresses. The buyer will then receive further information about the processing of the warranty claim, e.g. where they can send the product and what documentation is required. A warranty claim shall only be considered if the buyer can provide Beurer, or an authorised Beurer partner, with

• a copy of the invoice/purchase receipt, and
• the original product.

The following are explicitly excluded from this warranty:

• deterioration due to normal use or consumption of the product;
• accessories supplied with this product which are worn out or used up through proper use (e.g. batteries, rechargeable batteries, cuffs, seals, electrodes, light sources, attachments and nebuliser accessories);
• products that are used, cleaned, stored or maintained improperly and/or contrary to the provisions of the instructions for use, as well as products that have been opened, repaired  or modified by the buyer or by a service centre not authorised by Beurer;
• damage that arises during transport between manufacturer and customer, or between service centre and customer;
• products purchased as seconds or as used goods;
• consequential damage arising from a fault in this product (however, in this case, claims may exist arising from product liability or other compulsory statutory liability provisions).

Repairs or an exchange in full do not extend the warranty period under any circumstances. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG,Inc. and any use of such marks by Beurer GmbH is under license. Other trademarks and trade names are those of their respective owners. Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc., registered in the U.S. and other countries. Google Play and the Google Play logo are trademarks of Google Inc. Android is a trademark of Google Inc.

Beurer GmbH Söflinger Str. 218 89077 Ulm, Germany

• www.beurer.com
• www.beurer.healthguide.com
• www.beurer-gesundheitsratgeber.com

References

• Beurer Gesundheitsratgeber
• MDR & Zertifikate

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