medisana BU 540 Connect Blood Pressure Monitor Instruction Manual

BU 540 Connect Blood Pressure Monitor
Instruction Manual

Unit and LC-Display

Unit and LC-Display

1. Connector for the hose
2. Air hose
3. Battery compartment (on backside)
4. Cuff
5. User memory button
6. MEM – button (Memory)
7. SET – button
8. START/STOPP – button
9. LC – display
10. Display of systolic pressure
11. Display of diastolic pressure
12. Display of pulse rate
13. Time / Date
14. Bluetooth
15. – symbol t Inflation / Deflation symbol
16. Pulse / Arrhythmia display
17. Batteries low
18. Average value display (“AVG“)
19. User memory (A/B)
20. Blood Pressure Indicator (green – yellow – orange – red)
21. Memory display

Intended use

• This fully automatic electronic blood pressure monitor is intended for measuring blood pressure at home. It is a non-invasive blood pressure measurement system to measure the diastolic and systolic blood pressure and pulse of an adult using a noninvasive technique by means of a cuff, which needs to be fitted on the upper arm. The useable cuff circumference is 22 to 42 cm.
• It is intended for adult indoor use only.

Contraindications

• The device is not suitable for measuring the blood pressure of children. Ask your doctor before using it on older children.
• The device is not suitable for use on pregnant women and patients with implanted, electrical devices (e.g. pacemaker or defibrillator).

Explanation of symbols

IMPORTANT
Follow the instructions for use!
Non-observance of these instructions can result in serious injury or damage to the device.
WARNING
These warning notes must be observed to prevent any injury to the user.
CAUTION
These notes must be observed to prevent any damage to the device.
NOTE
These notes give you useful additional information on the installation or operation.
Device classification: type BF applied part
LOT number
SN Serial number
Manufacturer
**** Date of manufacture

Common factors of wrong measurements

• Please keep quiet for 5-10 minutes and avoid eating, drinking alcohol, smoking, exercising, and bathing before taking a measurement. All these factors will influence the measurement result.
• Remove any garment that fits closely to your upper arm.
• Always measure on the same arm (normally left).
• Measurements should be taken regularly at the same time each day, as the blood pressure varies even during the day.
• Any effort to support the arm during measurement may increase the measured blood pressure.
• Make sure, you are in a comfortable, relaxed position and do not move or constrict your muscles during measurement. Use a cushion to support your arm if necessary.
• If the arm artery lies lower or higher than the heart, a false reading will be obtained.
• A loose or open cuff causes false readings.
• With repeated measurements, blood accumulates in the arm which can lead to false readings. Consecutive blood pressure measurements should be repeated after 3 minutes pause or after the arm has been held up in order to allow the accumulated blood to flow away.

Safety Instructions

**** Read the instruction manual carefully before using this device, especially the safety instructions, and keep the instruction manual for future use. Should you give this device to another person, it is vital that you also pass on these instructions for use.

• The unit is intended only for private use in the home.
• The device should be placed at least 30 minutes before use in the area of use in order to properly adapt to the room temperature. Only use the device under the conditions mentioned in the technical details.
• Consult your doctor prior to using the blood pressure monitor if you are concerned about health matters.
• Only use the unit for its intended purpose in accordance with the instructions for use.
• Warranty claims become void if the unit is misused.
• The unit may not be used to check the heart rate of a pacemaker.
• Irregularity of pulse or arrhythmia can lead to difficulties in recording a correct reading when measurements are taken using oscillometric blood pressure devices. This device is electronically equipped to detect arrhythmia which it indicates with the icon 16. In this case, contact your physician.
• Do not use the unit in case of existing polyester resp. synthetic allergies.
• Like on any other oscillometric blood pressure measurement device, certain medical conditions can affect the measurement accuracy, among others: cardiac arrhythmias, low blood pressure, circulatory disorders, states of shock, diabetes, pregnancy, pre-eclampsia, etc. Always consult a physician before you use the device.
• Never apply the cuff over hurt skin.
• Do not take measurements, if any other equipment is applied to the same limb for monitoring. This could lead to disturbances or failures.
• If you experience discomfort during measurements, such as pain in the upper arm or other complaints, press the START/ STOP 8 button to release the air immediately from the cuff. Loosen the cuff and remove it from your arm.
• On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff immediately. Prolonged high pressure (cuff pressure >300 mmHg or constant pressure >15 mmHg for more than 3 minutes) applied to the arm may lead to ecchymosis.
• Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.
• Pay attention during use and storage, that cable and air hose will not cause strangulation.
• Never bend the air hose during use as this may lead to injuries. Also never squeeze or block the air hose in any way.
• Do not connect the air hose to other medical equipment, as this could cause air to be pumped into intravascular systems or high pressure, which could lead to dangerous injuries.
• This device is not suitable for continuous monitoring during medical emergencies or operations.
• This device cannot be used with surgical equipment at the same time.
• The unit may not be operated in the vicinity of appliances that emit strong electric radiation such as radio transmitters or mobile phones. This may affect the proper functioning (see „electromagnetic compatibility“).
• This device is not intended for patient transport outside a healthcare facility.
• Do not use equipment where flammable gas (such as anesthetic gas, oxygen, or hydrogen) is present.
• Do not take any therapeutic measures on the basis of a self-measurement. Never alter the dose of medicine prescribed by a doctor.
• This device is not designed to be used by persons with limited physical, sensory or mental abilities, or by persons with insufficient experience and/or knowledge, unless under observation by a person responsible for their safety, or unless they have been instructed in the use of the device.
• This device is intended to be used by adults. The unit is unsuitable for children or babies. Contact your doctor, if you want to use this device on young people.
• Please ensure that the unit is kept away from the reach of children and pets. The swallowing of small parts like packaging bags, batteries, battery covers, and so on may cause suffocation.
• Before use, make sure the device functions safely and is in proper working condition. Do not service or maintain while the device is in use.
• Please do not attempt to repair the unit yourself in the event of malfunctions. Only have repairs carried out by authorized service centers.
• Protect the unit from moisture. Should moisture enter the unit, remove the batteries and stop using them immediately. In this case, please contact either your dealer or us directly. You can find details of how to contact us on the address page.
• Only use original additional or spare parts from the manufacturer. Other parts could damage the device or could lead to personal injury.
• Please report to medicine if any unexpected operation or events occur.
• If the unit is not going to be used for a long period, please remove the batteries.

BATTERY SAFETY INFORMATION

• Do not disassemble batteries!
• Renew the batteries when the battery icon appears on the display.
• Remove discharged batteries from the device immediately, because they can leak and damage the device!
• Increased risk of leakage, avoid contact with skin, eyes, and mucous membranes! If battery acid comes in contact with any of these parts, rinse the affected area with copious amounts of fresh water and seek medical attention immediately!
• If a battery has been swallowed seek medical attention immediately!
• Replace all of the batteries simultaneously!
• Only replace with batteries of the same type, never use different types of batteries together or used batteries with new ones.
• Insert the batteries correctly, observing the polarity!
• Keep batteries out of children‘s reach!
• Do not attempt to recharge batteries, do not short-circuit, and do not throw them into a fire! There is a danger of an explosion!
• Do not throw used batteries into the household refuse; put them in a hazardous waste container or take them to a battery collection point, at the shop where they were purchased!

Scope of supply
Please check first of all that the unit is complete.
The following parts are included as standard:

• 1 medicine blood pressure monitor BU 540 connect
• 1 cuff with air tube
• 4 batteries (type AAA, LR03) 1.5 V
• 1 instruction manual and EMV leaflet

Please contact your supplier if you notice any transport damage on unpacking the unit.
WARNING
Please ensure that the polythene packing is kept away from the reach of children! Risk of suffocation!
How is blood pressure measured?
This medicine blood pressure monitor is a device, which is used to measure blood pressure in the upper arm. The measurement is carried out by a microprocessor – already during the inflating process of the cuff. The device detects the systole and the measurement is completed earlier than using conventional measurement methods. As a result, an unnecessarily excessive inflation pressure in the cuff is prevented. Additionally, your device is able to recognize unregular heartbeat (so-called arrhythmia), which may affect the measurements. In case an arrhythmia has been detected, the respective symbol will appear in the display of the unit.
How is blood pressure measured?
This medicine blood pressure monitor is a device, which is used to measure blood pressure in the upper arm. The measurement is carried out by a microprocessor – already during the inflating process of the cuff. The device detects the systole and the measurement is completed earlier than using conventional measurement methods. As a result, an unnecessarily excessive inflation pressure in the cuff is prevented. Additionally, your device is able to recognize unregular heartbeat (so-called arrhythmia), which may affect the measurements. In case an arrhythmia has been detected, the respective symbol will appear in the display of the unit.
Blood pressure classification

WARNING
Blood pressure that is too low represents just as great a health risk as blood pressure that is too high! Fits of dizziness may lead to dangerous situations arising (e.g. on stairs or in traffic)!
Influencing and evaluating readings

• Measure your blood pressure several times, then record and compare the results. Do not draw any conclusions from a single reading.
• Your blood pressure readings should always be evaluated by a doctor who is also familiar with your personal medical history. When using the unit regularly and recording the values for your doctor, you should visit the doctor from time to time to keep him updated.
• When taking readings, remember that daily values are influenced by several factors. Smoking, consumption of alcohol, drugs, and physical exertion influence the measured values in various ways.
• Measure your blood pressure before meals.
• Before taking readings, allow yourself at least five minutes of rest.
• If the systolic and diastolic readings seem unusual (too high or too low) on several occasions, despite the correct use of the unit, please inform your doctor. This also applies to the rare occasions when irregular or very weak pulse prevents you from taking readings.

Getting started

Inserting/changing batterie
You must insert the batteries provided before you can use your unit. The lid of battery compartment 3 is located on the underside of the unit. Open it, remove it and insert the 4 x 1,5 V batteries, type AAA / LR03 supplied. Ensure correct polarity when inserting the batteries (as marked inside the battery compartment). Close the battery compartment. Replace the batteries if the change battery symbol 17 appears on the display 9 or if nothing appears on the display after the unit has been switched on.
Settings

1. Date and time
   When the unit is switched off, press SET 7. The time will be displayed. Now press and hold the SET button 7 , until the year figure starts to flash for setting. Keep pressing the MEM button 6 until the actual year figure appears. Press SET 7 to confirm the year. Afterward, you can proceed with the month/date setting, followed by the time format setting (12 or 24 hours), as well as hours and minutes. Adjust the corresponding figures accordingly. When finished, “dOnE” appears on the display along with the adjusted values. Afterward, the device will switch off.

2. User memory setting
   The median blood pressure monitor features 2 separate memories, each with a capacity of 250 memory slots. By pressing the user memory button 5 when the device is switched on, you may choose between user  and user . The display shows the current selection 19.

Fitting the cuff

1. Connect the air hose to connector 1 on the left side of the device.
2. Slide the open end of the cuff through the metal bracket so that the Velcro fastener is on the outside and it becomes a cylindrical form (Fig.1). Slide the cuff over your left upper arm.
3. Position the air hose in the middle of your arm in line with your middle finger (Fig.2) (a). The lower edge of the cuff should be 2 – 3 cm above the crease of the elbow. (b). Pull the cuff tight and close the Velcro fastener (c).
4. Measure the blood pressure on your bare arm.
5. Only position the cuff on the right arm if it cannot be used on the left arm. Always carry out measurements on the same arm.
6. Correct measuring position for sitting (Fig.3).

Taking a blood pressure measurement
After the cuff has been appropriately positioned, the measurement can begin.

1. Switch the unit on by pressing the START/STOP button 8.
2. All display characters are shown (display test). This test can be used to check that the display is indicating properly and in full. The unit is ready for measurement and „0“ appears.
3. The device then automatically inflates the cuff slowly in order to measure your blood pressure. The rising pressure in the cuff is shown on the display.
4. When the device detects the signal, the heart symbol on the display starts to flash. If a result is determined, the device slowly will release the air from the cuff. The systolic and diastolic blood pressure and the pulse value with the time value appear on the display.
5. The blood pressure indicator 20 flashes next to the relevant colored bar depending on the blood pressure classification.
6. If the unit has detected an irregular heartbeat, the arrhythmia display 16 appears additionally.
7. The readings are automatically saved in the selected memory ( or ).
8. The measurement results will automatically be transferred via Bluetooth ® to receive-ready devices. During this process, the Bluetooth ® -symbol 14 will flash. If the transfer was successful, the Bluetooth ® -symbol 14 will disappear after approx. 5 seconds. If the transfer was not successful, the symbol will disappear after max. 3 minutes.
9. Switch off the device using the START/STOP button 8.

Transfer via Bluetooth®
The medicine upper arm blood pressure monitor BU 540 connect offers the possibility to transfer your measured values via Bluetooth ® to the VitaDock ® app. The VitaDock ® app allows the evaluation, storage, and synchronization of your data between multiple iOS- and Android devices to have access to it anytime and anywhere. You may share your results with your friends or your doctor. Therefore you need a free user account, which you can create on the website www.vitadock.com. For Android or iOS mobile devices, you may download the respective apps. You will find detailed instructions on how to install and use the software on the mentioned website. After each measurement, an automatic transfer of the values will take place (provided that Bluetooth® is activated and configurated on the receiving device).
WARNING

• Keep the device at least 20 centimeters away from the human body (especially the head) when the Bluetooth® data transmission is proceeding after measurement.
• The distance between the device and the receiver should be between 1 meter to 10 meters to avoid possible disturbances.
• To avoid interference with other electronic devices, these should be kept at least 1 meter away from the monitor.

Displaying stored results
This unit features 2 separate memories, each with a capacity of 250 memory slots. Results are automatically stored in the memory selected by the user. Press the MEM button 6 when power is off, to call up the measured values stored. The average values of the last 3 measurements appear on the display (if already 3 measurements have been stored for the respective user. Press the MEM button 6 again to call up the last measurement value. Repeatedly pressing the MEM button 6 displays the respective values measured in other measurements. Memory recall mode can be exited at any time by pressing the START/STOP button 8 , which will also switch the unit off. The oldest value is deleted if 250 measured values have been stored in the memory and a new value is saved.
Deleting memory
Press MEM-button 6 to enter the memory recall mode. If you are sure that you want to permanently remove all stored memories, press and hold the SET button 7 for approximately 3 seconds until „dEL ALL” appears on the display. Then press the SET button again to delete all the values. The device then switches off automatically. You may abort the deletion process by pressing the START/STOP button 8 beforehand.

Error messages and error remedying

Insert the batteries according to the instructions given.
+ Lo| Weak batteries| Batteries are weak or empty. Replace all 4 batteries with new ones (1.5V, type AAA / LR03).
E01| The cuff is not properly fitted| Wrap the cuff properly. Remeasure the incorrect way.
E02| Movement or speaking during the measurement| Rest 30 minutes and
remeasure incorrect way. Do not speak or move during the measurement.
E03| Pulse cannot be detected| Wrap the cuff properly. Loosen the clothing on the arm. Remeasure the incorrect way.
E04| Measurement failed| Wrap the cuff properly. Remeasure the incorrect way.
EExx| Calibration error
(“xx” can be a figure, e.g. 01, 02 etc.)| Wrap the cuff properly. Remeasure in the correct way.
out| Out of measurement range| Relax for a moment. Refasten the cuff and measure again.
If the problem persists, contact your physician.

Please contact the service center if you can’t solve the problem.
Do not disassemble the unit by yourself.

Cleaning and maintenance

Remove the batteries before cleaning the unit. Clean the unit using a soft cloth lightly moistened with a mild soapy solution. Never use abrasive cleaning agents, alcohol, naphtha, thinner or gasoline, etc.. Never immerse the unit or any component in water. Be cautious not to get any moisture in the main unit. Do not wet the cuff or attempt to clean the cuff with water. Using a dry cloth, gently wipe away any excess moisture that may remain on the cuff. Lay the cuff flat in an unrolled position and allow the cuff to air dry. Do not expose the unit to direct sunlight; protect it against dirt and moisture. Do not expose the unit to extreme hot or cold temperatures. Keep the device in the storage case when not in use. Store the unit in a clean and dry location.
Disposal
This product must not be disposed of together with domestic waste. All users are obliged to hand in all electrical or electronic devices, regardless of whether or not they contain toxic substances, at a municipal or commercial collection point so that they can be dis- posed of in an environmentally acceptable manner. Remove the batteries before disposing of the device/unit. Do not dispose of old batteries with your household waste, but at a battery collection station at a recycling site or in a shop. Consult your local authority or your supplier for information about disposal.
Guidelines/Standards
This blood pressure monitor meets the requirements of the EU standard for noninvasive blood pressure monitors. It is certified in accordance with EC Guidelines and carries the CE symbol (conformity symbol) “CE 0297”. The blood pressure monitor corresponds to European standards EN 60601-1, EN 60601-12, EN 1060-3, EN 81060-1, and EN 81060-2. The specifications of EU Guideline “93/42/EEC of the Council Directive dated 14 June 1993 concerning medical devices” are met and likewise those of the RED 2014/53/EC. You can request the complete Conformity Declaration from medicine GmbH, Carl-Schurz-Str. 2, 41460 Neuss, Germany, or you can also download it from the medicine homepage (www.medisana.de).
Electromagnetic compatibility: (see attached leaflet)

Technical specifications

700-1060 hPa atmospheric pressure
Storage conditions:| -20 °C to +60 °C, to 93 % max. relative humidity, non- condensing
Dimensions (L x W x H):| approx. 140 x 130 x 60 mm
Cuff:| 22 – 42 cm for adults
Weight (main unit):| approx. 230 g without batteries
Item number:| 51182
EAN number:| 40 15588 51182 0
Accessories:| Spare cuff
Art. No. 51299 / EAN 40 15588 51299 5

In accordance with our policy of continual product improvement, we reserve the right to make technical and visual changes without notice.
The current version of this instruction manual can be found at www.medisana.com

Warranty and repair terms

Please contact your supplier or the service center in case of a claim under the warranty. If you have to return the unit, please enclose a copy of your receipt and state what the defect is.
The following warranty terms apply

1. The warranty period for medicinal products is 3 years from the date of purchase. In case of a warranty claim, the date of purchase has to be proven by means of the sales receipt or invoice.

2. Defects in material or workmanship will be removed free of charge within the warranty period.

3. Repairs under warranty do not extend the warranty period either for the unit or for the replacement parts.

4. The following is excluded under the warranty:
   a. All damage that has arisen due to improper treatment, e.g. nonobservance of the user instructions.
   b. All damage is due to repairs or tampering by the customer or unauthorized third parties.
   c. Damage that has arisen during transport from the manufacturer to the consumer or during transport to the service center.
   d. Accessories that are subject to normal wear and tear.

5. Liability for direct or indirect consequential losses caused by the unit is excluded even if the damage to the unit is accepted as a warranty claim.

Medisana GmbH
Carl-Schurz-Str. 2
41460 NEUSS, GERMANY
The service center address is shown on the attached leaflet.

References

• medisana – Your health in good hands
• VitaDock Online | VitaDock Online
• Home page medisana – Your health in good hands
• Startseite medisana – Deine Gesundheit in guten Händen
• VitaDock Online | VitaDock Online

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