MD 15231 - Sphygmomanometer MEDION - Free user manual and instructions

Product Type	Blood Pressure Monitor (Wrist)
Brand	MEDION (health+)
Model	MD 15231
Measurement Method	Oscillometric
Blood Pressure Range	30 – 250 mmHg
Pulse Range	40 – 180 beats/min
Pressure Accuracy	±3 mmHg
Power Supply	2 x 1.5V batteries (AAA/LR03 alkaline)
Display	LCD (date, time, BP, pulse, color indicator)
Memory	2 units x 60 measurements each (120 total)
Sleeve Size (Wrist Circumference)	14 – 19.5 cm
Weight (without batteries)	Approx. 108 g
Operating Temperature	+5°C to +40°C
Operating Humidity	< 80% RH
Storage Temperature	-20°C to +55°C
Storage Humidity	< 95% RH
Intended Users	Healthy adults (14 years and older)
Special Features	Irregular heartbeat detection, blood pressure classification indicator (color)
Cleaning	Wipe with soft, lint-free cloth (no solvents)
Warranty	3 years
Safety Standards	CE0197, EN 1060-1/3, EU Medical Device Directive 93/42/EEC
Repair	Only by authorized service center; do not open device

Frequently Asked Questions - MD 15231 MEDION

How do I set the date and time on the MEDION MD 15231?

Press the ⏻ and M buttons simultaneously. The month flashes. Press M to set the month, then ⏻ to confirm and move to day. Repeat for hour and minutes. After setting, the device exits automatically after 10 seconds or press ⏻ to finish.

How should I attach the wrist cuff for accurate measurement?

Place the cuff about 5–10 mm from the palm of your left hand. Wrap it firmly around your wrist with no gap. Ensure it is neither too tight nor too loose. Your arm should be rested on a table with the cuff at heart height for correct measurement.

What does the irregular heartbeat symbol on the display mean?

The symbol appears when the device detects an irregular pulse rhythm (arrhythmia). If it occurs, repeat the measurement. If the condition persists, consult your doctor.

How do I delete stored measurements from a memory unit?

Press M to enter memory mode. Select the unit (U1/U2) using ⏻. Then press and hold M for more than 2 seconds until a confirmation tone sounds and two bars appear. All values in that unit are deleted.

What should I do if the display shows an error code like Er 0, Er 1, etc.?

Refer to the manual's error table. Common causes: Er 0 (unstable pressure) – remain still; Er 3/Er 4 (cuff issues) – adjust cuff; Er 5 (overinflation) – wait 5 minutes and retry. If errors persist, contact service center.

Can I use rechargeable batteries in this blood pressure monitor?

No. The manual states that rechargeable batteries are not suitable for operation. Use only 2 x 1.5V alkaline AAA/LR03 batteries.

How often should I clean the device and cuff?

Clean the device and cuff with a soft, lint-free cloth as needed. Do not use solvents or detergents. The cuff should not be washed or dry cleaned. Store the device in its storage box when not in use.

Is the MEDION MD 15231 waterproof?

No. The device is not waterproof. Never immerse it in water or expose it to moisture. Keep it away from extreme temperatures and humidity.

How long should I wait between consecutive blood pressure measurements?

You should wait at least 5 minutes between measurements. This allows the blood vessels in your wrist to return to normal and ensures accurate readings.

What is the intended use of this device?

This device is intended for comparative measurements of blood pressure at the wrist for healthy individuals aged 14 and above. It is not a medical diagnostic tool and should not replace medical advice. Always consult your doctor about readings.

USER MANUAL MD 15231 MEDION

Congratulations on choosing to buy a health+ product. By doing so you now have the assurance and peace of mind that comes with purchasing a product made by one of Europe's leading manufacturers.

All products brought to you by health+ are manufactured to the highest standards of performance and safety, and, as part of our philosophy of customer service and satisfaction, are backed by our comprehensive 3 Year Warranty.

Please fill in and return the Warranty Card to the address provided.

General information 2

• Please read these operating instructions thoroughly and follow them and the safety notes in particular before using the appliance for the first time!
• Anything done to or with this appliance may only be undertaken as described in the operating instructions.
• If you pass on your device to someone else, always include the operating instructions.

Safety instructions 3

• This device is not intended to be used by individuals with limited physical, sensory or intellectual abilities or limited experience, and/or a lack of knowledge (including children), unless they are being supervised by an individual responsible for their safety or receive instructions from them concerning how the device must be used.
• Children should be supervised in order to ensure that they do not play with the device.
• Keep the device and its accessories out of reach of small children.
• Keep the packing materials, such as foil away from children. The danger of suffocation could arise in the case of misuse.
• The device is suitable for healthy adults. Use the unit for comparative measurements, particularly during sporting activities. Do NOT use the unit for medical diagnosis. It can not replace medical intervention.
• Only start the air supply (ON/OFF button) once the unit is attached correctly.
• Do not drop the unit and do not place objects on top of it.

• Never immerse the unit in water. Do not expose it to water or moisture!

• Do not use the device under extreme temperature conditions!

• Do not bend the fixed part of the sleeve!

Batteries and Proper Treatment

Batteries may contain combustible materials. By misuse, this may cause battery leakage, heat, explosion or ignition, bringing about injury or damage to the device.

Please observe strictly the following matters:

• The unit is battery-operated. Batteries may endanger life if swallowed. For these reasons, keep the unit out of reach of children. If a battery is swallowed, please obtain immediate medical assistance.
• Clean the battery and device contacts, if necessary, before inserting batteries.
• Do not charge batteries (except rechargeable batteries).
• Do not forcibly discharge batteries.
• Do not short-circuit batteries.
• Do not heat or dispose off in fire.
• Do not disassemble or deform batteries. Your hands and fingers may be injured, or the liquid of the battery may get into your eyes or adhere to your skin. If this happens, rinse with a large quantity of water immediately and consult a doctor.

• Do not expose batteries to strong impact by dropping or throwing the batteries.

• Do not reverse the positive (+) and negative (-) terminals to avoid short-circuit.

• Do not mix used and new or different types of batteries together.
• Remove the used batteries promptly from the device.
• Remove the batteries from your device if it is not to be used for a long period.
• Replace all batteries with new batteries of the same type at the same time.

Disposal

• Your device is packaged to protect it against damage during transportation. The packaging is manufactured from materials that can be sent to a specialist recycling facility and disposed of in an environmentally-friendly way.
• At the end of its life, the appliance must not be disposed of in household rubbish.
• Do not dispose of used batteries in the household rubbish! They must be deposited at a collection point for used batteries.

Repair

- Leave all repairs of your device to authorized and qualified personnel only.

- Never try to open and/or repair the unit yourself. Repairs may only be undertaken by our Service Centre or other appropriate specialist workshop.

About this device 4

Purpose of use

The device is used to measure blood pressure at the wrist. It is suitable for healthy people above 14 years of age and can be used to make comparative measurements – especially during sporting activities.

The memories are stored in two units, and each unit can store 60 memories at most.

This device is only suitable for using in dry, internal rooms.

This device is intended for personal use only. It is not

intended to commercial use in a heavy industry

environment. Use under extreme environmental conditions

can result in damage to your device.

If the values obtained give you cause to be concerned about your health, take medical advice. Do not change your treatment/dosage of medication as a result of the values unless you have discussed this with your doctor!

Blood pressure values

When interpreting the values measured, please note that there can be differences in the values measured at the wrist and arm. However, because the values measured at the upper arm and wrist undergoes the same changes the values measured at the wrist can be used for comparative measurements.

The blood pressure measurement device displays blood pressure (systolic and diastolic values), pulse, date and time. The following summary can help you to assess the values you measure.

Classification of blood pressure in mmHg

The classification of blood pressure values is based on a definition and classification by the WORLD HEALTH ORGANISATION from 1999. The WHO defines high blood

pressure as values above 140 mmHg (systolic value) and 90 mmHg (diastolic value).

The new blood pressure classification indicator visually indicates user's blood pressure category,

Blood pressure classification	systolic mmHg	diastolic mmHg	Colour-indicator
Low < 90 < 50 Green
Normal 91 - 129 51 - 84 Green
High-Normal 130 - 139 85 - 89 Green
Hypertension stage I	140 – 159 90 – 99 Yellow
Hypertension stage II	160 – 179 100 – 109 Orange
Hypertension stage III	>180 >110 Red

Overview and Display 5

1. Colour indicator
2. Battery icon, the battery icon appears if the batteries need to be changed.
3. Time
4. Date (M month; D day)
5. M: Memory button: save measured blood values, set date and time,
6. Power button: Start measurement, confirm date and time setting.

1. Memory sign
2. Number of measurement (01 – 60) 01 last measurement, 02 previous measurement, etc.
3. Blood pressure classification
4. Pulse sign
5. Pulse frequency per minute
6. Diastolic pressure display Display of the memory unit (U1/U2)
7. Systolic pressure display,
8. Irregular heartbeat indication

Getting started 6

Inserting the batteries

1. Remove the cover of the battery compartment in the direction of the arrow.
2. Insert two 1.5V batteries size AAA/LR03 (alkaline). Pay attention to the polarity (the negative terminal faces the spring).
3. Close the battery compartment.

Replace the batteries

• if the battery icon appears on the display,
- if the display remains blank after pressing the ON/OFF button.

Replace all batteries with new batteries of the same type at the same time. Do not mix used and new or different types of batteries together.

Rechargeable batteries are not suitable for the operation of this device.

Setting the date and time

1. Press the buttons ⏻ and M at the same time. The current month flashes.
2. Press the M button repeatedly to set the current month.
3. Press the ⏻ button. The day flashes.
4. Press the M button repeatedly to set the current day.
5. Press the ⏻ button. The hour flashes.
6. Press the M button repeatedly to set the current hour.
7. Press the ⏻ button. The minutes flash.
8. Press the M button repeatedly to set the current minutes.

Date and time have been set. The flashing bar disappears after 10 seconds.

1. Press the ⏻ button to finish the date and time setting.

The device closes the setting mode automatically after one minute.

Usage 7

1. Attach the wrist sleeve in such a way that it is approx. 5 – 10 mm away from the palm of your left hand (see fig. B). Ensure that no articles of clothing are trapped in the sleeve.
2. Hold the lower part of the sleeve as shown in fig. C. Pull down and wrap it around and upwards, so that there is no gap between the sleeve and your wrist.
3. Use your thumb to hold the sleeve cover while you wrap it upwards.
4. Wrap the sleeve according to the shape of your wrist. If the sleeve is not firmly attached the pressure will increase and the wrist will become numb. Correct measurement is then no longer possible.

If the sleeve cannot be attached to your left arm and if it is not possible to measure your left arm, use your right one. Attach the sleeve as shown in fig. D.

Correct measurement 8

Place your elbow on the table or other supporting surface, and hold your arm so that the wrist sleeve is at heart height. In doing so, support your lower arm on the storage box or on a folded towel or similar.

To measure your blood pressure, sit comfortably on a chair, take 5 or 6 deep breaths and relax.

Always measure your blood pressure at the same time each day! It is important to measure your blood pressure at home and at the same time each day so that the blood pressure, which can change over the course of a day, is recorded properly.

Inform your doctor of the values measured so that he can give you medical advice.

Blood pressure measured at the wrist can vary from that measured at the upper arm. The values may be slightly different because of the different measurement positions and the strength of the blood vessels in the wrist and upper arm. In many cases, the difference for healthy people can be ±10 mmHg of the systolic and diastolic blood pressure.

Attention is advised for the following types of person: People with high blood pressure, diabetes, liver disease, hardened arteries, poor circulation.

Carrying out measurements

1. Attach the wrist sleeve to your wrist as described above.
2. Press the ⏻ button.

All indicators are displayed for a few seconds on the screen; then the screen shows the time and the most recently selected memory unit (U1/U2).

1. You can modify the current memory unit by pressing the button M.

If you have already stored measurements in this unit the display shows the latest values.

During measurement do not move the sleeve or your arm or hand muscles.

A few seconds later the monitor starts searching the zero point. When the air pressure is stable the monitor begins to measure automatically.

1. If you want to stop the measurement, press the button. The air is released from the sleeve.

If you want to repeat a measurement you should wait at least five minutes. The air must be completely removed from the sleeve.

Automatic Measurement

Measurement starts automatically; the device pumps up the sleeve. If the sleeve pressure is too low the device pauses and pumps up the sleeve again until it reaches a sleeve pressure that is appropriate for the measurement.

The device also measures your pulse. The value displayed will fall during measurement.

The sleeve deflates when the measurement is complete. The systolic and diastolic blood pressure and the pulse with the pulse icon appear in the display.

Indication of an irregular heartbeat (arrhythmia)

The pulse normally beats evenly (rhythmically). The symbol will appear in the display if the device perceives irregularities in the rhythm of the pulse.

Repeat the measurement in this case.

There can be different causes of irregularities in the rhythm of the pulse. Please consult your doctor if your pulse is arrhythmic in the long term.

If you want to repeat a measurement you should wait at least five minutes. The air must be completely removed from the sleeve.

Memory unit 9

Reading the stored values

The device has two memory units U1 and U2. Up to 60 measurements can be saved in each unit. You can also display the average values of the saved measurements.

1. The device should not be in measure mode. Switch it off if necessary.
2. Press the button M to enter the memory mode. On the display appear the memory sign, the memory unit and the number of measurements, which have been stored in this unit.
3. You can modify the current memory unit by pressing the ⏻ button.
4. Press the button M to display the stored values.
5. The measured values are displayed in reverse order. With each press of the button M the previous results appear.
6. Press the ⏻ button to exit the memory.

The saved values remain saved when the device is switched of with the ⏻ button.

Deleting memory

1. Press the button M to enter the memory mode.
   On the display appear the memory sign, the memory unit and the number of measurements, which have been stored in this unit.
2. Select the memory unit you want to delete by pressing the ⏻ button.
3. Press the button M for more than 2 seconds.
   A control tone signalizes the deletion. On the display appear two bars.
   The values of the selected memory unit are deleted.

Cleaning and maintenance 10

Notes on maintenance

It is recommended that you check the usability of the unit every three years.

Cleaning and storage

Clean the device with a soft, lint-free cloth. Do not use any solvents, corrosive or gaseous cleaning agents.

Store and transport the device in the storage box supplied. Do not bend the preshaped sleeve outwards. The sleeve should neither be washed nor dry cleaned.

If the appliance is not going to be used for long periods, remove the batteries.

Error messages 11

Defect Possible cause and solution

	The batteries are dead	Replace both batteries with 2 new 1.5V, LR03/ AAA batteries
Er 0	Pressure system is unstable before measurement	Take the measurement again. Don’t move and don’t speak during the measurement.
Er 1	Systolic pressure detect fail
Er 2	Diastolic pressure detect fail
Er 3	Pneumatic system blocked or cuff is too tight during inflation.	Place the cuff correctly and try again.
Er 4	Pneumatic system leakage or cuff is too loose during inflation

Defect Possible cause and solution

Er 5	Inflation above 300 mmHg	Take the measurement again after a 5 minute break. Contact the service centre if the error is indicated repeatedly over a long period of time.
Er 6	Over 3 minutes while pressure above 15 mmHg
Er 7	EEPROM accessing error
Er 8	Device parameter check error
Er 9	MCU self-verity error
Er A	Span error

If you detect failures on the display or wrong measurements, remove the batteries and replace them after 1 minute.

Technical Data 12

Measurement method: oscillometric

Measuring range: Blood pressure: 30 \~ 250 mmHg Pulse: 40 \~ 180 beats/min.

Power supply: 2 x 1.5 V batteries size LR03/AAA (alkaline)

Display: LCD

Memory space: 2 x 60 measurement results

Pressure built up: automatically by pump

Air release: automatically via one-way valve

Measuring accuracy +/- 3 mmHg pressure indicator

Operating temperature: +5 \~ +40 °C air humidity < 80 %

Storage temperature: -20 \~ +55 °C, air humidity < 95 %

Weight: ca. 108 g (excluding batteries)

Sleeve size: 14 \~ 19.5 cm

Subject to technical changes.

The product meets the requirements of the guideline 93/42/EWG for medical devices.

The device corresponds with standards EN 1060-1: 1995 and EN 1060-3: 1997 for non-invasive blood pressure measuring devices.

Type B

The device was manufactured in 2008.

CE0197

The serial number is arranged inside the battery compartment.

Appendix 13

Table 201

Guidelines and manufacturer's declaration – electromagnetic emissions

Model MD 15231 is designed for operation in an environment as described below: The customer or user of Model MD 15231 should ensure that it is operated in such an environment.

Interference emission measurements	In line with	Electromagnetic environment guidelines
HF emissions according to CISPR 11	Group 1	Model MD 15231 uses HF energy exclusively for its internal operation. Therefore its HF emission is very low and it is unlikely that nearby electronic devices should suffer interference.
Interference emission measurements	In line with	Electromagnetic environment – guidelines
HF emissions according to CISPR 11	Class B	Model MD 15231 is intended for use in all premises including residential areas and those that are directly connected to public supply networks that also supply buildings that are used for residential purposes.
Emission of harmonics according to IEC 61000-3-2	Not applicable
Emission of voltage fluctuations/flicker according to IEC 61000-3-3	Not applicable

Table 202

Guidelines and manufacturer's declaration – electromagnetic interference immunity

Model MD 15231 is intended for operation in an electromagnetic environment as described below: The customer or user of Model MD 15231 should ensure that it is operated in such an environment

Interference immunity tests	IEC 60601-test level	Pass level Electromagnetic environment – guidelines
Electrostatic discharge (ESD) according to IEC 61000-4-2	±6 kV contact discharge ±8 kV air discharge	N±8 kV Air discharge	Floors should be of wood or concrete or laid with ceramic tiles. If the floor is covered with synthetic material, the relative humidity should be at least 30%.
Fast, transient electrical interference/ bursts according to IEC 61000-4-4	±2 kV for supply lines ±1 kV for input and output lines	Not applicable	The quality of the power supply should match that of a typical business or hospital environment.
Voltage surges according to IEC 61000-4-5	±1 kV bipolar voltage ±2 kV unipolar voltage	Not applicable	The quality of the power supply should match that of a typical business or hospital environment.
Interference immunity tests	IEC 60601- test level	Pass level	Electromagnetic environment – guidelines
Voltage drop-outs, short-term breaks and drops in supply voltage according to IEC 61000-4-11	<5% UT1)40% UT2)70% UT3)<5% UT4)	Not applicable	The quality of the power supply should match that of a typical business or hospital environment. If the user of Model MD 15231 requires continued operation even if power supply drop-outs occur, we recommend supplying Model MD 15231 from an uninterruptible power supply or a battery.
Magnetic field at the power frequency (50/60 Hz) according to IEC 61000-4-8	3 A/m Not	applicable	Magnetic fields at the mains frequency should match the typical values found in business or hospital environments.
Note: VT is the main AC voltage before application of the test level.1)(>95% drop in VT) for 1⁄2 period2)(60% drop in VT) for 5 periods3)(30% drop in VT) for 25 periods4)(>95% drop in VT) for 5 s

Table 204

Guidelines and manufacturer's declaration – electromagnetic stability

Model MD 15231 is designed for operation in an electromagnetic environment as described below: The customer or user of Model MD 15231 should ensure that it is operated in such an environment.

Electromagnetic environment – guidelinesPortable and mobile should not be used closer to the [appliance or system] than the protection distance calculated using the equation applicable for the emission frequency.

Interference immunity tests	IEC 60601-test level	Pass level	Recommended protection distance:
Conducted HF interference according to IEC 61000-4-6	3 Veff 150 kHz to 80 MHz	3 Veff	d = 1,171/V *
Radiated HF interference according to IEC 61000-4-3	3 V/m80 MHz to 2,5 GHz	3 V/m	d = 1,17m/V * 80 MHz to 800 MHz
			d = 2,33m/V * 800 MHz to 2,5 GHz
Where P is the transmitter's nominal output in Watt (W) according to the information provided by the manufacturer of the transmitter and d is the recommended protection distance in metres (m).The field strength at all frequencies of stationary transmitters is, according to an on-site inspectiona, below the pass levelb. Interference may be experienced in the vicinity of appliances marked with the following symbol

NOTE 1: The higher applies at 80 MHz and 800 MHz.NOTE 2: These guidelines may not apply to all situations. The radiation of electromagnetic waves is influenced by absorption and reflection from buildings, objects and people.

aThe field strength of stationary transmitters, such as base stations for radio telephones and terrestrial mobile services, amateur stations, AM and FM radio and television transmitters cannot be determined precisely in theoretical terms. In order to determine the electromagnetic environment resulting from stationary HF transmitters we recommend an on-site inspection. If the field determined at the location of Model MD 15231 exceeds the pass level stated above the Model MD 15231 must be checked for normal operation at each point of use. If unusual performance characteristics are observed, it may be necessary to undertake additional measures such as realigning or moving Model MD 15231.bNot applicable in the frequency range from 150 kHz to 80 MHz.

Table 206

Recommended protective distances between portable and mobile HF telecommunication devices and the [DEVICE or SYSTEM]

Model MD 15231 is intended for operation in an electromagnetic environment in which the HF interference is controlled. The customer or user of Model MD 15231 can help to avoid electromagnetic interference by adhering to the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the Model MD 15231 – depending on the output of the communication device as shown below.

Nominal output of transmitter W	Protective distance depending on the transmission frequency m
	150 kHz to 80 MHz150 kHz to 80 MHz		80 MHz to 800 MHzd = 1.2 √P	800 MHz to 2.5 GHzd = 2.3 √P
	outside the ISM bands	within the ISM bands
0.01	N/A	N/A		0.12
0.1	N/A	N/A		0.38
1	N/A	N/A		1.2
10	N/A	N/A		3.8
100	N/A	N/A		12

For transmitters whose nominal output is not listed in the above table, the distance can be determined using the equation in the relevant column, where P is the transmitter's maximum nominal output in Watt (W) as specified in the information provided by the transmitter's manufacturer.

NOTE 1 The higher frequency range applies at 80 MHz and 800 MHz.

NOTE 2 The ISM frequency bands (for industrial, scientific and medical applications) between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz and 40.66 MHz to 40.70 MHz.

NOTE 3 The pass levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range from 80 MHz and 2.5 GHz are intended to reduce the probability that mobile/portable communication devices might cause interference if they are accidentally brought into the patient area. For this reason the additional 10/3 factor is applied when calculating the recommended protection distances in these frequency ranges.

NOTE 4 These guidelines may not apply to all situations. The radiation of electromagnetic waves is influenced by absorption and reflection from buildings, objects and people.