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Medion Blood Pressure Measurement Device MD 10544


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Manual

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doc0

Cover_Fold-out_Blutdruckmesser_MD15044_USA 06.FH11 Wed Oct 11 14:08:43 2006

Seite 1

C M Y CM MY CY CMY K
WRIST BLOOD PRESSURE MONITOR

MD 10544

MSN 5002 5595
Item #7221 Two-Year Limited Warranty Toll Free Customer Care: 1-866-633-4660

Distributed by MEDION

INSTRUCTION MANUAL

Please fold out!

Seite 2

DESCRIPTION OF PARTS

PACKAGE CONTENTS
1. Wrist blood pressure monitor 2. Storage case 3. 2 AAA batteries 4. Instruction Manual

1) 2) 3) 8) 7) 4) 5) 6)

TECHNICAL DATA
Measurement method: Measuring range: Power supply: Display: Memory spaces: Pressure build up: Air release: Measuring accuracy: Operating temperature: Storage temperature: Weight: Cuff accommodation: Oscillometric Blood pressure: 40 ~ 250mmHg Pulse: 40 ~ 199 beats/min. 2 AAA batteries LCD 2 x 50 measurement results Automatic by pump Automatic via one-way valve +/- 3mmHg pressure indicator +/- 5 % pulse frequency 50 F - 104 F, 40 ~ 85% air humidity 14 F - 140 F, 10 ~ 95% air humidity approx. 0.255 lb (excluding batteries) Suitable for 5-1/8" - 8-3/4"
1. Display 2. Battery compartment cover 3. Setting button 4. Dual user button
5. On/Off button 6. Cuff 7. Memory button 8. Date and time button
The device was manufactured in 2006

Table of contents

INTRODUCTION. SAFETY INSTRUCTIONS. COMPLIANCE WITH FCC RULES. MEDION LIMITED WARRANTY. ABOUT THIS DEVICE. FIRST OPERATION. THE DISPLAY. BLOOD PRESSURE INDICATOR. ATTACHING THE CUFF. CORRECT MEASUREMENT. CARRYING OUT MEASUREMENTS. STORING VALUES. CLEANING AND MAINTENANCE. ENVIRONMENTAL PROTECTION/DISPOSAL. ERROR MESSAGES. GUIDELINES AND MANUFACTURER'S DECLARATION FOR ELECTROMAGNETIC EMISSIONS (EMC).

. 4. 5. 6. 7. 8. 17 18

INTRODUCTION
Thank you for the trust you have placed in us!
Congratulations on the purchase of your new wrist blood pressure monitor! We are convinced that you will be delighted with this modern piece of equipment. In order to guarantee the optimum operation and performance of this device at all times and in order to protect your personal safety, we would make the following suggestions: Please read these operating instructions thoroughly and follow them and the safety notes before using the device for the first time! Anything done to or with this device may only be undertaken as described in the operating instructions. If you pass on this device to someone else, always include the operating instructions.

Packaging

Your blood pressure monitor is wrapped in packaging to protect it against transportation damage. Packaging is raw material and can be re-used or recycled.

SAFETY INSTRUCTIONS

Blood pressure measurements should only be interpreted by a physician or a trained health care professional who is familiar with your medical history. Through regular use of this device and recording of your measurements, you can keep your physician informed of the changes in your blood pressure. Perform your measurement in a quiet place.You should be seated in a relaxed position. Avoid smoking, eating, taking medication, alcohol consumption or physical activity 30 minutes prior to taking a reading. If you are exhibiting signs of stress, avoid taking your measurement until the feeling subsides. Rest 15 minutes prior to taking a reading. Remove any constrictive clothing or jewelry that may interfere with the cuff placement. Apply the cuff to the proper position on the left wrist. The unit should be located on the inside of your left wrist with the display panel in view. Keep the monitor stable during measurement to achieve an accurate reading. Remain still; do not talk during the measurement. Record your daily blood pressure and pulse readings on a chart. Take your readings at the same time, each day (or as recommended by your physician) to get an accurate indication of change in your true blood pressure. Wait a minimum of 15 minutes between readings to allow for the blood vessels to return to normal. The wait time may vary depending on your individual physiological characteristics. Although such cases are rare, for those with an extremely weak pulse or irregular pulse, errors may result which prevent proper measurement. If abnormal variations are noticed, consult with your physician or trained healthcare professional. This device is intended for adult use. While taking a measurement, you can stop the inflation or deflation process of the cuff at any time by pressing the ON/OFF button.

COMPLIANCE WITH FCC RULES
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiale radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Consult the dealer or an experienced radio/TV technician for help.

MEDION LIMITED WARRANTY

Medion warrants that the product accompanied by this limited warranty is free from manufacturing defects in material or workmanship for a period of 24 months from the date of original purchase. This warranty only applies to the original purchaser of the product. The limited warranty period also applies to any implied warranties that may exist under applicable law. Some States do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you. This limited warranty does not apply to products that have been opened, repaired (except by Medion or its authorized Service representatives), or otherwise altered. This limited warranty does also not apply to defects resulting from misuse, abuse, accident, neglect, improper maintenance or handling. If you believe the product is defective please return it to Medion in the manner described below within the limited warranty period. If Medion determines a defect covered by this limited warranty, Medion will, at its Option, repair or replace the product. This limited warranty extends to repaired products and replacement products only through the end of the original limited warranty period. In no event shall Medion or any of its distributors or resellers be liable for incidental, indirect or consequential damages relating to the product (including any repaired product or replacement product) or its use. Some States do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation and exclusion may not apply to you. This limited warranty gives you specific legal rights, and you may have other rights which vary from State to State. To make a claim under this limited warranty you must first contact Medion Customer Care using one of the options below to obtain a return merchandise authorization (RMA) number. Once you have received the RMA, please return the product as instructed by the RMA. This warranty does not apply to any products returned to Medion without a RMA. To obtain a RMA please contact Medion Toll Free Customer Care at: www.medionusa.com or 1-866-633-4660

ABOUT THIS DEVICE

The device is used to measure blood pressure at the wrist. It is suitable for healthy people above 12 years of age and can be used to make comparative measurements especially during sporting activities.
If the values obtained give you cause to be concerned about your health, seek medical advice. Do not change your treatment/dosage of medication as a result of the values unless you have discussed this with your doctor!
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 undergo the same changes the values measured at the wrist can be used for comparative measurements. The blood pressure monitor displays blood pressure (systolic and diastolic values), pulse, date, time and WHO indicator. The following summary can help you to assess the values you measure:

FIRST OPERATION

1. 2) 3)
Remove the cover of the battery compartment in the direction of the arrow. Insert two AAA batteries. Pay attention to the polarity (the negative terminal faces the spring). 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.
Setting the date and time
Make the settings within 10 seconds; then the display moves to the next setting. 1. 2) 3) 4) 5) Press the Press the Press the Press the button. The current month flashes. button repeatedly to set the current month. button. The day flashes. button repeatedly to set the current day.
Press the button. The hour flashes along with the "AM" (for the hours between 00:00 and 11:59) or "PM" (for the hours between 12:00 and 23:59). Press the Press the button repeatedly to set the current hour. button. The minutes flash.

6) 7) 8)

Press the button repeatedly to set the current minutes. Date and time have been set. The flashing bar disappears automatically after 10 seconds.

THE DISPLAY

User icon 1 or 2; select the user with the

button.

The battery icon appears if the batteries need to be changed. This symbol appears if the average blood pressure value is shown. The pulse sign appears when the pulse is displayed.
EE (E1, E2) Error notifications for operating and device errors.

BLOOD PRESSURE INDICATOR

The World Health Organization (WHO) and National High Blood Pressure Education Program Coordinating Committee have developed a blood pressure standard, classifying blood pressure ranges into 4 stages. This unit is equipped with an innovative blood pressure classification indicator, which visually indicates the assumed risk level (prehypertension/ stage 1 hypertension/ stage 2 hypertension) of the result for each measurement. Stage 2 Hypertension (>160/>100 mmHg)

Stage 1 Hypertension (140~159/90~99 mmHg)
Prehypertension (120~139/80~89 mmHg)
Normal (<120/<80 mmHg) (If one of the above symbols does not appear, you do not have high blood pressure according to the WHO standards.)

ATTACHING THE CUFF

Attach the cuff in such a way that it is approx. 0.2 0.4 inches away from the palm of your left hand (see fig. B). Ensure that no articles of clothing are trapped in the cuff. Hold the lower part of the cuff as shown in fig. C. Pull down and wrap it around and upwards so that there is no gap between the cuff and your wrist. Use your thumb to hold the cuff cover while you wrap it upwards. Wrap the cuff according to the shape of your wrist. If the cuff is not firmly attached the pressure will increase and the wrist will become numb. A correct measurement is then no longer possible.
If for some reason it is not possible to measure using your left arm, your right arm can be used. In this case, attach the sleeve as shown in fig. D.

CORRECT MEASUREMENT

Place your elbow on the table or other supporting surface, and hold your arm so that the cuff is at heart height. 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 proper 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.
Caution is advised for the following types of person: People with high blood pressure, diabetes, liver disease, hardened arteries, poor circulation. These persons should only use the device under advice from their doctor.
CARRYING OUT MEASUREMENTS
Attach the cuff to your wrist as described above. Press the ON/OFF button. All indicators are displayed for a few seconds on the screen; then the screen shows the time and the most recently selected memory space. Measurement starts automatically; the device inflates the cuff. If the pressure is too low, the device pauses and pumps up the cuff again until it reaches a pressure that is appropriate for measurement. The measuring process starts when the correct pressure has been reached. In order to receive an accurate reading, do not move the cuff, your arm or hand muscles during the measurement process. The device also measures your pulse. The value displayed will fall during measurement.
If you want to stop the measurement, press the ON/OFF button. The air is released from the cuff automatically. If you want to repeat a measurement you should wait at least five minutes. The air must be completely removed from the cuff.

4) The cuff automatically deflates when the measurement is complete. The systolic and diastolic blood pressure and the pulse with the pulse icon appear in the display. The entry flashes for a few seconds (see next page).
Press the ON/OFF button again to switch off the device.

STORING VALUES

This device contains memory storage for up to 2 individual users and. Up to 50 measurements can be stored for each user. You can also display the average values of the stored measurements. 1. 2) Before measuring, select the user with the DUAL USER button. flashes on the screen for
Take the measurement. When the values are displayed a few seconds. The measured value is stored in the chosen memory space.
Press the MEMORY button repeatedly to display the stored values. These values are displayed in reverse order with each press of the button. The entry shows the average value (for this to occur at least two values must be stored).
The date and time are shown successively with a few seconds in between.
The stored values remain saved when the device is switched on/off. These values are deleted when the batteries are changed.

CLEANING AND MAINTENANCE

Notes on maintenance
It is recommended that you check the usability of the unit every three years or after repairs. According to the "Operating Regulations for Medical Products," a technical measurement check must take place every 2 years if the device is used for commercial purposes.

Cleaning/storage

Do not clean the device with solvents that contain alcohol. Only use a soft cloth, which may be moistened, and a mild cleaning agent. Then dry the device carefully. Store and transport the device in the storage box supplied. Do not bend the preshaped cuff outwards. The cuff should neither be washed nor dry cleaned. If the device is not going to be used for long periods, remove the batteries to avoid corrosion.
ENVIRONMENTAL PROTECTION/ DISPOSAL
The unit is battery-operated. Do not dispose of dead batteries in the household trash. After the end of its life, ensure to dispose the product beneficial to the environment. Do not dispose the product in the household trash.

ERROR MESSAGES

Defect EE / E1 / E2
Possible cause and solution
The cuff is not attached correctly. Please refer to the notes in these instructions. Movement during measurement. Do not move or speak during measurement The device is not able to measure the values appropriately. Take the measurement again after a 5 minute break. Contact the service center if the error is indicated repeatedly over a long period of time. The batteries are dead. Replace both batteries with 2 new AAA batteries. Notice: If you detect failures on the display or wrong measurements, remove the batteries and replace them after 1 minute. Wait for 10 minutes and then turn the unit on again to start measurement. Be informed, all memory values are automatically deleted once batteries are changed!

GUIDELINES AND MANUFACTURER'S DECLARATION FOR ELECTROMAGNETIC EMISSIONS (EMC)
Guidelines and manufacturer's declaration electromagnetic emissions
Model MD 10544 is designed for operation in an environment as described below: The customer or user of Model MD 10544 should ensure that it is operated in such an environment. Interference emission measurements HF emissions according to CISPR 11 In line with Group 1 Electromagnetic environment guidelines Model MD 10544 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. Model MD 10544 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.
HF emissions according to CISPR 11 Emission of harmonics according to IEC 61000-3-2 Emission of voltage fluctuations/flicker according to IEC 61000-3-3

Class B Not applicable

Not applicable
Guidelines and manufacturer's declaration electromagnetic interference immunity Model MD 10544 is intended for operation in an electromagnetic environment as described below: The customer or user of Model MD 10544 should ensure that it is operated in such an environment. Interference immunity tests IEC 60601 test level Pass level Electromagnetic environment guidelines 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%. The quality of the power supply should match that of a typical business or hospital environment. The quality of the power supply should match that of a typical business or hospital environment.
Electrostatic discharge (ESD) 6 kV according to IEC 61000-4-2 contact discharge 8 kV air discharge Fast, transient electrical interference/ bursts according to IEC 61000-4-4 Voltage surges according to IEC 61000-4-kV for supply lines 1 kV for input and output lines 1 kV bipolar voltage 2 kV unipolar voltage Voltage drop-outs, short-term breaks and drops in supply voltage according to IEC 61000-4-11 < 5 % VT (> 95 % drop in VT) for period 40 % VT (60 % drop in VT) for 5 periods 70 % VT (30 % drop in VT) for 25 periods < 5 % VT (> 95 % drop in VT) for 5 s

N 8 kV Air discharge

The quality of the power supply should match that of a typical business or hospital environment. If the user of Model MD 10544 requires continued operation even if power supply drop-outs occur, we recommend supplying Model MD 10544 from an uninterruptible power supply or a battery.
Magnetic field at the power frequency (50/60 Hz) according to IEC 61000-4-8 NOTE
Magnetic fields at the mains frequency should match the typical values found in business or hospital environments.
VT is the mains AC voltage before application of the test level.
Guidelines and manufacturer's declaration electromagnetic stability Model MD 10544 is designed for operation in an electromagnetic environment as described below: The customer or user of Model MD 10544 should ensure that it is operated in such an environment. Interference immunity tests IEC 60601 test level Pass level Electromagnetic environment guidelines Portable 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. Recommended protection distance: Conducted HF interference according to IEC 61000-46 Radiated HF interference according to IEC 61000-Vrms 150 kHz to 80 MHz Not applicable Not applicable

3 V/m 80 MHz to 2.5 GHz

d = 1.2

80 MHz to 800 MHz

d = 2.3

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 a transmitters is, according to an on-site inspection , below the pass level b. Interference may be experienced in the vicinity of appliances marked with the following symbol.
NOTE 1 The higher value 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.
The 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 10544 exceeds the pass level stated above the Model MD 10544 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 10544. Not applicable in the frequency range from 150 kHz to 80 MHz.

Recommended protective distances between portable and mobile HF telecommunication devices and the [DEVICE or SYSTEM] Model MD 10544 is intended for operation in an electromagnetic environment in which the HF interference is controlled. The customer or user of Model MD 10544 can help to avoid electromagnetic interference by adhering to the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the Model MD 10544 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 MHz outside the ISM bands 150 kHz to 80 MHz within the ISM bands 80 MHz to 800 MHz d = 1.2 0.01 0.N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A 0.12 0.38 1.2 3.800 MHz to 2.5 GHz d = 2.3 0.23 0.73 2.3 7.3 23
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.

doc1

Table of contents

INTRODUCTION. SAFETY INSTRUCTIONS. ABOUT THIS DEVICE. FIRST OPERATION. THE DISPLAY. ATTACHING THE WRIST SLEEVE. CORRECT MEASUREMENT. CARRYING OUT MEASUREMENTS. SAVING VALUES. CLEANING AND MAINTENANCE. ENVIRONMENTAL PROTECTION. ERROR MESSAGES. Guidelines and manufacturer's declaration regarding EMC.

. 4. 5. 6. 7. 8. 15

INTRODUCTION
Thank you for the trust you have placed in us!
We congratulate you on the purchase of your new blood pressure device and are convinced that you will be delighted with this modern piece of equipment. In order to guarantee the optimum operation and performance of your blood pressure measuring device at all times and in order to protect your personal safety, we would make the following request: 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.

Packaging

Your blood pressure measuring device is wrapped in packaging to protect it against transportation damage. Packaging is raw material and can be re-used or added to the recycling system.

SAFETY INSTRUCTIONS

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. 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. Do not use rechargeable batteries, as this could lead to incorrect measurements due to the lower power of these batteries. Only start the air supply (ON/OFF button) once the unit is attached correctly to the arm. 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! Never try to open and/or repair the unit yourself. Repairs may only be undertaken by our Service Centre or other appropriate specialist workshop.
This symbol means: Caution: Please take note of the accompanying documents (operating instructions).

ABOUT THIS DEVICE

The device is used to measure blood pressure at the wrist. It is suitable for healthy people above 12 years of age and can be use to make comparative measurements especially during sporting activities.
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!
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 undergo 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:

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).

FIRST OPERATION

1. 2) 3)
Remove the cover of the battery compartment in the direction of the arrow. Insert two 1.5V batteries, AAA, LR03 (alkaline). Pay attention to the polarity (the negative terminal faces the spring). 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.
Setting the date and time
Make the settings within 10 seconds; then the display moves to the next setting. 1. 2) 3) 4) 5) Press the Press the Press the Press the button. The current month flashes. button repeatedly to set the current month. button. The day flashes. button repeatedly to set the current day.
Press the button. The hour flashes along with the "AM" (for the hours between 00:00 and 11:59) or "PM" (for the hours between 12:00 and 23:59). Press the Press the button repeatedly to set the current hour. button. The minutes flash.

6) 7) 8)

Press the button repeatedly to set the current minutes. Date and time have been set. The flashing bar disappears after 10 seconds.

THE DISPLAY

Memory area icon 1 or 2; select the memory area with the.

button.

The battery icon appears if the batteries need to be changed. The pulse sign appears when the pulse is displayed.
EE (E1, E2) Error notifications for operating and device errors.
ATTACHING THE WRIST SLEEVE
Attach the wrist sleeve in such a way that it is approx. 5 - 10mm away from the palm of your left hand (see fig. B). Ensure that no articles of clothing are trapped in the sleeve. 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. Use your thumb to hold the sleeve cover while you wrap it upwards. 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

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
Attach the wrist sleeve to your wrist as described above. Press the ON/OFF button. All indicators are displayed for a few seconds on the screen; then the screen shows the time and the most recently selected memory space. 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 measuring process starts when the correct sleeve pressure has been reached. During measurement do not move the sleeve or your arm or hand muscles. The device also measures your pulse. The value displayed will fall during measurement.
If you want to stop the measurement, press the ON/OFF 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.
4) 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. The MEM entry flashes for a few seconds (see next page).

Press the ON/OFF button again to switch off the device.

SAVING VALUES

The device has two memory areas and. Up to 50 measurements can be saved in each area. You can also display the average values of the saved measurements. 1. 2) Before measuring select the memory area with the memory area button.
Take the measurement. When the values are displayed MEM flashes on the screen for a few seconds. The measured value is saved into the chosen memory space. Press the MEMORY button repeatedly to display the saved values. The measured values are displayed in reverse order with each press of the button. The A entry shows the average value (for this to occur at least two values must be saved).
The date and time are shown successively with a few seconds in between.
Note: The saved values remain saved when the device is switched on/off. The values are deleted when the batteries are changed.

CLEANING AND MAINTENANCE

Notes on maintenance
It is recommended that you check the usability of the unit every three years or after repairs. According to the "Operating Regulations for Medical Products" a technical measurement check must take place every 2 years if the device is used for commercial purposes.

Cleaning/storage

Do not clean the device with solvents that contain alcohol. Only use a soft cloth, which may be moistened, and a mild cleaning agent. Then dry the device carefully. 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.
ENVIRONMENTAL PROTECTION/ DISPOSAL
The unit is battery-operated. Do not dispose of dead batteries in the household rubbish. After the end of its life, ensure to dispose the product beneficial to the environment. Do not dispose the product in the household rubbish.

ERROR MESSAGES

Defect EE / E1 / E2

Possible cause and solution
The sleeve is not attached correctly. Please refer to the notes in these instructions. Movement during measurement. Do not move or speak during measurement The device is not able to measure the values appropriately. 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. The batteries are dead. Replace both batteries with 2 new 1.5V, LR03 (alkaline) AAA batteries. Notice: If you detect failures on the display or wrong measurements, remove the batteries and replace them after 1 minute. Wait for 10 minutes and then turn the unit on again to start measurement. Be informed, that all memory values will be deleted after a battery changing!
Guidelines and manufacturer's declaration regarding EMC
Guidelines and manufacturer's declaration electromagnetic emissions
Model MD 10544 is designed for operation in an environment as described below: The customer or user of Model MD 10544 should ensure that it is operated in such an environment. Interference emission measurements RF emissions according to CISPR 11 In line with Group 1 Electromagnetic environment guidelines Model MD 10544 uses RF energy for its internal operation. Therefore its RF emission is very low and it is unlikely that nearby electronic devices should suffer interference.
The MD 10544 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
RF emissions according to CISPR 11 Emission of harmonics according to IEC 61000-3-2 Emission of voltage fluctuations/flicker according to IEC 61000-3-3

Class B Class A

Complies
Guidelines and manufacturer's declaration electromagnetic interference immunity Model MD 10544 is intended for operation in an electromagnetic environment as described below: The customer or user of Model MD 10544 should ensure that it is operated in such an environment. Interference immunity tests IEC 60601 test level Pass level Electromagnetic environment guidelines 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%.

Electrostatic discharge (ESD) 6 kV according to IEC 61000-4-2 contact discharge
6 kV contact 8 kV Air discharge
8 kV air discharge Fast, transient electrical interference/ bursts according to IEC 61000-4-4 Voltage surges according to IEC 61000-4-kV for power supply lines 1 kV for input and output lines 1 kV differential mode 2 kV common mode Not applicable Voltage drop-outs, short-term breaks and drops in supply voltage according to IEC 61000-4-11 < 5 % VT (> 95 % drop in VT) for period 40 % VT (60 % drop in VT) for 5 periods 70 % VT (30 % drop in VT) for 25 periods < 5 % VT (> 95 % drop in VT) for 5 s Not applicable 2 kV for power supply lines Not applicable Not applicable
The quality of the power supply should match that of a typical business or hospital environment.
The quality of the power supply should match that of a typical business or hospital environment. If the user of Model MD 10544 requires continued operation even if power supply drop-outs occur, we recommend supplying Model MD 10544 from an uninterruptible power supply or a battery.
Magnetic field at the power frequency (50/60 Hz) according to IEC 61000-4-8 NOTE

Not applicable

The MD 10544 contains no devices susceptible to magnetic fields.
UT is the mains AC voltage prior application of the test level.
Guidelines and manufacturer's declaration electromagnetic stability Model MD 10544 is designed for operation in an electromagnetic environment as described below: The customer or user of Model MD 10544 should ensure that it is operated in such an environment. Interference immunity tests IEC 60601 test level Pass level Electromagnetic environment guidelines Portable and mobile should not be used closer to the model MD 10544 than the protection distance calculated using the equation applicable for the emission frequency. Recommended protection distance: Conducted RF interference according to IEC 61000-46 Radiated RF interference according to IEC 61000-Vrms 150 kHz to 80 MHz 3 V/m d = 1,17 1/V *

3 V/m 80 MHz to 2.5 GHz

d = 1,17 m/V *

*80 MHz to 800 MHz

d = 2,33 m/V * 800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 The higher value applies at 80 MHz and 800 MHz. NOTE 2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MD 10544 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the MD 10544. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended protective distances between portable and mobile RF telecommunication devices and the MD 10544 Model MD 10544 is intended for operation in an electromagnetic environment in which the RF interference is controlled. The customer or user of Model MD 10544 can help to avoid electromagnetic interference by adhering to the minimum distance between portable and mobile RF telecommunication devices (transmitters) and the Model MD 10544 depending on the output of the communication device as shown below.
Separation distance according to frequency of transmitter Rated maximum output power of transmitter W
150 kHz to 80 MHz d = 1,17 1/V *

80 MHz to 800 MHz d = 1,17 m/V * 0,12 0,3,7 11,7
800 MHz to 2,5 GHz d = 2,33 m/V * 0,23 0,74 2,33 7,37 23,3

0.01 0.10 100

0,12 0,37 1,17 3,7 11,7
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 The higher frequency range applies at 80 MHz and 800 MHz. NOTE 2These guidelines may not apply to all situations. The radiation of electromagnetic waves is influenced by absorption and reflection from buildings, objects and people.

 

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