Manual Medisana BU A57 Tensiometru

Manual

99509 BU A57 19-Nov-2024 V1.7 (medisana tracking version)

Date issued May.15 2023 Rev.02 (Urion's version)

4 x LR6,

1,5 V, AA

(b) 2-3 cm

1

2

3

Unit and LCD Display:

Clinical Accuracy

The product was clinically investigated according to the requirements of ISO 81060-2 and com-

plies with the accuracy requirements of +/-5mmHg at a standard deviation of max. 8mmHg.

Warranty and repair terms

Your statutory warranty rights are not restricted by our guarantee below. Please contact your

dealer or the service centre 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 medisana products is three years from 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 which has arisen due to improper treatment, e.g. non-observance of the

user instructions.

b. All damage which is due to repairs or tampering by the customer or unauthorised third

parties.

c. Damage which has arisen during transport from the manufacturer to the consumer or

during transport to the service centre.

d. Accessories which are subject to normal wear and tear.

5. Liability for direct or indirect consequential losses caused by the unit are excluded even if the

damage to the unit is accepted as a warranty claim.

medisana GmbH

Carl-Schurz-Str. 2

41460 NEUSS, GERMANY

Shenzhen Urion Technology Co.,Ltd.

Floor 4-6th of Building D, Jiale Science&Technology Industrial Zone, No.3,

ChuangWei Road, Heshuikou Community, MaTian Street, GuangMing

New District, 518106 ShenZhen, PEOPLE'S REPUBLIC OF CHINA

Tel: (86)-755-29231308, E-Mail: [email protected]

Made in China

WellKang Ltd (www.CE-Marking.eu)

Enterprise Hub, NW Business Complex,

1 Beraghmore Road, Derry, BT48 8SE,

Northern Ireland

EC REP

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GB

Instruction Manual - Upper Arm Electronic

Blood Pressure Monitor

BU A57

Explanation of symbols

Intended purposes

This automatic blood pressure device is intended to measure systolic pressure,

diastolic pressure and pulse rate through upper arm. The device is expected to be

used in private homes and is intended for people over 12 years old.

Intended users

Adults or children over 12 years, who can read and understand the user manual.

Intended patient population

The device is intended to be used by people over 12 years of age, people who

need pulse or blood pressure measurement, including normal people or patients

with hypertension, hypotension, abnormal pulse.

Contraindication

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2.Do not use this product if you have coronary atherosclerotic heart disease

to avoid narrowing or blockage of the blood vessel lumen, which may cause

ischemia and lack of oxygen to the heart.

3.Do not use this product if you have diabetes, as it may cause damage to the

heart and blood vessels.

4.Pregnant women, patients with implanted, electronical devices, patients with

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disease and patients undergoing intravascular therapy or arterio-venous shunt

or people who received a mastectomy. Please consult your doctor prior to using

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5.Those who have arrhythmia, blood circulation or apoplexy problem, please use

under the physician's instruction, lest cause disease exacerbation.

IMPORTANT

Follow the instructions for use! Non-observance of these

instructions can result in serious injury or damage to the device.

WARNING

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injury or death.

CAUTION

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injury, product damage or property damage.

Ingress of water or particular matter into ME Equipment

Authorized Representative in the European Community

CE Mark: Conforms to essential requirements of

EU MDR 2017/745

DISPOSAL: Do not dispose this product as unsorted municipal

waste. Collection of such waste seperately for special treatment

is necessary.

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Manufacturer Date of manufacture

Direct current Medical Device

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Temperature range

Ambient pressure limitation Humidity range

Recycling symbols/codes:

These are used to provide information about the material and its

proper use and recycling.

Importer

IP21

EC REP

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SN

• The unit is intended only for use in the home. 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.

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occlusive disease.

• The unit may not be used to check the heart rate of a pacemaker.

• Pregnant women should take the necessary precautions and pay attention to their indi-

vidual circumstances. Please consult your doctor if necessary.

• If you experience discomfort during a measurement, such as pain in the upper arm or other

complaints, press the START button



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• The unit is unsuitable for children.

• Do not allow children to use the unit. Medical products are not toys!

• Please ensure that the unit is kept away from the reach of children.

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• The swallowing of small part like packaging bag, battery, battery cover and so on may

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• The user must check that the equipment functions safely and see that it is in proper working

condition before being used.

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• The device may not be operated in rooms with high levels of radiation or in the vicinity of

high-radiation devices, such as radio transmitters, mobile telephones or microwaves, as

this could cause functional defects or incorrect measurements.

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• Please do not attempt to repair the unit yourself in the event of malfunctions, since this will

void all warranty claims. Only have repairs carried out by authorised service centres.

• Protect the unit against moisture. If liquid does manage to penetrate into the unit, remove

the batteries immediately and do not continue to use the unit. In this case contact your

specialist dealer or notify us directly.

• Please don’t use a dilution agent, alcohol or petrol to clean the unit.

• Please don’t hit heavily or fall down the product from a high place.

• If the unit is not going to be used for a long period, please remove the batteries.

SAFETY NOTES FOR BATTERIES

• Do not disassemble batteries!

• Replace the new batteries if the unit display a low battery symbol.

• Never leave any low battery in the battery compartment since they may leak and cause

damage to the unit.

• Increased risk of leakage, avoid contact with skin, eyes and mucous membranes! If battery

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of fresh water and seek medical attention immediately!

• If a battery has been swallowed seek medical attention immediately!

• Replace all of the batteries simultaneously!

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or used batteries with new ones!

• Insert the batteries correctly, observing the polarity!

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• Remove the batteries from the device if it is not going to be used for an extended period!

• Keep batteries out of children's reach!

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There is a danger of 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!

Unit and LCD Display



Blood Pressure Monitor



MEM-button (Memory Recall)



START/STOP-button



SET-button



Battery compartment (on underside)



Push-in Connector for air tube



LCD screen (display)



Display of Date/Time



Display of Systolic Pressure



Display of Diastolic Pressure



Pulse symbol



Display of Pulse rate



Change Battery symbol



Irregular heartbeat display



Memory Location number



Memory-Symbol



Blood Pressure Indicator (green - yellow - orange - red)



User memory 1 / 2

Scope of supply

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• 1 medisana blood pressure monitor U82CH

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• 1 storage pouch • 1 instruction manual

Please contact your supplier if you notice any transport damage on unpacking the unit.

What is blood pressure?

Blood pressure is the pressure created in the blood vessels by each heart beat. When the

heart contracts (= systole) and pumps blood into the arteries, it brings about a rise in pres-

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ured. When the cardiac muscle relaxes to take in fresh blood, the pressure in the arteries

also falls. Once the arteries are relaxed, a second reading is taken – the diastolic pressure.

How is blood pressure measured?

The medisana U82CH is a blood pressure unit which is used to measure blood pressure at the

upper arm. The measurement is carried out by a microprocessor, which, via a pressure sensor,

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About irregular heartbeat

An irregular heartbeat is a heartbeat rhythm that varies

by more than 25% from the average heartbeat rhythm

detected while the device is measuring the systolic and

diastolic blood pressure. Irregular heartbeat (IHB) indicator

1.When P1 or P2>0.12s,

2.When P1/Pa*100%>25% or P2/Pa*100%>25%

Any of the above two conditions occurs, it is determined that irregular heartbeat may occur.

Remarks:

Pa is the mean value of the measured inter-beat intervals throughout the measurement.

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The Upper Arm Electronic Blood Pressure Monitor accurately measures the blood pressure

and heart rate of people aged 12 years and above, providing a convenient and low-cost

means for doctors or patients to track and assess blood pressure and pulse changes in

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pressure and pulse, improves blood pressure control and provides monitoring data for the

management and treatment of patients with hypertension or other conditions caused by hy-

pertension, allowing for appropriate responses to the diseases to guide medication.

Common factors of wrong measurement

• Please keep quiet for 5-10 minutes and avoid eating, drinking alcohol, smoking, exercising and

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• 5HPRYHDQ\JDUPHQWWKDW¿WVFORVHO\WR\RXUXSSHUDUP

• Always measure on the same arm (normally left).

• Take measurement regularly at the same time of every day, as blood pressure changes

even during the day.

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• Make sure you are in a comfortable, relax position and do not activate any of the muscles in

the measurement arm during measurement. Use a cushion for support if necessary.

• If the arm artery lies lower or higher than the heart, a false reading will be obtained.

Read the instructions for use carefully, especially the safety

instructions, before using the appliance and keep the instruc-

tions for use or hand them on when passing the appliance on.

GBSafety instructions

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Low blood pressure

Normal blood pressure

systolic <100 diastolic <60

(green display area



)

systolic 100 - 139 diastolic 60 - 89

Forms of hypertension

Mild hypertension

(yellow display area



)

systolic 140 – 159 diastolic 90 – 99

Moderate hypertension

(orange display area



)

systolic 160 – 179 diastolic 100 – 109

Severe hypertension

(red display area



)

systolicdiastolic

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• 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.

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values in various ways.

• Measure your blood pressure before meals.

• Before taking readings, allow yourself at least 5-10 minutes rest.

• If the systolic and diastolic readings seem unusual (too high or too low) on several occa-

sions, despite correct use of the unit, please inform your doctor. This also applies to the

rare occasions when an irregular or very weak pulse prevents you from taking readings.

Starting up: Insert / replace batteries

You must insert the batteries provided before you can use your unit. The lid of the battery

compartment



is located on the underside of the unit. Open it, remove it and insert the 4

AA LR6 type 1.5 V batteries 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



appears on the display



or if nothing appears on

the display after the unit has been switched on.

Settings

1. User setting:

Press SET button ZKHQSRZHURႇ

The screen will display

or , press MEM-button  to switch between and , press

SET button WRFRQ¿UPWKHXVHU$IWHUZDUGVWKHFRPSXWHUZLOOHQWHULQWR\HDUVHWWLQJPRGH

2. Year setting:

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required year appears. Press SET button ZKHQ\RXFRQ¿UPWKH\HDUWKHQLWZLOOVZLWFKWR

the month and date setting mode.

3. Month and date setting:

7KHPRQWKVWDUWVÀDVKLQJ.HHSSUHVVLQJWKHMEM-button  until the required month ap-

pears. Press SET button WRFRQ¿UPWKHPRQWKWKHQFRPSXWHUZLOOSURFHHGWRVHWWKHGDWH

As with the month setting, keep pressing the MEM-button  until the required day appears.

Press SET button WRFRQ¿UPWKHGDWHWKHQFRPSXWHUZLOOVZLWFKWRWLPHVHWWLQJPRGH

4. Time setting:

7KHKRXUVWDUWVÀDVKLQJ.HHSSUHVVLQJWKHMEM-button  until the required hour appears.

Press SET button WRFRQ¿UPWKHKRXUDQGSURFHHGLQWKHVDPHZD\IRUPLQXWHVHWWLQJ

Afterwards CL appears in the display. You can quit set-up mode by pressing SET button .

If the batteries are changed the information is lost and the date and time need to

be set again.

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1. Push the end piece of the air tube  into the hole on the left side of the unit prior to use.

2. 6OLGHWKHRSHQHQGRIWKHFXႇWKURXJKWKHPHWDOEUDFNHWVRWKDWWKH9HOFURIDVWHQHULV

on the outside and it becomes a cylindrical form (Fig.16OLGHWKHFXႇRYHU\RXUOHIW

upper arm.

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WKHFXႇWLJKWDQGFORVHWKH9HOFURIDVWHQHUF

4. Measure the pulse on your bare arm.

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out measurements on the same arm.

6. Correct measuring position for sitting (Fig.3).

Notes:

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ers parts will cause inaccurate measurement results.

• $ORRVHRURSHQFXႇFDXVHVIDOVHUHDGLQJ

• With repeated measurements, blood accumulates in the arm which can lead to false read-

ing. Consecutive blood pressure measurements should be repeated after 1 minute pause

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Taking a blood pressure measurement

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1. Switch the unit on by pressing the START/STOP button



.

2. If the START/STOP button



is pressed, two short beeps are heard and all display

characters are shown (display test). This test can be used to check that the display is

indicating properly and in full.

3. The unit is ready for measurement and the number 0ÀDVKHVIRUVHFRQGV,WDXWR-

PDWLFDOO\LQÀDWHVWKHFXႇVORZO\LQRUGHUWRPHDVXUH\RXUEORRGSUHVVXUH7KHULVLQJ

SUHVVXUHLQWKHFXႇLVVKRZQRQWKHGLVSOD\

4. 7KHXQLWLQÀDWHVWKHFXႇXQWLOVXႈFLHQWSUHVVXUHKDVEXLOWXSIRUDPHDVXUHPHQW7KHQ

WKHXQLWVORZO\UHOHDVHVDLUIURPWKHFXႇDQGFDUULHVRXWWKHPHDVXUHPHQW:KHQWKH

device detects the signal, the heart symbol

RQWKHGLVSOD\VWDUWVWRÀDVK\RXFDQ

hear the beep for every heartbeat once the heartbeat signal is detected.

5. :KHQWKHPHDVXUHPHQWLV¿QLVKHG\RXFDQKHDUDORQJEHHSDQGWKHFXႇLVGHÀDWHG

completely. The systolic and diastolic blood pressure and the pulse value with the

pulse symbol appear on the display



7KHEORRGSUHVVXUHLQGLFDWRUÀDVKHVQH[WWR

WKHUHOHYDQWFRORXUHGEDUGHSHQGLQJRQWKHEORRGSUHVVXUHFODVVL¿FDWLRQ,IWKHXQLWKDV

detected an irregular heartbeat, the symbol

DOVRÀDVKHV

6. The readings are automatically saved in the selected memory ( or ). Up to 90 meas-

ured values with date and time can be stored in each memory.

 7KHPHDVXUHPHQWUHDGLQJVUHPDLQRQWKHGLVSOD\7KHXQLWVZLWFKHVRႇDXWRPDWLFDOO\

DIWHUDSSUR[PLQXWHVLIQREXWWRQVDUHSUHVVHG7KHXQLWPD\DOVREHVZLWFKHGRႇ

using the START/STOP button



.

Discontinuing a measurement

If it is necessary to interrupt a blood pressure measurement for any reason (eg. the patient

feels unwell) the START/STOP button



can be pressed at any time. The device immedi-

DWHO\GHFUHDVHWKHFXႇSUHVVXUHDXWRPDWLFDOO\

Displaying stored values

This unit features 2 separate memories, each with a capacity of 90 memory slots. Results are

automatically stored in the memory selected by the user. Press the MEM button  when power

RႇWRFDOOXSWKHPHDVXUHGYDOXHVVWRUHG$OOYDOXHVDYHUDJHDSSHDURQWKHGLVSOD\3UHVVLQJ

the MEM button  again, the last measurement value will be shown. Repeatedly pressing the

MEM button  displays the respective values measured previously. If you have reached the

¿QDOHQWU\DQGGRQRWSUHVVDEXWWRQWKHXQLWDXWRPDWLFDOO\VZLWFKHVLWVHOIRႇDIWHUDSSUR[L-

mately 120 seconds in memory recall mode. Memory recall mode can be exited at any time

by pressing the START/STOP button ZKLFKZLOODOVRVZLWFKWKHXQLWRႇ7KHROGHVWYDOXH

is deleted if 90 measured values have been stored in the memory and a new value is saved.

Deleting stored values

If you are sure that you want to permanently remove all stored memories, press the SET but-

ton  for 7 times until CLDSSHDUVZKHQSRZHURႇ3UHVVWKH67$576723EXWWRQ, CL will

ÀDVKIRUWLPHVWRFOHDUDOOWKHPHPRULHV$IWHUWKLVSUHVV0(0EXWWRQ, M and “no” will be

shown on the display which mean that no memory in store.

Error messages and error remedying

Error indicators: The following symbol will appear on the display when measuring abnormal.

Symbol Cause Remedying

E-1 Weak signal or

pressure change

suddenly

:UDSWKHFXႇSURSHUO\5HPHDVXUHZLWK

correct way.

E-2 External strong

disturbance

When near cell phone or other high radiant

device, the measurement will be failed.

Keep quiet and no chatting when mesure.

E-3 ,QÀDWLRQHUURU :UDSWKHFXႇSURSHUO\0DNHVXUHWKDWKH

plug is properly inserted in the unit.

Remeasure.

E-5 Abnormal blood

pressure

Repeat the measurement after relax for

30 mins. If get unusual readings for 3

times, please contact your doctor.

Weak batteries The batteries are too low or empty.

Replace all four batteries with new 1.5V

type AA LR6 batteries.

Troubleshooting

Problem Check Cause and solutions

No power Check the battery po-

wer. Check the polarity

position.

Replace batteries. Check for cor-

rect installation of the batteries

(polarity).

1RLQÀDWLRQ Check whether the plug

is inserted correctly.

Check whether the plug

is broken or leak.

Insert into the air socket tightly.

&KDQJHFXႇ

Err appears &

measurement is

interrupted

Movement or speaking

during measurement.

Do not move or speak during the

measurement.

&XႇOHDNV Check whether the

FXႇLVGDPDJHGRUWRR

loose.

:UDSWKHFXႇWLJKWO\&KDQJH

FXႇ

Please contact the customer service if you can’t solve the problem. Do not disassemble

the unit by yourself.

Cleaning and care

Remove the batteries before cleaning the unit. Clean the unit using a soft cloth lightly mois-

tened with a mild soapy solution. Never use abrasive cleaning agents, alcohol, naphta, thin-

ner 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 expose the unit to direct sunlight; protect it against

dirt and moisture. Do not subject the unit to extreme hot or cold temperature. Keep the unit in

the storage case when no use. Store the unit in a clean and dry location.

&XႇFOHDQLQJDQGGLVLQIHFWLQJ

8VHDGXVWIUHHFORWKGLSSHGLQZDWHUWRZLSHWKHFXႇVXUIDFHXQWLOWKHUHLVQRYLVLEOHVWDLQDQG

WKHQXVHDGU\GXVWIUHHFORWKWRZLSHWKHZDWHURႇWKHFXႇVXUIDFH$IWHUFOHDQLQJFKHFNWKH

LQWHUQDODQGH[WHUQDOVXUIDFHVRIWKHFXႇWRHQVXUHWKDWWKHVHDUHFOHDQ,IGLUWLVIRXQGFOHDQ

repeatedly until there is no visible stain and then place it in a cool, ventilated and dry place

(high temperature treatment such as ironing and drying is not allowed).

'LVLQIHFWLQJWKHFOHDQHGDQGGULHGFXႇ:LSHWKHFXႇVXUIDFHEDFNDQGIRUWKZLWKDGXVW

free cloth dipped with 75% rubbing alcohol by volume to remove the sebum and other micro-

organisms from the surface for 1 minute each time, totally 10 times. After disinfection, dry it

ZLWKDFOHDQGXVWIUHHFORWKWRDOORZWKHUHVLGXDODOFRKROWRYRODWLOL]HQDWXUDOO\7KHFXႇFDQEH

F\FOHGDQGFOHDQHGWLPHVRXWRIXVHV:KHQWKHFXႇLQÀDWLRQWLPHH[FHHGVVHF-

RQGVGXULQJQRUPDOPHDVXUHPHQWRIWKHGHYLFHDQGWKHGHYLFHGLVSOD\V(WKHFXႇQHHGV

WREHUHSODFHG:KHQWKHFXႇERQGLQJVXUIDFHGRHVQRWELQGHႇHFWLYHO\WKHFXႇQHHGVWREH

UHSODFHG3OHDVHFRQWDFWWKHPDQXIDFWXUHULI\RXQHHGWRSXUFKDVHDVXLWDEOHFXႇ

7KHFXႇLVFRQVXPDEOHZLWKDVHUYLFHOLIHRIWLPHVXQGHUFRPSDQ\VWHVWFRQGLWLRQV,W

LVUHFRPPHQGHGWRUHSODFHLWLQWLPHWRDFFXUDWHO\PHDVXUHEORRGSUHVVXUH,IFXႇLVWRRVPDOO

please call the manufacturer or seller (retailer) for further information. In case of air leakage,

FRQWDFWWKHVHUYLFHFHQWUHIRUUHSODFHPHQW7KHFXႇLVWUHDWHGDVWKHDSSOLHGSDUW

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 disposed 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 author-

ity or your supplier for information about disposal.

Guidelines / Standards

This Upper Arm Electronic Blood Pressure Monitor cannot be used in an MRI environment.

It meets the requirements of the EU standard for noninvasive blood pressure monitors. It is

FHUWL¿HGLQDFFRUGDQFHZLWK(&*XLGHOLQHVDQGFDUULHVWKH&(V\PEROFRQIRUPLW\V\PERO

“CE 0123”. The device meets the requirements of IEC 80601-2-30, Part 2 for non-invasive

blood pressure monitors. Reporting adverse events for the users/patients/customers in EU

countries: If users/patients/customers think that they or someone in the family has experi-

enced a serious incident that has occurred in relation to the device, users/patients/customers

are encouraged to report the incident to the manufacturer and the competent authority of the

Member State in which the user/patient/customer is established.

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

WRGDQJHURXVVLWXDWLRQVDULVLQJHJRQVWDLUVRULQWUDႈF

WARNING

Do not take any therapeutic measures on the basis of a self-measure-

ment. Never alter the dose of a medicine prescribed by a doctor.

7HFKQLFDOVSHFL¿FDWLRQV

Name and model : Blood pressure monitor

Model: U82CH

Display system : Digital display

Memory slots : 2 x 90 for measurement values

Measuring method : Oscillometric

Voltage supply : 6V

, 4 x 1.5V batteries AA LR6

Measuring range blood pressure : 0 – 299 mmHg

Measuring range pulse : 40 – 199 beats/min.

Maximum measuring

deviation of static pressure

: ± 3 mmHg

Maximum measuring

deviation of pulse values

: ± 5 % of the values

Main unit lifetime : 10,000 times under normal use

Battery life : Could be used for 300 times at normal condition

Pressure generation : Automatic with pump

Air release : Automatic

$XWRPVZLWFKRႇ : after approx. 3 minutes

Operating environment : +5 °C to +40 °C, min. 15 to 93 % max. relative humi-

dity, air pressure 86kPa to 106kPa

Note: The product cannot be operated at an

altitude of 2,000 m or above.

Storage & transportation environment : -20 °C to +55 °C, min. 10 to 93 % max. relative humi-

dity, air pressure 86kPa to 106kPa

avoid crash, sunlight or rain during transportation.

Dimensions (L x W x H) : approx. 130 x 109 x 60 mm

&Xႇ : 500 x 150 mm / 22 - 36 cm for adults

Weight (main unit) : approx. 254 g without batteries

Item number : 99509

EAN number : 40 15588 99509 5

Accessories : &Xႇ0±FPIRUDGXOWVZLWK

average upper arm circumference

Art. No. 51193 / EAN 40 15588 51193 6

&Xႇ/FPIRUDGXOWVZLWKXSSHU

arm of large circumference (not included, can be

purchased separately)

Art. No. 51194 / EAN 40 15588 51194 3

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 under www.medisana.com

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