Dr Senst BP118A Digital Blood Pressure Monitor Instruction Manual

Dr Senst BP118A Digital Blood Pressure Monitor

DIGITAL BLOOD PRESSURE MONITOR
Automatic Upper Arm Style Instruction Manual
Model No: BP118A

Introduction

Features of the BP118A

1. The blood-pressure monitor BP118A (with integrated time/date display) is a fully automatic, digital blood- pressure measuring device for use on the arm, which enables very fast and reliable measurement of the systolic and diastolic blood-pressure as well as the pulse frequency by way of the oscillometric method of measuring.
2. The device offers a very high and clinical tested measurement accuracy and has been designed to provide a maximum of user-friendliness. The device is intended for self-use in home.
3. Before using, please read through this instruction manual carefully and then keep it in a safe place.
4. For further questions on the subject of blood-pressure and its measurement, please contact your doctor.

ATTENTION!

Important information about self-measurement

• Substitution of a different component might result in measurement error.
• cuff is replaceable only by an original.
• Do not use with neonatal patients.
• Do not intend to use with pregnant or pre-eclamptic patients
• It will cause harmful injury to the patient or effect the blood pressure due to connection tubing kinking.
• Too frequent measurements can cause injury to the patient due to blood flow interference.
• The application of the cuff over a wound can cause further injury.
• The application of the cuff and its pressurization on any limb where intravascular access or therapy, or an arteriovenous (A-V) shunt, is present because of temporary interference to blood flow and could result in injury to the patient.
• Do not let the cuff and its pressurization on the arm on the side of a mastectomy
• Pressurization of the cuff can temporarily cause loss of function of simultaneously used monitoring ME equipment on the same limb.
• The need to check that operation of the automated sphygmomanometer does not result in prolonged impairment of patient blood circulation.
• Not intended to be used together with HF surgical equipment.
• Do not forget: self-measurement means control, not diagnosis or treatment. Unusual values must always be discussed with your doctor. Under no circumstances should you alter the dosages of any drugs prescribed by your doctor.
• The pulse display is not suitable for checking the frequency of heart pacemakers!
• In cases of cardiac irregularity (Arrhythmia), measurements made with this instrument should only be evacuated after consultation with the doctor.

Electromagnetic interference
The device contains sensitive electronic components (Microcomputer). Therefore, avoid strong electrical or electromagnetic fields in the direct vicinity of the device (e.g. mobile telephones, microwave cookers). These can lead to temporary impairment of the measuring accuracy.

Important information on the subject of blood-pressure and its

measurement

How does high/low blood-pressure arise?
The level of blood-pressure is determined in a part of the brain, the so- called circulatory centre, and adapted to the respective situation by way of feedback via the nervous system. To adjust the blood-pressure, the strength and frequency of the heart (Pulse), as well as the with of circulatory blood vessels is altered. The latter is effected by way of fine muscles in the blood- vessel walls. The level of arterial blood-pressure changes periodically during the heart activity: During the «blood ejection» (Systole) the value is maximal (systolic blood- pressure value), at the end of the heart’s «rest period» (Diastole) minimal (diastolic blood-pressure value). The blood- pressure values must lie within certain normal ranges in order to prevent particular diseases.

Which values are normal?

• Blood pressure is too high if at rest, the diastolic pressure is above 90 mmHg and/or the systolic blood-pressure is over 160 mmHg. In this case, please consult your doctor immediately. Long-term values at this level endanger your health due to the associated advancing damage to the blood vessels in your body. Should the systolic blood-pressure values lie between 140 mmHg and 160 mmHg and/or the diastolic blood- pressure values lie between 90 mmHg and 100 mmHg, likewise, please consult your doctor, Furthermore, re- gular self-checks will be necessary.
• With blood-pressure values that are too low, i.e. sys- tolic values under 100 mmHg and/or diastolic values under 60 mmHg, likewise, please consult your doctor. Even with normal blood-pressure values, a regular self-check with your blood-pressure monitor is recom- mended. In this way you can detect possible changes in your values early and react appropriately. If you are undergoing medical treatment to control your blood pressure, please keep a record of the level of your blood pressure by carrying out regular self-mea- surements at specific times of the day. Show these values to your doctor. Never use the results of your measurements to alter independently the drug doses prescribed by your doctor.

Table for classifying blood-pressure values (unit: mmHg) according to World Health Organization:

Further information

• If your values are mostly standard under resting conditions but exceptionally high under conditions of physical or psychological stress, it is possible that you are suffering from so-called «labile hypertension». Please consult your doctor if you suspect that this might be the case.
• Correctly measured diastolic blood-pressure values above 120mmHg require immediate medical treatment.

The various components of the blood-pressure monitor

Putting the blood-pressure monitor into operation

Inserting the batteries

1. Insert the batteries (4 x size AA 1.5V), thereby observing the indicated polarity.
2. If the battery warning  icon appears in the display, the batteries remain 20% power to warn user the batteries will be run out.
3. If the battery warning icon appears in the display, the batteries are empty and must be replaced by new ones

ATTENTION!

• After the battery warning icon appears, the device is blocked until the batteries have been replaced.
• Please use «AA» Long-Life or Alkaline 1.5V Batteries. The use of 1.2V Accumulators is not recommended.
• If the blood-pressure monitor is left unused for long periods, please remove the batteries from the device.

How to select broadcasting languages (option in talking feature)

• This device has talking function: German & English & French & Italian.
• To press and hold « » button 3-5 seconds, then enter to language selection mode. the default language is German, and to press “memory button or setting button” sequentially to select German & English & French & Italian and mute (voice off) and go back to German, and so on …

Reading the set date
Please press the TIME button and the date will be shown in the display.

User selection and setting the time / date
User selection: This advanced blood pressure monitor allows you to track blood pressure readings for 2 individuals independently

1. Before measurement, make sure you set the unit for the intended user. The unit can track results for 2 individuals. (User 1, User 2)
2. Press the TIME button for at least 3 seconds. The display now indicates the set user, during which the set user blink, to confirm, press ON/OFF button
3. Click the MEMORY button to select User d) We suggest the first person to take their pressure to be User 1.
4. rapid user select button press the user button, then in is blinking, press again to change user,

Setting the time, date
This blood-pressure monitor incorporates an integrated clock with date display. This has the advantage, that at each measurement procedure, not only the blood-pressure values are stored, but also the exact moment of the measurement. After new batteries have been inserted, the clock begins to run TIME 12:00 and DATE 1-01. You must then re-enter the date and current time. For this, please proceed as follows.

1. Press the TIME button for at least 3 seconds firstly, user icon will blink. Then press TIME button again the display now indicates the set year, during which the four characters blink.
2. The correct year can be entered by pressing the MEMORY button
3. Press the TIME button again. The display now switches to the current date, during which the first character (month) blinks.
4. The corresponding month can now be entered by pressing the MEMORY button.
5. Press the TIME button again. The last two characters (day) are now blinking
6. The corresponding day can now be entered by pressing the MEMORY button.
7. Press the TIME button again. The display now switches to the current time, during which the first character (Hour) blinks
8. The corresponding hour can now be entered by pressing the MEMORY button.
9. Press the TIME button again. The last two characters (Minutes) now blink.
10. The exact time can now be entered by pressing the MEMORY button
11. Once you have made your settings, press the TIME button (or TIME / DATE or TIME). The setting is confirmed and the clock starts running.
12. Now after all settings have been made, press the TIME button once again. The date is briefly displayed and then the time. The input is now confirmed and the clock begins to run.

Further Information
With each press of the button (TIME, MEMORY) one input is made (e.g. switching over from hours to minutes mode, or altering the value by +1). However, if you keep the respective button depressed, you can switch more quickly to find the desired value respectively.

Carrying out a measurement

Before the measurement
Avoid eating, smoking as well as all forms of exertion directly before the measurement. All these factors influence the measurement result. Try and find time to relax by sitting in an armchair in a quite atmosphere for about ten minutes before the measurement.

• Measure always on the same arm (normally left).
• Attempt to carry out the measurements regularly at the same time of day, since the blood pressure changes during the course of the day.

Common sources of error
Note: Comparable blood-pressure measurements always require the same conditions! These are normally always quiet conditions.

• All efforts by the patient to support the arm can in- crease the blood-pressure. Make sure you are in a comfortable, relaxed position and do not activate any of the muscles in the measurement arm during the measurement. Use a cushion for support if necessary.
• The performance of the automated sphygmomanometer can be affected by extremes of temperature, humidity and altitude.
• Avoid compression or restriction of the connection tubing. A loose cuff causes false measurement values.
• With repeated measurements, blood accumulates in the respective arm, which can lead to false results. Correctly executed blood-pressure measurements should therefore first be repeated after a 5 minutes pause or after the arm has been held up in order to allow the accumulated blood to flow away (after at least 3 minutes).

Fitting the cuff
Insert air connector into air outlet shown in left photo and please make sure the fitting of the air connector completely and properly to avoid air leakage.

1. The distance between the edge of cuff and the elbow should be approx. 2~3cm.
2. Secure the cuff with the Velcro fastener, so that it lies comfortably and not too tight, whereby no space should remain between the cuff and the arm.
3. Lay the arm on a table, with the palm upwards. Sup- port the arm a little with a rest (cushion), so that the cuff rests at about the same height as the heart. Take care, that the cuff lies free. Remain so for 2 minutes sit- ting quietly, before beginning with the measurement.
4. Let legs uncrossed, feet flat on the floor, back and arm supported.

Measuring procedure
After the cuff has been appropriately positioned, the measurement can begin:

1. Press the ON/OFF button, the pump begins to inflate the cuff. In the display, the increasing cuff pressure is continually displayed.
2. After reaching the inflation pressure, the pump stops and the pressure slowly falls away. The cuff-pressure (large characters) is displayed during the measurement. When the device has detected the pulse, the heart symbol in the display begins to blink. c) When the measurement is complete, the measured systolic and diastolic blood pressure values and the pulse rate are displayed.

Example (Fig.) : Systole 118, Diastole 73, Pulse 75 The measurement results are displayed, until you switch the device off. If no button is pressed for 3 minutes, the device switches automatically off, to save the batteries.

Discontinuing a measurement
If it is necessary to interrupt a blood pressure measurement for any reason (e.g. the patient feels unwell), the “ON/OFF” power button can be pressed at any time. The device then immediately lowers the cuff-pressure automatically.

Memory – storage and recall of the measurements

• The blood-pressure monitor automatically stores each of the last 120 measurement values. By pressing the MEMORY button, an average value of the last 3 measurements as well as the last measurement and the further last 120 measurements (MR119, MR118, …, MR1) can be displayed one after the other
• (MR1: Values of the last measurement) (MR2-MR120: Values of the measurement before MR1)

Emory cancellation of all measurements
Attention! Before you delete all readings stored in the memory, make sure you will not need refer to the readings at a later date. Keeping a written record is prudent and may provide additional information for your doctor’s visit. In order to delete all stored readings, depress the MEMORY button for at least 5 seconds, the display will show the symbol «CL» and then release the button. To permanently clear the memory, Press the MEMORY button while «CL» is flashing.

Appearance of the Heart Arrhythmia Indicator for early Detection

• This symbol indicates that certain pulse irregularities were detected during the measurement. In this case, the result may deviate from your normal blood pressure – repeat the measurement. In most cases, this is no cause for concern. However, if the symbol appears on a regular basis (e.g. several times a week with measurements taken daily) we advise you to tell your doctor.
• Please show your doctor the following explanation Information for the doctor on frequent appearance of the Arrhythmia indicator This instrument is an oscillometric blood pressure monitor that also analyses pulse frequency during measurement.
• The instrument is clinically tested. The arrhythmia symbol is displayed after the measurement, if pulse irregularities occur during measurement. If the symbol appears more frequently (e.g. several times per week on measurements performed daily) we recommend the patient to seek medical advice.
• The instrument does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage

Error messages /malfunctions

If an error occurs during a measurement, the measurement is discontinued and a corresponding error code is displayed.

Further Information   The level of blood-pressure is subject to fluctuations even with healthy people. Important thereby is, that comparable measurements always require the same conditions (Quiet conditions)! If, in spite of observing all these factors, the fluctuations are larger than 15mmHg, and/or you hear irregular pulse tones on several occasions, please consult your doctor. For licensing, the device has been subjected to strict clinical tests, by which the computer program used to measure the blood-pressure values was tested by experienced specialist doctors in Germany. The same computer program is used in every individual device, and has thus also been clinically tested. The manufacture of the devices takes place according to the terms of the European standard for blood-pressure measuring devices (see technical data) You must consult your specialist dealer or chemist if there are technical problems with the blood-pressure instrument. Never attempt to repair the instrument yourself! Any unauthorised opening of the instrument invalidates all guarantee claims!

Other possible malfunctions and their elimination
If problems occur when using the device, the following points should be checked and if necessary, the corresponding measures are to be taken:

Care And Maintenance, Recalibration

1. Do not expose the device to either extreme temperatures, humidity, dust or direct sunlight.
2. The cuff contains a sensitive air-tight bubble. Handle this carefully and avoid all types of straining through twisting or buckling.
3. Clean the device with a soft, dry cloth. Do not use petrol, thinners or similar solvent. Spots on the cuff can be removed carefully with damp cloth and soapsuds. The cuff must not be washed!
4. Do not drop the instrument or treat it roughly in any way. Avoid strong vibrations.
5. Never open the device! Otherwise the manufacturer calibration becomes invalid!

Guarantee

• The blood-pressure monitor BP118A is guaranteed for 2 years from date of purchase.
• The guarantee does not apply to damage caused by improper handling, accidents, not following the operating instructions or alterations made to the instrument by third parties.
• The guarantee is only valid upon presentation of the guarantee card filled out by the dealer.

Service life
5 years

Battery life:
1000 times measurement with 4- size “AA” alkaline Batteries

Safety, care and disposal

Safety and protection

• This instrument maybe used only for the purpose described in this booklet. The manufacturer cannot be held liable for the damage caused by incorrect application.
• This instrument comprise sensitive components and must be treated with caution. Observe the storage and operating condition described in the “Technical specifications” section!
• Protect it from water and moisture, extreme temperatures, impact and dropping, contamination and dust, direct sunlight, heat and cold
• The cuffs are sensitive and must be handled with care
• Only pump up the cuff once fitted
• Do not use the instrument close to strong electromagnetic fields such as mobile telephones or radio installations
• Do not use the instrument if you think it is damaged or notice anything unusual.
• If the instrument is not going to be used for a prolonged period the batteries should be removed.
• Read the additional safety instructions in the individual sections of this booklet.
• Ensure that children do not use the instrument unsupervised: some parts are small enough to be swallowed
• Must use the recognized accessories, detachable parts and materials, if the use of other parts or materials can degrade minimum safety
• A warning to remove primary batteries if the instruments is not likely to be used for some time

Instrument care
Clean the instrument only with a soft, dry cloth

Disposal
Batteries and electronic instruments must be disposed of in accordance with the locally applicable regulati- ons, not with domestics waste.

Reference To Standards
Device standard:

• IEC60601-1-6:2010+A1:2013/EN60601-1-6:2010+A1:2015
• IEC60601-1:2005+A1:2012/EN60601-1:2006+A11:201 1+A1:2013+A12:2014
• IEC60601-1-2:2014/ EN60601-1-2:2015
• IEC/EN60601-1-11:2015 TEC80601-2-30:2009+A1:2013/EN80601-2- 30:2010+A1:2015
• stipulations of the EU-Guidelines 93/42 EEC for Medical Products Class III have been fulfilled.

Remark

Technical specifications

Please be noticed the power adapter is not supplied from the origin, users can buy the adapter in the market which must comply to EN60601-1, EN60601-1-2

Manufacturer’s Declaration

The BP118A is intended for use in the electromagnetic environment specified below. The customer or the user of the BP118A should assure that it is used in such an environment.

Electromagnetic Emissions: (IEC60601-1-2

Electromagnetic Immunity: (IEC60601-1-2)

Recommended Separation Distances:

Battery safety instructions

• Replace the batteries when the battery symbol appears in the display.
• Immediately remove weak batteries from the battery compartment, as they may leak and damage the device.
• In case of contact with battery acid, immediately rinse the affected areas with plenty of clean water and seek medical attention immediately.
• If a battery is swallowed, seek medical attention immediately.
• Always replace all batteries at the same time.
• Only use batteries of the same type, do not use different types or used and new batteries together.
• Insert batteries correctly, observe the polarity (+/-).
• Remove batteries if you do not use the device for at least 3 months.
• Keep batteries away from children.
• Do not recharge batteries! There is a danger of explosion!
• Do not short-circuit! There is a danger of explosion!
• Do not throw into fire! There is a danger of explosion!
• Do not dispose of used batteries and rechargeable batteries in the household waste, but in the special waste or in a battery collection station in the specialized trade.

Manufacturer information:
**Shenzhen Combei Technology Co.,Ltd 11-5B No.105, Huanguan South Road, Dahe Community, Guanlan, Longhua New District, Shenzhen, 518110 Guangdong, China
EC REP MedNet EC-REP GmbH, Borkstrasse 10, 48163 Münster, Germany
Item Number:** 521- 858203

Importer: # Dr. Senst GBT GmbH Geschäftsbereich Dr. Senst® An Gut Nazareth 18 a, 52353 Düren / Germany
Tel: +49 2421 / 20856 – 0 www.dr-senst.com
www.dr-senst.com

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