ri-champion N Instructions Rev A

1.

Introduction

1.1. Features The blood-pressure monitor is a fully automatic, digital blood-pressure measuring device for use on the upper arm, which enables very fast and reliable measurement of the systolic and diastolic bloodpressure as well as the pulse frequency by way of the oscillometric method of measuring. The device offers a very high and clinical tested measurement accuracy and has been designed to provide a maximum of userfriendliness. Thanks to the large LCD display, both operational status and cuff pressure are visible for the entire duration of the measurement. Before using, please read through this instruction manual carefully and then keep it in a safe place. For further questions on the subject of blood-pressure and its measurement, please contact your doctor. Attention! 1.2. Important information about self-measurement • 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 evaluated 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. Meaning of the symbol on the bottom label: Important: Please read the information in the papers accompanying this instrument.

!

Meaning of the symbol on the bottom label: Application Part Type BF Meaning of the symbol on the packaging: Cuffs contains natural rubber latex 21

2.

Important information on the subject of bloodpressure and its Measurement

Table for classifying blood-pressure values (units mmHg) according to World Health Organization: Range Hypotension Normal range Mild hypertension Moderately serious hypertension Serious hypertension

Systolic

Diastolic

Blood-pressure

Blood-pressure

Measures

lower than 100 between 100 and 140 between 140 and 160 between 160 and 180

lower than 60 between 60 and 90 between 90 and 100 between 100 and 110

Consult your doctor Self-check Consult your doctor Consult your doctor

higher than 180

higher than 110

Consult your doctor immediately

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.

3.

The various components of the blood-pressure monitor

The illustration shows the blood-pressure monitor, consisting of: a) Measuring unit

LCD-display

Cuff connection

Mains adapter power socket

clock button

O/I b) Upper arm cuff: Type M for arm circumference 22–32 cm Type L for arm circumference 32–42 cm Type S for arm circumference 13–20 cm 22

Memory button

4.

Putting the blood-pressure monitor into operation

4.1. Inserting the batteries After you have unpacked your device, first insert the batteries. The battery compartment is located on the back side of the device (see illustration). a) Remove cover as illustrated b) Insert the batteries (4 x size AA 1,5 V), thereby observing the indicated polarity. c) If the battery warning appears in the display, the batteries are empty and must be replaced by new ones. Attention! • After the battery warning 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. Functional check: Hold on the O/I button down to test all the display elements. When functioning correctly all segments must appear. 4.2. Use of a mains adaptor It is possible to use this device with a mains adaptor. Please take care that proper and safe function of the device can only be guaranteed if you use Riester products and accessories. a) Put the plug into the connector on the right side of the device b) Plug the mains adaptor into a 110/230V power outlet c) Test the function of the ri-champion® N by pushing the O/I-button Caution: • If the mains adaptor is connected to the device, no battery power will be used. • If the power supply voltage is disturbed during measurement (e.g. by pulling out the plug) you must reset the device by pulling out the plug at the ri-champion® N, too. Thereafter, the device will work again. • For questions concerning the mains adaptor please ask your retailer. 23

4.3. Tube connection Insert the cuff tube into the opening provided on the left side of the instrument, as shown in the diagram. 4.4 Setup time and date The blood-pressure monitor stores time and date for every measurement. This is a very important information because the blood pressure normally changes during the day. After insertion of new batteries you have to enter the actual date and time. Therefore push the CLOCK-Button for at least 3 seconds. The display shows now the year setup with 4 flashing numbers. By pushing the MEMORY-Button you can enter the actual year. HINT: This action is fastened if you keep the button pressed. If you push the CLOCK-Button your entry is confirmed and you attain the next setup step. Repeat this procedure until you have adjusted all entries (year, month, day, time). After that the clock starts working automatically.

5. Carrying out a measurement 5.1. 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 5 minutes before the measurement. • Remove any garment that fits closely to your upper arm. • 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. 5.2. 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 increase 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. • If the arm artery lies considerably lower (higher) than the heart, an erroneously higher (lower) bloodpressure will be measured! (Each 15cm difference in height results in a measurement error of10mmHg!) 24

•

•

Cuffs that are too narrow or too short result in false measurement values. Selecting the correct cuff is of extraordinary importance. The cuff size is dependent upon the circumference of the arm (measured in the centre). The permissible range is printed on the cuff. If this is not suitable for your use, please contact your dealer. Note: Only use clinically approved Original-Cuffs! A loose cuff or a sideways protruding air-pocket causes false measurement values.

5.3. Fitting the cuff a)

Push the cuff over the left upper arm so that the tube points in the direction of the lower arm.

b)

Lay the cuff on the arm as illustrated. Make certain that the lower edge of the cuff lies approximately 2 to 3 cm above the elbow and that the rubber tube leaves the cuff on the inner side of the arm. Important! The mark must lie exactly over the artery which runs down the inner side of the arm.

c)

Tighten the free end of the cuff and close the cuff with the closer.

d)

There must be no free space between the arm and the cuff as this would influence the result. Clothing must not restrict the arm. Any piece of clothing which does (e.g. a pullover) must be taken off.

e)

Secure the cuff with the Velcro closer in such a way that it lies comfortably and is not too tight. Lay the arm on the table (palm upwards) so that the cuff is at the same height as the heart. Make sure that the tube is not kinked.

2–3 cm

tube

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Comment: If it is not possible to fit the cuff to the left arm, it can also be placed on the right one. However all measurements should be made using the same arm 5.4. Measuring procedure After the cuff has been appropriately positioned the measurement can begin: a)

b)

c)

d)

e)

Press the O/I + MEMORY-button, – the pump begins to inflate the cuff. In the display, the increasing cuff-pressure is continually displayed. 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 and a peep tone is audible for every pulse beat. When the measurement has been concluded, a long peep tone sounds. The measured systolic and diastolic bloodpressure values as well as the pulse frequency are now displayed. The measurement results are displayed, until you switch the device off. If no button is pressed for 5 minutes, the device switches automatically off, to save the batteries.

5.5. Memory – displaying the last measurement The last 99 measured results are stored in the device until a new measurement is carried out or the batteries are removed. You can call up the stored values by pressing the MEMORY button. To clear the memory, please push the MEMORY-button approximately 3 seconds until CL appears in the display. 5.6. Discontinuing a measurement If it is necessary to interrupt a blood pressure measurement for any reason (e.g the patient feels unwell), the O/I button can be pressed at any time. The device then immediately lowers the cuff-pressure automatically. 26

5.7 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.

6. Error messages/malfunctions If an error occurs during a measurement, the measurement is discontinued and a corresponding error code is displayed. (Example Error no. 1) Error No. ERR 1

ERR 2

ERR 3 ERR 5

HI

LO

Possible cause(s) The systolic pressure was determined but afterwards the cuff pressure fell below 20 mmHg. This situation can occur, for example, if the tube becomes unplugged after the systolic blood pressure has been measured. Further possible cause: No pulse has been detected. Unnatural pressure impulses influence the measurement result. Reason: The arm was moved during the measurement (Artefact). Inflation of the cuff takes too long. The cuff is not correctly seated or the hose connection is not sealed. The measured readings indicated an unacceptable difference between systolic and diastolic pressures. Take another reading following directions carefully. Contact you doctor if you continue to get unusual readings. The pressure in the cuff is too high (over 300 mmHg) OR the pulse is too high (over 200 beats per minute). Relax for 5 minutes and repeat the measurement.* The pulse is too low (less than 40 beats per minute). Repeat the measurement.*

* Please consult your doctor, if this or any other problem occurs repeatedly.

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Other possible malfunctions and their eliminations If problems occur when using the device, the following points should be checked and if necessary, the corresponding measures are to be taken: Malfunction Remedy The display remains empty when the instrument is 1. Check whether the batteries are switched on although the batteries are in place. installed with the correct polarity and correct if necessary. 2. If the display is unusual, remove the batteries and then exchange them for new. The pressure does not rise although the pump • Check the connection of the cuff is running. tube and connect properly if necessary. The device frequently fails to measure the 1. Fit the cuff correctly on the arm. blood pressure values, or the values measured 2. Before starting the measurement are too low (too high). make sure that the cuff is not fitted too tightly and that there is no rolledup sleeve exerting pressure on the arm above the measuring position. Take off articles of clothing if necessary. 3. Measure the blood pressure again in complete peace and quiet. Every measurement results in different values • Please read the following informatialthough the device functions normally and on and the points listed under the values displayed. «Common sources of error». Repeat the measurement. The blood pressure values measured differ from • Record the daily development of those measured by the doctor. the valuesand consult your doctor about them.

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)! 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!

7. Care and maintenance, recalibration a) b) c) 28

Do not expose the device to either extreme temperatures, humidity, dust or direct sunlight. Handle the cuff and tube carefully and avoid all types of straining through twisting or buckling. Clean the device with a soft, dry cloth. Do not use petrol, thinners or similar solvent. Spots on the cuff can be removed

d) e) f)

carefully with a damp cloth and soapsuds. The cuff must not be washed! Remove the batteries if the device is not used for a longer period. Do not drop the instrument or treat it roughly in any way. Avoid strong vibrations. Never open the device! Otherwise the manufacturer calibration becomes invalid!

EMC-Notes The device corresponds to the EMC requirements according to IEC 60601-1-2. Portable and mobile HF-equipments (e.g. mobile phones) can influence medical devices. Medical-electronic devices need special requirements concerning EMC. A detailed description of the EMC requirements can be accessed at www.riester.de

Instructions for technical inspection EU countries except Germany: Legal regulations for monitoring instruments apply to all EU countries except Germany. Countries outside the EU: For any countries where no legal regulations exist for monitoring instruments, it is recommended to examine the accuracy of measuring instruments in 2-year intervals. The test is conducted according to the following procedure: 1. Procedure for checking and meeting the margin of error of the measurement display for cuff pressures 1.1. Test Equipment a) A sturdy metal vessel with a volume of 500 ml +/- 5%. b) A calibrated inspection manometer with a maximum permissible margin of error of 1.0 mmHg (0.1 kPa) c) A means of generating pressure, e.g., a bulb with release valve d) "T" connectors and tubes. 1.2. Sequence of Operations a) Replace the cuff of the device with the metal vessel (see 1.1 a). Connect the calibrated inspection manometer (see 29

1.1 b) to the cuff connector (see Fig. 1) using a "T" connector and tubes (see 1.1. d). Using an additional "T", connect the additional bulb (see 1.1.c) to the pneumatic system. Now, you have to remove the battery out of the battery container, press the start/stop button and push the button until the batteries are reinserted into the container. When releasing the start/stop button the device may switch into the calibration mode, this will be confirmed by 3 tones. To leave this test mode press the start/stop button. After leaving the calibration mode you have to re-enter date and time (see point 4.4). b) Test in steps of maximum 50 mmHg between 0 mmHg and maximum value of display. Overpressure may be randomly exceeded. Continue testing after reducing overpressure to required reading.

1. Inspection manometer (see 1.1.b) 2. Sphygmomanometer to be tested 3. Metal vessel (see 1.1.a) 4. Bulb with release valve (see 1.1.c)

Fig. 1: Test device for determination of limits of error of the measurement display for cuff pressures. Warning Opening the device will void your guarantee. Norm:

Electromagnetic compatibility: Clinical test:

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The device meets the european guidelines for non invasive blood pressure devices EN1060-1 EN1060-3 EN1060-4 ANSI/AAMI SP10 The device meets the specifications of the European Norm EN 60601-1-2 The clinical test was performed according to the EN1060-4:2004 and the BHS standard. The specifications of the EU-guideline 93/42/EWG for medical products of class IIa are met.

8. Technical specifications Weight: Size: Storage temperature: Operation temperature: Humidity: Display:

630 g (with batteries) 98 (W) x 163 (L) x 106 (H) mm –5 to +50°C 10 to 40°C 15 to 85% relative humidity maximum LCD-Display (Liquid Crystal Display) oscillometric capacitive

Measuring method: Pressure sensor: Measuring range: 30 to 280 mmHg SYS/DIA: Pulse: 40 to 200 per minute Cuff pressure display range: 0–299 mmHg Memory: Storing the last measurment automatically Measuring resolution: 1 mmHg Accuracy: Pressure within ± 3 mmHg Pulse ± 5 % of the reading Power source: a) 4 dry cells (batteries), size AA, 1.5 V b) mains adaptor 6 V DC 600 mA (voltage 4.5 V DC to 6 V DC) Cuffs: type M for arm circumference 22–32 cm type L for arm circumference 32–42 cm (optional) type L for arm circumference 13–20 cm (optional) Technical alterations reserved!

9. www.riester.de Detailed user information about our products as well as services can be found at www.riester.de.

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10. Warranty This product has been manufactured under the strictest quality standards and has undergone a thorough final quality check before leaving our factory. We are therefore pleased to be able to provide a warranty of 2 years from the date of purchase on all defects, which can verifiably be shown to be due to material or manufacturing faults. A warranty claim does not apply in the case of improper handling. All defective parts of the product will be replaced or repaired free of charge within the warranty period. This does not apply to wearing parts. A warranty claim can only be granted if this Warranty Card has been completed and stamped by the dealer and is enclosed with the product. Please remember that all warranty claims have to be made during the warranty period. We will, of course, be pleased to carry out checks or repairs after expiry of the warranty period at a charge. You are also welcome to request a provisional cost estimate from us free of charge. In case of a warranty claim or repair, please return the RIESTER product with the completed Warranty Card to the following address: Rudolf Riester GmbH Dept. Repairs RR Bruckstr. 31 72417 Jungingen Germany

Lot number

Date Stamp and signature of the specialist dealer

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