Visomat handy - Blood pressure monitor UEBE - Free user manual and instructions

USER MANUAL Visomat handy UEBE

Instructions for use

Mode d'emploi

C Operating the unit

1. Unit description 32

2. Control displays 33

3. Important instructions for use 34

4. Inserting/replacing the batteries 35

5. Activating and setting the date/time 36

6. Attaching the unit 37

7. Body posture when taking measurements 38

8. Measuring blood pressure 39

9. WHO traffic light function 40

10. Pulse pressure 41

11. Irregular pulse waves and cardiac arrhythmia 42

12. Using the memory 43

D What you should know about blood pressure

1. Systolic and diastolic blood pressure values 45

2. Reasons for measuring different values 45

3. Why you should measure blood pressure regularly 45

E Technical information

1. Failure and error messages 46

2. Customer service 48

3. Technical data 48

4. Original spare parts and accessories 50

5. Metrological inspection 50

F General provisions

1. Explanation of symbols 51

2. Disposal 51

G Maintaining the unit 52

H Warranty 53

Intended use

A

Thank you for choosing the visomat® handy wrist blood pressure monitor (also referred to in the following as the unit).

It's determined for measuring blood pressure and pulse at the wrist, those of people 15 years of age and over. This unit is recommended for patients with unstable blood pressure for domestic self administration blood pressure control and treatment support.

This unit uses the oscillometric method for measuring blood pressure and pulse rate.

The double-preformed comfort cuff can be easily attached and provides for a perfect fit during measurement. When the Start/Stop button is pressed, the system starts to build up pressure automatically. Using the pressure variations caused by the pulse at falling cuff pressure, the micro-computer calculates the values systole, diastole, and pulse. Afterwards, the cuff is deflated completely.

As well as indicating systole, diastole and pulse, the unit offers additional displays for determining irregular pulses and pulse pressure. Irregular pulses may be an indication of an irregular heartbeat but also of restlessness during the measurement. Pulse pressure provides an indication of the stretchability of the blood vessels. A memory stores the last 60 measurement results in each case.

These instructions are intended to help the user to use the unit safely and efficiently, and must be kept with the product and forwarded, if applicable.

The unit must be used in accordance with the procedures contained in these instructions and must not be used for other purposes. Please read these instructions carefully before using the unit.

EN-29

B

1. Important patient information

• Blood pressure measurements on children require specialist knowledge! Please consult your doctor if you wish to measure the blood pressure of a child. Do not under any circumstances use the unit on a baby/infant.
• The special double-preformed comfort cuff is designed for a wrist circumference of 12.5-21.5 cm.
• The measurement results of automatically measuring blood pressure monitors may be falsified by pregnancy, irregular heartbeats, or arteriosclerosis. Measure your own blood pressure in cooperation with your doctor.
• Do not under any circumstances place the cuff on or over any critical point, e.g. wound, aneurysm, etc. Risk of injuries! The supply via an intravascular access (infusion) or other medical monitoring devices might be interrupted.
• Do not use the unit without first consulting your doctor if you are undergoing dialysis treatment or taking anticoagulants, platelet aggregation inhibitors or steroids. Internal bleeding may be caused under these conditions.
• If you have had a mastectomy, do not measure blood pressure on the side of the body where the breast has been removed together with the lymph nodes from the armpit.
• The unit contains small parts which could be swallowed by children. It should therefore be kept out of the reach of children at all times.
• Measuring your own blood pressure does not constitute treatment. Do not modify of your own accord the dosage of drugs/medication prescribed by your doctor.
• Please refer to the chapter "Important instructions for use" (Page EN-34) before conducting any measurements yourself.

EN-30 EN-31

Safety instructions Safety instructions

B

2. Important technical information

• A constantly good power supply to the unit is necessary for trouble-free blood pressure measurements.
  — Please use long-life alkaline batteries only (LR03).
  – Always replace all batteries at the same time during battery replacement.
• You will need 2 × 1.5 ~V batteries. Rechargeable batteries have a voltage of only 1.2 ~V and are thus not suitable.

• If the unit is not used for an extended period of time, please remove the batteries. Essentially, all batteries can leak.

• The unit must only be operated with original parts. The warranty will be invalidated if the unit is damaged by non-approved accessories!

• Using the unit in the immediate vicinity of mobile phones, microwave appliances or other devices with strong electromagnetic fields may result in impaired functioning. Maintain a minimum distance of 3 m from such devices when using this unit.
• The display of the pulse frequency is not suitable for checking the frequency of cardiac pacemakers. Cardiac pacemakers and blood pressure monitors do not influence each other regarding their mode of operation.
• Never open or modify the unit or the cuff - this is a medical device. (Exception: replacing batteries). If the unit has been opened, it must be subjected to a metrological inspection by an authorised institution.
• The cuff may be inflated on the wrist only.
• Please comply with the specified operating conditions for measurement. See Technical data, Page EN-48.
• The inflating and measuring procedure can be stopped by pressing the Start/Stop button. In this case, the unit stops the inflation procedure and deflates the cuff.

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1. Unit description
   

visomat® handy 12:00 SYS mmHg DIA mmHg PUL 100ml Start Stop Speicher Memory 5 4 3 2

① Display
2 Cuff
3 Start/Stop button
4 Battery compartment (Removable battery compartment cover)
5 Memory button

EN-32 EN-33

Operating the unitOperating the unit

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1. Control displays
   

DATE TIME No.88/88 M 888 888 1 2 3 4 5 6 7 8

① SYS = Systole
② DIA = Diastole
3 PUL 1/min = Pulse Calculated pulse frequency per minute
4 Pulse signal display or irregular pulse waves

Battery check display

⑥ Inflating / Deflating

7 WHO classification (Page EN-40)

⑧ Memory identifier

9 Storage location or date/time

Failure and error messages (Page EN-46) Err-300, -1, -2 ...

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3. Important instructions for use

• Refrain from drinking alcoholic or caffeinated beverages and smoking at least one hour before measuring.
• Please rest at least 5 minutes before measuring. Depending on the previous degree of stress/exertion, this can even require up to one hour.
• Expose the wrist, the clothes must not impair the blood flow in or from the arm as this influences the blood pressure at the measurement point.

• Body posture must be relaxed.

• For this purpose, sit at a table (if possible the height of a dining table, not a coffee table!).
  — Rest your back against the backrest of the chair.
• Support your forearm so that the cuff is at the same height as your heart.
  — Place your feet on the floor and do not cross your legs.

- It is absolutely essential to sit still and remain quiet. Irregular movements, vibrations (shaking), talking and breathing heavily will affect and may even falsify the measurement. Look out for irregular pulse signals in the display; if necessary, repeat the measurement under more favourable conditions.

- Unusual measurement results are possible with all automatically measuring blood pressure measurement systems from time to time. Check yourself: did you comply with the instructions for use above? If necessary, repeat the measurement after allowing the blood circulation in the arm to recuperate briefly; rest for about 3-5 minutes for this purpose. Tip: Remain seated, your monitor will switch off automatically about 3 minutes after a measurement. Afterwards, we recommend that you repeat the measurement.

- In order to rule out differences between left and right and to obtain comparable measurement results, it is important always to take blood-pressure measurements on the same arm. Ask your doctor which arm he/she recommends you take your measurements on.

EN-34 EN-35

Operating the unitOperating the unit

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- Blood pressure is not a fixed value. It may fluctuate upwards or downwards by more than 20 mmHg on patients within a few minutes.

4. Inserting/replacing the batteries

• Opening the battery compartment Remove the cover of the battery compartment on the side of the unit.
• Inserting batteries Remove the old batteries from the unit and insert the new ones. Please observe proper polarity (marking in battery compartment).
• Closing the battery compartment Close the battery compartment by clipping the battery cover back into the unit.

When the display shows the "Flat battery □" symbol for the first time, the unit will still have enough charge for about 30 measurements. Please change the batteries during this period.

Note: After replacing the batteries, it will be necessary to reactivate the date/time function. See next chapter.

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5. Activating and setting the date/time

The unit has a date/time function which you can activate where necessary. This function is deactivated when the unit is delivered.

Activating the date/time function

To activate the date/time function, press the Start/Stop button and then immediately, while the full display is visible, the Memory button. This function can be deactivated at any time in the same way.

Setting the date/time

The four-digit number representing the year appears in the display first (Fig. 1). Press the Memory button to set the year. Press the Start/Stop button to confirm the selected year and proceed to setting the date.

Set the month with the Memory button and confirm this with the Start/Stop button. Set the day, hours and minutes in the same way (Fig. 2, Fig. 3).

Changing the date/time

To change the date/time function, take out a battery and wait until the display goes blank. Now you can reactivate the date/time function and reset the date and time again.

Deactivating the date/time function

To deactivate the date/time function, press the Start/Stop button and then immediately the Memory button.

When the date/time function is activated, the time is also shown in the display when the unit is switched off.

Fig. 1

Fig. 2

Fig. 3

EN-36 EN-37

Operating the unitOperating the unit

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6. Attaching the unit

The special double-preformed comfort cuff is easy to attach and provides for a perfect fit during measurement. The materials used have been tested for skin compatibility in accordance with ISO 10993.

• Expose your wrist, with the palm of your hand facing upwards.
• Slide the unit over your wrist. Make sure the gap between your wrist and the top edge of the cuff is approx. 1 cm.
• Now pull the free end of the cuff tight and close the cuff with the Velcro-type fastener.

Thanks to its optimised shape, the cuff fits very tightly to prevent measurement errors.

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7. Body posture when taking measurements

Whenever possible, measurements should be taken while sitting. In exceptional cases it is also permitted to take measurements while lying down.

• Measurement while sitting

Sit at a dining table, resting your back against the backrest of the chair. Bend your arm so that the cuff is at exactly the same height as your heart. Place your feet on the floor and do not cross your legs.

• Measurement while lying down

Lie on your back. Attach the unit to your wrist and hold the unit at the same height as your heart (e.g. by resting your arm on a pillow or cushion). Breathe deeply 5 or 6 times to relax before measurement.

Please note:

• Do not under any circumstances bend your wrist.
• Keep your hand relaxed, do not clench your hand or form a fist.
• If the cuff is lower or higher than heart height, the reading may in turn be higher or lower.
• While measuring keep your arm still and do not talk.

EN-38 EN-39

Operating the unitOperating the unit

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8. Measuring blood pressure

• Switch on the unit by pressing the Start/Stop button. The full display appears.
• The cuff is inflated to the required pressure. A "▲" flashes in the display.
• The actual measurement process starts with three beeps as the cuff is deflated. The “♥” symbol flashes in the display.
• A long beep denotes the end of measurement. The cuff is automatically deflated.
• The determined values of systole, diastole and pulse and the pulse pressure (PP) are shown alternately in the display.
• The unit switches off automatically after approx. 3 minutes.

DATE: No. 89/88 • 888 • 888 ↓ 188 • 182 153 • 132 79 85 PP 53

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9. WHO traffic light function

The unit categorises the blood pressure readings according to the guidelines of the World Health Organisation (WHO). You can use the coloured fields to read the categorisation of each reading:

• Upper dot (Red) signifies high pressure*
• Middle dot (Yellow) signifies borderline value*
  – Lower dot (Green) signifies normal value

WHO2003	Systolic pressure= Upper value mmHg**	Diastolic pressure= Lower value mmHg**
Red from	140* from 90*
Yellow	120 to 139 80 to 89
Green below	120 below 80

* It is sufficient for one of the values to be raised.

** millimetres of mercury

The categorisation according to WHO is stored with the readings and can be called up again together with the readings from the memory.

Operating the unitOperating the unit

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10. Pulse pressure

The pulse pressure – not to be confused with the pulse beat – provides an indication of the stretchability of the blood vessels. A hard system of vessels can have a negative effect on the cardiovascular system. Studies show that the cardiovascular risk increases if the pulse pressure value is consistently greater than 65 mmHg.

The heart works in two phases, the contraction phase (systole) and the relaxation phase (diastole). The pressure difference between systole and diastole is called the pulse pressure or pulse amplitude. The higher the pulse pressure, the harder the vessels.

High pulse pressure above 65 mmHg
Increased pulse pressure 55 to 65 mmHg
Normal pulse pressure below 55 mmHg

If your pulse pressure is permanently above 55 mmHg, consult your doctor.

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11. Irregular pulse waves and cardiac arrhythmia

If the "symbol for irregular pulse waves flashes after a measurement, the unit has recorded irregular pulses during the measurement.

This can be set off by an irregular heartbeat (arrhythmia), disturbances caused by movement, talking or even breathing in deeply. The symbol is stored with the respective measurement.

If the symbol appears more frequently, this may be caused by an irregular heartbeat and must be discussed with your doctor!

Measurement results accompanied by flashing pulse displays should therefore be viewed as critical and repeated under more favourable conditions.

EN-42 EN-43

Operating the unitOperating the unit

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12. Using the memory

Measured results are automatically stored in the memory. The memory can store up to 60 results and the average value. When more than 60 measured values have been stored, the oldest value (No. 60) is deleted to allow the latest value (No. 1) to be recorded.

Press the Memory button to call up data. The average value of the stored results is displayed with "A", the values for systole, diastole and pulse and the pulse pressure (PP) are shown alternately in the display.

When the Memory button is pressed again, the value measured last (No. 1) appears. When the date/time function is activated, systole, diastole and pulse are displayed alternately with memory number and date, followed by the pulse pressure (PP) and the time.

Press the Memory button repeatedly to call up further measured values.

The stored data remain visible in the display for around 30 seconds. The unit then switches itself off.

A 60 132 79 85 No. 1 132 79 85 DATE 22/9 132 79 85 TIME 9:55 PP 53

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Operating the unit

To delete individual measured values, press the Memory button repeatedly to call up the desired measured value. Then press the Memory button again and hold down for 8-10 seconds until the measured value has disappeared.

To delete the entire memory, call up the average value, press the Memory button again and hold down until the average value has disappeared. If the display flashes, the deletion process has not been completed and must be repeated.

If no value is stored, there is no display.

EN-44

What you should know about blood pressure

D

1. Systolic and diastolic blood pressure values

The cardiovascular system has the important function of supplying all organs and tissues in the body with sufficient amounts of blood and of transporting metabolites. For this, the heart contracts and expands at a regular rate of about 60 to 80 times per minute. The pressure of the flowing blood on the artery walls caused by the heart contracting is termed systolic. The pressure in the ensuing relaxation phase, when the heart refills with blood, is termed diastolic. During daily measurement you determine both values.

2. Reasons for measuring different values

Our blood pressure responds to internal and external influences like a sensitive measuring instrument. It can be affected by even slight changes. This explains why often values measured with the doctor or pharmacist are higher than those measured at home in the environment you are used to. Changes in the weather, climate changes, or physical or psychological stress can have effects as well.

3. Why you should measure blood pressure regularly

Even the time of day has an influence on your blood pressure. During the day the values are generally higher than during the periods of rest at night. One-off and irregular measurements therefore say little about your actual blood pressure. A reliable assessment is possible only when measurements are taken regularly. Discuss the measurement values with your doctor.

EN-45

E

1. Failure and error messages

Failure encountered	Possible cause Corrective	action
DisplayErr - 300	Excessive cuff pressure. Cuff inflated to maximum due to movement of the arm or body.	- Repeat measurement- Do not move arm- Do not talk
DisplayErr - 1	Measurement error. Measurement could not be carried out due to movement of the arm or body.	- Repeat measurement- Do not move arm- Do not talk
DisplayErr - 2	Inflation error, pressure built up too quickly or too slowly.	- Repeat measurement- Do not move- Do not talk- Check wrist circumferenceCall the Service hotline if this occurs repeatedly.
	Cuff is not correctly fitted.
DisplayErr - 3	Deflation rate too high or too low.	- Repeat measurement- Do not move- Do not talkCall the Service hotline if this occurs repeatedly.
	Movement or talking during measurement.
Display 00	Start/Stop button accidentally pressed while batteries were being changed.	Switch unit off and then on again with Start/Stop button.
	Irregular heartbeat, disruptive movements, shaking, wobbling (objects), breathing in deeply, etc.	Repeat measurement after 3-5 minutes rest. Possible factors (depending on the severity of the arrhythmia) affecting the measurement results must be discussed with your doctor!

EN-46 EN-47

Technical information Technical information

E

Failure encountered	Possible cause Corrective action
Unusual measured values	Movement or talking during measurement, resting time not observed, feet possibly crossed, smoking or coffee consumption.	Check conditions and repeat measurement. Observe instructions for use P. EN-34.
Measured values are too high or too low	Too little rest before the measurement. Movement or talking during measurement.	Repeat measurement after a break of approx. 3-5 mins. Observe instructions for use P. EN-34.
	Incorrect measurement position.
	Has the proper cuff been selected?	Check wrist circumference.
Consecutive measurements produce different measured values (readings).	Blood pressure is not a fixed quantity. It may vary in the upward or downward direction within a few minutes by more than 20 mmHg.	----
Measurement was interrupted and cuff first deflated and then inflated	Strong pulse restlessness or movement detected, unit rejects measurement.	If necessary, interrupt measurement, measure again after a break of 5 minutes.
	Movement during measurement
No display after unit is switched on	Batteries inserted incorrectly. Check position of batteries.
	Batteries flat. Change batteries.
	Battery contacts dirty. Clean battery contacts.
Measurement interrupted	Batteries flat. Change batteries.
Date/time not shown in display	- Function accidentally deactivated	Activate date and time as described on P. EN-36.

E

2. Customer service

The unit may only be repaired by the manufacturer or by an expressly authorised organisation.

Please contact:

UEBE Medical GmbH

Zum Ottersberg 9

97877 Wertheim, Germany

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Internet: www.uebe.com

1. Technical data

Unit type:	Digital automatic unit with electric pump for measuring blood pressure at the wrist
Dimensions:	approx. W = 70 mm x H = 70 mm x D = 80 mm with cuff
Weight:	121 g with cuff, not including batteries
Display:	LCD display (liquid crystal display) for measured values and check displays
Memory:	60 measured values (stored automatically) and average value (A)
Measurement procedure:	Oscillometric determination of systole, diastole and pulse
Reference procedure of clinical testing:	Auscultatory measurement
Inflating pressure:	Automatically controlled

EN-48 EN-49

Technical information Technical information

E

Pressure display range: 0-300 mmHg
Measurement range: Systolic: 50-250 mmHgDiastolic: 40-180 mmHgPulse measurement: 40-160 pulses/min
Error limits: Blood pressure measurement: corresponds to EN1060 Part 3Pressure measurement: ± 3 mmHgPulse measurement: ± 5%
Serial number: The unit bears a serial number SN which provides clear identification.
Power supply: Battery type: 2 x 1.5 V, AAA, LR 03, durability: over700 measurements in 2 years
Cuff: Cuff type visomat H5, wrist circumference 12.5 cm -21.5 cm
Operating conditions: Ambient temperature 10 to 40 °CRelative humidity up to 85%, non-condensing
Storage and transportation conditions:	Ambient temperature -5 to 50 °C, Rel. air humidityup to 85% not condensing,Air pressure 700 to 1040 hPa
Deflation valve: Electronically controlled
Automatic switch-off: approx. 3 minutes after end of measurement
Protection class IP: IP 20:	Protected against solid foreign particles witha diameter of more than 12.5 mm, no protectionagainst water.
Expected service life: 5 years
Classification: Internally powerd ME Equipment

E

Technical information

4. Original spare parts and accessories

The following original spare parts and accessories are available from specialist dealers:

Cuff type H5 (for wrist circumference 12.5-21.5 cm) Part no. 2105001, PZN 06414493

Subject to technical modifications.

Manufacturer:

UEBE Medical GmbH

Zum Ottersberg 9

97877 Wertheim, Germany

5. Metrological inspection

(previously calibration)

Basically, a metrological inspection is recommended at intervals of 2 years. However, professional users in Germany have to comply with the aforementioned according to “Regulation for Operators of Medical Devices”. This can be implemented either by UEBE Medical GmbH, an authority responsible for metrology, or authorised maintenance services. For this, please observe your national provisions. Upon request, responsible authorities or authorised maintenance services receive a “Test instruction for metrological inspection” from the manufacturer.

Important: No modifications, e.g. opening the unit (except to replace the batteries) may be made to this unit without the manufacturer's prior permission.

EN-50

General provisions

F

1. Explanation of symbols

This product complies with the Council Directive 93/42/EC from 5 September 2007 regarding medical devices and bears the mark CE 0123 (TÜV SÜD Product Service GmbH).

Degree of protection against electric shock: TYPE BF

Please observe operating instructions

Storage and transportation conditions Ambient temperature -5 to +50 °C

Protect against moisture/humidity Rel. air humidity up to 85 %

Keep dry

Protected against solid foreign particles with a diameter of more than 12.5 mm, no protection against water.

Manufacturer

2. Disposal

Batteries and technical appliances must not be disposed of with domestic waste, but should be handed in at the appropriate collection and disposal points.

EN-51

G

Maintaining the unit

• The unit contains sensitive parts and must be protected against strong variations in temperature, air humidity, dust and direct sunlight.
• If the unit has been stored at temperatures below 0 °C, let it stand at room temperature for at least 1 hour before use.
• Make sure when storing the unit that no heavy objects are left lying on the unit.
• The unit is neither impact-resistant nor shock-proof. We recommend that you have the intactness and accuracy of the display checked after heavier falls or impacts.
• The unit is not water-proof.
• If the unit becomes dirty during use, use a soft, dry cloth to clean the unit. Do not use benzene, thinners or other strong solvents.
• Do not scrub or machine-wash the cuff. If the cuff gets dirty during use, use a synthetic cleaner and softly rub the surface.
• If the unit has been opened, it must be subjected to a metrological inspection conducted by an authorised organisation.

EN-52

Warranty

H

The device has been manufactured and tested with great care. However, in the unlikely event of a defect being detected after delivery, we provide warranty in accordance with the following terms and conditions:

1. During the warranty period of 3 years from the date of purchase we reserve the right either to repair any such defect at our expense or to supply a perfect replacement unit. The cost of returning the unit to our factory shall be borne by the sender. UEBE shall refuse to accept return deliveries that have not been paid for by the sender.
2. Excluded from the warranty are parts subject to normal wear and tear as well as damage caused by non-compliance with the instructions for use, improper handling (e.g. unsuitable power sources, breakages, leaking batteries) and/or disassembly of the unit by the purchaser. Furthermore, no claims for damages against us are substantiated by the warranty.
3. Warranty claims can only be advanced in the warranty period and by presenting proof of purchase. In the event of a warranty claim, the unit must be sent to the following address together with the proof of purchase and a description of the complaint:

UEBE Medical GmbH

Service-Center

Zum Ottersberg 9

97877 Wertheim

Germany

The cost of returning the unit to our factory shall be borne by the sender. UEBE shall refuse to accept return deliveries that have not been paid for by the sender.

1. In the case of defectiveness of the goods, the contractual rights of the purchaser to claim against the seller in accordance with § 437 German Civil Code are not limited by the warranty.

Please note: In the event of a warranty claim it is essential to attach the proof of purchase.

EN-53

Sommaire

E Informations techniques

visomat® handy 12:00 SYS meaning DIA meaning PUL 1/24 Start Stop Speicher Memory 5 4 3 2

© Copyright 2013 UEBE Medical GmbH