Comfort 20 - Blood pressure monitor Visomat - Free user manual and instructions

Frequently Asked Questions - Comfort 20 Visomat

USER MANUAL Comfort 20 Visomat

Instructions for use

Mode d'emploi

European Society of Hypertension

Inhaltsverzeichnis

A Intended use 30
B Safety instructions

1. Important patient instructions 31
2. Important technical details 32

C Operating the unit

1. Unit description 34
2. Control displays 35
3. Important instructions for use 36
4. Initial operation of the unit 37
5. Inserting/replacing batteries 37
6. Activating and setting the date/time 38
7. Attaching the cuff 39
8. Measuring blood pressure 40
   9.WHO traffic light function 41
9. Pulse pressure 42
10. Irregular pulse waves and cardiac arrhythmia 42
11. 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

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 51

F General provisions

1.Explanation of symbols 52
2. Disposal 53

G Maintaining the unit 54
Warranty 55

A

Intended use

Thank you for choosing the visomat® comfort 20/40 upper arm blood pressure monitor (also referred to in the following as the unit).

It's determined for measuring blood pressure and pulse at the upper arm, 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 on the upper arm.

The cuff is first placed as shown in the illustration on the cuff on the upper arm and then connected to the unit. When the Start/Stop button is pressed, the system starts to build up pressure automatically. Within a very short space of time the unit records the small oscillations within the cuff which occur owing to expansion and contraction of the arteries in the arm (heartbeat). The build-up of pressure stops after systole, diastole and pulse are established, after which the cuff is deflated. The amplitude of each pressure wave is measured in millimetres of mercury (mmHg) converted and displayed in the LCD as a digital value.

As well as indicating systole, diastole and pulse, the unit offers a date/time function and 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 digital blood pressure monitor 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-30

Safety instructions

B

1. Important patient instructions

• 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 cuff has been specially developed for this unit and must not be used with other units. It is designed for an upper arm circumference of 23 - 43cm .
• 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.
• Make sure the air hose is not kinked. A kinked air hose can prevent the cuff from deflating and thereby interrupt the blood flow in the arm for too long.
• 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. The airhose poses a risk of strangulation. Please follow instructions regarding the handling of cuff to avoid such risk.
  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.

EN-31

B

• 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-36) before conducting any measurements yourself.

2. Important technical details

• A constantly good power supply to the unit is necessary for trouble-free blood pressure measurements.
• Please use long-life alkaline batteries only (LR6).
• Always replace all batteries simultaneously during battery replacement.
• You will need 4 × 1.5V batteries. Rechargeable batteries have a voltage of only 1.2V and are thus not suitable.
• When using the unit with a mains adapter, please use the type A1 mains adapter specially tested for medical devices only.
• Make sure when operating the unit with the mains adapter that the unit can be disconnected from the mains power supply at all times.
• If the unit is not used for an extended period of time, please remove the batteries. Essentially, all batteries can leak.
• If the unit has been stored at temperatures below 0^ , let it stand at room temperature for at least 1 hour before use.
• 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 3m from such devices when using this unit.

EN-32EN-33

Safety instructionsSafety instructions

B

• 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 arm only.
• Please comply with the specified operating conditions for measurement. See Technical data, Page EN-49.
• The inflation and measuring procedure can be cancelled by pressing the Start/ Stop button or by removing the cuff. In this case, the unit stops the inflation procedure and deflates the cuff.

C

1. Unit description

Memory button (memory recall button)
Measurement arrow for arm circumference
4 Connecting socket for mains adapter Airthose
Start/Stop button
Battery compartment (removable battery compartment cover)
Air socket/air connector
6 Display

EN-34EN-35

Operating the unit Operating the unit

C

2. Control displays

1 Memory location or date/time
SY5 = Systole
DIA = Diastole
PUL 1/min = Pulse calculates pulse frequency per minute
Battery charge display

6 Deflate cuff

Inflate cuff

Pulse signal display or irregular pulse waves

WHO classification (Page EN-41)

Memory identifier

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

C

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 upper arm, 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.
- Rest your forearm completely flat, with the palm of your hand facing upwards.
- 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.
- Blood pressure is not a fixed value. It may fluctuate upwards or downwards by more than 20mmHg on patients within a few minutes.
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-36EN-37

Operating the unit Operating the unit

C

4. Initial operation of the unit

Insert the supplied batteries into the unit.

If the unit is to be operated from the mains power supply, the cable plug of the mains adapter (not included in the scope of delivery) must be inserted into the connection socket on the right side of the unit. The batteries are switched off automatically.

Please use only the UEBE type A1 mains adapter. See original spare parts and accessories, Page EN-50.

5. Inserting/replacing batteries:

• Opening the battery compartment Remove the cover of the battery compartment on the underside 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.

C

6. 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 again 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-38EN-39

Operating the unit Operating the unit

C

7. Attaching the cuff

• Expose the upper arm.
• Push the cuff onto the upper arm until the lower edge of the cuff is 2-3 cm above the crook of the arm (Fig. 1, Fig. 2).
• When using the unit on the left arm, the air hose runs to the unit through the middle of the crook of the arm so that the 4 cm long artery marking is automatically located centrally above the pulse position (Fig. 3).
• When using the unit on the right arm, the cuff must be rotated to the left until the artery marking is on the pulse position. The air hose then runs along the inside of the upper arm (Fig. 4).
  The cuff should be tightened to such an extent that 2 fingers can still be inserted between arm and cuff. Tip:

Angle the arm slightly.
- The upper arm muscle is tensioned slightly.
-This increases the circumference of the arm slightly.

Now pull the free cuff end tight and close the Velcro fastener (Fig. 5).
- Check if the measurement arrow on the cuff is inside the "marking for arm circumference" at the edge of the cuff.

Fig. 1

Fig. 2

Fig. 3

Fig. 4

Fig.5

C

• Lay your extended and relaxed arm with the cuff on the dining table and do not move it during the measurement; do not talk. The palm of your hand should be facing upwards.
• Connect the cuff connector to the cuff socket on the left-hand side of the unit. Make sure the connector is fully inserted into the unit.

8. Measuring blood pressure

• Switch on the unit by pressing the Start/Stop button. The following display is visible.
  The automatically controlled inflation process begins once the unit has completed its calibration against the ambient air pressure.
  The cuff is inflated to the pressure necessary for measurement. The "▲" symbol flashes in the display.
  The measurement is taken while the cuff is being inflated. The "♥" symbol in the display flashes. Beeps also sound to denote the pulse.
  Inflation stops as soon as the measured values are determined, the cuff is then automatically deflated.
  A long beep denotes the end of measurement.

Operating the unit Operating the unit

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.

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:

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

WHO 2003	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.

C

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 65mmHg .

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	nmHg
Increased pulse pressure 55 to 65 mmHg
Normal pulse pressure below 55 mmHg

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

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-42EN-43

Operating the unit Operating the unit

C

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.

Operating the unit

To delete individual measured values, press the Memory button repeatedly to call up the desired measured value. Press the Memory button again and hold it until the value first flashes and then is replaced by dashes.

To delete the entire memory, recall the relevant average value display (A) and press the Memory button again, holding it down until the mean value first flashes and is then replaced by dashes.

If no value is stored, dashes are shown.

What you should know about blood pressure

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.

Failure encountered	Possible cause Corrective action
Display Err - 300 E	cessive cuff pressure. Cuff inflated to maximum due to movement of the arm or body.The hose may be kinked or the air connector blocked.	- Repeat measurement- Do not move arm- Do not talk- Check that hose with air connector is clear (unobstructed)
Display Err - 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
Display Err - 2 Inflation error, pressure built up too quickly or too slowly.	Check seating of air connector, repeat measurement.
Fault was recognised. Cuff is not correctly fitted.	- Repeat measurement- Do not move arm- Do not talk
Display 00 Start/Stop button accidentally pressed while battery was 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-46EN-47

Technical information Technical information

E

Failure encountered	Possible cause Corrective action
Measured values / pulse values are extremely high or 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-36.
	Has the proper cuff been selected? Cuffs that are too small result in excessive blood pressure values.	Measure your arm circumference in the middle of the upper arm and compare this with the details given on the cuff.
	Incorrect measurement position. Check conditions and repeat measurement. Observe instructions for use P. EN-36.
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.
No display after unit is switched on	Batteries inserted incorrectly Check position of batteries.
	Batteries flat Change batteries.
	Battery contacts dirty. Clean battery contacts.
Dashes in display after Memory button is pressed	No measured values stored. No display when no measured values are stored.
	Batteries flat Change batteries.
Measurement interrupted	Batteries flat Change batteries.
Date/time not shown in display	- Function accidentally deactivated - Function was not reactivated after battery replacement	Activate date and time as described on P. EN-38.

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 on upper arm
Dimensions:	L = 115 mm x W = 150 mm x H = 54 mm
Weight:	315 g not including batteries
Display:	LCD display (liquid crystal display) for measured values and control 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:	approx. 10-20 mmHg above systolic blood pressure

EN-48EN-49

Technical information Technical information

E

Pressure display range: 0-300	mmHg
Measurement range: Systolic	50-250 mmHgDiastolic: 40-150 mmHGPulse: 40-160 pulses/min
Error limits: Blood pressure m	measurement: corresponds to EN1060 Part 3Pressure measurement: ± 3 mmHGPulse measurement: ± 5%
Serial number: The unit bears	a serial number SN which providesclear identification.
Power supply: Battery type: 4	x 1.5 V round cells alkali manganese (LR 6) lithium (FR 6)Durability: over 800 measurements in 2 years
	Optional: Stabilised type A1 mains adapter, output6 VDC, minimum 600 mA
Cuff: Metal ring cuff for arm	circumferences of 23-43cm, type 2040
Operating conditions: Ambient	temperature 10 to 40 °C, rel. air humidityup to 85% not condensing, air pressure 700 to1040 hPa
Storage and transportconditions:	Ambient temperature -5 to 50 °C, rel. air humidityup to 85% not condensing,
Automatic switch-off: approx	3 minutes after end of measurement
Protection class IP: IP 20: Pro	ected against solid foreign particleswith a diameter of more than 12.5 mm, noprotection against water.
Expected service life: 5 years
Classification: Internal power	supply by battery

E

4. Original spare parts and accessories:

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

Universal cuff 23-43 cm Type 2040 Part.no.2404001 PZN 01021375
- Mains adapter type A1 Part. no. 2401020 PZN 03558547

Subject to technical modifications.

Manufacturer:

UEBE Medical GmbH

Zum Ottersberg 9

97877 Wertheim, Germany

EN-50EN-51

Technical information Technical information

E

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 the "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.

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: TYP BF

Please observe operating instructions

Storage and transportation conditions Ambient temperature -5 to +50^

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

Keep dry

IP20

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

Manufacturer

Mains adapter specifications:

If using the optionally available mains adapter:

Equipment class II (double-insulated)

Internal fuse

For indoor use only

Internal polarity positive

EN-52EN-53

General provisions General provisions

F

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.

Maintaining the unit

• The unit contains sensitive parts and must be protected against strong variations in temperature, air humidity, dust and direct sunlight.
  Make sure when storing the unit that no heavy objects are left lying on the unit or on the cuff and that the air hose is not kinked.
• 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.
  Make sure that liquid cannot get into the air hose. Dry thoroughly.

EN-54

Warranty

H

Warranty furnished

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-55

Sommaire

E Informations techniques