Medicus Control - Blood pressure monitor BOSO - Free user manual and instructions

USER MANUAL Medicus Control BOSO

boso medicus control

M 134 SYS mmHg DIA mmHg PUL mmHg R30 BOSCI medical mS M START

Diagram of a battery pack with two cells and four batteries, no text or symbols present

Bild 1

Medical device with a blood pressure monitor and a close-up of its internal grid structure (no visible text or symbols)

Bild 2

M 888 888 ♥ 888 C/7/2 "♥" Bild 5

Blutdruckmessung

Contents of package 39

Quick guide 40

Introduction......41

Blood pressure values 43

Systolic and diastolic blood pressure value 43

WHO blood pressure cut-off values 43

Starting up 45

Inserting batteries 45

Battery status 46

Changing batteries 46

General instructions for self-measurement 47

Preparing to measure your blood pressure 49

Note on cuff sizes 49

Attaching the cuff....50

Table of contents

Measuring your blood pressure....53

Interrupting a measurement....54

Measurement display 55

Note on guest mode....55

Completing the blood pressure record card / Retrieving the average value and WHO classification 57

Displaying individual stored values and clearing the memory store....59

Mains operation 60

Error messages....61

Cleaning and Disinfection....63

Warranty 63

Customer service / Disposal 64

Technical data....65

Calibration checks - Testing instructions (for trained specialist staff only)....68

Product features

Mains connector M SYS m240 DIA m240 PUL R30 Cuff connector M button START Start button LCD displayWHO classification

Battery status display see page 46

Measurement in progress see page 54

Irregular heartbeat during measurement see page 55, 62

Stored value see page 59

Contents of package

1 boso-medicus control blood pressure monitor

1 Warranty certificate

1 CA 04 universal cuff

4 LR 6 (AA) batteries

1 Case

1 User instructions

bosomedicus control Gehmacher- smaohang User Instructions Mode of repair Mensake of Use Menow del Usatzle

1 Blood pressure record card

WHO classification sticker

Quick guide

→Insert batteries, ensure correct positioning (P. 45)
→Connect cuff to monitor (P. 49)
→Attach cuff (P. 50)
→Start (and stop) a measurement by pressing the start button (P. 53)

Measured systolic, diastolic and pulse values are displayed after the measurement is completed (P. 55)

→Retrieving values from memory (P. 57): with the instrument switched off, press the M button. The first value displayed is the average value of all stored mea-

surements together with the WHO classification.

The total number of stored measurements is displayed at the same time, e.g. "A30". Repeated pressing of „M" the individual measurement values are then displayed in sequence.

This quick guide does not replace the detailed information on the use and safety of the blood pressure monitor featured in the user instructions.

Please be sure therefore to read the user instructions!

Introduction

Dear Customer,

We are delighted that you have decided to purchase a boso blood pressure monitor. The boso brand is synonymous with optimal quality and precision and is also number 1 among professionals: 77% of all German doctors currently use boso blood pressure monitors. The experience gained from decades of use by professionals has also been incorporated into all the patient monitors for home measurement.

This instrument has also passed our strict quality control procedures and is your reliable partner for monitoring your blood pressure values.

⚠️ Please read these user instructions before using the instrument for the first time, as correct blood pressure readings

can only be obtained if the instrument is operated correctly.

In these user instructions, "→" means an action by the user.

To get help concerning usage or maintenance please contact your dealer or the manufacturer (contact details can be found on the back cover of this manual).

An unexpected operating condition or an incidence which has worsened the health condition or could have worsened the health condition should be reported to the manufacturer immediately.

If the instrument is to be sold, ensure that these user instructions are enclosed.

Introduction

If the monitor is used in medical practice (in accordance with the legislation governing the operation of medical devices), it should be calibrated at regular intervals (see page 68).

The boso-medicus control blood pressure monitor is suitable for patients of all ages with an upper arm circumference of between 22 and 48 cm. The monitor is not suitable for neonatals.

Blood pressure values

To determine the blood pressure, two values need to be measured:

●Systolic (upper) blood pressure:

This is produced when the heart muscle contracts and blood is forced into the blood vessels.

●Diastolic (lower) blood pressure:

This is present when the heart muscle expands and fills with blood again.

Blood pressure measurement values are expressed in mmHg (mm of mercury).

The World Health Organization (WHO) has defined the following cut-off values for assessing blood pressure:
	systolic diastolic
High blood pressure (hypertension) over 140 mmHg over 90 mmHgBorderline normal blood pressure 130 to 139 mmHg 85 to 89 mmHgNormal blood pressure 120 to 129 mmHg 80 to 84 mmHgOptimum blood pressure up to 119 mmHg up to 79 mmHg

Blood pressure values

Whether medical treatment is necessary depends not only on the blood pressure, but also on the patient's risk profile. Please contact your GP if one of the values (systole, diastole) consistently exceeds the cut-off point for high blood pressure.

Self-measurement of blood pressure often produces somewhat lower values at home than at the doctor's. The German Hypertension League has therefore defined lower cut-off values for home measurements:

Home measurement: 135/85 mmHg Measurement in the doctor's surgery: 140/90 mmHg

Diagram of a battery pack with two black-and-white batteries and four white batteries, no text or symbols present

Illustration 1

→Use only high quality leak-proof batteries of the correct specifications (see "Technical data" P. 65).

⚠️ Never mix old and new batteries or different makes.
⚠️ If the batteries are not inserted correctly, the monitor will not work and this may cause the batteries to heat up and leak, damaging the monitor.

→Inserting the batteries

The battery compartment is located on the underside of the monitor. Insert batteries in the battery compartment as shown in illustration 1.

→Remove the batteries if the monitor is not to be used for any length of time.

Starting up

The monitor has a battery status display (see P. 38)

Battery fully charged.

Battery partially charged.

Replace battery soon.

Flashing! No further measurements possible. Replace battery.

⚠️ Care for the environment

Do not dispose of used batteries and charger units in domestic waste.

You can take these to collection sites for used batteries or special waste.

Contact your local authority for information.

⚠️ Change batteries only when the monitor is switched off!

The memory store is deleted if the batteries are removed for a prolonged period (more than 30 sec.)! The memory store is deleted immediately if the batteries are removed in measurement or store mode!

General instructions for self-measurement

1. Fluctuations in blood pressure are quite normal. Even when measurements are repeated, there can be marked differences. Single or irregular measurements do not provide reliable information about the actual blood pressure. A reliable evaluation is only possible if regular measurements are taken under comparable conditions and the measurement values entered in the blood pressure record card.
2. ⚠️ Self-testing does not mean self-treatment. Do not on any account change the dose of medicine prescribed by your doctor of your own accord.

3. Irregular heartbeats can affect the accuracy of the monitor or result in incorrect measurements (see page 62).

4. Incorrect measurements can also occur in patients with a weak pulse (possibly in patients wearing a pacemaker, for example). The blood pressure monitor itself has no effect on the pacemaker.

5. If you are pregnant, consult your doctor before using the monitor.
6. Always take the measurement in a calm and relaxed state. You are recommended to check your blood pressure twice a day – in the morning on getting up and in the evening once you have relaxed after work.
7. Always measure your blood pressure from the arm with the higher blood pressure values (where not required otherwise (see page 51)).

General instructions for self-measurement

To do this, measure the blood pressure first in both arms and thereafter always from the arm with the higher blood pressure.

1. Using the monitor in the vicinity of strong electromagnetic fields (e.g. radiation devices, mobile telephones) can cause it to malfunction. Medical electrical apparatuses are subject to specific precautions as regards electromagnetic compatibility (EMC). Relevant information can be obtained from the manufacturer on request (contact details can be found on the back cover of this manual).

Preparing to measure your blood pressure

Note on cuff sizes:

The monitor may only be used with the following cuff types. These should be chosen according to the upper arm circumference printed on them.

Type Arm Order numbercircumference

CA01 22 – 32 cm 143-4-764

CA02 32 – 48 cm 143-4-757

CA04 22 – 42 cm 143-4-765*

* Universal cuff supplied as standard.

Attach the cuff to the monitor by pressing the plug (click) into the socket on the left side of the unit. (See illustration 2).

Medical device with a blood pressure monitor and a close-up of its internal grid structure (no visible text or symbols)

Illustration 2

Preparing to measure your blood pressure

Observe the following instructions when measuring your blood pressure:

Avoid smoking or drinking coffee for one hour before measuring your blood pressure.

Sit comfortably for the blood pressure measurement. Support your back and arms. Do not cross your legs. Place your feet flat on the floor.

Relax for 5 minutes before taking a measurement.

Do not move during the measurement.

Attaching the cuff

The measurement should be taken from the bare upper arm.

In the case of tightly fitting outer clothing, ensure that the blood supply to the arm is not cut off when the sleeve is rolled up (if necessary remove the article of clothing before taking the measurement).

→Open out the cuff into the shape of a ring and slide it over the upper arm until the bottom edge of the cuff is about 2-3 cm above the elbow. The cuff must be positioned so that the marking is over the artery (see illustration 3).

Preparing to measure your blood pressure

Marking Artery 2-3 cm

Illustration 3

⚠️ Do not attach the cuff over wounds as this can cause further injuries.
⚠ Ensure that the cuff is not attached to an arm where arteries or veins are undergoing or have undergone medical treatment (e.g. shunt).
⚠ For women who have had a breast amputated, do not attach the cuff to the arm on the amputated side of the body.

⚠️ During the measurement, medical apparatus that are being used on the same arm at the same time, may malfunction.
⚠️ The cuff must not be too tight. There should be enough space to fit roughly two fingers between arm and cuff.
⚠ The metal ring should never lie over the artery (see illustration 3) as this may produce a false reading.
→Grasp the end of the cuff that feeds though the metal ring and wrap it around the outside of your arm. Attach the Velcro fastener by applying gentle pressure.

Preparing to measure your blood pressure

→Place your arm with the cuff attached on the table, holding it relaxed and slightly bent so that the cuff is level with your heart.

too low values correct values too high values

Illustration 4

Do not talk during the measurement.

⚠️ Check that the air tube is not kinked during the measurement. This could cause congestion of the blood flow and subsequent injury.

⚠ The blood pressure measurement should not prevent the flow of blood for an unnecessary length of time (> 2 minutes). If the monitor fails to function correctly, remove the cuff from the arm.

Excessive frequent measurements can cause injury by restricting blood flow.

Measuring your blood pressure

Your monitor has a memory with a capacity of 30 measurements.

→Start the measurement with the start button

Now hold the arm absolutely still and do not talk.

All the items on the LCD display appear briefly to indicate that the monitor is now ready for use (see illustration 5).

M 888 888 ♥ 888

Illustration 5

Measuring your blood pressure

The pump starts to inflate the cuff.

The monitor has an intelligent automatic inflation system for gentle inflation to the correct cuff pressure.

The increasing cuff pressure is displayed.

When the required pressure is reached, the pump switches off and the air is released slowly from the cuff.

Interrupting a measurement:

A measurement can be interrupted at any stage by pressing the start button; the cuff deflates automatically.

During the measurement phase the descending cuff pressure and the flashing ♥ symbol are displayed (see illustration 6).

145 ♥

Illustration 6

Measurement display

After the end of the measurement, the in-built valve opens automatically and the cuff deflates rapidly.

The measured blood pressure values (systole, diastole, pulse) are displayed (see illustration 7).

126 86 89

Illustration 7

Systole mmHg

Diastole mmHg

Pulse/min.

The measurement is stored automatically (except for guest mode, see below). If the memory store is full (30 measurements), the oldest measurement is deleted and the current one stored.

Note on guest mode:

If a measurement value is not be kept, press „M“ while the measured values are still on display.

Invalid measurements with an "Err" message (see page 61) are not stored.

If the symbol “he” appears after the measurement, it is recommended that the measurement is repeated, holding the arm completely still. If the “he” symbol

Measurement display

appears again even with the arm held still, this may be an indication of an irregular heartbeat. Please discuss this with your doctor at your next visit.

Blood pressure is a dynamic parameter and can be affected by the patient's position, e.g. sitting, standing, lying, moving, before or during the measurement, physical condition (stress, disease, etc.).

→If the measurement result is obviously wrong, repeat the measurement.

The unit switches itself off automatically after about 1 min. To repeat a measurement, press the start button again briefly.

Allow at least two minutes between measurements.

→If no further measurement is required, remove the cuff from the arm.

Completing the blood pressure record card Retrieving the average value and WHO classification

→Enter each individual value in your record card.
→When the unit is switched off, recall the average value after 30 recorded measurements by briefly pressing „M“.

The average value of all stored results (systole and diastole) appears. In the „Pulse“ display the number of the stored measurements flashes.(see illustration 8).

→Enter the average value in the field specifically reserved for this in your record card.

If there is no measurement in the memory, "O" is displayed for systole and diastole and "ROO" flashes for the number of measurements.

Completing the blood pressure record card Retrieving the average value and WHO classification

A dark rectangle appears on the left of the screen (see illustration 8), indicating the level of the average blood pressure value. Use the accompanying evaluation scale (see illustration 9) to identify the range within which your blood pressure falls under the WHO classification (see page 43).

→For your information, attach the sticker (WHO classification) supplied, to the back of your unit.

M 126 86 A30

Illustration 8

Average value Systole mmHg

Average value Diastole mmHg

Number of measurements

WHO classification

high blood pressure (hypertension) borderline normal blood pressure normal blood pressure optimum blood pressure

Illustration 9

Displaying individual stored values and clearing the memory store

→Recall the last measurement stored in the memory by pressing „M“ again after having recalled the average value. The number of the measurement appears in the display (see illustration 10).

The corresponding measurement value appears after 3 seconds (see illustration 11).

M π01

Illustration 10

M 126 86 89

Illustration 11

Systole mmHg

Diastole mmHg

Pulses/min.

→Repeated pressing of „M“ will now successively display all measurements contained in the memory as described above.
→To start a new measurement, simply press „START“.

If no button is pressed, the unit switches off automatically after 5 seconds.

Clearing the memory store

Press „M“ and hold for 5 seconds until the symbol M starts to flash. The memory store is now cleared.

Mains operation

The mains connection socket is located at the rear of the monitor. Where required, use only the boso power supply unit (order number 410-7-150). This power supply unit produces a rectified output of the correct polarity. Other commercially available power supply units can cause damage to the electronic components, which will invalidate the warranty. There is also a risk of fire with these other power supply units.

⚠️ If there are no batteries in the unit, the memory store is cleared when it is disconnected from the mains.

⚠️ If there are fully charged batteries in the unit, the memory store is not cleared when it is disconnected from the mains.

→Disconnecting from the mains:

With the monitor switched off, disconnect the plug from the blood measurement unit first of all and then disconnect the power supply unit from the wall socket

Error messages

If any problems occur during the measurement, the display will show an error message instead of a blood pressure reading.

Meaning of error messages:

Cause of Err message: Troubleshooting:

Excessive variation in cuff pressure Hold arm still during measurement

No valid pulse readings Check position of cuff (see page 50) and repeat measurement.

Systole – diastole difference Check position of cuff (see page 50) too small: and repeat measurement

Systole – diastole ≤10 mmHg

Cause of Err CuF message:

Incorrectly inflated Cuff possibly too

Troubleshooting:

loose, attach cuff more firmly (see page 50)

Error messages

“♥” Display: Troubleshooting:

Repeat measurement recommended, holding the arm absolutely still. If the “♥” symbol appears again, even with the arm held still, this may be an indication of an irregular heartbeat. Please discuss this with your doctor at your next visit.

Cleaning and Disinfection Warranty

Cleaning Monitor:

Use a soft, dry cloth to clean your monitor.

Cleaning Cuff:

Small stains on the cuff can be removed carefully with a proprietary washing-up liquid.

Disinfection Cuff:

For disinfectant wipes (at least 5 minutes exposure time) of the device and the cuff, we recommend the disinfectant antifect liquid (Schülke & Mayr). To disinfect the velcro of the cuff, we recommend spray disinfection.

In particular, if the device is used on multiple users is to pay attention to regular cleaning and disinfections of the cuff.

Warranty:

For details of the warranty conditions, please consult the warranty certificate supplied.

A claim under the warranty will only be accepted if the warranty certificate, completed and stamped by the dealer, is returned with the monitor.

Customer service

Customer service:

Warranty and repair work must be undertaken by trained and authorised personnel. Do not modify this equipment without authorization of the manufacturer.

Send the monitor, carefully packaged and with sufficient postage, to your authorised dealer or directly to:

Do not dispose of monitors and batteries in the domestic waste.

At the end of its lifespan, the monitor must be taken to a collection site for obsolete electronic items.

Please note that batteries and rechargeable batteries must be disposed of separately (local authority collection site).

Expected operational lifetime of the equipment: 10 years.

Expected operational lifetime of the cuff: 10.000 measurement cycles.

Technical data

Measurement principle: oscillometric

Measurement range: 40 to 240 mmHg, 40 to 200 pulses/min.

Cuff pressure: 0 to 320 mmHg

Memory store: 30 measurements

Display: LCD

Operating conditions: environmental temperature +10°C to +40°C Relative humidity 15 to 85%

Storage conditions: environmental temperature -10°C to +60°C Relative humidity 15 to 85%

Power supply: DC 6 V (4 x 1.5 V Mignon IEC LR 6 alkaline manganese batteries) Alternative special option: DC 6 V power supply unit, Order No. 410-7-150

Technical data

Typical battery life: 1.000 measurement cycles

(depending on inflation pressure and frequency of use).

Battery check: symbol display in LCD window

Weight: 300 g without batteries

Dimensions (WxHxD): 150 mm x 65 mm x 115 mm

Classification: Protection class II ( )

Type BF (☐)

Protection against solid IP21

objects and water:

Clinical test Accuracy complies with the requirements

(DIN 58130): of EN 1060 Part 3

Technical data

Maximum deviation of cuff ± 3 mmHg

pressure measurement:

Maximum deviation of ±5%

pulse rate display:

Applicable standards: EN 1060, Part 1: "Non-invasive sphygmomanometers – General requirements" and Part 3: "Supplementary requirements for electro-mechanical blood pressure measuring systems".

Calibration checks - Testing instructions

(for trained specialist staff only)

Calibration checks – every 2 years at the latest – must be performed by the following institutions or persons:

• Manufacturer
  – Trade measurements authorities
• Persons who fulfil the requirements of the legislation governing the operation of medical devices.

A) Function testing

Function testing of the monitor can only be carried out on a person or with a suitable simulator.

B) Testing of pressure circuit integrity and deviation of pressure display

Note:

a) When the pressure in measurement mode increases above 320 mmHg, the quick release valve is triggered and the pressure circuit opens. When the pressure in test mode increases above 320 mmHg, the measured value display flashes.
b) Remove the plug from the cuff tube for testing. Then attach the short connecting piece of the plug – previously inserted into the socket on the monitor – to the cuff tube and insert the long connecting piece of the plug into the monitor.

A pump ball must also be introduced into the pressure circuit.

Calibration checks - Testing instructions

(for trained specialist staff only)

Testing

1.) Remove batteries.
2.) Hold start button pressed down and insert batteries.
3.) Release start button. The monitor is now ready for testing; the current pressure is displayed in the SYS, DIA and PULS fields.
4.) Perform test for deviation of pressure display and pressure circuit integrity (observe setting time for cuff – at least 30 seconds) in the usual manner.

5.) Switch off monitor by pressing the start button again and re-establish all original connections.

C) Safety seal

As a safeguard, the upper and lower parts of the housing can be joined with a safety seal. Alternatively, a hole drilled in the bottom of the monitor for the connecting screw for the housing can be sealed for safety.

Table des matières

Diagram of a battery pack with four cells and two external components (no text or symbols)

Figure 1

Medical device with blood pressure monitor and close-up of a grid-based device (no visible text or symbols)

Figure 2

M 888 888 ♥ 888 c/77 "♥"

Figure 5

Diagram of a battery pack with two black-and-white segments and four white cells, no text or symbols present

Fig. 1

Medical device with a blood pressure monitor and a close-up of its internal grid component (no visible text or symbols)

Fig. 2

M 888 888 ♥ 888 C/73 (♥)

Fig. 5

Diagram of a battery pack with two black-and-white segments and four white cells, no text or symbols present

Figura 1

Medical device with a blood pressure monitor and a close-up of its internal grid structure (no visible text or symbols)

Figura 2

M 888 888 ♥ 888

Figura 5