Medicus Family 4 - Blood pressure monitor BOSO - Free user manual and instructions

USER MANUAL Medicus Family 4 BOSO

boso medicus family 4

medicus family 4 boso M AVG 120 SYS mmHg M DIA mmHg SET PUL min 65 START

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1 Blutdruckpass

Diagram showing two views of a device with battery and switch, no text or symbols present

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M AVG. 888 888 1 2 3 4 188 AM PM 8888

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Blutdruckmessung

Contents of package....45

Symbols on the blood pressure monitor 46

Symbols on the power supply unit 49

Quick guide....50

Introduction......51

Purpose....52

Blood pressure values....53

Systolic and diastolic blood pressure value....53

WHO blood pressure cut-off values....53

Starting up....55

Inserting batteries....55

Battery status....56

Set Time and Date....56

General instructions for self-measurement 58

Preparing to measure your blood pressure....60

Note on cuff sizes....60

Table of contents

Attaching the cuff 61

Select an user....64

Measuring your blood pressure....64

Interrupting a measurement....65

Measurement display....66

Note on guest mode....66

Completing the blood pressure record card / Retrieving the average value and WHO classification....68

Displaying individual stored values....70

Mains operation....71

Error messages....72

Cleaning and Disinfection....74

Warranty Conditions 75

Customer service / Disposal 76

Technical data 77

Calibration checks - Testing instructions

(for trained specialist staff only) 80

Product features

Mains connector Cuff connector WHO classification medicus family 4 baso 120 SYS DIA PUL SET START button LCD display

Contents of package

1 boso-medicus family blood pressure monitor

WHO classification sticker

Scanned document page with multiple Chinese text columns and a small diagram of a box, likely illustrating a technical or administrative form.

1 Blood pressure record card

Symbols on the blood pressure monitor

Symbol	Function/meaning
	START/STOP button
	M button (Memory button)
	SET button
	Direct current
	Serial number
	Year of manufacture
	Type BF: The device, cuff and tubing have been designed to protect the patient against electric shock.
	Select an user

Symbols on the blood pressure monitor

Symbol Function/meaning

♥	Reading in progress. Flashes as soon as a heartbeat was detected.
((♥)	Cardiac rhythm disorder or movement during reading..
	Movement during measurement.
	Rate of recurrence of cardiac arrhythmias.
	Stored value
AVG.	Display average value
	Battery fully charged.
	Battery partly discharged.
	Replace battery as soon as possible.
	Flashing! No further reading possible.Replace battery.

Symbols on the blood pressure monitor

Symbol Function/meaning

SYS	Systolic blood pressure in mmHg
DIA	Diastolic blood pressure in mmHg
PUL	Pulse per minute
CE0124	Device complies with the European Medical Devices Directive.
	Device must not be discarded with household waste.
	Manufacturer
	Read instructions for use
	Polarity of power supply port
	Protect against liquids

Symbols on the power supply unit

Symbol Function/meaning

	Only for use in enclosed spaces.
	Protection class II device
	Thermal fuse
	Fuse
CE	Device complies with the European Medical Devices Directive
	Polarity of the mains adapter plug

Quick guide

→Insert batteries, ensure correct positioning (P. 55)
→Connect cuff to monitor (P. 60)
→Attach cuff (P. 61)
→Start (and stop) a measurement by pressing the start button (P. 64)

Measured systolic, diastolic and pulse values are displayed after the measurement is completed (P. 66)

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.

→Retrieving values from memory (P. 68): Press the M-button with the monitor switched off. The first value displayed is the average value of all stored mea-

Please be sure therefore to read the user instructions!

Introduction

Dear Customer,

We are delighted that you have decided time, as correct blood pressure readings to purchase a boso blood pressure mon can only be obtained if the instrument is itor. The boso brand is synonymous with operated correctly.

optimal quality and precision and is alson these user instructions, „→” means an number 1 among professionals: 96% of action by the user.

all German general practitioners, physici-

ans and internists work in practice with To get help concerning usage or mainten-blood pressure instruments from boso ance please contact your dealer or the (API survey conducted by GfK 01/2016). manufacturer (contact details can be The experience gained from decades of found on the back cover of this manual). use by profession-als has also been incor-

porated into all the patient monitors for An unexpected operating condition or an home measurement. incidence which has worsened the health

This instrument has also passed our stricondition or could have worsened the quality control procedures and is your rehealth condition should be reported to the able partner for monitoring your blood manufacturer immediately.

pressure values.

Please read these user instructions

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

Introduction

Purpose

The boso-medicus family 4 blood pressu monitor is suitable for patients with an upper arm circumference of between 22 and 48 cm.

Non-invasive recording of systolic and diastolic blood pressure and pulse rate in adults. Not suitable for use on newborn babies and infants. The device is suitable for self-measurement at home. The

The use of accessories not referred to in these instructions for use can undermine safety.

ipatient is regarded as the operator.

The instrument can be used with any arm circumference as shown on the corre-

Wireless communication devices, such as sponding cuff. home networking devices, mobile phones, cordless phones and their base stations, walkie-talkies can affect this blood pressure monitor. Therefore, a minimum distance of 11 feet should be kept from such devices.

Blood pressure values

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

Diastolic (lower) blood pressure: This is present when the heart muscle expands and fills with blood again.

●Systolic (upper) blood pressure:

This is produced when the heart muscle blood pressure measurement values are contracts and blood is forced into the expressed in mmHg (mm of mercury). blood vessels.

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 than at the doctor's. The German depends not only on the blood pressure Hypertension League has therefore defi-but also on the patient's risk profile. Need lower cut-off values for home measu-Please contact your GP if one of the valements: ues (systole, diastole) consistently exceeds the cut-off point for high blood pressure.

Home measurement: 135/85 mmHg

Self-measurement of blood pressure often measurement in the produces somewhat lower values at home doctor's surgery: 140/90 mmHg

Starting up

The device must be installed and put into a Never mix old and new batteries or operation in accordance with the instructed different makes. tions in this manual.

Diagram showing two views of a device's internal components with battery and switch, no text or symbols present

Illustration 1

⚠️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.

→Use only high quality leak-proof batteries of the correct specifications (see "Technical data" P. 77).

⚠ Batteries that are short-circuited can become hot and cause burning.

Starting up

Set Time and Date

The monitor has a battery status displayYour device boso-medicus family 4 has a clock function. (see P. 47)

Battery fully charged.

Battery partially charged.

Replace battery soon.

Flashing! No further measurements possible. Replace battery.

To select date and time setting, press the button. Modification of the parameters are done with the < START > - button.

→Press button for about 2 seconds, release - setting of date (year flashes), set year with START button.

⚠️Care for the environment

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

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

Contact your local authority for information.

→briefly press - setting of date (month flashes), set month with START button

Set Time and Date

→briefly press - setting of date (day flashes), set day START button
→briefly press - setting of time (hour flashes), set hour with START button
→briefly press - setting of time ( minutes flashing) , set minute with START button
→briefly press - Setting of time mode (12h/24h/off flashes), set time mode with START button If you select 'off', no time will be displayed and the automatic switch-off period of the device will be extended to 60 minutes. N.B., this significantly increases battery

consumption, and so is recommended only within running the device on mains power.

→Briefly press , power is switched off

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
   reliableevaluation isonly possibleif reg-5. ular measurements are taken under comparableconditionsandthemeasurement values entered in the blood pressure record card.
   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.
   The device has not been validated for use on pregnant women.
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.
   Always take the measurement in a calm and relaxed state.
   You are recommended to check your blood pressure twice a day—inthemorning on getting up and in the evening once you have relaxed after work.
3. Always measure your blood pressure
4. Irregular heartbeats can affect the accu-from the arm with the higher blood racy of the monitor or result in incorrect pressure values (where not required measurements (see page 73). otherwise (see page 62)).

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.

Preparing to measure your blood pressure

Note on cuff sizes:

Attach the cuff to the monitor by pressing the plug (click) into the socket on the left

The monitor may only be used with side of the unit. (See illustration 2).

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.

Diagram of a medical device with a curved tube and connector, showing no text or symbols

Illustration 2

Preparing to measure your blood pressure

Observe the following instructions Attaching the cuff

when measuring your blood pressure:

The measurement should be taken from

Avoid smoking or drinking coffeethe bare upper arm.

for one hour before measuring your blood pressure.

⚠ In the case of tightly fitting outer clothing, ensure that the blood supply to

Sit comfortably for the blood prethe arm is not cut off when the sleeve sure measurement. Support your rolled up (if necessary remove the article of back and arms. Do not cross your clothing before taking the measurement).

legs. Place your feet flat on the floor.

Relax for 5 minutes before taking a measurement.

Do not move during the measurement.

→Open out the cuff into the shape of a g ring and slide it over the upper arm until the bottom edge of the cuff is e- 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

⚠️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.

⚠️Do not attach the cuff over wounds this can cause further injuries.
⚠ Ensure that the cuff is not attached an arm where arteries or veins are und going 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.

As 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⚠️The blood pressure measurement on the table, holding it relaxed and should not prevent the flow of blood for an slightly bent so that the cuff is levelunnecessary length of time (> 2 minutes). with your heart. If the monitor fails to function correctly, re-

too low values correct values too high values

Illustration 4

Excessive frequent measurements can cause injury by restricting blood flow.

⚠ The device may not be used by unsupervised children.

⚠️Do not use the device near infants. This can lead to accidents or damage.

⚠️Do not start the device without putting on the cuff.

There are small parts that may cause a choking hazard if swallowed by mistake by infants.

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.

Measuring your blood pressure

⚠️If the ambient temperature changes →Start the measurement with the start significantly, leave the device about an button hour to adapt to the new ambient temperature before using it.

The performance of the device can affected by excessive temperature, humidity or altitude.

Select an user

Your device boso-medicus family 4 has memories for 4 persons.

Pressing the button with the power switched off allows to select one of the users.

Then press button to determine the selected person.

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).

60 M AVG. 888 888 1 2 3 4 188 AM 8888 188 PM

Illustration 5

easuring your blood pressure

The pump starts to inflate the cuff. During the measurement phase the descending cuff pressure and the flashing

The monitor has an intelligent automatic♥ symbol are displayed (see illustrainflation system for gentle inflation to thion 6).

correct cuff pressure.

The increasing cuff pressure is displayed. Please keep your arm still if the symbol appears while a measurement is being

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 a stage by pressing the start button; the deflates automatically.

TV Cuff 145 1 PM 14:45

Illustration 6

Measurement display

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

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

The measurement is stored automatically (except for guest mode, see below). If the memory store is full (60 measurements), the oldest measurement is deleted and the current one stored. date

"♥" 126 86 1445 99

Systole mmHg

Diastole mmHg

Pulse/min.

Alternating time and date are displayed. Illustration 7

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 72) are not stored.

Measurement display

If the symbol ^he appears after the measurement, it is recommended that the measurement is repeated, holding the arm completely still. If the symbol appears again even with the arm held this may be an indication of an irregular heartbeat. Please discuss this with your doctor at your next visit.

→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.

The "symbol" indicates that the arm moved during measurement. You are advised to take another measurement.

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

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.).

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

→To recall the stored press the M key If there is no measurement in the memory, with the device switched off. "0" is displayed for systole, diastole and pulse.

The average values of all stored measurements (systolic, diastolic and pulse) are displayed. If measurements were recorded with irregular heart beat, there is an additional symbol showing the prevalence of cardiac

→Pressing the button during the arrhythmias:

memory-recall allows to select one of the users.

appears when up to 25% of the measurements have irregular heart beat.

appears when between 25% and 50% of the measurements have irregular heart beat.

appears when more than 50% of the measurements have irregular heart beat.

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

A dark rectangle appears on the left of the screen(seeillustration8), 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 53).

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

M AVG. 126 86 99

Illustration 8

Average value Systole mmHg

Average value Diastole mmHg

Pulses/min.

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 mem→Repeated pressing of „M“ ory by pressing „M“ again after having recalled will now successively dis-the average value. The number of the measure-play all measurements comment appears in the display (see illustration 10). tained in the memory as described above.

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

→Pressing the START button switches off the device.

EN

M NO. 1

Illustration 10

M 126 86 1445 89

Alternating time and date are displayed.
Illustration 11

Systole mmHg

Diastole mmHg

Pulses/min.

If no button is pressed, the device automatically switches off after 60 seconds.

Clearing the memory store Press „M“ and hold for 5 seconds until the symbol M starts to flash. The memory of the currently selected user is erased.

Mains operation

The mains connection socket is located the rear of the monitor.

Do not touch the batteries, the power supply unit socket and the patient at the

Where required, use only the boso power time.

supply unit (order number 410-7-150).

This power supply unit produces a rectified Remove the power supply unit plug output of the correct polarity. Other conform the blood pressure monitor when it is

mercially available power supply units cannot in use.

cause damage to the electronic compo-

nents, which will invalidate the warranty.

There is also a risk of fire with these other

power supply units.

Error messages

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

Meaning of error messages:

	Cause of Err message: Troubleshooting:
	Excessive variation in cuff pressure during measurement	Hold arm still.
	No valid pulse readings Check	position of cuff (see page 61) and repeat measurement.
	Systole – diastole difference Check position of cuff (see page 61 too small: and repeat measurement. Systole – diastole 10 mmHg
	Incorrectly inflated Cuff possibly	too loose, attach cuff more firmly (see page 61)

Error messages

Cause of Err message: Troubleshooting:
	The pulse value could check position of cuff not be determined and repeat measurement. correctly.
	Internal Error	Remove the batteries and briefly press START ton. Put the batteries back into the monitor. error persists, return the instrument for repairs to the manufacturer.
	“♡” 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

Cleaning Monitor:

Use a soft, dry cloth to clean your m

Cleaning Cuff:

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

Disinfection Cuff:

nFloor.disinfectant wipes (at least 5 minutes exposure time) of the device and the cuff, we recommend the disinfectant antifect lieduid (Schülke & Mayr). To disinfect 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 Conditions

We give 3 years warranty from the date of claims for damages against us are sub-purchase. The purchase date has to be substantiated by the warranty.

ven by the invoice. Within the warranty pe-

period defects are eliminated free of charge. the case of justified warranty claims the After repairs the warranty period is not device has to be sent along with the originated on the whole unit, but only to the invoice to:

replaced components.

BOSCH + SOHN GMBH U. CO. KG,

Excluded from the warranty are parts subBahnhofstr. 64, D-72417 Jungingen.

ject to normal wear and tear (e.g. cuff), transport damages and any damage caused by improper handling (e.g. non-compliance with the instructions for use). Damages due to disassembly by unauthorized persons are also excluded from warranty.

Customer service

Disposal

Customer service:

Warranty and repair work must be under

taken by trained and authorised personnel.

Do not modify this equipment without horization of the manufacturer.

Send the monitor, carefully packaged an

with sufficient postage, to your authorised

dealer or directly to:

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

AAt- the end of its lifespan, the monitor must be taken to a collection site for obsolete

ndelectronic items.

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

Expected operational lifetime of the equipment: 5 years (using the unit 6 times a day)

Expected operational lifetime of the cuff: 2 years (using the unit 6 times a day).

Technical data

Measurement principle: oscillometric

Measurement range: Systolic: 60 to 279 mmHg Diastolic: 40 to 200 mmHg Pulse: 40 to 180 per minute

Cuff pressure: 0 to 299 mmHg

Memory store: 4 x 60 measurements

Display: LCD

Operating conditions: environmental temperature +10°C to +40°C Relative humidity 15 to 85% Air pressure 800 hPa to 1060 hPa

Transport/ environmental temperature -20^ to +60^ Storage conditions: Relative humidity 10 to 95% Air pressure 700 hPa to 1060 hPa

Technical data

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

Typical battery life: 700 measurement cycles (depending on inflation pressure and frequency of use).

Battery check: symbol display in LCD window

Weight: 282 g without batteries

Dimensions (WxHxD): 140 mm x 60 mm x 106 mm

Classification: Medical device with internal energy source (in battery operation) / class II (in power supply unit operation), continuous operation mode

Applied part: Type BF ( )

Technical data

Protection against solid IP20

objects and water: IP classification is the degree of protection provided by enclosures in accordance with IEC 60529. This device is protected against solid foreign objects of 12mm diameter and greater such as fingers. This device is not protected against water.

Clinical test: Accuracy complies with the requirements

of ISO 81060 Part 2

Maximum deviation of cuff ± 3 mmHg or 2% of the reading

pressure measurement: (whichever is greater)

Maximum deviation of ± 5%

pulse rate display:

Applicable standard: IEC 80601-2-30 : "Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers"

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.

Note:

When the pressure in measurement mode increases above 299 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) For the calibration checks a special test plug must be used. The test plug is available for a fee from the manufacturer.

A) Function testing

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

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

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

Calibration checks - Testing instructions

(for trained specialist staff only)

Testing

5.) Switch off monitor by pressing the START button again.

1.) Remove batteries.
⚠ The device must not undergo service
2.) Hold start button pressed down and/or maintenance while it is in use. insert batteries.
3.) Release start button. The monitor is now ready for testing; the current pressure is displayed in the SYS and DIA 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.

Table des matières

Introduction......91

Destination 92

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1 carnet de suivi

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Figure 1

Diagram of a car door handle with a cable and connector, no text or symbols present

Figure 2

AVG. 888 888 1 2 3 4 188 AM PM 8888

Figure 5

"♥" 126 86 1445 99

Date / Heure en

Systole mmHg

Diastole mmHg

Pouls/min.

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Diagram showing battery charging process with one panel and two battery cells, no text or symbols present

Fig. 1

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Fig. 2

M AVG. 888 888 1 2 3 4 188 AM 888 PM

Fig. 5

"♥" 126 86 1445 99

P. sistolica mmHg

P. diastolica mmHg

Polso/min.

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Technical line drawing showing a device's internal components with battery and switch, no text or symbols present

Figura 1

ia em- I sion, ul- edi- aza- 14:50 PM 14:45

Figura 6

"♥" 126 86 1445 99

Sístole mmHg

Diástole mmHg

Pulsaciones/ minuto