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

USER MANUAL Medicus Smart BOSO

DIASTOLE (unterer Wert)

rechts im Display

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Bild 5

Contents of package....39

Symbols on the blood pressure monitor....40

Quick guide 43

Introduction......44

Purpose 45

Blood pressure values....46

Systolic and diastolic blood pressure value....46

WHO blood pressure cut-off values....46

Starting up 48

Inserting battery 48

Battery status....49

General instructions for self-measurement 50

Table of contents

Preparing to measure your blood pressure....52

Note on cuff sizes 52

Measuring your blood pressure....53

Attaching the cuff 53

Interrupting a measurement 57

Measurement display....58

Error messages....60

Cleaning and Disinfection....62

Warranty Conditions 63

Customer service / Disposal 64

Technical data....65

Calibration checks - Testing instructions

(for trained specialist staff only)....68

Product features

Pump ball release valve Cuff connector 132 x 86 Start button LCD display

Contents of package

1 boso medicus smart blood pressure monitor

or 132 86

1 LR 6 (AA) battery

1 CA 01 standard cuff

1 User instructions

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1 Case

1 Blood pressure record card

Symbols on the blood pressure monitor

Symbol Function/meaning

	START/STOP button
SN	Serial number
	Year of manufacture
	Type BF: The device, cuff and tubing have been designed to protect the patient against electric shock.
	Reading in progress. Flashes as soon as a heartbeat was detected.
	Cardiac rhythm disorder or movement during reading.

Symbols on the blood pressure monitor

Symbol Function/meaning

	Symbol inflation
	Symbol quick air release
	Battery fully charged.
	Battery partly discharged.
	Replace battery as soon as possible.
	Flashing! No further reading possible.Replace battery.
	Protect against liquids

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

Quick guide

→Insert battery, ensure correct positioning (P. 48)
→Press Start button(P. 53)
→Attach cuff (P. 53)
→Inflate the cuff to approx. 180 mmHg (P. 56)

Measured systolic, diastolic and pulse values are displayed after the measurement is completed (P. 58)

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 before using the instrument for the first to purchase a boso blood pressure monetime, as correct blood pressure readings tor. The boso brand is synonymous with can only be obtained if the instrument is optimum quality and precision and is also operated correctly.

number 1 among professionals: 96% of In these user instructions, „→“ means an all German general practitioners, physici-action by the user.

ans and internists work in practice with

blood pressure instruments from boso To get help concerning usage or mainten-(API survey conducted by GfK 01/2016).ance please contact your dealer or the The experience gained from decades of manufacturer (contact details can be use by professionals has also been incorfound on the back cover of this manual). porated into all the patient monitors for

home measurement.

This instrument has also passed our stricidence which has worsened the health quality control procedures and is your recondition or could have worsened the able partner for monitoring your blood health condition should be reported to the pressure values. manufacturer immediately.

Introduction Purpose

If the instrument is to be sold, ensure these user instructions are enclosed. Non-invasive recording of systolic and diastolic blood pressure and pulse rate in adults. Not suitable for use on newborn

The boso medicus smart blood pressure babies and infants. The device is suitable monitor is suitable for patients of all ages self-measurement at home. The with an upper arm circumference of be-patient is regarded as the operator. tween 22 and 48 cm.

The instrument can be used with any

The use of accessories not referred to circumference as shown on the correthese instructions for use can underminesponding cuff. safety.

Wireless communication devices, such as 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 vDiastolic (lower) blood pressure:

ues need to be measured:

Thisispresent whentheheart muscleexpands and fills with blood again.

●Systolic (upper) blood pressure:

This is produced when the heart must 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 defin-but also on the patient's risk profile. ed 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. If the battery is not inserted correctly, operation in accordance with the instructhe monitor will not work and this may tions in this manual. cause the battery to heat up and leak, da-

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→Inserting the battery

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

Illustration 1

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

→Use only a high quality leak-proof bat⚠️If the battery is short-circuited, it can tery of the correct specifications (see become hot and cause burning. "Technical data" P. 65).

Starting up

The monitor has a battery status display⚠️Care for the environment

Battery fully charged.

Battery partially charged.

Replace battery soon.

Flashing! No further measurements possible.

Replace battery.

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.

⚠️Do not touch the batteries and the patient at the same time.

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 evaluationisonly possibleif reg-5. ular measurements are taken under comparableconditionsand themeasurement 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 61). otherwise (see page 54)).

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:

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 numcircumference	ber
CA01	22 – 32 cm	43-4-762*
CA02	32 – 48 cm	43-4-763

* supplied as standard.

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.

Preparing to measure your blood pressure

→Press the Start button

All digital elements and function symbol light up momentarily to indicate that the unit is functioning correctly (see illustration 2).

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Illustration 2

Attaching the cuff

The measurement should be taken from the bare upper arm.

Is! In the case of tightly fitting outer clothing, ensure that the blood supply to the arm is not cut off when the sleeve 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

⚠️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 significantly, leave the device about an hour to adapt to the new ambient temperature before using it.

pressure in the cuff is higher than the systolic blood pressure (symbol disappears and the triple signal tone occurs).

The performance of the device can be at the following measurement the neces- affected by excessive temperature, humi-sary inflation pressure is adjusted by the dity or altitude. memomatic function, i.e. inflation pres- sure = SYSTOLIC of last measurement ta- → Now take the rubber ball into your right hand and inflate the cuff to approx. 180 mmHg.A triple signal tone indicated the correct pressure. occurs. The rising cuff pressure is shown on the digital display. In case Important: The additional increase in the the pressure in the cuff is not high enough, the symbol appears during the measurement. Please inflate the cuff by approx. 40 mmHg more. This procedure may be repeated until the cuff pressure can cause faulty readings. If this occurs, repeat the measurement after a 2 minute interval and this time inflate straight to above your upper (systolic) blood pressure value.

Measuring your blood pressure

⚠️Interruption of Measurement

To interrupt a measurement you can predicated by an extended bleep while the button of the release valve until all two measurement values in the display re-has been expelled from the cuff. (To remain static.

a measurement, simply reinflate the cuff.)

Symbol lights up to indicate that the

After inflation the air is automatically requick air release can now be initiated leased. The decreasing cuff pressure is re-

gistered the left side of the display. →To do this, press the valve button until As soon as the first pulsations are registe-all the air has been expelled from the red, symbol links in rhythm with the cuff.

pulse.

As soon as the registered pulse is ready to evaluated by the microprocessor the unit emits a bleep,againinpulserhythm.At this point it is crucial that the arm with the cuff is not being moved.

Measurement display

In the display appear your BP values:

SYSTOLE (upper value) left display

DIASTOLE (lower value) right display

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Illustration 5

automatically alternating with the above display:

PULSE (per minute)

PUL 76

Illustration 6

If the symbol 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 still, this may be an indication of an irregular heartbeat. Please discuss this with your doctor at your next visit.

Measuring your blood pressure

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.).

After an interval of two minutes a repeat measurement can take place. Only the cuff needs to be inflated again.

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

→If no further measurement is required,

remove the cuff from the arm.

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

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:

Err	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 53) and repeat measurement.
	Systole - diastole difference Check position of cuff (see page 53) too small: and repeat measurement. Systole - diastole≤10 mmHg
Err CUF	Cause of Err CuF message: Troubleshooting:
	Incorrectly inflated Cuff possibly	too loose, attach cuff more firmly (see page 54)

Error messages

Err 9	Cause of Err 9 message: Troubleshooting:
	Internal Error	Remove the batteries and briefly press START button. Put the batteries back into the monitor. If the error persists, return the instrument for repairs to the manufacturer.
126 86	“♥” 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 mo

Cleaning Cuff:

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

Disinfection Cuff:

Floor.disinfectant wipes (at least 5 minutes exposure time) of the device and the cuff, we recommend the disinfectant antifect li-

eduid (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 the case of justified warranty claims the purchase. The purchase date has to be p device has to be sent along with the origi- ven by the invoice. Within the warranty pel invoice to:

riod defects are eliminated free of charge.

After repairs the warranty period is not Bosch + SOHN GMBH U. CO. KG, tended on the whole unit, but only to Bahnhofstr. 64, 72417 Jungingen, replaced components. GERMANY.

Excluded from the warranty are parts subject 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.

No claims for damages against us are substantiated by the 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: 10 years.

Expected operational lifetime of the cuff: 10.000 measurement cycles.

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

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

Power supply: DC 1,5V (1 x 1.5 V Mignon IEC LR 6 alkaline manganese battery)

Typical battery life: 6.000 measurement cycles (depending on frequency of use).

Technical data

Battery check: symbol display in LCD window

Weight: 100 g without battery

Dimensions (WxHxD): 105 mm x 35 mm x 50 mm

Classification: Type BF ( )

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

Technical data

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: 2.

• 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 a suitable simulator.

B) Testing of Density of Pressure Circuit and Divergence from Pressure Indication

Remove battery.

1. Hold Start button pressed and at the same time insert battery.

Release Start button ^1 . The unit now is ready for testing. The displays of SYS and DIA now show the actual pressure.

1. Prior to testing the density, open the with battery compartment and take the T-connector off the unit. Wrap the cuff around a fixed cylinder and connect it with the T-connector (without deflation valve) to the pump ball and the unit.

Calibration checks - Testing instructions

(for trained specialist staff only)

Mind the setting time for cuff: at le6tPlacing of Safety Stamps 30 seconds.

Accomplish testing in the usual manner.

For complete safety cover up the drill hole for the base screw. Alternatively, connect upper housing and lower housing with a safety stamp placed directly on one of the housing edges.

1. Prior to testing the divergence of the pressure indication, open the battery compartment and take the T-connec-

tor off the unit. Connect the unit with The device must not undergo service the normal unit and a pump ball. or maintenance while it is in use.

Accomplish testing in the usual manner.

1. Switch off unit.

2. Re-connect the cuff and the pumpball with the T-connector.

Table des matières

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figure 2

Close-up of a white cable connector with internal components and a plus sign, no readable text or symbols beyond the label.

Fig. 1

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Figura 2

Ajuste del brazalete