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

USER MANUAL Medicus Uno BOSO

134 82 63 LPG LPG LPG

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

Bild 1

Medical device with digital display showing blood pressure measurement (no text or symbols visible)

Bild 2

M "♥" 888 888 188

Bild 5

Blutdruckmessung

"♥" 126 86 89

Systole mmHg

Diastole mmHg

Puls/min.

Bild 7

Contents of package 42

Quick guide 43

Symbols on the blood pressure monitor 46

Symbols on the power supply unit 47

Introduction......48

Purpose 49

Blood pressure values....50

Systolic and diastolic blood pressure value 50

WHO blood pressure cut-off values....50

Starting up....52

Inserting batteries....52

Battery status....53

Changing batteries....53

General instructions for self-measurement....54

Preparing to measure your blood pressure....56

Table of contents

Note on cuff sizes....56

Attaching the cuff 57

Measuring your blood pressure....60

Interrupting a measurement 61

EN

Measurement display....62

Recalling the last recorded measurement....64

Mains operation 65

Error messages....66

Cleaning and Disinfection 68

Warranty Conditions....69

Customer service / Disposal....70

Technical data....71

Calibration checks - Testing instructions

(for trained specialist staff only)....74

Product features

Mains connector boso medicus mmlHg SYS 134 82 63 DIA mmHg PUL min Cuff connector START button LCD display

Contents of package

1 boso-medicus uno blood pressure monitor

134 82 63 PGL GND CIA PGL CIA PGL

4 LR 6 (AA) batteries

1 CA 01 standard cuff

1 User instructions

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1 Blood pressure record card

Symbols on the blood pressure monitor

Symbol Function/meaning

START	START/STOP button
	Direct current
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.

Symbols on the blood pressure monitor

Symbol Function/meaning

	Cardiac rhythm disorder or movement during reading.
	Stored value
	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
	Polarity of power supply port

Symbols on the power supply unit

Symbol Function/meaning

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

Quick guide

→Insert batteries, ensure correct positioning (P. 52)
→Connect cuff to monitor (P. 56)
→Attach cuff (P. 57)
→Start (and stop) a measurement by pressing the start button (P. 60)

Measured systolic, diastolic and pulse values are displayed after the measurement is completed (P. 62)

→Retrieving values from memory (P. 64): with the instrument switched off, press the start button 3 seconds until "M" is displayed.

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 optimum quality and precision and is also number 1 among professionals: 96% of all German general practitioners, physicians and internists work in practice with blood pressure instruments from boso (API survey conducted by GfK 01/2016). 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.

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.

⚠️Please read these user instructions before using the instrument for the first

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

Introduction Purpose

The boso-medicus uno blood pressure monitor is suitable for patients of all ag with an upper arm circumference of between 22 and 48 cm.

The use of accessories not referred to in these instructions for use can undermine 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 12 inch should be kept from such devices.

Non-invasive recording of systolic and mediastolic 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 patient is regarded as the operator.

The instrument can be used with any arm circumference as shown on the corresponding cuff.

Blood pressure values

To determine the blood pressure, two valDiastolic (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 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 mmHg
Borderline normal blood pressure 130 to	139 mmHg 85 to 89 mmHg
Normal blood pressure 120 to 129 mmHg	80 to 84 mmHg
Optimum 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 defined but also on the patient's risk profile. ed lower cut-off values for home measures. Please contact your GP if one of the val-reements: 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 homedoctor's surgery:

140/90 mmHg

Starting up

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

Diagram of a car rear panel with battery cells and indicator lights (no text or labels)

Illustration 1

→Use only high quality leak-proof batteries of the correct specifications (see "Technical data" P. 71).

⚠️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.

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

Starting up

The monitor has a battery status display (see P. 44)

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 themeasurement values entered in the blood pres-6. sure 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. Always measure your blood pressure
4. Irregular heartbeats can affect the accuracy of the monitor or result in incorrect pressure values (where not required measurements (see page 67). otherwise (see page 58)).
   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.
   Always take the measurement in a calm and relaxed state.
   You are recommended to check your blood pressure twice a day – inthemoming on getting up and in the evening once you have relaxed after work.
   Always measure your blood pressure from the arm with the higher blood pressure values (where not required otherwise (see page 58)).

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 numbercircumference
CA01	22 – 32 cm	143-4-764*
CA02	32 – 48 cm	143-4-757

* 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 blood pressure monitor and blood pressure monitor connected via tubing (no visible 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 the bare upper arm.

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

⚠ 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

Sitcomfortablyforthebloodpressure measurement. Support your back and arms. Do not cross your legs. Place your feet flat on the floor.

(clothing before taking the measurement).

Relax for 5 minutes before taking a measurement. Do not move during 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 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.

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 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.

EN

⚠ 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.

⚠️If the ambient temperature changes significantly, leave the device about an hour to adapt to the new ambient temperature before using it.
The performance of the device can be affected by excessive temperature, humidity or altitude.

Measuring your blood pressure

→Start the measurement with your 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

eready for use (see illustration 5).

M 888 888 188

Illustration 5

Measuring 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 inflation system for gentle inflation to th

♥ symbol are displayed (see illustrat-

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.

145

⚠ Interrupting a measurement:

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

Illustration 6

Measurement display

After the end of the measurement, the inThe measurement is stored automatically. built valve opens automatically and the cuff deflates rapidly. Invalid measurements with an "Err" mes-

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

Invalid measurements with an "Err" message (see page 66) are not stored.

"♥II" 126 86 89

Systole mmHg

Diastole mmHg

Pulse/min.

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.

Illustration 7

Measurement display

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.).

Allow at least two minutes between measurements.

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

→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.

Recalling the last recorded measurement

To recall the result of the last measurement, press the enter each individual value START-button for approx. 3 seconds, while the unit is in your record card. switched off.

→To start a new measure-

The result of the last measurement appears for approximation, simply press 5 seconds. Afterwards the unit switches off automati- „START“. cally (see illustration 8).

M 126 86 89

Systole mmHg

Diastole mmHg

Pulses/min.

Illustration 8

The monitor switches off automatically 5 seconds after the last measurement is displayed.

Changing batteries when the monitor is switched on can result in loss of data (see page 53. Change batteries only when the monitor is switched off).

Mains operation

The mains connection socket is located at⚠️If there are fully charged batteries in the rear of the monitor. the unit, the memory store is not cleared

Where required, use only the boso powerwhen it is disconnected from the mains.

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

This power supply unit produces a rectified→Disconnecting from the mains:

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 unit from the wall socket power supply units.

With the monitor switched off, disconnect the plug from the unit first of all

and then disconnect the power supply

⚠️Do not touch the batteries, the power supply unit socket and the patient at the same time.

⚠️Remove the power supply unit plug from the blood pressure monitor when it is not in use.

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

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 during measurement	Hold arm still
	No valid pulse readings Check position of cuff (see page 57) and repeat measurement.
	Systole – diastole difference Check position of cuff (see page 57) too small: and repeat measurement.
	Systole – diastole≤10 mmHg
	Cause of Err CuF message: Troubleshooting:
	Incorrectly inflated Cuff possibly too loose, attach cuff more firmly (see page 58)

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 but ton. Put the batteries back into the monitor. If the 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 monit

Cleaning Cuff:

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

Disinfection Cuff:

bar 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 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 pro device has to be sent along with the origi- ven by the invoice. Within the warranty penal invoice to:

riod defects are eliminated free of charge.

After repairs the warranty period is not eBOSCH + SOHN GMBH U. CO. KG, tended on the whole unit, but only to the 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 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: Systolic: 60 to 279 mmHg Diastolic: 40 to 200 mmHg Pulse: 40 to 180 per minute

Cuff pressure: 0 to 299 mmHg

Memory store: 1 measurement

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 -10°C to +60°C Storage conditions: Relative humidity 15 to 85% 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: 280 g without batteries

Dimensions (WxHxD): 147 mm x 64,2 mm x 110 mm

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

Technical data

Protection against solid IP20

objects: 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 the higher)

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:

a) 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.

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

b) For the calibration checks a special test plug must be used. The test plug is with available for a fee from the manufacturer.

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 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.

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.

st! The device must not undergo service or maintenance while it is in use.

Table des matières

134 82 63 VOL VOL VOL VOL

4 piles LR 6 (AA)

1 brassard standard CA 01

1 mode d'emploi

1 carnet de suivi

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

Figure 1

Medical device with digital display showing blood pressure measurement (no text or symbols visible)

Figure 2

M "♥" 888 888 188 e

Figure 5

"♥" 126 86 89

Systole mmHg

Diastole mmHg

Pouls/min.

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

Fig. 1

Medical device with blood pressure monitor and pressure monitor connected to a black swab (no visible text or symbols)

Fig. 2

M "♥" 888 888 188

Fig. 5

"♥" 126 86 89

P. sistolica mmHg

P. diastolica mmHg

Polso/min.

boso medicusuno Digital Display Boso medicusuno Extractions anemizing User Instructions Mode 1-pointed Manual Inclusion Manual inclusion

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

Figura 1

Medical pressure monitor with digital readout showing blood pressure values (no text or symbols on device)

Figura 2

M "♥" 888 888 188

Figura 5

"♥" 126 86 89

Sístole mmHg

Diástole mmHg

Pulsaciones/ minuto

Figura 7