Használati útmutató Medel Dualstetho PRO

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ANEROIDS

USER MANUAL

ANEROIDS BLOOD PRESSURE DEVICE

INDEX

1. INTRODUCTION...............................................................1

2. WARNING...........................................................................1

3. COMPONENTS OF MEDEL ANEROID............................1

4. WORKING PRINCIPLES....................................................1

5. CARRYING OUT A MEASUREMENT...............................2

6. HOW TO USE THE BLOOD PRESSURE MONITOR.......2

7. IMPORTANT RECOMMENDATIONS..............................2

8. MANTAINANCE AND CARE ............................................3

9. SERVICING AND GAUGING.............................................3

10. TECHNICAL SPECIFICATIONS........................................3

11. WARRANTY CONDITIONS...............................................3

1. INTRODUCTION

ank you for buying a MEDEL aneroid blood-pressure monitor. is blood-pressure monitor works

according to the Riva Rocci/Korotko auscultating method.

MEDEL has a complete range of aneroid blood-pressure monitors with dierent features according to

their usage: home, or doctor’s practice.

Each MEDEL blood-pressure monitor is gauged and undergoes an accurate quality control.

Before usage read carefully and entirely this instruction manual and keep it in a safe place.

Please, check equipment and product characteristics described on the box.

2. WARNING

To carry out a measurement with the auscultating method requires a specic knowledge of this technique.

Incidental wrong interpretations and damages which can result from wrong usage cannot be ascribed

to the device.

is device is not a diagnostic device but a measurement system.

e measurement results must be evaluated by a doctor.

Auscultating method blood-pressure monitors are not recommended to persons with hearing problems.

3. COMPONENTS OF MEDEL ANEROID

MEDEL aneroid blood-pressure monitors consist in (Pic. 1):

4. WORKING PRINCIPLES

MEDEL aneroid blood-pressure monitors work according to the Riva Rocci/Korotko auscultating

method.

Measurement is carried out by occluding the radial artery through the pressure of a mu wrapped around

one arm (cu) and the following observation of the heart pulse tones (with the stethoscope) during the

deating phase.

It is reccomended to use the following points for auscultation:

• K5 in auscultation of adults

• K4 in auscultation of children aged 3 to12

• K5 in pregnant female patients, unless sounds are audible with cu deated, in which case K4

Manometer

Cuff

Release valve

Bulb with air

intake valve

Stethoscope

(if provided)

Pic.1

should be used (K5 is the point at which Korotko

sounds can no longer be heard; K4 is the change in the

tones heard through a stethoscope from a clear tapping

sound to a mued sound.)

In case of doubts about the method consult your doctor.

e latex bulb enables to generate the necessary air pressure

inside the cu in order to occlude the radial artery. e release

valve allows an accurate regulation of the air outlet from the

cu, permitting a gradual deation.

e stethoscope (furnished only with some models) allows to

survey the heart pulse tones.

Each manometer has a reading scale ranging from 0 to 300

mmHg (mmHg=millimeters of mercury). e scale is traced

every 2mmHg, with larger notches every 10mmHg for an easy

reading.

e measurement has a precision of +- 3mmHg.

5. CARRYING OUT A MEASUREMENT

Before the measurement:

• Avoid eating, smoking as well as any form of exertion before the measurement. All these factors

inuence the measurement results. Try to relax by sitting in an armchair in a quiet atmosphere

for about ten minutes before the measurement.

• Remove any garment that ts closely to your upper arm.

• Measure always on the same arm (normally le).

• Try to carry out the measurements regularly at the same time of day, as the blood-pressure chan-

ges during the course of the day.

Common sources of error:

Note: Comparable blood-pressure measurements require always the same conditions !

ese are normally quiet conditions.

• All eorts by the patient to hold up the arm can increase the arterial pressure. Make sure to sit

down in a comfortable, relaxed position, with legs uncrossed and not to activate any muscle of

the measurement arm during the measurement. Use a cushion for support if necessary.

• If the arm artery lies considerably lower (higher) than the heart, an erroneously higher (lower)

bloodpressure will be measured.

• Cus that are too narrow or too short result in false measurement values.

• Selecting the correct cu is very important. e cu size depends on the arm circumference

(measured in the middle). e permissible range is printed on the cu. If this is not suitable for

your arm, please contact your dealer.

• Use only Medel original cus !

• e device is furnished with a standard adult cu for arms of circumference between 26-38 cm.

6. HOW TO USE THE BLOOD PRESSURE MONITOR

Make sure the cu is completely at. Fasten the cu on the upper part of the le arm, making sure that

the tubing is facing downwards. If the device is provided with D-ring (please, check

the equipment on the box) put on the cu, place it in the correct way, pull the cu

lewards sliding it inside the metal bracket and x it to the velcro. (Pic. 2).

e lower edge of the cu must be at least 2 centimeters above the elbow, at heart’s

height (Pic. 3). ere should be enough space between cu and arm to t a nger

inside.

e arrow in the cu label must be in correspondance with the radial artery.

e stethoscope diaphragm should lie on the pulse position. Ask your doctor to

show it if necessary. Take the bulb and make sure that the pressure-release valve

is closed (turn it clockwise).nate the cu by squeezing the bulb, keep pumping I

until you reach 20-30mmHg beyond the highest expected pressure.

Slowly deate the cu turning the pressure-release valve anticlockwise, to obtain a

pressure decrease of 2- 3mmHg per second.

e rst audible tone corresponds to the highest (or systolic) pressure and the last

one corresponds to the lowest (or diastolic) pressure.

Open the release valve in order to deate completely the

cu. If it is necessary to interrupt a blood pressure measurement for any reason

(e.g. if the patient feels unwell), deate immediately the cu by opening completely

the release valve.

7. IMPORTANT RECOMMENDATIONS

• Never let air in beyond 300mmHg.

• e time used to measure blood pressure must not exceed 2 minutes.

Pic.3

Pic.2

2-3 cm

cu edge

tube

• Never make a second measurement before at least 5 minutes aer the rst one.

• Do not drop the device and handle it with care.

• Avoid strong vibrations.

• Do not expose the device to either extreme temperatures, humidity, dust or direct sunlight.

• Keep the device at a temperature between 10 and 40°C with a relative humidity not exceeding

85%.

• Keep the device and especially the rubber parts away from UV rays.

• Beware of damaging the rubber parts with sharp, cutting objects.

• Do not excessively bend the cu and the tubings.

• Clean the device with a so, dry cloth. Do not use petrol or solvents.

• Never open the device !

8. MANTAINANCE AND CARE

1) Manometer:the manometer requires no maintenance. If necessary, address to an authorized techni-

cal service centre or to your own dealer.

2) Bulb: if you have to replace the bulb make sure that the connecting parts are completely dry and clean

so that they can rmly hold together. You will thus avoid any air leak.

3) Cu: before cleaning the cu, remove the inner tube and close the velcro (placing the metal ring

inside in case of D-ring models). e cu can be washed at 30°C with a programme and a detergent

for delicate clothes.

DO NOT IRON.

You can also clean the cu with a sponge or a so brush and a detergent for delicate clothes. Rinse with

water.

9. SERVICING AND GAUGING

Each Medel blood-pressure monitor is gauged before being commercialized.

No recalibration is required.

Never open the device !

ere are no user-serviceable parts. e device requires no lubrication or maintenance.

In case of misfunctioning, address to MEDEL CUSTOMER SERVICE.

10. TECHNICAL SPECIFICATIONS

Storage and transportation conditions : -20 to +70°C

Humidity: 15 to 85% relative humidity (non-condensing)

Operation temperature: 10 to 40°C

Measuring method: auscultating method

Measuring range: 0 to 300 mmHg

Accuracy: ± 3 mmHg

Accessories: check equipment and product characteristics described on the box.

Medical Device Im Class (with measuring function)

e device complies with:

EU Medical Devices Directive 93/42/EEC and following amendments

Standards EN ISO 81060-1:2012 Non-invasive sphygmomanometers -- Part 1: Requirements and test

methods for non-automated measurement type.

11. SYMBOLS WARRANTY CONDITIONS

12. WARRANTY CONDITIONS

• The device is covered by a 2- year warranty from date of purchase for any defects in the

design or in the material used.

• -The warranty consists in the replacement and/or repair free of charge of originally de

tective components.

• The warranty does not cover the accessories supplied with the equipment and those parts

subject to normal wear and tear.

• The equipment must be repaired by authorized technical service centres only.

• The equipment must be sent to the authorized technical service centre for repair within 8

days after the defect is noticed.

• The transport costs for the equipment are at user’s charge. Any repair out of the warranty

conditions are at user’s charge.

• The warranty does not cover failures resulting from misuse, abuse of the product or in

case the damage is not due to manufacturer’s liability (accidental fall, rough transpor-

tation, etc…)

• The warranty does not involve any compensation for any kind of damages to persons or

things, either direct or indirect, occurred when the equipment is not operating.

• The warranty is valid from the date of purchase certified by the ticket or the invoice which

have to be peremptorily attached to the warranty coupon.

• -The lack of warranty coupon properly filled in and validated by a certification of purcha

se voids the warranty.

!

MANUFACTURER

0197

The CE labelling certifies that the product complies with the essential requirements of

Directive 93/42/EEC on medical products.

LOT

Batch number

SN

Serial number

ECREP

Authorised Representative in the Euro-

pean Community

REF

Manufacturer’s catalogue device number

WARNING

Manufacturer:

Wenzhou Bokang Instruments Co., Ltd.

Haining Road, Haibin, Longwan, Wenzhou 325024

PEOPLE’S REPUBLIC OF CHINA

ECREP

EC- Representative:

Shanghai International Trading Corp. GmbH

Eiffestrasse 80, 20537 HamburgGermany

Distributed by:

Medel International Srl

Via Villapizzone 26 - 20156 Milano / Italy

0197

REV.02_SEPTEMBER 2019_CODE 100201

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