Duronic BPM450 Instructions For Use Manual

Creative Consumer Electronics

Blood Pressure Monitor BPM450

PLEASE READ ALL THE INSTRUCTIONS BEFORE USE

English Manual

Manuel d’utilisation en français

Gebrauchsanleitung auf Deutsch

Manual de Instrucciones en Español

Manuale D’istruzioni In Italiano

101

Contents

English Manual

Contents

INTRODUCTION Safety Information LCD Display Signal Monitor Components

BEFORE YOU START The choice of power supply Installing and replacing the batteries Setting date, time and measurement unit

MEASUREMENT Tie the cuff Start a measurement

THE OPERATION OF RECALLING RECORDS Recall the records Delete the records

INFORMATION FOR USER Tips for operation Maintenance

ABOUT BLOOD PRESSURE What are systolic pressure and diastolic pressure?

What is the standard blood pressure classication? Why does my blood pressure uctuate throughout the day?

Why do I get a different blood pressure at home compared to the hospital? Is the result the same if measuring both arms?

TROUBLESHOOTING SPECIFICATIONS AUTHORIZED COMPONENT CONTACT INFORMATION COMPILED EUROPEAN STANDARDS LIST EMC GUIDANCE

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11 11 12

14 15

16 17

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20 20 21 21 21

22 23 24 25 24

Safety Information

Thank you for selecting SHINEMART arm type blood pressure monitor. The monitor features blood pressure measurement, pulse rate measurement and auto-save the result. The design provides you with two years of reliable service. Readings taken by the blood pressure monitor are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method. This manual contains important safety and care information, and provides step by step instruction for using the product. Read the manual thoroughly before using the product.

Features: 148mm×29mm Digital LCD display Touch sensor key Maximum 60 records per user

Measuring during ination technology

The below signs might be in the user manual, labeling or other component. They are the requirement of standard and using.

THE OPERATION GUIDE MUST BE READ

CE Mark: conforms to essential requirements of the Medical Device Directive 93/42/EEC.

Type BF Applied Parts

DISPOSAL: Do not dispose this product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary.

Authorized Representative in the European Community

Direct Current

Manufacturer

Manufacture Date

Species Serial Number

EC REP

This device is intended for adult use only. This device is intended for non-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement. Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.Do not begin or end medical treatment without asking a physician for treatment advice. If you are taking medication,consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your Physician. When the device was used to measure patients who have common arrhythmias such as atrial or

ventricular premature beats or atrial brillation, the results may deviate. Please consult your

physician about the result.

If the cuff pressure exceeds 40 kPa (300 mmHg), the unit will automatically deate. Should the cuff not deate when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the armand press the START/STOP button to stop ination. The equipment is not AP/APG equipment and not suitable for use in the presence of a ammable

anesthetic mixture with air of with oxygen or nitrous oxide. The operator should not touch the batteries /adapter and the patient simultaneously.

To avoid measurement errors, please avoid the condition of strong electromagnetic eld radiated

interference signal or electrical fast transient/burst signal. The user must check that the equipment functions safely and see that it is in proper working condition before being used. This device is contraindicated for any female who may be, or is pregnant. Besides providing inaccurate readings, the effects of this device on the fetus are unknown. Manufacturer will make available on request circuit diagrams, component parts list etc. This unit is not suitable for continuous monitoring during medical emergencies or operations. It

could cause the patient’s arm to become red and swollen due to the blood supply being cut off.

Please use the device under the environment which was provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced. During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensization or irritation reaction.

Please use ACCESSORIES and detachable partes specied/ authorised by MANUFACTURE.

Otherwise, it may cause damage to the unit or danger to the user/patients. The device does not need to be calibrated within two years of reliable service. Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines. If you have any problems with this device, such as setting up, maintaining or using, please contact the SERVICE PERSONNEL of SHINEMART. Do not open or repair the device by yourself. Please report to SHINEMART if any unexpected operation or events occur. Please use the soft cloth to clean the whole unit. Do not use any abrasive or volatile cleaners.

CAUTION

Average The average of blood pressure

Recalling The records will be shown

Arrhythmia Irregular heartbeat

Grade The grade of the blood pressure.

LCD display signal

SYS

DIA

Pul/min

8:59

mmHg

kPa

Symbol Description Explanation

Systolic blood pressure High pressure result

Low pressure result

Pulse/minute

CUFF air is exhausting

of deating

Measurement Unit of the

blood pressure

Measurement Unit of the blood

pressure (1kPa=7.5mmHg)

Batteries are low and

need to be replaced

Shocking will result in

inaccurate

Currently time

If “M” shows, the displayed measurement

values is from the memory.

Diastolic blood pressure

Pulse

Deating

Time (hour:minute)

Memory

mmHg

kPa

Low battery

Shocking remaining

Monitor Components

List

Air Hose

Cuff

DC Power Socket

Set/Up Button Start/Off Button

Mem/Down Button

LCD Display

Air Connector Plug

Battery Compartment

Component list of

pressure measuring system

1 Cuff

2 Air pipe

3 PCBA

4 Pump

5 Valve

1. Blood Pressure Monitor 2. Cuff (22-42cm) 3. 4*AAA Alkaline Batteries

4. User Manual

The Choice of Battery

The Installment And Replacement Of Battery

1.Battery powered mode: 6VDC 4*AAA batteries

2.AC adaptor powered mode:

(Can be supplied by AC adaptor model

UE08WCP-060100SPA only!)（Not Included)

Right picture is the socket for power adapter.

Caution In order to get the best results and protect your monitor, please use the right battery and special power adapter.

Caution Remove batteries if the device is not likely to be used for some time. The old batteries are harmful to the environment, do not dispose with other daily trash. Remove the old batteries from the device and follow your local recycling guidelines.

Do not dispose of batteries in re. Batteries may explode or leak.

1. Slide off the battery cover.

2. Install the batteries by matching the correct polarity, as shown.

3. Replace the cover.

Replace the batteries whenever the following happens:

The shows The display dims The display does not light up

Setting the date, time and measurement unit

It is important to set the clock before using your blood pressure monitor, so that a time stamp can be assigned to each record that is stored in the memory. (year :2000—2050,time:24 H)

1. When the unit is off, press and hold “SET” for 3 seconds to enter the mode for year setting.

2.Press the “MEM” to change the [YEAR].

3.When you get the right year, press “SET” to select and turn to next step automatically.

4. Repeat steps 2 and 3 to set the [MONTH] and [DAY].

5. Repeat steps 2 and 3 to set the [HOUR] and [MINUTE].

6. Repeat steps 2 and 3 to set the [UNIT].

7. After the unit is set,the right picture will show,then it turn off automatically.

Tie The Cuff

1. Tie the cuff on your upper arm, then position the tube off-center toward the inner side of arm in

line with the little nger.

2. The cuff should be snug but not too tight. You should be able to

insert one nger between the

cuff and your arm.

3. Sit comfortably with your left

arm resting on a at surface.

Rest for 5 minutes before measuring. Wait at least 3 minutes between measurements. This allows your blood circulation to recover. For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, on the same arm, or as directed by a physician.

Start The Measurement

1. Press the “START/STOP” to turn on

the monitor, and it will nish the whole

measurement automatically.

LCD display

Adjust to zero automatically.

Inating and

measuring automatically.

Display and save the results automatically.

2.Press the “START/STOP” to power off, otherwise it will turn off automatically within 1 minute.

Recalling the records

1. When the BPM is off, please press the “MEM” to show the average of the records. The sign of “AVG” will show in the right corner.

2. Press the “MEM” or “SET” to get the record you want.

Caution

The most recent record (1) is shown rst. Each new measurement is assigned to the rst (1) record. All other records

are pushed back one digit (e.g., 2 becomes 3, and so on), and the last record (60) is dropped from the list.

The order of the record,date, time will display alternately.

Deleting a measurement record from memory

1.Press and hold “MEM” for 3

seconds ,the ash

display will show.

2.Press “SET” to

conrm deleting and

the monitor will turn off automatically.

3.If you do not want to delete the records, press “START/STOP” to escape.

4. If there is no record. the right display will show.

If you did not get the correct measurement, you can delete all results by following steps below.

Tips For Measurement

Measurements may be inaccurate if taken in the following circumstances.

Wait at least 1 hour after dinner or drinking

Wait at least 20 minutes after taking a bath

In a very cold environment

When talking or moving

your ngers

When you need the toilet

Immediate measurement after tea, coffee, smoking

Maintenance

In order to get the best performance, please follow the below instructions.

Store in a dry place and avoid direct sunlight

Avoid intense shaking and collision

Use a wet cloth to remove the dirt

Avoid the dusty and unstable temperature environment

Avoid washing the cuff

Avoid touching water

What are systolic pressure and diastolic pressure?

When ventricles contract and pump blood out of the heart, blood pressure reaches its maximum value, the highest pressure in the cycle is known as systolic pressure. When the heart relaxes between heartbeats, the lowest blood pressure is diastolic pressure.

What is the standard blood pressure

classication?

Irregular Heartbeat Detector

Below illustrates the blood pressure

classication mode by World Health Organization

(WHO) and International Society of Hypertension (ISH) in 1999.

An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure. During each measurement, this equipment records the heartbeat intervals and works out the standard deviation. If the calculated value is larger than or equal to 15,the irregular heartbeat symbol appears on the symbol when the measurement results are displayed.

Caution: Only a physician can tell you your normal blood pressure range and the point at which you are at risk. Consult your physician to obtain these values. If the measurements taken with these products fall outside the range.

Caution: The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.

1. Individual blood pressure varies multiple times everyday. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same conditions.

2.If the person takes medicine, the pressure will vary more.

3.Wait at least 3 minutes for another measurement.

The blood pressure is different even throughout the day due to weather, emotion, exercise etc, Also, there is the “white coat” effect, which means blood pressure usually increases in clinical settings.

What you need to pay attention to when you measure your blood pressure at home: If the cuff is tied properly. If the cuff is too tight or too loose. If the cuff is tied on the upper arm. If you feel anxious. Taking 2-3 deep breaths before beginning will be better for measuring. Advice: Relax yourself for 4-5 minutes until you calm down.

It is ok for both arms, but there will be some different results for different people. We suggest you measure the same arm every time.

Why does my blood pressure vary

throughout the day?

Why do I get a different blood pressure at

home compared to the hospital?

Is the result the same if measuring on the right arm?

This section includes a list of error messages and frequently asked questions for problems you may encounter with your blood pressure monitor. If the products not operating as you think it should, check here before arranging for servicing.

Problem

No power

Low batteries

Error message

E1 shows

E2 shows

E3 shows

E10 or E11

shows

E20 shows

E21 shows

EExx,shows on

the display.

The cuff is not secure.

The cuff is very tight

The pressure of the cuff is excess.

The monitor detected motion while measuring.

The measurement process does not detect the pulse signal.

The treatment of the measurement failed.

A calibration error occurred.

Relax for a moment and then measure again.

Retake the measurement. If the problem persists, contact the retailer or our customer service department for further assistance. Refer to the warranty for contact information and return instructions.

Loosen the clothing on the arm and then measure again.

Relax for a moment and then measure again.

Movement can affect the measurement. Relax for a moment and then measure again.

Refasten the cuff and then measure again.

Show on the display

Display is dim or will not light up.

Batteries are exhausted.

Replace with new batteries.

Insert the batteries correctly.

Batteries are inserted incorrectly.

Batteries are low.

Replace with new batteries

Symptom Check This

Remedy

Power supply

Display moder

Measurement mode

Measurement range

Normal working condition

Storage & transportation condition

Accuracy

Measurement perimeter

of the upper arm

Weight

External dimensions

Attachment

Mode of operation

Degree of protection

Protection against

ingress of water

Pressure:

5℃~40℃within±0.4kPa(3mmHg) pulse value:±5%

Temperature:5℃~40℃ Relative humidity ≤85%

Atmospheric pressure: 86kPa to 106kPa

Temperature:-20℃ to 60℃ Relative humidity:10% to 93%

Atmospheric pressure: 50kPa to 106kPa

About 22cm~42cm

Approx.300g(Excluding the dry cells)

Approx.102*143*73mm

4*AA batteries,user manual

Continuous operation

Type BF applied part

IP21

Battery powered mode: 6VDC 4*AA batteries AC adapter powered mode: (Can be supplied by AC adaptor model UE08WCP-060100SPA only!) (Not Included)

Digital LCD V.A.80*60mm

Oscillographic testing mode

Rated cuff Pressure

0kPa~40kPa(0mmHg~300mmHg)

Measurement pressure: 5.3kPa-30.7kPa (40mmHg-230mmHg)

Pulse value: (40~199) beat/minute

Authorized Component

EMC Guidance

Contact Information

1.Please use the TRANSTEK authorized adapter. (Not Included)

Adapter

Input:100~240V 50~60Hz,400mA

Output: Type: UE08WCP-060100SPA

( Conforms to UL certicate )

1. MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS

2. Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d=3, 3m away from the equipment. (Note: As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d=3, 3m at an IMMUNITY LEVEL of 3V/m)

Distributed by

: SHINEMART LTD Unit 1, Spilsby Road, Harold Hill, Romford, Essex, RM3 8SB UK

Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd. Company: Guangdong Transtek Medical Electronics Co., Ltd. Address: Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China

Authorized European Representative: Company: MDSS - Medical Device Safety Service GmbH Address: Schiffgraben 41, 30175 Hannover, Germany

Complied European Standards List

Risk Management

Labeling

User Manual

Generl Requirements for Safety

Electromagnetic Compatibility

Performance requirements

Clinical investigation

Software Lifetime

Usability

IEC/EN 60601-1-6:2010 IEC/ EN 62366:2007

IEC/EN 62304:2006+AC:2008

ISO/EN 14971:2012

ISO/EN 15223-1:2012

EN 1041:2008

EN 60601-1:2006 IEC/EN 60601-1-11:2010

EN 1060-1:1995+A2:2009 EN 1060-3:1997+A2:2009

EN 1060-4:2004

IEC/EN 60601-1-2:2007

Warranty

1 Year Guarantee from Shine-Mart Ltd, Trademark owners of Duronic Products. NOTE: THESE STATEMENTS DO NOT AFFECT YOUR STATUTORY RIGHTS AS A CONSUMER

This product has been manufactured under the strictest or quality control procedures, and using the highest quality of materials, to ensure excellent performance and reliability. It will give very good and long lasting service, provided it is properly used and maintained. The product is guaranteed for 1 years from the date of original purchase. If any defect arises due to a faulty materials or poor workmanship, the faulty product must be returned to the original place of purchase. Refund or replacement is at the discretion of that company. Duronic Products are offered with a 1 year guarantee under the following conditions:

1. The product must be returned to the retailer with original proof of purchase.

2. The product must be installed and used in accordance with the instructions contained in this operating manual.

3. It must be used only for domestic purposes.

4. It does not cover wear and tear, malicious damage, misuse, neglect, inexpert repairs or consumable parts.

5. Shine-Mart Ltd has no responsibilities for accidental or consequential loss or damage.

6. Shine-Mart Ltd are not liable to carry out any type of servicing work, under the guarantee

7. Valid in the UK only

Imported by Shine-Mart Ltd, RM3 8SB

Information on waste Disposal for Consumers of

Electrical & Electronic Equipment.

This mark on a product and/or accompanying documents indicates that when it

is to be disposed of, it must be treated as Waste

Electrical & Electronic Equipment, (WEEE).

Any WEEE marked products must not be mixed with general household waste,

but kept separate for the treatment, recovery and recycling of the materials used.

For proper treatment, recovery and recycling; please take all WEEE marked

waste to your Local Authority Civic waste site,

where it will be accepted free of charge.

If customers dispose of Waste Electrical & Electronic Equipment correctly, they

will be helping to save valuable resources and preventing any potential negative

effects upon human health and the environment, of any hazardous materials that

the waste may contain.

Manuel d’utilisation en français

Catalogue

INTRODUCTION Information de sécurité

Afchage LCD

Eléments du tensiomètre

AVANT DE COMM

ENCER

Choix de l’alimentation

Installer et changer les piles Paramètres

MESURE

Serrer le brassard Commencez la mesure

MEMOIRE Parcourir les sauvegardes Supprimer les sauvegardes

INFORMATION POUR L’UTILISATEUR Astuce d’opération

Maintenance

A PROPOS DE LA PRESSION ARTERIELLE

Qu’est-ce que la pression systolique et diastolique ? Quelle est la classication des normes de pression artérielle ? Pourquoi est-ce que ma pression artérielle uctue au cours de la journée ? Pourquoi est-ce que la pression artérielle que j’obtiens à l’hôpital est différente

de celle mesurée a la maison ? Est-ce que la mesure est identique si la mesure est effectuée sur le bras droit ?

DEPANNAGE SPECIFICATIONS TECHNIQUES COMPOSANTS AUTORISES CONFORMES AUX NORMES COMPATIBILITE ELECTROMAGNETIQUE

31 33 34

35 35 36

38 39

40 41

42 43

44 44 45 45

46 47 48 48 49

+ 94 hidden pages

Duronic BPM450 Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual