BPM080 - Blood pressure monitor Duronic - Free user manual and instructions
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| Technical Features | Automatic electronic blood pressure monitor, measurement of systolic and diastolic blood pressure, heart rate, digital display. |
|---|---|
| Usage | Designed for home use, easy to use with a single button, clear display of results. |
| Maintenance and Repair | Clean with a soft cloth, do not immerse in water, regularly check the battery. |
| Safety | Do not use on irritated skin, consult a doctor if abnormal results occur. |
| General Information | 2-year warranty, user manual included, suitable for adults. |
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USER MANUAL BPM080 Duronic
Blood Pressure Monitor - BPM080
PLEASE READ ALL THE INSTRUCTIONS BEFORE USE
DURONIC
Contents
English Manual 5
- General Description
- Safety Information
- LCD Display Signal
- Monitor Components
BEFORE YOU START
- Installing and Replacing the Batteries
- Measurement Principle
- Setting the Date, Time and Measurement Unit
MEASUREMENT
- Tie the Cuff
- Start the Measurement
DATA MANAGEMENT
- Recall the Records
-Delete the Records
INFORMATION FOR USER
- Tips for measurement
- Maintenance
ABOUT BLOOD PRESSURE
- What are systolic pressure and diastolic pressure?
- What is the standard blood pressure classification?
- Why does my blood pressure fluctuate throughout the day?
- Why do I get a different blood pressure at home compared to the hospital?
- Is the result the same when measuring on different arms?
TROUBLESHOOTING
SPECIFICATIONS
CONTACT INFORMATION
COMPILED EUROPEAN STANDARDS LIST
EMC GUIDANCE
General Description
Thank you for selecting the SHINEMART arm type blood pressure monitor. The monitor features blood pressure measurement, pulse rate measurement and the result storage. 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 instructions for using the product.
Read the manual thoroughly before using the product.
Features:
60 × 40.5 mm Digital LCD display
Maximum 60 records
3rd generation of Oscillometric measuring technology
Safety Information
The signs below might appear in the user manual, labeling or other components. They are the requirement of standard and use.
| THE OPERATION GUIDE MUST BE READ | Type BF Applied Parts | ||
| CE0123 | CE Mark: conforms to essential requirements of the Medical Device Directive 93/42/EEC. | DISPOSAL: Do not dispose this product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary. | |
| Manufacturer | - - - | Direct Current | |
| SN | Specifies Serial Number | EC REP | Authorized Representative in the European Community |
| Manufacture Date |

Caution
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 is used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, the results may contain deviations. Please consult your physician about the results.
If the cuff pressure exceeds 40kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when pressures exceed 40kPa (300 mmHg), detach the cuff from the arm and press the START/STOP button to stop inflation.
The equipment is not AP/APG equipment and is not suitable for use in the presence of a flammable anesthetic mixture with air of with oxygen or nitrous oxide.
The operator should not touch the batteries and the patient simultaneously.
To avoid measurement errors, please avoid the condition of strong electromagnetic field 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. Circuit diagrams, component parts list etc. are available from the manufacturer upon request. This unit is not suitable for continuous monitoring during medical emergencies or operations. This could cause the patients arm to become red and swollen as the blood supply is 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 sensitization or irritation reaction.
Please use ACCESSORIES and detachable parts specified/ authorised by MANUFACTURE. The use of unauthorised parts may cause damage to the unit or danger to the user/patients.
The device does not need to be calibrated within the 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. Don't 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.
LCD Display

| Symbol Description | Explanation | |
| SYS | Systolic blood pressure High | pressure result |
| DIA | Diastolic blood pressure | Low pressure result |
| Pul/min | Pulse | Pulse/minute |
| MEM28 | Defl ting | CUFF air is exhausting of deflating |
| Memory | If “M” shows, the displayed measurement values is from the memory | |
| kPa | kPa | Measurement Unit of the blood pressure |
| mmHg | mmHg | Measurement Unit of the blood pressure |
| 0+ | Low battery | Batteries are low and need to be replaced |
| Arrhythmia | Irregular heartbeat | |
| 4 | Grade | The grade of the blood pressure |
| am 88:88 | Current Time | Year/Month/Day, Hour/Minute |
Monitor Components

LCD Display

Battery Compartment
Air Connector Plug
Component list of pressure measuring system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
List
- Blood
Pressure Monitor
- Cuff (Type
BF applied part)
(22~42cm)
-
4×AAA Batteries
-
User manual



Installing and Replacing the Batteries
- Open the battery cover.
- Install the batteries by matching the correct polarity, as shown.(Always select the authorized / specified battery: Four AAA-size batteries).
- Replace the cover.
Replace the batteries whenever the below happens
The 10 + 1 shows
The display dims
The display does not light up


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 fire. Batteries may explode or leak.
Measurement Principle
This product uses the Oscillometric Measuring method to detect blood pressure.
Before every measurement, the unit establishes a "zero pressure" equivalent to the air pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and also pulse rate.
The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval then calculates standard deviation. The device will displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25% .

CAUTION
1: When using this device, please pay attention to the following situations which may interrupt blood flow and influence blood circulation of the patient, thus cause harmful injury to the patient: too frequent and consecutive multiple measurements; the application of the CUFF and its pressurization on an arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; Inflating the cuff on the upper arm on the side of a mastectomy.
- Do not apply the cuff over a wound, otherwise it can cause further injury.
- Do not inflate the cuff on the same limb while other monitoring ME EQUIPMENT is simultaneously applied. This could cause temporary loss of function of those simultaneously-used monitoring ME EQUIPMENT.
- Do not kink the connection tube, otherwise the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the PATIENT.
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. (The setting range of the year :2014—2054 time format:12 H)
-
When the monitor is off, press and hold "S" for 3 seconds to enter the year setting mode. Or when the monitor is off, press "S" button shortly, it will display the time. Then hold pressing "S" button to enter the mode for year setting.
-
Press the M to change the year

- When you get the right year, press "S" to set down and turn to next step.


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


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


- After the unit is set, the LCD will display "done" and display all the settings which have been inputted and then it will turn off.
Tie the Cuff
- Tie the cuff on your upper arm, then position the tube off-center toward the inner side of arm in line with the little finger.
- The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm.
- Sit comfortably with your tested arm resting on a flat surface.
- Patients with Hypertension: The middle of the cuff should be at the level of the right atrium of the heart; Before starting measurement, please sit comfortably with legs uncrossed, feet flat on the floor, back and arm supported.
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, position of upper arm, or as directed by a physician.


Start the Measurement
- When the monitor is off, press the "START/STOP" to turn on the monitor and it will finish the whole measurement.

LCD Display

Adjust To Zero
Inflating and measuring. Display and save the results.


- Press the "START/STOP" to turn off, otherwise it will turn off within 1 minute.
Recall the Records
- When the monitor is off, please press the "M" to show the average value of the latest three records.

- Press the 'M' or "S" to get the record you want.

The date and time of the record will be shown alternately.

CAUTION
The most recent record (1) is shown first. Each new measurement is assigned to the first (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.
Delete the Records
If you did not get the correct measurement, you can delete all results by following steps below.
- Press and hold "M" for 3 seconds when the monitor is in the memory recall mode, the flash display will show.
- Press "S" to confirm deleting and the monitor will turn off.
- If you do not want to delete the records, press "START/STOP" to escape.
- If there is no record, the right display will show.


Tips for Measurement
Measurements may be inaccurate if taken in the following circumstances.


Within 1 hour after eating or drinking Immediate measurement after tea, coffee or smoking

Within 20 minutes after taking a bath

When talking or moving your fingers


In a very cold environment When you need the toilet
Maintenance
In order to get the best performance, please follow the instructions below.

Put in a dry place and avoid the sunshine

Do not submerge in water

Use a wet cloth to remove dirt

Avoid intense shaking and collisions

Avoid dusty and unstable temperature environments

Do not attempt to clean the reusable cuff with water and never immerse the cuff in water.
What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure.


What is the standard blood pressure classification
The blood pressure classification published by World Health Organization (WHO) and International Society of Hypertension (ISH) in 1999 is as follows:

CAUTION
Only a physician can tell your normal BP range.Please contact a physician if your measuring result falls out of the range. Please note that only a physician can tell whether your blood pressure value has reached a dangerous point.

| Level Blood Pressure (mmHg) | Normal | Mild | Moderate | Severe | ||
| SYS | <120 | 120~129 | 130~139 | 140~159 | 160~179 | ≥180 |
| DIA | <80 | 80~84 | 85~89 | 90~99 | 100~109 | ≥110 |
Irregular Heartbeat Detector
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
The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heart-beat 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.
Why does my blood pressure fluctuate throughout the day?
- 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.
- If the person takes medicine, the pressure will vary more.
- Wait at least 3 minutes for another measurement.
Why do I get a different blood pressure at home compared to the hospital?
The blood pressure is different even throughout the day due to weather, emotion, exercise etc. Also, the anxiety that comes with being in a hospital, means blood pressure usually increases in clinical settings.
Is the result the same measuring on both arms?
It is ok to measure both arms, but there will be some different results for different people. We suggest you measure the same arm every time.
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.
Troubleshooting
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 | Symptom Check | This | Remedy |
| No power | Display is dim or will not light up. | Batteries are exhausted. | Replace with new batteries. |
| Batteries are inserted incorrectly. | Insert the batteries correctly. | ||
| Low batteries | Show on the display | Batteries are low. | Replace with new batteries |
| Error message | E1 shows | The cuff is not secure. | Refasten the cuff and then measure again. |
| E2 shows | The cuff is very tight | Refasten the cuff and then measure again. | |
| E3 shows | The pressure of the cuff is excess. | Relax for a moment and then measure again. | |
| E10 or E11 shows | The monitor detected motion while measuring. | Movement can affect the measurement.Relax for a moment and then measure again. | |
| E20 shows | The measurement process does not detect the pulse signal. | Loosen the clothing on the arm and then measure again. | |
| E21 shows | The treatment of the measurement failed. | Relax for a moment and then measure again. | |
| EExx,shows on the display. | A calibration error occurred. | 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. |
| Power supply | Battery powered mode: 6VDC 4*AAA batteries |
| Display moder | Digital LCD V.A.80*60mm |
| Measurement mode | Oscillographic testing mode |
| Measurement range | Rated cuff Pressure 0kpa~40kpa(0mmHg~300mmHg) Measurement pressure: 5.3kPa-30.7kPa (40mmHg-230mmHg) Pulse value: (40~199) beat/minute |
| Accuracy | Pressure: 5°C~40°C within±0.4kpa(3mmHg) pulse value:±5% |
| Normal working condition | Temperature:5°C~40°C Relative humidity ≤85% Atmospheric pressure: 86kPa to 106kPa |
| Storage & transportation condition | Temperature:-20°C to 60°C Relative humidity:10% to 93% Atmospheric pressure: 50kPa to 106kPa |
| Measurement perimeter of the upper arm | About 22cm~42cm |
| Weight | Approx.175 g (Excluding the dry cells) |
| External dimensions | Approx.110*110*41mm |
| Attachment | 4*AAA batteries, user manual |
| Mode of operation | Continuous operation |
| Degree of protection | Type BF applied part |
| Protection against ingress of water | IP21 |
| Software Version | V01 |
Contact Information
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
WARNING: No modification of this equipment is allowed.
Complied European Standards List
| Risk Management | ISO/EN 14971:2012 |
| Labeling | ISO/EN 15223-1:2012 |
| User Manual | EN 1041:2008 |
| Generl Requirements for Safety | EN 60601-1:2006IEC/EN 60601-1-11:2010 |
| Electromagnetic Compatibility | IEC/EN 60601-1-2:2007 |
| Performance requirements | EN 1060-1:1995+A2:2009EN 1060-3:1997+A2:2009 |
| Clinical investigation | EN 1060-4:2004 |
| Software Lifetime | IEC/EN 62304:2006+AC:2008 |
| Usability | IEC/EN 60601-1-6:2010IEC/EN 62366:2007 |
EMC Guidance
- 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
- 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 2W yields d = 3 , 3m at an IMMUNITY LEVEL of 3V / m )
C∈0123

EC
RE
Model: TMB-995; Ref.No.:BPM080
Distributed by:
SHINEMART LTD Unit 1, Spilsby Road, Harold Hill, Romford, Essex, RM3 8SB UK
Guangdong Transtek Medical Electronics Co., Ltd
Zone A, No.105, Dongli Road, Torch Development District,
Zhongshan, 528437, Guangdong, China

MDSS - Medical Device Safety Service GmbH
Schiffgraben 41, 30175 Hannover, Germany
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:
- The product must be returned to the retailer with original proof of purchase.
- The product must be installed and used in accordance with the instructions contained in this operating manual.
- It must be used only for domestic purposes.
- It does not cover wear and tear, malicious damage, misuse, neglect, inexpert repairs or consumable parts.
- Shine-Mart Ltd has no responsibilities for accidental or consequential loss or damage.
- Shine-Mart Ltd are not liable to carry out any type of servicing work, under the guarantee
- 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.
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SHINEMART LTD Unit 1 Spilsby Road, Harold Hill, Romford, Essex, RM3 8SB, UK
Produit par: Guangdong Transtek Medical Electronics Co., Ltd.
Entreprise:Guangdong Transtek Medical Electronics Co., Ltd.
Adresse: Zone A, No.105, Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
SHINEMART LTD Unit 1, Spilsby Road, Harold Hill, Romford, Essex, RM3 8SB UK
Guangdong Transtek Medical Electronics Co., Ltd
Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China
EC|REP
MDSS - Medical Device Safety Service GmbH
Schiffgraben 41, 30175 Hannover, Germany
Garantie
SHINEMART LTD Unit 1, Spilsby Road, Harold Hill, Romford, Essex, RM3
Hersteller: Guangdong Transtek Medical Electronics Co., Ltd.
Unternehmen: Guangdong Transtek Medical Electronics Co., Ltd.
Adresse: Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China
SHINEMART LTD Unit 1, Spilsby Road, Harold Hill, Romford, Essex, RM3 8SB UK
Guangdong Transtek Medical Electronics Co., Ltd
Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China

MDSS - Medical Device Safety Service GmbH
Schiffgraben 41, 30175 Hannover, Germany
Gewährleistung
Dirección: Zone A, No.105, Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Distribuido por:
SHINEMART LTD Unit 1, Spilsby Road, Harold Hill, Romford, Essex, RM3 8SB UK
Authorized European Representative:
Compañía: MDSS - Medical Device Safety Service GmbH
Dirección Schiffraben 41, 30175 Hannover, Germany
SHINEMART LTD Unit 1, Spilsby Road, Harold Hill, Romford, Essex, RM3 8SB UK
Guangdong Transtek Medical Electronics Co., Ltd
Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China
MDSS - Medical Device Safety Service GmbH
Schiffgraben 41, 30175 Hannover, Germany
Garantía
Indirizzo: Zone A, No.105, Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Guangdong Transtek Medical Electronics Co., Ltd.
Distribuito da :
SHINEMART LTD Unit 1, Spilsby Road, Harold
Hill, Romford, Essex, RM3 8SB UK
Società: MDSS - Medical Device Safety Service GmbH
Indirizzo: Schiffraben 41, 30175 Hannover, Germany
SHINEMART LTD Unit 1, Spilsby Road, Harold Hill, Romford, Essex, RM3 8SB UK
Guangdong Transtek Medical Electronics Co., Ltd
Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China

MDSS - Medical Device Safety Service GmbH
Schiffgraben 41, 30175 Hannover, Germany
Garanzia
Dystrybutor:
SHINEMART LTD Unit 1, Spilsby Road, Harold Hill, Romford, Essex, RM3 8SB UK
Producent: Guangdong Transtek Medical Electronics Co., Ltd.
Firma: Guangdong Transtek Medical Electronics Co., Ltd.
Adres: Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China
Autoryzowany Przedstawiciel w UE:
Firma: MDSS - Medical Device Safety Service GmbH
Adres: Schiffgraben 41, 30175 Hannover, Germany
ZGODNOSC ELEKTROMAGNETYCZNA (EMC)
SHINEMART LTD Unit 1, Spilsby Road, Harold Hill, Romford, Essex, RM3 8SB UK
ECRB
Guangdong Transtek Medical Electronics Co, Ltd
Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China
MDSS - Medical Device Safety Service GmbH Schiffgraben 41,30175 Hannover, Germany