INVENTUM BDP421 - Sphygmomanometer

BDP421 - Sphygmomanometer INVENTUM - Free user manual and instructions

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Product TypeUpper Arm Blood Pressure Monitor
ModelBDP421
BrandInventum
Measurement MethodOscillometric
Measurement Range (Blood Pressure)0 – 299 mmHg
Measurement Range (Pulse)40 – 199 beats/min
Accuracy (Blood Pressure)±3 mmHg
Accuracy (Pulse)±5% of reading
Cuff Size22 – 36 cm arm circumference
DisplayLCD digital display
Memory2 x 120 readings (2 users)
Irregular Heartbeat DetectionYes
WHO Classification IndicatorYes
Power Supply4 x AA batteries (1.5V) or AC adapter (optional, 6V DC)
Dimensions (approx.)120 x 80 x 40 mm
Weight (without batteries)250 g
Automatic Shut-OffAfter 1 minute inactivity
Cuff MaterialNylon fabric
CleaningWipe with a soft dry cloth. Do not use solvents or immerse in water.
Storage Conditions-20°C to 55°C, 15% – 90% relative humidity
Operating Conditions10°C to 40°C, 15% – 90% relative humidity
ClassificationBF type applied part
Spare PartsReplacement cuffs available (model BDP421-CUFF)

Frequently Asked Questions - BDP421 INVENTUM

How do I set the date and time on my Inventum BDP421?
Press the 'Set' button until the year flashes. Use the 'Up' or 'Down' buttons to adjust. Press 'Set' again to move to month, day, hour, and minute. Confirm each step.
What should I do if the monitor shows an error message?
Common errors: 'E1' (cuff not connected properly), 'E2' (movement during measurement), 'E3' (battery low). Check cuff connection, stay still, or replace batteries. If persists, contact customer support.
How often should I replace the batteries?
With normal use (2-3 measurements per day), batteries last about 2-3 months. The low battery symbol will appear when replacement is needed. Use 4 x AA alkaline batteries.
Can I use the monitor on someone with an irregular heartbeat?
Yes, the BDP421 features irregular heartbeat detection. It will notify you if an irregular rhythm is detected during measurement. This is not a diagnostic tool; consult a doctor.
How do I clean the cuff and the monitor?
Wipe the monitor with a soft dry cloth. The cuff can be spot cleaned with a mild detergent and damp cloth. Do not machine wash or dry. Do not immerse in water.
What does the WHO classification indicator mean?
The monitor categorizes your reading into WHO color zones: Green (optimal), Yellow (normal), Orange (high normal), Red (mild to severe hypertension). This is a reference, not a medical diagnosis.
How many measurements can be stored?
Up to 120 readings per user (2 users total 240 readings). Readings are automatically stored with date and time. You can recall them by pressing the 'Memory' button.
Why does my reading seem high?
Ensure you are relaxed, seated with feet flat, and the cuff at heart level. Avoid caffeine, smoking, or exercise 30 minutes before. Measure at the same time daily. If consistently high, consult a doctor.
Can I use an AC adapter instead of batteries?
Yes, an optional AC adapter (6V DC, 600mA) can be used. Plug it into the DC jack on the monitor. Ensure the adapter is certified medical grade to avoid interferences.
How do I replace the cuff?
The cuff is detachable. Unplug the air hose from the monitor. Attach a new cuff by inserting the connector firmly. Use only Inventum BDP421-CUFF replacement cuffs.

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USER MANUAL BDP421 INVENTUM

1 safety instructions page 26

2 appliance description page 29

3 things to know about blood pressure page 31

4 before first use page 32

5 measuring blood pressure page 36

6 evaluating results page 38

7 saved records page 39

8 delete all saved records page 40

9 tips for measurement page 41

10 cleaning & maintenance page 41

11 frequently asked questions page 42

12 troubleshooting

page 43

13 specifications page 44

14 complied European standards list

page 46

15 EMC guidance page 47

Guarantee & after sales Service page 51

index·3

Nederlands

line | Blood Pressure Level | Systolic blood pressure (mmHg) | | :--- | :--- | | Optimal Blood Pressure | 120 | | Normal Blood Pressure | 130 | | High-removal Blood Pressure | 140 | | Subgroup borderline | 150 | | Grade 1 hyperintensiveness/mild | 160 | | Grade 2 hyperintensiveness/moderate | 170 | | Grade 3 hyperintensiveness/severe | 180 |
Bloeddruk (mmHg)Hypotonie (verlaagde bloeddruk)Optimaal NormaalHoog normaalMildehypertensie (type I)Matige hypertensie (type II)Ernstige hypertensie (type III)
SYS ≤ 105 106-120120 120-129 130-139140-159160-179≥ 180
DIA ≤ 60 < 60-8080-84 85-89 90-99100-109≥ 110
natural_image Diagram of a device with battery and two batteries, no text or symbols present

10 • Nederlands

INVENTUM BDP421 - • Nederlands - 1

PAS OP:

natural_image Cartoon illustration of a person wearing a heart-shaped bandage and a wristband, with no text or symbols present.

14 • Nederlands

Start de meting

1 safety instructions

The signs below might be in the user manual, on the labelling or on the appliance. The description of the symbols can be found in the table below.

(KZ4A)Symbol for “THE OPERATION GUIDE MUST BE READ” Symbol[WSYC]“TYPE BF APPLIED PARTS”
CE 0123Symbol for “COMPLIES WITH THE MDD 93/42/EEC REQUIREMENTS”[SWSD]Symbol for “ENVIRONMENTAL PROTECTION - Electrical waste products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice.”
[SYW3]Symbol for “MANUFACTURER” Symbol for “Authorised Representative in the European Community”
INVENTUM BDP421 - safety instructions - 1Symbol for “DIRECT CURRENT”
INVENTUM BDP421 - safety instructions - 2Symbol for “MANUFACTURE DATE”
INVENTUM BDP421 - safety instructions - 3Caution: These notes must be observed to prevent any damage to the device.

26 · English

INVENTUM BDP421 - safety instructions - 4

CAUTION

• This device is intended for adult use only.

• This appliance is intended for indoor 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 wrist 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.

• This device is intended for indication of the blood pressure and heartbeat only. A test for clinical results can be done by a physician.

- If the cuff pressure exceeds 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when pressures exceed 40 kPa (300 mmHg), detach the cuff from the wrist and press the START/STOP button to stop inflation.

- To avoid measurement errors, carefully read this manual before using the product.

- The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anaesthetic mixture with air of oxygen or nitrous oxide.

- The operator shall not touch the output of batteries and the patient simultaneously.

- Do not use the monitor under the conditions of strong electromagnetic field (e.g. medical RF equipment) that radiates 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.

- Please use the ACCESSORIES and detachable parts specified/authorised by the MANUFACTURER. Otherwise, it may cause damage to the unit or danger to the user/patients.

- 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. Otherwise, the patient's wrist and fingers will become numb, swollen and even purple due to a lack of blood.

- 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.

English • 27

  • 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 allergic reaction or contact injury.
  • The device doesn't need to be calibrated during two years of reliable service.
  • Please dispose of the ACCESSORIES, detachable parts and the ME EQUIPMENT according to the local guidelines.
  • When the device was used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, the best result may occur with a deviation. Please consult your physician about the result.
  • This device is contraindicated for any female subject who may be suspected of being, or is, pregnant. Besides providing inaccurate readings, the effects of this device on the foetus are unknown.
  • Please keep the unit out of reach of infants, children or pets, since inhalation or swallowing of small parts is dangerous or even fatal.
  • Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.
  • When using this device, please pay attention to the following situation 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 pressurisation on any wrist where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the wrist 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 which other monitoring ME EQUIPMENT is applied around simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring ME EQUIPMENT.
    • Using it in this case can result in prolonged impairment of the circulation of the blood of the PATIENT.
  • Don't kink the connection tube; otherwise, the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the PATIENT.

2 appliance description

LCD display grade time mem button set button systolic diastolic pulse rate start/stop button cuff battery compartment

English · 29

The following symbols can be found on the display:

Symbol Description Explanation
SYSSystolic blood pressure High pressure result
DIADiastolic blood pressure Low pressure result
Pulse Pulse/minute: heartbeats/minute
Shocking reminding Shocking will result in inaccurate
+LoLow battery Batteries are low and need to be replaced
kPa Measurement unit of the blood pressure(1 kPa=7.5 mmHg)
mmHgmmHg Measurement unit the blood pressure(1 mmHg=0.133 kPa)
irregular heartbeat irregular heartbeat detection
Current time Month/Day/Year, Hour/Minute
Grade The grade of the blood pressure
Heartbeat Heartbeat detection during the measurement

88.0 IPIA 88.0 PM 88.0 DIA Pul. min.

30·English

3 things to know about blood pressure

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 classification?

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

INVENTUM BDP421 - What is the standard blood pressure classification? - 1

CAUTION:

Only a physician can tell your normal blood pressure 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.

Systolic blood discharging artery press Diastolic blood entering vein relax

INVENTUM BDP421 - CAUTION: - 2

line | Blood Pressure Category | Systolic blood pressure (mmHg) | | :--- | :--- | | Optimal Blood Pressure | 120 | | Normal Blood Pressure | 130 | | High-Normal Blood Pressure | 140 | | Subgroup Borderline | 150 | | Grade 1 hypertension(ml/dL) | 160 | | Grade 2 hypertension(moderate) | 170 | | Grade 3 hypertension(severe) | 180 |
Blood pressure (mmHg)Hypotonia (degraded bl. pr.)Optimal NormalHigh normal Mildhypertension (Grade I)Moderate hypertension (Grade II)Severe hypertension (Grade III)
SYS ≤ 105 106-120120 120-129 130-139140-159 160-179≥ 180
DIA ≤ 60 < 60-8080-84 85-89 90-99 100-109≥ 110

English • 31

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.

INVENTUM BDP421 - Irregular heartbeat detector - 1

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.

4 before first use

Before you use the appliance for the first time, please do as follows: carefully unpack

the appliance and remove all the packaging material. Keep the material (plastic bags and cardboard) out of reach of children. Check the appliance after unpacking for any damage which may have occurred during transport.

  • Slide off the battery cover.
    • Install the batteries by matching the correct polarity, as shown below.
    Always use the correct battery type (2 x AAA batteries).
  • Replace the cover.

Replace the batteries whenever the below happen:

The □+Lo shows

The display dims

The display does not light up

INVENTUM BDP421 - before first use - 1

natural_image Diagram of a device with battery and two cylindrical batteries, no text or symbols present

32·English

INVENTUM BDP421 - 32·English - 1

CAUTION:

  • Remove the batteries if the device is not likely to be used for some time.
    • The old batteries are harmful to the environment; do not dispose of them 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.

Date, time and unit settings

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: 2014–2054, time format: 24 H/12 H)

  1. When the monitor is off, hold down the "MEM" button for about 3 seconds to enter into setting mode. The blinking numeral represents [YEAR].

  2. Press the "MEM" button to change the [YEAR]. Each press will increase the numeral by one in a cyclical manner.

20 4 20 15

English • 33

  1. When you get the right year, press the "START/STOP" button to confirm your selection and it will turn to the next step.
  2. Repeat steps 2 and 3 to confirm [MONTH] and [DAY].
  3. Then, the monitor diverts to the time format setting.

INVENTUM BDP421 - Date, time and unit settings - 2

5 i 5 H

24 h 12 h

34 • English

  1. Repeat steps 2 and 3 to confirm [HOUR] and [MINUTE].

  2. Repeat steps 2 and 3 to confirm the [MEASUREMENT UNIT].

  3. After confirming the measurement unit, the LCD will display all the settings you have done once again and then turn off.

12:00 7:00 7:41 × ×

English · 35

5 measuring blood pressure

Tie the cuff

  1. Remove all accessories (watch, bracelet, etc.) from your wrist. If your physician has diagnosed you with poor circulation in your wrist, use the other one.
  2. Roll or push up your sleeve to expose the skin.
  3. Apply the cuff to your wrist with your palm facing up. The display of the blood pressure monitor should be facing towards your body.
  4. Position the edge of the cuff about 1-1.5 cm from the wrist, as indicated on the cuff.
  5. Fasten the wrist cuff around your wrist, leaving no extra room between the cuff and your skin. If the cuff is too loose, the measurement will not be accurate.
  6. Sit comfortably with your other wrist resting on a flat surface. It is important that during the measurement the appliance is at the heart-level. Keeping the appliance lower or higher than at the heart-level can affect the measurement.
  7. 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 wrist supported.
  8. Rest for 5 minutes before measuring.
  9. Wait at least 3 minutes between measurements. This allows your blood circulation to recover.
  10. The patient must relax as much as possible and do not talk during the measurement procedure.
  11. For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, on the same wrist or as directed by a physician.

INVENTUM BDP421 - Tie the cuff - 1

natural_image Cartoon illustration of a person wearing a heart-shaped bandage and holding an ECG device (no text or symbols)

36 · English

Start the measurement

  1. When the monitor is off, press the "START/STOP" button to turn on the monitor, and it will finish the whole measurement automatically.

Adjust to zeroLCD display Inflating and measuring Result on display

INVENTUM BDP421 - Start the measurement - 1

INVENTUM BDP421 - Start the measurement - 2

INVENTUM BDP421 - Start the measurement - 3

INVENTUM BDP421 - Start the measurement - 4

  1. Press the "START/STOP" button to power off; otherwise, it will turn off automatically within 1 minute.

English·37

6 evaluating results

Irregular heartbeat indication

This instrument can identify possible cardiac arrhythmia disorders (irregular heartbeat) during measurement and if necessary indicates the measurement with the icon ♥. This may be an indicator of arrhythmia. Arrhythmia is a condition where the heart rhythm is abnormal as a result of defects in the bioelectrical system controlling the heartbeat. The symptoms (omitted or premature heart beats, slow or excessively fast heart rate) may be caused, among other things, by heart disease, age, physical predisposition, excessive use of stimulants, stress or lack of sleep. Arrhythmia can only be ascertained through examination by your doctor. Repeat the measurement if the flashing icon is displayed after the measurement. Please note that you should rest for 3 minutes between measurements and not talk or move during the measurement. If the icon appears often, please contact your doctor. Any self-diagnosis and treatment based on the results may be dangerous. It is vital to follow your doctor's instructions.

WHO classification

According to the WHO Guidelines/Definitions and the latest findings, the test results can be classified and evaluated according to the following chart. Your physician will tell you your normal blood pressure range as well as the point at which you will be considered at risk.

Table for classification of blood pressure values (unit of measurement mmHg) for adults:

Blood pressure (mmHg)Hypotonia (degraded bl. pr.)Optimal Normal High normal Mildhypertension (Grade I)Moderate hypertension (Grade II)Severe hyper-tension (Grade III)
SYS≤ 105106-120 120-129 130-139 140-159 160-179≥ 180
DIA≤ 60< 60-80 80-84 85-89 90-99 100-109≥ 110
ActionCheck with doctor-- Check withdoctorCheck with doctorSeek medical advice

38 · English

7 saved records

After finishing a measurement the appliance will save the result automatically. The max. number of saved measurements is 60. If this is exceeded, it will automatically delete the oldest measurement so that the new measurement can be saved. To recall the saved records, follow the steps below.

  1. When the monitor is off, press the "MEM" button to show the average value of the latest three measurement records.

INVENTUM BDP421 - saved records - 1

  1. Press the "MEM" button again, and it will display the latest measurement result, date and time. Press the "MEM" button again, it will display the next record, and so on. During the process of displaying the results, if there is no operation, the blood pressure monitor will turn off in one minute. Or you can press the "START/STOP" button to turn it off.

INVENTUM BDP421 - saved records - 2

The record number, date and time will display alternately.

√5

It means the total records is 5, the current number is number 1.

5/4

The corresponding date is 14 May.

8:15

The corresponding time is 8:16 PM.

8 delete all saved records

You can delete all records by following the steps below.

  1. In the memory mode, hold down the "MEM" button for 3 seconds, and the flash display "dEL ALL" will show.

  2. Press "MEM" to confirm deletion, and the LCD displays "dEL dONE" and the monitor will turn off.

Note: To exit out of delete mode without deleting any records, press the START/STOP button before pressing "MEM" to confirm any delete commands.

  1. If there is no record anymore, the display will show the following:

Please note that with this function all of the records will be deleted. It is not possible to delete only one, or a few records.

INVENTUM BDP421 - delete all saved records - 1

INVENTUM BDP421 - delete all saved records - 2

INVENTUM BDP421 - delete all saved records - 3

40 · English

9 tips for measurement

Measurements may be inaccurate if taken in the following circumstances.

• Results can be inaccurate when measuring within 1 hour after dinner or drinking.
• Results can be inaccurate when measuring immediate after drinking tea or coffee or after smoking.
- Results can be inaccurate when measuring within 20 minutes after taking a bath.
• Results can be inaccurate when measuring when talking or moving your fingers.
• Results can be inaccurate when measuring in a very cold environment.
• Results can be inaccurate when measuring when you want to discharge urine.

10 cleaning & maintenance

  • Clean your blood pressure monitor carefully only with a slightly moistened cloth.
  • Do not use detergents or solvents.
  • Never immerse the appliance in water or any other liquid to protect against electrical hazards and damage.
  • When storing the device, make sure that no heavy objects are placed on top of it. Remove the batteries. The cuff should not have any sharp kinks.
    • Always store the blood pressure monitor in a dry place and avoid sunshine.
  • Avoid intense shaking and collisions.
  • Avoid dusty and unstable temperature environments.
  • The cuff is not washable and cannot be cleaned with any liquid.

English • 41

11 frequently asked questions

Why does my blood pressure fluctuate throughout the day?

  1. Individual blood pressure varies multiple times every day. 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.
  4. Blood pressure might fluctuate after eating and drinking.

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, there is the “white coat” effect, which means blood pressure usually increases in clinical settings.

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

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

42 • English

12 troubleshooting

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

Problem SymptomCheck this Remedy
No powerDisplay doesn’t show anything.Batteries are exhausted. Replace with new batteries.
Batteries are inserted incorrectly.Insert the batteries correctly according to the symbols.
Low batteries☐+Lo shown on the displayBatteries are low. Replace with new batteries
Error messageE1 shows The inflation is toolow. Refasten the cuff and then measure again.
E2 shows The cuff is not secure. Refasten the cuff and then measure again.
E3 showsCan’t inflate the air during the process of measurementRefasten the cuff and then measure again.
E4 shows The cuff is too tight. Refasten the cuff and then measure again.
E5 showsThe pressure of the cuff is excessive.Relax for a moment and then measure again.
Error messageE6 showsThe voltage of the batteries is too low during the inflationMeasure again. If E6 appears again, please replace with new batteries.
E10 or E11 showsThe monitor detected motion while measuring.Movement can affect the measurement. Relax for a moment and then measure again.
E20 showsThe measurement process does not detect the pulse signal.Loosen the clothing on the wrist and then measure again.
E21 shows Measure incorrectly. 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 for further assistance. Refer to the warranty for contact information and return instructions.

13 specifications

Power supply Battery powered mode: 2 xAAA batteries (3V DC)
Display mode Digital LCD V.A. 32 mm x 45 mm
Measurement mode Oscillographic testing mode
Measurement principleOscillometric bloodpressure and heartbeat measuring with automatically 0-setting foratmospheric pressure at every measurement.

44 • English

Measurement rangeRated cuff pressure: 0 mmHg~300 mmHg (0 kPa ~40 kPa)Measurement pressure: SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa)DIA: 40 mmHg~130 mmHg (5.3 kPa~17.3 kPa)Pulse value: (40-199) beat/minute
AccuracyPressure: 5°C-40°C within ±0.4 kPa(3 mmHg)Pulse value: ±5%
Normal working conditionTemperature: 5°C to 40°CRelative humidity: ≤85%RHAtmospheric pressure: 86 kPa to 106 kPa
Storage & transportation conditionTemperature: -20°C to 60°CRelative humidity: 10%RH to 93%RHAtmospheric pressure: 50 kPa to 106 kPa
Measurement perimeter of the wrist About 13.5 cm-21.5 cm
Net weight Approx. 104 g (excluding the dry cells)
External dimensions Approx. 85 mm x 67 mm x 23 mm (exclude the cuff)
Attachment 2 x AAA batteries, user manual and storage case
Mode of operation Continuous operation
Degree of protection Type BF applied part
Protection against ingress of water IP22
Software version V01
Device classification Internally Powered ME Equipment

English·45

14 complied European standards list

Risk management EN ISO 14971: 2012 Medical devices - Application of risk management to medical devices
Labelling EN ISO 15223-1: 2016 Symbols for use in the labelling of medical devices
User manual EN 1041: 2008 Information supplied by the manufacturer of medical devices
General requirements for safetyEN 60601-1: 2006+A1: 2013 Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceEN 60601-1-11: 2010 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Electromagnetic compatibilityEN 60601-1-2: 2007 Medical electrical equipment: Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirement and tests
Performance requirementsEN ISO 81060-1: 2012 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement typeEN 1060-3: 1997+A2: 2009 Non-invasive blood pressure Part 3: Supplementary requirements for electromechanical blood pressure measuring system
Clinical investigationEN 1060-4: 2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers
UsabilityEN 60601-1-6: 2010 Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance - Collateral standard: UsabilityEN 62366: 2008 Medical devices - Application of usability engineering to medical devices
Software life-cycle processes EN 62304:2006+AC: 2008 Medical device software - Software life cycle processes

15 EMC guidance

  1. This equipment needs to be installed and put into service in accordance with the information provided in the user manual;
  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 at a distance d=3.3 m 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=3.3 m at an immunity level of 3 V/m)

English • 47

general terms and conditions of service and warranty

We do not need to remind you of the importance of service. After all, we develop our products to a standard so that you can enjoy them for many years, without any concerns. If, nevertheless, there is a problem, we believe you are entitled to a solution straight away. Hence our products come with an exchange service, on top of the rights and claims you are entitled to by law. By exchanging a product or part, we save you time, effort and costs.

2-year full manufacturer's warranty

  1. Customers enjoy a 2-year full manufacturer's warranty on all Inventum products. Within this period, a faulty product or part will always be exchanged for a new model, free of charge. In order to claim under the 2-year full manufacturer's warranty, you can either return the product to the shop you bought it from or contact the Inventum costumer service department via the form at www.inventum.eu/service-aanvraag.
  2. The 2-year warranty period starts from the date the product is bought.
  3. In order to claim under the warranty, you must produce a copy of the original receipt.
  4. The warranty applies only to normal domestic use of Inventum products within the Netherlands.

Breakdowns or faults outside the warranty period

  1. Breakdowns or faults in small or large domestic appliances outside the warranty period, can be reported to the costumer services department via the form at www.inventum.eu/service-aanyraag or by calling the costumer services department.
  2. The costumer services department may ask you to send the product for inspection or repair. The costs of dispatch will be at your expense.
  3. The inspection to establish whether repair is possible involves a charge. You need to grant your permission for this, in advance.
  4. In the event of a large domestic appliance, Inventum, at your request, can send out a service engineer. In that case, you will be charged the call-out costs, as well as parts and labour.

English • 51

  1. In the event of an instruction to repair, the repair costs must be paid in advance. In the event of a repair by a service engineer, the costs of the repair must be settled with the engineer onsite, preferably by means of PIN payment.

Warranty exclusions

  1. The following is excluded from the aforesaid warranties:

• normal wear and tear;
- improper use or misuse;
• insufficient maintenance;
- failure to comply with the operating and maintenance instructions;
- unprofessional installation or repairs by third parties or the customer himself;
• non-original parts used by the customer;
- use for commercial or business purposes;
- removal of the serial number and/or rating label.

  1. In addition, the warranty does not apply to normal consumer goods, such as:

  2. dough hooks, baking tins, (carbon) filters, etc.;

  3. batteries, bulbs, carbon filters, fat filters etc.;
    • external connection cables;
  4. glass accessories and glass parts such as oven doors;
    • and similar items.

  5. Transport damage not caused by Inventum is also excluded. Therefore, inspect your new device before starting to use it. If you detect any damage, you must report this to the store where you purchased the product within 5 working days, or to the Inventum customer service department via the form at www.inventum.eu/service-aanvraag. If transport damage is not reported within this period, Inventum does not accept any liability in this respect.

  6. The following are excluded from warranty and/or replacement: faults, loss of and damage to the device as a result of an event that is normally insured under the home contents insurance.

52 · English

Important to know

  1. The replacement or repair of a faulty product, or a part thereof, does not lead to an extension of the original warranty period.
  2. If a complaint is unfounded, all costs arising from it will be at the customer's expense.
  3. Following expiry of the warranty period, all costs of repair or replacement, including administration costs, dispatch and call-out charges, will be charged to the customer.
  4. Inventum cannot be held liable for damage caused by external events, unless this liability arises from mandatory statutory provisions.
  5. These warranty and service provisions are governed by Dutch law. Disputes will be settled exclusively by the competent Dutch court.

INVENTUM BDP421 - Important to know - 1

Guangdong Transtek Medical Electronics Co., Ltd.

Zone A, No. 105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China.

English • 53

INVENTUM BDP421 - Important to know - 2

klein huishoudelijk

INVENTUM BDP421 - Important to know - 3

witgoed vrijstaand

INVENTUM BDP421 - Important to know - 4

witgoed inbouw

INVENTUM BDP421 - Important to know - 5

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C€0123

Model no. TMB-1581

ECREP

MDSS - Medical Device Safety Service GmbH

Schiffgraben 41,30175 Hannover, Germany

BDP421/03.0318

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Product information

Brand : INVENTUM

Model : BDP421

Category : Sphygmomanometer