Microlife BPB1 Blood Pressure Monitor standard

Microlife BPB1 Blood Pressure Monitor Standard

A digital blood pressure monitor for home use is a medical device that uses the principles of oscillometric method based on cuffs and digital signal processing to calculate and measure blood pressure.
Gentle+
Optimal speed and pressure control
Prevents excessive inflation for the best comfort during a blood pressure measurement

30 memories and display of the average
30 memories for long-term monitoring of your blood pressure

Results stored with date and time
Displays the average of all stored measurements

Clinically validated
Highest accuracy with clinical A/A class according to the British and Irish Hypertension Society (BIHS) for the general population aged 12 years and older.

What is this product used for
This device is intended for measuring the brachial blood pressure
(systole and diastole) and the heart rate.

Intended user
The device is intended for use by adults and adolescents with sufficient vision, motor functions, and education, who are able to understand the instructions for use and operate general electrical household appliances.
Intended patient

The intended patients are normotensive and hypertensive
adults and adolescents (aged 12 years or older) from the general population.

Intended use environment and conditions
The device is intended for use in a home care environment
(e.g., a general household without medically trained personnel) by patients (e.g., for self-measurement) or by a healthcare provider.

Indications
This device measures blood pressure for indications of:
- Diagnosis of white coat hypertension and masked hypertension, and identification of the white coat effect and masked uncontrolled hypertension.
- Evaluation of blood pressure in response to treatment.
- Confirmation of the diagnosis of resistant hypertension.
- Detection of morning hypertension.

Instructions for use
Follow the instructions in the leaflet carefully.

Contraindications
- The device is not intended for measuring blood pressure in pediatric patients under 12 years of age (children, infants, or newborns).
- The device measures blood pressure using a pressure cuff. If the limbs being measured have injuries (e.g., open wounds) or under conditions or treatments (e.g., intravenous infusion) that make it unsuitable for contact with the surface or pressure application, do not use the device to prevent worsening of the injuries or conditions.
- Avoid measuring patients with conditions, diseases, and patients who are susceptible to environmental conditions that lead to uncontrollable movements (e.g., shaking or trembling) and patients who cannot communicate clearly (e.g., children and unconscious patients).
- The device uses an oscillometric method to determine blood pressure and requires a measured limb with normal blood flow. The device is not intended for use on a limb with restricted or disturbed blood circulation.

Consult your doctor if you have severe perfusion or blood disorders before using the device.

Ingredients
Blood pressure monitor

Warnings
NOTE: Warning items indicate potentially dangerous situations. If not avoided, they may lead to death or serious injury to the user or patient.

- Avoid measurements on the arm on the side of a mastectomy or lymph node removal.
- Do not take measurements on the arm with intravascular access or therapy or an arteriovenous (A-V) shunt. Cuff and pressure increase may temporarily disrupt blood flow and lead to injury.
- The presence of significant arrhythmias during the measurement may disrupt the blood pressure measurement and affect the reliability of the blood pressure readings. Consult your doctor to determine if the device is suitable for use in this case.
- Do not use this device in a moving vehicle (e.g., in a car or airplane).
- Do not use this device for purposes other than those described in this user manual. The manufacturer cannot
may be held liable for damage caused by improper use.
- The measurement result of this device is not a medical diagnosis and is not intended to replace consultation and diagnosis by a qualified professional healthcare provider (e.g., doctor, pharmacist, or other authorized healthcare providers).
- DO NOT use this device for self-diagnosis or self-treatment of a medical condition. Seek immediate
advice from a healthcare provider if the patient clearly feels unwell and/or shows physiological or medical symptoms.
- Inspect the device, the cuff, and other components for damage. DO NOT USE the device, the cuff, or components
DO NOT use if they appear damaged or are functioning abnormally.
- The blood flow from the arm is temporarily interrupted during the measurement by applying pressure to the cuff.
Prolonged pressure on the cuff reduces blood circulation.
Watch for signs (e.g., tissue discoloration) of impaired circulation during prolonged or multiple measurements. The
it is recommended to rest between measurements. Interrupt the measurement, loosen the cuff (or disconnect the cuff and the device), and rest to restore perfusion.
- Do not use this device in an oxygen-rich environment or near flammable gas.
- Do not use this device simultaneously with other medical electrical (ME) equipment. This may cause malfunctions in the device or inaccuracies in the measurements.
- Use and store the device, the cuff, and the components as specified in the «Technical specifications»
temperature and humidity conditions.

Using and storing the device, cuff, and parts in conditions outside the range specified in the 'Technical specifications' may lead to defects in the device and safety of use.
- Keep the device out of reach of children and persons who cannot operate the device. Be cautious of the risks of accidentally swallowing small parts and strangulation with the cables and hoses of this device and accessories.

Do not allow children to operate the device unsupervised.

Side effects
In rare cases, slight bruising may occur on the arm due to pressure after the measurement.

Storage advice
Keep dry
Temperature limitation for use or storage
Humidity limitation for use and storage
Limitation of atmospheric pressure
Read this instruction manual before using this device.
Dispose of in accordance with the directive on waste electrical and electronic equipment

Additional information
Medical device. Read the instructions for use before use.

Manufacturer / Distributor
Microlife Benelux, Retomed BV , Kruisboog 39, 3905 TE Veenendaal