Microlife BPB1 Blood Pressure Monitor Standard 1.00 pc(s)

Microlife BPB1 Blood Pressure Monitor Standard

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

30 memories and average display
30 memories for long-term tracking 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 grade according to the British and Irish Hypertension Society (BIHS) for the general population aged 12 and older.

Use
This device is intended for measuring brachial blood pressure(systole and diastole) and heart rate.Intended userThe device is intended for use by adults and adolescents with sufficient eyesight, motor functions, and education, who are able to understand the instructions for use and operate general electrical household appliances.Intended patientThe intended patients are normotensive and hypertensiveadults and adolescents (aged 12 or older) from the general population.Intended use environment and conditionsThe 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 caregiver.IndicationsThis 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.

Warnings
NOTE: Warning items indicate potentially hazardous situations. If not avoided, they could 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 dissection.
- Do not perform measurements on the arm with intravascular access or therapy or an arteriovenous (A-V) shunt. Cuff and pressure increase can temporarily disrupt blood flow and lead to injury.
- The presence of significant cardiac arrhythmias during measurement may interfere with blood pressure measurement and affect the reliability of blood pressure measurements. Consult your doctor 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 these instructions for use. The manufacturer cannot be
held liable for damage caused by improper application.
- 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 for self-treatment of a medical condition. Immediately seek
advice from a healthcare provider if the patient clearly feels unwell and/or exhibits physiological or medical symptoms.
- Inspect the device, cuff, and other components for damage. DO NOT use the device, cuff, or components
if they appear damaged or operate abnormally.
- Blood flow to the arm is temporarily interrupted during measurement by cuff pressurization.
Prolonged pressure on the cuff reduces circulation.
Pay attention to signs (e.g., tissue discoloration) of impaired circulation during prolonged or multiple measurements. It is
recommended to rest between measurements. Discontinue the measurement, loosen the cuff (or disconnect the cuff and 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 measurements.
- Use and store the device, cuff, and components under the temperature and humidity conditions specified in the «Technical Specifications».

Use and storage of the device, cuff, and components in conditions outside the range stated in the «Technical Specifications» may lead to device malfunction and compromise safety of use.
- Keep the device away from children and individuals who cannot operate the device. Beware of the risks of accidental swallowing of small parts and strangulation with the cables and tubes of this device and accessories.

DO NOT let children operate the device alone.

Storage advice
Keep dryTemperature limitation for use or storageHumidity limitation for use and storageAtmospheric pressure limitationRead these instructions for use before using this device.Disposal in accordance with the Waste Electrical and Electronic Equipment directive

Medical device. Read the leaflet before use.

Responsible for marketing
Retomed Health BV/Microlife