Microlife BPB1 Blood Pressure Monitor Standard 1 Piece

Microlife BPB1 Standard Blood Pressure Monitor

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

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

Results saved 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 over.

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

Intended user
The appliance 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 common household electrical appliances.
Intended patient

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

Intended use environment and circumstances
The device is intended for use in a home healthcare environment
(e.g. a general household without medically trained staff) 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.

Directions for use
Follow the instructions in the package insert carefully.

Contraindications
- The device is not intended for measuring blood pressure in pediatric patients under 12 years of age (children, infants, or neonates).
The device measures blood pressure using a pressure cuff. If the limb being measured is injured (e.g., open wounds) or is under conditions or treatments (e.g., intravenous infusion) that make it unsuitable for surface contact or pressure application, do not use the device to avoid worsening the injury or condition.
- Avoid measuring patients with conditions, illnesses and patients susceptible to environmental conditions that cause uncontrollable movements (e.g. tremors or shaking) 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 limb with normal blood flow to be measured. The device is not intended for use on a limb with limited or impaired blood circulation.

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

Ingredients
Blood pressure monitor

Warnings
NOTE: Warnings indicate potentially hazardous situations. If not avoided, they could result in 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 perform measurements on an arm with intravascular access or therapy, or an arteriovenous (AV) shunt. Cuffing and increased pressure can temporarily disrupt blood flow and lead to injury.
The presence of significant cardiac arrhythmias during measurement can disrupt blood pressure measurements and affect their reliability. Consult your doctor to determine whether the device is suitable for use in this situation.
- Do not use this device in a moving vehicle (e.g., in a car or airplane).
- Do not use this appliance for purposes other than those described in this manual. The manufacturer cannot
be held liable for damage caused by incorrect application.
- The measurement result from this device is not a medical diagnosis and is not intended to replace consultation and diagnosis by a qualified healthcare professional (e.g. physician, pharmacist or other licensed healthcare providers).
- DO NOT use this device for self-diagnosis or self-treatment of any medical condition. Ask for immediate medical advice.
Consult a healthcare professional if the patient feels clearly unwell and/or shows physiological or medical symptoms.
- Inspect the device, cuff, and other parts for damage. DO NOT USE the device, cuff, or parts.
NOT if they appear damaged or are functioning abnormally.
- The blood flow to the arm is temporarily interrupted during the measurement by applying pressure to the cuff.
Prolonged pressure on the cuff reduces blood circulation.
Look for signs (e.g., tissue discoloration) of compromised circulation during prolonged or multiple measurements.
It is recommended to rest between measurements. Stop the measurement, remove the cuff (or disconnect the cuff and the device), and rest to restore perfusion.
- Do not use this appliance in an oxygen rich environment or near flammable gas.
Do not use this device simultaneously with other medical electrical (ME) equipment. This may cause device malfunction or measurement inaccuracies.
- Use and store the device, cuff and parts under the conditions specified in the "Technical specifications".
temperature and humidity conditions.

Use and storage of the device, cuff and parts in conditions outside the range specified in the “Technical Specifications” may lead to malfunctions of the device and affect the safety of use.
Keep the appliance out of reach of children and people unable to operate it. Beware of the risk of accidental swallowing of small parts and strangulation from the cables and hoses of this appliance and its accessories.

DO NOT allow children to operate the appliance alone.

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

Storage advice
Keep dry
Temperature limitation for use or storage
Moisture restriction for use and storage
Limitation of atmospheric pressure
Read this instruction manual before using this appliance.
Dispose of in accordance with the Waste Electrical and Electronic Equipment Directive

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

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