1) Warnings
- Do not frequently measure blood pressure unless medically necessary. Excessive frequent measurements may injure the patient due to blood flow interference, potentially leading to poor circulation or bruising.
- If symptoms such as skin irritation occur during use, discontinue use and consult a physician; otherwise, symptoms may worsen.
- If the Blood Pressure Monitor malfunctions or feels abnormal, discontinue use and arrange for inspection and repair.
- Do not use simultaneously with other medical electrical equipment on the same limb. Cuff inflation may temporarily impair the function of monitoring ME equipment used concurrently on the same limb.
- Do not apply the cuff to an arm with wounds or inflammation; otherwise, symptoms may worsen.
- Do not use this product on an arm where other catheters are inserted, or on any limb undergoing intravascular intervention or treatment, or an arteriovenous (A-V) shunt, as this may temporarily interfere with blood flow and potentially injure the patient.
- Do not use this device on the arm on the side of a mastectomy or lymph node dissection.
- Do not use simultaneously with other medical electrical equipment, as there is a risk of this product malfunctioning.
- Ensure (e.g., by observing the relevant limb) that this product does not cause persistent damage to the patient's blood circulation. Patients with circulatory disorders or blood diseases shall use this product under medical supervision.
- When measuring blood pressure, please note whether there is continuous cuff pressure caused by internal tubing kinking; if so, please stop the measurement.
- Do not use in locations prone to fire or explosion, such as environments with flammable gases or high concentrations of oxygen.
- Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Blood Pressure Monitor, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
- Any serious incident related to this device shall be reported to the manufacturer and the competent authority of the EU Member State where the user/patient is located.
2) Caution
- Please follow your doctor's instructions, do not self-diagnose or treat based on measurement results
- When AFib, irregular heartbeat, or tachycardia prompts appear, it shall be confirmed after examination and diagnosis by a physician.
- Measurements may be inaccurate in cases of common arrhythmias (e.g., atrial or ventricular premature beats and atrial fibrillation), arteriosclerosis, poor perfusion, diabetes, old age, pregnancy, pre-eclampsia, kidney disease, patient movement, tremors, or shivering.
- Not suitable for neonates. The effectiveness of blood pressure measurement in pregnant women, including those with pre-eclampsia, has not been determined. Intended operators include patients.
- Do not place within reach of neonates or children. There is a risk of neonates or children becoming entangled in the cuff air tube or AC adapter, and component parts may cause choking if swallowed.
- During measurement, do not use electromagnetic interference-generating devices (e.g., mobile phones) near the device.
- During measurement, keep the Blood Pressure Monitor and its vicinity free from significant vibration.
- Do not use components not provided by the manufacturer; otherwise, measurement errors may occur.
- Do not disassemble or modify the main unit or cuff of the Blood Pressure Monitor yourself.
- Do not use beyond the product's service life.
- Used batteries, instruments, and components must not be disposed of as general household waste; they shall be handled in accordance with local regulations.
- Any blood pressure measurement is affected by the measuring site, posture, movement, and physiological condition of the measured individual. If you have doubts about the measurement results, rest for 5 minutes and remeasure, or consult a physician.
- If an abnormality occurs during measurement (e.g., the cuff remains excessively inflated), please remove the cuff; otherwise, the arm may be compressed, leading to bruising or paralysis.
- All functions of this product can be safely used by patients and can be simply maintained according to the cleaning and maintenance methods.
- If there are contaminants such as dust or lint on the device surface, clean it according to the cleaning and disinfection methods.
- Do not use this product in the following environments: near high-frequency surgical equipment, magnetic resonance imaging (MRI) devices, or CT scanners; or in high-oxygen environments.
- Do not use this product in moving vehicles such as cars or airplanes.
- Do not place the device in a location where unplugging it is difficult.
- Do not use the device in environments containing flammable anesthetic gases mixed with air, oxygen, or nitrous oxide.
- Do not use this product near televisions, microwave ovens, mobile phones, X-ray equipment, or other sources of strong electromagnetic fields, as these may interfere with measurements.
- This Blood Pressure Monitor and cuff are not waterproof, so avoid rain, sweat, and water. Do not use in damp or splash-prone areas.
- This Blood Pressure Monitor is a precision instrument; avoid excessive use in unsuitable environments such as high temperatures, low temperatures, humidity, direct sunlight, vibration, or dust.
- When the ambient temperature is 20°C, the Electronic Blood Pressure Monitor requires a 4-hour stabilization period after being moved from the minimum or maximum storage temperature before it is ready for measurement.
- Operating environment: Temperature: 5°C - 40°C, relative humidity: 15% - 90%, non-condensing, atmospheric pressure: 700hPa - 1060hPa.
- Transport and storage environment: Temperature: -20°C - 55°C, relative humidity: <93%, non-condensing, atmospheric pressure: 500hPa - 1060hPa.
- If stored or used outside the manufacturer's specified temperature, relative humidity, and atmospheric pressure ranges, the system may not achieve the claimed performance specifications.
- This device can be connected to an AC adapter via a Type-C interface for measurement. Please use an AC adapter that complies with the requirements of IEC 60601-1 standard.
- Non-transit-operable.
- Cuff is the applied part.
- This Blood Pressure Monitor has undergone clinical investigation in accordance with the requirements of ISO 81060-2:2018+AMD 1:2020.
- Communication with a smart device is paired and encrypted according to Bluetooth Low Energy specifications. Pairing requires user interaction.
3) Precautions
Battery
- Do not disassemble or replace the lithium battery, otherwise, it may cause battery heating, leakage, rupture, etc., damaging the blood pressure monitor's main unit.
- If the lithium battery's performance significantly degrades or it is damaged, please contact after-sales service personnel.
- Do not place the device near a fire source.
- Do not subject the lithium battery to pressure from hard objects.
- If the device is not used for an extended period (more than 6 months), please charge the battery, otherwise, it may cause over-discharge of the battery, damaging the device.
- Dispose of used batteries according to local environmental protection regulations.
- During use, if the product has no charging icon prompt when powered via USB cable, please contact the supplier promptly.
- Please use the original factory's legitimate AC adapter, disconnect the AC adapter from the power supply after the device is fully charged.
- When unplugging the AC adapter, hold the plug itself, and do not pull the AC adapter.
- When using the AC adapter, be careful to avoid damage. Do not modify, forcefully bend, stretch, bundle, or pinch it, and do not place heavy objects on it.
- Do not use damaged AC adapters or power plugs. Do not plug or unplug the AC adapter with wet hands.
- When not in use for an extended period, please unplug the AC adapter.
Cuff Wearing
- The cuff of this product contains sound wave sensors to collect Korotkoff Sound signals. To ensure that the product can obtain better Korotkoff Sound signals, it is advisable to leave a gap of one finger's width between the lower edge of the cuff and the skin after attachment. Excessive looseness or tightness may affect the accuracy of the measurement
- The cuff is a consumable component. Based on an estimated usage frequency of 6 times per day, it is recommended to replace the cuff every two years.
- If the cuff is damaged, develops air leaks, or exhibits other malfunctions, contact the after-sales service to purchase a replacement.
- The cuff is designed to measure arm circumferences ranging from 22 to 42 cm (8.66 - 16.54 inch) (measured at the midpoint of the upper arm). If the arm circumference falls outside this applicable range, measurement accuracy cannot be guaranteed.
Measuring Posture and Process
- Do not take measurements immediately after eating, drinking alcohol, smoking, exercising, or showering; wait at least 30 minutes before starting the measurement;
- Please empty your bladder before taking the measurement;
- Please measure the blood pressure indoors at an appropriate temperature;
- Before the first measurement, sit quietly for 5 minutes and try to relax as much as possible;
- Do not move or speak during the measurement; keep your body relaxed and your sitting posture natural.
- For consecutive measurements, allow an interval of at least 2 minutes;
- During normal use, the operator may be the patient themselves or another individual.
- If the operator is the patient, they must follow the above posture requirements;
- No special requirements apply to other operators;
- Ensure that the cuff connection tube is not compressed or restricted; Rated range of cuff pressure: 0 - 299 mmHg (0 - 39.9 kPa)
EMC related
- Portable and mobile RF communication equipment may affect the use of the Electronic Blood Pressure Monitor.
- During normal use of the Monitor, it is recommended to keep it away from portable and mobile RF communication equipment or ensure they are turned off.
- Warning: Using accessories from other manufacturers, other than those provided by our company, may lead to increased emissions from the Electronic Blood Pressure Monitor or reduced immunity to interference.
- The Electronic Blood Pressure Monitor shall not be used in close proximity to or stacked with other equipment that operates at the same or similar frequencies. If proximity or stacking is necessary, observation and verification shall ensure that it operates normally in the configured setup.
- When the Korotkoff Sound Blood Pressure Monitor is in normal use, it may generate electromagnetic interference to other diagnostic or therapeutic equipment. When in use, please maintain an appropriate distance from other equipment and carefully observe the correctness of data during the use of that equipment.
- To ensure the normal use of Korotkoff Sound Blood Pressure Monitor functions normally and that its emissions are not increased, and its immunity is not decreased, please use the cuff and related accessories provided by our company.
Cleaning and Maintenance
- When a user is using, the device cannot be maintained or serviced;
- Do not use high-pressure sterilization equipment or gas sterilization equipment; otherwise, the device may be damaged;
- Do not expose the device and accessories to high temperatures, high humidity, excessive dust, or direct sunlight;
- This device is not waterproof. Do not let liquid penetrate the main unit or cuff;
- Do not wipe with volatile oils, thinners, gasoline, etc.;
- Do not disassemble or repair this unit without authorization;
- Do not replace internal parts without authorization;
- If the device is not used for an extended period (more than 6 months), please charge the battery, otherwise it may cause over-discharge of the battery, damaging the device.
Calibration
- It is generally recommended to having the unit inspected once a year by the manufacturer, or manufacturer-authorized repair centers