Xiaomi wrist ECG and blood pressure recorder

Description

Medical device name: wrist ECG blood pressure recorder

Model/Specification: M2230W1

Structure and composition: The product consists of a host, a strap, an air bag, a charging base and a mobile phone APP software (release version V1).

Scope of application: The product is suitable for the collection of single-lead ECG data of adult wrists (excluding automatic analysis and diagnosis functions), as well as the oscillometric measurement of adult blood pressure and pulse rate. The values ​​are for clinical reference only.

Medical device registration certificate number or filing certificate number: Beijing Medical Device Registration Permit 20232070491

Registrant name: Xiaomi Communication Technology Co., Ltd.

Registrant address: No. 019, 9th Floor, Building 6, No. 33, Xierqi Middle Road, Haidian District, Beijing

Production license or filing certificate number: Guangdong Drug Administration Medical Device Production Permit 20235200

Business license or filing certificate number: Beijing Hai Food and Drug Administration Medical Device Business Permit 20170066

Product technical requirements number: Beijing Medical Device Registration Permit 20232070491

Contraindications:

The following persons should use the blood pressure measurement function of this product under the guidance of a doctor:

· People with poor blood circulation in the hands and feet due to diabetes, hyperlipidemia, hypertension, liver disease, kidney disease, arteriosclerosis, etc., and people with peripheral circulation disorders.
· Patients whose wrist blood pressure values ​​may differ greatly from those in the upper arm.
· Common arrhythmias (such as premature atrial contractions, premature ventricular contractions, and atrial fibrillation) may cause inaccurate or impossible blood pressure measurements.
· Patients with blood circulation disorders (such as varicose veins in the limbs) and blood diseases.
· People with a history of mastectomy or lymph node removal surgery.
The following people are prohibited from using this product for blood pressure measurement:

· Newborns, infants weighing less than 10kg, and people who cannot express their thoughts.
· People with limb shaking syndrome and those who cannot bend their arms voluntarily.
· People with wounds or inflammation in their arms or wrists.
· People whose arms or wrists are being infused, transfused, or have other catheters inserted.
· Patients who are using monitoring medical equipment. “