Rhythmedix LLC 10002 用户手册
Revison 0.8.6
Document No. 01424
Page 3
1. Descrip on
Caution: US Federal law restricts this device to sale by or on the order of a
physician.
The RhythmStar device is a portable, battery powered, wireless cardiac monitor
which may be worn by a patient to record ECG and activity level data for up to 30
consecutive
days. The device can capture patient activated and auto-triggered
cardiac events such as Bradycardia, Tachycardia, and Atrial Fibrillation as identified
by an embedded arrhythmia detection algorithm. The device is capable to
automatically deliver the data to the server. The data can be delivered to the server
wirelessly by using a built-in wireless data modem or via USB connection. A medical
professional, using the server, can adjust and program the device configuration and
auto-triggering parameters.
The RhythmStar device consists of a monitor, a patient ECG lead cable, an
externally rechargeable battery, and a wall battery charger. The RhythmStar device is
intended to be used with 3rd party lead electrodes supplied to a patient by a physician
or a monitoring enter. High quality FDA approved lead electrodes should be used.
The RhythmStar system supports USB connectivity that can be used to send and
receive data from/to RhythmStar and other devices. The server can deliver
configuration parameters to the device, such as monitoring duration, pre/post
activation recording duration, auto-trigger rate and duration limits, user interface
preferences, and requests for additional data stored in the device memory.
The device receives continuous ECG signal from lead electrode sensors attached to
the patient’s body, analyzes the data and stores it in the on-board flash memory.
Activity level data that represents the patient's activity related to the physical motion is
measured by a built-in accelerometer and also
stored in the device memory.