1. DESCRIPTION OF THE VITALOGRAPH BT12 ECG
The BT12 ECG measuring unit is an active medical product and in connection with a receiving unit serves as a mains-
independent, wireless ECG device which can be worn on the body for the following purposes:
Measurement of an ECG
Measurement of the heart rate with optical and acoustical signals when preset values are exceeded or fallen short
of
To supports a diagnosis from a physician
Documentation of ECGs
The ECG measuring unit can be used in the clinical area and in a doctor’s practice. The subject or relative – after being
instructed accordingly – can operate the device for patient monitoring at home. The ECG measuring unit is not suitable
for intracardial use.
Figure 1:
BT12 ECG Measuring Unit
The measured ECG is transferred via a Bluetooth interface to an external receiver unit such as a PC running monitor
software. Here, the data may be displayed specific to a subject, saved, commented, printed out and revised by expert
personnel.
The main components for the Vitalograph BT12 ECG are shown in Figure 2.
Warning: No modification of this equipment is allowed. Any unauthorised changes to the ECG device may
compromise product safety and/or data and as such Vitalograph cannot be held responsible and the device will
no longer be supported.
1.1 Indications for use
The BT12, hereafter referred to as the “BT Device”, is a battery powered device capable of acquiring and transmitting a
standard electrocardiogram (EKG) to be applied by medically trained persons for the purpose of cardiac monitoring and
diagnosis performed by medical professionals. The collected data is not interpreted by the BT device as this is done by
the monitoring device operated by medical professionals.
The collected data is processed by the BT device and then transmitted via a standard wireless link to a monitoring
device, such as a PC or hand-held device for display, review, printing, saving and post event processing by medical
professionals. Use of the BT device is not restricted to the adult population, but is also intended for infants weighing less
than 10Kg(22lbs).
Measurements taken by the BT device are only significant if considered in connection with other clinical findings. No
therapy or drugs can be administered based solely on ECG data derived from the BT device. The BT device is not
intended for monitoring critical patients and is not intended for intracardial use
Federal law restricts this device to sale by or on the order of a physician.
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