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3 Components

ers2 – 1-Channel ECG Telemetry System 23

201000401000 / Rev 04

3.1.1 Unique Device Identification (UDI)

The Unique Device Identification (UDI) system is a globally harmonized system for the identifica-

tion of medical devices in machine-readable form.

The following UDI information for each component of the ECG system is saved in the form of a bar

code on the respective type plates. This bar code can be read with an appropriate reading device

(e.g., a cell phone). The code will then be displayed on the cell phone:

Code structure:

1-channel transmitter, receiver

xxxxxxxxxxxxxx 11 xxxxxx 21 xxxxxxxxxx

Adapter

xxxxxxxxxxxxxx 10 xxxxxxxxxxxxx

3.2 1-Channel Transmitter

Via the applied part, the 1-channel transmitter acquires a single-channel, bipolar raw ECG signal

and sends it to a medical application software or other ME equipment by radio transmission. The

1-channel transmitter is a type CF, defibrillation-proof applied part.

ID Name Description

01 UDI basic DI 14-digit primary identification of the device model (all components)

11 UDI PI 6-digit date of manufacture, YYMMDD format (1-channel transmitter,

receiver)

21 UDI PI 10-digit serial number (1-channel transmitter, receiver)

10 UDI PI 13-digit lot or batch number (adapter)

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