Seite 8
Application and Function
1 Application and Function
1.1 General
The PADSY-Holter Holter-ECG system consists of a TELESMART recorder with a
Memory card, a recorder bag, a colour-coded patient cable to allow connection of
individual ECG channels, and the PADSY-Holter evaluation software. The
TELESMART-H recorder is used for ambulance or stationary recording of 2 to 3
channel Holter-ECGs.
The TELESMART recorder is a device for the recording of 2-channel (TELESMART-H
and -P) ans 3-channel Holter-ECGs of ambulatory and stationary patients.
The TELESMART-H recorder is also equipped with a connection to automatically
recognize the pacemaker voltage in channel B.
The TELESMART-H patient cable connected to the recorder allows a surface ECG to be
taken using Holter-ECG electrodes and, after an analog to digital conversion, to be
stored in the TELESMART-H recorder on the memory card.
The TELESMART-H recorder is applied by doctors and medical professionals, who
either carry the TELESMART-H in its recorder bag during their everyday activities, or
leave it stationary to make single recordings up to 7 days in length.
Once a recording is made, the memory card is removed from the recorder and placed
in a card-reader. The card-reader transfers the saved ECG data to the PC to be
evaluated using the PADSY-Holter evaluation software.
The recorder as part of the Holter-ECG System PADSY-Holter conforms to all relevant
parts of standard EN 60601-2-47 and therefore fulfills all performance specifications
as required by this standard.
Further hints and information for the intended use and performance specifications
can be found within the instructions for use for PADSY-Holter and PADSY and within
the appendix.
1.1.1 Variants
TELESMART can be ordered with modified functional specifications. Functional
specificaions of indiviual recorder variants can be found in chapter “Technical
Specifications”.
!
TELESMART-P is not intended for use with pacemaker patients. For examination of
patients, who carry an implanted pacemaker device, please use a TELESMART-H
recorder.
TELESMART-H/P - Holter-ECG-Recording System - version D