General Information
The PADSY-Holter Holter-ECG Recording system bears the CE mark:
According to directive 93/42/EEC of the Council with respect to medical products,
and complies with the fundamental requirements of Appendix I of this Directive.
The CE mark includes only those parts listed in the section "Accessories" and in the
CE Declaration of Conformity.
!
Safety notes
, non-compliance with which represents a danger to operators,
patients or the equipment, are visually emphasized by the adjacent graphic
symbol.
Follow instructions for use!
Caution, consult accompanying documentation. Safety precautions need to be
observed that are not stated on the product label!
Follow instructions for use!
Application part of type BF.
Name and address of the product manufacturer
Date of product manufacture, with four numbers to designate the year and,
possibly, two numbers to designate the month.
Denotes the range of humidity, which the medical device can be safely exposed to.
Denotes the range of athmospheric pressure, which the medical device can be
safely exposed to.
TELESMART-H/P - Holter-ECG-Recording System - version D