FIAB 4427 Easypace - Introduction; Classification, Standards and Regulations

Cardiac stimulator 4427 Easypace - Instructions for use
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1. INTRODUCTION
This manual forms an integral part of the product and must be stored for future
reference. It cannot be reproduced or photocopied, even partially, without prior
authorisation from FIAB. The use of the documentation material is reserved exclusively for
the Customer.
The present manual contains all the indications which should be observed in order to
guarantee correct use of the device. It is therefore recommended reading the entire
contents of this manual while observing the machine turned on and functioning, in the aim
of fully understanding its operation and gaining sufficient knowledge of its use in clinical
procedure.
1.1. Classification, standards and regulations
With regard to electrical safety the external 4427 Easypace pacemaker is classified
as an electromedical device with an internal power supply of the CF type seeing that it is
destined for application directly to the heart.
The heart stimulator 4427 Easypace is manufactured in compliance with the European
standards in force:
• EN 60601-1 “Medical electrical equipment - Part 1: General requirements for safety.”
File 4745 C (1998-12)
• EN 60601-2-31 "Medical electrical equipment - Part 2: Particular requirements for the
safety of external cardiac pacemakers with internal power source".
File 2689 E (1995-11)
• EN 60601-2-31/A1 "Medical electrical equipment - Part 2-31: Particular requirements
for safety of external cardiac pacemakers with internal power source".
File 5226 (1999-07)
• EN 60601-1-2 "Medical electrical equipment - Part 1: General requirements for safety
- Collateral standard: Electromagnetic compatibility - Requirements and tests".
File 6977 (2003-07)
• EN 14971 "Medical devices - Application of risk management to medical devices."
(2002-05).
• MDD 93/42/CEE.