CardioSoft - Jaken Medical...

CE Marking Information
CE Marking Information
Compliance
The product CardioSoft bears the CE marking CE-0459, notified body
GMED, indicating its conformity with the provisions of the Council
Directive 93/42/EEC concerning medical devices and fulfills the essential
requirements of Annex I of this directive.
The acquisition module is assigned to class IIa according to Annex IX of
the Council Directive 93/42/EEC.
The CE marking covers only the accessories listed in the Order
Information chapter.
The acquisition module complies with the electromagnetic immunity
requirements of standard IEC 60601-1-2 "Electromagnetic Compatibility
- Medical Electrical Equipment".
The radio interference emitted by the acquisition module is within the
limits specified in EN 55011 - class B.
Magnetic and electrical fields are capable of interfering with the proper
performance of the device. For this reason make sure that all external
devices operated in the vicinity of the system comply with the relevant
EMC requirements. X-ray equipment, MRI devices, radio systems,
cellular telephones, etc. are possible sources of interference as they may
emit higher levels of electromagnetic radiation. Keep the PC away from
these devices and verify the performance of CardioSoft before use.
The safety and effectiveness of this device has been verified against
previously distributed devices. Although all standards applicable to
presently marketed devices may not be appropriate for prior devices (i.e.,
electromagnetic compatibility standards), this device will not impair the
safe and effective use of those previously distributed devices (see
Operator's Manual).
The country of manufacture appears on the device label.
Revision A CardioSoft CE-1
2023324-053