Specifies labeling and performance requirements for a pacemaker emergency intervention system (EIS), which consists of a magnet and a bradycardial pacemaker. When a pacemaker conforming to this standard is perceived to be operating in a nonstandard way, or in a way that is not understood by the examiner, the magnet can be used to reprogram the pacemaker to a standard mode as specified by the standard. An EIS is intended to be used in emergency rooms, clinics, or other medical locations where a physician skilled in pacemakers is not immediately available. Follow-up to use of the EIS should always occur so that the pacemaker can be reprogrammed to an optimum setting by a physician skilled in the use of pacemakers.
Document identifier
AAMI PAC49:1993/(R)2000 [ Withdrawn ]
Title
Pacemaker Emergency Intervention System
AAMI Category
Other than Dialysis
Publication date
1993-09-01
International Relationship
Price |
75 vnd |