User Manual

9. PHYSICIAN GUIDELINES
PHYSICIAN TRAINING
Physicians should be familiar with sterile pulse generator. They must apply these procedures
according to professional medical training and experience.
Physicians should be familiar with follow-up evaluation and management of patients with a
pacemaker (or referral to such a physician).
This training guideline for implantation and follow-up of pacemakers comes from the Heart
Rhythm Society to provide standards for hospital credentialing bodies to help ensure
appropriate patient care and lead to improved patient outcomes. The following is a summary
of requirements for an alternate training pathway for pacemaker implantations
(1)
:
― Documentation of current experience: 35 pacemaker implantations per year and 100
implantations over the prior 3 years
― Completion of didactic course and/or IBRHE exam
― Monitoring of patient outcomes and complication rates
― Established patient follow-up
(1)
Please consult full text of both publications for details. 2004 Heart Rhythm Society Clinical
Competency Statement and the 2005 Addendum on Training Pathways for Implantation of
Cardioverter Defibrillators and Cardiac Resynchronization Devices. Heart Rhythm (2004) 3.
DIRECTIONS FOR USE
Pacemaker operating characteristics should be verified at the time of implantation and
recorded in the patient file. Complete the Patient Registration Form and return it to MicroPort,
as it provides necessary information for warranty purposes and patient tracking.
Additional programming instructions can be found by accessing Programming Guide on
the MicroPort dedicated website www.microportmanuals.com. Paper copies of Programming
Guide can be obtained by contacting your MicroPort representative.
MAINTAINING DEVICE QUALITY
This device is FOR SINGLE USE ONLY. Do not resterilize and reimplant explanted
pacemakers.
Do not implant the device when:
― It has been dropped on a hard surface because this could have damaged pulse
generator components.
― Its storage package has been pierced or altered, because this could have rendered it
non-sterile.
― It has been stored or transported outside the environmental temperature limits: 32 °F (0
°C) to 122 °F (50 °C)
― "Use by" date has expired, because this can adversely affect pulse generator longevity
or sterility.
9.1.
9.2.
9.3.
9. PHYSICIAN GUIDELINES
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