2
continuously monitored by medical personnel with the aid of a surface ECG
monitor.
Essential Performance
In order for the LATITUDE Programming System to meet its intended use, it
must communicate with Boston Scientific implantable PGs. Therefore those
functions that pertain to communications with the implanted PGs using
telemetry wands are considered essential performance.
LATITUDE Programming System performance determined to be essential by
Boston Scientific for electromagnetic compatibility testing, as per IEC 60601-1-
2, has the ability to:
•
Interrogate and program a supported PG using wanded telemetry
•
Initiate a PG STAT PACE, PSA STAT PACE, STAT SHOCK, or DIVERT
THERAPY command to a PG where supported
•
Display real-time intracardiac electrograms
•
Supports touchscreen tap and button press interactions
•
Deliver pacing and perform impedance lead measurements with the
Pacing System Analyzer (PSA) function
NOTE:
No recurring calibration of the LATITUDE Programming System or its
applications is required or needed.
Contraindications
The LATITUDE Programming System is contraindicated for use with any PG
other than a Boston Scientific PG. For contraindications for use related to the
PG, refer to the associated product literature for the PG being interrogated.
The PSA application is contraindicated for use with any programming system
other than the Boston Scientific Model 3300 LATITUDE Programming System.
The following uses of the PSA are contraindicated:
•
With AV conduction disorders; atrial single-chamber pacing
•
With competing intrinsic rhythms; asynchronous modes
•
With chronic atrial tachycardia as well as chronic atrial fibrillation or flutter;
modes with atrial control (DDD, VDD)
•
With poor tolerance of high ventricular rates (e.g., with angina pectoris);
tracking modes (i.e., atrial control modes) and propensity for atrial
tachycardia
•
Use as an external pacemaker
1
WARNINGS
•
Use of unspecified cables and accessories.
1.
During implantation, the PSA application is suitable for temporary external pacing while the
patient is being continuously monitored by medical personnel.
