User's Manual

1. WARNINGS AND PRECAUTIONS
― The programmer is not a life-saving device. In case of emergency, use an external
defibrillator.
― The programmer is Magnetic Resonance (MR) unsafe. Don’t bring the programmer into
MRI site Zone 3 or 4 as defined by the Guidance Document for Safe MR Practices
published by the American College of Radiology
1
.
― The equipment must be operated by qualified personnel only: physicians, nurses,
technical members of hospital staff, company representatives. All of them being trained
and having a comprehensive or partial knowledge of cardiac rhythm management,
in keeping with their assigned task: surgery, follow-up, servicing, etc. For additional
information please contact your company representative.
― To avoid damage or hazards, NEVER make any changes or modifications to the
equipment. For maintenance services and support, please contact your company
representative.
― To avoid the risk of electric shock, this equipment must only be connected to a mains
supply socket with protective earth. If earth protection is unsure, the tablet programmer
must be operated in battery mode.
― Make sure the means of disconnection/isolation from the mains supply are easily
accessible to the user.
― The programmer should not be used adjacent to or stacked with other equipment and if
adjacent or stacked use is necessary, check that the device is working normally in the
configuration in which it will be used.
― The use of accessories or cables other than those specified, with the exception of those
sold by the manufacturer as replacement parts, may result in increased emissions or
decreased immunity of the programming system.
― Be sure to eliminate any static charge from your body before touching the device when
you are in an environment with a risk of electrostatic discharge (carpeted floors, etc.).
In order to do so, touch a water line, gas line, etc. or, if none is available, a large metal
object (operating table, etc.).
― The operator shall not touch the patient and the metallic accessible connectors of the
programmer simultaneously.
― In high environmental temperatures, the inductive programming head may become hot
(up to 46 °C) and must not be directly applied to the patient's skin for longer than
10 minutes. For detailed information about the temperature constraints please refer to
chapter 13.6.
― Do not use the programmer should there be any sign of visible damage.
― Shocks or rough handling could damage the device's housing. Mishandling may affect
the programmer's operation. Even if the device appears to be operating well after the
impact, damage that is not immediately detectable may arise.
― When designing and manufacturing the device, every precaution is taken to minimize the
risks of infiltration. However, any liquid penetration shall alter its operation.
― Prolonged storage in a high-humidity location may alter the device's operation. For
detailed information about the storage humidity constraints please refer to section 13.7.
― The programmer must be stored in a secure and locked room when not in use.
1. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007
1. WARNINGS AND PRECAUTIONS
SmartTouch – UA10412A 5