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Use Instructions

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PROGRAMMER
Programmer Warnings
• Do not locate any programmer system
components inside the sterile operating
field.
Programmer Precautions
• The components of the Programmer
System should not be sterilized.
• The following are requirements to comply with IEC 60601-1 and IEC 60601-1-1:
o The computer/tablet and power supply should be located
outside the patient environment when the computer is
operated on mains power.
o The system should not be connected to other non-isolated
monitoring equipment or communication networks.
o The operator should not touch the computer/tablet and the
patient simultaneously when the computer/tablet is operated
on mains power.
o The USB cable should be fully inserted into the Programmer Interface USB
receptacle to avoid patient contact with the metal part of the USB
connector.
Note: The patient environment is defined as the area within 1.5m
(approximately 5ft) of the patient.
• Plug the Programmer System directly into an outlet or operate using battery
power. Do not plug the programmer system into a power strip or extension
cord.
• Do not modify the Programmer System (i.e. connect additional equipment via
USB) or install additional software. Doing so may result in reduced
performance, increased emissions, decreased immunity or equivalent
malfunction. Use of a USB Memory Device is acceptable.
• Do not immerse product in water or a safety hazard could arise during use. If
the Programmer System requires cleaning, clean the system components with a
soft cloth dampened with water. Do not allow pooling or ingress of liquid into
the Programmer Interface enclosure.
• Keep the Programmer System in a controlled location to prevent loss or theft.
Intentional misuse of the Programmer System could result in an IPG being
programmed to settings that are not as prescribed.
IMPLANT ADAPTER, IMPLANT TOOL
Warnings
• FOR SINGLE USE ONLY. Do not re-sterilize or reuse. Reuse of this product may
result in malfunction or adverse events such as infection or death.
• Do not use product if “Use Before” date has been reached.