8
Device Compliance
This device works with an app that can be downloaded from the iTunes App
store on your iPhone or iPad; it is free of charge. With this app, you will be
able to monitor how long you have worn your device every day and whether
or not you are being “compliant” with the study requirements. The App
provides detailed views of daily compliance information, will allow you
monitor treatments and also provides additional resource information.
Device Use and Care
• The RCStim device is for single patient use.
• The RCStim device is a technologically advanced electronic device and
should be handled with care. Dropping or other mishandling of the
RCStim device may damage the device and it may stop working.
• For safe usage, follow your physician’s instructions when using the
RCStim device. You are the intended operator of this device.
• Use of the device in any other manner could have harmful effects.
• Inspect the device prior to each use for wear, deterioration or damage.
• Do not use or charge the device if it does not appear to be in suitable
condition, displays an error or stops working. Contact the Clinical Studies
Helpline (1-866-657-7030) if any of these occur.
• WARNING: Do not modify this equipment as this could make it unsafe to
use. Do not attempt to open or disassemble the RCStim device as there
are no user serviceable parts inside.
• CAUTION: STRANGULATION HAZARD – Keep the device and power
supply cord out of the reach of children.
Care and Cleaning
When cleaning the RCStim device, follow these instructions:
• WARNING: Do not clean the device during treatment or charging.
• Clean the device by wiping surfaces with a damp, soft cloth (dampen
with water only).
• DO NOT sterilize the RCStim device.
• DO NOT expose the RCStim device to excessive moisture.
• DO NOT use solvents or alcohol-based liquids (anti-bacterial cleaners,
hand sanitizers, perfume, etc.) to clean the RCStim device.
