General Warnings, Training and Safety Notices – Read This First
NanoScope Manual
DFU-0298-1, Revision 0
Page 3 of 38
18.
The NanoScope Console contains a rechargeable lithium ion battery. A damaged
battery is a risk of excessive heat and potential for spontaneous combustion. If
the battery is damaged, disconnect NanoScope Console from the power source.
Do not touch the Console. If the Console sparks or is on fire, extinguish the fire
with Class C electrical fire suppression.
19.
Surface temperatures of the Handpiece or Console may rise during use.
20.
Do not re-sterilize the NanoScope Handpiece or kit components. A device labeled
as a single-use device must never be reused. Reuse may pose health and/or
safety risks that can include, but are not limited to cross-infection, breakage,
compromised mechanical or video image/optical performance due to wear, lack
of or no function, no guarantee of proper cleaning or sterilization of the device.
21.
Failure to use this device in accordance with the directions for use below may
result in device failure, render the device unsuitable for its intended use, or
compromise the procedure.
22.
The Console is not an applied part and is not intended to contact the patient.
23.
Prevent contact between the patient and any peripherals attached to the
Console, not including the NanoScope Handpiece.
24.
Never contact the Console or remove the applied NanoScope Handpiece while
the distal portion of the Handpiece is in contact with the patient.
The PRECAUTION! symbol identifies methods and procedures that must be
followed to avoid damaging the device or causing it to malfunction.
1.
Do not use for procedures other than those indicated.
2.
The warranty could be voided if:
•
Shipping or first-installation damage is not reported within seven (7)
business days of receiving the device
•
The device or the accessories are improperly used, prepared or
maintained
•
The instructions in the manual are not followed
•
Non-authorized persons perform repairs, adjustments or alterations
•
Non-authorized persons open the device
3.
Receipt of technical documentation from the manufacturer does not authorize
individuals to perform repairs, adjustments, or alterations to the device or
accessories.