Warnings And Cautions; Classification; Patents, Copyright And Trademark Notice - NeurOptics NPi-200 Instructions For Use Manual

Warnings and Cautions

Warnings
Warnings and Cautions appear throughout this manual where
they are relevant. The Warnings and Cautions listed here apply
generally any time you operate the device.
• Use of the Pupillometer - The Pupillometer is intended for
use by trained clinical personnel, under the direction of a
qualified physician.
• If a problem is recognized while operating the device, the
device must be removed from use and referred to qualified
personnel for servicing. Using an inoperative device may
result in inaccurate readings.
• Electric shock hazard - Do not open the device or the charging
station. There are no user serviceable parts.
• The battery in the NPi-200 Pupillometer is only replaceable by a
qualified service technician. Contact NeurOptics if you suspect
an inoperable battery.
• Use only the NeurOptics NPi-200 Charging Station for
charging the Pupillometer.
• Risk of fire or chemical burn – This device and its components
may present a risk of fire or chemical burn if mistreated. Do not
disassemble, expose to heat above 100°C, incinerate, or
dispose of in fire.
Cautions
The following cautions apply when cleaning the device or when
sterilizing device accessories.
• The internal components of the Pupillometer are not compatible
with sterilization techniques, such as ETO, Steam Sterilization,
Heat Sterilization and Gamma.
• DO NOT submerge the device or pour cleaning liquids over or
into the device.
• DO NOT use acetone to clean any surface of the Pupillometer
or Charging Station.
Electromechanical Compatibility (EMC) Notice
This device generates, uses, and can radiate radio frequency
energy.If not set up and used in accordance with the
instructions in this manual, electromagnetic interference
may result. The equipment has been tested and found to
comply with the limits set forth in EN60601-1-2 for Medical
Products. These limits provide reasonable protection against
electromagnetic interference when operated in the intended
use environments (e.g. hospitals, research laboratories).
Magnetic Resonance Imaging (MRI) Notice
This device contains components whose operation can be
affected by intense electromagnetic fields. Do not operate the
device in a MRI environment or in the vicinity of high-frequency
surgical diathermy equipment, defibrillators, or short-wave therapy
equipment. Electromagnetic interference could disrupt the
operation of the device.
NeurOptics® NPi®-200 Pupillometer System—Instructions for Use © 2018 NeurOptics, Inc.
Bluetooth® Notice
Do not attempt to pair the NPi-200 Pupillometer and the
SmartGuard® using the NeurOptics® Antimicrobial Barcode
Scanner by Socket® while simultaneously using another
barcode scanner in close proximity.

Classification

Type of Equipment: Medical Equipment, Class 1 886.1700
Trade name: NeurOptics® NPi®-200 Pupillometer
Manufactured by:
NeurOptics, Inc.
18101 Von Karman Avenue, Suite 1940
Irvine, CA 92612, USA
p: 949.250.9792
Toll Free North America: 866.99.PUPIL
info@NeurOptics.com
NeurOptics.com

Patents, Copyright and Trademark Notice

Copyright © 2018 NeurOptics, California.
This work is protected under Title 17 of the U.S. Code and is
the sole property of NeurOptics, Inc. (the Company). No part
of this document may be copied or otherwise reproduced, or
stored in any electronic information retrieval system, except
as specifically permitted under U.S. Copyright law, without the
prior written consent of the Company.
Pupillometers:
Pat. No. 6116736
Pat. No. 6260968
Pat. No. 6820979
Pat. No. 7147327
Pat. No. 7670002
Pat. No. 8235526
Pat. No. 8393734
Pat. No. 7967442
Pat. No. 8534840
Pat. No. 9198570
Canadian Pat. No. 2368232
Other Patents Pending
Federal Communications Commission Compliance
This device complies with Part 15 of the Federal
Communications Commission (FCC) Rules. Operation is
subject to the following two conditions: (1) this device may not
cause harmful interference , and (2) this device must accept
any interference received, including interference which may
cause undesired operation.
SmartGuard:
Pat. No. 7216985
Pat. No. 7488074
Pat. No. 7901079
Other Patents Pending
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