Warnings And Cautions; Classification; Patents, Copyright And Trademark Notice; Safety Information - NeurOptics NPi-300 Pupillometer Gebrauchsanweisung

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 NPi-300 Pupillometer – The NPi-300 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. Do not use the device
if damage to the housing or internal optical components
is apparent. 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-300 is only replaceable by
a qualified NeurOptics' service technician. Contact
NeurOptics if you suspect an inoperable battery.
• Use only the NeurOptics NPi-300 Charging Station for
charging the NPi-300.
• 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.
• Store and use the NPi-300 System in ambient
environments with non-condensing humidity levels
only. Using the NPi-300 with condensation on optical
surfaces may result in inaccurate readings.
• The SmartGuard is NOT a sterile product. It is not
intended to be cleaned between measurements. If the
SmartGuard appears soiled or if the clinician becomes
concerned about product cleanliness, the SmartGuard
should be discarded and replaced before using the
NPi-300 on a patient.
Cautions
The following cautions apply when cleaning the device.
The internal components of the NPi-300 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
NPi-300 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).
NeurOptics® NPi®-300 Pupillometer System—Instructions for Use ©2021 NeurOptics, Inc.
Magnetic Resonance Imaging (MRI) Notice
This device contains components whose operation can be
affected by intense electromagnetic fields. Do not operate
the device in an 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.
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.

Classification

Type of Equipment: Medical Equipment, Class 1 886.1700
Trade Name: NeurOptics® NPi®-300 Pupillometer
Manufactured by:
NeurOptics, Inc.
9223 Research Drive
Irvine, CA 92618, USA
p: 949.250.9792
Toll Free North America: 866.99.PUPIL
info@NeurOptics.com
NeurOptics.com

Patents, Copyright and Trademark Notice

Copyright ©2021 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.
For details, visit: www.NeurOptics.com/patents/

Safety Information

• Please review the following safety information prior to
operating the device.
• Please read these Instructions fully before attempting
to use the NPi-300. Attempting to operate the device
without fully understanding its features and functions
may result in unsafe operating conditions and/or
inaccurate results.
• If you have a question regarding the installation,
set-up, operation, or maintenance of the device, please
contact NeurOptics.
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