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897N203029A FDC NX600 Instruction Manual 2022.01
Introduction
Thank you for purchasing the
FUJI DRI-CHEM NX600
or
FUJI DRI-CHEM NX600i
.
Accompanying documents were originally drafted in the English language.
Installation may only be conducted by authorized service personnel.
<Intended Purpose>
The FUJI DRI-CHEM NX600 and FUJI DRI-CHEM NX600i (henceforth, the FDC NX600) is an in vitro
diagnostic medical device to automatically quantitate the concentration or the activity of the components
in blood or urine by colorimetric end-point, rate and ISE tests, using the FUJI DRI-CHEM SLIDEs. Do
not use the equipment for other purposes.
This equipment must be operated by Healthcare professionals who are familiar with its intended pur-
pose and correct operation. And, the equipment can be used in a near patient setting by Healthcare
professional.
CAUTIONS
1. No part or all of this manual may be reproduced in any form without prior permission.
2. The information contained in this manual may be subject to change without prior
notice.
3. FUJIFILM shall not be liable for malfunctions and damage resulting from installation,
relocation, remodeling, maintenance, and repair done by other than dealers specified
by FUJIFILM.
4. FUJIFILM shall not be liable for malfunctions and damage of FUJIFILM products due
to the use of products of other manufacturers not supplied by FUJIFILM.
5. FUJIFILM shall not be liable for malfunctions and damage resulting from remodeling,
maintenance, and repair using repair parts other than those specified by FUJIFILM.
6. FUJIFILM shall not be liable for malfunctions and damage resulting from negligence of
precautions and operating methods contained in this manual.
7. FUJIFILM shall not be liable for malfunctions and damage resulting from use under
environment conditions outside the range of conditions required for proper use of this
product, such as power supply, installation environment, etc. contained in this manual.
8. FUJIFILM shall not be liable for malfunctions and damage resulting from natural
disasters such as fires, earthquakes, floods, lightning, etc.
Regulation (EU) 2017/746 requires that any serious incident that has occurred in relation to the device
should be reported to the manufacturer or European Authorized Representative, and the competent
authority of your country. In case you become aware of any serious incident, please report immediately
to your local or our official dealer and the competent authority of your country.
Trademark
“DRI-CHEM” is a trademark or a registered trademark of FUJIFILM Corporation.
Other holder’s trademarks
“QR Code” is registered trademark of DENSO WAVE INCORPORATED.
* This product adopts the font of ARPHIC TECHNOLOGY CO., LTD.
Copyright © 2020-2022 FUJIFILM Corporation. All rights reserved.
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