Fresenius Medical Care GranuFlo 450368-03, Operator'S Manual

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GranuFlo® Concentrate Dissolution Unit II with Citrasate DRY Update Operator’s Manual
© 2013, 2015, 2016, 2017-2020 Fresenius USA, Inc. – All Rights Reserved.
This document contains proprietary and confidential information from Fresenius USA, Inc. The contents
of this manual may not be disclosed to third parties, copied, or duplicated in any form, in whole or in
part, without the prior written permission of Fresenius USA, Inc .
Fresenius Medical Care, the triangle logo and GranuFlo are trademarks of Fresenius Medical Care
Holdings, Inc. or its affiliated companies. Citrasate is a registered trademark of Advanced Renal
Technologies in the United States and is used under license. All other trademarks are the property of
their respective owners.
Caution: US Federal Law restricts this device to sale by or on the order of a physician.
Indications for Use: The Fresenius Medical Care GranuFlo® Dissolution Unit II mixes Fresenius Medical
Care distributed dry acid concentrate products with hemodialysis quality water. The resulting liquid acid
concentrates are intended for use in three-stream hemodialysis machines calibrated for acid and
bicarbonate concentrates.
As part of the Conditions for Coverage, it is the Medical Director’s responsibility that the Operators of the
Fresenius Medical Care GranuFlo Dissolution Unit II must be trained in its operation and thoroughly
familiar with the contents of this manual. Operators must be proficient and able to distinguish between
normal and abnormal operation.
Assembly, adjustment, or repair is to be performed only by persons authorized by the facility medical
director or by Fresenius USA, Inc. Installation is only to be performed by Fresenius USA, Inc. to prevent
voiding of product warranty. Fresenius Medical Care Concentrate GranuFlo® Dissolution Unit II spare
parts manual, PN 460009, Field Service Bulletins, and other documentation are located on the internet at
http://www.fmcna.com.
Only Original Equipment Manufacturer ( OEM) Fresenius Medical Care parts should be used in the repair
or upgrade of the Fresenius Medical Care GranuFlo Dissolution Unit II. Although, parts may look similar
to parts in various vendor catalogs or brick and mortar stores the GranuFlo Dissolution Unit II uses parts
that have been specified and tested in accordance to ANSI/AAMI/ISO guidelines. The use of non- OEM
parts will void your warranty and may cause patient harm.
For further information regarding the operation, repair, parts, or maintenance of the Fresenius Medical
Care GranuFlo Dissolution Unit II, please contact:
Fresenius USA, Inc.
ATTN: Service Department
4040 Nelson Avenue.
(800) 227-2572
Concord, CA 94520.