Varian Rotating Bottle Apparatus Operator’s Manual
P/N 70-9021
November 2010
Revision G
Rotating
Bottle Apparatus
Operator’s Manual
Limitation of Liability
The information in this document is subject to change without notice.
Varian, Inc. makes no warranty of any kind with regard to this material,
including, but not limited to, the implied warranties or merchantability and
fitness for a particular purpose. Varian, Inc. shall not be liable for errors
contained herein or for incidental consequential damages in connection
with the furnishing, performance, or use of this material.
All rights are reserved. Reproduction, adaptation, or translation without
prior written permission is prohibited, except as allowed under copyright
laws.
First Edition (November 2010)
Rotating Bottle Apparatus Operator’s Manual
Part Number 70-9021 Revision G
Printed in the United States of America
The following terms are trademarks of Varian, Inc.:
• Benchsaver
• BIO-DIS III
• Enhancer Cell
• Full Flow Filters
• Peak Vessel
TM
®
TM
• Practical Solutions
®
TM
• QA and QAII
• TruCenter
• VanKel
• VK
TM
®
®
®
TM
All other trademarks are the property of their respective owners.
Varian, Inc.
13000 Weston Parkway
Cary, North Carolina 27513-2250
800.229.1108
919.677.1108
Fax: 919.677.1138
www.varianinc.com
Copyright (c) 1999 - 2010 by Varian, Inc.
T a ble of Contents
Chapter 1 Safety Practices and Hazards 5
Electrical Hazards 6
Other 6
General 9
WEEE Directive 10
Chapter 2 Introduction 11
Conventions Used in this Manual 12
Varian, Inc.
Table of Contents
Chapter 3 Installation and Setup 13
Unpacking Your Equipment 13
Setting up the Water Bath and VK 750D 14
Initial Power Up 16
Power Cord Connections 16
Powering Up the VK 750D Heater / Circulator 16
Powering Up the Rotating Bottle Apparatus 17
Chapter 4 Operation 19
Chapter 5 Maintenance and Troubleshooting 23
Periodic Maintenance 23
Daily Maintenance 23
Weekly Maintenance 24
Monthly Maintenance 24
Annual Maintenance 24
Water Bath / Acrylic Care 25
Fuse Replacement 26
Troubleshooting 27
Chapter 6 Service and Warranty 29
Exclusions and Limitations 30
Obtaining Warranty Service 30
Warranty Limitations 30
Exclusive Remedies 31
Index 33
Tell Us How We Are Doing 35
Varian, Inc.
Chapter 1 Safety Practices
and Hazards
The Rotating Bottle Apparatus has been carefully designed so that when used properly
you have an accurate, fast, flexible, and safe instrument.
If the equipment is used in a manner not specified by the manufacturer, the protection
provided by the equipment may be impaired.
Operation of a Rotating Bottle Apparatus involves the use of solid dosage forms and
aqueous liquids. Unskilled, improper, or careless use of this instrument can create shock
hazards, fire hazards, or other hazards which can cause death, serious injury to
personnel, or severe damage to equipment and property.
Information on safety practices is provided with your instrument and operation manuals.
Before using your instrument or accessories, you must thoroughly read these safety
practices.
Observe all relevant safety practices at all times.
Varian, Inc.
Page 6 Rotating Bottle Apparatus Revision G, 11/10
Safety Practices and Hazards Operator’s Manual P/N 70-9021
Electrical Hazards
The Rotating Bottle Apparatus contains electrical circuits, devices, and components
operating at dangerous voltages. Contact with these circuits, devices, and components
can cause death, serious injury, or painful electric shock.
Panels or covers that are retained by fasteners which require t he use of a tool for removal
may be opened only by Varian-trained, Varian-qualified, or Varian-authorized service
engineers. Consult the manuals or product labels supplied with the Rotating Bottle
Apparatus to determine which parts are operator-accessible.
Application of the wrong supply voltage, connection of the instrument to an incorrectly
wired supply outlet, or lack of proper electrical grounding can create a fire hazard or a
potentially serious shock hazard and could seriously damage the instrument and any
attached ancillary equipment.
Always use a three-wire outlet with ground connection which is adequately rated for the
load. The installation must comply with local, state, and federal safety regulations.
Do not connect the instrument to the main power supply until you have made sure that
the operating voltage is correctly set for the main power supply in the specific outlet in
your laboratory to which the equipment will be connected.
Other
Other specific warnings and cautions appear in the manuals where appropriate and detail
the specific hazard, describe how to avoid it, and specify the possible consequences of
not heeding the warning or caution.
Warning
A ‘Warning’ message appears in the manual when failure to observe instructions or
precautions could result in death or injury. Symbols depicting the nature of the specific
hazard are also placed alongside warnings.
Varian, Inc.
Revision G, 11/10 Rotating Bottle Apparatus Page 7
P/N 70-9021 Operator’s Manual Safety Practices and Hazards
These symbols may be used on warning labels attached to the instrument. When you see
one of these symbols you must refer to the relevant operation or service manual for the
correct procedure referred to by that warning label.
The meaning of the symbols that appear alongside warnings in this manual are as
follows:
Electrical shock
Pinch point
Caution
Refer to accompanying documents
Read all warnings and cautions carefully and observe them at all times.
Varian, Inc.
Page 8 Rotating Bottle Apparatus Revision G, 11/10
Safety Practices and Hazards Operator’s Manual P/N 70-9021
Caution
A ‘Caution’ message appears in the manual when failure to observe instructions could
result in damage to equipment (Varian supplied and / or other associated equipment).
A ‘Note’ appears in the manual to give advice or information.
Information Symbols
Switches main power on
I
Switches main power off
0
Indicates single-phase alternating current
Indicates the product complies with the requirements of one or
more European Union (EU) directives
Indicates specific equipment meets consensus-based standards
of safety to provide assurance, required by OSHA, that these
products are safe for use in the workplace for North America
Indicates that this product must not be disposed of as unsorted
municipal waste (see “WEEE Directive” on page 10)
Varian, Inc.
Revision G, 11/10 Rotating Bottle Apparatus Page 9
P/N 70-9021 Operator’s Manual Safety Practices and Hazards
General
CE Compliant Products
The Rotating Bottle Apparatus has been designed to comply with the requirement s of the
Electro-magnetic Compatibility (EMC) Directive and the Low Voltage Directive (LVD) of
the EU.
Varian, Inc. has confirmed that each product complies with the relevant directives by
testing a prototype against the prescribed European Norm (EN) standards.
Proof that a product complies with the directives is indicated by:
• the CE marking appearing on the rear of the product.
• the documentation package that accompanies the product containing a copy of
the declaration of conformity. This declaration is the legal declaration by Varian,
Inc. that the product complies with the directives and also shows the EN standards
to which the product was tested to demonstrate compliance. The declaration of
conformity is signed by the representative of the manufacturing plant.
cTUVus - U.S. and Canadian Product Approvals
The Rotating Bottle Apparatus has been designed to comply with North American safety
requirements.
These products have been tested and certified for the North American market by TUV
Rheinland of North America, Inc. The TUVus mark signifies that these products have
been tested to U.S. standards and certified for the U.S. market. The cTUV mark signifies
that these products have been tested to Canadian standards and certified for the
Canadian market. When the two marks are coupled, the cTUV us mark signifies that these
products have been tested to standards and certified for both markets.
Varian, Inc.
Page 10 Rotating Bottle Apparatus Revision G, 11/10
Safety Practices and Hazards Operator’s Manual P/N 70-9021
WEEE Directive
All Varian products that are subject to the WEEE directive shipped after August 13, 2005
are compliant with the WEEE marking requirements. Such products are marked with the
“crossed out wheelie bin” WEEE symbol shown on page 8 in accordance with European
Standard EN 50419.
This symbol on the product or on its packaging indicates that this product must not be
disposed of as unsorted municipal waste. The separate collection and recycling of your
waste equipment at the time of disposal will help to conserve natural resources and
ensure that it is recycled in a manner that protects human health and the environment.
For more information on collection, reuse, and recycling systems, please contact your
local/regional waste administration, your local distributor, or Varian, Inc.
Varian, Inc.
Chapter 2 Introduction
The Rotating Bottle Apparatus is designed for release rate testing of tablets or capsules.
Manual changing of media during a test simulates a dosage passing through a pH
gradient.
The Rotating Bottle Apparatus includes the following items:
• One system drive with easy-to-read digital display
• One clear acrylic water bath, 19 x 12.7 x 15.3 inches, with VK 750D Heater /
Circulator or one clear acrylic water bath, 24 x 12 x 12 inches, for use with an
immersion circulator
• One stainless steel drive bar with 14 positions
• 20 standard 100 mL test bottles with caps
• Five decant caps with 40-mesh screen
Warning
The Rotating Bottle Apparatus contains electrical circuits,
devices, and components operating at dangerou s voltages.
Contact with these circuits, devices, and components can cause
death, serious injury, or painful electric shock.
Varian, Inc.
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