Millipore System Documentation Set
18 Operating and Maintenance Manual Publication XITXSP121 P Rev.A
Note: This instrument is designed to operate safely within the parameters defined in the
Operating and Maintenance Manual. Operating the equipment outside of the parameters
specified in this document may compromise protections that are designed for safe operation.
Scope of Supply
The Exacta meets the technological requirements for 21 CFR Part 11 compliance. Procedural
requirements of Part 11 must be implemented by the organization using the instrument to
achieve full compliance with the rule.
Make sure your package contains the following materials:
• Integritest Exacta Instrument
• Operating and Maintenance Manual
• Envelope for Registration Information
• Certificate of Quality
• Declaration of Conformity
• Inlet Tubing Assembly
• Millipore License Agreement
• Loop Back Tubing Assembly
• Outlet Tubing Assembly
• Paper for Internal Printer (5-Pack)
• Paper Roll Rod
• Laminated Installation Note
• Power Cord, 110v
• Power Cord, 240v
• Inkjet Ink Cartridge (3-pack)
If anything is missing or damaged, contact your local Millipore sales or service
representative or the Millipore office nearest you. The addresses and telephone numbers
for Millipore local and worldwide offices are listed in the section titled Contacting Millipore
on page 255 and in the Millipore Catalogue. Your representative will guide you through
the appropriate steps for replacing damaged or missing items.
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