Installation, Operation, and

Performance Qualification

DxU Microscopy Series

PN C79810AA
October 2021
Manufactured by
Beckman Coulter Ireland Inc.
Lismeehan
O’Callaghan’s Mills
Co. Clare, Ireland 353-65-683-1100
DxU Microscopy Series
Installation, Operation, and Qualification
PN C79810AA (October 2021)

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Inc. in the United States and other countries.

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are trademarks or registered trademarks of their
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May be covered by one or more pat. - see

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Find us on the World Wide Web at:

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Symbols Glossary is available at
www.beckmancoulter.com/techdocs. See Related
Documents for part number.

Rx Only in the U.S.A.

Original Instructions
 Revision History
This document applies to the latest software listed and higher versions. When a subsequent software
version affects the information in this document, a new issue will be released to the Beckman Coulter
website. For labeling updates, go to www.beckmancoulter.com and download the latest version of the
manual or system help for your instrument.

Issue AA, October 2021

DxU Microscopy Series Software Version 8.5

PN C79810AA iii
 Revision History

iv PN C79810AA
 Contents

Revision History, iii

Introduction, vii
Overview, vii

CHAPTER 1: Installation Qualification (IQ), 1-1

IQ Checklist, 1-1
Software and Documentation Checklist, 1-3
System Components, 1-4
Interface Installation Checklist, 1-6

CHAPTER 2: Operation Qualification (OQ), 2-1

OQ Checklist, 2-1

CHAPTER 3: Performance Qualification (PQ), 3-1

PQ Checklist, 3-1

CHAPTER 4: Additional Qualifications, 4-1

Additional Qualifications Checklist, 4-1

References
Related Documents

v
 Contents

vi
 Introduction

Overview

This document provides a checklist guideline for the management of installation processes for a
new DxU 850m Iris and DxU 810c Iris (DxU Microscopy Series) in anticipation of the system’s
implementation for customer’s patient analysis and reports.

The following definitions are excerpted from the Clinical and Laboratory Standards Institute’s
QMS18, Process Management guideline1:

Installation qualification (IQ) - a set of formal checks and records that confirms the equipment or process
and its components, including any integral hardware or software, were supplied as ordered and properly
installed in the laboratory or other environment; NOTE: IQ can be performed by the manufacturer’s
technical service engineer.

Operational qualification (OQ) - process and records to confirm that the equipment or process is
operational for its intended use and operation; NOTE: OQ can be performed by the manufacturer’s
technical service engineer.

Performance qualification (PQ) - process and records to confirm that the equipment or process will perform
to specified needs, producing acceptable results under normal operating conditions; NOTE: PQ must be
performed by laboratory staff.

IQ, OQ, and PQ are validation activities.2

Facility:

Address/Location:

Instance Number:

Instrument Serial Number:

Laboratory Representative:

PN C79810AA vii
 Introduction
Overview

viii PN C79810AA
 CHAPTER 1
Installation Qualification (IQ)

IQ Checklist

Instrument/SN:______________________________

See next page for approval signatures.

Table 1.1 IQ Checklist

Action Select One

N/A* ü
An operator is trained or scheduled to be trained within the next two weeks.
All the cartons on the shipping list have arrived.
All of the cartons are intact and undamaged. If any cartons are damaged, a claim was filed with the
carrier.
The shipping containers can clear the entrance doorways.
The instrument area is easily accessible for maintaining and servicing the instrument.
The space is sufficient for the placement of the instrument and printer.
The distance between the rear of the unit and the wall is at least 2 inches.
The female AC outlet for the power supply is within the area designated for the instrument.
The main AC outlet is a three-wire outlet supplying 90 to 240 V, 50 to 60 Hz; single-phase power.
The ground is a confirmed third-wire earth ground that can carry the full current of the circuit.
The circuit is independent and protected.
If the waste from the instrument will drain into an open drain instead of a waste container, the drain tubing
is directed to the designated waste area according to local regulations.
The drain or waste container is lower then the unit.
The drain or waste container is located so that the waste drain tubing is inside a waste container
(approximately 2 in). Make sure the waste container is lower than the unit.
The room temperature for this instrument is set up where the temperature can be controlled between
59oF (15oC) and 86oF (30oC), and humidity in a range of 20% to 80% indicated in the Instructions for Use
(IFU).
The unit is not where it may be affected by water, direct sunlight or draft. This may yield incorrect results,
and the unit may be damaged as indicated in the IFU.
The instrument reagents, calibrators, and controls are available and within expiration limits.
The paper supplies, tubes, and test strips are available.

* Some items may not apply depending on the instrument, test menu, laboratory protocol, and/or
local regulatory agency.

PN C79810AA 1-1
 Installation Qualification (IQ)
IQ Checklist

Approvals for IQ Checklist

Date:

Beckman Coulter Representative and Title

(sign):

Beckman Coulter Representative and Title

(print):

Date:

Laboratory Representative and Title (sign):

Laboratory Representative and Title (print):

Comments:

1-2 PN C79810AA
 Installation Qualification (IQ)
Software and Documentation Checklist 1

Software and Documentation Checklist

Instrument/SN:______________________________

Table 1.2 Software and Documentation Checklist

Action Select one

N/A* ü
All appropriate software, manuals, letters, and installation instructions are available on the Beckman
Coulter website. Replacements for missing components have been ordered.
Required Safety Data Sheet (SDS) documents are available.

Approvals for Software and Documentation Checklist

Date:

Beckman Coulter Representative and Title

(sign):

Beckman Coulter Representative and Title

(print):

Date:

Laboratory Representative and Title (sign):

Laboratory Representative and Title (print):

Comments:

PN C79810AA 1-3
 Installation Qualification (IQ)
System Components

System Components

Instrument/SN:______________________________

See next page for approval signatures.

Table 1.3 System Components

Instrument
Model:
Serial Number:
Report Printer
Model:
Serial Number:
IP Address:
Verify default printer;
Print test page from printer:
Computer
Model:
Serial Number:
IP Address (if applicable):
UPS (optional)
Model:
Serial Number:
Software
Version:

1-4 PN C79810AA
 Installation Qualification (IQ)
System Components 1

Approvals for System Components

Date:

Beckman Coulter Representative and Title

(sign):

Beckman Coulter Representative and Title

(print):

Date:

Laboratory Representative and Title (sign):

Laboratory Representative and Title (print):

Comments:

PN C79810AA 1-5
 Installation Qualification (IQ)
Interface Installation Checklist

Interface Installation Checklist

Instrument/SN:______________________________

Table 1.4 Interface Installation Checklist

Action Select one

N/A* ü
Connect the Ethernet cable to the System Manager.
Power ON the instrument.
Check that the instrument is communicating with the network.
Configure the interface device.
Check the communication between the instrument and the system.

Approvals for Interface Installation Checklist

Date:

Beckman Coulter Representative and Title (sign):

Beckman Coulter Representative and Title

(print):

Date:

Laboratory Representative and Title (sign):

Laboratory Representative and Title (print):

Comments:

1-6 PN C79810AA
 CHAPTER 2
Operation Qualification (OQ)

OQ Checklist

Instrument/SN:______________________________

See next page for approval signatures.

Table 2.1 OQ Checklist

Action Select one

N/A* ü
Ensure that all the panels and covers are installed and that the interlock bypass have been removed.
Perform an Initialization cycle and verify that the green light is illuminated indicating Standby mode.
Run the following controls/calibrator and verify that all the results are within acceptable limits:
• iQ200 Series Control/Focus Set
• iQ200 Series Precision Kit
• iQ200 Series Calibrator Set
NOTE If this is a new installation, retain all printouts.
If this is a system upgrade, verify the instrument’s performance

* Some items may not apply depending on the instrument, test menu, laboratory protocol, and/or
local regulatory agency.

PN C79810AA 2-1
 Operation Qualification (OQ)
OQ Checklist

Approvals for OQ Checklist

Date:

Beckman Coulter Representative and Title

(sign):

Beckman Coulter Representative and Title

(print):

Date:

Laboratory Representative and Title (sign):

Laboratory Representative and Title (print):

Comments:

2-2 PN C79810AA
 CHAPTER 3
Performance Qualification (PQ)

PQ Checklist

Instrument/SN:______________________________

See next page for approval signatures.

Table 3.1 PQ Checklist

Action Select one

N/A* ü
Reference: Verify list of actions as per the DxU Microscopy Series product.
Hardware installation data qualified
Precision qualified
Carryover qualified
Linearity qualified
Calibration
DMS/Workstation/System Manager set up
QC files set up
Interfacing to LIS (IT/LIS contact) set up
Formed particle, urine-auto classify, and auto release set up
All Settings established and setup (including formed particle setup, specimen screen, urine auto-classify,
urine gating, and urine auto-release)
Comparisons performed by laboratory staff:
• Samples run on new instrument and comparison method completed
• Real-time analysis and recheck
• Manual microscopy
Comparison data collated and submitted for data analysis
DxU Microscopy Series Linearity Validation qualified
DxU Microscopy Series Patient Correlation completed
Primary instrument verified (comparability) with backup instrument
Interfacing (trained operator and lab IT contact) tested
Data analysis reports reviewed with appropriate lab staff
Pathology/Lab Director sign-off

* Some items may not apply depending on the instrument, test menu, laboratory protocol, and/or
local regulatory agency.

PN C79810AA 3-1
 Performance Qualification (PQ)
PQ Checklist

Approvals for PQ Checklist

Date:

Beckman Coulter Representative and Title

(sign):

Beckman Coulter Representative and Title

(print):

Date:

Laboratory Representative and Title (sign):

Laboratory Representative and Title

(print):

Comments:

3-2 PN C79810AA
 CHAPTER 4
Additional Qualifications

Additional Qualifications Checklist

The items included in the Additional Qualifications Checklist may include items that are your
laboratory’s responsibility. They may be processes/procedures that are not included in the
Implementation Guide, but are agreed to by Beckman Coulter and your laboratory for which
Beckman Coulter will provide assistance.

Instrument/SN:______________________________

See next page for approval signatures.

Table 4.1 Additional Qualifications Checklist

Action Select one

N/A* ü

* Some items may not apply depending on instrument, test menu, laboratory protocol, and/or local
regulatory agency.

PN C79810AA 4-1
 Additional Qualifications
Additional Qualifications Checklist

Approvals for Additional Qualifications Checklist

Date:

Beckman Coulter Representative and Title

(sign):

Beckman Coulter Representative and Title

(print):

Date:

Laboratory Representative and Title (sign):

Laboratory Representative and Title (print):

Comments:

4-2 PN C79810AA
 References

1. QMS18 Process management; 2015. Clinical and Laboratory Standards Institute (CLSI), Wayne,
PA.
2. QMS01-A4 Process management; 2011. Clinical and Laboratory Standards Institute (CLSI),
Wayne, PA.

PN C79810AA References-1
 References

References-2 PN C79810AA
 Related Documents
Your documentation can be found on our
website at www.beckmancoulter.com/techdocs

Instructions for Use

PN C49320
• System Overview
• Operation Principles
• Startup
• Quality Control
• Sample Analysis
• Data Review
• Manual Orders
• Shutdown
• Setup
• Troubleshooting
• Quality Assurance
• Cleaning Procedures
• Replacement/Adjustment Procedures
• iWARE Expert System
• iQ Body Fluids Module
• Auto-Release
• Abbreviations and Acronyms
• Glossary
• References
• Index
• Warranty

Symbols Glossary
PN C26098

Host Transmission Manual

PN 300-4941

www.beckmancoulter.com

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