Professional Documents
Culture Documents
Iq 200 Series-iqoqpq
Iq 200 Series-iqoqpq
Iq 200 Series-iqoqpq
Performance Qualification
iQ 200 Series
PN B86793AB
August 2016
Manufactured by
IRIS Diagnostics
9172 Eton Avenue
Chatsworth, CA 91311
iQ 200 Series
Urine Microscopy System
Installation, Operation, and Performance Qualification
PN B86793AB (August 2016)
Original Instructions
Revision History
Initial Issue AA, 06/2016
This document applies to the latest software listed and higher versions. When a subsequent software
version changes the information in this document, a new issue will be released.
PN B86793AB iii
Revision History
iv PN B86793AB
Contents
References
Related Documents
v
Contents
vi
Introduction
Overview
This document provides a checklist guideline for the management of installation processes for a
new iQ 200 Series Urine Chemistry system 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.
Facility
Address/Location
Instance Number
Instrument Serial Number
Laboratory Representative
PN B86793AB vii
Introduction
Overview
viii PN B86793AB
CHAPTER 1
IQ Checklist
Instrument/SN:______________________________
N/A*
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 than 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 system.
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.
PN B86793AB 1-1
Installation Qualification (IQ)
IQ Checklist
N/A*
The instrument reagents, calibrators, and controls are available and within expiration limits.
The paper supplies, tubes, racks, and test strips are available.
* Some items may not apply depending on the instrument, test menu, laboratory protocol, and/or
local regulatory agency.
Date:
Date:
Comments:
1-2 PN B86793AB
Installation Qualification (IQ)
Software and Documentation Checklist 1
Instrument/SN:______________________________
N/A*
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.
Date:
Date:
Comments:
PN B86793AB 1-3
Installation Qualification (IQ)
System Components
System Components
Instrument/SN:______________________________
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 B86793AB
Installation Qualification (IQ)
System Components 1
Date:
Date:
Comments:
PN B86793AB 1-5
Installation Qualification (IQ)
Interface Installation Checklist
Instrument/SN:______________________________
N/A*
Connect the Ethernet cable to the System Manager.
Power ON the instrument.
Check that the instrument is communicating with the network.
Configure the system and the interface device.
Check the communication between the instrument and the system.
Date:
Date:
Comments:
1-6 PN B86793AB
CHAPTER 2
OQ Checklist
Instrument/SN:______________________________
N/A*
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 iluminated indicating Standby mode..
Run the following controls/calibrator and verify that all the results are within acceptable limits:
• iQ 200 Control/Focus Set
• iQ 200 Precision Kit
• iQ200 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 B86793AB 2-1
Operation Qualification (OQ)
OQ Checklist
Date:
Date:
Comments:
2-2 PN B86793AB
CHAPTER 3
PQ Checklist
Instrument/SN:______________________________
N/A*
Reference: Verify list of actions as per the iQ200 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
Urine Gating
Comparisons performed by laboratory staff:
• Samples run on new instrument and comparison method completed
• Real-time analysis and recheck
• Manual microscopy
• Mixing of the supernatant and sediment
Comparison data collated and submitted for data analysis
iQ 200 Series Linearity Validation qualified
iQ 200 Series Correlation Report qualified
Primary instrument verified (comparability) with backup instrument
Interfacing (trained operator and lab IT contact) tested
PN B86793AB 3-1
Performance Qualification (PQ)
PQ Checklist
N/A*
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.
Date:
Date:
Comments:
3-2 PN B86793AB
CHAPTER 4
Additional Qualifications
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:______________________________
N/A*
PN B86793AB 4-1
Additional Qualifications
Additional Qualifications Checklist
N/A*
* Some items may not apply depending on instrument, test menu, laboratory protocol, and/or local
regulatory agency.
Date:
Date:
Comments:
4-2 PN B86793AB
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 B86793AB References-1
Related Documents
Your iQ 200 Series Operator’s Manual
documentation can be found on our website at
www.beckmancoulter.com.
PN 300-4320
• Introduction
• System Description
• Setup
• Sample Process ing
• Quality Control
• Calibration
• Results
• Maintenance & Service
• iQ Body Fluid Module
• iWARE Expert System
• Auto Release
• Consumable Traceability
• Appendix
Host Transmission
PN 300-4941
www.beckmancoulter.com