Iris Diagnostics IQ200 Sprint User manual

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200 Sprint ™

Service Manual

Iris Diagnostics, a Division of Iris International, Inc.

1 - Introduction

Intended Use ...................................................................................................... 1-2

How to use this Manual ......................................................................................1-2

Precautions and Warnings .................................................................................1-4

Notes .................................................................................................................. 1-4

Cautions .............................................................................................................1-4

Warnings ............................................................................................................1-4

Biological Warning..............................................................................................1-4

Warranty.............................................................................................................1-5

Limitation of Liability........................................................................................... 1-6

Use of Third Party Computer Products ..............................................................1-6

Iris Diagnostics Contact Information...................................................................1-7

2 - Installation Procedures

Installation Requirements...................................................................................2-2

Space Requirements..........................................................................................2-2

Workstation ........................................................................................................2-2

Location.............................................................................................................. 2-2

Requirements .....................................................................................................2-2

Installation ..........................................................................................................2-2

Shipping Cartons................................................................................................2-3

Instrument Carton...............................................................................................2-3

Starter Kit A Carton ............................................................................................ 2-4

Starter Kit B Carton (needs refrigeration)...........................................................2-4

Optional .............................................................................................................. 2-4

Installation ..........................................................................................................2-5

Precautions ........................................................................................................2-5

Connecting the Sampler.....................................................................................2-6

Adjust the Height of the Analyzer .......................................................................2-6

Adjust Sampler ...................................................................................................2-7

Installing the Lamina Container..........................................................................2-7

Connecting the Drain Tubing..............................................................................2-7

Computer Connections.......................................................................................2-8

iQ200 Rear Panel SIC Connection Configurations ............................................2-9

iQ200 / AX-4280 Connection Bridge Instructions............................................. 2-10

Optional Load/Unload Station Installation ........................................................ 2-15

Load Station - iQ200 Connection ..................................................................... 2-15

Load Station - AX-4280 Connection.................................................................2-17

Unload Station..................................................................................................2-19

Startup..............................................................................................................2-21

Run Focus ........................................................................................................ 2-22

Iris Diagnostics, a Division of Iris International, Inc.

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Table of Contents

Run Calibration Rack .......................................................................................2-22

Run Control Rack .............................................................................................2-22

Verify Load/Unload and Bridge Connections ...................................................2-22

Preparation for Starting Operation ...................................................................2-22

Perform Setup .................................................................................................. 2-22

3 – Components

Sample Transport Mechanism ...........................................................................3-3

Sampler # 700-3006...........................................................................................3-3

Specimen Tube Detector # 700-3725 ................................................................3-4

Barcode Reader # 700-3315 ..............................................................................3-5

Specimen Presentation Assembly # 700-3700 ..................................................3-6

Crash Detect Function........................................................................................3-6

Waste/Rinse Well # 700-3830............................................................................3-7

Diaphragm Pumps..............................................................................................3-8

Air Pump # 700-3877 .........................................................................................3-8

Waste Pump # 700-3809....................................................................................3-8

Rinse Pump # 700-3874.....................................................................................3-8

Fill Pump # 700-3874 ......................................................................................... 3-8

Peristaltic Pumps # 700-3820 ..........................................................................3-10

Cannula Pump..................................................................................................3-10

Lamina Pump ................................................................................................... 3-10

Evacuation Pump ............................................................................................. 3-10

Pump Cover Closed and Cassette-In-Place Detection ....................................3-10

Lamina Tank # 700-3784 .................................................................................3-12

Air Tank # 700-3802.........................................................................................3-13

Valves...............................................................................................................3-14

Solenoid Valves................................................................................................3-14

Drain Valve # 700-3844....................................................................................3-14

Evacuation Bypass Valve # 700-3843..............................................................3-14

Lamina Bypass Valve # 700-3842....................................................................3-14

Cannula Bypass Valve # 700-3881 ..................................................................3-14

Pipettor Bypass Valve # 700-3880 ...................................................................3-14

Air Valves ......................................................................................................... 3-15

Air Mix Valve # 700-3887 .................................................................................3-15

Air Charge Valve # 700-3888 ...........................................................................3-15

Optical Bench Assembly #700-3500 ................................................................ 3-16

Flow Cell # 525-3077 .......................................................................................3-17

Strobe Light # 065-0059...................................................................................3-17

CCD Camera # 700-3565.................................................................................3-17

20 x Objective # 220-3009 ...............................................................................3-17

Auto Focus System # 700-3505 .......................................................................3-17

Power System Assembly # 230-3000 ..............................................................3-18

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Table of Contents

Cooling Fans # 700-3892 & 700-3412 .............................................................3-18

Fuses and Visible LEDs ...................................................................................3-18

Backplane Fuses and LEDs ............................................................................. 3-19

PCBA Summary ...............................................................................................3-21

Cardcage..........................................................................................................3-22

High Level Control Board (HLCB), # 101-5000 ................................................3-22

Motor/Scanner Control Board (MSCB), # 101-5001.........................................3-22

DC Valve Board (DCVB), # 101-5043 ..............................................................3-22

Stepper/Scanner/Motor Board (SSMB), # 101-5007........................................3-23

Backplane # 101-5003 .....................................................................................3-23

Signal Interface Concentrators (SICs)..............................................................3-24

Power SIC # 101-5020 .....................................................................................3-24

Pump SIC #101-5020.......................................................................................3-25

FSV SIC # 101-5045 ........................................................................................ 3-25

SPA SIC # 101-5004 ........................................................................................3-27

SPA SIC Visible LEDs......................................................................................3-27

SPA SIC Push-Button Switches .......................................................................3-27

OBA SIC #101-5053.........................................................................................3-28

Do-All SIC # 101-5046 .....................................................................................3-29

Rear Panel SIC # 101-5030 ............................................................................. 3-30

STM SIC # 101-5014........................................................................................3-30

Other PCBAs....................................................................................................3-30

ESN Board # 101-5049 .................................................................................... 3-30

Lamina ESN # 101-5048 ..................................................................................3-30

FITD PCBA # 101-5041 ...................................................................................3-30

SM Status Board PCBA # 101-5032 ................................................................3-31

STD PCBA # 101-5034 .................................................................................... 3-31

Pressure Transducer Board #101-5016 ...........................................................3-31

SPA Optical Board # 101-5052 ........................................................................ 3-31

LED Visual Indicators ....................................................................................... 3-31

4 – Adjustments

Accessing the Service Screen............................................................................4-3

Calibration Table ................................................................................................ 4-4

Calibration Auto-Sets .........................................................................................4-4

Sampler Calibration............................................................................................4-6

Material required ................................................................................................4-6

Procedure...........................................................................................................4-6

Specimen Tube Detector Alignment...................................................................4-7

Material required ................................................................................................4-7

Procedure...........................................................................................................4-7

Specimen Tube Detector Calibration .................................................................4-8

Material required ................................................................................................4-8

Iris Diagnostics, a Division of Iris International, Inc.

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Table of Contents

Procedure...........................................................................................................4-8

STD Verification Procedure................................................................................4-9

Specimen Presentation Assembly (SPA) and Waste/Rinse Well Calibration ..4-10

Material required ..............................................................................................4-10

Procedure.........................................................................................................4-10

Waste Well Positioning.....................................................................................4-10

Test Tube Centering Position...........................................................................4-11

Test Tube Depth Positioning ............................................................................ 4-11

Waste Well Depth Positioning ..........................................................................4-12

Lamina Consumption Adjustment ....................................................................4-12

Air Pressure Calibration ...................................................................................4-13

Material required ..............................................................................................4-13

Procedure.........................................................................................................4-13

Barcode Reader Alignment .............................................................................. 4-14

Material Required .............................................................................................4-14

Procedure.........................................................................................................4-14

Prepare Barcode Reader Connections ............................................................4-14

Load the Alignment Tool ..................................................................................4-15

Perform barcode alignment ..............................................................................4-15

Validation..........................................................................................................4-18

Collimation........................................................................................................4-19

What is a Collimation?......................................................................................4-19

Condenser Alignment.......................................................................................4-19

Run Auto Focus................................................................................................4-20

Flow Cell Replacement ....................................................................................4-21

Flow Cell Removal ...........................................................................................4-21

Flow Cell Installation ........................................................................................4-21

Flow Cell Lateral Adjustment............................................................................4-22

Flow Cell Tilt Adjustment..................................................................................4-23

5 - Service Application Software

Accessing the Service Screen............................................................................5-3

Startup................................................................................................................5-3

Establishing Link ................................................................................................5-4

Live Operation ....................................................................................................5-5

Tree View Pane..................................................................................................5-5

Commands .........................................................................................................5-6

Preset Moves .....................................................................................................5-6

Sensors ..............................................................................................................5-6

Calibration Table ................................................................................................ 5-7

Calibration Auto-Sets .........................................................................................5-7

Sequences .........................................................................................................5-7

Iris Diagnostics, a Division of Iris International, Inc.

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Table of Contents

Fluid Schematic Pane ........................................................................................5-8

Diaphragm Pumps..............................................................................................5-8

Peristaltic Pumps................................................................................................5-8

3-Way Valves ..................................................................................................... 5-9

2-Way Valves ..................................................................................................... 5-9

Motors ................................................................................................................5-9

Tube Connectors..............................................................................................5-10

Other Regions of Interest ................................................................................. 5-10

Menu Bar..........................................................................................................5-10

File Menu..........................................................................................................5-10

View Event Log ................................................................................................5-10

Show Versions Report......................................................................................5-11

Exit ...................................................................................................................5-11

Edit Menu ......................................................................................................... 5-11

View Menu........................................................................................................5-11

Toolbar .............................................................................................................5-11

Status Bar.........................................................................................................5-12

Polling...............................................................................................................5-12

Video ................................................................................................................5-12

Record Video Statistics .................................................................................... 5-12

Terminal ...........................................................................................................5-12

Jog Menu..........................................................................................................5-13

Status Bar.........................................................................................................5-13

Current Message Status...................................................................................5-13

Link Status........................................................................................................5-14

“Starting ASTM”................................................................................................5-14

“Establishing link (may take a minute)” ............................................................5-14

“Could not establish link”..................................................................................5-15

Troubleshooting Failure to Establish Link ........................................................5-15

“Connection established”..................................................................................5-15

“Sending initialization messages”..................................................................... 5-16

“Sending initial query messages” ..................................................................... 5-16

“Sending query messages” ..............................................................................5-16

“Idle” .................................................................................................................5-16

Caps Lock Status .............................................................................................5-16

Num Lock Status ..............................................................................................5-16

Scroll Lock Status.............................................................................................5-16

Sequences & Sensor Identifications for Troubleshooting.................................5-17

Master (Master Controller) ...............................................................................5-17

Sequences .......................................................................................................5-17

Level sensors ...................................................................................................5-17

SPA .................................................................................................................. 5-17

Pumps/Evacuation pump/Sensors ...................................................................5-18

STM..................................................................................................................5-18

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Table of Contents

Sensors ............................................................................................................5-18

FBA ..................................................................................................................5-18

Pumps/Sheath pump/Sensors..........................................................................5-18

Pumps/Cannula pump/Sensors........................................................................5-18

Program Operation...........................................................................................5-19

Frequently Asked Questions (FAQ) .................................................................5-19

Why Does a Sensor Display the Wrong Value?...............................................5-19

Which Controller Does Component X (Pump, Valve, etc.) Belong To? ...........5-19

What Are the Communication Addresses of the Major System Components? 5-20

What Should I Do If the Service Application Appears to Hang?.......................5-20

Service Tree .....................................................................................................5-21

Master ..............................................................................................................5-21

SPA Motors ......................................................................................................5-22

SPA Pumps and Valves ...................................................................................5-23

FBA Pumps and Sequences ............................................................................5-25

STM Motors 1...................................................................................................5-26

STM Motors 2, Sensors, Calibration Table and Sequences ............................5-27

OBA..................................................................................................................5-28

Versions 1 ........................................................................................................5-29

Versions 2 ........................................................................................................5-30

6 - Troubleshooting

Bypassing Error Condition..................................................................................6-2

Decoding the Valves field in Valve Error Reports ..............................................6-2

Iris Diagnostics Contact Information...................................................................6-2

Troubleshooting Guide ....................................................................................... 6-3

System locked up ...............................................................................................6-3

Autofocus failed.................................................................................................. 6-3

IQ 200 fails to go to Standby .............................................................................. 6-4

ID errors .............................................................................................................6-4

Illumination/Sequential errors.............................................................................6-5

Valve failure to open or close .............................................................................6-5

System does not go into Standby mode.............................................................6-5

Samples take more than 60 secs to process and complete...............................6-5

Positive control failure ........................................................................................6-5

Calibration rack failed......................................................................................... 6-5

Non uniform flow in Runfile ................................................................................6-6

Inconsistent cell count from run to run in Runfile ...............................................6-6

SP-FLI (spatial flow index) is high in all Runfiles................................................6-6

SP-KSP are high in all Runfiles..........................................................................6-6

Bubbles are present in fluid system ...................................................................6-6

Waste well overflow............................................................................................6-6

Event Log Error Messages.................................................................................6-7

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Table of Contents

7 - Electronics

Electronics..........................................................................................................7-2

General Functions .............................................................................................. 7-2

Cabling Diagram Overview.................................................................................7-3

View of Backplane inside Cardcage...................................................................7-4

Rear view of Backplane -- Fuses and Connections to Internal parts of Microscopy

Module................................................................................................................7-5

Addresses and Summary ................................................................................... 7-6

Hardware Bit Assignments and Details ............................................................7-11

Hardware Assignment Cross Reference ..........................................................7-21

ESN I2C Addresses .........................................................................................7-27

8 - Schematics

998-3006 SM SMCS Assemblies Block Diagram...............................................8-3

700-3800 System Fluid Assembly......................................................................8-4

Master Controller State records .........................................................................8-5

SPA State records............................................................................................8-21

FBA State records ............................................................................................ 8-25

STM State records ...........................................................................................8-27

9 - Preventive Maintenance

Material...............................................................................................................9-2

Semi-Annual PM kit Part Number 799-3050 ......................................................9-2

Annual PM Kit Part Number 799-3051 ..............................................................9-2

Cleaning .............................................................................................................9-3

Instrument Clean Up ..........................................................................................9-3

Fluidics Clean Up ............................................................................................... 9-3

Rinse/Waste Well Clean Up ...............................................................................9-3

Air blow...............................................................................................................9-3

Computers Clean Up..........................................................................................9-3

Laser Printer.......................................................................................................9-3

Fluidics ...............................................................................................................9-4

Liquid Waste.......................................................................................................9-4

Peristaltic pump cassette replacement...............................................................9-4

Tubing replacements..........................................................................................9-4

Adjustment verification ....................................................................................... 9-5

Sampler Rack alignment .................................................................................... 9-5

Specimen Tube Detector verification .................................................................9-5

Barcode Reader alignment verification ..............................................................9-5

SPA alignment verification .................................................................................9-5

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Table of Contents

Fluidic inspection................................................................................................9-6

Autofocus run .....................................................................................................9-6

Optical Bench Verification .................................................................................. 9-6

Replenish Consumables ....................................................................................9-6

Performance verification.....................................................................................9-7

Software ............................................................................................................. 9-7

Calibration run .................................................................................................... 9-7

Control run..........................................................................................................9-7

Documenting the Preventive Maintenance.........................................................9-7

Iris Diagnostics, a Division of Iris International, Inc.

200 Sprint™ (2G) Automated Urine Microscopy Analyzer Service Manual 300-4949 Rev A 01/2005 8

1. Introduction

Introduction

Intended Use.................................................................................................................. 1-2

How to use this Manual..................................................................................................1-2

Precautions and Warnings ............................................................................................. 1-4

Notes ..........................................................................................................................1-4

Cautions .....................................................................................................................1-4

Warnings ....................................................................................................................1-4

Biological Warning...................................................................................................... 1-4

Warranty.........................................................................................................................1-5

Limitation of Liability.......................................................................................................1-6

Use of Third Party Computer Products ..........................................................................1-6

Iris Diagnostics Contact Information ..............................................................................1-7

Iris Diagnostics, a Division of Iris International, Inc.

200 Sprint™ (2G) Automated Urine Microscopy Analyzer Service Manual 300-4949 Rev A 01/2005 1-1

1. Introduction

Intended Use

This Service Manual is intended for the generation Automated Urine Microscopy Analyzer – HVL (High Volume Laboratory).

There are two HVL configurations:

• The

These instruments have a new fluidic design, the capability of connecting Load and Unload stations, and improved error reporting.

The vitro diagnostic use device composed of the Microscopy Analyzer ( the AUTION MAX™ AX-4280 Automated Urine Chemistry Analyzer (AX-

4280), and a workstation. The complete routine urinalysis profile, including urine test strip chemistry panel, specific gravity, color, clarity, and microscopic analysis, providing quantitative or qualitative counts of formed elements, such as cells, casts, crystals, and organisms.

Optionally, the as a stand-alone device for microscopic analysis, and the results from the

This manual is intended to be used by Iris Diagnostics trained personnel.

200 can be combined with other urine chemistry results.

200 Sprint and the

200 Sprint can process 101 samples per hour

200 Sprint™ Automated Urinalysis System (

200 2

generation can process 60 samples per hour

200), connected physically and electronically to

200 System is used to automate the

200 Automated Urine Microscopy Analyzer can be used

200 2

200 System) is an in-

200 Automated Urine

How to use this Manual

References are made to other sections within the Manual. In order to avoid searching for a specific document or section, electronic hyperlinks have been created to let you jump to other locations and to give you immediate access to related information.

Iris Diagnostics, a Division of Iris International, Inc.

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1. Introduction

To follow a link:

1. Select the hand tool

2. Links are indicated in the following manner:

• The text is colored blue and underlined. Example: Iris Diagnostics

Contact Information.

3. Position the pointer over the linked area on the page until the pointer changes to the hand with a pointing finger . Then click the link.

4. To return to the previous section, click on the Go to Previous View button.

5. The Bookmark pane, located on the left side of the screen, can be used as a “linked” table of contents. Click on the + or - sign located next to the title to expand or collapse the selection for a bookmark. Clicking on a bookmark will take you automatically to the starting page of the selected section.

Iris Diagnostics, a Division of Iris International, Inc.

200 Sprint™ (2G) Automated Urine Microscopy Analyzer Service Manual 300-4949 Rev A 01/2005 1-3

1. Introduction

Precautions and Warnings

The Manual includes information and warnings that must be observed by the operator to ensure safe operation of the system. Important messages are highlighted with borders and special icons identifying the type of message enclosed.

There are four types of messages.

Notes

NOTE: Highlights important facts, gives helpful information and tips, and clarifies procedures.

Cautions

CAUTION: Electrical caution! Unplug before handling.

CAUTION: If any liquid is spilled onto the Sampler, wipe the area clean

before testing. Leaving the spill may cause crystals to form and block the movement of the sample racks.

Warnings

WARNING: Identifies potentially hazardous situations that could result in

serious injury to laboratory personnel.

Biological Warning

WARNING: Wear protective gloves to prevent exposure to pathogens. Discard contaminated materials according to applicable regulations.

Iris Diagnostics, a Division of Iris International, Inc.

200 Sprint™ (2G) Automated Urine Microscopy Analyzer Service Manual 300-4949 Rev A 01/2005 1-4

1. Introduction

Warranty

Iris Diagnostics, a subsidiary of Iris International, (Iris) warrants that the products manufactured by it, its divisions or subsidiaries and sold hereunder shall be free from defects in material and/or workmanship, under normal use and service, for the period expiring twelve (12) months from the completion of installation under standard procedure by Iris Diagnostics or an authorized Iris Diagnostics distributor, or upon Purchaser’s signature on Iris Warranty/Acceptance form, or eighteen (18) months from shipment, whichever occurs first. Iris Diagnostics makes no warranty whatsoever regarding products manufactured by persons other than Iris Diagnostics, its Divisions or Subsidiaries and Purchaser’s sole source of warranty therefore, if any, is the original manufacturer’s warranty.

No warranty extended by Iris Diagnostics shall apply to any products which have been modified, altered, or repaired by persons others than those authorized or approved by Iris or to products sold as “used.”

Iris Diagnostics’ obligation under this warranty is limited SOLELY to the repair or replacement, at Iris Diagnostics’ option, of defective parts, F.O.B. warehouse or local Iris office, or as otherwise specified by Iris. Repairs or replacement deliveries shall not interrupt or prolong the term of this warranty. Iris Diagnostics warranty does not apply to consumable materials, except as specially stated in writing, not to products or parts thereof manufactured by Purchaser.

This limited warranty is made on condition that immediate written notice of any defect be given to Iris Diagnostics and that Iris inspection reveals that the Purchaser’s claim is valid under the terms of this warranty.

Iris Diagnostics makes no warranty other than the one set forth herein or that which may be provided in a separate warranty covering the applicable product category. Such limited warranty is in lieu of all other warranties, expressed or implied, including but not limited to any expressed or implied warranty of merchantability or fitness for particular purposes and such constitutes the only warranty made with respect to the products.

Iris Diagnostics, a Division of Iris International, Inc.

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1. Introduction

Limitation of Liability

Iris Diagnostics shall not be liable for any loss of use, revenue or anticipated profits, or for any consequential or incidental damages resulting from the sale or use of the products.

Use of Third Party Computer Products

Iris Diagnostics does not recommend that the workstation provided as a

functional part of the

200 System be employed for performing any software or hardware-

based applications other than those specifically furnished to operate and support the Iris instrument system, or those recommended and offered by Iris Diagnostics specifically as accessories or enhancements for the Iris instrument system. No other third party application software should be installed in these microcomputers in addition to those provided or recommended by Iris Diagnostics, without the expressed approval of Iris Diagnostics Technical Services, in order to avoid potential performance and reliability problems which can result from incompatibility factors, errors in use of such software, or software-based “viruses.”

Installation of such third party software, or non-approved electronic cards or other devices, without advance Iris Diagnostics approval may affect the terms of or void any Iris Diagnostics warranty otherwise in effect, covering Iris Diagnostics supplied software and hardware on the microcomputers and the overall performance and reliability of the entire Iris Diagnostics instrument system.

200 Automated Urine Microscopy Analyzer or the

Iris Diagnostics, a Division of Iris International, Inc.

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1. Introduction

Iris Diagnostics Contact Information

Iris Diagnostics

A Division of Iris International, Inc.

9172 Eton Avenue Chatsworth, CA 91311 USA

Telephone:

From U.S. locations (800) PRO-IRIS (776-4747)

From outside the U.S. +1-818-709-1244

Fax: +1-(818) 700-9661

e-mail: sales@proiris.com

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2. Installation Procedures

Installation

Procedures

Installation Requirements ..............................................................................................2-2

Space Requirements .................................................................................................. 2-2

Workstation.................................................................................................................2-2

Location......................................................................................................................2-2

Requirements .............................................................................................................2-2

Installation ..................................................................................................................2-2

Shipping Cartons ...........................................................................................................2-3

Instrument Carton.......................................................................................................2-3

Starter Kit A Carton ....................................................................................................2-4

Starter Kit B Carton (needs refrigeration) ...................................................................2-4

Optional ......................................................................................................................2-4

Installation......................................................................................................................2-5

Precautions.................................................................................................................2-5

Connecting the Sampler .............................................................................................2-6

Adjust the Height of the Analyzer ...............................................................................2-6

Adjust Sampler ...........................................................................................................2-7

Installing the Lamina Container..................................................................................2-7

Connecting the Drain Tubing...................................................................................... 2-7

Computer Connections...............................................................................................2-8

iQ200 Rear Panel SIC Connection Configurations.....................................................2-9

iQ200 / AX-4280 Connection Bridge Instructions.....................................................2-10

Optional Load/Unload Station Installation ................................................................2-16

Load Station - iQ200 Connection.......................................................................... 2-16

Load Station - AX-4280 Connection .....................................................................2-20

Unload Station ......................................................................................................2-24

Startup .........................................................................................................................2-27

Run Focus ................................................................................................................2-28

Run Calibration Rack................................................................................................2-28

Run Control Rack .....................................................................................................2-28

Verify Load/Unload and Bridge Connections............................................................2-28

Preparation for Starting Operation ...............................................................................2-29

Perform Setup....................................................................................................... 2-29

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2. Installation Procedures

Installation Requirements

Space Requirements

The

0.9m) height countertop of approximately 36 inches wide by 24 inches

deep (91cm by 61cm), with vertical clearance of at least 24 inches (61cm).

With optional Load and Unload stations, the width requirement is 60 inches (147 cm.)

Workstation

The Workstation is composed of a desktop computer, video monitor, keyboard and mouse requiring a suitable counter or desktop, providing comfortable access and a good viewing angle. It is suggested that, if possible, the WorkStation be placed in a work area, which can be semidarkened to increase screen display visibility and reduce glare.

The data connections are made between the (and the AX-4280 and the WorkStation, if applicable) via the special cables provided.

200 is a tabletop unit requiring free space on a standard (36 inch:

200 and the Workstation

Location

For most laboratories, the area which can be used for preparation of urine tubes and sample racks. All data transmissions from the routed to the Workstation, which manages and controls all communications to the Laboratory Information System (LIS) via serial connections.

Requirements

The nor frequency parameters are customer configurable. Uninterruptible power supplies are recommended and available from Iris Diagnostics for the system operation during short power outages and brownouts. This allows for an orderly shutdown of instruments without the loss of data.

Installation

The Diagnostics.

200 is placed near an open benchtop work

200 (and the Ax-4280, if used) are

200 uses 90 to 240V AC, 50-60Hz input source. Neither voltage

200 and the Workstation (and the AX-4280 if applicable) to maintain

200 will be installed by a factory-trained representative from Iris

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2. Installation Procedures

Shipping Cartons

The

Instrument Carton

Item number Description Qty

800-3320 800-3322

700-3103 Printer

250-3082 Printer Cable 1

700-3120

210-3004

700-3101

700-3022

700-3008

700-3007

700-3781

700-3701

700-3702

250-3501

700-3011

200 is shipped in three cartons.

Computer Version 3.0

Flat Panel Monitor

Keyboard and Mouse

Sample Racks (1 Set of 9) 1

Calibrator Rack

Control/Focus Rack

iQ Lamina Cap & Filter

Drain Tubing

Lamina Tubing

Serial Cable, PC to Microscopy Module

Operators Manual CD

200 60/hour or

200 Sprint

101/hour

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2. Installation Procedures

Starter Kit A Carton

Item number Description Qty

475-0047

475-0021

475-0003

660-0036

800-3211

200 Lamina

Iris Diluent

Iris System Cleanser

Culture Tube, 16x100 250 pack

200 Dilution Labels Package

Starter Kit B Carton (needs refrigeration)

Item number Description Qty

800-3104

800-3103

200 Control/Focus Set (four bottles)

200 Calibrator (four bottles)

Optional

Item number Description Qty

800-3810

800-3514

800-3515

800-3501

Load and Unload Set

Load Station (only)

Unload Station (only)

Ax-4280 Bridge Connection Kit

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2. Installation Procedures

Installation

To ensure safety, we advise you to read these installation instructions very carefully and take all proper precautions.

Precautions

The entire unit weighs approximately 140 lbs (63.5k). The Load and Unload Stations weigh 14 lbs (6.35) each. Choose a place to set up the unit before completing its assembly.

If the unit must be moved, separate the Sampler from the analyzer before moving. If these two units come apart while being carried, it may result in injury or severe damage.

Always keep a distance of at least 2 inches (5 cm) between the rear of the unit and the wall. If this distance is not maintained, the connecting tubes and cables may overheat and / or be subjected to mechanical stress.

Do NOT use power frequencies or voltage other than those specified in this document. Connection to an inappropriate power source may damage the instrument.

Make certain that the power supply for the that provides power to no other instruments or appliances. If power is not clean and steady, a UPS and/or power conditioner is recommended.

Do NOT disassemble or modify the unit. Doing so may cause injury and/or instrument malfunction.

Place the unit on a stable and level surface free of vibration. Failure to do so may cause injury or malfunction of the unit.

Do NOT place the unit where it may be affected by chemicals, corrosive gases or electronic noise. Doing so may cause injury or malfunction of the unit.

Do NOT place the unit where it may be affected by water, direct sunlight or draft. This may yield incorrect results, and the unit may be damaged.

Select a room to set up the unit where the temperature can be controlled between 50 80%.

F (10oC) and 86oF (30oC), and humidity in a range of 20% to

200 is from a dedicated line

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2. Installation Procedures

Unpacking the Instrument

Carefully remove the instrument from the shipping container. Remove all packing material from inside the instrument surrounding the SPA, the microscope and the waste well.

Connecting the Sampler

In order to protect the Analyzer and Sampler from damage during transport, each section is secured with tape. Follow the procedure below before installing the unit.

1. Remove the left side panel of the analyzer and the EMI shielding panel.

2. Remove the four screws securing the STM SIC and diaphragm pumps.

3. Connect the grey ribbon cable from the sampler to J01 on PCBA 101-5014 STM SIC.

4. Connect the multi-colored wiring cable to J02 on PCBA 101-5014 STM SIC.

5. Connect the black specimen tube detector cable to J9 on PCBA 1015014 STM SIC.

6. Connect the ground cables to the chassis of the microscopy module.

7. Insert the hooks of the sampler into the slots of the analyzer. Be careful not to catch the cables.

8. Reattach the STM SIC and diaphragm pumps to the chassis.

Ground

Adjust the Height of the Analyzer

• Using a 7/16” wrench, loosen the

locking nuts located under the analyzer.

• Adjust the height of the Sampler by

rotating the feet. The space between the bench top and the analyzer must be ¾ inch.

• After adjusting the height, tighten the

locking nuts.

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¾ inch

2. Installation Procedures

Adjust Sampler

Two adjustment feet are located under the Sampler. They are accessed from the top of the Sampler. Each foot must be in contact with the benchtop.

• Using a flat head

screwdriver, remove the two rubber caps located on the front corners of the Sampler. The top of the feet (screws) can be seen.

• Using a Phillips screwdriver

(+), turn each of the two screws clockwise until the adjustment feet touch the bench top.

• Reinsert the rubber caps.

CAUTION: Make sure the height of the Sampler is adjusted correctly. Otherwise, the Sampler and the Probe may be damaged.

Installing the Lamina Container

• Install the Lamina cap with

filter on a fresh Lamina container.

• Connect one end of the

Lamina tubing to the top fitting on the right side of the analyzer. Connect the other end to the fitting of the Lamina cap.

Connecting the Drain Tubing

• Connect the drain tubing to the bottom fitting on the right side of

the analyzer.

• The Drain Tubing can be directed to the designated waste area

according to local regulations.

• If direct drainage is not an option, slide the Drain Tubing inside a

waste container (approximately 2 in. (5cm)) Make sure the waste container is lower than the microscopy module.

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2. Installation Procedures

Computer Connections

1. Connect the video monitor cable to the video monitor and the video port.

2. Connect the keyboard cable to the keyboard port.

3. Connect the mouse cable to the mouse port.

4. Connect the power cord into the power inlet, and then plug into an electrical outlet.

5. Connect the printer cable to the printer and the printer port.

6. Connect the 100-pin camera data cable to the frame grabber port.

7. Connect one end of the RS232 cable to the serial port on the computer; connect the other end to the serial port 1 (top port) on the

back of the

200.

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2. Installation Procedures

iQ200 Rear Panel SIC Connection Configurations

WARNING: Before making any connections to Load or Unload ports on

the Rear Panel SIC of the iQ200, ensure the jumpers are in the correct configuration depending on the system options.

AX-4280 Connection to the iQ200

The second port labeled “Load” should have all three jumpers removed from the port. CAUTION! If the jumpers are not removed, a fuse will blow on the backplane of the card cage (F10) inside the Microscopy Module.

Load Station Connection to the iQ200

The second port labeled “Load” should have all three jumpers installed in the port. CAUTION! If the jumpers are not in place, the connection will not work and no power will be supplied to the Load Station.

Unload Station Connection to the iQ200

The third port labeled “Unload” should have all three jumpers installed in the port. CAUTION! If the jumpers are not in place, the connection will not work and no power will be supplied to the unload Station. Currently, the only configuration for this port is all three jumpers in place.

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2. Installation Procedures

iQ200 / AX-4280 Bridge Installation Instructions

“iQ200-AX4280 Sample bridge kit” PN 800-3501.

1. Remove left side cover from the AX-4280 sampler.

2. Unplug connector # S1-10 (white label) from the circuit board and replace with connector# S1-10 (Side Sampler) stored in bottom of sampler.

3. At the bottom of the sampler, remove the screw (as indicated on the picture on the right) securing carry arm stop post. Remove the post from the sampler.

4. Extend the lever from the sampler. Attach the rack push arm to the lever with two (2, M3x5) flat head and one (1, M3x6 pan head) screws.

5. Break the tab on the side cover to allow the rack to transfer from the Load Station to the sampler.

6. Replace left side cover.

7. Back out the screw located inside the right frame of the test strip disposal compartment to hold the spring loaded return plate.

8. Install the new waste box provided with the connection kit.

9. Install an alignment bracket under each analyzer aligning the pins with the two holes located under the front of each instrument. Align the brackets and join with the connection bracket. Secure with four (4, M3x10 pan head) screws.

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2. Installation Procedures

10. Install the bridge faceplate between the two samplers. Center and secure with the thumbscrews located underneath the faceplate.

11. Secure the bridge between the two samplers with two (2, M3x6 flat head) screws. Make sure the guide spring points to the left. Check for proper alignment and adjust the analyzer level and/or position to provide a smooth transition.

12. Make the cable connections between the analyzers, and the computer according to the layout diagram.

NOTE: Do not use the grey cable provided with the Arkray kit, the pin out for this cable will not work due to incorrect pin positioning.

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REMOVE jumpers on

COM2 “Load” port before connecting

directly to AX-4280

2. Installation Procedures

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2. Installation Procedures

13. Power up the AX-4280 while holding the STOP button to access the Service mode. a. Press -4280-. b. Press 1: “User set up” then press 2: “User detail”. c. Press ENTER until “Sampler” is displayed. d. Press the “-” button until [LOWER] is displayed and then press

ENTER.

e. Save these settings when prompted. f. Press ESC until the first menu is displayed. g. Press 2: “Adjust”. Press 2: “Pulse & LED”. Press 1: “Pulse

adjust”.

h. Press the “-“ button until [RACK] is displayed, then press ENTER. i. Press the “-“ button until [Carry send] is displayed. Place a rack

on the left side of the AX-4280 sampler in the area where the rack can be transferred to the iQ200 from the AX-4280 and press

ENTER. Verify that the carry arm moves the rack to the iQ

sampler and is positioned on the iQ 200 sampler fully.

j. If the distance needs to be adjusted, change the pulse number on

the AX-4280 to the proper position. A larger number carries the rack further. Use the keypad to change the value.

Press 7 to increase the pulse number by 1 Press 4 to decrease the pulse number by 1 Press 9 to increase the pulse number by 10 Press 6 to decrease the pulse number by 10

k. Press MENU until the third menu is displayed. l. Press 2: System Option. Press 1: Edit rack ID. m. Enter the following rack ID information-

Rack numbers 1-11 Standard ID Rack number 12 Start Rack numbers 13-24 Standard ID Rack numbers 25-27 Standard ID Rack number 28 STAT/CTRL Rack numbers 29-30 PASS Rack number 31 NONE

14. Save these settings when prompted.

15. Return to Standby mode.

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2. Installation Procedures

16. Load the AX Connectivity CD PN 700-3106 on the Analysis Processor.

17. From the Main Menu screen of the iQ, click on the Settings button.

18. Click on Interfaces.

19. Verify that the “Enable direct connection” checkbox with the AX- 4280 is selected.

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2. Installation Procedures

20. Run a patient barcoded sample tube with diluent on the AX-4280 and verify the rack transfers to the iQ 200 without error and the chemistry results attach to the microscopy results.

21. If the chemistry results do not cross over to the worklist, check the LIS output on the AX-4280 for correct setup:

i. Enter “-4280-“ ii. Enter “1” for user setup iii. Press “MENU” iv. Press “2” for Online v. Press “ENTER” until “RS232C Normal” is displayed vi. Change “RS232C Normal” to ”ON” by pressing “-“, then press

ENTER

vii. Change “RS232C STAT” to “ON” by pressing “-“, then press ENTER viii. Change “RS232C Ctrl” to “ON” by pressing “-“, then press ENTER ix. SAVE? Yes (1) No (0) Press “1” to save x. Press “ESC”, then press “STOP”, AX-4280 will initialize

22. If the chemistry cross over but do not attach to the microscopy, make sure the barcode reader is setup correctly and reads the label the same on both units. The label ID’s should match in order to attach the chemistry and microscopy results together.

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2. Installation Procedures

Optional Load/Unload Station Installation

Load Station - iQ200 Connection

NOTE: The Load Station may be connected to either the AX-4280 or the

iQ200.

1. Remove the right side cover from the iQ200 sampler.

2. Break the tab on the side cover to allow the rack to transfer from the Load Station to the Sampler.

3. Reinstall the right side cover. DO NOT install the bottom screw located on the backside of the sampler cover.

4. Assemble the bridge (see picture below)

Note position of guide plate

Securing Brace

Load station bridge assembly

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2. Installation Procedures

5. Connect the assembled bridge between the iQ200 sampler and the load station. (see picture below)

6. Attach the load station cable to port 2 labeled “Load” on the Rear Panel SIC (jumpers in.)

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2. Installation Procedures

7. Adjust the leveling feet under the Load Station to assure a smooth transfer of racks.

8. Attach the securing brace to the bottom screw port on the backside of the iQ200 sampler side cover. The brace mount is attached to the Load Station with an adhesive strip. Secure the brace to the brace mount using the setscrew. (see picture below.)

Brace Mount

Securing Brace

Set Screw

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2. Installation Procedures

NOTE: Smooth rack transfer between stations and samplers is critical for

proper operation.

9. Turn “ON” the power switch located on the back of the Load Station.

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2. Installation Procedures

Load Station - AX-4280 Connection

1. Remove the right side cover from the AX-4280 sampler.

2. Break the tab on the side cover to allow the rack to transfer from the Load Station to the Sampler.

3. Disconnect and remove the optical sensor from the right side of the sampler.

4. Unplug connector # S2-22 (white label) from the circuit board and replace with connector# S2-22 (side sampler) stored in the bottom of the sampler. Push the sensor cable inside the sampler cover.

5. Remove the metal base plate from the STAT station.

6. Extract the sensor cable located on the right side of the STAT holder.

7. Install the new metal base plate, (included in with the load station) in the STAT station, passing the sensor cable through the hole on the right of the plate.

8. Attach the new metal base plate using the screws from the original plate.

9. Remove the black optical sensor from the mounting bracket, and connect it to the sensor cable at the STAT station.

10. Secure the black optical sensor to the side of the base plate touching the front of the sampler, using the hardware included in the bridge connection kit. (see picture below)

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2. Installation Procedures

11. Install and secure the sensor cover to the base plate. (see picture below)

Note position of guide plate

12. Reinstall the right side cover. DO NOT install the bottom screw located on the backside of the sampler cover.

13. Assemble the bridge (see picture below)

Load station bridge assembly

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2. Installation Procedures

14. Connect the assembled bridge between the AX-4280 sampler and the load station. (see picture below)

15. Adjust the leveling feet under the Load Station to assure a smooth transfer of racks.

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2. Installation Procedures

16. Attach the securing brace to the bottom screw port on the backside of the AX-4280 sampler cover (see picture below.)

Brace Mount

Securing Brace

Set Screw

NOTE: Smooth rack transfer between stations and samplers is critical for proper operation.

17. Attach the load station cable to port labeled “Start” on the Rear Panel of the AX-4280.

18. Power up the AX-4280 while holding the STOP button to access the Service mode. a. Press -4280-. b. Press 1: “User set up” then press 2: “User detail”. c. Press ENTER until “Sampler” is displayed. d. Press the “-” button until [UP & LOW] is displayed and then press

ENTER.

19. Save these settings when prompted.

20. Turn “ON” the power switch located on the back of the Load Station.

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2. Installation Procedures

Unload Station

1. Remove left side cover from the iQ200 sampler.

2. Unplug connector # S1-10 (white label) from the circuit board and replace with connector# S1-10 (side sampler) stored in the bottom of the sampler.

3. On the bottom side of the sampler, remove the screw (as indicated on the picture on the right) securing the carry arm stop post. Remove the post from the inside of the sampler.

4. Extend the lever from the sampler. Attach the rack push arm to the lever with two (2, M3x5) flat head and one (1, M3x6 pan head) screws.

5. Break the tab on the side cover to allow the leaver to extend when the cover is in place.

6. Reinstall the left side sampler cover. DO NOT install the bottom screw located on the backside of the sampler cover.

7. Assemble the bridge (see picture below)

Note position of guide plate

200 Sprint™ (2G) Automated Urine Microscopy Analyzer Service Manual 300-4949 Rev A 01/2005 2-24

Unload station bridge assembly

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2. Installation Procedures

8. Connect the assembled bridge between the iQ200 sampler and the Unload station. (see picture below)

9. Adjust the leveling feet under the Unload Station to assure a smooth transfer of racks.

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2. Installation Procedures

10. Attach the securing brace to the bottom screw port on the backside of the iQ200 sampler cover. (see picture on the right)

NOTE: Smooth rack transfer between stations and samplers is critical for proper operation.

11. Attach the unload station cable to port 3 labeled “Unload” on the Rear Panel SIC (jumpers in.)

12. Turn “ON” the power switch located on the back of the Unload Station.

13. Enter the Service Application and calibrate the STM Unload station cal value cal[3]

“Distance to eject to stock yard” so the

rack transfers the correct distances onto the unload station. The rack should transfer smoothly and end up 3mm from the left side of the unload station.(See Sampler Calibration Chapter 4)

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2. Installation Procedures

Startup

Note: Before power up, check inside the instrument and ensure the

cables and tubing are secured and remove any packaging material.

Turn on power in the following order:

1. Computer

2. Video monitor

3. Main power switch on the back of the Microscopy Module

Note: Wait until the Instrument screen is displayed. Check the status on the top left corner of the screen is “OFF”.

4. Press the green ON/OFF button on the front of the Microscopy Module

5. Press the ON/OFF button on the back of the Loading/Unloading stations.

6. Remove the panel and the EMI shielding from the left side of the Microscopy Module to access the card cage.

Note: Verify NO red LEDs are present on the circuit boards inside the cardcage. If red LEDs are observed, clear the fault before continuing the installation.

7. Logon to the workstation. Identifier [IRIS] password iris2k1 (lowercases).

Note: Verify the Microscopy Module is in Standby mode as indicated by a status light (green) on the instrument and displayed on the top left side of the screen.

8. After startup, the Lamina tank located inside the Microscopy Module will fill automatically.

9. Place three tubes in the first three positions of the Control rack. Fill each tube with Iris Diluent.

10. Run the Control rack twice to prime the lines located after the Lamina tank.

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2. Installation Procedures

Run Focus

1. Place provided Focus barcode label onto a glass sample tube.

2. Place a sample tube with 6 mL of iQ Focus material (REF 475-0060) in position 5 of the Control rack.

3. Load the Control rack onto right side of the

4. Press the Start on the top left side of the Microscopy Module.

Run Calibration Rack

1. Transfer 3 mL of iQ Calibrator into 10 round-bottom 16 x 100 mm glass test tubes.

NOTE: Do not use plastic tubes or pipetting devices.

2. Place provided barcodes on each test tube and place the test tubes into the Calibration rack (gray inserts).

3. Load the Calibration rack onto right side of the

4. Press the Start on the top left side of the Microscopy Module.

5. Verify the Run Equivalency Factor (REF) is between 1.4 and 2.7.

200 sampler.

Run Control Rack

1. Place provided Positive and Negative barcode labels onto glass samples tubes (one each).

2. Load the tubes into a control rack, positions 6 and 7.

3. Fill the tubes with 3 mL of control.

5. Load the Control rack onto right side of the

6. Press the Start on the top left side of the Microscopy Module.

7. Verify the QC values are within the specifications.

8. Repeat Control rack 10 times and verify CV’s of < 5% for the positive control runs.

Verify Load/Unload and Bridge Connections

1. Transfer 6 mL of Iris Diluent into five sample tubes.

2. Place one sample tube per rack at positions 1 or 10.

3. Place the five racks into the Load Station.

4. Verify that the transfer between each station and samplers are smooth and level, and that racks travel throughout the system without jam or error.

200 sampler.

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2. Installation Procedures

Preparation for Starting Operation

Perform Setup

See Operator’s Manual - Setup.

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3. Components

Components

Sample Transport Mechanism .......................................................................................3-3

Sampler # 700-3006 ................................................................................................... 3-3

Specimen Tube Detector # 700-3725.........................................................................3-4

Barcode Reader # 700-3315.......................................................................................... 3-5

Specimen Presentation Assembly # 700-3700 .............................................................. 3-6

Crash Detect Function................................................................................................ 3-6

Waste/Rinse Well # 700-3830 .......................................................................................3-7

Diaphragm Pumps .........................................................................................................3-8

Air Pump # 700-3877..................................................................................................3-8

Waste Pump # 700-3809............................................................................................3-8

Rinse Pump # 700-3874.............................................................................................3-8

Fill Pump # 700-3874 .................................................................................................3-8

Peristaltic Pumps # 700-3820 ......................................................................................3-10

Cannula Pump..........................................................................................................3-10

Lamina Pump ...........................................................................................................3-10

Evacuation Pump .....................................................................................................3-10

Pump Cover Closed and Cassette-In-Place Detection .........................................3-10

Lamina Tank # 700-3784 .............................................................................................3-12

Air Tank # 700-3802 ....................................................................................................3-13

Valves ..........................................................................................................................3-14

Solenoid Valves........................................................................................................3-14

Drain Valve # 700-3844 ........................................................................................3-14

Evacuation Bypass Valve # 700-3843 ..................................................................3-14

Lamina Bypass Valve # 700-3842 ........................................................................ 3-14

Cannula Bypass Valve # 700-3881.......................................................................3-14

Pipettor Bypass Valve # 700-3880........................................................................3-14

Air Valves .................................................................................................................3-15

Air Mix Valve # 700-3887......................................................................................3-15

Air Charge Valve # 700-3888................................................................................3-15

Optical Bench Assembly #700-3500............................................................................ 3-16

Flow Cell # 525-3077............................................................................................3-17

Strobe Light # 065-0059 .......................................................................................3-17

CCD Camera # 700-3565 ..................................................................................... 3-17

20 x Objective # 220-3009 .................................................................................... 3-17

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3. Components

Auto Focus System # 700-3505............................................................................3-17

Power System Assembly # 230-3000 .......................................................................... 3-18

Cooling Fans # 700-3892 & 700-3412 .........................................................................3-18

Fuses and Visible LEDs...............................................................................................3-18

Backplane Fuses and LEDs .....................................................................................3-19

PCBA Summary........................................................................................................... 3-21

Cardcage .....................................................................................................................3-22

High Level Control Board (HLCB), # 101-5057 ........................................................3-22

Motor/Scanner Control Board (MSCB), # 101-5001.................................................3-22

DC Valve Board (DCVB), # 101-5043 ...................................................................... 3-22

Stepper/Scanner/Motor Board (SSMB), # 101-5059 ................................................3-23

Backplane # 101-5003..............................................................................................3-23

Signal Interface Concentrators (SICs) ......................................................................... 3-24

Power SIC # 101-5020 ............................................................................................. 3-24

Pump SIC #101-5020 ...............................................................................................3-25

FSV SIC # 101-5045 ................................................................................................3-25

SPA SIC # 101-5004.................................................................................................... 3-27

SPA SIC Visible LEDs ..........................................................................................3-27

SPA SIC Push-Button Switches............................................................................3-28

OBA SIC #101-5053.................................................................................................3-29

Do-All SIC # 101-5046..............................................................................................3-30

Rear Panel SIC # 101-5058 .....................................................................................3-31

STM SIC # 101-5014................................................................................................3-31

Other PCBAs ...............................................................................................................3-31

Lamina ESN # 101-5048 ..........................................................................................3-31

FITD PCBA # 101-5041............................................................................................3-31

SM Status Board PCBA # 101-5032 ........................................................................3-31

STD PCBA # 101-5034 ............................................................................................3-31

Pressure Transducer Board #101-5016 ...................................................................3-32

SPA Optical Board # 101-5052 ................................................................................3-32

LED Visual Indicators................................................................................................... 3-32

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3. Components

Sample Transport Mechanism

The Sample Transport Mechanism refers to the mechanisms associated with delivering test tubes of specimen to the Specimen Presentation Assembly. The STM is composed of the Sampler and the Specimen Tube Detector.

Specimen Tube Detector

Sampler # 700-3006

The Sampler is located on the front of the sampler used on the AX-4280. A bridge connection can be installed between the two systems allowing automatic transfer of sample racks after they have been processed on the AX-4280.

Sample racks, each capable of holding 10 tubes, are loaded on the right side of the sampler. To start the transport of the racks to the pipetting station, the operator presses the “Start” button. The Sampler presents sample tubes loaded onto racks at the pipetting station. The Sampler also has electro-optical sensing of various internal (relating to motor and actuator positions) and external (relating to rack position) status. The SM was specifically designed to use the Arkray Sampler.

200 and is similar to the

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3. Components

Specimen Tube Detector # 700-3725

This small assembly uses specially focused visible light to determine if a sample tube is present at the position where the pipette can extract specimen. Because racks are not necessarily filled with samples tubes, the specimen tube detector allows the Microscopy Module to skip positions where there is no sample tube, avoiding using consumables for non-existent specimens, and achieving higher specimen throughput.

Component drawings may change without notice. Please contact IRIS

Diagnostics to determine the current revision level.

IRIS Diagnostics 9172 Eton Ave Chatsworth, Ca 91311 Ph# 818-709-1244

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3. Components

Barcode Reader # 700-3315

The Barcode Reader uses CCD Array optical scanning process to read barcodes.

Component drawings may change without notice. Please contact IRIS

Diagnostics to determine the current revision level.

IRIS Diagnostics 9172 Eton Ave Chatsworth, Ca 91311 Ph# 818-709-1244

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3. Components

Specimen Presentation Assembly # 700-3700

The SPA or “Specimen Presentation Assembly,” is associated with the “front end” handling of the urine. Mechanically, the SPA mixes the specimen within the sample tube for uniform particle distribution, aspirates sample from the test tube, and delivers it to the next process in the Microscopy Module. The pipette (a vertical two-lumen tube) is mounted onto a two-axis arm, and provides the means for positioning the pipette down into the sample tube. The SPA includes two DC motors with integral encoders—one for vertical translation of the pipette arm, and one for rotation of the pipette arm.

Top board

Crash Detect Function

The Crash Detect function senses one switch (of a pair of snap-action switches mounted on the SPA arm itself). A latched relay on the SPA SIC is held pulled-in until the Hard Crash switch on the SPA arm opens (due to a crash), the relay drops out, and drive to the vertical motor is interrupted. When the relay is pulled in, the green “Vert OK” LED is on. When the relay is dropped out, the red “Vert Crash” LED is on. At Microscopy Module power-up, the Hard Crash condition is automatically reset by an alternate signal on the SPA SIC. There is a push-button switch on the SPA SIC to manually reset the Hard Crash condition if the incoming Hard Crash signal (from the Hard Crash switch on the SPA arm) is no longer asserted. Under normal conditions, the manual switch is not used. Even when the vertical motor is disabled by the crash relay dropping out, the SPA SIC will still allow upward vertical motion of the SPA arm, but not downward motion.

Pipette

Belt

Rotation motor

Vertical motor

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3. Components

Waste/Rinse Well # 700-3830

The Rinse function is used to fill the well with Lamina in order to clean the pipette between sampling.

The Waste function collects all waste liquids (samples and Lamina) used during sample processing, then drains the fluids through the Waste Pump into the waste tubing.

Component drawings may change without notice. Please contact IRIS

Diagnostics to determine the current revision level.

IRIS Diagnostics 9172 Eton Ave Chatsworth, Ca 91311 Ph# 818-709-1244

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3. Components

Diaphragm Pumps

The diaphragm pumps are DC motor driven pumps located on the left side of the instrument next to the sampler. They are from left to right:

1. Air Pump

2. Waste Pump

3. Rinse Pump

4. Fill Pump

Air Pump # 700-3877

This pump fills the air tank and is used for mixing the specimen through the charge and air mix valves.

Waste Pump # 700-3809

This pump drains the waste well.

Rinse Pump # 700-3874

This pump fills the rinse well for cleaning the pipette.

Fill Pump # 700-3874

This pump maintains the level inside the Lamina tank.

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3. Components

Component drawings may change without notice. Please contact IRIS

Diagnostics to determine the current revision level.

IRIS Diagnostics 9172 Eton Ave Chatsworth, Ca 91311 Ph# 818-709-1244

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3. Components

Peristaltic Pumps

Cannula Pump # 700-3820

This pump is used to push the sample into the Flow Cell.

Lamina Pump # 700-3804

This pump is used to backwash the fluidic system. During sample processing, the pump is in Home position allowing Lamina to be directed into the Flow Cell.

Evacuation Pump # 700-3820

This pump is used to:

• aspirate the sample into the pipette

• evacuate liquids from the Flow Cell to the Waste Well

• draw Lamina into the Flow Cell when the Lamina Pump is in

Home position.

Pump Cover Closed and Cassette-In-Place Detection

Three switches are located on the Pump SIC for cover-closed detection, and for cassette-in-place detection.

The cover-closed detection senses the end of the shaft of the threaded knob that closes the pump cover. If the knob is not fully screwed, the pump will not run.

The Cassette-In-Place detection senses the presence of a small tab on the cassette indicating that the cassette has been inserted into the pump. If the tab is not detected, the pump will not run.

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3. Components

Component drawings may change without notice. Please contact IRIS

Diagnostics to determine the current revision level.

IRIS Diagnostics 9172 Eton Ave Chatsworth, Ca 91311 Ph# 818-709-1244

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3. Components

Lamina Tank # 700-3784

The Lamina Tank, located on a bracket above the air tank, is used as a reserve to avoid running out of Lamina. The Fill pump fills the Lamina Tank directly from the external Lamina container.

Four liquid level sensors are inside the Lamina tank. From top to bottom:

1. Overflow detector – when this level is reached, the Fill Pump stops filling the tank.

2. Refill detector – when this level is reached, the Fill Pump is activated to refill the tank.

3. Low-level detector – the external Lamina container is empty. An error message with medium priority is generated, sample processing continues.

4. Empty level detector – the external Lamina container is empty. An error message with high priority is generated; sample processing is stopped until a new container is installed.

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3. Components

Air Tank # 700-3802

The Air Tank maintains air pressure used for the air mixing of the specimen inside the sample tube before pipetting.

Component drawings may change without notice. Please contact IRIS

Diagnostics to determine the current revision level.

IRIS Diagnostics 9172 Eton Ave Chatsworth, Ca 91311 Ph# 818-709-1244

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3. Components

Valves

Solenoid Valves

Located inside the microscopy module, on the right of the Lamina Tank, from top to bottom:

Drain Valve # 700-3844

The Drain Valve is used to remove any air bubble present inside the Flow Cell.

Evacuation Bypass Valve # 700-3843

When this valve is opened, the Evacuation Peristaltic pump aspirates fluids from the drain outlet of the Flow Cell into the Waste Well.

When closed, the valve diverts the flow from the Evacuation Pump to the Waste Well.

Lamina Bypass Valve # 700-3842

When this valve is opened, Lamina goes to the Waste Well.

When closed, Lamina goes to the Flow Cell.

Cannula Bypass Valve # 700-3881

When this valve is opened, Lamina goes to the Flow Cell via the Pipettor Bypass Valve.

When closed, Lamina goes to the Waste Well.

Pipettor Bypass Valve # 700-3880

Located on the Specimen Presentation Assembly. When this valve is opened, sample and/or Lamina go to the Flow Cell.

When closed, sample is aspirated in the flow line.

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3. Components

Air Valves

The Air Valves are located on the right front side of the instrument, underneath the Optical Bench Assembly.

Air Mix Valve # 700-3887

The Air Mix Valve is used to mix the specimen inside the sample tube.

Air Charge Valve # 700-3888

The Air Charge Valve is used to refill the pressure in the Air Line for the mixing circuit.

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3. Components

Optical Bench Assembly #700-3500

Sample is presented as a lamina sandwiched between enveloping layers of suspending fluid. The fluids pass into the Flow Cell in front of a microscope. The lamination positions the specimen exactly within the depth of focus and field of view of the objective lens of the microscope. A CCD (charge coupling device) video camera, connected to the microscope, captures five hundred frames per sample, as each microscopic field of view is illuminated by the flash of a strobe lamp. The resulting pictures are digitized and delivered to the Analysis Processor computer.

The Optical Bench Assembly (OBA) is a mechanical/electro-optical assembly that provides for the microscopic images of a transmissivelyilluminated ultra-thin sheet of the specimen to be captured as a video image by the CCD camera. Three thermistors are mounted on different component parts of the OBA to check that the temperature is stable. When temperatures are changing, because of the sub-micron accuracy required for proper images the OBA requires re-focusing.

The mechanical part of the OBA includes:

1. Flow Cell

2. Strobe Light

3. CCD camera

4. 20 x Objective

Auto Focus Motor

Strobe Light

Flow Cell

CCD camera

5. Auto Focus Motor

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3. Components

Flow Cell # 525-3077

This precision assembly is where the thin sheet of liquid specimen is presented in a continuous flow microscope-slide manner for observation by the image capturing system. The sample is pulled into the Flow Cell by the Evacuation pump. Lamina encases the sample, keeping the specimen in thin sheet, and keeps the specimen away from the Flow Cell surfaces to minimize surface contamination.

Strobe Light # 065-0059

The strobe light provides short, high-intensity, parallel-light strobe-light pulses on a controlled basis through the thin sheet of specimen. This subsystem includes a 400V to 1000V strobe power supply and a high intensity strobe flash tube.

CCD Camera # 700-3565

The CCD camera, coupled to the Microscope, takes magnified highresolution digital pictures of the sample going through the Flow Cell.

20 x Objective # 220-3009

The objective magnifies the sample going through the Flow Cell.

Autofocus Motor ” Micro-nudger” # 700-3505

This mechanism allows moving the Flow Cell into the appropriate position where the thin specimen is focused for image capture. Focus position is achieved with an ultra-fine-pitch stepper motor providing a movement of about 0.2 microns per full step.

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3. Components

Power Supply # 230-3000

This assembly includes the international-voltage-range AC-line-to-DC converters to generate +24V and +5V regulated DC for the entire Microscopy Module, and the strobe power supply. The regulated voltages out of the Power system assembly are brought to the Power SIC through a 10-wire cable and a locking Molex connector.

Cooling Fans # 700-3892 & 700-3412

While the Microscopy Module is designed to operate with only natural convection, at higher ambient temperatures, it may be necessary to use some forced-air cooling.

Two fans are present: one in the card cage area, and one in the main instrument area. These fans are turned on by +24V power switched on when the temperature sensed by a local thermistor goes above

C ± 1oC and switched off when the temperature goes below 29 These fans plug into individual 2-pin connectors on the Backplane.

C ± 1oC.

Fuses and Visible LEDs

The fuses are quick-acting, miniature and pluggable. The fuse socket is soldered to the PCB and has a threaded plastic cap that mechanically retains the fuse. Three different fuse ratings are used:

• 0.50 A Iris 056-3000

• 1.0 A Iris 056-3004

• 2.5 A Iris 056-3001

The Backplane has 22 fuses and 22 visible red LEDs. Each LED is associated with a power protection fuse, and the LED lights only when DC power is on (via the Power SIC) and the fuse is blown.

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3. Components

The fuses are mounted in two rows, with even number fuses on the top and odd numbered fuses on the bottom; fuse numbers increasing from left to right. The LEDs are mounted in a single row between the fuses, and each vertically aligned with its associated fuse.

Assignment of these Fuses and LEDs is given in the table below where the “Protects power through” column refers to the Backplane connector through which the protected power leaves the Backplane PCBA.

Note that three of the fuses have their power provided through SSMB circuits, and the LEDs will not light, even when the fuse is blown, if the corresponding SSMB is not plugged into the Backplane.

Backplane Fuses and LEDs

Fuse &

LED

Fuse

Rating

Protects

power

through

Voltage and Function Protected

F3 D3 0.50A J19 +5V SPA SIC

F4 D4 2.5A J20

F5 D5 2.5A J20 +24V Sampler front stepper (through SSMB1)

F6 D6 0.50A J23 +5V Pump SIC: Lamina Pump, STM SIC

F7 D7 0.50A J22 +5V Pump SIC: Cannula Pump

F8 D8 0.50A J21 +5V STM Sampler

F9 D9 0.50A J14 +5V OBA power

F10 D10 1.0A J11 +24V Rear Panel SIC power

F11 D11 2.5A J18 +24V Do-All SIC power

F12 D12 0.50A J18 +5V Do-All SIC power

F13 D13 0.50A J11 +5V Rear Panel SIC power

+24V Sampler measurement stepper (through SSMB1)

F14 D14 0.50A J21 +24V Sample Transport Module SIC power

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3. Components

Fuse &

LED

F15 D15 0.50A J14

F16 D16 0.50A J10 +5V Status Board power

F17 D17 0.50A J12 +5V FSV SIC power

F18 D18 0.50A J13 +5V Barcode Reader power

F19 D19 1.0A J12 +24V FSV SIC power

F20 D20 0.50A J17 +5V Pump SIC: Evacuation Pump

F21 D21 0.50A J24, J25 +24V Fan power

F22 D22 0.50A J16 +5V Power SIC Camera Circuits power

F23 D23 2.5A J16 +24V Strobe Power Supply power

F24 D24 1.0A J16 +24V Camera 24VDC to 12VDC Inverter power

Fuse

Rating

Protects

power

through

Voltage and Function Protected

+24V OBA focus stepper power (through SSMB2)

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3. Components

PCBA Summary

Many of the boards have LEDs indicating dynamic operating status of the board and its controlling firmware.

Item No Board name or Sub assembly Number

1 HLCB 101-5057 1 Card cage

2 MSCB 101-5001 4 Card cage

3 DCVB 101-5043 2 Card cage

4 SSMB 101-5059 2 Card cage

5 Backplane 101-5003 1 Card Cage

6 SPA SIC 101-5004 1 Behind SPA

7 Pump SIC 101-5010 3 Behind Peri-pump

8 OBA SIC 101-5053 1 Side of Optical bench

9 STM SIC 101-5014 1

10 Pressure Transducer Board 101-5016 2

11 Power SIC 101-5020 1 Above cardcage

12 Rear Panel SIC 101-5058 1 Behind backplane

13 SM Status Board 101-5032 1 Top left front panel

14 STD Board 101-5034 1 Inside tube detector

15 FITD 101-5041 4

16 FSV SIC 101-5045 1

17 Do-All SIC 101-5046 1

18 Waste Well Electrode Board 101-5047 1 Waste well

19 ESN Board 101-5049 42

20 SPA Opto Board 101-5052 1 SPA

21 Lamina ESN Bd 101-5048 1

22 Waste Well FITD 101-5054 1 Waste well

23 OBA Focus Home 101-5055 1 Above CCD camera

# in

system

Location

Above pumps left

Valves mounting next

to optical bench

Waste well –

pressure transducer

Right board behind

lamina container

Left board behind

lamina container

Inside lamina

container

panel

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3. Components

Cardcage

The Microscopy Module control center is the cardcage, and is composed of the Microscopy Module backplane, assembly number 101-5003, and nine circuit boards (called the Cardcage boards). The backplane has nine 120pin DIN connectors into which the Cardcage boards plug. The color of the card guides for each slot position identifies the type of board required in the slot—the color of the board’s plastic card ejector should match the color of the card guide. There are also 16 other connectors on the backplane for interface to the rest of the SMCS system.

High Level Control Board (HLCB), # 101-5057

The HLCB, located in slot #1, is the highest level controlling entity in the Microscopy Module. It includes the Master Controller, six high-level controllers, and the FQM low-level controller that itself controls a multipoint scanner. There is one HLCB with white card ejectors.

Motor/Scanner Control Board (MSCB), # 101-5001

The MSCB provides low-level closed-loop control over two independent DC motor/encoders and a multi-point scanner. There are four MSCB boards with blue card ejectors. They are interchangeable.

• Slot 2 Sample Presentation Assembly

• Slot 3 Sample Presentation Assembly

• Slot 6 Fluidic block

• Slot 7 Sample Transport Module (sampler)

DC Valve Board (DCVB), # 101-5043

The DCVB provides control for solenoid-operated valves, and includes the ability to electrically measure activation and release operation of the valves being controlled. There are two DCVB boards with green card ejectors. They are interchangeable.

• Slot 4 Sample Presentation Assembly

• Slot 5 Fluidic block

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3. Components

Stepper/Scanner/Motor Board (SSMB), # 101-5059

The SSMB, located in slots 8 and 9, provides control for two stepper motors, low-level closed-loop control DC for one DC motor/encoders, and a multi-point scanner. There are two SSMB boards with yellow card ejectors. They are interchangeable.

• Slot 8 Sample Transport Module (sampler)

• Slot 9 Optical Bench Assembly

Backplane # 101-5003

Except for power and signal distribution, analog input signal EMI filtering, protection of power, and fuse status resistor divider networks, the backplane has no other function. It has no active elements.

Backplane SMCS Interconnect Connectors

Connector Type Connects to Function

J10 20-pin ribbon header SM Status Board J1 SM Status Board signals J11 26-pin ribbon header Rear Panel SIC J5 Rear Panel SIC J12 40-pin ribbon header FSV SIC J1 FSV Valve interface J13 10-pin ribbon header Barcode Reader Bar Code Reader J14 20-pin ribbon header OBA SIC J1 OBA signals J15 10-pin ribbon header Power SIC J3 Strobe PIC control J16 14-pin Molex

receptacle.

J17 20-pin ribbon header Evacuation Pump

J18 40-pin ribbon header Do-All SIC J1 Do-All SIC signals J19 34-pin ribbon header SPA SIC J1 SPA SIC signals J20 16-pin ribbon header STM SIC J12 STM Motor signals, STM J02 J21 34-pin ribbon header STM SIC J11 STM Optical signals, STM

J22 20-pin ribbon header Cannula Pump SIC

J23 20-pin ribbon header Lamina Pump SIC J1 Lamina Pump J24 2-pin receptacle. Cardcage Fan Cardcage fan J25 2-pin receptacle. Main SM Fan Main SM fan

Power SIC J2 Power to/from Power SIC

Evacuation Pump

SIC J1

J01, STM STD, diaphragm pumps, STM tether ESN, Barcode reader ESN tether. Cannula Pump

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3. Components

Signal Interface Concentrators (SICs)

While the SMCS card cage is the central brain of the SMCS, the control and monitor signals of the SMCS must reach the electrical hardware that it is measuring and controlling. To achieve this signal distribution, the SMCS includes many “Signal Interface Concentrators’ PCBAs (SICs) located throughout the SM.

The SICs provide a local place where the individual elements of the particular subsystem of the SM have their electrical signals “concentrated.” In some cases, there is ESN capability on the SICs.

Power SIC # 101-5020

The Power SIC provides a controlled interface between the DC power supply, and the rest of the SMCS. It also provides controlled power to the Strobe. The Power SIC is mounted atop the SMCS Cardcage, and interfaces to backplane connector J15 through a 10-wire ribbon connector, and to backplane connector J16, a 14-wire discrete wire connector with large gauge wires carrying the actual power signals. The Power SIC receives power directly from the DC Power supply via another 10-pin discrete wire connector. It also provides 12-volt regulated power to the CCD camera. The power delivered to the Cardcage (and the rest of the SMCS) is switched off and on by a logical signal from the SM front panel “Standby” switch.

The Power SIC connectors are summarized in table below.

Connect. Type Connects to Function

J4 5-pin discrete header Cable to Video Camera

J5 6-pin discrete header

J6 3-pin discrete header

J202

J203

10-pin discrete female header Molex MiniFit Jr 12-pin discrete female header Molex MiniFit Jr 10-pin ribbon header w/locks

20-pin shrouded ribbon header 10-pin shrouded ribbon header

Power Supply DC

terminals Cable, P1

Cable to Backplane, J16

Cable to Backplane, J15 OBA SIC PIC16 control

Cable to Strobe power

supply

Cable to SM front panel

standby-switch

(test programming cable)

(test diagnostic cable)

Unswitched regulated power from power supply Switched/Fused power to/from backplane

Power to camera, sync from camera Strobe power, strobe trigger SMCS power off/on logic control, +24V to indicator LED in switch PIC programming during test Quad RS-232 driver bd (test & diagnostics)

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3. Components

Pump SIC #101-5020

The Pump SIC concentrates the signals from the elements of a peristaltic pump assembly, including: the DC pump motor, its rotation encoder, the home detect optical sensor, a cassette-in-place switch and a pair of cover-closed switches. The signals from a Pump SIC connect to the SMCS backplane through a 20-wire ribbon cable. The three Pump SICs in the SMCS:

1. Evacuation Pump assembly, connected into backplane connector J17,

2. Cannula Pump assembly, connected into backplane connector J22,

3. Sheath Pump assembly, connected into backplane connector J23.

The Pump SIC connectors are summarized in table below.

Connect. Type Connects to Function

20-pin ribbon header

12-pin female ESN

Backplane: J17 (Evacuation pump) J22 (Cannula pump) J23 (Lamina pump) DC motor and encoder assy, P1

Main signals to SMCS for: Evacuation pump, Cannula pump, or Lamina pump Motor and Encoder signals

FSV SIC # 101-5045

The Fluid System Valve (FSV) SIC concentrates the leads from up to 12 solenoid valves that operate the fluid system. The signals are brought to SMCS backplane J25 through a 40-wire ribbon cable. The FSV SIC is mounted alongside the Do-All SIC on the Fluid System Valve Assembly.

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3. Components

The FSV SIC connectors are summarized in table below.

Connect. Type Connects to Function

J2 12-pin female Not used J3 12-pin female Not used J4 12-pin female Not used J5 12-pin female Not used J6 12-pin female CBV Operates CBV J7 12-pin female ACV Operates ACV J8 12-pin female LBV Operates LBV

J9 12-pin female DRV Operates DRV J10 12-pin female AMV Operates AMV J11 12-pin female PBV Operates PBV J12 12-pin female EBV Operates EBV J13 12-pin female Not used J14 12-pin female Not used J15 12-pin female Not used J16 12-pin female Not used

40-pin ribbon

header

Backplane J12 Main signals to SMCS

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3. Components

SPA SIC # 101-5004

The SPA SIC incorporates signals from the SPA. It is mounted directly to the SPA assembly. It has two 12-pin ESN connectors for the interface to the two DC motors/encoders (rotational and vertical) of the SPA, an ESN connector for the bottom vertical limit sensor, a 10-pin ribbon header for connection to the SPA Optical Board (for detection of rotational limits and vertical top limit), an ESN connector for the crash detection assembly, and a final ESN connector for a tethered ESN to the entire SPA assembly. The interface from the SPA SIC to SMCS backplane J19 is through a 34-wire ribbon cable.

SPA SIC Visible LEDs

The SPA SIC has 7 visible LEDs though which an observer can deduce operational status of the SPA. The LEDs are identified in table below.

Item LED legends LED color # LEDs

Vertical Motor Encoder Signals Rot A, Rot B Green 2

Horizontal Motor Encoder Signals Rot A, Rot B Green 2

Crash Status Vert OK Green 1

Crash Status Vert Crash Red 1

Motors Disabled Motors Disabled Red 1

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3. Components

SPA SIC Push-Button Switches

There is a single push-button on the SPA SIC that manually resets the Hard Crash condition if the incoming Hard Crash signal (from the Hard Crash switch on the SPA arm) is no longer asserted.

Connect. Type Connects to Function

J1 34-pin ribbon header Backplane J19 Main signals to SMCS

J2 12-pin female

J3 12-pin female ESN

J4 12 pin female ESN

J5 12-pin female

J6 12-pin female

J10 10-pin ribbon header SPA Opto Bd

SPA Assy Tether

ESN

SPA Vertical Motor

ESN

SPA Rotation

Motor

SPA Crash

Detector Switches

SPA Bottom

Sensor switch ESN

SPA Assy ESN

SPA Vertical Motor ESN, DC motor and encoder SPA Rotation Motor ESN, DC motor and encoder

SPA Crash Detection

SPA Bottom Sensor ESN and switch

SPA vertical & rotational homes and other limit.

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3. Components

OBA SIC #101-5053

The OBA (Optical Bench Assembly) SIC incorporates all of the signals from the optical bench. The interface to SMCS backplane J14 is through a 20-wire ribbon cable (J1). The OBA SIC translates the unipolar stepper drive signals from the SSMB to bipolar drives suited for the micro-stepper used in the OBA. The OBA SIC reads the sense signals from the stepper motor assembly to limit movement in the event of reaching a motion limit in one direction or the other. The OBA SIC is physically mounted on the OBA.

The OBA SIC connectors are summarized in table below.

Connector Type Connects to Function

20-pin

ribbon header

Backplane J14 Main signals to SMCS

J10

J11

J12

12-pin female ESN

Focus Stepper Motor P1

OBA thermistors P1 OBA ESN

Not used Camera tethered ESN

Not used

Not used Strobe Bulb tethered ESN

Not used Flow Cell tethered ESN

Focus Position Optical Sensors P1

Stepper Motor Phase Coils

Strobe Trigger Unit tethered ESN

Iris config.: Dual opto-focus home. Newport config.: end limits for linear actuator.

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Do-All SIC # 101-5046

The Do-All SIC is used for interfacing to SMCS backplane J18 through a 40-wire ribbon cable, and providing a concentrating place for the cables to all of the SMCS pressure transducers, the FITDs. The Do-All SIC is mounted alongside the FSV SIC on the Fluid System Valve Assembly.

The Do-All SIC connectors are summarized on the table below.

Connect. Type Connects to Function

J1 40-pin ribbon header Backplane J18 Main signals to SMCS

J2 10-pin ribbon header Pressure Transducer #1 Pressure Transducer #1

J3 10-pin ribbon header Not used Not used

J4 10-pin ribbon header Not used Not used

J5 10-pin ribbon header Not used Not used

J6 12-pin female Not used Not used

J7 12-pin female Not used Not used

J8 12-pin female ESN FITD #3 P1 Specimen FITD

J9 12-pin female ESN FITD #4 P1 Waste Well FITD

J10 12-pin female Not used Not used

J11 12-pin female Not used Not used

J12 12-pin female Not used Not used

J13 12-pin female Not used Not used

J14 12-pin female Not used Not used

J15 12-pin female Not used Not used

J16 12-pin female Not used Not used

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Rear Panel SIC # 101-5058

The Rear Panel SIC provides the signal interface from the SM to the external world through three DB9F connectors. It has in internal interface to the internal Lamina Container level sensor. It provides an ESN connector for the cooling fan, and a tethered ESN for identifying the SMCS power supply. It connects to backplane connector J11 through a 26-wire ribbon cable (J1).

STM SIC # 101-5014

The STM SIC provides an interconnect capability between the two built-in cables from the Arkray STM to the Microscopy Module. It interfaces to the cardcage backplane connectors J20 and J21. It is also the interface point for the diaphragm pumps of the Microscopy Module, the Specimen Tube Detector (mounted on the STM), and the tethered ESNs for the STM and for the Barcode Reader.

Other PCBAs

Lamina cable # 101-5048

The Lamina cable is used as part of the Lamina Container Assembly for interfacing (and identifying) the float sensor switches of that assembly. It provides for three of the four switches on the Lamina Container Assembly to be summed through a weighted resistor network for a pseudo-analog level detection scheme.

FITD PCBA # 101-5041

The PCB of this assembly is incorporated into two different subassemblies for detecting the presence of water-based fluids in its proximity.

SM Status Board PCBA # 101-5032

The SM Status board is both a display panel providing a user visual interface and covers interlock switches for the top cover and the front access door. It interfaces to SMCS backplane J10 through a 20-wire ribbon cable.

STD PCBA # 101-5034

The Specimen Tube Detector board is a small electro-optics assembly that is part of the Specimen Tube Detector. It senses the presence of a

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specimen test tube at the STM test station. It has a 6-pin connector for interface to the STM SIC.

Pressure Transducer Board #101-5016

The Pressure Transducer board is mounted to a pressure transducer and a signal-conditioning amplifier to provide a pressure signal from a liquid or air medium. The board electrical interface is via an integral 10-pin ribbon cable. The Air Storage pressure transducer connects to J2 of the Do-All SIC.

SPA Optical Board # 101-5052

This board supports three optical interrupters, and is mounted on the top of the SPA assembly. Two of the interrupters are for the SPA arm rotation movement home and forward limit detections, and the third is for the Vertical movement (top) home detection.

LED Visual Indicators

LED visual indicators are used throughout the SMCS to provide local indication of status. LEDs will be red, green, and yellow (or amber). Generally, the red LED will indicate a fault condition, and the yellow LED will indicate a “caution” condition.

1. On the Cardcage boards, the LEDs are positioned in two rows at the front edge of the board where they are viewed normal to the board’s surface, but they can be seen in a front view of the card cage by viewing slightly towards the component side of the PCBs.

2. On the SMCS backplane, they are located in the area above the connectors, generally non-obscured by the cables connected to the backplane. All of the LEDs on the backplane are red, and indicate which (if any) of the 22 fuses are blown.

3. On the various remote circuit boards, they are appropriately placed for the application.

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Adjustments

Accessing the Service Screen ....................................................................................... 4-3

Calibration Table ........................................................................................................4-4

Calibration Auto-Sets .............................................................................................. 4-4

Sampler Calibration .......................................................................................................4-6

Material required.........................................................................................................4-6

Procedure...................................................................................................................4-6

Distance to eject the rack to the stockyard.................................................................4-7

Material required.........................................................................................................4-7

One glass 16 x 100mm test tube ................................................................................... 4-7

Procedure...................................................................................................................4-7

Material required.........................................................................................................4-8

Procedure...................................................................................................................4-8

STD Verification Procedure .........................................................................................4-10

Specimen Presentation Assembly (SPA) and Waste/Rinse Well Calibration .............. 4-11

Material required.......................................................................................................4-11

Procedure.................................................................................................................4-11

Waste Well Positioning .........................................................................................4-11

Test Tube Centering Position ...............................................................................4-12

Test Tube Depth Positioning.................................................................................4-13

Waste Well Depth Positioning...............................................................................4-15

Lamina Consumption Adjustment ......................................................................... 4-15

Air Pressure Calibration ...............................................................................................4-16

Material required.......................................................................................................4-16

Procedure.................................................................................................................4-16

Barcode Reader Alignment.......................................................................................... 4-17

Material Required .....................................................................................................4-17

Procedure.................................................................................................................4-17

Prepare Barcode Reader Connections ................................................................. 4-17

Load the Alignment Tool ....................................................................................... 4-18

Perform barcode alignment...................................................................................4-18

Validation ..............................................................................................................4-21

Collimation ................................................................................................................... 4-22

What is a Collimation?.............................................................................................. 4-22

Condenser Alignment ............................................................................................... 4-22

Run Auto Focus........................................................................................................4-23

Flow Cell Replacement ................................................................................................4-24

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Flow Cell Removal....................................................................................................4-24

Flow Cell Installation.................................................................................................4-25

Flow Cell Lateral Adjustment ....................................................................................... 4-26

Flow Cell Tilt Adjustment .............................................................................................4-27

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Accessing the Service Screen

Press the Windows key on the keyboard (located between Ctrl and Alt keys). The Windows toolbar will be displayed at the bottom of the screen.

On the tool bar, left click on SM. The screen will display the SM screen. Select File – Switch to Service Application.

Select Yes to switch to Service Application. The system will prompt to switch off the Microscopy Module. When connections are established with the Results Processor, the system will prompt you to turn the Microscopy Module back on. After about 1 minute, the Service Screen will be displayed.

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Calibration Table

The tree displays relevant calibration table entries. Each entry indicates its calibration table position as well as its purpose and often the sequence from which it’s activated (e.g., “cal[1]: RC: CP Velocity for fast push” indicates calibration table index 1, activated from sequence “RC”, purpose “Velocity for fast push”). In general, if you double-click on a calibration table entry you will be prompted for a new value to set.

Calibration Auto-Sets

In some cases there is more than one item in the tree for a given calibration table entry. In such cases, the second entry provides a more convenient way to set the value. The label indicates what the shortcut will do; double-click on the shortcut to perform the action. For example, “cal[1]: Double-click here to auto-set (Register 0x0A - cal[0])” will set calibration table entry 1 to the difference of register 0x0A and calibration table entry 0. See Register 0x0A

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Sampler Calibration

Test tube position #5

The purpose of this calibration is to properly set the location of the #5 test tube rack position. The other positions are set automatically.

Material required

Normal control rack with rubber tube rest removed from tube position 5.

Procedure

1. Start Service Application, then power up the iQ200.

2. Place the control rack on the right side of the Sample Transport Assembly.

3. Open the “STM” from the Service Application menu tree then “Sequences” then double click “Initialize Rack (‘M1’)” then “OK”.

4. From the Service Application menu tree under (STM, Sequences) select, then double click “Move Next” (‘MN’)” then “OK”. Repeat 4 times so as to be in the 5

5. The hole in the bottom of tube position 5 should be centered over the floor plates of the Sampler. a. If the hole is aligned directly in the center of the floor plates, no

further calibration is required.

b. If the hole has stopped short of or passed over the floor plate

edges, a new calibration value must be entered.

6. To change the calibration value, go to the STM’s Calibration branch and double click on “Delta position from home to tube –1=XXXXX”. The position is controlled by Table Index “XP 00” which is set to a value of “00000280”. Re-set this value higher or lower depending on the position desired.

Note: Value “00000275” will position the rack short of the original value, “00000285” will move the rack further than the original value.

position of the rack.

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Distance to eject the rack to the unload station.

The purpose of this calibration is to properly set the distance to eject the rack from the sampler so the rack transfers the correct distance onto the unload station.

Material required

Two routine racks One glass 16 x 100mm test tube

Procedure

1. Start Service Application.

2. Place a routine rack on the left side of the Sampler in the transfer position.

3. Place a routine rack on the right side of the sampler.

4. From the Service Application menu, click on “STM” then “Calibration

table”

5. Click on “Sequences” then double click “Initialize Rack (‘M1’)” then “OK” to activate the Sampler and present the test tube rack to the #1 position.

6. When you double-click on the “MN” “Move Next” command, a signal is sent to eject the rack to the unload station.

7. Measure the distance between the end of the rack and the frame of the unload station. There should be approximately three millimeters between the rack and the frame.

8. If this distance is not correct, change the cal [3]: Distance to eject to

stock yard.

9. Double click on the line cal [3]: Distance to eject to stockyard to bring up the cal value entry window. Increase or decrease the number to change the distance the rack is ejected to the unload station.

Note: Changing the value 10 Hex will change the rack move distance approximately 1 millimeter.

10. Repeat the “MN” “Move Next” command as needed to repeat this test.

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Specimen Tube Detector Calibration

The purpose of this calibration is to set both the tube detector alignment and sensitivity. The Specimen Tube Detector is an electro optical device used to detect the presence of a specimen tube in the tube rack. The STD emits a beam of light directed at the #1 tube position, which reflects off the surface of the tube back to a collector in the STD. The intensity of the reflected beam is converted to a hexadecimal value. This value is compared to the pre-set threshold value. If the value is above the threshold, the software concludes a tube is present.

Note: Make sure the Sampler calibration has been performed BEFORE calibrating the Specimen Tube Detector.

Material required

Routine rack with retaining clip on #5 position. One glass 16 x 100mm test tube with blank label with vertical centerline drawn on it.

Procedure

1. Start Service Application.

2. Insert the tube with white label and vertical centerline drawn on it, making sure it is correctly oriented in #5 position. Place the Routine Rack on the right side of the Sampler.

3. From the Service Application menu, click on “STM” then “Sequences” then double click “Initialize Rack (‘M1’)” then “OK” to activate the Sampler and present the test tube rack to the #1 position.

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4. Double-click on “MN” “Move Next” command until the tube is presented before the tube detector.

5. Verify that the tube detector’s red spot is centered on the tube’s centerline as shown. Physically adjust the tube detector if necessary: a. Loosen the retaining screws. b. Adjust the STD position until the red spot is

centered on the line.

c. Tighten the retaining screws to secure the

STD.

6. Double-click on “MN”, then OK to move to the next empty position.

7. From the Service Application STM menu, click on “Sensors” then double-click “tube detect (raw)”

8. Record the value for no tube position.

9. Use the hexadecimal calculator to compute the new threshold value: (no tube recorded value + 5 Hex). Example: If the no tube threshold is 1F + 5 Hex = 24. Enter this

calculated value in the Tube Detect Threshold field.

10. From the Service Application menu, click on STM’s “Calibration

Table”, then click on “Tube Detect Threshold”, enter the calculated

value and click “OK”.

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STD Verification Procedure

Test Configuration Tube Detect Range Your value

Glass tube with white label facing STD Between 0X90 – 0XFF

No tube Between 0X20 – 0X80

Range =

Using the hexadecimal calculator, subtract No Tube value from glass tube with label value to obtain the range.

Range should be greater than 0X30Hex

Replace STD assembly if this test fails

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Specimen Presentation Assembly (SPA) and Waste/Rinse Well Calibration

This procedure describes the steps necessary to calibrate the SPA module and the Waste Well with respect to each other and the #1 tube position of the Sampler.

Material required

Procedure

Note: Make sure the Sampler calibration has been performed BEFORE

calibrating the Specimen Tube Detector.

Normal Specimen Rack with test tube in position #1.

Waste Well Positioning

1. Start Service Application.

2. Insert a Normal Specimen rack with a standard glass tube in position #1 and place the rack on the right side of the sampler.

3. From the Service Application menu tree, open SPA and then open the

SPA’s Calibration table.

4. From the top windows tool bar click Jog.

5. Select SPA Rotational Jog (The Jog Velocity window will appear)

6. From the Jog Velocity window, select Home.

NOTE: The pipette tip should be located directly behind the rinse/waste well.

7. Using the up down arrows on the keyboard, center the pipettor over the Waste Well and click Home then “OK”.

8. From the Service Applications menu tree SPA Calibration table Double click on “cal[0] Double-click here to auto-set the new waste well calibration value.

9. Click YES to confirm. Your new calibration value has now been set.

10. Verify proper setting: a. From the SPA menu tree open Sequences and select “Pipettor

Home (‘PH’) and then OK to execute. Verify the pipette tip is

centered over the Waste Well.

NOTE: This should position the test tube located in position 1 into the correct sampling position. If not recalibrate the STM.

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Test Tube Centering Position

1. Open the STM branch from the Service Application menu tree.

2. Open Sequences and double click Initialize Rack “M1” and click OK to execute the command. This positions the rack at the #1 tube position.

3. From the top windows tool bar click Jog.

4. Select SPA Rotational Jog (The Velocity window will appear).

5. From the Jog Velocity window, select Home.

6. Using the up down arrows on the keyboard, center the pipette over the center of test tube located in position #1 and then click Home then “OK”.

7. From the SPA calibration table Double click on cal[1]:Double-click

here to auto set to store test tube #1’s new calibration value.

8. Click YES to confirm. Your new calibration value has now been set.

9. Immediately, double-click on Cal [2]: Double-click here to auto set to auto set neg value of CAL 1.

10. Click YES to confirm.

11. Verify proper setting: a. From the Service Application menu tree, under SPA Sequences

double click on “Pipettor Home “PH”.

b. Click OK to execute and verify the pipette tip is centered over the

Waste Well.

c. Double click on To Tube “TT” and click OK to execute and verify

the pipette tip is centered directly over the center of test tube #1.

12. Exit the service application.

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Test Tube depth positioning

SPA pipette depth calibration check:

1. On the Service Application’s SPA “HVL Sequences” branch, click on “P0” pipette home and rotate to the tube

2. Then click on “P0” pipette home and rotate to the tube

3. Then click on “P1” pipette down to tube – during this sequence you should check that the pipette descended down with only 3mm clearance with a tolerance of +/- 0.5mm.

4. Then click on “P2” pipette up and rotate and down to waste well and

finally up from waste well.

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SPA pipette depth adjustment:

1. This procedure should only be done if it is determined that the test

tube depth positioning is incorrect. From the top windows tool bar click Jog.

2. Select SPA Vertical Jog (The Velocity window will appear).

3. From the Jog Velocity window, select Home.

4. Using the up down arrows on the keyboard, lower the pipette into the

test tube until it’s 3mm from the bottom of the tube (the test tube can be lifted to determine the distance the pipette is from the bottom of the tube) then click Home then “OK”.

5. From the Service Applications menu tree SPA Calibration table

Double click on cal[3]:Double click here to auto set .

6. Click YES to confirm. The new calibration value has now been set.

7. From the SPA sequence menu, double-click PH-Pipettor Home.

8. Perform the “SPA pipette depth calibration check” procedure. If the

system hangs during this procedure, you will need to call Iris Technical Service for cal [31] to determine this new calibration value.

9. Exit Service Mode.

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4. Adjustments

Waste Well Depth Positioning

Cal 31 value is pre-set in factory. If any adjustment is needed, contact Iris Technical Services.

Lamina Consumption Adjustment

Cal 30 value is pre-set in factory. If any adjustment is needed, contact Iris Technical Services.

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Air Pressure Calibration

Material required

Calibrated air pressure gauge 16 x 100 mm round bottom glass tubes Iris Diluent

Procedure

1. Remove the shield to access the front of the instrument.

2. Insert a T fitting between the air pressure pump line and the air pressure bottle (black connector).

3. Run a line from the T fitting to a calibrated air pressure gauge.

4. Place a tube with 10mL of Diluent in a rack.

5. Place the rack on the right side of the sampler and press GO. The air system pressurizes during the fluid wash procedure.

6. Read the air pressure on the air pressure gauge following the sample cycle. The air pressure should be between 5.0 ±0.5psi.

7. If the air pressure needs to be adjusted, proceed with the following steps: a. Start the Service Application. b. Under the SPA Calibration, adjust the value cal [14]: pressure

setting. If the air pressure is too high, decrease the pressure

setting value by one step at the time (2 Hex = 1 psi.)

c. Repeat steps 4 through 6 until the air pressure reading on the

gauge is within the acceptable range.

8. Process several samples after the adjustment has been made: a. When the pipette descends into a sample tube, the pipette

releases a single large bolus of air. The sample will shoot up inside the tube to about 1 cm from the top of the tube.

b. If the sample overflows the top of the tube, decrease the air

pressure.

9. Acceptance criteria: a. Air pressure: 5.0 ±0.5psi.

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Barcode Reader Alignment

Material Required

Procedure

NOTE: The light beam from the Barcode Reader is of low intensity and

usually difficult to see. Reducing the ambient light will increase the visibility of the beam.

Routine Rack 16 x 100 mm glass test tube Barcode reader alignment tool PN 725-3090 Barcode reader Y cable PN 250-3084 Barcode Reader Field Software PN 700-3110

Make sure the Sampler Calibration has been performed.

Prepare Barcode Reader Connections

1. Turn the iQ200 microscopy unit off.

2. Remove the Lower Front Panel assembly.

3. Use the Barcode Reader “Y” cable (IRIS part# 250-3084) for RS232 and 5 VDC power connection to the Barcode Reader.

Connect to barcode reader

Connect to RS232 laptop communication port

Connect to J13 on back plane for 5volts

ower

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4. Connect the permanent cable from the Barcode reader to the female receptacle on the “Y” cable for the alignment.

5. Connect the J13 connector on the “Y” cable to J13 on the Backplane. Do not force the J13 connector, it is keyed to go in one way.

6. Turn on the iQ200 to power up the barcode scanner.

7. Connect the RS 232 cable to the communication port of the laptop.

Load the Alignment Tool

1. Load the “Barcode Reader Alignment Tool” (IRIS part# 725-3090) like a normal rack in the iQ200 sampler.

Alignment Graphic

Barcode Reader Alignment Tool

2. Start the Service Application.

3. From the Service Application, click on STM, then Sequences.

4. Double-click on Initialize Rack M1 and then click OK.

5. Double-click on Move Next MN and then click OK until the rack is positioned at the fifth position.

6. Leave the Alignment tool in the fifth (5

) position.

Perform barcode alignment

1. Start the “Barcode Utility Program” from the Laptop computer.

2. Use the COM Setup drop down menu on the main screen to select an open COM port (probably COM1 on a laptop) in order to establish communication between the Barcode reader and the laptop. The main screen view should display “Online” if the connection is successful.

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3. Click the “Align” button to perform the Barcode Scanner alignment. The screen on the right will be displayed.

4. The screen will probably be like one of the next two views:

• Red is way out of alignment

• Green is close to being aligned

If the indicator is

The barcode reader positioned HIGH Needs to be aimed lower LOW Needs to be aimed higher LEFT Needs to move to the right RIGHT Needs to move to the left CLOSE Is to close FAR Is to far

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Tilt pivot, “up and down

Tilt locking screw

Focus, “close and

Lateral adjustment slots, “left and right”

far” slots

5. Move the reader until the green circle is perfectly centered on the cross hairs, and the distance bar is centered and green. Tighten all the screws to hold the readers position when it is aligned.

6. Install the Lower Front Panel assembly. Ensure that the “Barcode Utility Program” Alignment screen is still the same. There should be no change in the alignment on the screen.

7. Click the Exit button when the alignment is completed and the reader is aligned.

8. Close the “Barcode Utility Program”.

9. Ensure that all of the alignment and mounting screws are tight.

10. Turn off the iQ200 power.

11. Remove the “Y” Cable.

12. Plug the cable from the reader into J13 on the Backplane. Do not force the J13 connector it is keyed to go in one way (key is facing down for proper orientation).

13. Exit the Service Application.

14. Restart the entire iQ200 system.

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Validation

1. To ensure the barcode reader is reading and the system is working, load an iQ200 control rack with properly labeled tubes to perform Prime (first three tubes), Focus (5

and 7th tube). Check the results to be sure that the system is

working properly.

2. Load a rack with tubes labeled with the customers labels filled with any material (focus, positive control, diluent, tap water etc.) Run the rack on the iQ200 system and check the results in the Work list to be sure that all labels read properly. If connected to an AX-4280, run the sample rack on both analyzers, and make sure that chemistry and microscopy results are attached.

3. If the system performs properly, the procedure is complete

4. If the barcodes do not read properly, recheck the alignment (it will be necessary to reinstall the “y” cable and hook up the laptop again to do so).

tube) and Positive / Negative QC

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4. Adjustments

Collimation

What is a Collimation?

Collimation is the adjustment of the alignment of each optical element with regard to the others. The collimation is a way of improving considerably the optical performance. No high-resolution result can be obtained without an near perfect collimation, since image processing is incapable of compensating for the damages caused by a misalignment.

Condenser Alignment

1. Open the Service application.

2. From the Service application, click on View then Video to display the live video.

3. In Video View, the Avg light should be about 210 and the Var. should be lower than .035.

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4. Turn the vertical knob clockwise to reach one edge of iris.

5. Turn the vertical adjustment knob counter clockwise to the other edge of the iris.

6. Adjust the vertical knob until the condenser is centered.

7. Repeat above steps with the horizontal knob until the image is centered.

8. Close the Live Video window.

9. Exit the Service Application.

Run Auto Focus

Run one glass tube with barcode label filled with 6mL of Focus in position 5 of a QC rack.

Vertical adjustment

Horizontal adjustment

Iris Diagnostics, a Division of International Remote Imaging Systems, Inc.

200 Sprint™ Automated Urine Microscopy Analyzer Service Manual 300-4949 Rev A 01/2005 4-23

Iris Diagnostics IQ200 Sprint User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Service Manual

Table of Contents

1 - Introduction

2 - Installation Procedures

3 – Components

4 – Adjustments

5 - Service Application Software

6 - Troubleshooting

7 - Electronics

8 - Schematics

9 - Preventive Maintenance

Intended Use

How to use this Manual

Precautions and Warnings

Notes

Cautions

Warnings

Biological Warning

Warranty

Limitation of Liability

Use of Third Party Computer Products

Iris Diagnostics Contact Information

Installation

Installation Requirements

Space Requirements

Workstation

Location

Requirements

Installation

Shipping Cartons

Instrument Carton

Starter Kit A Carton

Starter Kit B Carton (needs refrigeration)

Optional

Installation

Precautions

Unpacking the Instrument

Connecting the Sampler

Adjust the Height of the Analyzer

Adjust Sampler

Installing the Lamina Container

Connecting the Drain Tubing

Computer Connections

iQ200 Rear Panel SIC Connection Configurations

iQ200 / AX-4280 Bridge Installation Instructions

Optional Load/Unload Station Installation

Load Station - iQ200 Connection

Load Station - AX-4280 Connection

Unload Station

Startup

Run Focus

Run Calibration Rack

Run Control Rack

Verify Load/Unload and Bridge Connections

Preparation for Starting Operation

Perform Setup

3. Components

Sample Transport Mechanism

Sampler # 700-3006

Specimen Tube Detector # 700-3725

Barcode Reader # 700-3315

Specimen Presentation Assembly # 700-3700

Crash Detect Function

Waste/Rinse Well # 700-3830

Diaphragm Pumps

Air Pump # 700-3877

Waste Pump # 700-3809

Rinse Pump # 700-3874

Fill Pump # 700-3874

Peristaltic Pumps

Cannula Pump # 700-3820

Lamina Pump # 700-3804

Evacuation Pump # 700-3820

Pump Cover Closed and Cassette-In-Place Detection

Lamina Tank # 700-3784

Air Tank # 700-3802