CLINITEK Atlas Automated Urine Chemistry Analyzer Operating Manual June 2007

Contents 1 INTRODUCTION General Information/Intended Use... 1-1 Physical Characteristics... 1-4 Control System-Analyzer... 1-4 Control System-Rack Sample Handler... 1-6 Sample Transport System... 1-7 Pipetting System... 1-8 Reagent Transport... 1-9 SG Refractometer/Clarity Device... 1-10 Rinse/Waste Systems... 1-11 Detection Systems... 1-12 Automated Bar Code Reader... 1-13 Rear of the Instrument... 1-14 Power Supply-Rack Sample Handler... 1-15 Optical System... 1-16

Specifications... 1-17

2 INSTALLATION AND POWER UP Installation... 2-1 Environmental Factors... 2-1 Power-Up... 2-2 STATUS Display... 2-4

3 MAIN MENU Recall/Delete Results... 3-2 Set Sequence Number... 3-2 Set Date/Time... 3-3 Change Date Format... 3-3 Change Date... 3-3 Change Time Format... 3-3 Change Time... 3-4

Load/Unload Reagents... 3-4 Prime Pump... 3-4

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CLINTEK ATLAS with Rack Sample Handler Operating Manual

Clean SG Well... 3-5 Set Tone Volume... 3-6 Set Up Analyzer... 3-6 Analyzer Diagnostics... 3-6 Softkey Options... 3-7 Print QA Report... 3-7 Print Setup... 3-8

4 CUSTOMIZING THE SOFTWARE General Information... 4-1 User Setup Mode-Sample Handler... 4-1 Rack Circulation... 4-2 Bar Code Reader... 4-3 Bar Code Errors... 4-5 Rack Number Reset... 4-6 Pipette Height... 4-6 Review Setup Parameters... 4-7

Set Up Analyzer Routine - Instrument... 4-8 Analyzer Operation Menu... 4-9 Reagent Pak Name... 4-9 Sample Tray Type... 4-9 Results Format... 4-9 Result Units... 4-11 Waste Bottle... 4-11 STAT Reset Time... 4-12 QA Memory Status... 4-12 Auto. Run After Cal... 4-14 End of Run Review... 4-14 Return to the Setup Analyzer Menu... 4-15

Specimen Information Menu... 4-15 Specimen ID Source... 4-16 Load List Deletion... 4-19 Record Urine Color... 4-20 Color Determined By... 4-20 Select Colors... 4-21 Set Color Normal Range... 4-21 Record Urine Clarity... 4-22 Clarity Determined By... 4-23 Adjust Clarity Ranges... 4-23

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Return to the Setup Analyzer Menu... 4-24

Analyte Information Menu... 4-25 Analytes Reported... 4-25 Analyte Report Order... 4-26 Use PLUS System... 4-27 SG Measurement... 4-27 Alter Ranges... 4-28 Mark Abnormal Results... 4-30 Set Normal Ranges... 4-31 Sieve Results (Version 7.11 or Higher)... 4-32 Define Sieves... 4-33 Return to Set Up Analyzer Menu... 4-34

Connect to Computer Menu... 4-35 Port Connection... 4-35 Baud Rate... 4-36 Data Bits... 4-36 Parity... 4-36 Stop Bits... 4-36 Handshake... 4-37 Checksum... 4-37

Second Connect to Computer Menu... 4-37 Send Color... 4-38 Send Clarity... 4-38 Send Control Results... 4-39 Send STAT Results... 4-39 Send Calibration Results... 4-39 Send Tray/Tube with Data... 4-40 Return to the Setup Analyzer Menu... 4-40

Connect to Printer Menu... 4-41 Port Connection... 4-41 Paper Type... 4-42 Printout Format... 4-42 Print Routine Results... 4-43 Print STAT Results... 4-43 Print Control Results... 4-44 Form Feed End of Run... 4-44 Return to the Setup Analyzer Menu... 4-44

Language... 4-45 Complete Set Up Analyzer and Print Configuration Changes... 4-45 Operating Note... 4-45

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CLINTEK ATLAS with Rack Sample Handler Operating Manual

5 LOADING THE REAGENT ROLL 6 CALIBRATION/TESTING CONTROLS Calibration... 6-1 Testing Controls... 6-5 If Control Results are Out of Range... 6-8

7 ROUTINE OPERATION Standby Mode - Analyzer... 7-1 Standby Mode - Sample Handler... 7-2 Menu Mode - Sample Handler... 7-3 Bar Code Error... 7-3 Starting Rack Number... 7-4 Starting Sample Number... 7-4

Routine Analysis... 7-5 Prepare Specimen Racks... 7-5 Place Racks onto Sample Handler... 7-7 Analysis... 7-8

Operating Notes... 7-10 Testing STAT Specimens... 7-11 Using the STAT Holder... 7-11 Using the STAT Rack... 7-11 Obtaining STAT Results... 7-12

Recovering from Rack Sample Handler Errors... 7-13 To begin testing again... 7-13

End of Run Review... 7-14 Error Conditions... 7-15 Specimen Information... 7-15 Sieve Lists... 7-18

Disposal of System Waste and Supplies... 7-20

8 RECALLING AND DELETING RESULTS Recalling Results... 8-1 Recall Results By Sequence Number... 8-2 Recall Results By Specimen ID... 8-3 Recall Results By Lot ID... 8-3

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Recall Results By Date... 8-3 Results Screen... 8-4

Deleting Results... 8-5

9 MAINTENANCE General Information... 9-1 Daily Maintenance... 9-2 Sample Handler/Racks... 9-2 SG Well... 9-2

Periodic Maintenance... 9-3 When Loading New Reagent Roll... 9-3 Readhead Assembly and Platform... 9-4 Readhead Sockets... 9-5 Tube and Rack Sensors... 9-9 Checking for Leakage... 9-11 Cleaning the Rack Movement Pawls... 9-12

Disinfection of the Instrument... 9-13 Maintenance Log - CLINITEK ATLAS® with Rack Sample Handler... 9-1

10

TROUBLESHOOTING Troubleshooting - General Information... 10-1 Warnings in the Standby Mode (Ready for Testing Screen)... 10-2 When to call for assistance... 10-2 Messages Displayed on the Sample Handler Screen... 10-3 Messages Displayed on the Analyzer Screen... 10-5

11

ANALYZER DIAGNOSTICS Replace Hardware... 11-1 Adjust Tube Detector... 11-1 Reset Analyzer Setup Defaults... 11-2 Display Rev. Level/Cycles/Password... 11-2 Display Calibration Data... 11-3 Display Test Data... 11-3 Display Sensor Status... 11-3 Test Display, Keypad, and Ports... 11-4

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CLINTEK ATLAS with Rack Sample Handler Operating Manual

Serial Port Loop Back Test... 11-4 Serial Port Output Character Test... 11-5 Parallel Port Output Test... 11-5 Display Test... 11-6 Keypad Test... 11-6

Return to Diagnostics Menu... 11-7 Install Shipping Lock... 11-7 Return to Main Menu... 11-7

12

MINOR REPLACEMENT AND ADJUSTMENTS Replacing the Fuse... 12-2 Materials Required... 12-2 Procedure... 12-2

Replacing the Lamp Assembly... 12-4 Materials Required... 12-4 Procedure... 12-4

Replacing the Pipette Assembly... 12-7 Materials Required... 12-7 Procedure... 12-7

Replacing the Rinse Tubing... 12-11 Materials Required... 12-11 Procedure... 12-11

Replacing the Syringe... 12-15 Materials Required... 12-15 Procedure... 12-15

Replacing the Valve... 12-18 Materials Required... 12-18 Procedure... 12-18

Lubricating the Syringe Lead Screw... 12-21 Materials Required... 12-21 Procedure... 12-21

13

SERVICE, SUPPLIES AND PARTS Service Information... 13-1 When You Have a Problem With the Instrument... 13-1 Where to Call for Service... 13-1

Preservice Checklist... 13-2 To Order Supplies and Replacement Parts... 13-4

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CLINITEK ATLAS Supply Items... 13-5 Other (Optional) Supplies... 13-7

Replacement Parts... 13-7 Instrument Information... 13-9

14

BAR CODE Reader General Information... 14-1 Installation... 14-1 Setting Up and Testing the Bar Code Reader... 14-1 Troubleshooting... 14-2 Specifications... 14-3 Bar Code Formats... 14-3 Bar Code Symbols and Labels... 14-4

Routine Care... 14-5

Appendix A: List of Symbols Appendix B: List of Offices Appendix C: Protecting Yourself from Biohazards Appendix D: Laser Safety Appendix E: Readhead Optic Placement Appendix F: Customer Bulletins

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CLINTEK ATLAS with Rack Sample Handler Operating Manual

1 INTRODUCTION General Information/Intended Use The CLINITEK ATLAS® Automated Urine Chemistry Analyzer is a fully automated reflectance spectrophotometer. It is intended for professional in vitro diagnostic use in performing urinalysis testing. The CLINITEK ATLAS uses CLINITEK ATLAS Reagent Paks that are made specifically for use with this instrument. Each Reagent Pak contains a roll of reagent strips, each containing reagent areas for testing glucose, bilirubin, ketone (acetoacetic acid), occult blood, pH, protein, urobilinogen, nitrite, and leukocytes. The reagent roll also includes a pad for determining the color of the specimen. The instrument determines the specimen’s specific gravity (SG) using the refractive index method. It also determines the clarity by measuring the transmission and scattering of light that passes through the specimen. The CLINITEK ATLAS Rack Sample Handler is designed specifically for use with the CLINITEK ATLAS Analyzer, attaching to the front of the instrument. It allows an unlimited number of specimens to be analyzed sequentially (as long as there are reagent strips remaining on the roll). Depending on the option selected, an unattended run can also consist of a maximum of either 100 or 200 specimens.

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CLINTEK ATLAS with Rack Sample Handler Operating Manual

Figure 1-1 The CLINITEK ATLAS instrument analyzes the color and intensity of the light reflected from the reagent area and converts the results into clinically meaningful units (see Tables 4.1 to 4.10). The optical system includes a tungsten filament halogen read lamp, illuminating a large fiber optic bundle of fourteen separate fiber optics. The fiber optics conduct lamp light to the pad surfaces and to a the reference area (fourteenth channel position). Reflected light at specific wavelengths enters a second set of fourteen return fiber optics. This reflected light is channeled to ten interference filters at different wavelengths. The reflected light then hits a photo detector. The photo detector output provides an analog signal (representing an amount of reflected light) that is converted into a digital value that represents meaningful units of measurement for each reagent pad. No calculations are required by the operator. Results may be recalled to the display screen or transferred to a printer and/or host computer. The electronic design and automated features of the analyzer enable the instrument to perform 12 separate tests on each urine specimen at a rate of 16 seconds per specimen. The instrument is left on at all times, which minimizes warm-up times and allows for proper maintenance of the SG refractometer.

INTRODUCTION

1-3

The instrument is calibrated using four solutions found in the CLINITEK ATLAS Calibration Kit. A cleaning cycle and dry pad calibration are also performed as part of the Calibration Mode. At least 490 specimens, including calibrators and controls, can be tested with each reagent roll. Refer to your laboratory quality assurance program to ensure quality throughout the entire testing process. Tubes containing samples to be tested are loaded into racks that each hold 10 tubes. Up to ten racks can be placed into the rack area on the right side (infeed). A minimum of two (2) mL of urine is required for testing. This Operating Manual is designed to provide the user with the necessary information to operate and maintain the CLINITEK ATLAS System. The entire manual should be read before using the instrument. Pay special attention to Section 3 through Section 8.

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CLINTEK ATLAS with Rack Sample Handler Operating Manual

Physical Characteristics Control System-Analyzer

1

12-Line Display

2

Soft Keys

3

Keyboard

Figure 1-2 Communications between the operator and the instrument are made through the keyboard and the 12-line display. All instructions, menus, and messages are shown on the display, and the operator responds through the keyboard. A screen saver will activate after 60 minutes of no activity on the keyboard. Press any key to return to the previous screen. (Version 7.11 or higher)

INTRODUCTION

1-5

The keyboard consists of ten numeric keys (0-9) plus three additional keys, whose functions are described below: Key

Definition

Description

BACKUP

Returns the display to the previous (most recent) screen. If the cursor is in a data entry field, moves the cursor one position to the left and, in some cases, deletes that character. When the cursor is at the left-most position, restores the prior entry in the data entry field. If pressed again, exits the data entry field.

STANDBY

Saves the data on the current screen, then returns the display to the Standby Mode (“Ready for Testing” screen).

ENTER

Enters into memory the numeric information input or selects the menu option on which the cursor is located.

In addition to the 13 predefined keys, there are four “soft” keys along the bottom of the display. The function of these keys is defined by the specific screen being displayed. The specific key function is displayed immediately above the key. Not all of the softkeys are functional in every screen display. Whenever an active keypad is pressed, a confirmatory key click sounds, unless this option has been turned off by the user. If an inactive keypad is pressed, a series of three short tones sounds.

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CLINTEK ATLAS with Rack Sample Handler Operating Manual

Control System-Rack Sample Handler

1

LED Keys

2

LCD Display

Figure 1-3 Communication between the operator and the Sample Handler is accomplished through the use of an LCD display and three LED keys located on the Sample Handler. During certain modes, each key lights up in a different color (green, yellow, or red) that corresponds to the function of the key. The key functions are also defined by the specific screen being displayed, in the same manner as the “soft” keys on the Analyzer display.

INTRODUCTION

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Sample Transport System

1

Sample Handler Outfeed

2

Circulation Area

3

STAT Holder

4

Sampling Area

5

Sample Handler Infeed

Figure 1-4 The platform of the Rack Sample Handler consists of two rack loading or unloading areas, the infeed on the right side and the outfeed on the left. Racks can be loaded onto the right side only or onto both sides. Each rack is moved from front to back on the right side. It is then moved across the sampling area (right to left), then pushed from back to front on the left side. If the circulation function is selected, the racks continue to move across the front of the Rack Sample Handler (through the circulation area) from the left side to the right. The racks are moved through the pushing action of sets of pawls, one on each side of the rack for forward/backward movement and a single one at the end the rack for side-to-side movement. The STAT holder holds a single sample tube for processing in the STAT mode. It also holds the tube of bleach for performing the SG well cleaning cycle.

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CLINTEK ATLAS with Rack Sample Handler Operating Manual

Pipetting System

1

Syringe Pump

2

Pipette

3

Pipette Transport

Figure 1-5 The pipetting system consists of the syringe pump, pipette, and pipette transport. For each sample: 1. The pipette moves to the appropriate tube on the sample tray and senses the sample level.

The pipette will not detect non ionic solutions such as distilled or deionized water. 2. It then aspirates a small amount of the sample. 3. The pipette moves into position above the first reagent pad and dispenses a specific

amount of sample onto each of the reagent strip pads and into the SG well for determination of the specific gravity and clarity. 4. It dispenses the remaining sample, followed by a larger volume of Rinse Solution, into

the rinse well. This rinses both the inside and outside of the pipette. 5. Finally, the pipette dispenses the Rinse Solution into the SG well to ensure complete

rinsing of the well.

INTRODUCTION

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Reagent Transport

1

Reagent Storage Module

2

Readhead Assembly

3

Takeup Shaft

Figure 1-6 The reagents, which are carried on a plastic backing, are transported from the reagent storage module through a series of sprockets. Each reagent strip is transported beneath the pipette, where a precise volume of urine sample is dispensed, then under the readhead assembly for reading. It then moves to the take up shaft where the backing is rolled around the shaft.

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CLINTEK ATLAS with Rack Sample Handler Operating Manual

SG Refractometer/Clarity Device

1

SG Well

Figure 1-7 Specific gravity is determined through the use of a fiber optic refractive index method. Light is transmitted through a specially shaped fiber optic onto which the sample is dispensed. The amount of light passing through the fiber optic is constantly measured at one end. The closer the sample’s refractive index is to that of the fiber optic, the more light is lost from the optic. Since refractive index is proportional to specific gravity, the light measured at the end of the fiber optic loop is linearly related to the specific gravity of the sample. The refractive index of the Rinse Solution is determined between each sample as a reference value, compensating for temperature and light source variations. The clarity is also determined in this same area by measuring the transmission and scattering of light that passes through the specimen. When samples are not being processed, the instrument dispenses a specific volume of Rinse Solution into the SG well every 15 minutes. This hydration step ensures that sample residues do not dry in the SG well and contaminate the fiber optic. Dried residue will influence the accuracy of subsequent SG readings until the well is cleaned. For this reason, the instrument must be left on at all times.

INTRODUCTION

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Rinse/Waste Systems

1

Rinse Bottle

2

Waste Bottle

Figure 1-8 The instrument uses a Rinse Solution prepared by adding 2 mL of CLINITEK ATLAS Rinse Additive to 1000 mL of distilled or deionized water. The rinse bottle holds sufficient Rinse Solution for the use of one full reagent roll (490 tests). The waste bottle is connected to the waste drain with tubing to allow easy access for emptying. It holds a sufficient volume of waste for the use of a full reagent roll. The Rinse Solution tubing can be connected to a larger, non-pressurized container, and the waste tubing can be routed to an external drain.