ESR-Auto Plus Model 505 Operators Manual Ver 1.0-3.0

Welcome to Streck! Thank you for choosing the ESR-Auto Plus®, the most accurate, reliable and user-friendly automated sed-rate analyzer available today! Our dedicated employees are here to make your ESR-Auto Plus experience as simple as possible. This manual covers the operation and configuration of the ESR-Auto Plus Model 505, the ESR-657 Mixer and the ESR Barcode Scanner. The following items are included with this manual for your convenience:

• QUICK REFERENCE GUIDE – a simple, condensed guide to the most common instrument functions. • SERVICES & SUPPORT BROCHURE – an overview of the many FREE services to assist you. TECHNICAL SERVICE DEPARTMENT 800-843-0912 (ext. 7510) The ESR-Auto Plus is supported by a staff of experienced Medical Laboratory Scientists who welcome the opportunity to assist you. Our on-site Technical Service representatives have immediate access to the ESR-Auto Plus, and they are an excellent resource to answer your product questions. Streck Technical Service Representatives: • Assist with implementation of the ESR-Auto Plus • Provide technical support for the entire ESR product line • Process ESR-Auto Plus correlation data We want your relationship with our company to extend beyond being satisfied with our product. It is our privilege to serve you, and we are looking forward to your next call. STANDARD WARRANTY Streck warrants the ESR-Auto Plus, ESR-657 Mixer and ESR Barcode Scanner to be free from defects in workmanship and materials during normal use for a period of one year from the date of purchase. If any defects occur during the warranty period, contact Technical Service at 800-843-0912 x 7510. This warranty does not cover defects or malfunctions which occur due to instrument abuse, improper maintenance or unauthorized repairs. INSTRUMENT RETURN POLICY Any claim for credit or return of instruments for any reason must be made within 30 days of receipt of the instrument. Returns executed within 30 days of receipt will result in an automatic reassignment of the instrument title back to Streck. The customer will be responsible for return freight charges on all customer-initiated instrument returns. All instruments approved for return will be subject to a $100 return fee. • The customer must repackage the instrument(s) in its original packaging to ensure that the components do not shift during shipment. See section 1.8 for repackaging instructions. • The customer must contact their Streck Sales Representative to obtain a return authorization number, which must be clearly marked on the outside of the package. Manufactured For: Streck 7002 S. 109 Street Omaha, NE USA 68128 800-843-0912 402-333-1982

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TABLE OF CONTENTS 1. INTRODUCTION...1 1.1 ESR Components...1 1.2 Unpacking Instructions...1 1.3 Barcode Scanner Installation...2 1.4 Cable Connections...2 1.5 Installing Paper...2 1.6 Removing Paper...3 1.7 Disconnect Device...3 1.8 Repackaging Instructions...3 2. SAMPLE PREPARATION...4 2.1 ESR-Vacuum Tubes...4 2.2 Sample Collection...4 2.3 Phlebotomy Guideline...4 2.4 Secondary Patient Labels...5 2.5 ESR Tube Labeling Sleeves...6 2.6 Mixing a Sample...6 3. RUNNING A SAMPLE...7 3.1 Keypad Overview...7 3.2 Starting a Sample...7 3.3 Reporting Results...7 3.4 Canceling a Sample...7 4. MENU FUNCTIONS 1-5...8 4.1 Standby Menu...8 4.2 Menu 1: Search Sample...8 4.3 Menu 2: Check Position...8 4.4 Sample Status...9 4.5 Menu 3: Print Log File...9 4.6 Menu 4: Control Samples: Run, Show, Register and Edit Controls... 10 4.7 Menu 5: Run Test Rack...15 5. MENU FUNCTION 6: OPTIONS/USER CONFIGURATION MENU... 15 5.1 Accessing Menu...15 5.2 Set Date and Time...16 5.3 Set ESR Method and Calibration: Tube Type, Calibration, Measuring Time... 16 5.4 Audible Alarm...17 5.5 Set Printouts...17 5.6 Configure Ports...18 5.7 Print Set Up...19 5.8 Set Access Code...19 5.9 See System Info...19 6. MENU FUNCTION 6: OPTIONS/SERVICE MENU...20 6.1 Accessing Menu...20 6.2 Set Language...20 6.3 Set Date and Time Style Formats...20 6.4 User Configuration Code...21 6.5 Set IR Power...21 6.6 LCD Contrast...22 6.7 Set Alarms...22 6.8 Motor Settings...22 6.9 Printouts...23 6.10 Prediction...23 6.11 Registering Test Rack...23 6.12 Set Thermometer...24 ii

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6.13 Test Mode...25 6.14 Reading Test...25 6.15 Power Test...25 6.16 RAM Reset...26

7. BACKGROUND OF THE ESR TEST...26 THE ESR TEST 7.1 The History...26 7.2 The Original 200mm System...27 7.3 The 100mm Vacuum System...27 7.4 BD Standard Scale vs. QuickMode Method...27 7.5 The ESR-Vacuum Tube...28 THE SEDIMENTATION REACTION 7.6 A Typical ESR Reaction...28 7.7 Temperature Correlation...29 7.8 Reproducibility...29 8. TECHNICAL INFORMATION...30 8.1 Overview...30 8.2 Measuring Abnormal Samples with IR Light...30 8.3 Checking a Secondary Label...31 8.4 Fill Level...31 8.5 Barcode Input...31 8.6 COM PORT Communication...32 8.7 ESR-Auto Plus Precision...32 8.8 Preventive Maintenance...32 8.9 Cleaning Instructions...32 8.10 Technical Specifications ESR-Auto Plus...33 8.11 Technical Specifications ESR-657 Mixer...34 8.12 Environmental Conditions...34 8.13 Transportation Environment...34 8.14 Disclaimer...34 9. SAFETY PRECAUTIONS...35 9.1 User Precautions...35 9.2 Electrical Equipment...35 9.3 Sample Analysis...35 9.4 Application of Secondary Labels...35 9.5 Removal of ESR-Vacuum Tubes...35 9.6 Glossary of Safety Symbols...35 10. TROUBLESHOOTING...36 10.1 Error Codes...36 10.2 Decoding Error and Status Codes...37 10.3 Troubleshooting Guide...38 11. QUICK REFERENCE GUIDE...39 11.1 Standby Screen...39 11.2 Mix Tubes...39 11.3 Run Test Rack...39 11.4 Register New QC Lot...39 11.5 Run QC Sample...39 11.6 Run Patient Sample...40 11.7 Cancel Measurement...40 11.8 Predict Sample Result...40 11.9 Re-Register Test Rack...40 ESR-AUTO PLUS QC / MAINTENANCE RECORD...41

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1

INTRODUCTION The ESR-Auto Plus® is designed to accurately and precisely measure the sedimentation rate of erythrocytes (red blood cells) in ESR-Vacuum Tubes. The results are recorded as millimeters (mm) per hour (Westergren method) by converting to the QuickMode method, a scientifically developed method for measuring ESR in only 30 minutes. The instrument compensates for temperatures above 26°C (77°F). Results are automatically reported to an internal printer. The instrument may also be interfaced with a Laboratory Information System (LIS) or a computer. For easier and safer ID-Code handling, the instrument can be equipped with a barcode scanner. The mixing process prior to evaluation of an ESR sample is critical. For this reason, the ESR-657 Mixer is available as an additional accessory. The ESR-657 Mixer slowly mixes the ESR samples through a full 360° rotation, which ensures complete mixing and more accurate results. The ESR-Auto Plus and ESR-657 Mixer are IVD Medical Equipment.

1.1

ESR Components ESR-Auto Plus The ESR-Auto Plus analyzer can process up to 20 samples per hour. Samples are read by infrared light using a measuring arm, which is controlled by a motor. ESR-657 Mixer The ESR-657 Mixer is specifically designed to mix ESR-Vacuum Tubes prior to evaluation. Its unique motion assures proper mixing of samples. The ESR-657 Mixer can hold up to 10 ESR-Vacuum Tubes. ESR-Vacuum Tubes ESR-Vacuum Tubes are available in 1.2ml and 2.0ml vacuum draw sizes and are designed specifically for use with the ESR-Auto Plus, ESR-100 and ESR-10 Manual Rack. High Altitude and Safety Coated 1.2ml tube configurations are also available. ESR Barcode Scanner Symbol barcode scanner (catalog #240329, mfr part #LS1902T-i000 or LS2208-SR20001) connects to the ESR-Auto Plus using a COM port cable, (mfr part #25-55591-20). It is compatible with most available barcodes: EAN, UPC, Codabar, Code 39, Code 93, Code 128, Interleaved 2 of 5, and several more. The barcode scanners are considered to be Class 1 lasers that emit Class 2 laser light.

1.2

Unpacking Instructions

Retain all packaging materials for shipping, moving or storing the instrument. 1. Open the box and remove the top foam piece, which contains accessories such as the barcode scanner, power cords and paper. 2. Carefully lift the instrument out of the bottom foam piece and remove the anti-static shipping bag. 3. Remove the ESR-657 Mixer from the bottom foam piece. 4. Install the ESR-Auto Plus and ESR-657 Mixer on a level, supported surface that is free from any vibra- tions or temperature fluctuations. Note: Vibrations and temperature fluctuations may adversely affect ESR results. Refer to Sections 6.12 and 7.7 for more information on the impact of temperatures on ESR results.

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1.3

Barcode Scanner Installation 1. Line up holes in barcode scanner bracket with pre-drilled holes on the right side of the ESR-Auto Plus. (See Figure 1a.) 2. Tighten the screws using the 3mm allen wrench (provided). Do not over-tighten screws. (See Figure 1b.) 3. Connect the barcode scanner to the socket marked “BC Scanner” on the back of the instrument. (See Figure 1c.) 4. Scan a patient barcode three times to calibrate the barcode scanner. 5. Insert the barcode scanner into the barcode scanner bracket as shown. (See Figure 1d.)

Figure 1c. Figure 1b. Figure 1d. Figure 1a. Note: The barcode scanner has been pre-programmed. If you encounter any problems with the operation of the barcode scanner, contact Technical Service before making any changes to the settings. 1.4 Cable Connections 1. Connect the 24V AC power cable to the ESR-657 Mixer and turn the power switch to the “on” position. The mixer will rotate continuously when the power switch is on. 2. Connect the external printer cable or mainframe computer cable (LIS) to the socket marked “COM 1” (optional). COM PORT settings can be adjusted in the User Configuration Menu.

Figure 2: Rear view cable connections.

3. Connect the AC power cord to the power connector on the back of the ESR-Auto Plus. NOTE: Install paper before turning unit “ON” during initial instrument installation. 4. Plug the power cord into the main power outlet. Note: It is recommended that the ESR-Auto Plus be plugged into a power surge protector for additional protection from power surges and fluctua tions. 1.5

Installing Paper 1. Before installing the paper, remove any residual glue or tape sealing the new roll. 2. Press the printer lever to release the platen roller bar on the top of the printer. The platen roller bar will completely separate from the instrument. (See Figure 3a.) 3. Place a roll of paper in the paper holder and align the paper between the paper guides in the printer. (See Figure 3b.)

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4. Insert the platen roller bar into the printer and press firmly on the ends marked “Press Here” to install the platen roller bar. (See Figure 3c.)

ESR-AUTO PLUS V0002 (101618)

5. Turn the power switch “ON.” The display will show the software version for about 5 seconds before motor initiation begins. The instrument will automatically calibrate and reset the motor. Allow the motor initialization process to finish and the display will advance to standby mode.

INITIATING MOTOR. . .

6. Press the blue paper feed button next to the printer, or on the keypad to advance the paper and verify the platen roller bar is installed correctly. If the paper does not feed properly, release the printer level and re-insert the platen roller bar.

12:00 NEXT SAMPLE. .

7. The ESR-Auto Plus is in Standby mode and ready to accept new samples when “Next Sample” ap- pears on the display.

Figure 3a. 1.6

Figure 3b.

Figure 3c.

Removing Paper CAUTION: Do not remove the paper by pulling the roll out backwards. Damage may occur. 1. Press the printer lever to release the platen roller bar. 2. Remove the paper and reinsert the platen roller bar into the printer.

1.7

Disconnect Device To disconnect the instrument, turn the power switch to the “Off” position and unplug the power cable from the wall outlet. It is not necessary to routinely disconnect the instrument when it is not in use. Note: Turn the power switch off before removing or reinstalling any connectors on the ESR-Auto Plus.

1.8

Repackaging Instructions The ESR-Auto Plus contains delicate electrical components and needs to be properly packed in the approved foam inserts and carton before shipping. Please contact Streck Technical Service at 800-843-0912 x7510 with any questions or to obtain the correct packaging materials.

1. Unplug the instrument. Remove the paper, test rack, cables, barcode scanner bracket and other accessories. 2. Wipe the outer surface of the instrument and test rack with an ethanol or isopropanol solution. 3. Place the bottom foam piece in the shipping carton. (See Figure 4a.) 4. Insert the test rack into the ESR-Auto Plus and place the instrument inside the antistatic bag supplied with the approved packaging. 5. Place the instrument and mixer in the designated slot in the bottom foam piece. (See Figure 4b.) 6. Place the top foam piece in the shipping carton with the flat side down. (See Figure 4c.) 7. Place the barcode scanner bracket and any other accessories inside the top foam piece. (See Figure 4d.)

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8. Fill any extra space with packing material before closing the box. 9. Always ship the instruments and components as “FRAGILE”!

Figure 4a.

Figure 4b.

Figure 4c.

Figure 4d.

2

SAMPLE PREPARATION

2.1

ESR-Vacuum Tubes The ESR-Auto Plus is intended for use with 1.2ml ESR-Vacuum Tubes. However, 2.0ml ESR-Vacuum Tubes may be used by selecting the alternate tube size in the User Configuration Menu. ESR-Vacuum Tubes are also available in High Altitude and Safety Coated 1.2ml configurations. All Streck ESR-Vacuum Tubes preserve the integrity of the patient sample for up to 72 hours from the time of blood collection when transported or stored at 2-10˚ C, or up to 4 hours at 18-30º C. Follow the Clinical Laboratory Standards Institute (CLSI) Approved Standard “Procedure for the Erythrocyte Sedimentation Rate Test,” CLSI Document H02, for stability of specimens collected in EDTA tubes.

2.2

Sample Collection Patient samples may be drawn directly into the Streck ESR-Vacuum Tube or into an EDTA vacuum tube. When using an EDTA tube, transfer the well-mixed patient sample into the Streck ESR-Vacuum Tube. Fill the ESR-Vacuum Tube to the fill line. Do not remove the sodium citrate in the ESR-Vacuum Tube. ESR-Vacuum Tubes contain liquid anticoagulant and must be thoroughly mixed with the blood sample im- mediately after the tube has filled. Failure to mix the sample completely and immediately may result in the formation of microscopic blood clots/aggregates that could alter results. Proper collection and prepara- tion of the ESR sample is critical to obtain accurate results. Inaccurate results are most often a result of improper sample handling. CAUTION: Handle all biological samples and blood collection sharps according to your standard laboratory procedures. Seek medical attention in the case of exposure to biological specimens. Transmission of infectious diseases may occur. Follow the CLSI Approved Standard “Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture”, CLSI Document H03.

2.3

Phlebotomy Guideline

1. Insert the ESR-Vacuum tube into the plastic holder as shown in Figure 5a. Hold the tube so the cap is flush against the needle holder as the sample is collected. 2. Angle the tube so the blood stream hits the tube wall before mixing with the citrate solution to minimize the formation of bubbles. 3. Watch for an air bubble to rise in the sample as the tube fills to indicate the draw is complete and remove the tube immediately.

Figure 5a: Venipuncture

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4. The ideal fill level and acceptable fill range are indicated on the tube. • 1.2ml ESR-Vacuum Tubes: 60mm ± 5mm • 2.0ml ESR-Vacuum Tubes: 100mm ± 8mm 5. It is especially important to mix Streck ESR-Vacuum Tubes thoroughly by inverting them 8-10 times due to their smaller tube diameter and draw volumes (1.2ml and 2.0ml) compared to an EDTA tube as shown in Figure 5b. 6. Prior to analysis, thoroughly mix the sample again. Rotating the tubes on the ESR-657 Mixer for three minutes is adequate, or minimum 10 complete inversions by hand mixing.

Min 8x Figure 5b: Mixing

7. Samples can be maintained from the time of blood collection for up to 72 hours prior to analysis when transported and stored at 2-10° C, or up to 4 hours at 18-30º C. 8. Refer to the ESR-Vacuum Tube Instructions For Use (IFU) for more details.

2.4

The mixing procedure is very important! If the citrate is not properly mixed with the blood, clots/aggregates may form and cause results to appear higher than they actually are.

Secondary Patient Labels The ESR-Auto Plus reads the sample using infrared light. This light is very strong and can read through one layer of most commonly used labels. Note: Caution must be taken when applying additional labels to ESR-Vacuum Tubes if the sample is scanned within the label area. 1.2ml Tubes The 1.2ml ESR-Vacuum Tube is the primary tube used in ESR-Auto Plus.

120 110 108 mm 100 place additional labels in this area

ideal fill range 92 mm

90

87 mm 80

70 mm

2. Additional labels should be applied as close to the cap as possible.

70

65 mm 60

ideal fill range 55 mm

50

Leave this area blank

place additional labels in this area leave a label-free gap on side of the tube

40

0 mm

10 0 mm

2.0 ml

1.2 ml

30 20

1. The ideal fill level of the 1.2ml tube is 60mm ± 5mm from the bottom of the tube. The ideal fill level and range are printed on the tube label. The fill range can extend to as much as ± 9mm from the fill line without compromising the integrity of the sample.

Note: Leave a space of at least 3mm between the blood level in the tube and any additional labels to ensure accurate reading of the sample. (See Figure 6.) 2.0ml Tubes The 2.0ml ESR-Vacuum Tube can be used in the ESRAuto Plus as long as the tube is inserted in the ESRAuto Plus correctly and additional labels are applied correctly.

0 mm

Figure 6: 1.2ml and 2.0ml label placement (not to scale) Page 5

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1. Do not place additional labels above the fill level printed at the top of the original label. 2. Place additional labels facing the same direction as the original label, creating a label-free gap on one side of the tube. Note: This gap is critical to allow accurate measurement of the level of blood in the tube. (See Figure 6.) 3. Insert the tube in the ESR-Auto Plus with the label facing forward, leaving the label-free side at the rear to ensure accurate reading of the sample.

2.5

ESR Tube Labeling Sleeves ESR tube labeling sleeves (Streck part number 240363) are available to provide an easy method of identifying samples without obstructing the blood column during analysis. 1. Remove all 5 labeling sleeves from the sheet by folding along the perforated edges. Separate the individual labeling sleeves by folding along the perforated lines between each sleeve. 2. Collect or transfer a valid blood specimen into an ESR-Vacuum Tube. 3. Bend both sides of the labeling sleeve by creasing the tabs along the scored lines. (See Figure 7a.) 4. Insert the tube through the hole in the labeling sleeve with the tabs pointing up around the rubber stopper. (See Figure 7b.) 5. Apply the patient-specific identification label across both tabs of the labeling sleeve. (See Figure 7c.) Note: The patient-specific identification label may extend beyond the end of the labeling sleeve, depending on the size of the patient label. Additional identification labels placed on the tube must be placed outside the scanning area of the tube. Apply label here

Bend at scored lines

Figure 7b.

Figure 7a. 2.6

Figure 7c.

Mixing a Sample Samples must be thoroughly mixed prior to analysis. The ESR-657 Mixer is an optional accessory designed to accompany the ESR-Auto Plus. The automated mixer holds up to 10 ESR-Vacuum tubes at one time. 1. Place the mixer on a level surface. 2. Gently snap ESR-Vacuum Tube samples into the slots on the mixer. 3. Locate the power switch on the top of the mixer to turn the unit “on.” 4. The ESR-657 Mixer rotates the samples during the mixing process. 5. Allow the samples to mix for 3-5 minutes before analyzing.

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3

RUNNING A SAMPLE

3.1

Keypad Overview

• • •

The keypad consists of alpha numeric characters A-J and 0-9 which are used to manually input a specimen ID, and also to select various prompts as indicated in this manual. The “√” is used to accept entries or view additional menu settings. The “X” is used to change settings or move past the prompts.

Figure 8. Keypad 3.2

Starting a Sample 12:00 NEXT SAMPLE..

ENTER ID: 12345_

•

The ESR-Auto Plus is ready to accept a sample when the “Next Sample” standby mode appears in the display window. Scan the patient barcode with the barcode scanner, or enter the sample ID code manually on the keypad.

•

An ID code may contain up to 10 digits. When manually entering an ID code, press “X” to delete incorrect digits and “√” to confirm the code. The instrument will automatically add the “√” signal when using the barcode scanner. Alpha numeric characters A-J and 0-9 can be entered manually using the keypad. Letters greater than J can only be entered using the barcode scanner.

INSERT 12345 IN FREE POSITION •

Figure 9. Starting a Sample

After the barcode is scanned or the ID code is entered, insert the well-mixed, room temperature sample in any free position as indicated by a green light. The position light will turn red and the ESR-Auto Plus will initiate testing. NOTE: All samples should be properly mixed and at room temperature before analyzing. A sedimented sample may require several minutes of mixing.

3.3

Reporting Results After measurement is complete, the ESR-Auto Plus automatically prints results on the internal printer and the COM PORT. The COM PORT and desired printer can be configured in the software. Refer to the Set Printouts section in the User Configuration Menu.

3.4

Canceling a Sample To cancel a sample, remove it from the slot. A)12345 5 MINUTES LEFT A)12345 1. PREDICT RESULT A)12345 2. ABORT READ

• The display will show the position, sample ID and time remaining on the sample. • The display will show 2 menu options: 1.Predict Result and 2.Abort Read. Select the desired function by pressing 1 or 2 on the keypad followed by “√”. • If the sample is aborted, the red light will change to green on the position indicator. To cancel the menu functions and read the sample, replace the tube in its original position. Note: Disturbing a sample during the analysis period may invalidate results.

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This manual is written in the order as the prompts appear on the instrument. Pressing the “X” will advance to the next prompt. 4

MENU FUNCTIONS 1-5

4.1

Standby Menu 12:00 NEXT SAMPLE..

• The instrument is ready to accept a new sample in standby mode. If the instrument is in a menu selection or in a different sequence of the program, press “X” to advance to the standby display.

MAIN MENU 1-SEARCH SAMPLE

• From standby, press and hold “X” until you hear a beep to access the user menus. Enter the corresponding numeric value to select the desired menu function or press “√” on the desired function as it appears on the display.

The available user menus will scroll on the display:

1 - SEARCH SAMPLE

2 - CHECK POSITION

3 - PRINT LOG FILE

4 - CONTROL SAMPLES

5 - RUN TEST RACK

6 - OPTIONS

4.2

Menu 1: Search Sample The ESR-Auto Plus will store a maximum of 500 sample records. It is advised that labs print the Log File regularly and purge data to avoid exceeding storage capacity. The ESR-Auto Plus searches all samples currently in process for an ID match before searching the sample log internal memory. MENU 1-SEARCH SAMPLE SEARCH SAMPLE ID: 123_

• Select Menu Function 1 to search for a sample result by sample ID. • Enter the sample ID code using the keyboard or barcode scanner. Partial ID codes can be used. For example, to search for ID code 12345, enter 123 to return all ID codes starting with 123. • Press and hold the number keys to display the corresponding letters A-J. A blank entry will display all samples contained in the log file on the LCD in ascending alpha-numeric order. Use the blank entry to search for patient ID numbers that begin with a letter greater than J.

4.3

Menu 2: Check Position Sample results may also be retrieved using the position where the sample was run. The results will print on the internal printer and enabled COM PORT. MENU 2-CHECK POS. A-J

•

Select Menu Function 2 to search for a sample result by position.

CHECK POS GIVE POS: A_

•

Enter the position A-J as listed on the ESR-Auto Plus and press “√”.

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4.4

Sample Status Search Sample and Check Position sample results are displayed in the same manner. Samples can have two different status options: In Process, or Completed. Sample In Process •

If the sample is currently in process, the display will show the position of the sample, the sample ID and the time remaining until the sample is complete. After a few seconds, the second row of the display will show menu options.

A)12345 1-PREDICT RESULT

•

1-PREDICT RESULT will predict the sample result.

A)12345 1-ABORT READ

•

2-ABORT READ will cancel the measurement of the sample. Press “X” to continue to the next sample fitting the search criteria.

A)12345 7 MINUTES LEFT

NOTE: Correlation to Westergren Method will decrease the earlier a sample is predicted. It is not recommended to predict a sample more than 15 minutes early. The predicted result should always be confirmed when the final result is available. Completed Sample A)12345 (1/5) 030101 09:00 [OK]

•

If the sample is complete and results are available, the display will show position, sample ID, number of samples that fit the search criteria and the date/time for the most recently analyzed sample that fits the search criteria.

A)12345 ESR 110

(1/5) ER1024

•

Press “X” to view the next matching sample, or “√” to view details of the current sample. The second row will show the result and any error code.

A)12345 REPRINT ?

(1/5) [OK]

•

When prompted, press “√” to reprint, or “X” to view sample. To end the Search sequence, press and hold “X” for one second.

NOTE: Reprinted results will print in ticket style, regardless of the print format selected. 4.5

Menu 3: Print Log File The ESR-Auto Plus will store a maximum of 500 sample records. It is advised that labs print the Log File regularly and purge data to avoid exceeding storage capacity. MENU 3-PRINT LOG FILE

• Select Menu Function 3 to print all sample results stored in memory. The Log File header will repeat after every 50 samples.

PRINT LOG FILE [OK] TO START

• Press “√” to print log file, or “X” to advance to the next menu selection. • Press “X” while printing to cancel print job. (See Figure 10)

LOG FILE CLEAR LOG?

• Press “√” to clear log file, or “X” to exit the menu.

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********* LOG FILE ESR-AUTO PLUS ********* YYYY-MM-DD 15:00 SER. NO. 505-0000 ID ESR ERR ST 1234563456 53 12 449 1234586754 1 0 449 1234456734 123 8 449 1234567987 4 0 449 1234567345 18 21 449 1234567555 57 0 449 1234532756 65 0 449 *

PO A C E F H J I

DATE 030101 030101 030101 030101 030101 030101 030101

TIME 18.00 18.01 18.01 18.05 18.05 18.25 18.25

Figure 10: Log File Printout 4.6

Menu 4: Control Samples The Control Sample Menu Function is designed to monitor commercially available bi-level quality control samples. The Control Sample Menu Function accepts two levels of control. Control samples are analyzed, compared to the registered assay value and stored in a control sample database. NOTE: Streck recommends running 2 levels of ESR-Chex controls daily to ensure the accuracy of the instrument. The Quality Control Menu contains 4 options: MENU 4-CONTR.SAMPLES

4.6.1

Run Control CONTROLS MENU 1. RUN CONTROL START CONTROL LEVEL:_

• 1. RUN, 2. SHOW, 3. REGISTER NEW, 4. EDIT CONTROL RANGE • Press the corresponding number, or “√” when the desired menu function is displayed.

• Once a control lot has been registered, select #1 “Run Control” in the Con- trols Menu to run a control sample. • Enter the appropriate level and press “√”. The ESR-Auto Plus will automatically identify the sample, the registered lot number and a sequence number.

• For example, if this is the first sample analyzed for lot 12345A, the automatic ID number will be 12345A/00. The next sample of this level will be named INSERT 12345A/01 12345A/01, then 12345A/02, etc... IN A FREE POSITION 1. Refer to ESR-Chex control insert for handling instructions. 2. Transfer the well-mixed control into the ESR-Vacuum Tube. 3. Fill to the fill line specified on the tube label and mix thoroughly, approximately 3-5 min. 4. Insert the control sample into any free position. 5. The ESR-Auto Plus will automatically start measuring the sample. The control sample printout is similar to a ticket style patient sample printout. If the result is outside the expected range, an alarm message will be reported.

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**** CONTROL SAMPLE RESULT LEVEL 1 **** MMDDYY 08:00 POS:A E3072 S2401 LOT#/SEQ ESR:

:

23445A/00

42 MM WESTERGREN(QM PAED TUBE)

ALARMS: SAMPLE OVERFILLED

Figure 11: Control Example Printout

4.6.2

Note: QM Paed Tube = 1.2ml ESR-Vacuum Tube ER is the error code reported on a control sample. The “base” error codes for control samples are L1 control = 2048; L2 control = 4096. The reported error code (ER) - “base” error code = actual error. Refer to section 10, Troubleshooting, for complete list of error codes. L1 Example: 3072 - 2048 = 1024, overfill 2048 - 2048 = 0, no error 2052 - 2048 = 4, low fill

L2 Example: 5120 - 4096 = 1024,overfill 4096 - 4096 = 0, no error 4100 - 4096 = 4, low fill

Show Control Control samples are stored in a control log file, which holds up to 100 samples per level. Once the QC log file reaches the memory capacity of 100 runs per level, additional QC runs will not be held in memory. It is advised that labs print and purge data on a weekly or biweekly basis to avoid exceeding storage capacity.The ESR-Auto Plus can generate statistical reports or display control information on the LCD from the stored data. CONTROLS MENU 2. SHOW CONTROLS

•

Select #2 ”Show Control” in the Controls Menu to access the following options: SHORT REPORT, LONG REPORT, SHOW ON LCD or CLEAR QC LOG FILE.

•

The Short Report will generate a statistical report for the specified level. Select level 1 or 2 and press “√” to start the printout.

•

Press “1” to select the Short Report. (See Figure 12a.)

•

Press “2” to select the Long Report. (See Figure 12b.)

•

The Long Report will generate a statistical report and the complete log file for the specified level. Select level 1 or 2 and press “√” to start the printout.

1. Short Report SHOW CONTROLS 1. SHORT REPORT SHORT REPORT LEVEL:_

2. Long Report SHOW CONTROLS 2. LONG REPORT LONG REPORT LEVEL:_

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********** ESR CONTROL REPORT *********

LOT NO LEVEL EXPIRY DATE EXP. RANGE STATISTICS POP. SIZE AVERAGE HIGHEST LOWEST SD CV%

************ ESR CONTROL REPORT ************

: : : :

12345A 1 MM-DD-YY 30-40

LOT NO : LEVEL : EXPIRY DATE EXP. RANGE

12345A 1 : MM-DD-YY : 30-40

: : : : : :

10 36 42 34 2.0 5.5

STATISTICS POP. SIZE AVERAGE HIGHEST LOWEST: SD : CV% :

: : : 34 2.0 5.5

10 36 42

ERR 4224 4224 4224 4224 4224 4224 4224 4224 4224 4224

PO E B C G D A D A D D

Figure 12a: Short Report

LOT#/SEQ 123454A/10 123454A/09 123454A/08 123454A/07 123454A/06 123454A/05 123454A/04 123454A/03 123454A/02 123454A/01

ESR 38 34 36 39 39 39 39 34 39 42

DATE 013111 013011 012911 012811 012711 012611 012511 012411 012311 012211

TIME 12:00 12:00 12:00 12:00 12:00 12:00 12:00 12:00 12:00 12:00

Figure 12b: Long Report

3. Show on LCD Control information can be viewed manually on the LCD and individual runs may be deleted. SHOW CONTROLS 3. SHOW ON LCD

•

Press “3” to select Show on LCD function.

•

Select level 1 or 2 and press “√” to view.

SHOWVALUES LEVEL: 1_

•

The LCD will show the lane position, lot/sequence #, ESR result and associated error code for the most recent sample of that level.

•

After a few seconds, two options will scroll on the display.

•

1 - Reprint ticket for this sample.

•

2 - Delete this sample record.

•

Press “1” to print or “2” to delete the current record.

•

Press “X” to advance to the next sample.

•

Press and hold “X” for 1 second to exit the sequence.

E)12345A/10 ESR: 36 ERR:4224 E)12345A/10 1.REPRINT E)12345A/10 2.DELETE

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4. Clear QC Log File All daily QC data contained in the QC log file may be cleared in its entirety using the Clear QC Log function in the Show Controls Menu. Control lot information, such as lot number and min/max ranges, will not be affected by clearing the QC log file. SHOW CONTROLS 4. CLEAR QC LOG CLEAR QC LOG CLEAR QC LOG?

4.6.3

•

Press “4” to select the “Clear QC Log” function.

•

Press “√” to clear the QC log, or “X” to exit the menu without clearing the QC log.

Register New Control Register the lot number and assay ranges before using a new lot of control material. Note: Registering a new level of control lot will delete all data collected for the previous control lot of that level. CONTROLS MENU 3. REG NEW CONTR. RE.NEWCONTROL LEVEL: 1_

• Select #3 “Register New Control” in the Controls Menu to register a new control.

• Enter the desired control level 1 or 2 and press “√”. Note: This operation will delete old statistics for this control level.

STATS.LEVEL1 CLEAR OLD STATS?

• Press “√” to clear old values and register a new control lot. • Press “X” to exit the control registration menu.

NEW CONTROL (1) LOT: 12345A

• Enter the lot number stated on the control assay insert.

NEW CONTROL (1) EXPIRY: MM-DD-YY

• Enter the expiration date stated on the control assay and press “√”. The date format is MM-DD-YY.

• Press and hold a numeric key for 1 second to enter the corresponding letter A-J.

• Enter the minimum assay value as stated on the control assay insert and press “√”. (See Figure 13.)

NEW CONTROL (1) RANGE(min): 30

• Enter the maximum assay value in a similar manner.

NEW CONTROL ASSAY VALUES: YYYYMMDD 12:00

LOT NO LEVEL EXPIRY DATE EXP. RANGE

: : : :

12345A 1 MM-DD-YY 30-40

Figure 13: Control Report

Note: A report of the assay values will then be printed. Press “√” to accept the data. The new lot is now registered and ready to use. ESR-Auto Plus stores up to 100 samples of control data per level. If 100 samples are exceeded, the oldest value will be deleted.

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4.6.4

Edit Control Ranges Only control levels previously registered in the Register Controls Menu are available in the Edit Control Ranges Menu. For example, if only Level 1 control values have been registered, then the Edit Control Ranges Menu will allow edits to the minimum and maximum values for Level 1, but will not display any Level 2 information. If no controls have been registered or run, the instrument will display “No Control Data Registered” and no changes will be allowed. •

Select #4 “Edit Control Range” in the Controls Menu to edit the ranges.

•

Press “√” to accept the displayed values, or “X” to delete the displayed value. Retype the new minimum value and press “√” to accept the new value.

CONTROLS (1) RANGE (MAX): X

•

Press “√” to accept the displayed value, or “X” to delete the displayed value. Retype the new maximum value and press “√” to accept the new value.

CONTROLS (2) RANGE (MIN): X

•

Press “√” to accept the displayed value, or “X” to delete the displayed value. Retype the new minimum value and press “√” to accept the new value.

•

Press “√” to accept the displayed value, or “X” to delete the displayed value. Retype the new maximum value and press “√” to accept the new value.

CONTROLS MENU 4. EDIT CONT RANG CONTROLS (1) RANGE (MIN): X

CONTROLS (2) RANGE (MAX): X

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4.7

Menu 5: Run Test Rack The ESR-Auto Plus uses a special test rack to verify the proper function of each lane and test the accuracy of results throughout the reportable range (0-120 mm/hr). The test rack is designed to simulate ESR levels. The instrument scans the test rack and compares the readings to the reference values stored in memory. The combined use of the test rack and Quality Control material will ensure accuracy of all reported ESR results throughout the reportable range. Note: Streck recommends running the test rack at the beginning of each day that the ESR-Auto Plus is in use. **ESR- AUTO PLUS RESULT VERIFICATION** • To run the test rack, select Menu 5 YYYY-MM-DD MENU - Run Test Rack. INSTRUMENT SERIAL No: 505-0000 5-RUN TEST RACK SOFTWARE VER: • The display will prompt you to ESR-AUTO PLUS insert the test rack. Insert the test SCANNER TEST V0001 (000000) rack and press “√” to start the INSERT RACK [OK] SAMPLE COUNTER: X procedure. (See Figure 14.) HARDWARE INIT DATE YY/MM/DD TECHNICAL SETUP: After the reading is complete, the MOTORSPEED: 12 SEC/R results will print on the internal V-OFFSET :20 DEG printer. (See Figure 15.) REF-CYCLE :2711 IR POWER :56% A ±2mm range is acceptable. If TEST RACK LEVELS: (REAL mm) the readings are outside the READ VALUE EXPECTED VALUE acceptable range compared to POS MM MM the expected values, the A 7.7mm 7.7mm instrument will alert that the test B 12.3mm 12.3mm failed and ask if you want to retry. C 23.6mm 23.6mm D 33.7mm 33.7mm Press “√” to retry or “X” to exit. E 38.5mm 38.5mm Figure 14: ESR-Auto Plus F 43.1mm 43.1mm If the test rack fails a second Test rack G 47.7mm 47.7mm time, re-register the test rack. See H 52.1mm 52.1mm Section 6.11 or the Quick Refer I 61.3mm 61.3mm rence Guide at the end of this J 70.8mm 70.8mm manual for instructions. SCANNER TEST OK Figure 15: Test Rack Report

5.

MENU FUNCTION 6: OPTIONS - USER CONFIGURATION MENU

5.1

Accessing Menu The two sections of the Options menu are the User Configuration Menu and the Service Menu. Both sections can be protected by an access code to prevent changing settings by mistake. See Section 6.4 for instructions on how to set or view an access code. This manual is written in the order as the prompts appear on the instrument. Pressing the “X” will advance to the next prompt. MENU • From standby, press and hold “X” to access the user menus. 6-OPTIONS OPTIONS USER CONFIG?

•

Enter “6” to select the options menu.

•

Press “√” to access the User Configuration Menu.

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5.2

Set Date and Time The instrument has an internal realtime clock with battery backup. Date and time will be maintained when the instrument power is turned off. To set the date or time, press “√” when prompted. Date USER CONFIG • Press “√” if the date is correct, or “X” if the date is incorrect. SET DATE&TIME? •

To change the date, use the numeric keypad.

DATE YY-MM-DD OK?

•

Press “√” after the last digit to proceed to the time setting.

SET DATE: 00-00-00 (Y-M-D)

Time • Press “√” if the time is correct, or “X” to change.

TIME: 12:00:00 OK?

•

Use the numeric keypad for the numerical value and press the “X” to change from AM to PM.

•

Press “√” to accept changes.

NOTE: Date and time format can be changed to display different international standards. See Option 6 - Service Menu to change date and time formats. 5.3

Set ESR Method and Calibration The ESR-Auto Plus measures samples according to the QuickMode method, a scientifically developed method for measuring the ESR in only 30 minutes. ESR-Auto Plus can read 1.2ml, 2.0ml or both 1.2ml and 2ml ESR-Vacuum Tubes.

5.3.1

Set Tube Type USER CONFIG SET ESR METHOD? ESR METHOD SET TUBE TYPE? SET TUBE TYPE 1.2ml (PAED)?

•

Press “√” to set ESR Method.

•

Press “√” to set tube type, or “X” to advance to the next menu selection.

•

Press “√” to select 1.2ml tubes, or “X” to advance to the next tube type.

•

Press “√” to select 2.0ml tubes, or “X” to advance to the next tube type.

•

Press “√” to select both 1.2ml & 2.0ml tubes, or “X” to return to the 1.2ml prompt.

SET TUBE TYPE 2ml? SET TUBE TYPE BOTH 1.2ml & 2ml?

Note: If both tube sizes are enabled, the instrument will read tubes filled more than 70mm as 2.0ml tubes and all others as 1.2ml tubes. 5.3.2

Set Calibration QuickMode results correspond to the original 200mm Westergren Method ESR. Since there are many different 200mm pipettes that produce slightly different results, QuickMode results can be calibrated. At the time of delivery, the calibration factor will be set to +0%. Please contact Streck Technical Service before adjusting the calibration factor.

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