Hitachi OPTIGEN AP3600 Скачать руководство пользователя | Manualshive

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Glossary

Table E-1. Glossary

Name

Description

AP3600 System

The AP3600 system is the instrument into which the patient sera and the Pette test chambers are placed. The AP3600 is a fully auto-
mated instrument which tests and tracks each sample after the samples and Pettes are placed into it. Operation is started from the
DMS software.

DHCP (Dynamic Host Con-
figuration Protocol)

The network protocol used on the AP3600 to obtain an IP address.

DMS (Data Management
System)

This is the software used to run the AP3600 system.

LMC (Luminometer Count)

This value refers to the amount of light emitted by each well in the Pette. The amount of light emitted by each allergen well at th end of
testing is directly proportional to the amount of allergen-specific IgE in the patient serum.

Negative Blanking Control

This compensates for non-specific IgE binding that may occur.

OPTIGEN

®

This is the in vitro chemiluminescent assay used by the AP3600 system. OPTIGEN is a registered trademark of Hitachi Chemical
Diagnostics.

Pette Test Chamber (Pette)

This single use, disposable plastic device contains 36 allergens or allergen mixes and 2 controls (38 lenslets total). The Pette also
contains Positive Procedural Control and Negative Blanking Control wells.

Pette Tip

A single use, disposable tip is placed onto a Pette test chamber before use. When the tip is pressed down, it is opened for aspiration
or draining.

Positive Procedural Con-
trol

This confirms reagent performance and provides a check for correct testing procedure.

Sample Cup

This plastic cup holds a patient’s serum in the sample cup carousel of the AP3600.

Sodium Azide

This compound is used as a preservative in the Wash Buffer concentrate. It is highly toxic by inhalation, ingestion, or skin absorption.

Tween

™

20

This non-ionic surfactant is used in the Wash Buffer concentrate to suppress non-specific reactions between antibodies, antigens, and
other molecules.

E-1

Glossary

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Содержание OPTIGEN AP3600

Страница 1: ...OPTIGEN AP3600 AUTOMATED INSTRUMENT USER MANUAL ...

Страница 2: ...OPTIGEN AP3600 Automated Instrument UserManual Rx Only ...

Страница 3: ... of the following United States Patent Nos 3 941 876 4 031 197 4 459 360 and corresponding patents issued in Canada Australia Japan Spain France Germany Italy Sweden and Great Britain 4 510 393 4 558 013 5 567 149 and corresponding patents issued in Canada Australia Japan Spain France Germany Italy Sweden Switzerland Austria Belgium the Netherlands Luxembourg and Great Britain 4 568 184 285 485 4 ...

Страница 4: ...nsumables 2 6 Symbols Used on the Equipment 2 8 Sample Preparation 3 1 Principle of the Procedure 3 1 Proper Storage of Samples and Supplies 3 1 Specimen Collection and Preparation 3 2 General Preparation 3 2 Prepare the AP3600 System for the Assay 4 1 Starting the AP3600 System 4 1 Screen Display Buttons 4 3 Manage Account and Password 4 4 Set Up Run Wizard 5 1 Prepare AP3600 Instrument 5 1 Set U...

Страница 5: ...LIS Settings 9 4 Panel Favorite 9 5 Export Results Automatically 9 5 Print Results Automatically 9 6 Set Up Printer 9 6 End of Run 10 1 Rinse and Drain 10 1 Cleanup and Waste Disposal 10 3 Cleaning the Wash Buffer Bottle 10 3 Cleaning the Waste Bottles 10 3 Cleaning the Transfer Tip Waste Container 10 3 Troubleshooting 11 1 Regulatory Compliance A 1 Specifications and Ordering Information B 1 Phys...

Страница 6: ...OPTIGEN AP3600 AUTOMATED INSTRUMENT USER MANUAL Glossary E 1 v Table of Contents ...

Страница 7: ...0 Main Power Switch 4 3 FIGURE 5 1 AP3600 Transfer Tip Rack Sample Vial Racks and Sample Cup Carousel 5 1 FIGURE 5 2 Input Bottles on AP3600 5 2 FIGURE 5 3 Load Pettes in Carousel 5 2 FIGURE 5 4 Set Up Sample Racks Screen 5 3 FIGURE 5 5 Sample Vial Rack Window 5 3 FIGURE 5 6 Loaded Sample Vial Rack 5 4 FIGURE 5 7 Read Sample Vial Barcodes 5 4 FIGURE 5 8 Samples with no Assigned Panels 5 5 FIGURE 5...

Страница 8: ...rocess Window 10 2 FIGURE 10 4 Finished Draining Process Window 10 2 FIGURE 10 5 Shutdown Window 10 3 FIGURE 10 6 AP3600 Main Power Switch 10 3 FIGURE C 1 Instrument Clearances all dimensions in mm C 1 FIGURE C 2 Height Clearance for AP3600 Instrument C 2 FIGURE C 3 Removing Packing Materials from Black Box C 2 FIGURE C 4 Removing Fixing Plates C 3 FIGURE C 5 Install Bottle Connector and Install B...

Страница 9: ...e AP3600 system not performed by Hitachi Chemical Diagnostics or an authorized agent Moving Parts Exercise caution when working inside the instrument Ensure fingers clothing etc do not get caught between moving parts The dark box lid on the right side of the AP3600 is locked during operation If the dark box lid is to remain open for work inside the instrument depress the button on the left side hi...

Страница 10: ...your country s requirements Personal Protec tive Equipment PPE should be used while handling patient sera Common PPE might include but is not limited to the following gloves gowns laboratory coats face shields or masks eye protection or other devices The sample cups Pettes transfer tips and Pette tips used in the AP3600 are single use disposable products ...

Страница 11: ...er concentrate Handling Always use proper personal protective equipment such as gloves and eye protection Avoid sodium azide contact with lead or copper where there is potential for sodium azide to become metal azides Avoid touching or replacing corroded materials if the corrosion may be due to sodium azide contact the manufacturer for guidance on how to clean or replace corrodedparts Storage Do n...

Страница 12: ...prevent metal azide buildup in plumbingsystems Heavy Objects The AP3600 instrument weighs approximately 170 kg 375 lbs If a cart is not available to move the instrument and it must be manually moved have four persons minimum lift the instrument by the base plate of the instrument avoiding the areas outlined in red in Figure 1 4 below Make sure that the loading weight for each person does not excee...

Страница 13: ... Confirm no foreign objects are located inside the instrument that will obstruct operation movement of any parts 4 Perform a visual inspection of all visible tubing and confirm all tubing is securely connected 5 Confirm the Pette carousel is installed correctly 6 Confirm the transfer tip waste container is emptied after each run 7 Confirm all reagent bottle caps and waste container lids are correc...

Страница 14: ...1 6 Safety This page intentionally left blank ...

Страница 15: ...ergens which are tested simultaneously Various geographically and categorically specific Pettes are available The entire procedure takes less than six hours to run 50 Pette test chambers The results can then be reported to the physician for consideration and treatment options FIGURE 2 1 AP3600 System Features Fully Automated Easy to use Results can be printed or downloaded directly from the AP3600...

Страница 16: ... instrument There are six USB ports located under the moni tor for use with USB devices for exporting results performing a system update connecting a barcode scanner or a printer The monitor also has an LIS connection via the Ethernet port Note The AP3600 instrument has several USB ports available so additional accessories barcode scanner printer or USB device can be used with the Data Management ...

Страница 17: ...posal Unit The components at the right side of the AP3600 instrument include Reagent rack This rack provides storage for reagents used with the OPTIGEN assay Antibody Photoreagent I and Photoreagent II See Figure 2 6 Weight sensors load cells are located under each reagent bottle to verify there is sufficient reagent via weight volume prior to operation Wash Buffer and DI Water supply This tubing ...

Страница 18: ...nt Rack Compartment and Wash Solution Supply FIGURE 2 6 Reagent Rack FIGURE 2 7 Waste DI Water and Wash Buffer Bottles Wash Buffer and DI Water Supply Connections Antibody Bottle Photoreagent I Bottle Photoreagent II Bottle Wash Buffer Bottle DI Water Bottle Waste Bottle ...

Страница 19: ... each hold patient samples while they are being scanned and the patient sera is transferred into the sample cups for the assay Load racks one at a time After the sample barcodes are scanned the instrument advances the loaded rack one position to the right so the next rack can be loaded The sera handling area door is locked during this operation and not unlocked until sample aspiration is complete ...

Страница 20: ...and include Sample Cups These plastic cups are used to hold sera that will be aspirated into the Pettes Sample cups are placed into the sample cup carousel Transfer Tips These tips are used when transferring sera from the sample vials directly into the sample cups by the AP3600 automated process Pettes These plastic test chambers hold up to 36 wells with various allergens or allergen mixes Pettes ...

Страница 21: ...2 7 Introduction and System Wash Buffer Concentrate FIGURE 2 10 AP3600 Consumables Pette with Pette Tip attached Sample Cup Antibody andPhotoreagents Transfer Tips ...

Страница 22: ...Symbols Used on the Equipment TABLE 2 1 Equipment Symbols Symbol Description Biological hazard Crush and Moving Parts hazard ...

Страница 23: ...anti human IgE antibody binds to allergen specific IgE bound to the allergen coated wells 8 Second Buffer wash 9 Photoreagent aspiration 10 Photoreagent incubation The photoreagent mixture reacts with the labeled antibody to produce chemiluminescence 11 Measurement of the amount of light emitted by each well The amount of light is directly proportional to the amount of allergen specific IgE in the...

Страница 24: ... C for up to one week Note For longer storage store samples frozen at 20 C Repeated freezing and thawing of sera should be avoided Frozen sera that has been thawed should be thoroughly mixed before centrifugation 6 After removal from storage and immediately prior to performing the assay re centrifuge the serum for 10 20 minutes at 2000 3000 x g 7 The minimum volume of patient serum needed for a si...

Страница 25: ... plastic bag Reseal plastic bag and return unused Pette s to the refrigerator for storage 3 Insert a Pette tip onto the end of each Pette Note The Pettes and Pette tips are disposable items Do not reuse the Pette tip or Pette after it has been placed into the instrument 4 Insert the Pettes into the Pette carousel The barcode label must face the center of the Pette carousel so the barcode can be re...

Страница 26: ... 2 Check to see that any crystals that may have formed during refrigeration have dissolved If crystals persist place the tightly closed buffer bottle into a beaker of warm water until all crystals are dissolved 3 Remove Wash Buffer bottle from AP3600 Instrument and rinse the bottle with distilled water 4 Gently invert the Wash Buffer Concentrate bottle several times to thoroughly mix contents Note...

Страница 27: ...w 15 minutes for the instrument to warm up Contact an authorized service representative if the check fails The Optics Check Screen will not be displayed if the unit is already powered on FIGURE 4 1 DMS Loading Screen 3 Log into the system with an appropriate account Users should log in with a User account User 1 through User 10 Note The Service account should only be selected by authorized service...

Страница 28: ...e AP3600 System for the Assay FIGURE 4 2 DMS Login Screen 4 Enter the password for the selected user and press arrow key FIGURE 4 3 DMS Login Password Screen 5 The program opens to the Home screen shown in Figure 4 4 ...

Страница 29: ...nWizard Chapter 6 Work List Screen Chapter 7 Results Screen Chapter 8 Utilities Screen Chapter 9 System Settings Screen The buttons on the right side of the Home screen allow the operator to perform either of the following tasks Log Off Touch the Log Off button to log the operator out of the DMS software The instrument will remain on Shutdown Touch the Shutdown button to exit the DMS software To s...

Страница 30: ...o the new Users Step 2 Administrator adds a new User Maximum 10 Users 1 On Manage User Accounts screen select the Add button 2 On Manage User Accounts screen select a User press the Delete button and then select the Add button 3 Enter name for the new User maximum 20 characters SelectSubmit 4 Log off as Administrator Step 3 New User enters new customizedpassword 1 Login as new User using the above...

Страница 31: ... Note The assay will not start if the rack is not fully populated FIGURE 5 1 AP3600 Transfer Tip Rack Sample Vial Racks and Sample Cup Carousel 2 Fill the sample cup carousel with new cups Refer to Figure 5 1 3 Fill the DI water and wash buffer bottles Confirm there is sufficient Wash Buffer and DI water available to run the number of tests planned 4 Load the reagent bottles Antibody Photoreagent ...

Страница 32: ...ttach a Pette tip to each Pette and load it into the Pette carousel starting at position 1 and leave no empty spaces between pettes Load the Pettes into the carousel so that the barcode label faces the inside of the instrument The pettes can be loaded in random positions there is no need to match the sample position FIGURE 5 3 Load Pettes in Carousel Pette Pette Tip ...

Страница 33: ...ten vials See Figure 5 4 FIGURE 5 4 Set Up Sample Racks Screen Confirm the sample vials are loaded with sufficient volume and their barcodes face the rack window FIGURE 5 5 Sample Vial Rack Window Slide the rack into the instrument as shown in Figure 5 6 Note The sample vial rack does not need to be filled and positions can be skipped in the rack ...

Страница 34: ... Sample Vial Rack Press the Read Barcode button to have the AP3600 instrument scan the sample vial barcodes for tracking See Figure 5 7 FIGURE 5 7 Read Sample Vial Barcodes Wait for the AP3600 instrument to finish scanning before continuing ...

Страница 35: ... Press the field for the Sample ID s missing Panel assignments displayed in dark light red cells The Edit Sample Details screen opens Select the desired panel s that will be used with the patient sera from the Available panels list at the bottom of the screen For additional information on Favorite Panels please refer to section 9 System Settings See Figure 5 9 FIGURE 5 9 Assigning a Panel to the S...

Страница 36: ...perator must confirm that sufficient serum is present to run all selected tests See Figure 5 10 FIGURE 5 10 Sample with Multiple Assigned Panels Once all samples in the first rack have assigned panels see Figure 5 11 press one of the following buttons to continue Load Press to continue loading sample racks This advances the loaded rack by one position so the next rack can be loaded Unload Press to...

Страница 37: ...ens a pre run checklist see Figure 5 12 Press the button next to each item on the list to verify the steps have been completed or press Start Run if run settings have been selected FIGURE 5 12 Pre run Checklist Note An additional check may be added to confirm that sufficient reagents DI water and Wash Buffer is present ...

Страница 38: ...drain settings following assay completion Set to Drain if the instrument will automatically drain liquid from the Pettes at the end of testing FIGURE 5 13 Pre run Checklist Run Settings Press the Start Run button to lock the AP3600 instrument doors and begin the automated run process Note To cancel the test at this time press the Unload Racks button to move the racks back to the load unload positi...

Страница 39: ... be reused on the AP3600 after a test is canceled FIGURE 5 14 Running Tests Screen Each Pette number is listed on the right The Step column displays the current step A checkmark appears in the relevant column as the following checks are complete S Serum aspiration verified by CCD camera check A Antibody aspiration verified by CCD camera check P Photoreagent aspiration verified by CCD camera check ...

Страница 40: ...er the network or onto a USB drive Post Run Steps Remove all reagent bottles Antibody Photoreagent I and Photoreagent II from the AP3600 instrument Cap tightly to prevent any evaporation and store the bottles in a refrigerator 2 8 C After the run the operator must follow the instructions in Rinse and Drain on page 10 1 to flush the system tubing and pumps Replace the reagent bottles Antibody Photo...

Страница 41: ...rk List screen displays the list of scheduled assays If the AP3600 system uses the Laboratory Information System LIS the work list is automatically loaded In addition the Work List also displays the status of the test FIGURE 6 1 Work List Status Screen 6 1 Work List Screen ...

Страница 42: ...OPTIGEN AP3600 AUTOMATED INSTRUMENT USER MANUAL This page intentionally left blank 6 2 Work List Screen ...

Страница 43: ...es analyzed by the AP3600 The list provides information about each sample and allows the operator to export the test results By selecting a sample ID from the list the operator can bring up information in the Details screen for that sample The following is provided for each entry in the Results list Checkbox Check this box to view detailed information for the item when the Details button at the bo...

Страница 44: ...een shows the test results from the selected test FIGURE 7 2 Details Screen Test and Sample Details Details about the selected test are displayed on the left side of the screen Test Details Date Date and time the test wascompleted Pette ID Unique ID for the Pette tested with the patient sera Panel Name Common name for the Pette test chamber Result Status Result status for thetest Sample Details Sa...

Страница 45: ... chemiliuminescence unit measured for each allergen Class Displays the response number 0 6 for each allergen with 6 representing the greatest response The color bar to the right also illustrates the response level darker colors indicate a greater allergic reaction from the patient to that particular allergen Details Screen Button The following buttons are provided at the bottom of the screen Print...

Страница 46: ...7 4 Results Screen OPTIGEN AP3600 AUTOMATED INSTRUMENT USER MANUAL This page intentionally left blank ...

Страница 47: ...setting up the AP3600 system Note The following utilities are available to operators logged in with the User 1 through User 10 accounts Screens available to operators logged in with the Service accounts are not discussed below FIGURE 8 1 Utilities Screen Available Utilities for User 1 through User 10 ...

Страница 48: ...nts have access to this screen FIGURE 8 2 About Screen Manually Start Self Check Ensure all doors are securely closed Then select the Manually Start Self Check item to run an optical self check of the AP3600 instrument A message appears after the check is complete indicating if the check passed or not FIGURE 8 3 Optics Check Passed Message ...

Страница 49: ...he list on the left side of the screen to view the event data on the right Each event has a timestamp and the event text The following actions can be taken on this screen Click the Export To USB button to save the log file in onto a USB drive USB ports are located on the front of the AP3600 instrument and under themonitor Click the Print File button to print the log file FIGURE 8 4 Log File Utilit...

Страница 50: ... and start AP3600 system rinse and drain cycles Click the Rinse or Drain and buttons to increase decrease the number of cycles that will be run Note The system must be flushed after each run is complete See Rinse and Drain on page 10 1 for details steps on performing a flush operation FIGURE 8 5 Maintenance Utility Screen ...

Страница 51: ...Use this screen to determine what printer types are supported FIGURE 8 6 Printer Screen LCD Backlight Use this screen to configure the flat panel display brightness Volume Use this screen to configure the DMS software alerts volume ...

Страница 52: ...ility Admin Software updates should only be performed by qualified personnel Information for the Software Update Utility is in the AP3600 Service Manual Note Screen not shown must be logged in at Admin level Panels Update Utility Admin The Panels Update Utility screen allows updates to panels The updated panels must be located on an USB memory device and formatted correctly using a spreadsheet Not...

Страница 53: ... Must be logged in at Admin level FIGURE 8 9 Backup Restore Utility Manage User Accounts Admin The Manage User Accounts screen allows users to have individual names and passwords Note Screen not shown must be logged in at Admin level Remove All Results Admin The Remove All Results screen allows the removal of all previous test results Note Screen not shown must be logged in at Admin level ...

Страница 54: ...8 8 Utilities Screen This page intentionally left blank ...

Страница 55: ... available to operators logged in with the User 1 through User 10 and Admin accounts Screens available to operators logged in with the Service accounts are not discussed below FIGURE 9 1 System Settings Screen Language Currently English is the only language available Date Time Admin Only 1 Select Format for the time 2 Select Date Format for thedate 3 Select Submit when finished User Admin ...

Страница 56: ...ttings Screen FIGURE 9 2 Date and Time Edit Laboratory Details Admin Only 1 Select this item to input Laboratory information Name Address Phone Number Fax Number and email if available FIGURE 9 3 Laboratory Details ...

Страница 57: ... to discard changes and return to the System Settings screen FIGURE 9 4 Change Password Screen Network Details Admin Only 1 Select this item to modify network settings of the AP3600 Enable DHCP When checked the device will use DHCP to obtain an IP address automatically from the network When unchecked the following fields become available IP Address Manually specify IP address Netmask Manually spec...

Страница 58: ...current state of the AP3600 LIS connectivity Instrument Information Instrument Type Device designation Instrument Name Specify name of device for destination LIS Instrument State Indicates current state of the AP3600 instrument IP Address Indicates current IP address of the AP3600 instrument Options Auto send Enable or disable automatic sending of results toLIS FIGURE 9 6 LIS Settings Screen ...

Страница 59: ...Favorites Select Submit to apply panel favorites to all samples 2 Option 2 Select panels for each sample individually Select sample Choose any panel from Favorite Panels or Available Panels FIGURE 9 7 Panel Favorites Screen Export Results Automatically Admin Only Check the Export Results Automatically option to have all results automatically printed FIGURE 9 8 System Setting Screen ...

Страница 60: ...min Only 1 Connect a printer to theinstrument 2 Load 8 5 x 11 paper onto theprinter 3 Power off then power on theinstrument 4 Log in as Admin 5 Select Utilities Printer Printer setup screen is displayed 6 Select Refresh option 7 Select the correct printer driver and listed printer device for the connected printer 8 Select Submit option 9 Printer is now set up for use with theinstrument 10 Printer ...

Страница 61: ...9 7 System Settings Screen This page intentionally left blank ...

Страница 62: ......

Страница 63: ... Instrument Rinse and Drain 1 Remove the reagents and Wash Buffer from the AP3600 instrument Replace all four reagent bottles and the Wash Buffer with bot tles containing DI water FIGURE 10 1 DI Water Bottles 2 Open the Utilities screen 3 Press the Maintenance Utility button to open the Maintenance Utility screen for rinsing and draining the instrument ...

Страница 64: ...complete FIGURE 10 3 Finished Rinsing Process Window 6 Once the cycle has ended disconnect water bottles from all lines Place all disconnected lines onto a clean absorbent material 7 Set the desired number of drain cycles and then press the Start Drain Cycle button to start the cycle Refer to Figure 10 2 The fol lowing number of cycles are recommended based on when the instrument will be next used...

Страница 65: ... In the win dow that appears select Shutdown now to power down the monitor FIGURE 10 5 Shutdown Window 6 Turn the main power switch of the AP3600 instrument to the OFF position 0 FIGURE 10 6 AP3600 Main Power Switch Cleaning the Wash Buffer Bottle Clean the four liter Wash Buffer bottle weekly with Distilled DI water The Wash Buffer bottle is autoclavable Cleaning the Waste Bottle Clean the waste ...

Страница 66: ...10 4 End of Run This page intentionally left blank ...

Страница 67: ... in or replace the Pette and tip Verify the content of the warning display Read the warning display items carefully and resolve the cause of the alarm If the cause of the alarm is mechanical or electrical such as sensor error display repair is necessary 3 There is no movement after start ing the operation sensor error warning is displayed Electrical system failure Repair is necessary Mechanical se...

Страница 68: ...OPTIGEN AP3600 AUTOMATED INSTRUMENT USER MANUAL This page intentionally left blank 11 2 Troubleshooting ...

Страница 69: ...ications only This instrument should not be modified or altered in any way Alteration of this instrument will void the manufacturer s warranty void the I E C 61010 1 certification and create a potential safety hazard for the user The AP3600 system conforms to class A standards for Electromagnetic Emissions intended for laboratory equipment applications It is possible that emissions from this produ...

Страница 70: ...OPTIGEN AP3600 AUTOMATED INSTRUMENT USER MANUAL This page intentionally left blank A 2 Regulatory Compliance ...

Страница 71: ...turer KAWASAKI ELECTRIC WIRE CO LTD KDK Model KP 30SVT3 18AWG Countries using 200 240 VAC 250V 7A cord Acquire power cord locally WARNING Do not use an inadequately rated power cord with the AP3600 Instrument This may damage the instrument Processing Specifications Number of Pettes Processed Maximum of 50 Pettes per run Processing Time One run completes in 5 5 hours excludes automatic waste soluti...

Страница 72: ...OPTIGEN AP3600 AUTOMATED INSTRUMENT USER MANUAL This page intentionally left blank B 2 Specifications and Ordering Information ...

Страница 73: ...ighs approximately 170 kg 375 lbs Four persons are required to assist when lifting the system Refer to Heavy Objects on page 1 4 for details Installing a New System 1 Prepare the system location The AP3600 instrument must be installed on a stable flat surface that meets the following specifica tions see Figure C 1 and Figure C 2 Surface Dimensions 1800 x 1060 x 1200 mm W x H xD Supports a load of ...

Страница 74: ...e instrument Open the dark box and serum handling area covers 3 Remove tape and cushions from the Sample Distribution Nozzle Head and Reagent and Wash Nozzle Heads See Figure C 3 FIGURE C 3 Removing Packing Materials from Black Box Remove cushions from Sample Distribution Nozzle Head Remove cushions from Reagent and Wash Nozzle Heads Remove foam piece from Pette Carousel ...

Страница 75: ...chment connector See Figure C 5 7 Install the correct caps with tubing for the Wash Buffer DI water and waste bottles The overflow tubing and bottles should be placed below the instrument on the waste station tray because the overflow liquid drains by gravity All caps are color coded See Figure C 5 FIGURE C 5 Install Bottle Connector and Install Bottles Under Instrument 8 Connect the AC power cord...

Страница 76: ...C 4 Moving and Installing the System 11 Verify the instrument properly initializes and the optical check runs successfully Note The AP3600 system is now ready for normal operation ...

Страница 77: ...ies in the serum handling area sample vial racks trans fer tip rack and sample cups Close the sera handling area door 3 Open the dark box cover 4 Remove any Pettes installed in the Pettecarousel 5 Tape the cushions that the system shipped with to secure the Sample Distribution Nozzle Head and Reagent and Wash Nozzle Heads Place foam piece over Pette Carousel See Figure C 6 FIGURE C 6 Securing the ...

Страница 78: ...thernet port or USB connections on the front of the instrument and under the monitor 11 Disconnect the power cable from the back of the AP3600 instrument and disconnect the cable from the Bottle Unit 12 Secure the outside of the AP3600 with tape and bubble wrap See Figure C 8 FIGURE C 8 Place Tape and Bubble Wrap to Secure Items 13 Lift the AP3600 Instrument from the bottom of the unit and place i...

Страница 79: ...th DI water Attach antibody with 10 bleach solution and both Photoreagents with DI water to the instrument 3 Replace the main DI water container with the 10 bleach solution separate container Place the wash buffer line into the main DI water container 4 Perform one 1 rinse cycle see Figure D 1 Allow the solution to stay in the lines for ten 10 minutes FIGURE D 1 Maintenance Utility Screen 5 Discon...

Страница 80: ...1 Once strip testing returns 0 ppm result perform 2 additional rinses Replacing Fuses Required Tools and Materials Flat screwdriver Replacement fuses AC 100 120V T10A 250V AC 200 240V T7A 250V Procedure 1 Turn the main power switch of the AP3600 instrument to the OFF position 0 FIGURE D 2 AP3600 Main Power Switch 2 Unplug the AC power cord to the AP3600 instrument 3 Use a flat screwdriver to rotat...

Страница 81: ...bly 5 Reinstall the fuse holder and rotate the fuse box clockwise to secure it 6 Reinstall the AC power cord to the AP3600 instrument 7 Turn the main power switch of the AP3600 instrument to the ON position I Fuse Fuse Holder Fuse Holder Assembly ...

Страница 82: ...D 4 Maintenance This page intentionally left blank ...

Страница 83: ...ccur OPTIGEN This is the in vitro chemiluminescent assay used by the AP3600 system OPTIGEN is a registered trademark of Hitachi Chemical Diagnostics Pette Test Chamber Pette This single use disposable plastic device contains 36 allergens or allergen mixes and 2 controls 38 lenslets total The Pette also contains Positive Procedural Control and Negative Blanking Control wells Pette Tip A single use ...

Страница 84: ...OPTIGEN AP3600 AUTOMATED INSTRUMENT USER MANUAL This page intentionally left blank E 2 Glossary ...

Страница 85: ...961 5501 European Office Hitachi Chemical Diagnostics Inc Hitachi Europe Ltd Whitebrook Park Lower Cookham Road Maidenhead Berkshire SL6 8YA United Kingdom 44 0 1628 585 590 Please contact your distributor for customer service and warranty terms 2016 Hitachi Chemical Diagnostics Inc All rights reserved ...

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