Hybridizer | Handbook Dako Hybridizer | Handbook 1
Hybridizer | Handbook Document Number 0003061 Revision C July 2007 For In Vitro Diagnostic Use Dako Colorado, Inc. 4850 Innovation Drive Ft. Collins, CO 80525 USA 970-226-2200 Dako Hybridizer (120 V) - Code No. S2450 Dako Hybridizer (240 V) - Code No. S2451 Dako Hybridizer Control Strips - Code No.
Copyright© 2007 Dako Colorado, Inc. All rights reserved This document may not be copied in whole or in part or reproduced in any other media without the express written permission of Dako. Please note that under copyright law, copying includes translation into another language. Contact Dako Manufacturer Corporate Headquarters Dako Colorado, Inc. Dako Denmark A/S 4850 Innovation Drive Produktionsvej 42 Fort Collins, CO 80528 USA DK-2600 Glostrup Denmark www.dako.com www.dako.
Table of Contents | Handbook Section 1 | Unpacking and Installation................................................................... 8 Inspect Packaging........................................................................................................................... 8 Verify Contents................................................................................................................................ 8 Installation of the Hybridizer........................................................
Section 5 | Edit a Program..................................................................................... 28 Opening and Closing the Lid......................................................................................................... 28 Turn Unit On.................................................................................................................................. 28 Edit a Program ....................................................................................................
How to use this handbook This handbook along with information contained on product labels should provide all the information needed to operate and maintain the Hybridizer. Notes appear in italics to highlight information. When the information requires special attention, a caution symbol appears next to the italicized text: Please pay close attention to the instructions that accompany the notes and symbols as well as the standard laboratory practices outlined by your facility and local regulatory agencies.
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Section 1 | Unpacking and Installation Inspect Packaging The Hybridizer and its accessories are delivered in one carton. If the instrument or accessories have suffered any damage in transport, please inform your carrier immediately. Note: Save shipping carton and components to simplify return should service be required. Verify Contents The package contains: One Hybridizer, code No.
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Section 2 | System Overview Principle and Intended Use IVD For in vitro diagnostic use to co-denature and hybridize probes to targets in specimens on glass microscope slides. The Hybridizer is a microprocessor controlled small bench top hot plate with lid. The Hybridizer allows storage of 40 programs, of 3 operating options; Denaturing and Hybridization, Hybridization Only or Fixed Temperature. Capacity for 12 slides and maximum temperature of 99°C. The instrument is UL / CUL listed and CE marked.
Symbols and Definitions (cont.
Audible Indicators Single beep – on all legal keystrokes. Two quick beeps – upon accepting a field and cursor has moved to the next field. Five beeps at 0.5 second interval – completion of process. Audible Error Indicators Three short beeps – Entering of illegal or non-functioning keystrokes. Low tone beep – Attempt to enter a value out of acceptable range. Continuous beep – Instrument is not performing within acceptable range or program condition. Turn off main power and restart.
High ambient temperature condition: The instrument will attempt to achieve process set temperatures. However, if the cooling fan cannot achieve the set temperature within 10 minutes, an error message will appear to inform the user that the ambient temperature is high. A constant beep will sound. The counter will continue to count. The present temperature will be displayed. Hitting the “Stop” button will allow the user to abort the process.
If the ambient temperature changes during a process and causes the instrument process set temperature to change beyond the +/- 1°C specification for more than 2 minutes, a message will appear to inform the user that the ambient temperature is “high”. A constant beep will sound. The counter will continue to count. The present temperature will be displayed. Hitting the “Stop” button will allow user to abort the process. A new screen will be displayed asking user if they are sure they want to abort.
If the ambient temperature changes after a process is completed, but before the user removes the slides and causes the instrument process set temperature to change beyond the +/- 1°C specification for more than 2 minutes a message will appear to inform the user that the ambient temperature is “high”. A constant beep will sound. The counter will continue to count. The present temperature will be displayed. Hitting the “Stop” button will allow user to abort the process.
Section 3 | Programming Opening and Closing the Lid The plate may be hot. Use caution and check temperature on display before handling slides. Improper precaution can cause a burn. Depressions located on either side of the lid allow user to lift lid into position. The lid should offer some resistance when opening. To close reverse process, assure front is completely down and no obstructions prevent gasket seal from sealing on housing base.
Note: If all 40 program numbers have been used, the “Create a PGM” line in the Main Menu will no longer appear. An existing program must be edited. See section 5. Create a Denaturation and Hybridization Program (Denat & Hyb) Turn unit on and wait for the Main Menu screen. Use the arrow keys to move cursor to “Create a PGM” and press “Enter” button to accept. Cursor highlights “Denat & Hyb” line; press “Enter” button to accept. Hybridizer will advance to the next available program number.
Create a Hybridization Only Program (Hyb Only) Turn unit on and wait for the Main Menu screen. Use the arrows keys to move the cursor to “Create a PGM” and press “Enter” button to accept. With arrow keys move cursor to “Hyb only” line and press the “Enter” button to accept. Hybridizer will advance to the next available program number. PGM 02 Name Enter: Hyb: Temp 30°C Time 00:00 Hybridizer allows creating a program name.
Create a Fixed Temperature Program (Fixed Temp) Use the arrows keys to move cursor to “Create a PGM” line and press “Enter” button to accept. With arrow keys move cursor to “Fixed Temp” line and press “Enter” button to accept. Hybridizer will advance to the next available program number. PGM 03 Name Enter: Fixed: Temp 30°C Hybridizer allows creating a program name. Cursor highlights the first name character position.
Section 4 | Operating Instructions Opening and Closing the Lid The plate may be hot. Use caution and check temperature on display before handling slides. Improper precaution can cause a burn. Depressions located on either side of the lid allow user to lift lid into position. The lid should offer some resistance when opening. To close reverse process, assure front is completely down and no obstructions prevent gasket seal from sealing on housing base.
Display will confirm PGM number/name and Denat & Hyb times and temperatures. Cursor highlights “Run PGM” line. PGM 01 HER2 82°C :05; 45°C 20:00 Run PGM Main Menu Press “Enter” button to accept. The display prompts to “Add Slides and Close Lid”. Before adding slides insert two Humidity Control Strips into the inside slide lid. After slides have been added saturate strips with distilled water or equivalent (approx. 13 mL for dry strips) and close lid. Cursor highlights “Start” line.
The Hybridizer will automatically cool to hybridization set temperature once denaturation is completed. Please Wait Cooling to Hyb 45°C Present Temp: 58°C “Ambient Temp High!” flashes alternately on “Present Temp” line. Hybridization time will count down from the set time once temperature reaches hybridization set point. PGM 01 HER2 Hyb in Process Hyb: 45°C 12:48 Present Temp: 45°C Upon program completion Hybridizer will beep five times and the display will show “PROCESS COMPLETE”.
Display will confirm PGM number/name and Hyb Only times and temperatures. Cursor highlights the “Run PGM” line. PGM 02 EBV Hyb: 55°C 01:30 Run PGM Main Menu Press “Enter” button to run program. The display prompts to “Add Slides and Close Lid”. Before adding slides insert two Humidity Control Strips into the inside slide lid. After slides have been added saturate strips with distilled water or equivalent (approx. 13 mL for dry strips) and close lid. Cursor highlights “Start” line.
Upon program completion Hybridizer will beep five times and the display will show “Process Complete”. Hybridization temperature will be maintained until “End PGM/Main Menu” is accepted by pressing “Enter” button. Before pressing “Enter” button, remove slides for further processing. If “End PGM/Main Menu” is not accepted within the first minute of program completion, hybridization time will start counting the total time at hybridization temperature.
When the fixed temp set temperature is reached the display prompts to “Add Slides and Close Lid”. Before adding slides insert two Humidity Control Strips into the inside slide lid. After slides have been added saturate strips with distilled water or equivalent (approx. 13 mL for dry strips) and close lid. Cursor highlights “Start” line. Press “Enter” button again to run the program. (To return to the Main Menu, move the cursor to highlight “Main Menu” line and press “Enter” button).
Recommended for Best Results Place glass coverslip over probe and sample Apply sealant along all coverslip edges Use Dako Humidity Control Strips S 2452 Slide Location Hybridizer accommodates up to 12 slides per run. When prompted, lift lid and load slides onto plate using slide locator for easy positioning. Frosted and/or label end of slides should be away from slide locator. Move slides across plate until they rest against slide locator.
Predefined Limits Program Mode Temperature Range Timer Limits Denature 50°C to 99°C 0-30 minutes Hybridization Room temp, 30°C or ambient + 5°C (whichever is higher) to 70°C 0-99 hours Fixed Temp Room temp, 30°C or ambient +5°C (whichever is higher) to 99°C 0-99 hours Dako Hybridizer | Handbook 27
Section 5 | Edit a Program Opening and Closing the Lid The plate may be hot. Use caution and check temperature on display before handling slides. Improper precaution can cause a burn. Depressions located on either side of the lid allow user to lift lid into position. The lid should offer some resistance when opening. To close reverse process, assure front is completely down and no obstructions prevent gasket seal from sealing on housing base.
Cursor highlights existing program type: “Denat & Hyb”, “Hyb only” or “Fixed Temp”. Press “Enter” button to accept existing program type or use arrow keys to move cursor to a different program type. Press “Enter” button to accept. Select PGM Type Denat & Hyb Hyb Only Fixed Temp Use numeric keypad to enter new values for Temperatures and/or Time. Procedure and limits are the same as those for creating a program. Note: Hybridizer allows 40 programs to be entered and stored.
Section 6 | Maintenance Overview Dako recommends that instrument operators perform periodic inspections and preventative maintenance on Hybridizer. Contact Dako’s Customer Service if the Hybridizer is not functioning properly. CAUTION - Unplug Hybridizer from the wall outlet before performing maintenance. WARNING - Do not expose Hybridizer to strong or concentrated acids, bases, esters, aromatic or halogenated hydrocarbons, ketones or strong oxidizing agents.
Troubleshooting Unit does not turn on, no power. Check both cord ends are plugged in. Poor results on slides. Verify selected protocol against probe manufacturer’s recommendation. Check Fuses located on rear panel next to power switch. Replace with same type and value. Ensure Humidity Control Strips are in place and moist. Ensure cover slip sealant was applied. Ensure plate is heating. Ensure lid is properly closed. Ensure air intake and outlet are not obstructed.
Appendix A | Specifications Code Numbers Electrical Processing Time Program Number Heating Time Cooling Time Program Types Temp. Uniformity Capacity Dimensions Environmental S 2450 S 2451 100-120 VAC @ 3.0 A 220-240 VAC @ 1.6A 0-99 hours 40 37°C to 95°C; 2 minutes 95°C to 45°C; 5 minutes Denaturation and Hybridization Hybridization only Fixed temperature Within +/- 1°C on the heat plate Up to 12 slides Depth 45.1 cm/ 17 3/4 in Width 22.8 cm/ 9 in Height 14.0 cm/ 5 1/2 in Weight 8.
