ThermoBrite®® Slide Hybridization/ Denaturation System Operator’s Manual A Division of IRIS International, Inc.
Operator’s Manual ® StatSpin ThermoBrite ® Model Number S500 FOR IN VITRO DIAGNOSTIC USE StatSpin and Iris are registered trademarks of IRIS International, Inc. Copyright 2011 Printed in U.S.A.
Table of Contents Table of Contents ........................................................................................................... ii How to use this manual .................................................................................... iii Section 1 ............................................................................................................ 1 Unpacking and Installation ..........................................................................................
How to use this manual This manual along with information contained on product labels should provide you with all the information you need to operate and maintain the ThermoBrite. Notes appear in italics to highlight information. When the information requires special attention, a caution symbol appears next to the italicized text.
Section 1 Unpacking and Installation Inspect Packaging The ThermoBrite 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 StatSpin ThermoBrite (Model No. S500) One Line Cord One Operator’s Manual Two Humidity Control Cards (Reorder # HC10- QTY 10) Install System 1.
Section 2 System Overview Principle and Intended Use IVD For in vitro diagnostic use for denaturation/hybridization for slide-based FISH procedures. The StatSpin ThermoBrite is a microprocessor controlled small bench top hot plate with lid. The ThermoBrite allows storage of 40 programs, three operating modes, Fixed Temperature, Hybridization Only or Denaturation and Hybridization, capacity for twelve slides and a maximum temperature of 99°C. The instrument is UL / cUL listed and CE marked.
Symbols and Definitions (cont.) Manufactured By Indicates Manufacturer of the Device Electric Shock Indicates a potential risk of electrical shock.
Error Messages Instrument cannot achieve a set temperature by heating within 10 minutes an error message appears to inform user to turn unit off and call service. A constant beep will sound. SYSTEM ERROR! TURN UNIT OFF! CALL SERVICE If the instrument cannot measure the temperature, the software will automatically turn off the heating. An error message will appear to inform the user to turn off the unit and call service. A constant beep will sound.
Hyb only: PGM -- namexxxxxx Hyb in Process (“Ambient Temp High!” flashes alternately on this line) Hyb --C --:-Present Temp: --C Fixed Temp: PGM -- namexxxxxx Fixed Temp --C (“Ambient Temp High!” flashes alternately on this line) Reset Timer 00:00:00 End PGM/Main Menu Abort Screen Message ABORTING!! Are You Sure? No Yes – Main Menu 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
Section 3 Operating Instructions Opening and Closing the Lid The platen 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 simply 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.
(To return to the Main Menu, move the cursor to highlight “Main Menu” line and press “Enter” button). Denaturation and Hybridization: Display indicates present temperature of the slides. Once temperature reaches denaturation set point, ThermoBrite will beep twice and denaturation time will count down from the set time. PGM 01 Her2 Denat in Process Denat: 82°C 02:28 Present Temp: 82°C The ThermoBrite will automatically cool to hybridization set temperature once denaturation is completed.
Turn unit on and wait for the Main Menu screen. Cursor highlights “Run a PGM” line. Timer counts elapsed time. (Pressing “Enter” button will reset timer to zero). PGM 03 Appl Fixed Temp: 65°C Reset Timer 01:18:10 End PGM/Main Menu Use Arrow keys to move to “End PGM/Main Menu” line and press “Enter” button to accept. Note: If ambient temperature is programmed the fan will continually cycle until the program is aborted.
Predefined Limits Program Mode Temperature Range Timer Limits Denature 50ºC to 99ºC 0-30 minutes Hybridization Room temp: 30ºC to 70ºC 0-99 hours Fixed Temp Room temp: 30ºC to 99ºC 0-99 hours 9
Section 4 Programming Overview StatSpin ThermoBrite is capable of storing 40 different programs. Each program can be one of three program types: o Denaturation and Hybridization (Denat & Hyb), o Hybridization Only (Hyb Only) or o Fixed Temperature (Fixed Temp). Select PGM Type Denat & Hyb Hyb Only Fixed Temp Programming is simple. Select program type, and follow screen prompts to enter run times and set temperatures. ThermoBrite maintains set temperatures for duration of the processing.
PGM 01 Enter: Denat: Hyb: name Temp °C °C Time :00 00:00 (Reference Character Selection for additional information in regards to working with the keypad.) Cursor will advance to “Denat Temp”. With numeric keypad enter a two-digit temperature value in degrees Celsius (50-99ºC). Cursor advances to “Denat Time”. With numeric keypad enter a two-digit time value in minutes (0 – 30) Cursor advances to “Hyb Temp”. With numeric keypad enter a two-digit temperature value in degrees Celsius (30-70ºC).
Press “Enter” button to accept the program values; or press “Backspace” button to return to previous screen to modify program values; or press “Stop” button to abort. Creating a Fixed Temperature Program (Fixed Temp) From the Main Screen, use the arrow keys to move cursor to “Create a PGM” and press “Enter” button to accept. With arrow keys move cursor to “Fixed Temp” line and press “Enter” button to accept. ThermoBrite will advance to the next available program number.
Section 5 Maintenance Overview Iris Sample Processing recommends that instrument operators perform periodic inspections and preventative maintenance on all Iris Sample Processing instruments. Contact Iris Sample Processing’s customer service department or distributor if, at any time, the instrument is not functioning properly. CAUTION - Unplug the ThermoBrite from the wall outlet before performing maintenance.
Troubleshooting Unit does not turn on or No power. Check both cord ends are plugged in. Check Fuses located on rear panel next to power switch. Replace with same type and value. Poor results on slides. Verify selected protocol against probe manufacturer’s recommendation. 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 Appendix A - Specifications Product No. Model No. TS01 TS02 S500-12 S500-24 Capacity Up to 12 slides Processing Time 0-100 hours Number of Programs Ramp Time Cooling Time Electrical Dimensions 40 37 – 95ºC in less than 3 minutes 95 - 45ºC in less than 6 minutes 120 VAC @ 3.0 A 240 VAC @ 1.6A Depth 45.1 cm Width 22.8 cm Height 13.5 cm Weight 8.
References 1. 2. 3. 4. NCCLS. “Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline-Second Edition.” NCCLS document M29-A2 [ISBN 1-56238-453-8]. NCCLS, 940 West Valley Rd, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2001. CDC. Recommendations for prevention of HIV transmission in health care settings. MMWR (Suppl. No. 2S):2S-18S, 1987. CDC.
Iris Sample Processing Warranty Iris Sample Processing, a Division of IRIS International, Inc. warrants that the instruments shall be free from defects in material and/or workmanship, under normal use and service, for the period expiring twelve (12) months from the date of installation, provided the purchaser has completed and forwarded to Iris Sample Processing the Warranty Registration Card.