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1. negative result no bacterial growth self contained biological indicators must be incubated for the appropriate length of time incubation time Refer to the instructions for use that came with your biologi cal indicators for the proper incubation time and temperature Immediately upon activation place the indicator into one of the thirteen numbered incubation cavi ties Record the incubation start time and cavity number Observe the color of the growth medium in the BI at regular intervals during incubation A color change to yellow during the incubation time indi cates bacterial growth positive test If the incuba tion time expires and no color change to yellow is observed this indicates a negative test no bacte rial growth Caution If a positive control does not grow do not use the remaining units from the box and contact your dealer imme diately A positive control that does not turn yellow is a serious problem Fortunately the causes are few a grossly malfunctioning incubator inadvertent ster ilization of the control vial inadvertent sterilization of the box of indicators or im proper storage If the control is negative because of one of the latter two causes do not use any of the other biological indica tors in the same box Dispose of positive or negative Bls immediately per the instructions for use that accompany each box of indicators or per your organization s policy CON_CHMSTL
2. in a location where temperature is maintained between 10 C 50 F and 35 C 95 F 1 Remove the incubator from its packaging 2 Unpack the power supply The power supply ships with four interchangeable blades plugs Select the appropriate blades for your region and attach the blades to the power supply 3 Plug the power supply into a power source 4 Insert the small connector from power sup ply into the matching receptacle in the back of incubator The incubator will automatically power on and perform a self test Upon completion the in stalled firmware revision will be displayed on the LED screen for two seconds The incubator will begin its warm up phase During this time the configured temperature setpoint will fade in and out on the LED screen The incubator is ready to use when the LED screen displays the current operating tempera ture of the incubator Temperature Selection The incubator can be configured to operate at 60 C for biological indicators containing Geoba cillus stearothermophilus The incubator is initially configured to operate at 60 C Note It may take between 15 and 30 minutes for the in cubator to come up to oper ating temperature depending on the selected incubation temperature and the temperature of the environment in which the incubator is in stalled CON_CHMSTLMONITORS_ML_AccuFast1410_0511_EN_US OPERATION Note Refer to the instruc tions for use supplied with yo
3. GETINGE GETINGE GROUP GETINGE 1410 INCUBATOR USER MANUAL Always with you 2 GETINGE 1410 Incubator Manual Infection Control TABLE OF CONTENTS PREFACE ooie eaa ea EE AEE E 2 SAFETY dninn O AA a a 3 INTRODUCTION eraren ae a E E RA cuca aE E E E E EA E E EE eA E E ER 4 instalaron amd Wann UD EE SEERE 4 OPERATION Biological Indicator Activation Laeti o ROMS AEO AE EE OEE ENA A EE AE EA E E 5 MAINTENANCE Cleaning Temperature Verification SS OLVICG OEE EAIA E N E ENAT INEEN RENEA E AN ENEE 6 aa SPECIFICATIONS cc e 255 cscsccscsctsdzctcehctecaccnscee ctcsidsats pacsagedecnseydnsescapeseia dea daszscedsssdesestvsnacaastesiccdcisy 7 PREFACE The Getinge 1410 Incubator is designed for 60 C Geobacillus stearothermophilus incubation of Getinge AccuFast biological indicators The incubator features a built in thermometer with LED display an inte grated crushing activation crushing cavity and 13 incubation cavities A Getinge AccuFast self contained biological indicator consists of a capped thermoplastic culturing vial containing a glass media ampoule and a carrier inoculated with bacterial spores Upon removal from the sterilizer the indicator is activated by flexing the plastic culturing vial to crush the inner glass ampoule which allows the growth medium to contact the spore carrier The activated indicator is then incubated for a speci fied length of time and observed for color change of th
4. MONITORS_ML_AccuFast1410_0511_EN_US 6 GETINGE 1410 Incubator Manual Infection Control MAINTENANCE The incubator requires no maintenance other than cleaning as necessary Cleaning 1 Unplug the incubator before cleaning 2 To clean the exterior use a cloth dampened with isopropyl alcohol 3 To clean the incubation and activation cavities use a cotton swab dampened with isopropyl alcohol Caution Do not immerse the unit in any liquid and do not spray or pour liquid directly onto the unit Doing so may damage the incu bator and void your warranty Temperature Verification The incubator including the LED temperature dis play is factory calibrated using an NIST traceable temperature standard and does not require user calibration Incubation temperature can be verified by placing an NIST traceable thermometer into one of the incubation cavities and allowing 30 minutes for temperature stabilization The temperature read ing should be within 2 C of the incubator set point temperature Service The incubator is not field servicable In the unfor tunate event of an incubator malfunction please contact Getinge Service immediately When requesting service have ready the model and serial number of the incubator The model and serial number are located on the bottom of the unit CON_CHMSTLMONITORS_ML_AccuFast1410_0511_EN_US GETINGE 1410 Incubator Manual Infection Control SPECIFICATIONS Geti
5. e growth medium If the medium turns yellow during incubation the test is positive indicating growth and inadequate sterilization CON_CHMSTLMONITORS_ML_AccuFast1410_0511_EN_US GETINGE 1410 Incubator Manual Infection Control SAFETY Handle with caution The surface of the incubator may become hot to the touch The incubator has been designed with function reliabil ity and safety in mind It is the user s responsibility to install it in conformance with local electrical codes For safe operation please pay attention to the alert boxes throughout the manual Warning Refer to manual Caution Cautions alert you to potential equipment damage and hazards Note L Notes alert you to pertinent facts and conditions Use Only as Directed e Indoor use only e Temperature 10 C to 35 C e Maximum relative humidity 80 for temperatures up to 31 C decreasing linearly to 50 relative humidity at 35 C e Main power supply voltage fluctuations not to exceed 10 of the nominal voltage e Installation Class 2 service e Pollution Degree 2 environments e Altitude less than 2000 m CON_CHMSTLMONITORS_ML_AccuFast1410_0511_EN_US 4 GETINGE 1410 Incubator Manual Infection Control INTRODUCTION Installation and Warm Up The incubator is designed for continuous operation and does not have a power switch The incubator will power up when it is plugged into a power source Note The incubator must be installed
6. nge 1410 Incubator Getinge Part Number 61301606649 Overall Dimensions Width 3 5 in 9cm Height 2 0 in 5 8 cm Depth 4 0 in 10 2 cm Weight 0 89 lb 0 4 kg Incubation Cavities Number 13 Diameter 0 375 in 0 94 cm Depth 1 in 2 54 cm Thermometer Accuracy 1 C Electrical Ratings for use with certified Volts 12 Vdc Class 2 power supply Watts 18 0 Amps 1500 mA Operating Temperature Temperature 60 C Environmental Conditions Ambient Temperature 10 C 35 C Relative Humidity 20 80 Non condensing Conformance CSA C US CE RoHS FCC Part 15 Class A ICES 003 Class A a O Catalog Number P6 1000 Rated Input Voltage 100 240 Vac Input Voltage Range 90 264 Vac Rated Frequency 50 60Hz Rated Input Current 1 0A Output Voltage 12 Vdc Max Output Current 2 5A Max Output Wattage 30W Safety Approvals EMC EMI RoHS Compliant Storage Temperature Storage Humidity Operating Temperature Operating Relative Humidity UL cUL GS CCC RCM FCC class B CE VCC class II Yes 10 C 70 C 10 90 0 40 C 20 80 CON_CHMSTLMONITORS_ML_AccuFast1410_0511_EN_US 7 COMPLETE SOLUTIONS FOR INFECTION CONTROL Getinge is the world s leading provider of solutions for effective cleaning disinfection and sterilization in the healthcare and life science sectors We are dedicated to helping our customers provide better care at a lower cost We do this by offering well th
7. ought through and customized solutions This means that we are with our customers all the way from architectural planning and education to traceability and support with complete solutions long term commitment and global presence Getinge Always with you Getinge USA Inc 1777 East Henrietta Road Rochester New York 14623 3133 U S A Phone 800 475 9040 Fax 585 272 5033 info getingeusa com GETINGE GROUP is a leading global provider of products and systems that G E T N G E contribute to quality enhancement and cost efficiency within healthcare and life sciences We operate under the three brands of ArjoHuntleigh GETINGE and MAQUET ArjoHuntleigh focuses on patient mobility and wound management GETINGE GROUP solutions GETINGE provides solutions for infection control within healthcare andcontamination prevention within life sciences MAQUET specializes in solu www getingeusa com tions therapies and products for surgical interventions and intensive care CON_CHMSTLMONITORS_ML_AccuFast1410_0511_EN_US 2011 Getinge USA Inc Printed in U S A ArjoHuntleigh GETINGE and MAQUET are registered trademarks All other product names or trademarks belong fo their respective owners We reserve the right to make technical and construction changes
8. ur biological indicators for information on processing incubation inter pretation of results and using positive con trols When the incubator has warmed up to the con figured temperature the actual temperature of the incubator will be shown on the LED display indi cating that the unit is ready to accept biological indicators Verify that the temperature displayed is within the allowable range for your biological indicator before proceeding see the instructions for use that came with your biological indicators Biological Indicator Activation Prior to incubation the biological indicator must be activated by crushing its internal glass medium ampoule This allows the color change medium from the ampoule to contact the spore carrier Warning Allow a processed BI to cool for at least 15 minutes upon removal from the sterilizer Failure to do so may cause the glass medium ampoule to burst during activa tion resulting in injury from hot liquid or flying debris The incubator contains an activation crushing cavity to simplify activation Place the processed or positive control biological indicator into the left side of the activation cavity and flex the indicator to the right until the glass ampoule breaks Note You may have to grip the incubator by the base while activating a BI so that it does not tip over GETINGE 1410 Incubator Manual Infection Control 5 Incubation To confirm adequate sterilization
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