3M 1780 Projector User Manual
Contents
1. could result in serious injury or death Do not immerse the Attest 290 Auto reader in any liquid Use indoors only Disconnect power cord before cleaning To clean use only a mild detergent and wipe with a damp cloth There are no user serviceable parts The Attest 290 Auto reader must be returned to the manufacturer for repair Make sure a properly rated power cord is installed on the Attest 290 Auto reader power supply To avoid a potentially hazardous situation which if not avoided may result in minor or moderate injury Avoid contact with the hot surface of the metal incubator block To avoid possible environmental contamination dispose of the Attest 290 Auto reader according to applicable governmental regulations To avoid RRBI vial from absorbing fluorescent residue from a chemical indicator or tape place the RRBI vial so it does not come in direct contact with chemical indicators or tape To reduce the risk of using incompletely sterilized loads Match the color on the exterior label of the incubator with the same color cap on the RRBI Do not remove RRBI until incubation cycle is complete Do not use on a vibrating surface Explanation of symbols There is a glass ampule inside the plastic vial of the RRBI To avoid the risk of injury from flying debris due to a ruptured RRBI which if not avoided could result in serious injury or death Allow the RRBI to cool for the2. recommended time period before crushing Crushing or excessive handling of the biological indicator before cooling may cause the glass ampule to burst Wear safety glasses and gloves when removing the RRBI from the sterilizer Wear safety glasses when crushing the RRBI Handle the RRBI by the cap when crushing and tapping Do not use your fingers to crush the Attention Refer to accompanying glass ampule documents Do not roll the RRBI between your fingers to wet the spore strip Caution Risk of electric shock 3M 2003 78 8078 8977 5 Page 2 of 9 Attest 290 Auto reader SAFETY INFORMATION Power Supply Specifications Power supply Operating Condition Units Voltage Range 100 240 Volts AC Frequency 50 60 Hertz Current 2 Amps Environmental Operating Conditions Environmental Condition Operating Condition Units Altitude 2500 max meters Operating Temperature 16 43 C Relative Humidity 20 80 non condensing Voltage Range 12 Volts DC Frequency DC Current 2 4 Amps Installation Over Voltage Category II Pollution Degree 2 Health and Safety Information Device Safety Compliance The Attest 290 Auto reader complies with the standard IEC EN 61010 1 as demonstrated by the CB Scheme Certificate and test report that Underwriters Laboratories Inc UL generated The Attest 290 Auto reader is listed as Laboratory equipment and carries the UL and c UL marks based on compliance to the standards UL 3101 1
3. 3M Attest 290 Auto reader Operator s Manual Read and understand all safety information before using this product INTENDED USE 1 Cover 6 Green Light Negative Indicator 2 Incubation Reader Wells 7 Buzzer Alarm OFF Button 3 Crusher Well 8 Digital Display Panel 4 Red Light Positive Indicator 9 Time Remaining Button 5 Yellow Light Test In Progress Indicator Intended Use The 3M Attest 290 Auto reader is designed to A positive fluorescence reading or a visual color incubate and automatically read the 3M Attest change indicates a steam sterilization process 1291 Rapid Readout Biological Indicators RRBI failure and or 3M Attest 1292 Rapid Readout Biological Indicators at 60 C for a final negative Other biological indicators BIs are not compatible fluorescence reading at hour for 1291 or 3 hours with this device and cannot be used for 1292 The unit is designed to be used only with the Power The 3M Attest 290 Auto reader is also Supply module supplied by 3M designed to allow for further incubation of the 3M Attest 1291 RRBI and or 3M Attest 1292 RRBI for a final negative visual pH color change of the growth media at 24 hours for 1291 and 48 hours for 1292 3M 2003 78 8078 8977 5 Page 1 of 9 Attest 290 Auto reader SAFETY INFORMATION Z CAUTION Z WARNING To avoid the risk of electric shock which if not avoided
4. RRBI requires 1 hour of incubation and the Attest 1292 RRBI requires 3 hours of incubation before a negative result will be shown The negative result will be shown automatically after completion of the required incubation time The processed indicator and the positive control may also be further incubated for a visual pH color change The final negative reading media remains purple for a visual color change is made at 24 hours 1291 or 48 hours 1292 The positive control should show a yellow color change of the growth media For any incubation beyond 24 hours 1291 or 48 hours 1292 RRBIs should be moved to a humidified environment Each facility must establish final readout time in its policy and procedures The policy should be based on manufacturer s instructions for use scientific knowledge current recommendation practices applicable compliance requirements inventory levels and the risk to the patient if the medical device is not sterile Attest 290 Auto reader INSTRUCTIONS FOR USE Positive Control Crush tap and incubate at least one non processed Attest 1291 or 1292 RRBI to use as the positive control each day that a processed RRBI 1s incubated and read by the unit Write a C for control and the date on the label The positive control can be placed in any incubator well of the unit The positive control should be the same part number from the same manufacturing date and lot number as the p
5. USE Wells are color coded to match the cap of each type of biological indicator i e the 1291 RRBI with a blue cap goes into a blue well and the 1292 RRBI with a brown cap goes into a brown well A yellow light will come on to indicate the RRBI is incubating in the reader well and should not be touched A yellow light indicates the results are not available and incubation is in progress Do not remove RRBIs until the red or green light indicates the test is complete Note If RRBIs are inadvertently removed before the incubation period is complete an alarm will sound and all three lights and for that incubation well will light C2 Caution code will also be displayed You must return the RRBI to the reader well within 10 seconds or the results will be lost Z WARNING Do not remove or change placement of RRBI once it is placed into a well Doing so may result in loss of results and the RRBI test may be invalid 3M 2003 78 8078 8977 5 Page 5 of 9 All red yellow and green lights will flash for one second when the cover is opened demonstrating they are functional The cover should only be opened when placing additional RRBIs into incubation wells or when removing RRBIs at the completion of the designated incubation period A positive result will automatically be shown as soon as it is detected The full incubation period is required before a negative result is shown The Attest 1291
6. and CSA 22 2 No 1010 1 92 The Attest 290 Auto reader complies with the CE mark related to the Low Voltage Directive 73 23 EEC as confirmed in the Declaration of Conformity EMC Compliance The Attest 290 Auto reader complies with IEC EN 61326 1 as confirmed in the Certificate of Compliance generated by 3M The Attest 290 Auto reader complies with the EMC requirements of the CE mark EMC Directive 89 336 EEC The Attest 290 Auto reader complies with the Australian EMC requirements as confirmed in the Supplier s Declaration of Conformity that is linked to the C tick mark 3M 2003 78 8078 8977 5 Page 3 of 9 Note This equipment has been tested and found to comply with the limits for a Class A digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide a reasonable protection against harmful interference when the equipment is Operated in a commercial environment This equipment generates and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at their own expense This Class A digital apparatus meets all requirements of the Canadian Interference Causing Equipment Regulations Cet appareil numerique de la classe A respecte t
7. ed by an error code Refer to the Trouble Shooting Guide section for error code explanations Attest 290 Auto reader TROUBLESHOOTING GUIDE Trouble Shooting Guide In the event of an error code unplug the Attest 290 Auto reader and plug it back in to initiate the self diagnostic test If error code re occurs call for repair or replacement The display panel will indicate malfunctions detected by a specific error code Refer to the following Code Cl C2 El E3 E4 E7 E8 E9 3M 2003 78 8078 8977 5 Problem Unit Warm up Caution Incubation block not at temperature RRBI readings are disabled until incubator block reaches 60 C 2 C RRBI has been removed before incubation complete All three lights for affected RRBI will light and alarm will sound 1f active Temperature Control Error This error will occur if system is no longer able to control the temperature of the incubator block 60 C 2 C Memory Error Analog Digital Conversion Error Communications Error This error will occur if internal communications have failed Bulb Error This error occurs if the system detects that the bulb is too dim to properly read RRBI results Transport Error This error will occur if the system detects a motor failure or positioning problem Page 8 of 9 Solution Allow a 30 minute warm up after Attest 290 Auto reader is plugged in Replace RRBI in proper well within 10 seconds Call f
8. icating that the alarm is again active Time Remaining When the time remaining button is pressed the incubation time remaining for each individual incubation reader well that contains a RRBI will be displayed All three lights for each individual incubation reader well will illuminate as the time remaining is displayed The process begins with the incubation reader well containing a RRBI on the left and proceeds to the right The time remaining appears in hours until there is less than an hour remaining when it displays minutes remaining Temperature Monitoring The Attest 290 Auto reader contains an internal temperature self diagnostic program Should the temperature fall outside the specified range 60 C 2 C an error code will be displayed Power Cord Retaining Clip Place the power cord through the power cord retaining clip on the rear of the Attest 290 Auto reader near the plug in This will help to ensure that the power connection does not become inadvertently disconnected Clean the exterior surface of the Attest 290 Auto reader with the dust cover closed by wiping it with a damp cloth moistened with a mild detergent Do not open the dust cover and attempt to clean interior components If additional cleaning of the wells is required call for repair or replacement Note The Attest 290 Auto reader does not contain any user serviceable parts or require any routine maintenance Any malfunctions will be indicat
9. or repair or replacement Call for repair or replacement Call for repair or replacement Call for repair or replacement Call for repair or replacement Call for repair or replacement Attest 290 Auto reader TROUBLESHOOTING GUIDE Trouble Shooting Guide Continued Code Problem Other Unwanted alarm sounds when positive detected Other All three lights blink and buzzer sounds RRBI has been removed from incubation reader well prematurely Other Red yellow or green lights do not illuminate when expected such as following insertion of a RRBI or when time remaining button is pressed Other Negative Control Vial Vial not crushed Media did not wet the spore strip Control vial was sterilized Other Unexplained positive Adhesive residue on vial Test vial is absorbing fluorescent residue from a chemical indicator or tape Repair and Replacement Attest 290 Auto readers must be repaired at 3M Health Care Service Center Suite 200 Bldg 502 3350 Granada Avenue North Oakdale MN 55128 1 800 292 6298 Fax 1 800 770 8016 Outside of the USA contact your local 3M Subsidiary Solution Turn alarm off refer to features Section Replace RRBI in incubation reader well within 10 seconds to prevent loss of data collected Specific light burned out Call for repair or replacement Crush vial before inserting into well Tap vial on table until media wets spore strip Use a non sterilized vial as a con
10. outes les exigences due Reglement sur le materiel brouilleur du Canada Attest 290 Auto reader INSTRUCTIONS FOR USE Operating Instructions Start up Readout Procedure Place unit on a firm level surface Plug unit into an Follow this procedure for every RRBI to be read appropriate AC grounded outlet Allow a 30 minute warm up period before placing RRBIs into the incubation wells The C1 caution code will disappear when proper incubation temperature is reached It is recommended that the unit be left on to eliminate warm up periods The unit may be turned off when it is anticipated that it will not be used for an extended period LSS ES Step 1 While wearing gloves and Step 2 CRUSH the glass ampule Step 3 Hold the RRBI by the cap safety glasses CLOSE RRBI cap containing growth media in the and TAP bottom of the vial on a by pressing down designated crushing well built tabletop until media wets spore into the incubator strip at bottom of vial Do not tap vial on unit ZAWARNING Do not remove or change placement of RRBI once it is placed into a well Doing SO may result in loss of results and the RRBI test Step 4 Open the cover and Step 5 CLOSE the cover on the may be invalid PLACE the RRBI into an Attest 290 Auto reader and wait incubation reader well for either the red or green indicator light to signal the result 3M 2003 78 8078 8977 5 Page 4 of 9 Attest 290 Auto reader INSTRUCTIONS FOR
11. rocessed RRBI in the unit Interpretation of Results Each incubation reader well has three corresponding indicator lights a red yellow and green light After placing a RRBI into a corresponding color coded well a yellow light will illuminate to indicate that incubation reading is in progress A red light will illuminate and an alarm will sound if the sound feature is turned on as soon as a positive RRBI result is detected At the end of the specified incubation time if a negative RRBI result is detected the green light will illuminate indicating an acceptable sterilization process After either the green or red light comes on the RRBI can be removed from the well The RRBI should not be removed or touched when the yellow light is on The positive unprocessed control RRBI must provide a positive fluorescent result red light Processed RRBI results are not valid until the positive control reads fluorescent positive red light With the processed RRBI a positive red light result means a sterilization process failure may have occurred Disposal Dispose of the used Attest RRBI according to your healthcare facility policy 3M 2003 78 8078 8977 5 Page 6 of 9 It is good practice to use a positive control each day a sterilized RRBI is processed This helps ensure correct incubation temperatures are met viability of spores has not been altered due to improper storage tempera
12. s in the least amount of time without the need to manually take frequent readings An alarm will also sound if a RRBI is removed from the Attest 290 Auto reader well before a final result has been detected Data will be lost if the RRBI is not replaced in the reader incubation well within 10 seconds Alarm On Off The audible alarm for positive results can be turned off or on for a particular RRBI This is accomplished by pressing the alarm off button after the alarm has sounded This will turn off the alarm for that RRBI only Any positive RRBI results detected in other wells will result in the alarm sounding Removing the RRBI will reactivate the alarm for that well Pressing the alarm off button will not silence the alarm for error or caution code alarm warnings To turn alarm function off disable press both the alarm off and time remaining buttons at the same time A yellow period will appear on the lower right corner of the display panel to indicate the alarm is disabled The alarm will be disabled for all positive RRBIs error codes and caution code alarm warnings Care and Cleaning Z WARNING Always unplug the Attest 290 Auto reader and allow to cool before cleaning Do not immerse the unit in liquid 3M 2003 78 8078 8977 5 Page 7 of 9 To turn the alarm function back on press the alarm off and time remaining buttons at the same time The yellow period on the display panel will turn off ind
13. trol Check chemical indicator on label Do not place tape or labels on vial Place the vial so it does not come in direct contact with chemical indicators or tape If you have questions call our Customer Service number 1 800 292 6298 3M 2003 78 8078 8977 5 Page 9 of 9 Attest 290 Auto reader 3M Health Care 3M Center Building 275 4E 01 St Paul MN 55144 1000 1 800 228 3957 CE 3M Health Care D 41460 Neuss Germany Recycled paper 40 pre consumer 10 post consumer Litho in U S A with 3M film proofing systems and offset plates Attest is a registered trademark of 3M 3M 2003 78 8078 8977 5 Rev D Lit Code 70 2009 4089 1
14. ture humidity or proximity to chemicals capability of media to promote rapid growth and proper functioning of Attest 290 Auto reader components The final negative processed RRBI reading for a fluorescence change green light after 1 hour 1291 or 3 hours 1292 indicates an acceptable sterilization process The positive control should read positive red light If the processed RRBI is further incubated for a visual pH color change when special studies are desired the media color change from purple to yellow will also indicate a sterilization failure The positive control should show a yellow color change at 24 hours 1291 or 48 hours 1292 A final negative color change result no color change media remains purple is made at 24 hours 1291 or 48 hours 1292 Act on any positive result immediately The positive result indicates a sterilization process failure may have occurred Determine the cause of the positive RRBI following current facility policies and procedures Always retest the sterilizer and do not use the sterilizer for processing loads until 3 consecutive RRBI results are negative You may wish to sterilize any positive RRBI prior to disposal Attest 290 Auto reader FEATURES CARE AND CLEANING Features Audible Alarm An audible alarm will sound and the positive red light will illuminate for the designated incubation reader well when a positive result is detected This provides result
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