Attest Auto Reader 290 User Manual

  1. Attest Auto Reader 290 Service Manual
  2. Attest Auto Reader 1292
  3. 3m Attest 290 Service Manual
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Attest Auto Reader 290 Service Manual

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Class 2 Device Recall 3M AttestTM Autoreader
Date Initiated by FirmJune 09, 2014
Date PostedJuly 07, 2014
Recall Status1Terminated 3 on June 03, 2015
Z-2002-2014
Recall Event ID68415
Indicator, biological sterilization process - Product CodeFRC
Product3M Attest Auto-reader. Model numbers 390, 390G,and 490.
These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.
Code InformationAll serial numbers.
Recalling Firm/
Manufacturer
3M Company - Health Care Business
3M Center 2510 Conway Ave , B# 275-5-W-6
Saint Paul MN 55144
For Additional Information Contact3M Health Care Helpline
800-228-3957
Labeling on units shipped prior to May 16th, 2014 did not contain the statement 'This product contains dry natural rubber' as required by the United States Food and Drug Administration (FDA) for medical devices. The non-slip pads at the bottom of the unit contain dry natural rubber. One incident of an allergic reaction in a sensitized individual has been reported.
Labeling Change Control
Consignees were sent on 6/9/2014 a 3M 'Urgent Medical Devices Correction' letter dated May 21, 2014. The letter described the problem and the product involved in the recall. The letter described what action is 3M taking and what action was required of the consignees. Consignees were sent an adhesive label and a response card. They requested consignees to adhere the label to a portion of the plastic covering each unit in a location where it is visible to the end-user. After that, they are requested to fill out and return the response card.
5343 (2621 USA, 2722 OUS)
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of AUSTRALIA, CANADA, CHILE , COLOMBIA, COSTA RICA, SOUTH AFRICA, BRAZIL, GERMANY, ECUADOR, DUBAI, JAPAN, HONG KONG , CHINA, KOREA, MALAYSIA, PANAMA, SINGAPORE, VATICAN, and THAILAND.
TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FRC and Original Applicant = 3M COMPANY
510(K)s with Product Code = FRC and Original Applicant = 3M COMPANY-3M HEALTH CARE
Attest Auto Reader 290 User Manual

Attest Auto Reader 1292

  • Page 1: 3M 290

    3 M ™ Attest ™ 290 Auto -reader Operator ’ s Manual Read and understand all s afety information before usin g this product.[...]

  • Page 2: 3M 290

    [...]

  • Page 3: 3M 290

    3M © 2003 78-8 078-8977-5 Page 1 of 9 Attest 29 0 Auto-reader INTENDED USE 1. Cover 2. Incubation/Reader Wells 3. Crusher Well 4. Red Light Pos itive (+) Ind icator 5. Yello w Light ( •) Test In P r o gress Ind icat o r 6. Green Light Negative (-) Indicator 7. Buzzer Alarm OFF Button 8. Digital Dis play Panel 9. Time Re m aining Button Intended [...]

  • Page 4: 3M 290

    3M © 2003 78-8 078-8977-5 Page 2 of 9 Attest 290 A uto-reader SAFETY INFORMATION Explan ation of sym bols: Caution – Risk of electric shock Attention – Refer t o accompanying documents WARNING WARNING WARNING WARNING • To avoid the r isk of ele ctric sh ock, which if n ot avoided co uld result i n serious inj ury or death: - Do not immer se [...]

  • Page 5: 3M 290

    3M © 2003 78-8 078-8977-5 Page 3 of 9 Attest 29 0 Auto-reader SAFETY INFORMATION Power Supply Specifications Power supply Operating Co ndition Units Voltag e Range 100-240 Volts A C Frequen cy 50/60 Hertz Current 1.2 Amps Environm ental Operating Condi tions Environme nt a l Co ndition Operating Co ndition Units Alti tude 2500 (max ) mete rs Opera[...]

  • Page 6: 3M 290

    3M © 2003 78-8 078-8977-5 Page 4 of 9 Attest 290 A uto-reader INSTRUCTIONS FOR USE Operating Instructions Start- up Place unit on a firm level surface. Plug unit into an appropriate AC grounded outlet. All o w a 30 minute warm-u p period before pl acing RRBIs i nto the i ncubatio n well s. T he C1 caution code w ill disappear when proper incubatio[...]

  • Page 7: 3M 290

    3M © 2003 78-8 078-8977-5 Page 5 of 9 Attest 29 0 Auto-reader INSTRUCTIONS FOR USE Wells are color coded to match the cap of each type of bio logical indicato r ; i.e. the 1291 RRBI with a blue cap g oes into a blue well and the 1292 RRBI w ith a brown cap goes into a brow n well. A yellow light will co me on to indicate the RRB I is incubatin g i[...]

  • Page 8: 3M 290

    3M © 2003 78-8 078-8977-5 Page 6 of 9 Attest 290 A uto-reader INSTRUCTIONS FOR USE Positive Control Crush, tap and incubat e at least one n on-processed Attest 1291 or 1292 R RBI to use as the posit ive control each day that a processed RRBI is incu bated and read by the unit. Write a “C” (for “control”) an d the date on the label. T he po[...]

  • Page 9: 3M 290

    3M © 2003 78-8 078-8977-5 Page 7 of 9 Attest 29 0 Auto-reader FEATURES, CARE AND CLEANIN G Features Audible Alar m An audible alar m will sound a nd the po siti ve red (+) light will illumina te for the d esignated incubatio n/reader well when a po sitive result is detected. This pr o vides results in the least a mount of time witho ut the need to[...]

  • Page 10: 3M 290

    3M © 2003 78-8 078-8977-5 Page 8 of 9 Attest 290 A uto-reader TROUBLES HOOTING G UIDE Troub le Shooting G uide In the even t of an error code, u nplug th e Attest 290 Auto- reader and plug it back in to in itiate the s elf- diagnos tic test. If error code r e-occurs, call for repair or replacem ent. The display panel will indicate malfunctions det[...]

  • Page 11: 3M 290

    3M © 2003 78-8 078-8977-5 Page 9 of 9 Attest 29 0 Auto-reader TROUBLES HOOTING GUIDE Trouble Shoo ting Guide (Co ntinued) Code Proble m Solution Other Unwanted alarm sounds when Turn alarm off, ref er to features positive detected . Section. Other All three lights blink and buzzer sou nds. Replace RRBI in incubation/ r eader RRBI has be e n re mov[...]

  • Page 12: 3M 290

    3M © 2003 78-8 078-8977-5 Page 10 of 9 Attest 290 A uto-reader 3M Health Care 3M Center Buil ding 275-4E- 01 St. Paul , MN 55144-1000 1-800- 228-3957 3M Health Care D-41460 Neus s, Germany Recycled paper 40% pre-con sumer 10% post- consumer Litho in U.S.A. with 3M film , proofin g system s and off set plates. Attest is a regis tered trademark of 3[...]

3m Attest 290 Service Manual

3M Attest Rapid Readout Biological Indicator For Steam is a dual readout biological indicator system specifically designed for rapid and reliable monitoring for 121-123°C Gravity and 132-135°C Vacuum-Assisted steam sterilization processes when used in conjunction with the 3M Attest Auto-reader 290 or the 3M Attest Auto-reader 390. 3m Attest 1291 Manual workshop used 3m 290 attest tester autoclave tabletop for 94 shadow 600 owners manual medical: 3m attest indicator 1292 rapid readout chevrolet lumina apv manuals 3m 5xl sterilizer service manual booklad.org yamaha tourer used 3m attest 290 incubator sterilizer for sale.