Professional Documents
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TM
Attest Auto-reader
™
Service Manual
78-8078-8270-5 Rev. A
Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including
photocopying, microfilming, recording, or by any information storage and retrieval system, without permission from 3M Health Care.
Copyright © 3M(IPC) November 1999. All rights reserved. i
i
Revision History Auto-reader Service Manual
Revision History
Revision Date Page(s) Changed Change
1. Operator’s Manual
Intended Use 1-1
Daily Calibration 1-3
Readout Procedure 1-4
Troubleshooting Guide 1-5
UV Lamp/Starter Replacement 1-7
Care and Cleaning 1-9
Replacement Parts 1-9
UV Lamp/Starter Replacement Kit Form 1-10
4. Theory of Operation
Functional Block Diagram 4-1
Circuit Operation 4-1
5. Schematics
Wiring Diagrams 5-1
Model 190 5-2
Model 191 5-3
Model 193 5-4
Intended Use:
The 3M™ Attest™ Auto-reader is designed to read the fluorescence produced by positive 3M™ Attest™ Rapid Readout
Biological Indicators. Detection of fluorescence indicates a sterilization process failure.
Safety Information
WARNING: Fuse provides protection against fire. Replace with 5 x 20 mm, F 0.315AH/250V Fuse.
CAUTION: To reduce the risk of electrical shock, remove power cord from supply before removing
top cover.
Precautions:
Model Nominal Voltage Voltage Range Frequency
190/190G 120 V 108-132 V 50/60 Hz
191/191G 240 V 216-264 V 50/60 Hz (Australia)
193/193G 230 V 207-253 V 50-60 Hz
190J/190JG 100 V 90-110 V 50/60 Hz
This equipment is designed for use in an indoor environment with temperatures from 16-43°C (60-110°F) for models
190, 191, 193, 190J and 16-29°C (60-85°F) for models 190G, 191G, 193G, 190JG and a relative humidity 20%-80%
non-condensing.
The following instructions must be followed for the biological indicator results to be valid.
If the calibration light starts flashing while the test and control vials are incubating:
• do not read the test and control vials until the auto-reader is recalibrated.
• recalibrate the auto-reader with a sterilized non-incubated vial.
• read the test and control vials at the appropriate incubation times.
1. After cooling a sterilized biological indicator for at least 10 minutes, while wearing safety
glasses, close the cap by pressing cap down between thumb and index finger.
2. Crush media ampule of sterilized biological indicator by placing vial in left side of crusher
well and pushing cap toward right well until media ampule breaks.
3. Remove sterilized biological indicator, hold cap and tap bottom of vial several times on
tabletop until the growth media wets the strip at bottom of vial.
4. Using your left hand, press and hold sterilized biological indicator in reader well. After
the red (+) or green (-) light illuminates, use your right hand to depress and hold the red
calibration button on back right side of reader with right hand while continuing to hold the
sterilized BI in the reader well. Release calibration button when the green light (-) remains
illuminated and the calibration light stops flashing.
5. Immediately recheck the calibration using the same Attest rapid readout sterilized indicator.
Remove the indicator from the reader well, rotate the indicator and place it back in the reader
well. Hold the indicator down and observe the green (-) light. If the green (-) light does not
illuminate, then repeat the calibration procedure (step 4).
4. Place the sterilized Attest rapid readout biological indicator in incubation well and incubate
for recommended time.
The calibration step is complete. (Do not press the red calibration button during the remaining
readout procedure.)
Readout Procedure:
CAUTION: Incubator block is hot. Avoid contact.
Sterilized Vials
1. After cooling a sterilized biological indicator for at least 10 minutes, while wearing safety glasses: (a) close the
cap; (b) crush the biological indicator; (c) hold cap and tap bottom of vial several times on the tabletop until
growth media wets spore strip at bottom of vial; and (d) place in incubation well.
Positive Controls
2. Close, crush, tap, and incubate at least one positive control (non-sterilized) biological indicator each day a
sterilized vial is incubated or every time the auto-reader is calibrated. The positive control vial should be from the
same lot number as the sterilized vials.
3. After incubation, press and hold sterilized biological indicator down into reader well and (e) read red (+) or green
(-) result. Do not press the red calibration button. A red light indicates a sterilization process failure. A green
light indicates an acceptable sterilization process.
4. When reading sterilized biological indicators, also read the positive control biological indicator for a red (+)
result. If the control biological indicator is negative (green (-) light), check:
• the incubator temperature
• the auto-reader UV light
• the troubleshooting guide
5. Discard the sterilized indicator. It is good practice to incubate the positive control for a visual color change
readout (yellow color change) to monitor the incubator temperature, viability of spores, capability of media to
promote growth, and proper functioning of the auto-reader components.
6. Immediately act on any positive (+) tests per healthcare facility’s policy.
Troubleshooting Guide
Negative Control Auto-reader calibrated with a positive or Recalibrate with a sterilized, non-
non-sterilized vial. incubated vial.
Negative Control UV Lamp burned out (fluorescent orange Change UV lamp and starter. If lamp
UV display light not illuminated) or does not illuminate, call 3M sales
starter not functioning. representative to obtain a replacement
auto-reader.
Negative Control Media did not wet out spore strip. Tap vial on table until media wets
out spore strip, incubate, re-read
control vial.
Negative Control Control vial was sterilized. Check Use a non-sterilized vial as a control.
chemical indicator on label.
Negative Control Calibrate button was pushed before or Recalibrate auto-reader with a
during reading of control or test vial. sterilized, non-incubated vial and
re-read control and test vials.
Calibration light on Twelve hours since last calibration, Recalibrate with a sterilized, non-
power surge, power interrupted. incubated vial. Then read the test and
control vials that are incubating.
All sterilized indicators Power surge or electrical interference. Move auto-reader to another circuit or
are positives or the same away from equipment that produces
sterilized indicator reads the interference, recalibrate, and re-
positive and negative read indicators.
All sterilized indicators Adhesive residue on vials. Do not place tape or label on vial.
are positives or the same
sterilized indicator reads
positive and negative
All sterilized indicators The test vial is coming in contact with an Place the internal chemical indicator
are positives or the same internal chemical indicator that could be so it is not next to the test vial.
sterilized indicator reads transferring fluorescence to the vial.
positive and negative
All sterilized vials Incorrect calibration. Recalibrate. Wait until the red or
are positives green light illuminates before pressing
the calibration button. Do not remove
the test vial from reader well until
the green light remains illuminated
and the yellow calibration light
stops flashing.
Fluorescent orange UV UV lamp not illuminated or starter not Change UV lamp and starter.
light not illuminated functioning.
Incubator temperature is Auto-reader malfunction, power problem. Check power source and/or return
not correct auto-reader to repair and replacement
location for repair.
Reader will not calibrate Not holding vial down in reader well Recalibrate by holding vial down,
and/or releasing calibration pressing calibration button and
button before green light illuminates. releasing when the green light remains
illuminated and the yellow calibration
light stops flashing.
2. Remove the two screws from the top of the black cover and carefully lift, being careful not to stretch the
attached enclosure lid wiring (see Figure 1).
3. Determine whether the auto-reader is a non-refurbished unit or a new/refurbished unit by inspecting the
calibration switch (see Figure 1). If the auto-reader is a non-refurbished unit, proceed to step 5.
Figure 2: Figure 3:
New and Refurbished Auto-readers, Non-refurbished Auto-reader,
Top View (Enclosure Lid Removed) Top View (Enclosure Lid Removed)
6. Set the black cover in its original position and replace the two screws (see Figure 1).
7. Plug in the power cord and make sure the UV light indicator is illuminated (see Figure 1).
8. Circle the 6 month interval that the UV lamp and starter needs to be changed on the reminder label located on
the side of the auto-reader.
11. Run a positive control (non-sterilized vial). The positive control must read red or (+) before the auto-reader is
put into use.
To clean the Attest auto-reader, unplug the power cord, allow to cool to room temperature, and wipe with a mild
detergent solution. Wipe with a clean, damp cloth and dry. Do not immerse the auto-reader in any liquid or use
water in the reader or incubation wells.
Lamp Disposal
The UV lamp contains small amounts of mercury. Disposal or recycling should
be done in accordance with applicable local, state and federal regulations.
Replacement units may be obtained by calling your local 3M sales representative. The replacement unit will be a
refurbished model.
Replacement Parts
UV lamp/starter replacement kits must be purchased at 3M. Copy and complete the form on the next page and mail
or fax to (USA only):
In Canada, contact 3M Canada, Inc. P.O. Box 5757, London, Ontario N6A 4T1.
1-800-563-2921.
In Australia, contact 3M Health Care, 9-15 Chilvers Road, Thornleigh, N.S.W. 2120, Australia 02-9875-6207.
In Japan, contact Sumitomo 3M Limited, Sagamihara Site, 8-8 Minami Hashimoto 3-chome, Sagamihara-shi,
Kanagawa-ken, 229-1185 Japan (0427) 79-2111.
In Germany, contact 3M Medica Service Center, Gelsenkirchener Strasse 11, D-46325 Borken Germany 2861-950.
Regulatory Information: (193, 193G)
CE marked in accordance with the EMC Directive 89/336/EEC as amended by Directive 93/68/EEC and the Low
Voltage Directive 73/23/EEC as amended by Directive 93/68EEC.
C-Tick marked in accordance with EMC requirements for Australia: (191, 191G)
Equipment Safety Approvals: (190, 190G)
3M is authorized to apply the Underwriters Laboratory Inc. (UL) and Canadian Standards Association (CSA)
marks to the 190/190G Auto-readers.
Please Ship ______ (ea.) Model 191/191G or 193/193G UV Lamp/Starter Replacement Kits
(P/N 78-8078-7351-4) One lamp/starter/box
Customer Information:
Address:_____________________________________________________________________
City/State/Zip: ________________________________________________________________
Attention: ____________________________________________________________________
Applicable Products
Test Equipment
Acronyms
Reference Documents
1. Applicable Standard Operating Procedures (SOP) pertaining to working with and near high voltages and
ultraviolet light.
Special Notes
1. CAUTION: Only trained personnel should use this procedure. Personnel are exposed to dangerous voltages
and ultraviolet light during testing. Follow appropriate safety guidelines.
2. If a hardware failure occurs during testing, repair the unit and completely retest the unit.
4. Instructions listed with a “†” prefix indicate that different models have different test requirements
5. Test points and components requiring adjustment are shown in Figures 4 and 5.
R34
Figure 4 - Test Point and Component Locations for Auto-reader Models 190, 190G, 190J, 190JG
R34
Figure 5 - Test Point and Component Locations for Auto-reader Models 191, 191G, 193, 193G
Procedure
1. Pre-Burn-in
2. Post-Burn-in
a. Verify the “UV Light” indicator is illuminated after the 48-hour burn-in.
b. Verify the “Calibrate” LED blinks after the 48-hour burn-in.
c. Remove UUT power plug from wall outlet.
Model Fuses
190, 190G, 190J, 190JG ......................One fuse, 0.75 A
191, 191G, 193, 193G .......................Two fuses, 0.315 A
d. Verify fasteners are proper, tight, and that glyptol is applied as required.
5. Test Setup
† 6. Boost Transformer Voltage Check (This section applicable to Models 190J/190JG only)
Model Voltage
190, 190G .................. Not applicable
190J, 190JG ............ 100 VAC ± 2VAC
191, 191G .................. Not applicable
193, 193G .................. Not applicable
7. Temperature Adjustment
Model Temperature
19X: 190, 190J, 191, 193...........................60.0° ± 1.0°C
19XG: 190G, 190JG, 191G, 193G ...............37.0° ± 1.0°C
d. Record the final temperature meter readings from temperature probes “A” and “B”.
j. Record “V”.
k. Verify V(+,TP3) = 3.60 VDC ± 0.05 VDC. If “V(+,TP3)” is not within these limits, perform
the following:
(1) Fine adjust R7 until V(+,TP3) = 3.60 VDC ± 0.05 VDC
(2) Replace the “+” vial with the “C” vial in the reader well.
(3) Repeat procedure from step 11(g).
l. Remove the “+” vial from reader well.
m. Record “V(C,TP3)” and “V(+,TP3) ”.
n. Insert the “C” vial into the reader well.
† o. Measure the voltage “V(C,TP3)” between TP3 and Ground (TP6) while sweeping the AC source through the
voltage range listed below.
p. Verify V(C,TP3) = 2.70 ± 0.10 VDC. If “V(C,TP3)” is not within these limits, perform
the following:
(1) Adjust the AC source to the appropriate voltage setting listed below.
Model Voltage
190, 190G ...............120 VAC ± 1 VAC
190J, 190JG ............100 VAC ± 2 VAC
191, 191G ...............240 VAC ± 2 VAC
193, 193G ...............230 VAC ± 2 VAC
Model Voltage
190, 190G ...............120 VAC ± 1 VAC
190J, 190JG ............100 VAC ± 2 VAC
191, 191G ...............240 VAC ± 2 VAC
193, 193G ...............230 VAC ± 2 VAC
a. Insert and depress the “C” vial into the reader well.
b. Depress the red calibrate button until the yellow Calibrate “LED” stops flashing and the
green (-) “LED” illuminates.
c. Release the calibration button.
d. Remove the “C” vial from the reader well.
e. Measure the voltage “V(C,cal,TP5)” between TP5 and Ground (TP6).
f. Record “V(C,cal,TP5)”.
g. Verify that “V(C,cal,TP5) ” is .40 VDC ± .05 VDC higher than voltage “V(C)” recorded in step 11(m).
Model Voltage
190, 190G ...................... 105 VAC
190J, 190JG .................... 90 VAC
191, 191G ...................... 216 VAC
193, 193G ...................... 207 VAC
Model Voltage
190, 190G ...............120 VAC ± 1 VAC
190J, 190JG ............100 VAC ± 2 VAC
191, 191G ...............240 VAC ± 2 VAC
193, 193G ...............230 VAC ± 2 VAC
a. Assemble enclosure lid on enclosure base, being careful not to pinch wires during assembly.
b. Tighten four enclosure lid screws into enclosure base.
c. Apply inspectors lacquer to left, rear screw.
d. Record observation that final assembly is complete.
1. Pre-Burn-in
c. Verify the “UV Light” indicator is illuminated. ................................................................ ____ Observed
d. Verify the “Calibrate” LED blinks. ................................................................................... ____ Observed
2. Post-Burn-in
a. Verify the “UV Light” indicator is illuminated after the 48-hour burn-in. ........................ ____ Observed
b. Verify the “Calibrate” LED blinks after the 48-hour burn-in. ............................................ ____ Observed
5. Test Setup
c. Verify the “UV Light” indicator is illuminated. ................................................................ ____ Observed
d. Verify the “Calibrate” LED blinks. ................................................................................... ____ Observed
e. Verify the fan is operating (Models 190G, 190JG, 191G and 193G only). ..................... ____ Observed
6. Boost Transformer Voltage Check (This section applicable to Models 190J/190JG only)
e. Verify V (P11-2/P12-4) = 112 VAC ± 3 VAC .................................................................. ____ Observed
7. Temperature Adjustment
d. Final temperature readings (19X: 60.0°C±1.0°C; 19XG: 37.0°C±1.0°C) ............... Probe “A” ______°C
Probe “B” ______°C
j(c). Observe “-” LED illuminate five times with “C” vial (low line voltage) ........................ ____ Observed
j(g). Observe “+” LED illuminate five times with “+” vial (low line voltage)........................ ____ Observed
l(c). Observe “-” LED illuminate five times with “C” vial (high line voltage) ....................... ____ Observed
l(g). Observe “+” LED illuminate five times with “+” vial (high line voltage)....................... ____ Observed
14. Assembly
d. Final assembly complete.............................................. . Enclosure lid screws tightened ______ Observed
Lacquer seal applied to left, rear screw ______ Observed
______________________________________________________________________________
COVER ASSEMBLY
______________________________________________________________________________
COVER ASSEMBLY (continued)
Item Part Description Quantity
Num. Number Required
B 14 2 1
VIEW B---B
____ _____________________________________________________
ENCLOSURE LID ASSEMBLY
Item Part Description Quantity
Num. Number Required
5HPLQGHU
11
12
10 13
__________________________________________ ____________________________________
_____________________MODEL 190J, 190JG_ENCLOSURE ASSEMBLY____ ________
Item Part Description Quantity
Num. Number Required
14
5HPLQGHU
11
12
10 13
5HPLQGHU
15
10 11 13
________________________ENCLOSURE ASSEMBLY______________________________
Item Part Description Quantity
Num. Number Required
C
A F
D G J
H
B E I
Theory of Operation
Refer to the Functional Block Diagram above with this description of the circuit operation.
Circuit Operation
The UV lamp “B” produces florescence from the sample “A” which is detected by photodiode “C”. The
photodiode generates a current in the picoamp range and is converted to millivolts by the transconductance
amplifier as measured at “D”. The millivolt signal is further amplified by the high gain amplifier to the 1 to 2 volt
level measured at “F”.
Automatic gain control action is accomplished by monitoring the light output of the UV lamp with phototransistor
“E” which in turn controls the gain of the high gain amplifier. This circuit is designed to provide compensation
for very minor changes in the lamp output due to line voltage variations, lamp age, temperature, and individual
lamp characteristics.
The amplified signal at “F” is then filtered and rectified at “G” providing a DC voltage for the comparator at input at
“H”. The DC signal at “H” is a function of the amount florescence detected by the photodiode “C”. An increase in
florescence causes an increase in the voltage at point “H”. As the signal at “H” increases above the voltage at “I” the
output of the comparator “J” switches from a nominal plus 6 volts to a nominal minus 6 volts.
When a vial is inserted in the well a 3-second signal settling time delay is initiated to delay either the pass or fail
LED. If the voltage at “H” is greater than the reference at “I”, the fail (+) LED will turn on. If the voltage at “H” is
less than the reference at “I”, the pass (-) LED will turn on.
The automatic calibration and hysteresis settings are set by inserting a sterilized non-incubated vial into the chamber
which results in a voltage input to the comparator at “H”. While holding the vial down, pushing the calibration
switch starts a ramp voltage at point “I”. The ramp voltage starts at near zero and stops at the instant point “I” is
equal to point “H”. At that point 400 millivolts of hysteresis is added to the reference voltage at “I”. This ensures
that a fail (+) LED can only result from a sample which is at least 400 millivolts greater in florescence that a
sterilized non-incubated vial.
Schematics