3M attest-290-operators-manual 1200cc Suction Canister Directions for Use

™

3M™ Attest

290 Auto-reader

Operator’s Manual

Read and understand all safety information before using this product.

INTENDED USE

3

2

1

9

4

5

6

1. Cover

2. Incubation/Reader Wells

3. Crusher Well

4. Red Light Positive (+) Indicator

5. Yellow Light (•) Test In Progress Indicator

Intended Use

The 3M
incubate and automatically read the 3M
1291 Rapid Readout Biological Indicators (RRBI)
and/or 3M
Biological Indicators at 60
fluorescence reading at 1 hour for 1291 or 3 hours
for 1292.

The 3M
designed to allow for further incubation of the
3M
1292 RRBI for a final negative, visual pH color
change of the growth media at 24 hours for 1291
and 48 hours for 1292.

TM

AttestTM 290 Auto-reader is designed to

TM

AttestTM 1292 Rapid Readout

TM

AttestTM 290 Auto-reader is also

TM

AttestTM 1291 RRBI and/or 3MTM AttestTM

o

C for a final negative

TM

AttestTM

8

7

6. Green Light Negative (-) Indicator

7. Buzzer Alarm OFF Button

8. Digital Display Panel

9. Time Remaining Button

A positive fluorescence reading or a visual color
change indicates a steam sterilization process
failure.

Other biological indicators (BIs), are not compatible
with this device and cannot be used.

The unit is designed to be used only with the Power
Supply module supplied by 3M.

3M © 2003 78-8078-8977-5 Page 1 of 9 Attest 290 Auto-reader

p

SAFETY INFORMATION

WARNING

• To avoid the risk of electric shock,
which if not avoided 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 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.

• 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 the

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

glass ampule.

- Do not roll the RRBI between your

WARNING

WARNINGWARNING

fingers to wet the spore strip.

CAUTION

• 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 regu l ation s.

• 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 ta

CAUTION

CAUTIONCAUTION

e.

Explanation of symbols:

Caution – Risk of electric shock

Attention – Refer to accompanying
documents

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 1.2 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 rep ort 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
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 gene rated 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.

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
toutes les exigences due Reglement sur le materiel
brouilleur du Canada.

3M © 2003 78-8078-8977-5 Page 3 of 9 Attest 290 Auto-reader

INSTRUCTIONS FOR USE

Operating Instructions

Start-up

Place unit on a firm level surface. Plug unit into an
appropriate AC grounded outlet.

Allow a 30 minute warm-up period before placing
RRBIs into the incubatio n 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 anticipate d that it will not be
used for an extended period.

Readout Procedure

Follow this procedure for every RRBI to be read:

Step 1. While wearing gloves and
safety glasse s, CLOSE RRBI cap
by pressing down.

Step 4. Open the cover and
PLACE the RRBI into an

incubation/reader well.

Step 2. CRUSH the glass ampule
(containing growth med i a) in the
designated crushing well built
into the incubator.

Step 5. CLOSE the cover on the
Attest 290 Auto-reader and wait
for either the red or green
indicator light to signal the result.

Step 3. Hold the RRBI by the cap
and TAP bottom of the vial on a
tabletop until media wets spore
strip at bottom of vial. Do not tap
vial on unit.

WARNING

WARNING

WARNINGWARNING

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 4 of 9 Attest 290 Auto-reader

INSTRUCTIONS FOR 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

reader well within 10 seconds or the results will
be lost.

WWWWARNING

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.

return the RRBI to the

ARNING

ARNINGARNING

All red, yellow and green light s 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 incub a tion 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 p e r iod is
required before a negative result (-) is shown. The
Attest 1291 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 co ntr ol
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 read out time in its
policy and procedures. The policy should be based
on manufactur e r’s instructions for use, sc ientific
knowledge, current recommendation practices,
applicable compliance requirements, inventory
levels, and the risk to the patient if the med ical
device is not sterile.

3M © 2003 78-8078-8977-5 Page 5 of 9 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 is 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 processed RRBI in the unit.

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 temperature, humidity, or
proximity to chemicals

- capability of media to p r omote rapid growth,
and

- proper functioning of Attest 290 Auto-reader
components.

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 r e sult ( red light +).
Processed RRBI results are not valid until the
positive control reads fluor e scent positive (red light
+). With the processed RRBI, a positive (red light
+) result means a sterilization process failure may
have occurred.

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 contro l 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 colo r change),
media remains purple , is made at 24 hours (1291)
or 48 hours (1292).

Act on any positive result immediately. The p ositive
result indicates a sterilization process failure may
have occurred. Determine the cause of the positive
RRBI following curr ent facility policies and
procedures. Always retest the sterilizer and do not
use the sterilizer for processing loads u ntil 3
consecutive RRBI results are negative.

Disposal

Dispose of the used Attest RRBI according to your
healthcare facility policy.

You may wish to sterilize any positive R RBI prior
to disposal.

3M © 2003 78-8078-8977-5 Page 6 of 9 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 results in the least amount
of time without the need to manual ly 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 well s 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

WARNING

Always unplug the Attest 290 Auto­reader and allow to cool before
cleaning. Do not immerse the unit in
liquid.

WARNING

WARNINGWARNING

To turn the alarm function back o n, press the "alarm
off" and "time remaining" buttons at the same time.
The yellow period on the display panel will turn off,
indicating 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 illu minate 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 progra m. Should the
temperature fall outside the specified range (60ºC
+/-2ºC) an error code will be displayed.

Power Cord Retaining Clip

Place the power cord through the power cord­retaining clip on the rear of the Attest 290 Auto­reader 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 Auto­reader, 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. A ny mal f unctio ns wil l be indica ted b y
an error code. Refer to the Troub le Shooting Guide
section for error code explanations.

3M © 2003 78-8078-8977-5 Page 7 of 9 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 self­diagnostic 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 Problem Solution

C1 Unit Warm-up Caution Allow a 30 minute warm-up after
Incubation block not at temperature Attest 290 Auto-reader is plugged in.
(RRBI readings are disabled until
incubator block reaches 60ºC +/-2ºC).

C2 RRBI has been removed before incubation Replace RRBI in proper well within 10 seconds.
complete. All three lights for affected RRBI
will light and alarm will sound if active.

E1 T emperature Control Error Call for repair or replacement.
This error will occur if system is no
longer able to control the temp erature of
the incubator block (60ºC +/-2ºC).

E3 Memory Error. Call for repair or replacement.

E4 Analog-Digital Conversion Error. Call for repair or replacement.

E7 Communications Error Call for repair or replacement.
This error will occur if internal
communications have failed.

E8 Bulb Error Call for repair or replacement.
This error occurs if the system detects
that the bulb is too dim to properly read
RRBI results.

E9 T ransport Error Call for repair or replacement.
This error will occur if the system detects
a motor failure or positioni ng problem.

3M © 2003 78-8078-8977-5 Page 8 of 9 Attest 290 Auto-reader

TROUBLESHOOTING GUIDE

Trouble Shooting Guide (Co nt inued)

Code Problem Solution

Other Unwanted alarm sounds when Turn alarm off, refer to features
positive detected. Section.

Other All three lights blink and buzzer sounds. Replace RRBI in incubation/reader
RRBI has been removed from well within 10 seconds to prevent
incubation/reader well prematurely. loss of data collected.

Other Red, yellow, or green lights do not Specific light burned out.
illuminate when expected such as Call for repair or replacement.
following insertion of a RRBI or when
time remaining butto n is pressed.

Other Negati ve Control Vial

Vial not crushed . Crush vial befo re inserting into well.

Media did not wet the spore strip. Tap vial on table until media wets spore strip.

Control vial was sterilized. Use a non-sterilized vial as a control.
Check chemical indicator on label.
Other Unexplained positive

Adhesive residue on vial. Do not place tape or labels on vial.

Test vial is absorbing fluorescent Place the vial so it does not come in
residue from a chemical indicator or direct contact with chemical
tape. indicators 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: [phone]

Outside of the USA, contact your local 3M Subsidiary.

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

3M © 2003 78-8078-8977-5 Page 10 of 9 Attest 290 Auto-reader

3M Health Care

D-41460 Neuss, Germany

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proofing systems and offset
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Attest is a registered trademark
of 3M.
 3M 2003
78-8078-8977-5 Rev. D
Lit. Code: 70-2009-4089-1