3M™ Attest™ Auto-reader 390G
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Operator’s Manual
Manuel de l’utilisateur
Benutzerhandbuch
Manuale dell’operatore
Manual del usuario
Manual del operador
Bedieningshandleiding
Användarhandbok
Brugsvejledning
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Manual do Utilizador
Manual do Operador
Εγχειρίδιο Χειριστή
Instrukcja obsługi
Příručka pro obsluhu
Priročnik za uporabo
Инструкция по эксплуатации
Upute za korištenje
Operatör Kılavuzu
操作指南
Brukerhåndbok
Käyttöopas
คู่มือปฏิบัติงาน
작업자 매뉴얼
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Warnings and Safety Precautions
The following warnings and precautions should be followed to avoid unsafe actions that
could result in personal injury or damage to the instrument.
PREFACE
Manual Revision History
Date
Revision Reason For Revision
WARNING: To reduce the risk associated with hazardous voltage
Use indoors only.
November 2012
A
Initial Issue
To clarify, in the Indications for Use section, that
Attest™ 1294 Biological Indicators are used to
monitor the ethylene oxide sterilization process.
February 2013
July 2013
B
Do not use the equipment if it is not working properly or if it has suffered any damage.
Use only the power supply specified for this product and certified for the country
of use.
To revise: the Warranty statement; and the WEEE
symbol and associated explanatory text.
C
Content Disclaimers
CAUTION: To reduce the risk of injury or instrument damage
Pictorial Disclaimer
Do not spill liquid onto or into the instrument. Do not immerse the unit in liquid.
Always unplug the 3M™ Attest™ Auto‑reader 390G and allow to cool before cleaning.
Clean external surfaces using only the instructions provided by the manufacturer.
Do not open the instrument housing – there are no user serviceable parts.
The instrument must be returned to the manufacturer for repair.
Sample printouts, graphics, displays and screens are for information and illustration
purposes only, and shall not be used for clinical or maintenance evaluations. Data shown
in sample printouts and screens do not reflect actual patient names or test results.
Hardware Disclaimer
The 3M™ Attest™ Auto‑reader 390G hardware specifications are subject to change.
The system images, hardware components and hardware specifications included in
the manual may not match the system installed. Any changes or modifications to the
authorized system installation have been verified as compatible with the functionality
outlined in this document.
Allow the 3M™ Attest™ Rapid Readout Biological Indicator to cool for the
recommended time period before activating. Activating or excessive handling of the
biological indicator before cooling may cause the glass ampoule to burst.
Wear safety glasses when activating the 3M™ Attest™ Rapid Readout Biological
Indicator.
INDICATIONS FOR USE
The 3M™ Attest™ Auto‑reader 390G is designed to incubate and automatically read the
3M™ Attest™ Rapid Readout Biological Indicator for Ethylene Oxide, 1294, at 37°C for a
final fluorescent result at 4 hours.
WARNING: To reduce the risk associated with incorrect results
WARRANTY
Instrument is to be used by operators familiar with the device, device functionality, and
Operator’s Manual.
The 3M™ Attest™ Auto‑reader 390G has a one year limited product warranty. The US
warranty, remedy and limitations are described in the Price Quote form and in the Direct
Price Pages. For countries outside of the US, any warranty is established by the subsidiary
with responsibility for service of the 3M™ Attest™ Auto‑reader 390G.
Do not place the instrument in environment exposed to sunlight or strong
incandescent light.
Do not place instrument close to any device that emits a strong electro‑magnetic field.
Do not use on a vibrating surface.
Serial Number
For easy identification, each 3M™ Attest™ Auto‑reader 390G has a unique serial number
printed on a label found on the back of the unit and displayed on the left side of the upper
Match the cap color of the 3M™ Attest™ Rapid Readout Biological Indicator with the
color‑coded configuration sticker surrounding the 3M™ Attest™ Auto‑reader 390G
incubation wells.
row of text on the LCD Display when the user depresses the
your serial number in this manual for future reference: ___________________.
button. Please record
Do not remove or change placement of 3M™ Attest™ Rapid Readout Biological
Indicator once it is placed into a well.
SAFETY AND PRECAUTIONS
Do not remove the 3M™ Attest™ Rapid Readout Biological Indicator from the
incubation well until the (+) or (‑) symbol on the LCD panel indicates the test
is complete.
The 3M™ Attest™ Auto‑reader 390G and its related devices and accessories are
designed to provide safe and reliable service when used according to the instructions
provided. Please read, understand, and follow all safety information contained in the
instructions for use included with the 3M™ Attest™ Auto‑reader 390G and 1294 Rapid
Readout Biological Indicator devices prior to use. Use this equipment only for the purpose
described in this Operator’s Manual. Retain these instructions for future reference.
Caution: To reduce the risk associated with incorrect results
The unit is designed to be used only with the Power Supply module and Ethernet cable
supplied by 3M. If this product is used in a manner not specified, the protection provided
by the product may be impaired.
To avoid the possibility of the 3M™ Attest™ Rapid Readout Biological Indicator
vial absorbing fluorescent residue from a chemical indicator or tape, place the
3M™ Attest™ Rapid Readout Biological Indicator vial so it does not come in direct
contact with chemical indicators or tape.
Explanation of Single Word Consequences
Warning: Indicates a hazardous situation, which, if not avoided, could result in
death or serious injury.
Caution: Indicates a hazardous situation, which, if not avoided, could result in
minor or moderate injury.
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HEALTH AND SAFETY INFORMATION
EXPLANATION OF PRODUCT AND PACKAGING
LABEL SYMBOLS
Device Safety Compliance
Attention ‑ Refer to the instructions for use
The 3M™ Attest™ Auto‑reader 390G complies with the following standards as
demonstrated by the CB Scheme Certificate and test report issued by Underwriters
Laboratories (UL):
Waste Electrical and Electronic Equipment (WEEE) and EU Battery Directive.
This symbol indicates that both the device and the lithium ion battery
contained therein need to be disposed of properly.
•
IEC 61010‑1 (2001) Second Edition. Safety requirements for electrical equipment for
measurement, control, and laboratory use ‑ Part 1: General requirements
IEC 61010‑2‑010 (2003) Second Edition. Safety requirements for electrical equipment
for measurement, control, and laboratory use ‑ Part 2‑010: Particular requirements for
laboratory equipment for the heating of materials
Li
•
UL Listed to US and Canadian Safety Standards
Mark of Conformity to European Directives
Direct current
The 3M™ Attest™ Auto‑reader 390G is listed as Laboratory equipment and carries the
UL mark with adjacent indicators “C” and “US” based on compliance to the standards UL
61010‑1 and CAN/CSA 22.2 No. 61010‑1.
Compliant to all applicable ACMA regulatory arrangements (RCM)
Manufacturer
The 3M™ Attest™ Auto‑reader 390G complies with the CE mark related to the Low
Voltage Directive (LVD) 2006/95/EC as confirmed in the Declaration of Conformity.
The 3M™ Attest™ Auto‑reader 390G complies with the RoHS Directive, Directive
2011/65/EU of the European Parliament and of the Council of 8 June 2011 on
the restriction of the use of certain hazardous substances in electrical and
electronic equipment.
Catalog number
REF
Authorized representative for the European Community
The 3M™ Attest™ Auto‑reader 390G complies with the WEEE Directive, Directive
2012/19/EU of the European Parliament and of the Council of 04 July 2012 on waste
electrical and electronic equipment (WEEE).
Serial number
1294
EMC Compliance
The 3M™ Attest™ Auto‑reader 390G complies with the following EMC standards as
confirmed in the Certificate of Compliance generated by 3M:
The 3M™ Attest™ Auto‑reader 390G is not designed to incubate
3M™ Attest™ 1264 EO Biological Indicators, which have a sterilant
entry port in the center of the top of the cap. The 3M™ Attest™
Auto‑reader 390G is designed to incubate and read only 3M™ Attest™
Rapid Readout Biological Indicators for EO, catalog number 1294. Other
biological indicators (BIs) are not compatible with this device and cannot
be used.
IEC 61326‑1 Electrical equipment for measurement, control and laboratory use ‑ EMC
requirements ‑ Part 1: General requirements
The 3M™ Attest™ Auto‑reader 390G complies with the EMC requirements of the CE
mark EMC Directive 2004/108/EC.
The 3M™ Attest™ Auto‑reader 390G complies with the Australian and New Zealand
electrical safety and electromagnetic compatibility requirements as confirmed in the
Supplier’s Declaration of Conformity that is linked to the Australian/New Zealand RCM
(Regulatory Compliance Mark).
Note: This equipment has been tested and found to comply with the limits for a Class A
digital device pursuant to Part 15, Subpart B, 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 device meets all requirements of the Canadian Interference‑Causing
Equipment Regulations.
Class 1 LED Product
An investigation was conducted on the 3M™ Attest™ Auto‑reader 390G per the
requirements of IEC 60825‑1 Ed. 1.2 (A2:2001). The 3M™ Attest™ Auto‑reader 390G is a
Class 1 LED product with Class 1 Internal Radiation.
The LED apertures are located at the bottom of each Incubator/Reader well perpendicular
to the opening of each well.
NOTE: Class 1 products are safe for unprotected exposure of the eyes.
Caution ‑ Use of controls or adjustments or performance of procedures other than
those specified herein may result in hazardous radiation exposure.
Note: The use of the term “controls” in the above caution statement as required by
IEC 60825‑1 Ed. 1.2 (A2:2001) refers to mechanisms by which the 3M™ Attest™
Auto‑reader 390G may be controlled and not to the use of biological indicator controls.
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SPECIFICATIONS
Power Supply Specifications
Power supply
Operating Condition
Units
Voltage Range
100‑240
Volts AC
Frequency
Current
50/60
0.6
Hertz
Amps
Environmental Operating Conditions
Environmental Condition
Operating Condition
Units
Altitude
3000 (max)
Meters
Operating Temperature
Storage Temperature
Operating Relative Humidity
Voltage Range
16 – 29
ºC
‑10 to 50
ºC
20‑80 (non‑condensing)
%
12
Volts DC
Frequency
DC
Current
1.2
Amps
Installation/Over Voltage
Pollution Degree
Category II
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INSTRUCTIONS FOR USE – Initial Set‑up
Choose Location
WARNING:
Place 3M™ Attest™ Auto‑reader 390G on a firm and level surface, away from sunlight
and incandescent light. To save counter space, units may be stacked two high.
•
•
•
Do not place the instrument in environment exposed to sunlight or strong
incandescent light.
Do not place instrument close to any device that emits a strong
electro‑magnetic field.
Do not use on a vibrating surface.
Select & Install Correct Power Plug
WARNING: Use only the power supply specified for this product and certified for
the country of use.
The 3M™ Attest™ Auto‑reader 390G power supply comes with multiple blade
configurations. Install the blade configuration appropriate for your country into the power
supply and plug into appropriate AC grounded outlet.
Wait 30 Minutes Before Using
Once plugged in, allow a 30 minute warm‑up period before placing 3M™ Attest™ Rapid Readout Biological Indicators into the incubation wells. The C1 caution code will disappear
when proper incubation temperature is reached.
Special Considerations
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.
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INSTRUCTIONS FOR USE – Wells, Buttons, & Display Interpretation
Please familiarize yourself with the face of the 3M™ Attest™ Auto‑reader 390G:
INSTRUCTIONS FOR USE – 3M™ Attest™
Auto‑reader 390G Configuration
Wells
Note: Ideally, the 3M™ Attest™ Auto‑reader 390G should be empty (i.e., have no
incubating BIs) when it is reconfigured.
1. Incubation/Reader Wells – The 3M™ Attest™ Auto‑reader 390G has ten
incubation wells.
Buttons
Press the
and
buttons on the front of the 3M™ Attest™ Auto‑reader 390G
simultaneously for 3 seconds to enter configuration mode. Once in configuration mode,
2. Information / Up Arrow Button
use the Up and Down buttons to set the 3M™ Attest™ Auto‑reader 390G
3. Temperature / Down Arrow Button
clock and audible alarm as desired. The
button acts as an “Enter” key and moves the
flashing cursor to the next changeable setting.
4. Buzzer Alarm OFF / Enter Button
Setting the 3M™ Attest™ Auto‑reader 390G Clock
Information Display
The 3M™ Attest™ Auto‑reader 390G date and time are displayed in this format:
YYYY‑MM‑DD HH:MM, with the time displayed using a 24 hour clock. To change the year,
5. LCD Display – Display is backlit
6. LCD Display – Example of Error Message for well #6
7. LCD Display – Example of Remaining Incubation Time, in minutes, for well #10
8. LCD Display – Example of Negative ( ‑ ) BI result for well #9
9. LCD Display – Example of Positive ( + ) BI result for well #8
10. LCD Display – Alarm Enabled Indicator
if necessary, push the up or down buttons to set desired year, then press
to advance
to the month, adjust as necessary and press
to advance to the day. Use the
button to move to the time and set the hours and minutes.
Setting the Audible Alarm Function
Color‑Coded Configuration Indicator
11. Incubation well configuration sticker is color‑coded green
BI Crusher
Move across the top row of text by pushing the
button. The flashing “B” in Buzzer
indicates this is a changeable setting. It is recommended this be set at “Buzzer Enabled”
to audibly alert the operator to a positive BI but it may be set to “Buzzer Disabled” by
using either the up or down button. Note: If Buzzer Disabled is selected, and the changes
accepted, the speaker icon ( ) will disappear from the LCD panel and the alarm will be
disabled for all positive 3M™ Attest™ Rapid Readout Biological Indicators, error codes,
and caution code alarm warnings. Note: The 3M™ Attest™ Auto‑reader 390G display
backlight flashes whenever an audible alarm sounds. Disabling the audible alarm does
NOT disable the LCD display backlight flashing.
12. BI Crusher Well
Press
to select the desired option and advance to the Accept screen.
Accept Screen
Use the up or down buttons to toggle between Yes and No, press
to accept changes
(Yes selected) or retain current settings (No selected) and exit the configuration mode. The
LCD panel will return to the standard display.
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INSTRUCTIONS FOR USE ‑ Readout Procedure
INSTRUCTIONS FOR USE – Additional Information
Instructions for Biological Indicator (BI) Activation and Incubation
BI Placement
Remaining incubation time, in minutes, will be displayed on the LCD display to indicate
the 3M™ Attest™ Rapid Readout Biological Indicator is incubating in the reader well and
should not be touched. The time remaining display indicates the results are not available
and incubation is in progress.
CAUTION: To avoid the possibility of the 3M™ Attest™ Rapid Readout
Biological Indicator vial absorbing fluorescent residue from a chemical indicator or
tape, place the 3M™ Attest™ Rapid Readout Biological Indicator vial so it does not
come in direct contact with chemical indicators or tape.
Do not remove 3M™ Attest™ Rapid Readout Biological Indicator until the (+) or (‑)
symbol on the LCD panel indicates the test is complete.
Note: If 3M™ Attest™ Rapid Readout Biological Indicator is inadvertently removed
before the incubation period is complete, an alarm will sound and a C2 Caution code will
be displayed on the LCD panel under that well. You must return the 3M™ Attest™
Rapid Readout Biological Indicator to the reader well within 10 seconds or the
results will be lost.
WARNING: Match the green cap color of the 3M™ Attest™ 1294 Rapid
Readout Biological Indicator with the green color‑coded configuration sticker
surrounding the 3M™ Attest™ Auto‑reader 390G incubation wells.
CAUTION: Wear safety glasses when activating 3M™ Attest™ Rapid Readout
Biological Indicators.
WARNING: Do not remove or change placement of 3M™ Attest™ Rapid
Readout Biological Indicator once it is placed into a well. Doing so may result in loss of
results and the 3M™ Attest™ Rapid Readout Biological Indicator test may be invalid.
Follow this procedure for every 3M™ Attest™ 1294 Rapid Readout Biological Indicator to
be read.
While wearing safety glasses, CLOSE the cap of the
cooled 3M™ Attest™ 1294 Rapid Readout Biological
Indicator (BI) by pushing cap down.
INSTRUCTIONS FOR USE – Positive Control
Positive Control
Activate and incubate at least one non‑processed 3M™ Attest™ 1294 Rapid
Readout Biological Indicator to use as the positive control each day that a processed
3M™ Attest™ 1294 Rapid Readout Biological Indicator 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 incubation well. The positive control should be the same part number and have the
same lot number as the processed 3M™ Attest™ Rapid Readout Biological Indicator in
the unit.
CRUSH the glass media ampoule in the Crusher Well
built into the top of the 390G Auto‑reader.
The positive control biological indicator helps confirm:
•
•
correct incubation temperatures are met (heater block reading of 37ºC +/‑2ºC);
viability of spores has not been altered due to improper storage temperature, humidity,
or proximity to chemicals;
•
•
capability of media to promote rapid growth; and
proper functioning of 3M™ Attest™ Auto‑reader 390G components.
Holding BI by the cap, TAP the bottom of the vial on a
tabletop until media wets spore strip at bottom of vial.
Do not tap BI on Auto‑reader.
INSTRUCTIONS FOR USE – Interpretation of Results
Fluorescent Results
After placing a 3M™ Attest™ Rapid Readout Biological Indicator into an incubation
well, the 3M™ Attest™ Auto‑reader 390G LCD panel will display ***, **, * and then
the remaining minutes of incubation directly below the incubating BI to indicate that
incubation/reading is in progress.
PLACE the crushed BI in color‑coded incubation well.
Observe 3M™ Attest™ Auto‑reader 390G LCD panel
to confirm correct placement of the BI. If the BI is
correctly seated, the 3M™ Attest™ Auto‑reader 390G
LCD panel will display ***, **, * and then 240 remaining
minutes of incubation directly below the incubating BI.
A (+) will display on the LCD panel directly under the BI and an alarm will sound (if the
sound feature is enabled) as soon as a positive 3M™ Attest™ Rapid Readout Biological
Indicator result is detected.
At the end of the four hour incubation time, if a negative 3M™ Attest™ Rapid Readout
Biological Indicator result is detected, a (‑) will display on the LCD panel directly under
the incubating BI. The final negative fluorescent result (‑) for a processed 3M™ Attest™
1294 Rapid Readout Biological Indicator after 4 hours of incubation indicates an
acceptable sterilization process. The positive control should read positive (+).
RECORD BI result.
After either the + or – symbol is displayed, and the result is recorded, the 3M™ Attest™
Rapid Readout Biological Indicator can be removed from the well. The 3M™ Attest™
Rapid Readout Biological Indicator should not be removed or touched when the display
indicates remaining incubation time.
WARNING: Do not remove the 3M™ Attest™ 1294 Rapid Readout Biological
Indicator from the incubation well until the (+) or (‑) symbol on the LCD panel indicates
the test is complete.
The positive (unprocessed) control 3M™ Attest™ 1294 Rapid Readout Biological Indicator
must provide a positive fluorescent result (+). Processed 3M™ Attest™ Rapid Readout
Biological Indicator results are not valid until the positive control reads fluorescent positive
(+). With a processed 3M™ Attest™ Rapid Readout Biological Indicator, a positive (+)
result indicates a sterilization process failure.
Act on any positive test results immediately. Determine the cause of the positive
3M™ Attest™ Rapid Readout Biological Indicator and retest the sterilizer following
current facility policies and procedures.
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Optional Visual pH Color Change Result
Easy Configuration
3M™ Attest™ 1294 Rapid Readout Biological Indicators may be further incubated for
a visual pH color change. Due to the high sensitivity of the fluorescent result, there is no
advantage to incubating the 3M™ Attest™ 1294 Rapid Readout Biological Indicators
beyond 4 hours. This optional further incubation is not intended for routine use but may
be used for special studies. A humidified incubator will be required to avoid media dry out.
In the case of a positive control BI, a yellow color change of the growth media will appear
within 7 days. Any observation of a yellow color within the vial indicates a positive result.
The pH color change result can be recorded and the BI discarded as soon as the yellow
color is observed and the result recorded. In the case of a processed BI, a media color
change from blue‑green to yellow indicates a sterilization process failure. A negative pH
color change result, i.e., media remains blue‑green, can be assessed at 7 days.
The 3M™ Attest™ Auto‑reader 390G may be configured using either the buttons located
on the front of the unit or using the optional 3M™ Attest™ Auto‑reader 390G Web App.
Optional 3M™ Attest™ Auto‑reader 390G Web App
If desired, the 3M™ Attest™ Auto‑reader 390G may be connected to a PC via an Ethernet
connection for additional capabilities:
•
Remotely view current status of BIs in the 3M™ Attest™ Auto‑reader 390G via PC
or mobile hand held devices. For full functionality, the use of an HTML5 compliant
browser with JavaScript enabled is recommended.
•
•
•
Remotely view and configure 3M™ Attest™ Auto‑reader 390G settings.
View the last 100 BI records.
Print out documentation using a local or networked printer and/or save documentation
as an electronic file.*
INSTRUCTIONS FOR USE – Disposal
Instrument contains a lithium battery. Dispose of instrument in accordance with federal,
state, and local requirements.
Note: To access the 3M™ Attest™ Auto‑reader 390G Web App within a secure network,
the PC or mobile device must have access to the secure network; options include
connecting via a network Ethernet cable, signing in to the facility’s wireless network, or
connecting via a virtual private network (VPN).
FEATURES OF THE 3M™ ATTEST™ AUTO‑READER 390G
* Refer to your facility’s record keeping policy and procedure.
Audible Alarm
An audible alarm will sound, the LCD display backlight will flash, and a (+) symbol will
be displayed on the LCD panel directly under the incubating BI when a positive result is
detected. An alarm will also sound if a 3M™ Attest™ Rapid Readout Biological Indicator
is removed from the 3M™ Attest™ Auto‑reader 390G well before a final result has been
detected. Data will be lost if the 3M™ Attest™ Rapid Readout Biological Indicator is not
replaced in the incubation well within 10 seconds.
CARE AND CLEANING
CAUTION: Always unplug the 3M™ Attest™ Auto‑reader 390G and allow to
cool before cleaning.
Do not spill liquid onto or into the instrument. Do not immerse the unit in liquid.
Clean external surfaces using only the instructions provided by the manufacturer.
The instrument must be returned to the manufacturer for repair.
Alarm On/Off
The audible alarm for positive results can be turned off for a particular 3M™ Attest™
Rapid Readout Biological Indicator. This is accomplished by pressing the “Buzzer Alarm
OFF” button after the alarm has sounded. This will turn off the alarm for that BI only. Any
positive 3M™ Attest™ Rapid Readout Biological Indicator results subsequently detected
in other wells will result in the alarm sounding. Removing the 3M™ Attest™ Rapid
Readout Biological Indicator will reactivate the alarm for that well. Pressing the “Buzzer
Alarm OFF” button will not silence the alarm for error or caution code alarm warnings. To
disable the alarm, see configuration section.
Clean the exterior surface of the 3M™ Attest™ Auto‑reader 390G by wiping it with a
damp cloth moistened with a mild detergent. Do not attempt to clean interior components.
If additional cleaning of the wells is required, call for repair or replacement.
Note: The 3M™ Attest™ Auto‑reader 390G does not contain any user serviceable parts
or require any routine maintenance. Any malfunctions will be indicated by an error code.
Refer to the Troubleshooting Guide section for error code explanations.
Stackable
To save counter space, 3M™ Attest™ Auto‑reader 390Gs may be stacked two high.
Information Button
When the Information button is pressed once the 3M™ Attest™ Auto‑reader 390G
displays two lines of text in the LCD display.
The top row indicates (left to right):
•
•
•
3M™ Attest™ Auto‑reader 390G serial number
3M™ Attest™ Auto‑reader 390G embedded software version (V X.Y.Z)
Current date and time.
The bottom row indicates (left to right):
•
•
The BI type configuration for wells 1‑5.
The BI type configuration for wells 6‑10.
Press the information button twice and the 3M™ Attest™ Auto‑reader 390G LCD panel
will display two additional lines of text.
The top row indicates:
•
Dynamic IP address (if unit is connected to an Ethernet jack).
The bottom row indicates (left to right):
•
Date (YYYY‑MM‑DD) and time that power was supplied to the 3M™ Attest™
Auto‑reader 390G.
Temperature Monitoring
The 3M™ Attest™ Auto‑reader 390G contains an internal temperature self‑diagnostic
program. Should the temperature fall outside the specified range (37ºC +/‑2ºC) an error
code will be displayed. The heater block temperature may be checked by depressing the
Temperature button once.
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TROUBLESHOOTING GUIDE
In the event of an error code, unplug the 3M™ Attest™ Auto‑reader 390G and plug it back in to initiate the self‑diagnostic test. If error code re‑occurs, call for repair or replacement.
The LCD display panel will indicate detected malfunctions by displaying a caution or error code under affected BI wells. The audible alarm, if active, sounds and the LCD display
backlight flashes to alert the user to all caution (except C1) and error codes. The alarm and backlight can be silenced and extinguished, respectively, by pressing the Buzzer Alarm OFF
button
. Note that disabling the audible alarm does not disable the flashing LCD display backlight. Refer to the following:
Code/Issue
Problem
Solution
Unit Warm‑up Caution
Allow a 30 minute warm‑up after 3M™ Attest™ Auto‑reader 390G is plugged in. (Note: 3M™ Attest™
Rapid Readout BI readings are disabled until incubator block reaches 37ºC +/‑ 2ºC).
C1
Incubation block not at temperature.
BI Removed from Well Caution
Replace 3M™ Attest™ Rapid Readout BI in proper well within 10 seconds to prevent loss of collected
data.
C2
C4
E1
3M™ Attest™ Rapid Readout BI has been removed before
incubation is complete.
Ambient Light Caution
Move 3M™ Attest™ Auto‑reader 390G to reduced ambient light conditions.
Temperature Control Error
Unplug the unit and plug it back in to clear error.
If error doesn’t clear, call for repair or replacement.
This error will occur if system is no longer able to control
the temperature of the incubator block (37ºC +/‑ 2ºC).
Memory Error
Unplug the unit and plug it back in to clear error.
If error doesn’t clear, call for repair or replacement.
E3
E7
E8
3M™ Attest™ Auto‑reader 390G unable to save/read data
from memory.
Communications Error
Call for repair or replacement.
This error will occur if internal communications have failed.
LED Error
Unplug the unit and plug it back in to clear error.
This error occurs for a specific well if the system detects
that a UV LED or Optics Detection circuit is not working.
If error doesn’t clear, call for repair or replacement. Do not use affected incubation well.
BI Inserted Incorrectly Error
Ensure BI is designed to be incubated and read in the 3M™ Attest™ Auto‑reader 390G.
Ensure BI is fully inserted into incubation well.
E11
E12
Incubation time remaining will not display and fluorescent
readings are not taken.
Power Failure Error
Ensure power supply connection to Auto‑reader is secure.
Power to Auto‑reader was off for too long to provide valid
result for affected BI(s).
Ambient Light Error (occupied well)
Fluorescent result will not display.
Unwanted alarm sounds when positive BI detected.
Alarm Sounds
Rely on optional visual pH color change result for BI in affected well. Move 3M™ Attest™
Auto‑reader 390G to reduced ambient light conditions to avoid future occurrences.
E14
Other
Disable alarm; refer to 3M™ Attest™ Auto‑reader 390G Configuration section for instructions.
Replace 3M™ Attest™ Rapid Readout Biological Indicator in incubation/reader well within 10 seconds
to prevent loss of data collected.
Other
3M™ Attest™ Rapid Readout Biological Indicator has been
removed from incubation/reader well prematurely.
Other
Other
LCD panel does not display properly.
Negative Control Vial
Unplug the unit and plug it back in. If problem persists call for repair or replacement.
Ensure BI cap is closed, and glass ampoule is crushed. Tap BI until media flows to and wets spore strip
at bottom of BI.
BI not properly activated/ media did not contact spore strip.
Negative Control Vial
Other
Other
Check process indicator on BI label. Use a non‑sterilized vial as a control.
Do not place tape or labels on vial.
Control vial was sterilized.
Unexplained Positive BI
Adhesive residue on vial.
Unexplained Positive BI
Other
Place the vial so it does not come in direct contact with chemical indicators or tape.
Test vial is absorbing fluorescent residue from a chemical
indicator or tape.
3M™ Attest™ Auto‑reader 390G will not enter
Configuration mode.
On 3M™ Attest™ Auto‑reader 390G Web App Configuration Page, go to Pushbutton Configuration and
Other
Other
select the Enable radio button. Save changes to begin using new setting.
Pushbutton Configuration may be disabled on
3M™ Attest™ Auto‑reader 390G Web App.
3M™ Attest™ Auto‑reader 390G LCD display flashes
and asterisks (***) and/or E11 and/or C4 codes appear on
display below unoccupied incubation wells.
Move 3M™ Attest™ Auto‑reader 390G away from sunlight or sources of incandescent light.
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OPTIONAL 3M™ ATTEST™ AUTO‑READER 390G WEB APP
Web Browser Requirements
About the 3M™ Attest™ Auto‑reader 390G Web App Pages
The 3M™ Attest™ Auto‑reader 390G Web App includes four pages:
a) Status page
The Web Interface is designed to be viewed in Internet Explorer 8.0 or higher. Earlier
versions of Internet Explorer or other browsers may result in some web pages being
displayed in a less‑than‑optimum manner. For best results, switching to Internet Explorer
8.0 or higher is recommended. For full functionality, the use of an HTML5 compliant
browser with JavaScript enabled is recommended.
3M™ Attest™ Auto-reader 390G
Connecting to the 3M™ Attest™ Auto‑reader 390G Web App
Status
History
To use the 3M™ Attest™ Auto‑reader 390G Web App, the 3M™ Attest™ 390G
Auto‑reader must be connected to the facility network using the supplied Ethernet
cable. Consult with your facility IT personnel for assistance with network connectivity.
Users may connect to the 3M™ Attest™ Auto‑reader 390G Web App using a URL based
upon either the 3M™ Attest™ Auto‑reader 390G serial number or the IP Address. To
view the 3M™ Attest™ Auto‑reader 390G Web App from a wireless device such as a
mobile hand‑held device or a computer on a sub‑net different from that to which the
3M™ Attest™ Auto‑reader 390G is connected, use the IP Address URL.
ATTEST 1294
ATTEST 1294
1
2
3
4
5
6
7
8
9
10
+
–
85
240
2012-10-31 12:32
100122
SN
1. User‑entered nickname (optional)
2. Well Configuration (1‑5 and 6‑10)
3. Well Number
4. BI Result/Remaining Incubation Time
5. Date and Time
Note: To access the 3M™ Attest™ Auto‑reader 390G Web App within a secure network,
the PC or mobile device must have access to the secure network; options include
connecting via a network Ethernet cable, signing in to the facility’s wireless network, or
connecting via a virtual private network (VPN).
A. Serial number URL
6. 3M™ Attest™ Auto‑reader 390G Serial Number
1. Connect the supplied Ethernet cable from the 3M™ Attest™ Auto‑reader 390G to an
Ethernet jack.
The Status page provides a real‑time representation of the 3M™ Attest™
Auto‑reader 390G LCD panel display. The current date and time and 3M™ Attest™
Auto‑reader 390G serial number are also indicated on this page. From this page, the user
may navigate to:
2. Depress the
button once to display the 3M™ Attest™ Auto‑reader 390G 6‑digit
serial number on the left side of the top row of text on the LCD display.
•
•
the History page by clicking on History on the left of the screen.
the Results Detail page by clicking on the well number of an occupied well (i.e., a well
that currently has an incubating BI). Clicking on an unoccupied well takes the user to
the History page.
attest401008) from Step 2 in PC web browser address bar and press Go.
4. 3M™ Attest™ Auto‑reader 390G Web App Status page will display on PC. For future
ease of use, add this page to your web browser “Favorites.”
b) Results Detail page
B. IP Address URL
The 3M™ Attest™ Auto‑reader 390G Web App may also be accessed using either a
dynamic or static IP address.
3M™ Attest™ Auto-reader 390G Results Detail
Status
History
Print
1. Dynamic IP Address
A dynamic IP address is assigned when the Ethernet cable is connected from the
3M™ Attest™ Auto‑reader 390G to a live Ethernet jack.
Result
–
Start Time
2012-10-29 11:08:04
#3 1294
100122
Well# and Configuration
390G Serial Number
Control?
BI Lot#
Press and release the
button twice to display the 3M™ Attest™ Auto‑reader 390G’s
Load#
address bar of the PC or mobile hand‑held device and press Enter. The 3M™ Attest™
Auto‑reader 390G Web App Status page will display.
Sterilizer#
Technician
This page provides an individual record for an incubated BI. For complete documentation,
the user may print a hard copy and/or save the record as an electronic file.
2. Static IP address
Some facility IT personnel may require devices connecting to the network to use a Static
IP address. If this is the case at your facility, contact the IT department to request a Static
IP address.
Note 1: The top four rows (highlighted in green) are populated automatically by the
3M™ Attest™ Auto‑reader 390G and cannot be changed by the user. The remaining rows
are completed by the user to satisfy the documentation requirements of their facility.
Note 2: The Results Detail page refreshes less frequently that the Status page. Until the BI
result is available, the Results Detail page displays remaining minutes of incubation in the
results field.
Record the static IP address provided by your facility IT department here: ___________.
You may wish to label the Ethernet jack with the assigned address. Enter
PC or mobile hand‑held device and press Enter. The 3M™ Attest™ Auto‑reader 390G
Web App Status page will display.
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c) History page
Important! Data is only stored for the last 100 incubated BIs.
Embedded software in the 3M™ Attest™ Auto‑reader 390G saves the data from the
auto‑populated (i.e., green highlighted) fields. The application relies on the temporary
storage in the user’s web browser to save the data in the user‑populated fields. In both
cases, data is only stored for the last 100 records, i.e., the 101st incubated BI will erase
the information saved for the 1st incubated BI. To retain the Results Detail information for
future reference it is best practice to print the page or save to an electronic file as soon as
the BI result is available.
3M™ Attest™ Auto-reader 390G
Result
Status
History
ID Well# and Configuration
Start Time
1
2
3
4
5
6
7
8
#4 1294
#3 1294
#3 1294
#4 1294
#5 1294
#1 1294
#4 1294
#4 1294
2012-10-30 12:31:25 ---
2012-10-30 09:57:01 ---
2012-10-30 07:51:51
2012-10-30 16:15:55
2012-10-30 16:01:07
2012-10-30 15:58:18
2012-10-30 11:52:27
+
–
–
+
–
Using the BI History Page
2012-10-30 11:42:26 C2
The 3M™ Attest™ Auto‑reader 390G stores results for the last 100 incubated BIs on
embedded software. The 3M™ Attest™ Auto‑reader 390G Web App History page provides
a summary of these last 100 results.
3M™ Attest™ Auto-reader 390G
Status
History
ID Well# and Configuration
Start Time
Result
1
2
3
4
5
6
7
8
#4 1294
#3 1294
#3 1294
#4 1294
#5 1294
#1 1294
#4 1294
#4 1294
2012-10-30 12:31:25 ---
2012-10-30 09:57:01 ---
d) Configuration page
This page allows the configuration of the 3M™ Attest™ Auto‑reader 390G’s network and
language settings from the 3M™ Attest™ Auto‑reader 390G Web App.
2012-10-30 07:51:51
2012-10-30 16:15:55
2012-10-30 16:01:07
2012-10-30 15:58:18
2012-10-30 11:52:27
+
–
–
+
–
Documenting BI Results using the 3M™ Attest™ Auto‑reader 390G
Web App
2012-10-30 11:42:26 C2
To view or print an individual record, click on the ID number of the desired record to
navigate to the Results Detail page for that BI.
Note 1: Column 1, “ID” is the assigned ID number with ID 1 representing the newest
record and ID 100 representing the oldest record. For convenience, all columns are
sortable; to help find a particular record, simply click once on the column heading to sort
in ascending order and click a second time to reverse the order.
3M™ Attest™ Auto-reader 390G
Status
History
ATTEST 1294
ATTEST 1294
1
2
3
4
5
6
7
8
9
10
Note 2: The History page refreshes less frequently than the Status page. Until the BI result
is available, the History page displays ••• in the Results column indicating incubation is
still in‑process.
229
–
–
–
231
2012-10-30 16:06
100122
SN
1. Open the Results Detail page
After inserting a new 3M™ Attest™ Rapid Readout BI in the 3M™ Attest™
Auto‑reader 390G, it is a best practice to open the 3M™ Attest™ Auto‑reader 390G
Web App Results Detail page for that BI by clicking on the appropriate well number
from the Status page.
2. Enter the specific information for that BI (e.g., BI Lot #, sterilizer/load number,
Technician name, etc.) in the provided editable fields. Use the Notes section to capture
information not prescribed in the provided row titles; for example, you may wish to use
this field to record load items.
3M™ Attest™ Auto-reader 390G Results Detail
Status
History
Print
Result
223
Start Time
2012-10-30 15:58:18
Well# and Configuration
390G Serial Number
#1 1294
100122
Control?
BI Lot#
No
2014-11AD
Load#
1
Sterilizer#
Technician
2
sdf
3. The entered information is saved automatically to temporary web browser storage on
the user’s PC every 60 seconds, or by leaving the Results Details page.
4. Print/File. Once the BI result is available, print or file the Results Detail page to create
a record. The page may be physically printed and/or saved as an electronic file.
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Using the Configuration Page
Certain set‑up and configuration options are available on the password‑protected 3M™ Attest™ Auto‑reader 390G Web App Configuration page. Ideally, the 3M™ Attest™
Auto‑reader 390G should be empty (i.e., have no incubating BIs) when it is reconfigured. Navigate to the Configuration page by entering either:
in the web browser address bar and pressing Go or Enter. A security screen will appear. Fill in the fields as follows:
User name: manager
Password: Attest
and press OK.
Click on the desired radio buttons to change settings.
Selected setting indicates language in which text on 3M™ Attest™ Auto‑reader 390G Web App pages will appear on the PC/mobile device
screen.
Language
Selecting Enable allows the user to configure the 3M™ Attest™ Auto‑reader 390G from the buttons on the unit itself.
Pushbutton Configuration
Selecting Disable prevents the user from being able to configure the 3M™ Attest™ Auto‑reader 390G from the buttons on the unit
itself.
Selecting Enable enables the audible alarm. The speaker icon will appear on the 3M™ Attest™ Auto‑reader 390G LCD panel.
Buzzer Configuration
Selecting Disable disables the audible alarm. The speaker icon will disappear from the 3M™ Attest™ Auto‑reader 390G LCD panel.
Naming the 3M™ Attest™ Auto‑reader 390G may be useful in facilities with multiple units. The assigned nickname will appear on the
3M™ Attest™ Auto‑reader 390G Web App Status page.
Attest Auto‑reader 390G Nickname
Default: Setting is checked indicating the Web App will use the Dynamic IP address automatically assigned when the 3M™ Attest™
Enable DHCP
Auto‑reader 390G is connected to the network. Remove the check if you wish to use a Static IP address assigned by your facility IT.
IP Address
Enter Static IP address assigned by IT.
Gateway
Enter Gateway.
Subnet Mask
Primary DNS
Use Computer Time
Enter Subnet Mask.
Enter Primary DNS.
Check this box if you wish to set the clock on‑board the 3M™ Attest™ Auto‑reader 390G using the computer’s clock.
Alternatively, leave the Use Computer Time box unchecked and complete the date and time boxes to set the
3M™ Attest™ Auto‑reader 390G clock.
Attest Auto‑reader 390G Time
After changing desired settings, click on Save Config button to save your changes. A new screen confirming the settings were successfully changed appears.
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TROUBLESHOOTING THE 3M™ ATTEST™ AUTO‑READER 390G WEB APP
Issue
Problem
Solution
Ensure 3M™ Attest™ Auto‑reader 390G Ethernet cable is connected to a live jack and that
connection to 3M™ Attest™ Auto‑reader 390G is secure.
Unable to access 3M™ Attest™
Auto‑reader 390G Web App on
networked computer
Ensure computer is connected to network.
3M™ Attest™ Auto‑reader 390G and/or
computer not connected to network.
If failure is with connection attempted using 3M™ Attest™ Auto‑reader 390G serial number
URL, try connecting using IP address URL.
Contact facility IT or 3M if problem persists.
3M™ Attest™ Auto‑reader 390G not
connected to network.
Ensure 3M™ Attest™ Auto‑reader 390G Ethernet cable is connected to a live jack and that
connection to 3M™ Attest™ Auto‑reader 390G is secure.
Unable to access 3M™ Attest™
Auto‑reader 390G Web App on
mobile device
For security reasons, facility firewall may
prevent mobile devices not connected to
the facility network from connecting to
secure IP addresses.
Contact facility IT for their recommendation on connecting to the secure network. Solutions may
include enabling Wi‑Fi on the mobile device and signing into the facility network or connecting
to the facility virtual private network (VPN) on the mobile device.
User entered data is written to temporary
web browser storage. Browser may have
cleared data.
Set web browser to accept (allow or enable) cookies.
Data entered by user on Results
Detail page disappears
As a best practice, print or save Results Detail record as soon as BI result is final.
BI result displayed on 3M™ Attest™
Auto‑reader 390G LCD panel does
not appear on Results Detail page
The Results Detail page has not
refreshed yet.
Use your browser to refresh the Results Detail page, or wait up to 60 seconds for the page to
automatically refresh.
The Results Detail page only opens
from the Status page for occupied
3M™ Attest™ Auto‑reader 390G wells.
Results Detail page will not open
from the Status page
Do not attempt to navigate to the Results Detail page from unoccupied wells on the Status page.
REPAIR AND REPLACEMENT
In the U.S.A., 3M™ Attest™ Auto‑reader 390Gs 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 U.S.A., contact your local 3M Subsidiary.
If you have questions, call our Customer Service number: 1‑800‑292‑6298.
Made in U.S.A. by
3M Health Care
2510 Conway Ave
St. Paul, MN 55144
1‑800‑228‑3957
© 2013, 3M. All rights reserved.
3M and Attest are trademarks of 3M.
Used under license in Canada.
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Made in U.S.A. by
3M Health Care
© 2013, 3M. All rights reserved.
3M and Attest are trademarks of 3M.
Used under license in Canada.
EC REP
3M Deutschland GmbH
Health Care Business
Carl-Schurz-Str. 1
41453 Neuss
2510 Conway Ave.
St. Paul, MN 55144
1-800-228-3957
Issue Date: 2013-08
34-8712-0286-6
Germany
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