3M Clean-Trace Luminometer LX25 User manual

1
1English
Issue Date: 2017-04
Clean‑Trace™Luminometer LX25
User Manual
CONTENTS
IMPORTANTSAFETYINFORMATION...........................................................................................2
PRODUCTDESCRIPTIONANDINTENDEDUSE: .................................................................................2
LIMITEDWARRANTY..........................................................................................................5
OPERATING THE CLEAN‑TRACELUMINOMETERLX25 ..........................................................................5
USERRESPONSIBILITY ..................................................................................................5
CLEANTRACELUMINOMETERLX25DESIGNANDCOMPONENTS........................................................6
BATTERYUSAGEANDMAINTENANCE...................................................................................6
INSERTING A CLEAN‑TRACE ATP TEST UXC OR H2O INTO THE CLEAN‑TRACELUMINOMETERLX25........................ 7
HOWTOPERFORMAQUICKTEST....................................................................................... 7
COMMUNICATINGWITHTHE3MQUALITYCONTROLDATAMANGERQCDM ........................................... 7
REGISTER A CLEAN‑TRACELUMINOMETERLX25TOANORGANIZATIONONQCDM................................ 7
ROUTINESYNCHRONIZATION ....................................................................................8
DEREGISTRATION ...............................................................................................8
WIFISETUP............................................................................................................9
VERIFYINGDATAUPLOADTOQCDM ....................................................................................9
APPLICATIONWORKFLOW....................................................................................................9
STARTINGTHEAUDIT...................................................................................................9
HOMESCREEN........................................................................................................10
1.FLEXIBLEENDOSCOPEWORKFLOW..................................................................................10
2.ENVIRONMENTALSURFACESWORKFLOW ............................................................................11
3.SURGICALINSTRUMENTWORKFLOW................................................................................ 12
PERFORMINGARETEST...................................................................................................... 12
ADMINISTRATIVEFUNCTIONS................................................................................................ 13
ACCESSINGADMINISTRATIVEFUNCTIONS............................................................................. 13
SETTINGSMENU....................................................................................................... 13
TROUBLESHOOTING ......................................................................................................... 14
CLEANINGANDDECONTAMINATION ........................................................................................ 15
CONTACTUS................................................................................................................ 15

2
Important Safety Information
3M™Clean‑Trace LuminometerLX25
Please read, understand, and follow all safety information
contained in these instructions prior to the use of this
3M™ Clean‑Trace™ Luminometer. Retain these instructions
for future reference.
Product Description and Intended Use:
The 3M™ Clean-Trace™ LuminometerLX25 is a battery operated
Luminometer utilized primarily for objective and sensitive
determination of the end result of 3M™ Clean-Trace™ Adenosine
Tri-Phosphate (ATP) tests. The Clean-Trace LuminometerLX25
power supply is provided to charge the battery.
3M has not designed nor documented the Clean-Trace
LuminometerLX25 or Clean-Trace LuminometerLX25 power
supply for use with other manufacturers’ products, use with
other manufacturers’ designs, or use in any other application
that has not been evaluated or documented by 3M and may lead
to an unsafe condition. The Clean-Trace LuminometerLX25
is not intended to be used in potentially flammable or
explosive environments. Surfaces or solutions should not be
considered sterile based on results from the 3M Clean-Trace
LuminometerLX25. The 3M Clean-Trace LuminometerLX25 is
not intended to be used in the diagnosis of conditions in humans
or animals. The user is responsible to know and follow applicable
workplace regulations. Clean-Trace ATP tests, equipment, and
software must be utilized by technicians that have been properly
trained on the 3M™ Clean-Trace™ ATP Monitoring System
according to all applicable instructions for use.
If this product is used in a manner not specified, the results
provided by the product may be impaired.
Explanation of Signal Word Consequences
WARNING: Indicates a hazardous situation which, if
not avoided, could result in serious injury ordeath
CAUTION: Indicates a hazardous situation which, if
not avoided, could result in minor or moderate injury
and/or property damage.
NOTICE: Indicates a situation which, if not avoided, could
result in propertydamage.
Explanation of Safety RelatedSymbols
Warning: Hazardous Voltage
Attention: Read AccompanyingDocumentation
CAUTION: Recycle 3M™Clean-Trace
LuminometerLX25to avoid environmental
contamination. This product contains recyclable
parts. For information on recycling, in the US
please contact 3M Health Care Service Center
at 1-800-292-6298 for additional information.
Outside of the US contact your local 3Moffice.
Li
WEEE mark - This product contains electrical
and electronic components and must not be
disposed of using standard refuse collection.
Please consult local directives for disposal of
electrical and electronic equipment.
Class II: Class two insulation referred to as
double insulation.
Applies to 3M Clean-Trace
LuminometerLX25Power Supply: Alternating
current AC source.
Applies to 3M Clean-Trace
LuminometerLX25Power Supply: Direct
current DC source.
ULNRTLmark(USandCanadaelectricalsafety)
CE mark (conforms to applicable requirements
for European EconomicArea).
RCM mark (Australia electrical safety andEMC)
BC mark (California regulation for battery
chargingsystems)
REF The 3M Clean-Trace LuminometerLX25model
number, which isLX25.
The 3M Clean-Trace
LuminometerLX25serialnumber
Efficiency: Complies to section
301of Energy Independence
and Security Act (EISA)
complies with Energy Startier.
2(North America), ECP
tier 2(China), MEPS tier
2(Australia), Code of
Conduct (Europe)
Description:
Base File Name:
Software:
SGS Contact:
Email:
Printer:
Printer Location:
Supplier:
3M™ Clean‑Trace™
LuminometerLX25 User Manual
Requester: Carol Engdahl
Reference: LX25
Die # / Doc. Size: 8.5" x 11"
Item Spec#: 34-8720-2654-6
Supersedes#:
Cat/Product#:
Structure#:
Insert
PA: LX25_34872026546.indd
GA:
InDesign CC 2014
PROCESS
BLACK
PROCESS
CYAN
PROCESS
MAGENTA
PROCESS
YELLOW
4567348 4
04.17.17 New Build kmh
04.24.17 Alts per Marked up PDF and job ticket kmh
05.26.17 Alts per Marked up PDF kmh
06.12.17 Update images in the Chart. Jer

3
!WARNING
•To reduce the risks associated with fire andexplosion:
−Do not incinerate or dispose of battery or
3MClean-Trace LuminometerLX25infire.
−Do not use or store the Clean-Trace
LuminometerLX25or power supply in potentially
flammable or explosive environments. The Clean-Trace
LuminometerLX25system is not designed or
categorized as “Intrinsically Safe.”
−Do not use or place the Clean-Trace
LuminometerLX25on wetsurfaces.
•To reduce the risks associated with hazardous voltage
andfire:
−Do not modify any part of the Clean-Trace
LuminometerLX25and powersupply.
−Keep power supply visible and accessible at all times.
The plug connected to the outlet is used to disconnect
the Clean-Trace LuminometerLX25from the main
powersupply.
−Do not use any power supply cord or USB cord (power
supply cord) other than those specified by3M.
−Do not allow the power supply to getwet.
•To reduce the risks associated with hazardousvoltage:
−Disconnect the Clean-Trace LuminometerLX25from
the outlet or the computer beforecleaning.
−Do not modify or service the Clean-Trace
LuminometerLX25or power supply. Only 3M
authorized service personnel should provide service
orrepair.
−Do not use the Clean-Trace LuminometerLX25or
power supply if the enclosure isbroken.
−Do not use a damaged power supply or damaged power
supply cord.
−Replace damaged components with 3M designated
replacement parts only.
•To reduce the risks associated with illness orinfection:
−Do not use the Clean-Trace LuminometerLX25and 3M
Clean-Trace ATP Tests in the diagnosis of conditions in
humans or animals.
−Do not use the Clean-Trace LuminometerLX25and 3M
Clean-Trace ATP Tests as an indication of disinfection or
sterilization of surfaces ordevices.
!CAUTION
•To reduce the risks associated with exposure
to chemicals:
−Always wear protective apparel while using
these products.
•To reduce the risks associated with crosscontamination:
−Always perform decontamination procedures as
documented in the Clean-Trace LuminometerLX25
User Manual after eachuse.
−Do not use the 3M Clean-Trace LuminometerLX25with
ATP tests manufactured by companies other than3M.
−AlwaysperformATPTestswithintemperatureuserange
of 15-25OC. Performing tests outside of temperature
use range can result in false negativereadings.
−Ensure annual recommended service and calibration of
the 3M Clean-Trace LuminometerLX25is completed
through the 3M Service Center or 3M authorized
service personnel.
•To reduce the risks associated with sharp objects and
property damage:
−Dropping of or impact to the Clean-Trace
LuminometerLX25may result in damage to the device
or introduction of particulate into sensitive areas of
theinstrument.
•To reduce the risks associated with
environmental contamination:
−Always follow applicable regulations and facility
policies when disposing of the Clean-Trace
LuminometerLX25, power supply, andbattery.

4
NOTICE
•To reduce risk of damage and ensure an accurate result
with the 3M™Clean‑Trace™ LuminometerLX25:
−Do not operate the Clean-Trace LuminometerLX25in
close proximity to strong magneticfields.
−Do not store or operate the Clean-Trace
LuminometerLX25at temperatures above70°C.
−Do not store or operate the Clean-Trace
LuminometerLX25at temperatures below -40°C as
condensation may occur. The instrument should be
allowed to warm to room temperature before use
and a cloth or tissue should be used to wipe dry the
outersurfaces.
−Only insert 3M™Clean-Trace™ ATP Tests into the
Clean-Trace LuminometerLX25chamber.
−Do not use cleaning agents in the Clean-Trace
LuminometerLX25chamber.
−Ensure the ATP Test is inserted into the Test sleeve and
activated before inserting the Test into the Clean-Trace
LuminometerLX25chamber.
−Do not tilt the Clean-Trace LuminometerLX25while
ATP Tests are in thechamber.
−Do not leave a used (activated) ATP Test in the
Clean-Trace LuminometerLX25chamber after the
result has been read andrecorded.
−Ensure annual recommended service and calibration of
the Clean-Trace LuminometerLX25is completed by the
3M Service Center or 3M authorized servicepersonnel.
−Periodically inspect the Clean-Trace
LuminometerLX25for damage, including cracks
or swelling.
−Do not store or use the Clean-Trace
LuminometerLX25or power supply in a location
exposed to steam, high humidity, dust, or
strong vibration.
−Reference the Environmental Operating Conditions
table in the Important Safety Information for
Clean-Trace LuminometerLX25in this UserManual.
−Use only 3M Clean-Trace ATP Tests and 3M accessories
supplied by your local 3M sales representative
ordistributor.
−Do not use the Clean-Trace LuminometerLX25if liquid
or a foreign object gets inside thedevice.
Environmental Operating Conditions
Environmental Condition Operating Condition Units
Indoor Use only - Only use the data connections to a
computer that conform to IEC/EN/UL/
CSA60950-1
Notapplicable
- Keep Clean-Trace Luminometer LX25
away from liquids and high humidity.
Altitude 3000maximum Meters
Operating Temperature Range +5to +40(+41to +104) °C(°F)
Relative Humidity 10– 90Non-condensing %
Storage Temperature Range -40to +70(-40to +158) °C(°F)
AC voltage for powersupply 100-240 Volts
Mains supply voltage fluctuations up to +10% of
nominal voltage
Temporary overvoltages occurring on the mains supply
Frequency 50-60 Hertz
AC Current for power supply 300 mA
Power supply output voltage 5 VoltsDC
Power supply output current 1.2 Amps
Input current 850 mAMPs
Overvoltage Category II Notapplicable
Pollution Degree 2 Notapplicable

5
REGULATORY COMPLIANCE
The CE Mark denotes compliance of the 3M™Clean‑Trace™
LuminometerLX25with the following EuropeanDirectives:
•R&TTE Directive 1999/5/EC – Radio and
telecommunications terminal equipment directive
FCC Radio Frequency Rules andRegulations
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 reasonable
protection against harmful interference when the equipment
is operated in a commercial environment. This equipment
generates, uses, and can radiate radio frequency energy and, if
not installed and used in accordance with this User 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 his ownexpense.
FCC Intentional RadiatorCertification
Contains FCC ID:Z64-WL18SBMOD
This equipment contains an intentional radiator approved by
the FCC under the FCC ID number shown above. This device
complies with Part 15of the FCC Rules. Operation is subject
to the following two conditions: (1) this device may not cause
harmful interference, and (2) this device must accept any
interference received, including interference that may cause
undesired operation.
NO MODIFICATIONS. Modifications to this device shall not be
made without the written consent of 3M Company. Unauthorized
modifications may void the authority granted underFederal
Communications Commission Rules permitting the operation of
this device.
Industry Canada Radio Frequency Rules and Regulations CAN
ICES-3(A)/NMB-3(A): This Class A digital apparatus meets all
requirements of the CanadianICES-003.
Contains transmitter module IC ID:451I-WL18SBMOD
Operation is subject to the following two conditions: (1) this
device may not cause interference, and (2) this device must
accept any interference received, including interference that may
cause undesired operation of thedevice.
LIMITEDWARRANTY
3M Infection Prevention Division Hardware (“Hardware”)
includes the 3M™Clean-Trace™ LuminometerLX25and any
associated software, on-line service and other components
supplied by 3M which are described in the applicable Site
Planning and Installation Guide and Operator Manuals.
(“UserDocumentation”).
LIMITED WARRANTY ANDDISCLAIMER
3M warrants that for one year from the date of sale, that
the Hardware will substantially perform in accordance with
the User Documentation. THIS WARRANTY IS VOID IF: (A)
THE HARDWARE HAS BEEN REPAIRED BY PERSONS NOT
AUTHORIZED BY 3M; OR (B) THE HARDWARE HAS BEEN
ALTERED, MODIFIED, OR MISUSED; OR (C) THE HARDWARE
IS USED WITH PRODUCTS, SUPPLIES, COMPONENTS OR
SOFTWARE NOT SUPPLIED BY 3M FOR USE WITH THE
HARDWARE; OR (D) THE HARDWARE OR A COMPONENT IS
USED FOR OTHER USES (FOR EXAMPLE USE WITH OTHER
CIRCUIT BOARDS OR SOFTWARE) OR (E) THE HARDWARE
HAS NOT BEEN MAINTAINED OR USED IN ACCORDANCE
WITH THE USER DOCUMENTATION. UNLESS PROHIBITED
BY LAW, THIS WARRANTY IS MADE IN LIEU OF ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT
LIMITED TO THE IMPLIED WARRANTY OF FITNESS FOR
A PARTICULAR PURPOSE, THE IMPLIED WARRANTY OF
MERCHANTABILITY, OR ANY IMPLIED WARRANTY ARISING
OUT OF A COURSE OF DEALING OR OF PERFORMANCE,
CUSTOM OR USAGE OF TRADE. 3M DOES NOT WARRANT
THAT THE SOFTWARE OR ON-LINE SERVICE WILL FUNCTION
ERRORFREE.
If within one year from date of purchase, the Hardware does
not conform to the express warranty set forth above, 3M’s sole
obligation and User’s sole remedy shall be, at 3M’s option: 1) to
repair or replace the non-conforming component; or, 2) refund
the purchaseprice.
LIMITATION OFLIABILITY
UNLESS PROHIBITED BY LAW, 3M WILL NOT BE LIABLE
TO USER OR OTHERS FOR ANY OTHER DIRECT, INDIRECT,
CONSEQUENTIAL, INCIDENTAL OR SPECIAL DAMAGES
INCLUDING, FOR EXAMPLE, LOST PROFITS, BUSINESS,
INVESTMENTS, OR OPPORTUNITIES EVEN IF 3M HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. The
parties agree that 3M’s total cumulative liability to User for direct
damages for all causes shall not exceed One Hundred Dollars, or
the price paid for the Hardware, whichever is higher. Some states
or countries may have laws which require liability rights different
from those stated above. In such state or countries, the minimum
required liability terms shallapply.
Within the US, please contact the 3M Healthcare Helpline
1-800-228-3957to request service under this warranty. Outside
of the US, please contact your local 3M office to requestservice.
Operating the Clean‑Trace Luminometer LX25
User Responsibility
Users are responsible for familiarizing themselves with product
instructions and information. When selecting a test method it is
important to recognize that external factors such as sampling
methods, testing protocols, sample preparation, handling and
laboratory technique may influenceresults.
It is the user’s responsibility in selecting any test method,
environmental surface or medical device to evaluate a sufficient
number of samples to satisfy the user that the chosen test
method meets the user’scriteria.
It is also the user’s responsibility to determine that
any test methods and results meet its customers’ and
suppliers’ requirements.

6
Clean‑Trace Luminometer LX25 Design and Components
1. Power On/Off button
2. Cursor controlbuttons
3. Touch screen
4. USB/Powerport
5. ATP TestChamber
6. Base
7. KickStand
8. Power cord andadapters
Battery Usage andMaintenance
The Clean-Trace LuminometerLX25has an internal rechargeable
lithium ionbattery.
Charging thebattery
• Select and attach the charger adapter to the
power cord that is appropriate for power in
your country.
• Connect the power cord to the Clean-Trace
LuminometerLX25.
• Connect the power cord to a poweroutlet.
• The battery becomes fully charged in
approximately 3hours using the power supply.
If charging via PC connection, time to fully charge is
approximately 5 hours.
• To monitor the charge status, turn on the Clean-Trace
LuminometerLX25. A lightning bolt appears in the battery
level indicator icon (Figure1).
When the battery ischarged
• Disconnect the power cord from the
poweroutlet.
• Unplug the power cord from the Clean-Trace
LuminometerLX25.
Using the battery levelindicator
• The battery level indicator is located in the upper right
corner of thescreen.
• When a Clean-Trace LuminometerLX25is on, the indicator
shows the remaining batterylevel.
• In Figure 2, the indicator shows the battery is fullycharged
• As the battery charge decreases, the blue segment of the
indicator becomes smaller.
• When the battery level is less than 10%, the indicator
becomes red, signifying the battery should berecharged.
Managing thebattery
• During typical use the battery provides up to eight hours of
charge capacity.
• As the battery ages, it will provide less than eight hours of
charge capacity.
• The battery must be charged when the indicator is red,
indicating less than 10% chargecapacity
• The battery does not need to be fully discharged
before recharging.
• When storing a Clean-Trace LuminometerLX25for
more than a month, the battery level should be at
50% or less charge. Do not store a Clean-Trace
LuminometerLX25with a fully discharged battery
because the battery may lose the ability to berecharged.
• Battery replacement is recommended after two years
of normal use or if the battery has been misused, or if
the Clean-Trace LuminometerLX25is overheating or its
shape is distorted. Battery replacement is performed by
3M Health Care Service Center or authorized 3M Service
Provider. See Care andMaintenance.
Power On/Off/SleepMode
• To power up the Clean-Trace LuminometerLX25,
press and hold the grey power button for 2seconds.
• To power off the Clean-Trace LuminometerLX25,
press and hold the grey power button for 2seconds.
Accept prompts to shut down Clean-Trace
LuminometerLX25.
• You can force the Clean-Trace LuminometerLX25to
power off by holding the grey power button down for
20seconds.
• The Clean-Trace LuminometerLX25will automatically
power itself off after 2hours of inactivity or if the battery
charge is 5% of remaining life. It is recommended to keep
the device charging when not inuse.
• The Clean-Trace LuminometerLX25will go into ‘Sleep
Mode’ after 1-30minutes ofinactivity.
o
To customize the time until sleep mode starts go to the
‘Screen Timeout’ screen which is found in the
Settings menu.
o
To exit sleep mode, press the “Up” cursor
control button.
• Sleep Mode vs. Power Off: The screen is blank for Sleep
Mode and when the device is PoweredOff.
o
When you encounter a device with a blank screen, first
press the Up button, this will bring it out of SleepMode.
o
If the device does not respond to this, it is likely
Powered Off. Hold the Power Button for 2seconds to
power on thedevice.
Figure 1
Figure 2

7
Inserting a Clean‑Trace ATP Test UXC or H2O into the
Clean‑Trace Luminometer LX25
• Press the rocker cap to open the test chamber(1).
• Insert an activated Clean-Trace ATP Test UXC or H2O(2).
• The Test handle should be visible at the top of the
chamber(3).
• After the reading is complete, press the rocker cap to open
the test chamber and remove the ATP Test UXC or H2O.
•If an ATP Test UXC or H2O remains in the Clean-Trace
LuminometerLX25chamber for more than 30seconds,
the Swab Sensor notifies with an audibletone.
•Keep the Clean‑Trace LuminometerLX25upright
whenever a test device is in the chamber, to ensure
accurate results and avoid spillage of reagents, which
could damage the sensitive components of theinstrument.
• If the Clean-Trace LuminometerLX25is held at greater
than 68degrees from vertical when a test is in the
chamber, a message notifies the user that the Clean-Trace
LuminometerLX25is in the incorrect position for testing
and to use a more vertical position whentesting.
o
Tap “OK” then hold the Clean-Trace
LuminometerLX25in a vertical position and repeat
the measurement.
How to Perform a QuickTest
A quick test is performed under circumstances where results are
not uploaded to the Quality Control Data Manager (e.g. training,
demonstrations, no access to Quality Control DataManager).
To perform a QuickTest
• Power on the Clean-Trace
LuminometerLX25.
• After successful completion of
System Diagnostics this landing
screen withappear:
• Log in is not required to perform a
QuickTest.
• Tap “QuickTest”
• Follow the Clean-Trace ATP Test
UXC or H2O Instructions for Use to
collect the sample, activate the ATP
Test and insert into the Clean-Trace
LuminometerLX25.
• Tap “Start” to take ameasurement.
• Remove the ATP Test UXC or H2O after the measurement
iscomplete.
• All results should berecorded.
o
Only the last 20Quick Tests are saved on the
Clean-Trace LuminometerLX25.
o
The results of a quick test are not saved to the Quality
Control DataManager.
Communicating with the
3M Quality Control DataManger(QCDM)
Before the Clean-Trace LuminometerLX25can be used with
the Quality Control Data Manager (QCDM) it must first be
synchronized to the facility’s QCDMorganization.
To register the Clean-Trace LuminometerLX25, the facility
account must be linked to the facility’s organization and
the 3M™Synchronization Manager Software installed on a
workstation (desktop/laptop). Registration cannot be performed
using the Clean-Trace LuminometerLX25Wi-Fifunction.
Register a Clean‑Trace LuminometerLX25
to an Organization onQCDM
1. Find the Synchronization Manager icon in system tray,
right click on the icon and choose “Showwindow”.
2. Power up the Clean-Trace LuminometerLX25and launch
the app if not alreadylaunched.
a. Follow the steps in the set-up
menus for language, date, time
and timezone.
b. Skip Wi-Fi setup.
c. Wait for diagnostics
tocomplete.
d. When the landing screen
appears - STOP – remain on
landing screen – DO NOT
LOGIN.
3. Using the USB cable provided, connect the Clean-Trace
Luminometer LX25 to the workstation running the
Synchronization Manager software.
4. After a short period, a red, spinning
circle appears on the Clean-Trace
LuminometerLX25screen,
indicating your Clean-Trace
LuminometerLX25is connected
to the Synchronization
Manager Software.

8
5. On the workstation, log into Synchronization
Manager Software.
6. Select the “Register” button on
the workstation Synchronization
Manager Software.
7. Start the Synchronization on the
workstation Synchronization
Manger Software.
8. Wait for synchronization to complete.
9. Unplug the USB cord from the Clean-Trace
LuminometerLX25.
10.The Clean-Trace LuminometerLX25is now ready foruse.
Routine Synchronization
1. Power on Clean-Trace LuminometerLX25.
2. Wait for diagnostics tocomplete.
3. When the landing page appears-
STOP – remain on landing page
– DO NOT LOGIN.
4. Connect the Clean-Trace LuminometerLX25to the
workstation running the Synchronization Manager
Software using the USBcable.
5. After a short period, a
red, spinning circle will
appear on the Clean-Trace
LuminometerLX25indicating the
Clean-Trace LuminometerLX25is
connected to the
Synchronization Manager.
6. On the workstation, log into Synchronization
Manager Software.
7. Select the “Start Synchronization” button
on the workstation Synchronization
Manager Software.
8. Start the Synchronization on the
workstation Synchronization
Manager Software.
9. Wait for synchronization tocomplete.
De‑registration
How to Deregister a Clean‑Trace Luminometer LX25
1. Log into facility organization on the QCDM website.
2. Click “Tools” from the ribbon at top of screen.
3. Click “Luminometers”.
4. Find the Clean-Trace LuminometerLX25with the correct
serial number in list, click on the trash canicon.
5. The Clean-Trace LuminometerLX25will no longer be
displayed in list and is nowde-registered.

9
Wi‑Fi Set up
Wi‑Fi Connection
Data is automatically uploaded to the QCDM in real-time using
the Wi-Fi function on the Clean-Trace LuminometerLX25.
Before the Wi-Fi function can be used, the Clean-Trace
LuminometerLX25must first be registered to the QCDM
using the USB cable connection to a workstation running the
Synchronization Manager Software.
Set up Wi‑Fi
• Tap the “hamburger menu” in the
upper right-hand corner of the
Homescreen.
• Tap“Settings”
• Tap “Wi-FiSettings”
• Turn on Wi-Fi by sliding the indicator from “OFF” to
read“ON”
• Select the appropriate Wi-Fi network and enter security
credentials if required.
o
Security credentials are stored in the Clean-Trace
LuminometerLX25.
o
Authentication takes place each time the Clean-Trace
LuminometerLX25is turned on and Wi-Fi isenabled.
• Tap“Done”
• Return to the “Settings” menu by tapping the Wi-Fi
network icon in the upper left hand corner of thescreen.
• Exit the “Settings” screen by tapping the < button in the
upper left corner of thescreen.
Verifying Data Upload to QCDM
• When connected to Wi-Fi,
test results will automatically
be uploaded to QCDM. A “Link”
icon will appear after successful
upload. An unsuccessful upload
will result in a triangle.
• If using the Synchronization Manager Software to upload
results, refer to section on “Routine Synchronization of
Results” in this document. All results will be marked with
a triangle until LX25 results are synchronized and data is
uploaded to the QCDMsoftware.
Application Workflow
Before access to the workflow screens is available, an
organization hierarchy must be set up in QCDM, and the
Clean-Trace Luminometer LX25 must be registered to a
QCDMorganization.
Workflows are application specific. There are applications
available for assessing the cleanliness of flexible endoscopes,
environmental surfaces and surgical instruments.
Starting theAudit
• Power up the Clean-Trace Luminometer LX25.
• After power up the Clean-Trace
Luminometer LX25 will run a
device diagnostic.
• After the diagnostic is complete
a landing screen appears.
Tap“LogIn”
• If the organization is part of a
multi-hospital set up, select
desired organization from the
drop-down menu then selectuser.
•EnterPIN
o
An initial user and PIN can be
found in the Welcome Letter
emailed to the facility when
the organization was first set
up. A User name and PIN is
established for each operator of
the Clean-Trace Luminometer
LX25. The User can change
the assigned User and PIN
the first time logging onto the
Clean-Trace Luminometer LX25.

10
Home Screen
• Shows recentaudits
• Use the arrow in the gray bar to
toggle between a list of “Recent
audits” and “Recent failed audits”
The 3M™Clean-Trace™ Luminometer LX25 has a unique
workflow for each application. Please choose the appropriate
application and follow the screen prompts. All available
application workflow are outlined below.
1. Flexible Endoscope Workflow
2. Environmental Surfaces Workflow
3. Surgical Instrument Workflow
1. Flexible EndoscopeWorkflow
• From the Home screen tap “Start”
to begin new test or select a
recent failed audit for retest
• Select device type
• Select Device. This is the serial
number or other unique identifier.
• Select “Reprocessing Step”
• Review selections
o
Select technician.
o
Can change device,
reprocessing step and test plan
o
Tap “Perform Audit”
• Select test point
• Review selections
• Insert ATP Test
• Press “Begin Measurement”
and wait until blue “Reading
Result” screen disappears then
press“Return”
• Repeat process until all test points
have been tested. Press “Done”.

11
2. Environmental Surfaces Workflow
• From Home screen tap “Start” to
begin new test or select a recent
failed audit for retest
• Select Area
•SelectRoom
• Review Selections
o
Can change Room number,
testplan
o
Select Housekeeper and
Isolation room option
o
Tap “Perform Audit”
• Choose testpoint
• Insert ATP Test UXC or H2O
• Press “Begin Measurement”
and wait until blue “Reading
Result” screen disappears then
press“Return”
• Repeat process until all test points
have been tested. Press “Done”.

12
3. Surgical InstrumentWorkflow
• From Home screen select“Start”
• From select “Test Plan” screen,
select “RoutineAudit”
• Review selections then select
“Performaudit”
• Selectinstrument
•Reviewselection
• Insert ATP Test UXC or H2O
• Press “Begin Measurement”
and wait until blue “Reading
Result” screen disappears then
press“Return”
• Repeat process until all test points
have been tested. Press“Done”.
Performing aRetest
To retest a failed test point:
• From the home screen, select
the audit that requires retesting;
marked with a red “X”.
• Select the test point that requires
retesting; marked with a red “X”.
• Follow the prompts and select any additional test points
if required.
• Complete the retest
• Select “Done”
• All retest data is recorded on the Clean-Trace
Luminometer LX25 and in QCDM.

13
Administrative Functions
Accessing administrative functions
To access administrative functions, tap the “hamburger” menu at
the top, right-hand corner of the Homescreen.
• Settings allow access to administrativefunctions
• Force Sync initiates a synchronization between the
Clean-Trace LuminometerLX25and the Quality Control
Data Manager software.
• Quick Test – see instructions located under “Operating
the Clean-Trace LuminometerLX25”
• System Diagnostics – tap to
initiate device diagnostictest.
Settings menu
• Settings Menu Functions(detail)
o
Wi-Fi Settings – turn Wi-Fi on/
off, set upnetwork
o
Server settings – select or
change serverconnection
o
Screen brightness – increase or
decrease screen brightness
o
Screen timeout – choose length
of time before screen goes
tosleep
o
Date – set currentdate
o
Time – set currenttime
o
Time Zone – choose timezone
o
Language – chooselanguage
o
About – lists app, firmware,
service versions, LX25serial
number and calibration due date
o
Restart – restarts Clean-Trace
LuminometerLX25

14
Troubleshooting
This section is intended to help solve problems that may be encountered when using the Clean-Trace LuminometerLX25.
Contact 3M or your local 3M distributor for moreinformation.
Problem Probable Cause Remedy
Diagnostic Check Failed Chamber Door isopen Close the chamber door and retry the DiagnosticCheck
Operating Clean-Trace
LuminometerLX25out of
correct temperaturerange
Operate the Clean-Trace LuminometerLX25between 5°C and
40°C. Retry the DiagnosticCheck.
ATP Test UXC or H2O left in
ATP testchamber
Remove the ATP Test UXC or H2O from the test chamber and retry
the DiagnosticCheck.
If the Diagnostic Check fails after a retry, contact 3M or your
localdistributor.
Battery Low Battery needs to be charged Connect the power cord cable to the Clean-Trace
LuminometerLX25and connect the cord to a power outlet to
recharge thebattery.
Chamber Door Open Chamber door was open
while attempting to start the
reading process
Close the chamber door after inserting a Clean-Trace ATP Test UXC
or H2O and before starting the readingprocess.
No Swab Detected Insert a Clean-Trace ATP Test UXC or H2O.
Instrument temperature is not
within normal operating range
Instrument temperature is
>40°C or <5°C
Use the Clean-Trace LuminometerLX25at ambient temperature
between 5°C and 40°C. If the problem persists, contact 3M or your
localdistributor.
Swab Left in Chamber The Clean-Trace LuminometerLX25has a sensor to determine if a
Clean-Trace ATP Test UXC or H2O has been left in the chamber for
more than 30seconds following the completion of a measurement.
If this situation is detected, the instrument will display a “Swab
Left In Chamber” error message on the screen and provide an
audible beep to remind the user to remove the Test following
the measurement.
No Display Battery fullydischarged Recharge thebattery.
Clean-Trace
LuminometerLX25is in Sleep
Mode or has been turnedoff.
Press the “Up” button on the cursor control to wake from sleep
mode. If no response, press the “Power” button for 3seconds to
turn on the Clean-Trace LuminometerLX25.
Instrument malfunction Contact 3M or your localdistributor.
Results Lower than Expected Sample / reagentproblem Check to ensure correct sample technique was used and ATP Test
UXC or H2O activation was followed according to Clean-Trace ATP
Test instructions for use. Verify with known positive samples such
as a 3M Positive ControlTest.
Instrument malfunction Contact 3M or your localdistributor.
Results Higher than Expected Direct sunlight or static
discharge can cause ATP Test
to phosphoresce and cause
high readings
After exposure to sunlight or static discharge an immediate repeat
reading is 50% of the first reading, if this is the cause of the higher
than expected results. Subsequent readings become incrementally
lower and finally return tonormal.
Avoid exposing ATP Test UXC or H2O to direct sunlight or
static discharge.
Other Errors 1. Turn off the Clean-Trace LuminometerLX25and power back
onagain.
2. Retry ATP Test UXC or H2O using the Clean-Trace
LuminometerLX25.
3. If the problem persists, contact 3M or your localdistributor.

15
Cleaning and Decontamination
Clean and low-level disinfect the Clean-Trace
LuminometerLX25immediately if any spills occur or you suspect
contamination or after use in a room under contactprecautions.
If any liquid is spilled inside the ATP Test chamber, do NOT
attempt to clean inside the test chamber itself. Contact your 3M
Health Care Service Center or local representativeimmediately.
Clean and disinfect the external surfaces of the Clean-Trace
LuminometerLX25once per day at aminimum.
Cleaning and Disinfecting the ExternalSurfaces:
1. Power down the Clean-Trace LuminometerLX25and
disconnect the USB/Powercable.
2. Using a disposable towel lightly dampened with
disinfectant, gently wipe the outer surfaces of the
Clean-Trace LuminometerLX25. Make sure the towel used
is just damp notdripping.
3. When cleaning the Clean-Trace LuminometerLX25avoid
the USB cable connection on the side of the Clean-Trace
LuminometerLX25.
4. Rinse disinfectant from Clean-Trace LuminometerLX25by
repeating the procedure (2-3) using another disposable
towel slightly dampened with distilled or deionizedwater.
5. Allow Clean-Trace LuminometerLX25to dry for at least
1hour.
6. Do NOT reconnect the USB/Power cable until the
Clean-Trace LuminometerLX25has been allowed todry.
The following disinfectants may be used to clean and disinfect
the Clean-Trace LuminometerLX25.
• Sodium Hypochlorite (chlorine bleach)
(up to .8%concentrations)
• Quaternary Ammonium Compounds (contains ammonium
chlorides, Isopropyl Alcohol, and/or Ethanol)
Contact Us
For questions or additional information on the
3M™ Clean-Trace ™ Luminometer LX25 call
the Clean-Trace Helpline at 1-800-228-3957.

Made in U.S.A. for
3M HealthCare
2510ConwayAve.
St. Paul, MN 55144 USA
www.3M.com/Medical
3M and Clean-Trace
are trademarks of3M.
Used under license in Canada.
© 2017, 3M.All rightsreserved.
Issue Date:2017-04
34-8720-2654-6
3M Deutschland GmbH
Health Care Business
Carl-Schurz-Str. 1
41453 Neuss
Germany