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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 .

Содержание Clean-Trace Luminometer LX25

Страница 1: ...ETER LX25 7 HOW TO PERFORM A QUICK TEST 7 COMMUNICATING WITH THE 3M QUALITY CONTROL DATA MANGER QCDM 7 REGISTER A CLEAN TRACE LUMINOMETER LX25 TO AN ORGANIZATION ON QCDM 7 ROUTINE SYNCHRONIZATION 8 DE REGISTRATION 8 WI FI SET UP 9 VERIFYING DATA UPLOAD TO QCDM 9 APPLICATION WORKFLOW 9 STARTING THE AUDIT 9 HOME SCREEN 10 1 FLEXIBLE ENDOSCOPE WORKFLOW 10 2 ENVIRONMENTAL SURFACES WORKFLOW 11 3 SURGIC...

Страница 2: ...ided 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 S...

Страница 3: ...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 t...

Страница 4: ...lly 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 Test...

Страница 5: ...ntation 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 HA...

Страница 6: ...ing 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 o...

Страница 7: ...n 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 Qu...

Страница 8: ...sing 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 workstat...

Страница 9: ...d 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 hier...

Страница 10: ...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...

Страница 11: ... Select Room 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 ...

Страница 12: ...lt 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 Do...

Страница 13: ... 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 cur...

Страница 14: ...an 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 Lumin...

Страница 15: ...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 Lum...

Страница 16: ... 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 ...

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