3M Clean-Trace NGi Luminometer Manuel utilisateur

Important Safety

Information And

User Manual

3M™ Clean-Trace™ NGi Luminometer

and

Docking Station

Important Safety Information

3M™ Clean-Trace™ NG Luminometer and

Docking Station

Important Informational Reading

Read, understand, and follow all safety information contained in these instructions and the manufacturer‘s

Installation and Use Guide prior to using the 3M™ Clean-Trace™ NG Luminometer and Docking Station.

Retain these instructions for future reference.

Product Description and Intended Use:

The 3M™ Clean-Trace™ ATP System is designed for the rapid detection of biological residues in aqueous

solutions and on surfaces.

The 3M™ Clean-Trace™ NG Luminometer 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 3M™ Clean-Trace™ NG Luminometer Docking Station is available as an optional accessory and is an

instrument holder which provides instant connection to main charger and PC communications. It has been

designed for battery charging and the transfer of data from the 3M™ Clean-Trace™ NG Luminometer.

Contact an official 3M Health Care representative for a current listing of 3M™ Clean-Trace™ Luminometers

documented for use with the 3M™ Clean-Trace™ NG Luminometer Docking Station.

3M has not designed nor documented the 3M™ Clean-Trace™ NG Luminometer Docking Station 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 3M™ Clean-Trace™ System

is not intended to be used in potentially flammable or explosive environments. Although the 3M™ Clean-Trace™

System is very sensitive, surfaces should not be considered sterile based on results from the 3M™ Clean-Trace™

System. The 3M™ Clean-Trace™ System 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.

3M anticipates that the 3M™ Clean-Trace™ ATP tests and equipment will be utilized by technicians that have been

properly trained on the 3M™ Clean-Trace™ ATP test methods.

If this product is used in a manner not specified, the protection provided by the product may be impaired.

USER RESPONSIBILITY

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 to evaluate a sufficient number of samples with the

appropriate matrices and challenges 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.

As with any test method, results obtained from use of this product do not constitute a guarantee of the quality of

the matrices or processes tested.

SAFETY INFORMATION

Explanation of Signal 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.

NOTICE:Indicates a hazardous situation, which, if not avoided, may result in property damage

Explanation of Safety Related Symbols

WARNING: Read Accompanying Documentation

CAUTION: Recycle Luminometer to avoid environmental contamination

This product contains recyclable parts for information on recycling – please contact

your nearest 3M Service Center for advice.

This system is subject to the European WEEE Directive 2002/96/EC

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 NG Power Supply: Alternating current AC source

WARNING

To reduce the risks associated with hazardous voltage:

• do not service the 3M™ Clean-Trace™ Luminometer, docking station or power supply. Use only 3M authorized

service personnel.

• do not use the 3M™ Clean-Trace™ Luminometer or power supply if the enclosure is broken.

• do not use a damaged power supply or detachable power supply cord.

• replace damaged components with only the 3M designated replacement parts.

• disconnect the 3M™ Clean-Trace™ Luminometer or Docking Station from the AC power before cleaning.

To reduce the risks associated with hazardous voltage and fire:

• do not modify any part of the 3M™ Clean-Trace™ Luminometer system.

• do not use a power supply other than the one specified by 3M.

• do not allow the power supply to get wet.

• keep power supply visible and accessible at all times. The plug at the wall socket is used to disconnect the

device from the main power supply.

To reduce the risks associated with strangulation due to the carrying pouch strap:

• keep the pouch away from children.

To reduce the risks associated with entanglement due to the carrying pouch strap:

• use care when operating near machinery.

To reduce the risks associated with fire and explosion:

• do not dispose of battery or luminometer in fire.

• do not use or store the luminometer, docking station, printer or power supply in potentially flammable or

explosive environments. The 3M™ Clean-Trace™ System was not designed to be categorized as "Intrinsically

Safe".

• do not short circuit the battery.

To reduce the risks associated with illness or infection:

• do not use the 3M™ Clean-Trace™ System in the diagnosis of conditions in humans or animals.

• do not use the 3M™ Clean-Trace™ System as an indication of sterility of surfaces or solutions

CAUTION

Read, understand and follow all safety information contained in the associated kit user instruction insert

prior to use.

To reduce the risks associated with exposure to chemicals:

• always wear protective apparel and eye protection while using these products.

To reduce the risks associated with environmental contamination:

• follow applicable regulations when disposing of the luminometer, docking station, printer, power supply and battery.

• follow industry standards for disposal of contaminated waste including used or expired test kits.

NOTICE

To avoid exposure to contaminated surface, water, or beverage outside the users validated RLU

specifications:

• handle the sensitive 3M™ Clean-Trace™ Luminometer with care.

• do not use if damaged.

• do not use an out-of-calibration 3M™ Clean-Trace™ Luminometer. Contact an authorized 3M Service Center for

service and calibration.

• always remove the sample before switching OFF.

• use only reagents or accessories supplied by your local 3M distributor.

• use and store reagent test kits in accordance with the instructions provided with the kit.

• perform tests in the temperature range between 15-25°C. A lower reading will be seen at temperatures below

15°C. However, if tests are always performed at this lower temperature, consistent results can be obtained.

• do not use the 3M™ Clean-Trace™ Luminometer if liquid or a foreign objects gets inside.

• do not store in environments greater than 90% relative humidity and 40°C.

To avoid damage to luminometer:

• do not use a power supply other than the one specified by 3M.

• ensure the battery is attached to the Clean-Trace NG Luminometer before connecting to the power supply.

• do not store the 3M™ Clean-Trace™ NG Luminometer or Docking Station at temperatures above 40°C.

• do not store the 3M™ Clean-Trace™ NG Luminometer or Docking Station at temperatures below 4°C as

condensation may occur. The instrument should be allowed to warm to room temperature before use and a cloth

or tissue used to wipe dry the outer surfaces.

• do not store or use the 3M™ Clean-Trace™ Luminometer, Power Supply, or Docking Station in a location

exposed to steam high humidity, dust or strong vibration.

• Ensure that the battery charger power supply connector is in the right orientation before inserting into

luminometer. If oriented properly, it connects easily, do not use excessive force when connecting.

REGULATORY COMPLIANCE

The CE Mark denotes compliance of the Clean Trace NG Luminometer with the following European Directives

• Electromagnetic Compatibility as set out in the EMC Directive 2004/108/EC and

• Electrical Safety as set out in the Low Voltage Directive 2006/95/EC.

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.

Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to

part 15 of the FCC Rules. These limits are designed to provide 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 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 his own expense.

This Class (A) digital apparatus complies with Canadian ICES-003.

ENVIRONMENTAL OPERATING CONDITIONS

Environmental Condition Operating Condition Units

Altitude Not limited metres

Operating Temperature Range +15 to +35 (+59 to +95) °C (°F)

Relative Humidity 10 - 90 (Non-condensing) %

AC Voltage (US/Canada) 120 Volts

AC Voltage (Europe) 230 Volts

AC Voltage (Japan) 100 Volts

Frequency 50/60 Hertz

AC Current (US/Canada) 190 m A

AC Current (Europe) 110 m A

AC Current (Japan) 230 m A

PACKAGE CONTENTS

3M Supplied Equipment:

3M™ Clean-Trace™ NG Luminometer

• Important Safety Information

• 3M™ Clean-Trace™ NG Luminometer complete with detachable Lithium-Ion Battery Pack

• Power Supply

• Quick Start Protocol Card

• 3M™ Clean-Trace™ Data Trending Software (not available with all models)

• Electronic Manual (Multi-Language)

• USB 2.0 min-B communications cable

• Certificate of Conformity

Docking Station

• 3M™ Clean-Trace™ NG Luminometer Docking Station.

Replacement of Fuses

This section applies only to the United Kingdom.

In cases where AC Mains lead power cords are fitted with a fused wall plug the following applies.

In the event of a fuse failure in the power supply AC Main power cord lead wall plug, replace the fuse with only an

approved fuse carrying the BSI or ASTA mark.

The preferred replacement part reference is to BS 1362 for example Bussmann 3A.

The fuse should only be replaced by a competent person.

LIMITED WARRANTY AND DISCLAIMER.

3M warrants that for one year from the date of shipment that the 3M™ Clean-Trace™ NG Luminometer or Docking

Station will substantially perform in accordance with the User Documentation. The terms of this Agreement do not

affect or prejudice the statutory rights of a consumer acquiring the 3M™ Clean-Trace™ NG Luminometer or 3M™

Clean-Trace™ Docking Station otherwise than in the normal course of a business.

THIS WARRANTY DOES NOT APPLY IN THE FOLLOWING CIRCUMSTANCES:

(A) THE 3M™ Clean-Trace™ NG Luminometer or Docking Station HAS BEEN REPAIRED BY PERSONS NOT

AUTHORIZED BY 3M; OR

(B) THE 3M™ Clean-Trace™ NG Luminometer or Docking Station HAS BEEN ALTERED, MODIFIED, OR

MISUSED; OR

Luminometer System COMPONENTS; OR

(D) THE 3M™ Clean-Trace™ NG Luminometer or Docking Station OR A COMPONENT IS USED FOR OTHER

USES (FOR EXAMPLE USE WITH OTHER CIRCUIT BOARDS OR SOFTWARE) OR

(E) THE 3M™ Clean-Trace™ NG Luminometer or Docking Station HAS NOT BEEN MAINTAINED OR USED

IN ACCORDANCE WITH THE INSTALLATION AND USE GUIDE. 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 3M™ Clean-Trace™ NG Luminometer Docking Station WILL FUNCTION ERROR FREE.

If within one year after shipment, the 3M™ Clean-Trace™ NG Luminometer or 3M™ Clean-Trace™ Docking

Station 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 under this

Agreement shall not exceed One Hundred Dollars, or the price paid for the 3M™ Clean-Trace™ NG Luminometer

or Docking Station, whichever is higher. Some states or countries may have laws which require liability rights

different from those stated above. In such states or countries, the minimum required liability terms shall apply.

3M Health Care - Product and Service Information

3M Product Information: www.3M.com

To obtain warranty service, call 3M Health Care Helpline (USA) 1 800 228 3957 or for outside the USA contact

your local 3M Subsidary or a 3M Health Care Representative.

Made in UK for 3M Health Care, St. Paul, MN 55144-1000

EC REP 3M Health Care

D-41453 Neuss, Germany

Trademarks

3M and Clean-Trace are trademarks of 3M or Biotrace International PLC, a 3M Company, and used under license

in Canada.

3M Pkg Document ID # (rev #) Month Year

User Manual

3MTM Clean TraceTM NGi Luminometer

and Docking Station

Index

1 Product Description

1.01 How the 3M™ Clean-Trace™ NGi Luminometer works to Measure Contamination

1.02 ATP and Surface Hygiene Testing

1.03 ATP and Water Testing

2 Instrument overview

2.01 Parts of the 3M™ Clean-Trace™ NGi Luminometer

2.02 General Features

2.03 Charging the Battery

2.04 Switching the Instrument ON

2.05 Measurement Modes

2.06 Inserting a Test

2.07 Swab Sensor

2.08 Low Power Mode

2.09 PC Communications

3 Accessories

3.01 3M™ Clean-Trace™ NGi Luminometer Docking Station

3.02 3M™ Clean-Trace™ NGi Luminometer Printer

3.03 3M™ Clean-Trace™ NGi Luminometer Soft Carry Case

4 Measure Sample

4.01 What is MEASURE SAMPLE

4.02 How to Test using MEASURE SAMPLE

5 Program Mode

5.01 What is PROGRAM MODE and how do I use it

5.02 How to Use Program Mode

5.03 Retesting

5.04 Reviewing results

5.05 Printing results

6 SETUP Menu

6.01 What the SETUP MENU allows

6.02 How to find the SETUP MENU

6.03 Setting Date Format

6.04 Setting the Time Format

6.05 Setting the Date

6.06 Setting the Time

6.07 Setting the Language

6.08 Performing a Self Check

6.09 Setting the Backlight Timeout

7 Upload Results

7.01 What is UPLOAD RESULTS used for

7.02 How to UPLOAD RESULTS

8 User Guidelines

9 Care of the 3M™ Clean-Trace™ NGi Luminometer

9.01 Cleaning

9.02 Temperature

10 Troubleshooting

10.01 General

10.02 Battery Error Screens

10.03 Communication Error screens

10.04 Self Check Error Screen

10.05 Login and Password Error Screens

10.06 Other Error Screens

10.07 Inadvertent changing of language setting

11 Appendices

11.01 Technical Specifications

11.02 Terms and Conventions

1.0 Product Description

1.01 How the 3M™ Clean-Trace™ NGi Luminometer works to Measure Contamination

1.02 ATP and Surface Hygiene Testing

1.03 ATP and Water Testing

1.01 How the 3M™ Clean-Trace™ NGi Luminometer works to Measure

Contamination

The 3M™ Clean-Trace™ NGi Luminometer is a luminometer used in conjunction with 3M reagent kits to measure

levels of contamination on surfaces and in water samples. The technology used is Adenosine Triphosphate (ATP)

bioluminescence. ATP is a substance present in all animal and vegetable matter, including most food debris,

bacteria, fungi and other micro-organisms. Measurement of ATP is performed using an enzyme reaction which

occurs naturally in the tail of fireflies.

Luciferin/Luciferase (firefly reagent) + ATP = Light

The light emitted is in proportion to the amount of ATP. The intensity of the light emitted from a sample is

measured by the 3M™ Clean-Trace™ NGi Luminometer and is displayed in Relative Light Units (RLU).

1.02 ATP and Surface Hygiene Testing.

The 3M™ Clean-Trace™ NGi Luminometer, together with the appropriate test kit, is an effective method for

monitoring the hygiene status of surfaces. ATP from both micro-organisms and product residues are detected.

Measurement of "total ATP" provides an important insight to the overall cleanliness. Product residues remaining

on surfaces after cleaning will be a source of nutrients for any remaining micro-organisms and may also protect

the micro-organisms from disinfectant action. Because of the fast results, use of the 3M™ Clean-Trace™ NGi

Luminometer allows immediate remedial action to be taken if an unacceptable result is obtained. Surfaces can be

re-cleaned before use, ensuring good sanitation and contamination control.

The test kit instructions should be read carefully before use.

1.03 ATP and Water Testing.

Test kits are available for the assessment of contamination in liquid samples. Measurement of the total ATP in

final rinse water samples is an indicator of the effectiveness of Clean in Place (CIP) processes. The total ATP in

process and waste water, water tanks and cooling towers can be used to determine and monitor the efficiency of

the biocide treatment program.

Measurement of free or non microbial ATP can be performed in addition to total ATP for further information on the

nature of the contamination.

The test kit instructions should be read carefully before use.

Chamber cap

Cap release

Battery level indicator

Display screen

Navigation buttons

Cursor control

On/Off switch

RS 232 to PC (not functional on NGi Luminometer)

USB to PC

Power from Charger

2.0 INSTRUMENT OVERVIEW

2.01 Parts of the 3M™ Clean-Trace™ NGi Luminometer

2.02 General Features

2.03 Charging the Battery

2.04 Switching the Instrument ON

2.05 Measurement Modes

2.06 Inserting a Test

2.07 Swab Sensor

2.08 Low Power Mode

2.09 PC Communications

2.01 Parts of the 3M™ Clean-Trace™ NGi Luminometer

The purpose of each of the Function Buttons can change according to the menu screen being displayed. Once a

menu is selected the button functions will be displayed at the bottom of the screen directly above each button.

Figure 1

Figure 2

2.02 General Features

The 3M™ Clean-Trace™ NGi Luminometer is a light-weight, fully portable instrument with alphanumeric LCD

display. The instrument is for use in production areas, healthcare settings and laboratories and can be supplied

with a carrying pouch. A separate internal Lithium Battery is used to retain information in the instruments memory,

with regard to sample plans, test points, data and calibration setting.

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