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Cleaning Challenge
Devices for Endoscope
Reprocessors

Endoscopes are extremely complex reusable medical devices. Due to their contact with mucous membranes and human tissues, cleaning and high-level disinfection processes prior to reuse must be carried out in order to avoid pathogen transmission. Endoscope reprocessing involving Automatic Endoscope Reprocessors (AERs) requires minimal user intervention and encloses highly reproducible washing cycles. Therefore, it becomes indispensable to control the efficacy of these processes in order to guarantee compliance with the cleaning standards.


Terragene® Lumenia is an innovative line of challenge devices and test soils to control flexible endoscopes washing efficiency.

PCD capsule allows
the use of 2 chemical
indicators, one internal
and one external
Safe handle, no
residual blood
Easy interpretation
of results
Adhesive on the back
of the cleaning
indicator strips
facilitates result’s
registration
Consists of a challenge device (Chemdye® Lumenia CCDER61) and cleaning indicators (Chemdye® Lumenia CDWE) for monitoring cleaning performance in Automated Endoscope Reprocessors.

The challenge device consists of three hoses with an inner diameter of 1 mm, two hoses with an inner diameter of 2 mm, and one hose

channel with an inner diameter of 4 mm; all of them 1.5 m long.

Each channel has a special connector in one end for plugging it to the Endoscope Reprocessor and a capsule in the other end, where the Chemdye® Lumenia CDWE cleaning indicators are placed (one strip in the inner cavity

of the capsule and the other one in an external slot).

Each of the six capsules have different colours that match the channels’ diameters to be monitored, and are in line with the colour scheme that the AER has in its output terminals.

DIAMETER
3 PTFE TUBES 1 OF MM.
2 PTFE TUBES OF 2 MM.
1 PTFE TUBES OF 4 MM.
CHALLENGE KIT
DESIGNED FOR MONITORING THE
EFECTIVENESS OF CLEANING
PERFORMANCE OF AUTOMATIC
ENDOSCOPE REPROCESSORS
INDICATOR STRIP
INTERNAL &
EXTERNAL
MINITORING
BLOCKAGE
TEST
CAPSULE
PLASTIC
TWEEZER
1,5 M LONG

FINAL CONDITION
TOTAL ELIMINATION
OF THE FUCHSIA
ORGANIC INK

FINAL CONDITION
TOTAL ELIMINATION
OF THE FUCHSIA
ORGANIC INK

INITIAL CONDITION
PINK TEST SOIL

LSF1 RECORD CARD:
FOR EASY
REGISTRATION AND
ANALYSIS OF 12
STRIPS (6 INTERNAL
+ 6 EXTERNAL)
SIMULTANEOUSLY

CDWE

Chemdye® Lumenia CDWE cleaning indicator was specially designed for monitoring these processes. It consists of a synthetic, self-adhesive and thermostable strip, printed with a test soil made up from a mixture of specially combined colored natural components.

The test soil was developed and validated in compliance with the requirements described in ISO 15883-5:2005 Standard.

The indicator’s formulation allows the detection of failures that may affect the cleaning performance of endoscopes (in both their internal and external surfaces) in AERs.

The test soil must be completely washed off in the internal as well as in the external side of the capsule.

UNPROCESSED

REJECTED | FAILED
ACCEPTED

Six Flow LSF1
Record Card

The Six Flow LSF1 Card was designed for facilitating the correct record of CDWE strips and for making the Lumenia Six Flow kit compatible with the Trazanto system. This card enables the analysis and interpretation of the 12 CDWE washing indicators in a single step when using the Trazanto scanner.

Lumenia and Trazanto help you to streamline your work, save time and optimize monitoring processes.

 

 

LSF1 Record Card allocates the CDWE indicator strips used to monitor the AER’s washing effectiveness. CDWE indicators are self-adhesive, thus allowing easy affixing on the LSF1 card and then inserted into the Trazanto scanner and analysed and verified with Bionova® Cloud.

COMPATIBLE WITH

Artificial Intelligence
to help you make
better decisions

Analyse, monitor and verify the process with Trazanto and Bionova® Cloud.

LUMENIA
L1, L2 & L122

LUMENIA L1
-1 PTFE tube
-2 m long and 1 mm inner diameter
-Luer-lock connector
LUMENIA L2
-1 PTFE tube
-2 m long and 2 mm inner diameter
-Luer-lock connector
LUMENIA L122
-1 PTFE tube 1 mm inner diameter
-2 PTFE tubes 2 mm inner diameter
2 m long
-Luer-lock connectors

Chemdye® Lumenia L1, L2 and L122 have been designed to control the flexible endoscope washing process efficacy in AERs. The L1 and L2 simulate 1 and 2 mm inner diameter endoscope channels, respectively; whilst the L122 offers three channels (a 1 mm inner diameter channel and two 2 mm inner diameter channels), thereby representing an endoscope in a realistic mode.

All three devices are capable of housing the Chemdye® Lumenia CDWE cleaning indicator strips. Complete removal of the indicator’s pink test soil 

confirms an adequate cleaning efficacy of internal and external surfaces of endoscopes. If indicator ink is observed after the validation washing cycle, the AER cannot be considered effective in the washing process of the endoscopes, so it should not be used until accepted results are obtained.

Chemdye® Lumenia CDWE cleaning indicator strips can be individually read and interpreted by the Trazanto system, thus allowing result’s digitalization as well as automatic interpretation and registration of the results. 

The monitoring of Cleaning performance
is essential for guaranteeing compliance of

CLEANING & DISINFECTION
STANDARS

Cleaning Challenge
Devices for Endoscope
Reprocessors

Endoscopes are extremely complex reusable medical devices. Due to their contact with mucous membranes and human tissues, cleaning and high-level disinfection processes prior to reuse must be carried out in order to avoid pathogen transmission. Endoscope reprocessing involving Automatic Endoscope Reprocessors (AERs) requires minimal user intervention and encloses highly reproducible washing cycles. Therefore, it becomes indispensable to control the efficacy of these processes in order to guarantee compliance with the cleaning standards.

Terragene® Lumenia is an innovative line of challenge devices and test soils to control flexible endoscopes washing efficiency. 

PCD capsule allows the use of 2 chemical indicators, one internarl an on external

Safe handling, no
residual blood

Easy interpretation
of results

Adhesive on the
back of the cleaning
indicator strip
facilitates results
registration

Consists of a challenge device (Chemdye® Lumenia CCDER61) and cleaning indicators (Chemdye® Lumenia CDWE) for monitoring cleaning performance in Automated Endoscope Reprocessors.
The challenge device consists of three channels with an inner diameter of 1 mm, two channels with an inner diameter of 2 mm, and one channel with an inner diameter of 4 mm; all of them 1.5 m long.

Each channel has a special connector in one end for plugging it to the Endoscope Reprocessor and a capsule in the other end, where the Chemdye® Lumenia CDWE cleaning indicators are placed (one strip in the inner cavity of the capsule and the other one in an external slot).

Each of the six capsules have different colours that match the channels’ diameters to be monitored, and are in line with the colour scheme that the AER has in its output terminals. 

CDWE

Chemdye® Lumenia CDWE cleaning indicator was specially designed for monitoring these processes. It consists of a synthetic, self-adhesive and thermostable strip, printed with a test soil made up from a mixture of specially combined colored natural components.

The test soil was developed and validated in compliance with the requirements described in ISO 15883-5:2005 Standard.

The indicator’s formulation allows the detection of failures that may affect the cleaning performance of endoscopes (in both their internal and external surfaces) in AERs.

The test soil must be completely washed off in the internal as well as in the external side of the capsule. 

UNPROCESSED
REJECTED |
FAILED
ACCEPTED

Six Flow LSF1
Record Card

The Six Flow LSF1 Card was designed for facilitating the correct record of CDWE strips and for making the Lumenia Six Flow kit compatible with the Trazanto system. This card enables the analysis and interpretation of the 12 CDWE washing indicators in a single step when using the Trazanto scanner.
Lumenia and Trazanto help you to streamline your work, save time and optimize monitoring processes.
LSF1 Record Card allocates the CDWE indicator strips used to monitor the AER’s washing effectiveness. CDWE indicators are self-adhesive, thus allowing easy affixing on the LSF1 card and then inserted into the Trazanto scanner and analysed and verified with Bionova® Cloud.

COMPATIBLE WITH

Artificial Intelligence
to help you make
better decisions

Analyse, monitor and verify the
process with Trazanto and Bionova® Cloud.

LUMENIA
L1,L2 & L122

LUMENIA L1

-1 PTFE tube
-2 m long and 1 mm inner diameter -Luer-lock connector

LUMENIA L2

-1 PTFE tube -2 m long and 2 mm inner diameter -Luer-lock connector

LUMENIA L122

-1 PTFE tube 1 mm inner diameter
-2 PTFE tubes 2 mm inner diameter 2m long
-Luer-lock connectors

Chemdye® Lumenia L1, L2 and L122 have been designed to control the flexible endoscope washing process efficacy in AERs. The L1 and L2 simulate 1 and 2 mm inner diameter endoscope channels, respectively; whilst the L122 offers three channels (a 1 mm inner diameter channel and two 2 mm inner diameter channels), thereby representing an endoscope in a realistic mode.

All three devices are capable of housing the Chemdye® Lumenia CDWE cleaning indicator strips. Complete removal of the indicator’s pink test soil confirms an adequate cleaning efficacy of internal and external surfaces of endoscopes. If indicator ink is observed after the validation washing cycle, the AER cannot be considered effective in the washing process of the endoscopes, so it should not be used until accepted results are obtained.

Chemdye® Lumenia CDWE cleaning indicator strips can be individually read and interpreted by the Trazanto system, thus allowing result’s digitalization as well as automatic interpretation and registration of the results. 

The monitoring of Cleaning performance
is essential for guaranteeing compliance of
CLEANING & DISINFECTION
STANDARS

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Process
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