Product Overview

Lumenia SixFlow Cleaning Challenge Kit For Automatic Endoscope Reprocessors.

Product Details

Size (mm): Length: 235 x Width: 235 x Height:

Weight: kg

Key Benefits

Allows direct and distinct determination of external and internal successful cleaning efficacy of flexible endoscopes when using AERs.

The indicator cleaning ink formulation allows monitoring and integration of all-important parameters of the process.

Lumenia cleaning indicator use grants very simple interpretation of results, avoiding the need of special skills or training of operators.

When using Trazanto System, results can be easily registered and traced, thanks to the special design of the Lumenia cleaning indicator.

Very resistant and durable devices, thanks to the high-quality materials used.

Product Code: LUMENIA 6 FLOW.

Shipping Information

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Shipment processing time

All orders are processed within 2-3 business days. Orders are not shipped or delivered on weekends or holidays. If we are experiencing a high volume of orders, shipments may be delayed by a few days. Please allow additional days in transit for delivery. If there will be a significant delay in shipment of your order, we will contact you via email or telephone.

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Christmas shipping

Over the festive period, please note you may experience time delays when waiting for receipt of your order. However, we will endeavour to get all orders out as soon as possible.

Additional Information

Usage
Challenge Kit designed to evaluate the effectiveness of flexible endoscopes cleaning to be reprocessed in Automatic Endoscope Reprocessors.
Applicable Regulation
Designed under Quality Management System standard ISO 13485:2016/NS-EN ISO 13485:2016.
ISO 15883-4:2018, ISO/TS 15883-5:2005
Characteristics
Challenge Device
Chemdye® Lumenia SixFlow Test Kit consists of a challenge device (Chemdye® Lumenia CCDER6) and cleaning indicators (Chemdye® Lumenia CDWE) for monitoring cleaning performance in Automated Endoscope Reprocessors. The challenge device consists of three polytetrafluoroethylene (PTFE) tubes with an inner diameter of 1 mm, two PTFE tubes with an inner diameter of 2 mm, and a PTFE tube with an inner diameter of 4 mm, all of them 1.5 m long. Each tube has special connectors in one of its ends for plugging it to the Endoscope Reprocessor and a device in the other end that simulates an endoscope´s lumen and where the Chemdye® Lumenia CDWE cleaning indicators are placed (one in the inner cavity of the device and the other one in an external slot). Each of the six devices have different colors that match the channels’ diameters to be monitored, and are in line with the color scheme that every Reprocessor Machine has in its output terminals. The end of each PTFE tube opposite to that one connected to the device is identified with a colored mark, allowing a fast recognition of the output terminal to which it will be connected. The tubes are joined and protected through a hose that covers them entirely.
Cleaning indicator
Chemdye® Lumenia CDWE cleaning indicator was especially designed for monitoring these processes. It consists of a test soil, developed in accordance with the requirements described in ISO/TS 15883-5:2005 standard, arranged on a self-adhesive thermolabile synthetic support. The formulation of the cleaning indicator allows to detect the factors that affect the result of the cleaning process.
Size of the indicator strip: 38 mm x 6 mm.
Initial condition: fuchsia color.
Final condition: total elimination of the fuchsia organic substance.
The indicator’s ink is not toxic.
NOTE: If unfavorable results are obtained, check quality/quantity of chemicals, water pressure, temperature, cleaning time and general condition of the washing machine.
Rev.0 / 08.2019 Infection Control Division | Cleaning Indicators Page 2 / 4
EN
Environmental conditions during manufacture
T = 15-30 ºC, R.H. = 30-80%.
Storage conditions
T = 10-30 ºC, R.H. = 30-80%. Store in dark place.
Transportation conditions
Storage conditions should be strictly followed.
Transport in closed and strengthened boxes in order to avoid damages. Transportation of this product does not represent a risk for health.
Shelf-life
Challenge device: 200 cycles.
Cleaning indicator: 5 years.
Packing
1 Challenge Device + 2400 cleaning indicators + 6 blockage test capsules + 1 plastic tweezer.
Packing information: product code and description, intended use, presentation, regulation, storage conditions, manufacturer information and data on label.
Labeling
On product´s pack: product code, kit batch number and its components batch number, manufacture and expiration date, barcode and datamatrix code.
Possible target markets
Healthcare and Medical Industries.
Other important information
Read product’s instructions for use thoroughly before use.
Description of identified and/or predictable risks which could represent a risk for the product
Store the product within its original package, away from light, disinfectants, gases and humidity.
Do not re-use the indicator.
Do not touch indicator ink with your hands.


Lumenia SixFlow

Endoscopy process challenge device

£598.80

Allows direct and distinct determination of external and internal successful cleaning efficacy of flexible endoscopes when using AERs.

The indicator cleaning ink formulation allows monitoring and integration of all-important parameters of the process.

Lumenia cleaning indicator use grants very simple interpretation of results, avoiding the need of special skills or training of operators.

When using Trazanto System, results can be easily registered and traced, thanks to the special design of the Lumenia cleaning indicator.

Very resistant and durable devices, thanks to the high-quality materials used.

Product Code: LUMENIA 6 FLOW.