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Additional information
| Brand | Chemdye |
|---|---|
| Process | Hygiene Monitoring |
| Regulations | ISO 13485:2016/NS-EN ISO 13485:2016 |
| Packaging | 5 |
| Fields of activity | Healthcare |
Description
Chemdye® SWE high-absorption swabs for use with Chemdye® PRO 1 ENDO
Usage:
Chemdye® SWE high-absorption swabs have been specifically designed for use with cannulated instruments. These swabs must be inserted through the internal channel of the cannula, allowing the collection of contaminants that may persist after the cleaning process. SWE swabs are designed for use with Chemdye® PRO1 ENDO system, enabling the verification of the cleaning efficacy of cannulated instruments by detecting and quantifying protein residues that may remain after the cleaning process.
Applicable standards
Designed under Quality Management System standards ISO 13485:2016/NS-EN ISO 13485:2016.
Characteristics:
Length: 2.5 m.
Diameter: 1.7 mm.
Recommended swab diameter:
Storage conditions
Chemdye® SWE swabs should be stored at temperatures between 15-30 °C, protected from light and relative humidity (RH) of 20-80 %.
Transport conditions
It is recommended to respect storage conditions during transport. Transport in closed and strengthened boxes in order to avoid damages. The transport of this product does not represent a risk for health.
Shelf life
24 months when stored at the declared temperatures.
Packaging
Box with 5 units.
Packaging information:
Product code and description, presentation, storage conditions, manufacturer information and data on label.
Labelling
On product’s box: product code, batch number, manufacture and expiration date, bar code and datamatrix code.
Possible target markets:
Healthcare, Pharmaceutical and Medical industries.
Other important information.
Read product’s instructions for use thoroughly before use.
Precautions
Handle with gloves at all times.
Do not open until use.
Do not reuse.
Do not re-incubate.
Do not swab surfaces that have not been subjected to a cleaning process or visibly contaminated areas.
Avoid touching the absorbent part of the swab or the inside of the device with your hands. Use gloves, a mask and other hygiene measures.
Do not freeze.
Do not use Chemdye® SWE swabs on any device other than
Chemdye® PRO 1 ENDO.
High concentrations of alkaline detergents may cause false-negative results in some cases. Oxidizing disinfectants (such as hydrogen peroxide or peracetic acid) may cause a false-positive color change reaction. Although Chemdye® PRO1 ENDO has high sensitivity, its intended use corresponds to the monitoring of channels after the cleaning process, so the test result is not evidence that the device is sterile.
Description
Chemdye® SWE high-absorption swabs for use with Chemdye® PRO 1 ENDO
Usage:
Chemdye® SWE high-absorption swabs have been specifically designed for use with cannulated instruments. These swabs must be inserted through the internal channel of the cannula, allowing the collection of contaminants that may persist after the cleaning process. SWE swabs are designed for use with Chemdye® PRO1 ENDO system, enabling the verification of the cleaning efficacy of cannulated instruments by detecting and quantifying protein residues that may remain after the cleaning process.
Applicable standards
Designed under Quality Management System standards ISO 13485:2016/NS-EN ISO 13485:2016.
Characteristics:
Length: 2.5 m.
Diameter: 1.7 mm.
Recommended swab diameter:
Storage conditions
Chemdye® SWE swabs should be stored at temperatures between 15-30 °C, protected from light and relative humidity (RH) of 20-80 %.
Transport conditions
It is recommended to respect storage conditions during transport. Transport in closed and strengthened boxes in order to avoid damages. The transport of this product does not represent a risk for health.
Shelf life
24 months when stored at the declared temperatures.
Packaging
Box with 5 units.
Packaging information:
Product code and description, presentation, storage conditions, manufacturer information and data on label.
Labelling
On product’s box: product code, batch number, manufacture and expiration date, bar code and datamatrix code.
Possible target markets:
Healthcare, Pharmaceutical and Medical industries.
Other important information.
Read product’s instructions for use thoroughly before use.
Precautions
Handle with gloves at all times.
Do not open until use.
Do not reuse.
Do not re-incubate.
Do not swab surfaces that have not been subjected to a cleaning process or visibly contaminated areas.
Avoid touching the absorbent part of the swab or the inside of the device with your hands. Use gloves, a mask and other hygiene measures.
Do not freeze.
Do not use Chemdye® SWE swabs on any device other than
Chemdye® PRO 1 ENDO.
High concentrations of alkaline detergents may cause false-negative results in some cases. Oxidizing disinfectants (such as hydrogen peroxide or peracetic acid) may cause a false-positive color change reaction. Although Chemdye® PRO1 ENDO has high sensitivity, its intended use corresponds to the monitoring of channels after the cleaning process, so the test result is not evidence that the device is sterile.