PRO1 ENDO Hygiene Monitoring System

Usage

The Chemdye® PRO1 ENDO Hygiene Monitoring System is specifically formulated to assess the cleanliness of cannulated instruments by detecting residual proteins that may persist after routine cleaning. This system is intended for use in combination with Chemdye® SWE high-absorption swabs, which are specially designed to effectively sample the internal channels of these instruments. Together, they provide a reliable method to monitor and verify the removal of protein contaminants, helping to maintain high hygiene standards and patient safety.

Applicable Regulation

The system is manufactured under Quality Management System standards ISO 13485:2016/NS-EN ISO 13485:2016, ensuring compliance with international hygiene and safety requirements.

Characteristics

Consists of a reactive solution and is used with a high absorption swab for collecting samples from the internal channels of cannulated instruments.

Limit of quantification: 1.0 µg of BSA.

Supports quantitative analysis through Bionova® IC10/20FR, IC10/20FRLCD, or MiniPro auto-reader incubators (incubation: 4–7 minutes at 60 ± 2 °C).

Enables qualitative analysis via incubation and visual interpretation using the color reference guide included in the product box.

Storage Conditions

Store at 2–8 °C, protected from light and within a relative humidity range of 30–80%.

Store vertically as indicated on packaging.

Transport Conditions

Respect storage conditions during transport.

Transport in closed and reinforced boxes to prevent damage; product transport poses no health risk.

Shelf Life

24 months when refrigerated (2–8 °C).

6 months shelf life at room temperature (25–30 °C).

Packing and Labelling

Packaging: Box with 20 units (1 aluminum bag with 20 pens + 4 moisturizer solution vials).

Packing information includes product code, description, presentation, storage conditions, and manufacturer details.

Labelling: Product and box display codes, batch numbers, manufacture/expiration dates, plus datamatrix and bar codes for traceability.

Possible Target Markets

• Healthcare
• Pharmaceutical
• Medical industry sectors

Precautions

• Handle with gloves and avoid touching the absorbent part of the swab or device interior.
• Single-use only; do not reuse, re-incubate, or freeze.
• Do not swab surfaces that have not undergone cleaning or are visibly contaminated.
• Only use Chemdye® SWE swabs with this system.
• High concentrations of alkaline detergents may cause false negatives, oxidizing disinfectants may cause false-positive color changes.
• The test result does not indicate device sterility, only cleanliness.

Other Important Information

Always read and follow product instructions before use