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Thermodisinfection Indicator for moist heat disinfection 10 minute, 200 strips/bag
Thermo-Disinfection Indicator, turns from green to purple if exposed to 93°C after 10 minute in washer disinfector. Specifically designed for monitoring moist heat disinfection processes in washer-disinfectors.
Product code: C1-TDI-10
Mfr. IT27W-10 Integron
Features:
- One-sided-laminated strip with an initial color of green, final color of purple.
- size of 69.5 mm x 30 mm.
- 100% toxic heavy metal-free, providing a safe disinfection monitoring solution.
- Environmental Conditions during Manufacture:
- Manufactured under controlled environmental conditions of T= 15-30 °C and RH 30-80%.
- Storage Conditions:
- Store between 0 °C and 4 °C in a refrigerator with RH= 30-80%, avoiding direct light.
- Storage at temperatures up to 25 °C is permissible for a maximum of 15 days.
- Transport Conditions and Shelf Life: Follow strict storage conditions during transport.
- Products can be transported at temperatures below 25 ºC for up to 15 days.
- The product has a shelf life of 5 years.
- Packing:
- Each unit is packed in aluminum foil bags, with 200 units per bag.
- Labelling:
- The product's packing includes essential information such as product code and description, manufacturer details, storage conditions, presentation, conditions of use, batch number, manufacture date, expiration date, bar code, and datamatrix code.
- Possible Target Markets:
- Suitable for use in both healthcare and industrial settings, offering versatile applications in disinfection monitoring.
Use the correspondent Integron Indicator for monitoring thermal disinfection step in washer-disinfectors according to the following programs:
| Item # | Mfr # | Description (Indications for use) | Dimensions | Cost | | C1-TDI-1 | IT27W-1 | 90 ºC, 1 minute. A0 = 600 | 69.5 mm x 30 mm. | $132.75 | | C1-TDI-5 | IT27W-5 | 90 ºC, 5 minutes. A0 =3000 | 69.5 mm x 30 mm. | $132.75 | | C1-TDI-10 | IT27W-10 | 93 ºC, 10 minutes. BGA/RKI/Epidemic Program | 69.5 mm x 30 mm. | $132.75 |
To interpret results visually, use the results reference guide on product´s instructions for use.
Instructions for use - Place the indicator on the Chemdye Holder.
- Place the system on the tray along with the material.
- Run the selected disinfection program and once finished remove the indicator.
- Visually analyze indicators and record results. The indicator must change to the reference color for considering that the desired disinfection conditions were met. If unsatisfactory results are obtained, perform the actions indicated therein and repeat the disinfection process.
- Use one Integron indicator for each cycle.
NOTE: if any serious incident occurs in relation to the device, it should be reported to Terragene S.A. and the competent authority of the State in which the user is established
Indicator Ink and Emulation Condition:
Printed with synthetic temperature-stable support and initial color green, the strip turns purple under emulation conditions of 10 min. at 93 °C, BGA/RKI/Epidemic Program
Usage: Designed for monitoring moist heat disinfection processes in washerdisinfectors. Emulation condition: 10 min., 93 °C (BGA/RKI/EPIDEMIC PROGRAM) or equivalent.
Applicable regulation
Designed under Quality Management System standards ISO 13485:2016/NS-EN ISO 13485:2016. Characteristics - One-sided-laminated strip printed with indicator ink, synthetic temperature-stable support.
- Initial Color: Green.
- Final color: Purple.
- Size: 69.5 mm x 30 mm.
- 100 % Toxic Heavy Metal free
Environmental conditions during manufacture T= 15-30 °C, RH 30-80 %.
Storage conditions Store at temperatures between 0 °C and 4 °C in refrigerator, RH= 30-80 %, keep out of direct light. Storage at temperature up to 25 °C is possible for a period no longer than 15 days.
Transport conditions Storage conditions should be strictly followed. Products should be transported in closed and reinforced boxes in order to avoid damages. The transport of this product does not represent any risk for human health. Product can be kept at temperature below 25 ºC for up to 15 days during transport.
Shelf life 5 years
Packing 200 units per aluminium foil bag.
Labelling On product’s packing: product code and description, manufacturer information, storage conditions, presentation, conditions of use, batch number, manufacture date, expiration date, bar code and datamatrix code.
Possible target markets Healthcare and Industry.
Other important information Read product’s instructions for use thoroughly before use.
Precautions
Store the product within its original package, away from light, disinfectants, gases and humidity.
Under inadequate storage conditions, results can be erroneous.
Do not wet.
Do not reuse the product.
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