KH2X15-18.0Y/P – 18 Min. Helix-PCD + Teststreifen Kit für Dampfsterilisatoren (250 Stk.)

KH2X15-18.0Y/P

Helix-PCD + Chemical Indicator test strips Kit.
For Steam sterilization processes control.

Usage

Process Challenge Device for Steam sterilization processes control. For safe release of hollow loads.
Conditions: 18 min at 134 ºC.

Applicable regulation

Designed under Quality Management System standards ISO 13485:2016/NS-EN ISO 13485:2016.
EN 867-5, EN 285, ISO 11140-1:2014.

Classification

Class 1, according to risk (ANMAT).

Characteristics

Helix-PCD
Plastic capsule of great resistance and durability, to hold a Chemical Indicator designed for this system. The capsule is connected to a high resistance plastic tube of 1.5 m length (see catalogue for other lengths) and 2 mm internal diameter. Special silicone connector coated by external connector.

PCD-A-18.0Y
Type 2 Chemical Indicator.
Self-adhesive varnished strip printed with indicator ink. Size: 76 x 6 mm.
10 strips per sheet. Size: 80 x 98.5 mm.
Initial color: yellow
Final color: dark brown/black
Authorization: ANMAT (Argentinean National Administration of Drugs, Food and Medical Devices) PM-1614-4.

NOTE: If the 4 bars change to the final color, the sterilization cycle was successful, the load can be securely released. If one or more bars did not turn to the final color, this shows a failure in sterilizing agentpenetration, the load cannot be considered sterile, that is, it cannot be released.

100 % Toxic Heavy Metals free

Environmental conditions during manufacture

T = 15-30 ºC, RH 30-80 %.

Storage conditions

T = 10-30 ºC, RH 30-80 %, store in dark place.

Transport conditions

Storage conditions should be strictly followed. Transport in closed and reinforced boxes in order to avoid damages. The transport of this product does not represent a risk for health.

Shelf life

PCD-A-18.0Y: 5 years.
Helix-PCD: 250 cycles.

Packing

250 PCD-A-18.0Y strips in sheets of 10 units + 1 Helix-PCD + 1 cotton bag.
Packing information: manufacturer information, storage conditions and data on label.

Labelling

On product’s packing: product code and description, process for intended use, presentation, classification according to regulation, kit batch number and CDPCD batch number, manufacture date, expiration date, bar code and datamatrix code.
On helix-PCD bag: product code and description, presentation, batch number, bar code and datamatrix code.
On PCD-A-18.0Y packing: product code, process for intended use, presentation, color change, batch number, manufacture date, expiration date, bar code and datamatrix code.

Possible target markets

Healthcare, Food, Pharmaceutical and Medical industries.

Other important information

Read product instructions for use thoroughly before use.

Precautions

Do not store the product near sterilizing agents.
Do not expose this product to EO, Dry Heat, Formaldehyde or any sterilization processes other than Steam.
Do not reuse the sterilizer until the color change of the chemical indicator is the one indicated in the product.