DENTAL-PMS - CSSD PRODUCTS

gke Steri-Record Dental -BMS
Dental Batch Monitoring System(Dental-BMS) for staem sterilization processes

Application

Product Description

This gke Steri-Record® Dental-BMS is a class 2 indicator according to EN ISO 11140-1 consisting of a “specific test load“ (process challenge device = PCD). A specifically designed external case contains an internal stainless steel tube connected with a stainless steel capsule holding the “indicator system“ (indicator strip) inside. The oval cross section of the PCD with a flat height of 2,5 cm allows the PCD to be placed in a table-top sterilizer horizontally.

Performance Characteristics

This Dental-BMS is validated with an “equivalence test” according to DIN 58921 using a typical dental instrument load configuration. The “equivalence test” is carried out in a laboratory accredited according to the standard EN ISO 17025. A test report is available on request. The inside of hand pieces is the most difficult part of an instrument to be sterilized. The successful sterilization of hand pieces does not only depend on the efficiency of the sterilizer program but also on the construction of the hand piece.There are instruments on the market which cannot be sterilized with the most efficient steam sterilization processes due to inappropriate constructions preventing steam penetration in sealed areas resulting in non-sterility. These instruments are unsuitable and cannot be used in steam sterilization processes.The use of the Dental-BMS ensures that typical dental load configurations are sterilized successfully.

Operation Description

If all four bars of the chemical indicator turn from yellow to black it is an indication of sufficient steam penetration inside the PCD. This result ensures air removal and steam penetration into the whole load under the condition that the PCD is representing the load configuration.

Benefits

The gke Steri-Record® Dental BMS is thefirst Batch Monitoring System tailored to monitor Dental loads in steam sterilization processes.

The use of this Dental-BMS allows the monitoring of sterility inside of hand pieces not provided by recording pressure, temperature and steam quality in the chamber and/or using exposed indicator strips.

The batch can be released without opening the pack to check the internal packaging indicator.

All information relevant to release the load is supplied on completion of the process so that the person authorized can release the batch.

Cost effective. Only one indicator strip is required for each sterilization process instead of one in each pack.

Easy interpretation of the results due to precise colour change.

The graduated colour change of the indicator bars informs about the magnitude of air removal and steam penetration into the PCD.

Environmentally friendly, no unnecessary waste.

gke self-adhesive labels simplify recording with the gke Steri-Record® documentation system.

The indicator colour chemistry is a nonreversible chemical reaction. The indicator strip can be documented proof for several years without changing back to its original colour.

The screw-cap consists of a highly thermal resistant material and stainless steel sandwichconstruction that protects hands from high temperatures. The chemical indicator may be easily removed and evaluated on completion of each cycle.

The innovative design and rationalized production provide a sensitive and cost effective test, where the PCD can be used for a considerable number of cycles. Its specifications remain constant over the lifetime of the device.

All important parts are made of stainless steel or thermal resistant polymers. Seals are replaced easily.

Continuous reproducibility of the results over the lifetime of the PCD if seals are precautiously replaced .

All gke chemical indicators are protected from bleeding by a polymer binders and surface coating and can be disposed with normal garbage.

Assurance that only sterile released packs go into the operating room.

Order information

Each start-up kit contains one Compact-PCD® and 100 integrating indicator strips as well as a documentation sheet to be copied before daily use. Test devices are available separately as well. The indicator strips are available as refill packs without test devices containing one seal ring for the screw cap.