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


The first Dental-BMS worldwide

The gke-Record® Dental Batch Monitoring System (BMS) is the first (BMS) tailored to monitor dental loads in steam sterilization processes.


Quick evaluation of the results

The outside parts of the Dental-BMS are made of thermal insulating material and protect the hands from high temperatures after taking the test device out of the sterilizer chamber. Results can be checked immediately at the end of the cycle.


Durable and resistant

All important parts are made of stainless steel and are protected by an outside durable plastic case of highly thermal resistant materials.


Cost-effective and environmentally friendly

In contradiction to conventional systems the chemical indicator strip is the only consumable. Most conventional class 2 indicators are single-use systems where the PCD is disposed. The construction of the Dental-BMS requires only one indicator strip. The indicator is selfadhesive and can be placed on a documentation sheet after sterilization


No Pollution and Non-Toxic

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


Easy interpretation

The indicator strip can be evaluated easily. Errors in the sterilization process are quickly identified. The graduated response allows the user to evaluate the magnitude of malfunction, i.e. insufficient steam penetration or an inadequate temperature-time integral.


Class 2 indicators

The gke Steri-Record® BMS is a class 2 indicator according to EN ISO 11140-1 and consists of a PCD and an indicator strip called “indicator system“.


Innovative design

The advanced international p a ten te d “ mu l t i-s tage ” technology combines the steampenetration characteristics of Dental loads BMS representing the characteristics of real loads such as hand pieces etc..


Reproducible Results

T he Dental Process Challenge Device (PCD) can be used for an unlimited number of cycles. The durable materials ensure reproducible results..


Application

Medical Products cochin

This Batch Monitoring System (BMS) is used for routine monitoring of dental instruments in each cycle. The process challenge device (PCD) is designed to prove the steam penetration requirements of each load in order to get a successful test result where hand pieces are the most difficult instruments to sterilize. If more complex instruments are used that are not included in the dental load configuration of the Dental-BMS, it is recommended to use thegke Steri-Record®Process Monitoring System (PMS), art.-no. 211-264. It is required that the instruments have been cleaned and disinfected in advance and the design of the instruments is validated so it can be sterilized in steam sterilization processes. If a new instrument is launched into the market the European Medical Device Directive (MDD) requires a validated reprocessing procedure according to the European Standard EN ISO 17664 stated in the directions for use. It is strongly recommended that the users assure that the reprocessing procedure according to EN ISO 17664 is available from the manufacturer when ordering new instruments, e.g. hand pieces

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.

Sufficient temperature, time and steam penetration
Insufficient air removal and steam penetration
Temperature achieved, but no air removal and no steam penetration
Insufficient temperature, no air removal and no steam penetration

Background Information

gke presents the next generation of BMS: the gke Steri-Record® Dental-BMS is especially designed for Dental applications: extremely durable and resistant against mechanical stress and heat, easy to handle and usable for an unlimited number of test cycles. Medical Products cochinThe Process Challenge Device has been developed to monitor air removal and steam penetration in steam sterilization processes inside typical Dental loads. Not only the surfaces but also the interior of Dental hand pieces are checked for sterility.

CDs were used to check if the requirements of sterilizer standards (type test according to EN 285 BD-Test or EN ISO 13060 “Hollow Load Test”) are met to ensure that the sterilizer is working properly. However, the assurance that a sterilizer is working according to the sterilizer standard specification does not ensure that the load inside the sterilizer is sterilized successfully. The efficacy of the sterilizer could be sufficient or insufficient according to the requirements of the load. Therefore the new developed Dental-BMS is not calibrated to the requirements of a sterilizer standard but to the requirements for a typical packaged Dental load.

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.

Medical Products Bangalore