Product series description STERIVAP HP
General and Actively Provable Quality
The device complies with all the European standards for steam sterilizers, in particular EN 285. For this purpose, the company BMT Medical Technology s.r.o. obtained certification of the complete quality management system according to the following regulations:
- EN ISO 13485 standard and European Directive 93/42 / EEC for medical devices
- EN ISO 9001 standard for products and together with the European Directive No. 2014/68 / EU, module H for pressure equipment
- EN ISO 14001 standard, Environmental Management Certificate
- The company BMT Medical Technology Ltd. also operates the Accredited Testing Laboratory No. 1325.
Individually Built Sterilization Technology
STERIVAP® HP is designed for the sterilisation of solid, porous, plastic materials and solutions in open bottles. The basic version of the device comes with a utilizable volume of 148 – 1490 litres. The STERIVAP® HP sterilizer – safe, quick, ergonomically designed, easy to handle, with possibility of individual modifications and with versatile use. The superior production quality, modern electronic and high quality materials are in case of STERIVAP® HP equally obvious as the user properties or extraordinary safety and reliability level.
New Design, New Construction Version
- the all stainless steel instrument jacket
- divided all stainless steel instrument frame with attractive dimensions and width only 100 cm
- the massive chamber, door and the heating jacket are made of high-quality stainless steel AISI 316 L with polished surface with surface roughness of Ra 1,25 μm (50 μinch)
- the outer insulating jacket of the sterilising chamber is made of dip galvanised sheet (optionally of aluminium or stainless steel AISI 304) with high-quality insulation, which reduces substantially the heat losses
- integrated device for supply water saving for suction pump, which saves approx. 15% of operating costs
- unique divided double chamber jacket with new system of steam filling to the sterilising chamber, which reduces the demi-water consumption by approx. 20%
- thermo-degassing of demi-water for the steam generator with minimising of content of the incondensable gasses for higher sterilizing reliability
- high- performance, noiseless, two-stage suction pump for higher efficiency and reliability (except of STERIVAP® HP 6612 and higher)
- innovative, colour, large-scale, ergonomically adjustable touch-screen 12“
- double-processor PLC control by two independent systems (Master-Slave) for highest safety
- cycle control by dual independent sensors of absolute pressure and temperature, ensuring operating accuracy, control and independent cycle documentation
- integrated drain – due to dampness elimination in the instrument all pipes are led to one common sump
- unique solution of steam distribution for heating and sterilising process – enables accurate meeting of physical requirements standards
- simple mechanical filter on steam and supply water inlet
- the integrated steam generator is equipped as a standard by automatic clarifying device and is made as well as the heating elements of stainless steel AISI 316 Ti, optionally AISI 316 L
- motor driven door of sterilizing chamber with unique spring-loaded mechanism reduces the instrument weight approx. by 50–100 kg
- piping distributions and fittings leading steam to the chamber are as a standard made of stainless steel
New Control Panel with Intuitive Control
- modern technology of “touch-screen” display 12“ with ergonomically adjustable panel provides well-organized and simple using on loading side of the device
- on unloading side (in case of two-door version) of the device there is the “touch-screen” display 5,7“ with the possibility of monitoring the current work phase and pressure in the sterilization chamber
- control panels are located out of the thermally exposed zone
- two built-in microprocessor control systems (Master-Slave) with own sensors for independent assessment, control and documentation of work cycles
- “Emergency push button” – the control panel integrated function allows for the device to be put into idle state if necessary
- built-in printer for documentation of sterilization processes
- program selection and start even from the clean side
- the function “Automatic morning switch on” allows for the device to be switched on in pre-set time without presence of users, automatic pre-heating of the device and Vacuum test performance
- “History of errors” – the function allows displaying of recent 20 error messages on the display
- “Additional comments” – the devices allows for the user to write additional comments on individual programs, respectively cycles
Broad Range of Operating Programmes Options
As a standard, the device is equipped with the “Preheating program” (134°C/1min)
- Tools - quick 134°C/ 4 min, with following short drying, for unpacked tools for immediate consequent use
- Universal 134°C/ 7 min, with following short drying
- Universal containers 134°C/ 7 min, with intensive drying
- Packed glass, rubber and plastic products 121°C/ 20 min, with intensive drying
Standard testing programs for routine checks:
- Vacuum test - chamber air tightness test, settlement phase duration 5 min, test duration 10 min
- Bowie & Dick test 134 – steam penetration test, 134°C / 3.5 min
Documentation of Batches
It is possible to arrange well-organized documentation of operation cycles by:
- independent documentation of operation cycles with recording with the possibility of saving recent protocols for the whole service life of the device
- connection to PC and by saving protocols in the computer memory using the “PrinterArchiv” software
- connection of the sterilizer to computer network (LAN) together with software application Ecosoft
- the electronic process documentation, data archiving and Audit Trail together meet FDA 21 CFR part 11 requirements
- by built-in printer
- possibility of batches export to PDF on the USB flash disc in the A4 format
Equipment for Service
The PLC automatics is equipped with extensive software for easy control, maintenance and testing (interactive schemes of tube connection, testing programs allowing testing of safety elements of the device, calibration settings, etc).
Client Service Arrangement
Together with classic supplies of instrumentation, we offer a complete spectrum of services connected with development of central and chart room sterilizations.
- consultancy and project processing, including logistics and capacity calculations
- instrumentation supply including individual information systems “on turnkey”
Service and support of users are fully arranged by a worldwide network of contractual organisations of the company BMT Medical Technology s.r.o. We have an extensive network of brand service work sites connected to HOT-LINE service providing fast response to clients’ questions and requirements. So as to arrange user comfort and fast and high-quality service intervention we developed a special auto-diagnostic program. We offer internet diagnostics and monitoring of the sterilization device (RMS), providing fast and direct communication with the instrumentation and it arranges fluent and trouble-free operation of a work site. All these features guarantee low operation costs and long service life of the device.
The device meets all and any current environmental requirements. It represents no burden for the work and life environment. A powerful suction pump with built-in device for feeding water saving saves approximately 15% of operation costs. The unique construction of the steam generator with automatic desalting arranges permanently high quality of steam.
High quality materials guaranteeing long service life of the device are used for its manufacture. Optionally, the device can be equipped with an element for additional cooling of waste water, allowing its temperature setting. The device does not produce any harmful waste. Environment – friendly methods are used for its manufacture in the workshop. All the main parts of the device as well as the packages are recyclable.
The device consists of 95% of steel, 4% of other materials, 1% of electro material and plastics. Environment-friendly liquidation to be performed after dismantling by an authorised person in compliance with EU regulations, corresponding with the WEEE directive (Waste Electric and Electronic Equipment).