Product series description UNISTERI HP
Individually Built Sterilization Technology
The UNISTERI® HP is designed for rapid sterilization in medical facilities:
- one-day surgical clinics and surgeries of polyclinics for sterilization of all and any necessary materials: tools, glass, textile, rubber articles,…
- surgical workplaces of hospitals that are far from the central sterilization department, especially to optimize the reuse of the necessary instruments
- medical clinics and first aid centres where rapid sterilization of medical supplies is needed
- dental practice, where table models of sterilizers cannot accommodate the necessary volume of material
- microbiological workplaces of medical facilities for sterilization of solutions in semi-closed bottles, cultivation media,…
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 MDR 2017/745 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.
New Design, New Construction Version
- 8.4” touch-screen control panel for maximum operator and service convenience
- 5.7” touch-screen display on the unloading side of the device for well organised and easy operation
- automatic closing and sealing system for (manually operated) hinged doors, user-friendly operation
- steam generator with reduced power input (from 7.5 kW)
- powerful water ring vacuum pump for short batch times, fast and accurate course of cycles
- dual-CPU PLC control with two independent systems for reliable, efficient and safe course of cycles
- a special method of controlling the continuous inflow of steam into the steam sterilizer chamber
- the device is made of high quality stainless steel for long life
Modular Layout System
- single-door and double-door (pass-through) version with possibility of building into the stainless steel wall
- optional steam source – own, external, combined
- optional roughness of inner surface of the sterilization chamber
- system for manual insertion of materials and system of transport and charging carriages
- wide range of optional program equipment
- various possibilities of batch documentation processing
- wide range of optional equipment for minimization of operation costs
- possibility of specific additives selection (e.g. possibility of chamber equipment with a flexible sensor PT 100 for safe and precise control of cycles while working with microbiological cultures and solutions, wide range of individual adjustments of programs, …)
- wide spectrum of services
Microprocessor Control
- the highest possible operation safety, double system of sensors for process information collection and assessment and for their continuous comparison and assessment
- two built-in microprocessor control systems for independent assessment, control and documentation of operation cycles
- the system allows users administration and assigning of permissions to individual functions
- storing the logs directly into your device for the whole duration of its life
- unique error protocol for exact and fast diagnostics of errorsb
- the basic program equipment includes up to 50 standard programs
- easy realization of individual adjustments of programs
- easy import/export of programs using a USB flash disc
- easy and intuitive access for service allows a technician to comfortably set all and any calibrations and configurations and to perform fast diagnostics of the device
Pressure Sterilization Chamber
- pressure chamber, steam-heated via heating shell, made of high quality stainless steel 1.4404 (AISI 316 L)
- special way of control of continuous steam intake to the steam sterilizer chamber
- down bottom of the sterilization chamber for perfect drying
- sterilization chamber with ground surface with roughness of Ra 1,25 μm (Ra 50 μinch)
- thanks to high-quality insulation materials Rockwool used (no chlorides), equipped with an Al foil, there are reduced the radiated heat losses and requirements towards airconditioning
- as a standard, all the sterilization chambers are equipped for validation with two easily accessible inlet necks according to EN 285
- thanks to the special door hinge, the operator is provided with an extended handling area for comfortable and safe material handling and it allows easy cleaning of the inside of the door
- possibility of setting the passthrough sterilizer so that there does not occur any contamination of any side with material and air from the contaminated side
Steam Generator
- the steam generator and the heating bodies are made of high quality stainless steel DIN 1.4571 (AISI 316 Ti)
- high quality insulation Rockwool with AL foil – significant reduction of heat losses
- reduced feed water conductivity requirement of 15 μS / cm compared to the value recommended by the EN 285 standard provides significant savings in water treatment costs
- unique automatic control of the steam generator including water filling
- thermal degassing of the feeding demi water (optional equipment) and automatic desalination to minimize non-condensable gases and for consistently high steam quality
New Control Panel
- user friendly, with intuitive control
- two built-in microprocessor control systems with own sensors for independent assessment, control and documentation of operation cycles
- ergonomic position of the touch control panel
- the 8,4” touch screen technology provides well-organised and simple servicing on loading side
- on unloading side of the device (in case of the two-door version) the 5,7” touch screen arranges well-organised and simple service
- the “emergency stop” function integrated to the control panel allows for the device to be put into standby status if needed
- possibility of language selection for communication with the device
- well organised digital displaying of steam pressure in sterilization chamber shell and in the steam generator, pressure and temperature in sterilization chamber (reference bottle)
- clock – an improved estimation of remaining time of the program
- error protocol with recording of all and any parameters at the moment of a fault for the possibility of fast and remote service
- visual and acoustic signalling of statuses and processes
- possibility of building-in a printer for sterilization processes documentation (optional equipment)
The basic program equipment offers up to 50 programs
As a standard, the device is equipped with the “Preheating program” (134°C/1min)
Standard programs:
- 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.
Environmental Awareness
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).