5.5.5.1.1 Hardware
- One set of personal computer or laptop, attached with inkjet printer for record and print out the data of process.
- At less one port of 3.0 USB for connect with external drive
- Hard drive storage that can collect at least 72 months record (10 records per day)
- One set of recorder for recording graph
5.5.1.2 Software Specifications
The TFT color LCD monitor fitted in the front panel displays a variety of screens to be accessed by touching the screen, and offers the following choice:
1. Security level, at least five levels of access, named: Operator, Supervisor, Technical manager, Maintenance and system administrator. Each user has its own password.
2. Cycle. This screen displays the set of parameters configuring a sterilization cycle: temperatures, pressure and the various time phases. The technical manager can create as many recipes as necessary, so that each cycle is identified by the name of the product for which it has been designed. One of the pre-recorded cycles is the chamber leak test.
3. Cycle start. This includes selection and starting of the required cycle. The sterilization cycle can be started only under the following conditions: all doors are closed and all suppliers available.
4. Historic. All running cycle parameters are recorded on the PC hard disk, so they can be recovered at any time and used to compose a complete report. The report may comprise set parameter, actual parameter throughout the cycle, list of phases performed with their time count, list of events and graphs.
5. Diagrams. This screen shows a diagram of the autoclave including all valves and motors, and their status, operation mode or any possible alarm. It also shows the main current parameters of the cycle and the phase in process.
6. Graphics. The graphic of chamber and jacket pressure, both chamber temperature and the filter housing temperature can be displayed in this screen.
7. Cycle control. Enables viewing not only current cycle parameters, but also set parameters and changing them while the cycle is running. It also allows phase skip, cycle stopping, continuation or final aborting.
8. Alarm. Whenever an alarm signal is given, a massage is shown on the screen and recorded in the cycle history. The acoustic alarm can be stopped with the mouse.
5.5.2 Operation
5.5.2.1 Basic configurable cycles or phases required:
1. Chamber leak test
2. Automatic vent filter SIP (Sterilization-In-Place)
3. Bowie Dick Test
4. Dry goods load: Instruments, Machinery parts, etc
5. Porous load: Rubber goods, textiles, filter, etc
5.5.2.2 The control system allows the possibility of storing in memory up to thirty (30) different recipes in memory by setting up its parameters.
5.5.2.3 The system shall be able to run the multiphase cycle from start to finish with no operator interaction required after the cycle is properly initiated.
5.5.5.1.1 Hardware
- One set of personal computer or laptop, attached with inkjet printer for record and print out the data of process.
- At less one port of 3.0 USB for connect with external drive
- Hard drive storage that can collect at least 72 months record (10 records per day)
- One set of recorder for recording graph
5.5.1.2 Software Specifications
The TFT color LCD monitor fitted in the front panel displays a variety of screens to be accessed by touching the screen, and offers the following choice:
1. Security level, at least five levels of access, named: Operator, Supervisor, Technical manager, Maintenance and system administrator. Each user has its own password.
2. Cycle. This screen displays the set of parameters configuring a sterilization cycle: temperatures, pressure and the various time phases. The technical manager can create as many recipes as necessary, so that each cycle is identified by the name of the product for which it has been designed. One of the pre-recorded cycles is the chamber leak test.
3. Cycle start. This includes selection and starting of the required cycle. The sterilization cycle can be started only under the following conditions: all doors are closed and all suppliers available.
4. Historic. All running cycle parameters are recorded on the PC hard disk, so they can be recovered at any time and used to compose a complete report. The report may comprise set parameter, actual parameter throughout the cycle, list of phases performed with their time count, list of events and graphs.
5. Diagrams. This screen shows a diagram of the autoclave including all valves and motors, and their status, operation mode or any possible alarm. It also shows the main current parameters of the cycle and the phase in process.
6. Graphics. The graphic of chamber and jacket pressure, both chamber temperature and the filter housing temperature can be displayed in this screen.
7. Cycle control. Enables viewing not only current cycle parameters, but also set parameters and changing them while the cycle is running. It also allows phase skip, cycle stopping, continuation or final aborting.
8. Alarm. Whenever an alarm signal is given, a massage is shown on the screen and recorded in the cycle history. The acoustic alarm can be stopped with the mouse.
5.5.2 Operation
5.5.2.1 Basic configurable cycles or phases required:
1. Chamber leak test
2. Automatic vent filter SIP (Sterilization-In-Place)
3. Bowie Dick Test
4. Dry goods load: Instruments, Machinery parts, etc
5. Porous load: Rubber goods, textiles, filter, etc
5.5.2.2 The control system allows the possibility of storing in memory up to thirty (30) different recipes in memory by setting up its parameters.
5.5.2.3 The system shall be able to run the multiphase cycle from start to finish with no operator interaction required after the cycle is properly initiated.
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