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Summary of Contents for ENBIO S
- Page 1 2022.04.27 The latest version of the manual is available at www.enbio.com Enbio S / Enbio PRO User Manual...
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Page 2: Table Of Contents
Condensate outlet WATER Main switch 3.4. Water recycling connection (Enbio Magic Filter) 3.4.1 WATER IN feed water connection with Enbio Magic FIlter 3.4.2 WATER OUT wastewater connection with Enbio Magic FIlter 3.5. Setting up the device Enbio PRO 3.6. Connecting the device to the power supply... -
Page 3: Introduction
1.4. Purpose of the device The ENBIO S and ENBIO PRO devices are small class B steam sterilizers in accordance with the EN 13060 Purpose and scope standard; they are also classified as class IIb medical devices according to Annex IX of the Medical Devices Directive 93/42 / EEC. -
Page 4: Enbio S Sterilization Parameters
The table below, which presents the characteristics of the individual sterilization programs in the Enbio S device, should be read in detail. It is the user's responsibility to select the program appropriate to the type of load and not to exceed the maximum weight of the sterilized load. -
Page 5: Enbio Pro Sterilization Parameters
The table below shows the characteristics of each sterilization program in Enbio PRO. It is the user's responsibility to select a program suitable for the type of load and not to exceed the maximum weight of the sterilized load. Failure to observe the following precautions may compromise patient health and device operation. -
Page 6: Symbols Used On The Device
It is the user's responsibility to perform timely maintenance and inspections of the device - under penalty of losing the warranty. • It is the user's responsibility to select a program appropriate to the type of load and not to exceed the maximum weight of the load to be sterilized. 1.8. -
Page 7: Scope Of Delivery And Unpacking
2.1. Unpacking the device items should be included in the package Enbio S / Enbio PRO sterilizer 2. HEPA filter (inside the chamber of the device). If the sterilizer has been transported or stored at a temperature and humidity different 3. -
Page 8: Installation And Preparation For Operation
The total mineral content of the sterilization water must be less than 10 ppm or, in the case of conductivity measurement, it must be less than 15 μS/cm - therefore tap water cannot be used as feed water for the device. -
Page 9: Water Connection With Feed And Wastewater Tank
3.3. Water connection with feed and wastewater tank To connect the Enbio autoclave, you need 2 water tanks (feed and waste) of identical capacity, or a feed water tank and drainage access to the sewage system. 3.3.1 Connecting the WATER IN feed water •... -
Page 10: Water Out Wastewater Connection With Enbio Magic Filter
Wastewater should be drained into a water tank. To secure and immobilize the water drain hose from the unit, use the plug supplied with Enbio Magic Filter and insert the plug into the opening of the water tank. The unsecured tubing may jump out of the tank and flood the room. -
Page 11: Setting Up The Device
3.5. Setting up the device • The unit should be placed on a flat, level surface. Do not use the unit if it is at an angle. • Only demineralized or distilled water should be used in the devices. The use of incorrectly specified water (see "3.2. -
Page 12: Preparation And Loading Of Instruments
• The 134 ° C FAST program is intended only for sterilization of unwrapped instruments (see "1.5 Enbio S bottom of the tray (this ensures faster and more efficient drying of the packs). -
Page 13: Operating The Device
On the next screen, we can go to sterilization, test the device or open the information menu. The following sterilization programs can be selected from the main menu: 121 ° C, 134 ° C, 134 ° C FAST and 134 ° C PRION (Enbio PRO only). Program selection... - Page 14 If work continues or the START field has been selected, a symbolic pressure diagram of the When the chamber is closed by turning the entire process is displayed on the screen with the current program progress highlighted locking knob clockwise, the START symbol against a background and information on the next process steps in the upper left corner of appears on the display, which informs that the the screen.
- Page 15 • vacuum pump capacity. • tightness of the pneumatic system. Enbio S / Enbio PRO Bowie & Dick / Helix Vacuum test Process temperature 134°C – After selecting a vacuum test program and starting...
- Page 16 The package manufacturer. is not an accessory of the device, the user should purchase it on his own. This test evaluates the device's performance in sterilizing loads of porous objects: • Pre-vacuum performance and steam penetration.
- Page 17 How to run the test: • The test must be carried out with an empty chamber in accordance with EN 13060 • Follow the test manufacturer's guidelines • Place the test in the center of the tray in the chamber. Key sounds deactivation •...
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Page 18: Led Lighting
Enbio S and Enbio PRO sterilizers record the number of processes performed. This lets you know when you need to replace consumable parts and when a service inspection is due. ENBIO sterilizers count down to the required overhaul 12 months or 1500 processes from the time the first process was performed, whichever occurs first. -
Page 19: Restart
By selecting the field, we can return to the welcome screen. In the event of an error, we must additionally enter the 4-digit security code 0000. Entering this code is tantamount to the operator's declaration that he is aware that the sterilization process has not been carried out properly and that the batch is non-sterile. -
Page 20: Maintenance And Upkeep
Enter the code again. The arrow enables erasing incorrectly entered digits. After entering the correct code, a welcome screen will appear on the display of the device. Enbio S Enbio PRO Lift the tray up gently and pull away from the front Unscrew the 3 screws securing the tray to the front face. - Page 21 During this time, protect the device against damage. Name Part no HEPA filter Enbio S / PRO 1-8-27720A5 Replacement of consumables Enbio S front kit with gasket 1-8-14672D2...
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Page 22: Data Archiving
Data archiving To ensure proper functioning of the Enbio S / Enbio PRO steriliser, it is recommended that the wearing parts be replaced according to the schedule below. And periodic inspection of the individual components of the sterilizer in accordance with the following guidelines. -
Page 23: Enbio Data Viewer Software
The software is delivered with the device and is on a portable drive - USB flash After clicking "Next>", the folder where the drive or the latest version can be downloaded from the manufacturer's website program should be installed is selected. -
Page 24: Program Structure And Main Functionalities
8.2 Program structure and main functionalities After the installation, the following message appears. The main window consists of three main areas We can now run the software or finish the installation without running the software by clicking the Finish button. If you select the option with immediate start, the main program window is displayed. - Page 25 08-03-22 12:07:41 ST01-CH-21-10835 Program Stop Firmware 134 Fast (S) 12:15:02 33.3 By clicking on the Tools window, we have access to the following options: • synchronization of all files with saved processes after selecting memory location on pendrive (this process, depending on the number of sterilizations and tests performed...
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Page 26: Warning Messages And Error Codes
The item to be replaced is highlighted in red, and the screens are displayed alternately. (max. 0.5 kg S, 0.8 kg PRO) • Contact with the service "Process over Process temperature too high Contact with the service temperature"... - Page 27 "Chamber heating error" Chamber heating error • Mains voltage too low - consult an Messages electrician for the location where the "Aborted by user" Process interrupted by the This message appears when the user autoclave is to be installed • Contact with the service user.
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Page 28: Complaint Procedure
Alternating screens: pressure equalization, please wait. In order to report a problem with the device, complete the complaint form on the manufacturer's website www.enbio.com or contact the hotline. In the event of transport damage, a claim should be sent along with a bill of lading and a purchase document as well as photos documenting the damage. -
Page 29: Technical Data
12. Technical data Device parameters Enbio S Enbio PRO Power supply 220-240V AC 50 / 60Hz 220-240V AC 50 / 60Hz Test connector - for use by authorized service only. If found to Installed power 2.25 kW max. 3.25 kW max. -
Page 30: Ec Declaration Of Conformity
13. EC declaration of conformity EC Declaration of Conformity Company: Enbio Technology Sp. z o. o., ul. Sportowa 8 C, 81-300 Gdynia, Poland declares with sole responsibility, that medical devices: STEAM STERILIZERS, models: • Enbio S • Enbio PRO • Enbio XS complies with provisions of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (as amended).
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