ENBIO Enbio Pro User Manual Download Page 8

3.   Installation and preparation for operation

Please read these operating instructions carefully before using the ENBIO S or ENBIO PRO. 
During operation, observe the guidelines in these instructions as well as the applicable local 
health and safety rules. The ENBIO S and ENBIO PRO units are designed for self-assembly by 
the user and do not require specialized installation on site. The user is responsible for proper 
installation of the unit on site in accordance with these instructions.

3.1. HEPA filter installation. 

To protect the component during transport, a HEPA filter is not installed in the device. It was 
placed inside the chamber, on a tray. Take it out of the chamber, take it out of the bag and by 
yourself, carefully screw it into the slot provided for this purpose (see fig.). The filter should be 
screwed in by hand (approx. 7 turns) until resistance is felt - further screwing in will damage 
the filter and immobilize the sterilizer. 

3.2. Feed water quality

It is unacceptable to use any liquids, solutions, chemicals, additives to the feed water - the device may be 
powered only with demineralized or distilled water of appropriate quality. 
No chemicals or additives must be added to the sterilization water, even if they are specifically intended 
for use in steam generators, steam production or for use as additives in sterilization, disinfection, cleaning 
or corrosion protection. 
The use of incorrect quality water or solutions other than water reduces the effectiveness of sterilization 
and leads to damage to the device and loss of warranty. 
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.
The table below shows recommended water hardness and conductivity parameters for Enbio S and Enbio 
PRO sterilizers.

Permissible parameters of water used for sterilization 
•  hardness <0.02 mmol / l
•  conductivity (at 20 ° C) <15 μS / cm
•  pH - from 5 to 7.5
•  chemical additives - none 

The use of water with an impurity content in excess of the above levels will damage the 
device and will void the warranty. 

The water in the supply tank should be replaced at least every three months (due to 
increased conductivity due to prolonged contact with air). If the tank is dirty, also change it 
to a new one. The tank should be closed with the attached stopper so that water does not 
deteriorate its chemical composition as a result of contact with air. 

The guarantee granted by the manufacturer becomes void if the autoclave has been used 
with water of a quality inconsistent with the recommended

If the autoclave is operated in a water recycling system using the Enbio Magic Filter, 
the filter must be replaced with a new one every 6 months or less when the resin has 
completely discolored to an amber color. As long as the blue color is visible, the resin has 
still water-purifying properties, i.e. water hardness <0.02 mmol / l and conductivity <15 
μS / cm. In order to ensure the correct parameters of the water supplying the device, it is 
recommended to check the water tank at least quarterly. In the event of contamination, the 
tank should be emptied, cleaned and filled with new demineralized water. Failure to comply 
with these obligations may disrupt the sterilization process and will void the warranty on 
the sterilizer. 

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Summary of Contents for Enbio Pro

Page 1: ...2022 04 27 Enbio S Enbio PRO User Manual The latest version of the manual is available at www enbio com EN...

Page 2: ...ging packs on sterilizer tray sterilizing packaged loads 4 3 Arranging the packages on the sterilizer tray sterilization of loads without packaging 5 Operating the device 5 1 First run 5 2 Program sel...

Page 3: ...are suitable for sterilizing loads for which steam sterilization is specified The following medical devices can be sterilized in the ENBIO S and ENBIO PRO solid loads small porous items small porous...

Page 4: ...multiple layers 134 C 4 minutes 3 minutes 500 grams 3 load of 100 grams 13 minutes 115 ml B 121 C solid loads small porous objects small porous loads full porous loads simple dimpled objects narrow c...

Page 5: ...al process time for a load of specified weight Max water consumption Sterilization process class 134 C solid loads small porous objects small porous loads full porous loads simple dimpled objects narr...

Page 6: ...Representative The correct and safe operation of the device is based on a thorough reading and observance of this document on the installation and use of the device in accordance with the description...

Page 7: ...ure and humidity different from that in the place of installation wait at least 60 minutes after delivery If the device is moved from a cold to a warm place it may contain humidity which by adversely...

Page 8: ...sterilization water must be less than 10 ppm or in the case of conductivity measurement it must be less than 15 S cm therefore tap water cannot be used as feed water for the device The table below sh...

Page 9: ...nect the blue connection hose to the blue feedwater connection which is marked on the rear panel of the WATER IN device The tubing should be inserted into the connector to the depth of the black line...

Page 10: ...of feedwater WATER IN with Enbio Magic Filter Connect the shorter part of the blue Enbio Magic Filter connection hose to the blue water supply connection which is marked on the rear panel of the WATER...

Page 11: ...or other places where the unit could be flooded danger of short circuit The device should be installed in a well ventilated room far from heat sources and rooms where mixtures of gases or liquids or...

Page 12: ...the packaging material must not be placed too loosely or be tightly stretched so as not to affect pressure variations during sterilization a label with information about the contents of the package th...

Page 13: ...IO PRO device does not affect the biocompatibility of the materials All device components that come into direct contact with the sterilized load do not cause toxicity sensitization or irritation Proce...

Page 14: ...rner of the screen During the program run the screen displays the temperature of the selected sterilization program or the current temperature in the process chamber in the lower left corner the curre...

Page 15: ...tal process time 15 min 16 min Vacuum test The vacuum test should only be performed on a cold device before starting work During the test the device verifies vacuum pump capacity tightness of the pneu...

Page 16: ...x B D test program can be stopped at any time by pressing the STOP field which is associated with incorrect termination of the test When the test program is complete alternating screens are displayed...

Page 17: ...ly check that the tubing is not clogged and obstructed and repeat the test WARNING The test kit will be hot To correctly interpret the test refer to the instructions provided by the test manufacturer...

Page 18: ...user can reset the values by pressing the RESET button The value for the service check can only be reset by an authorized service technician During the first process Vacuum Helix FAST 134 121 the uni...

Page 19: ...ps the process by pressing the STOP field in the case of a power outage or an error during the process for example lack of supply water If the STOP field is selected the following messages are display...

Page 20: ...tion of the device It is recommended to clean the inside of the process chamber once a week with a mild detergent without the addition of chlorine After cleaning the chamber should be wiped dry with a...

Page 21: ...n process and the correct functioning of the device it is recommended to replace consumables in a timely manner New filter Filter half used up Need to replace 6 1 Consumables The table below contains...

Page 22: ...g guidelines Name Replacement frequency HEPA bacteriological filter Every 1000 cycles or every 12 months Connection drain hose If damage is observed or once a year Plugs for water condensate container...

Page 23: ...on can be downloaded from the manufacturer s website http enbio com service 8 1 Installing the software To install the software double click on the software installation file After this operation an i...

Page 24: ...n window consists of three main areas Tree of all processes that have been synchronized with the flash drive have been sorted by execution dates Temperature and pressure graph with main autoclave and...

Page 25: ...he program and its version Search The program allows you to search for processes by date range process number process type process outcome success fail PDF report The program allows you to generate a...

Page 26: ...tle with the blue hose Correct the position of the blue hose so that the end is completely submerged in water Add a sinker to eliminate the problem in the future Check that the water supply hose blue...

Page 27: ...rds along its entire length no section may point upwards Clean the chamber door seal Contact with the service 13 Power failure Momentary voltage loss during operation Restart the device and make sure...

Page 28: ...ort enbio com WARNING The complaint process will be started when the service department receives a correctly completed complaint application When returning the device for service clean the chamber and...

Page 29: ...ange from 5 C to 25 C Relative humidity 0 90 Storage temperature range 20 C to 60 C Relative humidity 0 90 Ambient pressure range 900 1100 hPa Rating plate located on the bottom of the device Enbio S...

Page 30: ...June 1993 concerning medical devices as amended The device has been classified in Class IIb in accordance with rule 15 of Annex IX of the above mentioned Directive Conformity assessment has been carri...

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