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The devices are suitable for sterilization of loads for which steam sterilization is stipulated. The 
instruments must be sterilized only if they are clean and dry. Therefore they must be washed and 
disinfected before being loaded onto the tray in accordance with applicable regulations. Residues of used 
chemicals or other solid particles may render the sterilization process impossible or even damage the 
device. In addition, sterilization of instruments that have not been previously cleaned and disinfected is a 
biological hazard and can lead to damage (both to the instruments and to the sterilizer). For instruments 
that must be lubricated, use steam sterilization lubricants. Excess lubricant must also always be removed 
•  The 134 ° C FAST program is intended only for sterilization of unwrapped instruments (see "1.5 Enbio S 

Sterilization Parameters" and / or "1.6 Enbio PRO Sterilization Parameters").

•  After sterilization with 134°C FAST the instruments are moist - it is recommended to leave the drawer 

open for a few minutes to evaporate excess moisture.

•  After sterilization of unpackaged loads, they are intended for immediate use.

4.1.   Preparation of packages

It is recommended to use sterilization packaging that meets the requirements of EN ISO 11607-1: 2020 and 
EN 868-2: 2017. Appropriate packaging should:
•  ensure good penetration of the sterilizing agent into the inside of the package,
•  provide resistance to damage during the sterilization process,
•  ensure tight and durable sealing of contents and safe removal for use,
•  provide a barrier to microorganisms and unwanted substances and contaminants,
•  Use disposable sterilization sleeves (intended for steam sterilization) as recommended by their 

manufacturer

•  sleeves should only be filled to about 3/4 full to allow for proper sealing and minimize the risk of 

damage to the package

•  a distance of at least 30 mm should be maintained between the seals and the sterilized load. 30 mm
•  the sharp edges of the load should be protected to avoid damaging the packaging
•  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, the code of the packer, date of sterilization 

and use-by date as well as parameters of the sterilization process should be placed on the package

4.2.   Arranging packages on the sterilizer tray (sterilization of packed items)

•  packets on the tray should be placed so that the paper side touches the paper side, because 

penetration of the sterilizing agent and air exchange can only take place through the paper

•  the packages should be placed on the tray in such a way as to eliminate the contact of the 

package with the door seal and the phase of the sterilization chamber - failure to comply with this 
rule may cause the chamber to become unsealed and the sterilization cycle incorrectly carried out

•  the edges of the packs must not protrude beyond the sterilizer tray, as this would cause the 

chamber to leak and the sterilization cycle to fail

•  if the sterilizer chamber is heavily loaded, the first packs must face the foil side towards the 

bottom of the tray (this ensures faster and more efficient drying of the packs).

4.3.   Arranging tools on the sterilizer tray (sterilization of loads without packaging) 

•  in the case of sterilization without packages - the instruments must be placed in such a way that 

they do not have direct contact with each other, no element of them falls into the openings of the 
tray, and does not rest against the edge of the tray or protrude beyond its outline

•  Failure to follow the above recommendations may cause permanent and irreversible damage to the 

sterilization chamber phase, which will result in the lack of tightness of the sterilizer and loss of 
warranty

Do not exceed the maximum load weight: 500 g for Enbio S devices and 800 g for 
Enbio PRO devices. In order to verify the correctness of the performed sterilization, it is 
recommended to place a sterilization chemical indicator in the chamber for each process, 
which discoloration during properly conducted sterilization.

Example of a packed load.

Example of an unpacked load.

4.   Preparation and loading of instruments

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Содержание Enbio Pro

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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