ENBIO Enbio Pro User Manual Download Page 16

Bowie & Dick test

The Bowie & Dick test, also known as the steam penetration test, simulates a small, highly porous load. To 
perform the test it is necessary to have a special test packet and placed inside the chamber. The package 
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.
•  Temperature and pressure of saturated steam reached for a certain period of time.

How to run the test:
•  The test must be carried out with an empty chamber in accordance with EN 13060.
•  Place the Bowie-Dick test package in the chamber in the center of the tray.

After selecting the Helix / B & D test program and starting 
it with the START button, the program sequence screen is 
displayed.
Information about the process parameters is displayed.

The Helix / 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:
[READY] Test complete / [READY] Chamber is safe to open.
The process chamber of the sterilizer can be safely opened. 

After opening the process chamber, the 
welcome screen is displayed.

The control test should be removed.

WARNING! The package will be hot.
To correctly interpret the test, refer to the instructions provided by the test 
manufacturer.

Open the package and remove the indicator chemical from the center of the package.

Any color change, uneven coloring of the test, indicates the presence of air during the 
test cycle due to a malfunction of the sterilizer. If the test result is abnormal, check the 
expiration date of the test pack and repeat the test.

Positive result

The chemical indicator turned a 
uniform dark color over the entire 
surface.

Negative result

A bright field remained in the 
middle of the test because of the 
remaining air inside the tested 
device.

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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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