ENBIO Enbio Pro User Manual Download Page 17

The Helix test corresponds to the sterilization of instruments with A-holes in accordance 
with EN 13060. It consists of a 1500 mm long tube open on one side and a closed test 
capsule on the other side. The indicator strip is inside the test capsule.

Helix test

Helix test kit

This test is used to evaluate the efficiency of the device in the sterilization of hollow and porous 
loads, in particular:
•  Pre-vacuum performance and speed and uniformity of steam penetration.
•  Saturated steam temperatures and pressures 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
•  Follow the test manufacturer's guidelines
•  Place the test in the center of the tray in the chamber.
•  At the end of the cycle, open the sterilizer and remove the test.

Positive result

all areas of the indicator strip have 
turned dark

Negative result

Part of the indicator strip did not turn dark due 
to the presence of air inside the capsule.

Insufficient color change of the indicator strip fields indicates the presence of air during the test cycle 
due to a malfunction of the sterilizer. If the test result is incorrect, check the use-by date of the test pack, 
additionally 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. Open the capsule and remove the test strip.

5.4   Information menu

The info menu is accessible by pressing the Info. button.
This level displays information about the unit type, serial number, number of processes 
performed and available USB memory space for saving process data, as well as the 

COUNTERS

 service menu - process counters for filter changes. It is also possible to 

change the date and time. To set the date or time touch the digits on the display. When a 
certain field is selected, it starts flashing and the arrows for changing the value up or down 
are displayed. This is how to set the date and time correctly. Pressing the number again 
confirms it and you can move on to changing the settings of the next parameter. In the 
same way, you can select the language by clicking on its abbreviation.

The button labeled 

B

 turns off and on the blue backlight in the depth of the screen.

Clicking the 

LED

 button launches the backlight control menu on the sides of the device. 

Clicking a button  button turns off the button sounds.

Process 

count

Autoclave 

serial number

Language 

choice

Counter 

settings

Key sounds 

deactivation

Disable shaded 

background

Setting the 

date and time

LED illumination 

settings (Enbio 

S only)

30

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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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