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1.7.  Symbols used on the device

1.8.  Precautions, requirements, recommendations

•  The user is responsible for the correct installation, proper use and maintenance of the unit in 

accordance with the guidelines in this document. If necessary, contact the service department or your 
device supplier.

•  The sterilizer must not be used in the presence of flammable gases or explosive vapors in the ambient 

air.

•  At the end of each sterilization cycle, the load is hot. Instruments or packages should be removed from 

the chamber using appropriate protective gloves or other equipment to prevent burns.

•  Do not remove the rating plate or other markings from the unit - otherwise the warranty will be void.
•  Do not disassemble the unit's housing or other parts - otherwise the warranty will be void.
•  Follow the guidelines for preparing instruments for sterilization.
•  Flooding the device with water or other liquids may cause a short circuit and threaten the user's safety. 
•  Turn off the unit and disconnect the power supply before inspecting, performing maintenance, or 

servicing.

•  Inspection and servicing of the device may be carried out only by trained service technicians using 

original spare parts.

•  After sterilization at 134°C FAST the loads are wet. It is recommended to leave the drawer ajar to 

evaporate the remaining water and to lower the temperature of the instruments. 

•  ** After sterilization in the 134 ° C FAST program, the instruments are intended for immediate use. 

This symbol is located on the front of the appliance, on top of the drawer front, and 
advises extreme caution due to the high temperature of the compartment and its 
immediate surroundings. 

This symbol is located on the unit's rating plate and identifies its individual serial 
number.

This symbol appears on the unit's rating plate and identifies the Notified Body involved 
in the conformity assessment process for Directive 93/42/EEC.

This symbol is located on the unit's rating plate and identifies the year the unit was 
manufactured.

This symbol is located on the equipment rating plate and identifies the equipment 
manufacturer.

This symbol can be found on the unit's rating plate and requires the user to read and 
follow the information in this manual.

This symbol is located on the unit's rating plate and identifies the Authorized 
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 descriptions given therein 
and on the observance of all safety conditions. Any other use, not complying with this manual, may lead 
to dangerous accidents, for which the manufacturer will not be held responsible.

•  Access to the device must be restricted to unauthorized persons and the operating personnel must be 

trained. Operating personnel are understood to be persons who, as a result of their training, experience 
and knowledge of the relevant standards, documentation and regulations relating to safety and working 
conditions, are authorized to carry out sterilization and who can recognize possible dangers and avoid 
them.

•  This document must be supplied with the appliance; it contains detailed information on assembly and 

installation as well as commissioning, use, repair and maintenance. If the appliance is operated as 
intended, this manual contains sufficient information necessary for qualified personnel. 

•  This document should always be kept near the device and easily accessible. 
•  The manufacturer reserves the right to make changes that do not affect the safety of operation and 

maintenance of the device, without notice to users.

•  The manufacturer shall not be liable for damages during the period of waiting for service, inspections 

and warranty repairs, or any other damage to the Customer's property other than the device, in 
particular for errors resulting from improper installation or incorrect operation of the device.

•  Failure to follow the instructions in this document may endanger the safety of the device user and 

patients. 

•  The user must follow all unpacking, installation and operation guidelines - otherwise the warranty is 

void.

•  In particular, the user must ensure the availability of water of adequate quality - under the pain of losing 

the warranty. 

•  It is unacceptable to use any liquids, solutions, chemicals in the sterilization process - the device can be 

powered only with water of appropriate quality. The use of water of incorrect quality or solutions other 
than water will void the warranty. 

•  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. 

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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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