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NTA

3015/78 C

Appendix 2

DEX | Page 5/11

Summary of Contents for ISOTEST

Page 2: ...74 Version C Date 07 07 2010 REVISION HISTORY Date Version Description Written by 22 12 2009 A First issue 09 186 E Delombaerde 12 02 2010 B General update 10 037 S Chauvin 07 07 2010 C Issue of softw...

Page 3: ...8 3 1 DEFINITIONS AND WARNINGS 8 3 2 GENERAL 9 4 GENERAL OPERATION AND RANGE OF APPLICATIONS 10 5 SAFETY INFORMATION 11 6 COMMISSIONING 13 7 EQUIPMENT DESCRIPTION 14 7 1 OVERVIEW 14 7 2 OPERATOR INTE...

Page 4: ...IONS FOR THE TOOLS AND ACCESSORIES 56 9 1 DPTE BETA BAG TM 56 9 2 TUBING SYSTEM 56 10 OPTION LIST 59 10 1 CONTROL SYSTEM 59 10 2 ACCESSORIES 59 10 3 CONSUMABLES 59 11 DEFINITION OF THE TECHNICAL TERMS...

Page 5: ...ICATION 1 1 ISOLATOR BRAND AND DESCRIPTION ISOTEST Rigid wall isolator for the performance of sterility tests European version 1 2 VERSION OF THE ISOLATOR AND THE SOFTWARE The isolator is identified b...

Page 6: ...ent Electronic signature DEX Page 6 74 1 3 MANUFACTURER S NAME AND ADDRESS GETINGE LA CALHENE 1 rue du Comt de Donegal 41102 Vend me cedex France 33 0 254 734 747 33 0 254 734 710 www getinge lacalhen...

Page 7: ...31 EEC 93 68 EEC 92 31 EEC Low voltage directive no 73 23 EEC Test voltage standard test as per EN 61 010 1 2001 issue Overvoltage classification II pollution level 2 Electrical safety as per EN 61 01...

Page 8: ...triangle that failure to apply the correct safety measures may result in mild injury CAUTION Means when not placed next to a warning triangle that failure to apply the correct safety measures may resu...

Page 9: ...ed by the equipment manufacturer may result in fires electric shocks and injuries IMPORTANT This manual must be kept within reach nearby the equipment and a copy must be sent to every user All measure...

Page 10: ...tains an overpressure inside the sterile volume while guaranteeing minimum air renewal with HEPA filtered air The isolator is furthermore equipped with transfer systems allowing the insertion and remo...

Page 11: ...rogen peroxide Only persons who have been trained in using the ISOCYT isolator are authorised to perform biodecontamination cycles In the event of a leak of hydrogen peroxide in liquid or gaseous form...

Page 12: ...y type of object even on a temporary basis This may affect the adjustment of the door compromising its seal DANGER Before opening the inner door it is advisable to make sure that no objects on the wor...

Page 13: ...EST User manual NTA 3015 78 C Approuv informatiquement Electronic signature DEX Page 13 74 6 COMMISSIONING Set the master switch to position 1 Check that the operator panel switches on The welcome vie...

Page 14: ...Electronic signature DEX Page 14 74 7 EQUIPMENT DESCRIPTION 7 1 OVERVIEW Number Designation 1 Work station 2 Sleeves and gloves 3 Quick biodecontamination airlock 4 H2O2 container 5 Red green LEDs fo...

Page 15: ...anual NTA 3015 78 C Approuv informatiquement Electronic signature DEX Page 15 74 Number Designation 1 Ventilation Filtration 2 Control command 3 Biodecontamination airlock 4 Built in STERITRACE II hyd...

Page 16: ...NE ISOTEST User manual NTA 3015 78 C Approuv informatiquement Electronic signature DEX Page 16 74 7 2 OPERATOR INTERFACE Number Designation 1 Master power switch 2 EMERGENCY AERATION push button 3 Tou...

Page 17: ...nt Electronic signature DEX Page 17 74 7 3 WORK STATION Number Designation 1 Steritest pump 2 DPTE S transfer system 3 Basket hanging bars 4 Sleeve and glove DANGER Special precautions must be taken w...

Page 18: ...18 74 7 4 BIODECONTAMINATION AIRLOCK Number Designation 1 Transfer trolley 2 Biodecontamination airlock door 3 Sealing gaskets 4 Inner door 5 Basket 6 Inspection window IMPORTANT To help when loading...

Page 19: ...A 3015 78 C Approuv informatiquement Electronic signature DEX Page 19 74 7 5 STERITRACE II STERILIZER INTERFACE Number Designation 1 Needle positioning lever perforation of the cap of the vial 2 Vial...

Page 20: ...for replacing a glove without breach of containment is as follows Installation of gloves for an isolator under positive pressure Pull the glove 2 to be replaced inside out into the sleeve 1 Remove the...

Page 21: ...y in concentrated form chloroform bleach etc Note This list is not exhaustive and it is always preferable to perform a test on one glove before beginning general application of any new method or produ...

Page 22: ...GETINGE LA CALHENE ISOTEST User manual NTA 3015 78 C Approuv informatiquement Electronic signature DEX Page 22 74 PVC Divetex sleeve Neoprene glove Hypalon sleeve Hypalon glove...

Page 23: ...f a DPTE DispoBagTM transfer system to ensure safe evacuation of liquid solid waste The other one is fixed to the vertical wall for connecting the Tubing system for evacuating tests Once the Beta part...

Page 24: ...d to the Alpha part and likewise the Beta part can only be disconnected if the door is closed The dummy container is used to facilitate biodecontamination of the seal surface It can be replaced with a...

Page 25: ...SOTEST User manual NTA 3015 78 C Approuv informatiquement Electronic signature DEX Page 25 74 8 2 PROCESS After a power failure or when a user logs off the following view appears To access the user vi...

Page 26: ...ross section of the machine 3 User logged in 4 Alarm in progress appears when an alarm is active OR providing access to the process values or the curves or the PID 5 Buttons to access the various menu...

Page 27: ...ss in the case of a biodecontamination the airlock automatically launches the emergency phase Launches the airlock cycle Pressing this button displays the locking conditions Allows the user to select...

Page 28: ...ny of the buttons are pressed the following screen appears Enter the username default Oper followed by the password default 101 Confirm your entry by pressing the OK button The logged in user can then...

Page 29: ...ain inside the isolator scales etc can remain there Objects that are left inside the isolator may risk compromising the quality of the biodecontamination since the biodecontamination cycle parameters...

Page 30: ...open Make sure a vial of HYDROCYDE is inserted in the container of the Steritrace II sterilizer and that the needle positioning lever is in the bottom position Step 2 If the Start button is displayed...

Page 31: ...Not ready button and the following window appears All the locking parameters must be set to YES in order to begin the cycle Yes Condition met No Condition missing Press the enter key to return to the...

Page 32: ...If the verification of the H2O2 bottle is correct the following window appears The following phases then succeed one another automatically see steps 3 and 4 If the cycle takes place without any fault...

Page 33: ...ct the missing condition and then restart the process from step 1 Three possible alarms H2O2 quantity for next cycle fault H2O2 vial expiry date fault H2O2 vial presence fault Replace the H2O2 vial an...

Page 34: ...t a production phase press button the following windows appears Step 7 Enter a batch number and press Start new batch button the production phase starts automatically Perform the following operations...

Page 35: ...ars The operator can transfer the load in the presence of a load into the isolator and then close the door Step 8 The isolator door is closed The airlock is in loading phase The airlock is not sterile...

Page 36: ...he load is inserted the operator can close the airlock door Step 10 The airlock door is closed The airlock is in loading phase The airlock is not sterile The operator can still open the airlock door i...

Page 37: ...t Press this button to move on to step 9 The operator wants to select another recipe for the biodecontamination phase Press the Recipe selection button and the following view appears Select a recipe a...

Page 38: ...H2O2 bottle If the verification of the sensor is not correct the following window appears Note Correct the missing condition and then restart the process from step 7 Three possible alarms H2O2 quantit...

Page 39: ...the test phase is correct the following phases then succeed one another automatically see steps 10 and 11 If the cycle takes place without any faults and the test is declared non compliant the followi...

Page 40: ...74 Step 12 The test phase is correct If the leak test phase is correct the biodecontamination cycle starts and the following animation appears Step 13 If the biodecontamination phase is completed wit...

Page 41: ...he load to the isolator After transferring the load to the isolator the operator can close the door again Step 14 The isolator door is closed The airlock is in loading phase The airlock is not sterile...

Page 42: ...e The airlock is not sterile The following animation appears When the load is inserted the operator can close the airlock door Step 16 The airlock door is closed The airlock is in loading phase The ai...

Page 43: ...age 43 74 If the test phase is not valid the following animation appears Perform the same steps for subsequent cycles 8 3 STOPPING A CYCLE BY THE USER The operator can halt a cycle by pressing the iso...

Page 44: ...esents a risk of inhalation for the operator when opening the outer door of the biodecontamination airlock If the NO button is pressed the cycle continues The following view appears during production...

Page 45: ...end of each phase The data from the preceding cycle are always stored in the memory and can then be printed from the user screen This is particularly useful for reprinting in the event of a printer e...

Page 46: ...ALHENE ISOTEST User manual NTA 3015 78 C Approuv informatiquement Electronic signature DEX Page 46 74 Select current cycle or last cycle Press the button to scroll down the menu until the following wi...

Page 47: ...LHENE ISOTEST User manual NTA 3015 78 C Approuv informatiquement Electronic signature DEX Page 47 74 Press the button to scroll down the menu until the following window appears Press the button to pri...

Page 48: ...GETINGE LA CALHENE ISOTEST User manual NTA 3015 78 C Approuv informatiquement Electronic signature DEX Page 48 74 Perform the same steps for all the subsequent phases...

Page 49: ...ge 49 74 Procedure for printing the alarm log In the user view press the alarm button and the following view appears Press the print button There are two options for printing the alarm log All Prints...

Page 50: ...EST User manual NTA 3015 78 C Approuv informatiquement Electronic signature DEX Page 50 74 Alarm log Alarm status A alarm appearing A D alarm disappearing and acknowledged Alarm status Alarm time Alar...

Page 51: ...Any error occurring during a cycle is displayed in the alarm view and must be acknowledged Alarm status A alarm appearing in red A D alarm disappearing and acknowledged in green Deletes all the alarm...

Page 52: ...d from the main view with at least validation access level WARNING Do not modify the parameters of the Isolator biodecontamination Airlock biodecontamination Isolator emergency and Emergency recipes w...

Page 53: ...be modified The following window opens Press the button to print the recipe Perform the same steps for the recipes of the isolator biodecontamination production unloading loading and emergency phases...

Page 54: ...pears Number Designation 1 Allows the user to select a recipe 2 Number of the selected recipe 3 Name of the parameter to be changed 4 Prints the selected recipe 5 Saves the selected recipe with a new...

Page 55: ...8 CLEANING It is advisable prior to any cleaning operation on the isolator to consult the leaflet NT 3015 12 CAUTION Before beginning to use any other cleaning products it is essential to check their...

Page 56: ...se and gamma sterilized Like all the DPTE systems they provide transversal airtight protection between the operator and the environment 9 2 TUBING SYSTEM The Tubing system has been designed to allow d...

Page 57: ...ent Electronic signature DEX Page 57 74 9 2 1 Basket The baskets are made of 316 L stainless steel Dimensions mm 240 x 160 x 370 Max admissible load 2 kg 9 2 2 Basket campaign The basket is made of 31...

Page 58: ...machine The welding machine and its frame are made of 316L stainless steel The welding machine consists of a double welding line and a cutting system This machine makes it possible to isolate the prod...

Page 59: ...2 ACCESSORIES Trolley for mixed waste 4 stainless steel baskets H2O2 metering system for the operator room 2 ergonomic seats 1 welding machine Tubing system only as an option 2 welding machines Tubin...

Page 60: ...of the DPTE mounted on the isolator wall DPTE BETA Container clamp container door container body assembly Mobile part of the DPTE for example a container DPTE BetaBag TM System for evacuating waste w...

Page 61: ...GETINGE LA CALHENE ISOTEST User manual NTA 3015 78 C Approuv informatiquement Electronic signature DEX Page 61 74 APPENDICES 2 appendices...

Page 62: ...NTA 3015 78 C Appendix 1 DEX Page 1 1...

Page 63: ...NTA 3015 78 C Appendix 2 DEX Page 1 11...

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Page 74: ...uctivity in the most cost efficient way We do this by offering well thought through and customized solutions This means that we are with our customers all theway from architectural planning and educat...

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