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K-MINC-1000 User Manual

1. Cook Australia warrants to the purchasers of this device that at time of manufacture the product was prepared and tested in accordance with good manufacturing practices and guidelines specified by the Australian Therapeutic Goods Administration or relevant competent authority In the event of product failure under normal use due to defects in material or workmanship within a period of one 1 year from the date of purchase the product will be repaired or at Cook s option replaced at no charge This limited warranty does not apply to products subjected to abnormal use or conditions improper storage damaged by accident misuse or abuse improper line voltage or to products altered or serviced by anyone other than Cook Australia or its authorised agent The foregoing limited warranty is exclusive and in lieu of all other warranties whether written oral expressed or implied In particular Cook Australia does not warrant that the product is suitable for the needs of the purchaser and there are no warranties given as to merchantability or fitness for a particular purpose Cook Australia s representations concerning fitness for purpose or suitability for use by any purchaser does not extend beyond those representations set out in the Cook Australia literature that accompanies the product Cook Australia assumes that the purchaser is experienced in the use of this device and is able to judge from his her own expertise the suitability or otherwise of
2. K MINC 1000 Instructions for Use English AN WARNING ELECTRIC SHOCK HAZARD Determine if the available voltage corresponds to the device Connecting to the wrong voltage will cause the MINC to malfunction or may permanently damage the device The power cord must be equipped with a safety plug Use the enclosed power cord for the connection between the power plug and the device socket WITHIN CANADA amp U S A Use only a listed detachable power supply cable type SJT minimum 18AWGx30 3 conductors one end configured for NEMA 5 15 other end for IEC 320 CEE22 To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth 3 4 Rear of the device 1 Mains power inlet Connect the appropriate power cord to this point 2 Gas inlet Connect gas supply to this point 3 Gas outlet Blanking plug shown 4 External alarm contacts Connect to external alarm if required 5 USB connector Type B socket provided External alarm connection Use only with suitable alarm transmitters activated by means of contact closure Battery or Safety Extra Low Voltage powered alarm equipment not exceeding stated contact ratings may be connected to the external alarm terminals Refer to Technical Specifications 8 for alarm contact rating USB connection Use only with Laptop or Desktop PC standard USB connections USB 1 1 and USB 2 0 compliant Gas connections Refer to
3. EEL EE K MINC 1000 Du n de s rie A803560 Manuel d utilisation l utilisateur doit se familiariser aux directives de s curit avant d utiliser l appareil l utilisation de cet appareil est r serv e aux m decins et au personnel m dical ayant les comp tences techniques appropri es K MINC 1000 Ar to og piak ap u A803560 Eyyeipidio yononc NapakaAouue c oketwOEiTE uE TIG OSNyiEG AOMAAEIac TIPLV TH XENON TNG OUOKEUMG Auth OvoKEeun urope va ypNnolwortoinPEi vo anr tatpoUs amd Bon8oUc atpwv oi onoioi 61aBETOUV TNV KATGAANAN TEXVIKH EKTIOIOSUOH Sezione Kal MUN E Di K MINC 1000 Dal n di serie A803560 Manuale d uso Prima di usare il dispositivo leggere con attenzione le istruzioni di sicurezza Il presente dispositivo deve essere usato esclusivamente da medici e assistenti medici in possesso delle qualifiche appropriate Gedeelte KINN E K MINC 1000 Vanaf serienummer A803560 Gebruikshandleiding V r gebruik van dit instrument dient u zich vertrouwd te maken met de veiligheidsinstructies Dit instrument mag uitsluitend worden gebruikt door artsen en medisch personeel met de juiste technische kwalificatie Rozdziat FON SM hae cesses A EA O A A Nese cat T EA E sence OE N A A neue OEA E E A E K MINC 1000 Z nr serii A803560 Podr cznik u ytkownika Przed u yciem tego urz dzenia nale y zapozna si z instrukcjami dotycz cymi bezpiecze stwa Niniejszego urz dzenia mog u ywa tylko lekarze i persone
4. IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the MINC Benchtop Incubator requires continued operation during power mains interruptions it is recommended that the MINC Benchtop Incubator be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Portable and mobile RF communications equipment should be used no closer to any part of the MINC Benchtop Incubator including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommend separation distance d 1 2 VP Recommend separation distance d 1 2 VP 80 MHz to 800 MHz d 2 3 VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an e
5. K MINC 1000 From Serial No A803560 User Manual Please familiarise yourself with the safety instructions before using the device This device may only be used by physicians and medical assistants with the appropriate technical qualification C 0123 COOb MEDICAL www cookmedical com K MINC 1000 Instructions for Use Section Kapitola Eelere K MINC 1000 Od s riov ho sla A803560 U ivatelsk p ru ka Ne za nete toto za zen pou vat prostudujte si pros m bezpe nostn pokyny Toto za zen sm j pou vat pouze l ka i a zdravotni t pracovn ci s odpov daj c technickou kvalifikac Afsnit N I EE a K MINC 1000 Fra serienr A803560 Brugervejledning Du bedes g re dig bekendt med sikkerhedsanvisningerne inden enheden tages i brug Denne enhed m kun anvendes af l ger og sygeplejepersonale med de rette tekniske kvalifikationer Abschnitt MIT EE K MINC 1000 Ab Seriennummer A803560 Benutzerhandbuch Vor der Anwendung des Gerats bitte die Sicherheitsanweisungen lesen Dieses Gerat darf nur von Arzten und medizinischen Assistenten mit angemessener technischer Qualifikation verwendet werden A F partado Eiere K MINC 1000 A partir del N de serie A803560 Manual del usuario Familiaricese con las instrucciones de seguridad antes de utilizar el dispositivo Este dispositivo s lo pueden utilizarlo m dicos y personal de enfermer a con la cualificaci n t cnica adecuada
6. and a beep should be emitted from the MINC approximately every 30 seconds The contacts should close approximately 2 minutes later If the contacts fail to close then contact your Cook representative 6 4 Inspection by an authorised service agent Inspections at least once a year For ongoing operational safety of the MINC an authorised service agent must maintain the device annually as per Service Manual SMA30002 The service agent will asses the operational functionality of the gas and temperature control systems and external alarm contacts Authorised service agents All services such as alterations repairs calibrations etc may only be performed by the manufacturer or by service agents who are authorised by the manufacturer as per Service Manual SMA30002 Liability The manufacturer is free from all liability for the operational safety of the MINC if the device has been wilfully opened and unauthorised persons have performed repairs or alterations on it during the warranty period Certification The MINC owner will receive a signed certificate from the service agent for all inspections or repairs This certificate states the type and scope of the services rendered the service date and the name of the service company Technical documentation If the manufacturer provides technical documentation this does not authorise the user to perform repairs adjustments or alterations to the MINC or disposables 6 5 Return procedure
7. AN WARNING Electric shock hazard WARNING Explosion hazard Well WARNING Radio Frequency Interference IMPORTANT NOTE This provides special information that facilitates maintenance or clarifies important instructions Please pay particular attention to the Safety Instructions see 1 Manual Structure This manual has a table of contents page 2 to help you find section titles quickly Additionally an index can be found on page 27 A list of error messages and warning indications can be found on page 14 and there is a trouble shooting guide on page 25 K MINC 1000 Instructions for Use English A WARNING Please familiarise yourself with the safety instructions before using the MINC AN WARNING ELECTRIC SHOCK HAZARD A WARNING Do not sterilise the device A WARNING No user serviceable parts inside A WARNING This device should only be operated by appropriately qualified personnel WARNING EXPLOSION HAZARD Device can cause explosion in presence of flammable gases b WARNING Use the correct gas connecting hose A WARNING Use only original disposables This manual describes the operation and intended use of the MINC Benchtop Incubator MINC for devices with serial numbers from A803560 onwards It is essential to use this manual to familiarise yourself with the functions and the operation of the MINC before use Not following these instructions can result in damage or breakdown of the d
8. All devices or disposables that are returned must be prepared as described below for the protection of the service agent and for safety during transportation 1 Clean as detailed in 6 2 2 Seal in a plastic bag and seal within a second plastic bag 3 Place in the original packaging 4 Enclose the following information e Owner s name e Owner s address e Model type e Serial number of the equipment see identification plate e Description of the damage or fault The manufacturer has the right to refuse to carry out repairs if the products it receives are contaminated E IMPORTANT NOTE For optimal functioning of the incubator use only original disposables Order No Description K MINC CTS S Disposable Humidification Flask gas tubing and filter set supplied K MINC 1000 Instructions for Use English Classification according to IEC 60601 1 Type of protection against electric shock Degree of protection against harmful ingress of solids and water General specifications Power Supply Frequency Maximum power consumption Alarm contact rating Environmental operating conditions Storage and transport directions Manufactured and tested to the following standards Dimensions Weight Gas supply type Gas supply pressure Gas flow rate capability Gas flow rate accuracy Chamber temperature capability Chamber temperature accuracy Class equipment IP31 100 240 VAC 50 6
9. C The front panel displays will show actual temperatures of each chamber in degrees Celsius C 3 11 1 Turn the chamber on or off e Press and release the heating start stop touch pad e This will turn the chamber on or off depending on the current state 3 11 2 Display the temperature set point e Press and release one of the temperature selection touch pads e The MINC will beep and display the temperature set point for that chamber e After approximately one second the temperature display will revert to the actual chamber temperature status K MINC 1000 Instructions for Use English ic IMPORTANT NOTE For the MINC to maintain an appropriate environment in the chambers the lid must be securely latched when it is closed ic IMPORTANT NOTE For the gas flow to be active one or both of the chambers must be active See 3 11 1 Ty IMPORTANT NOTE Follow these steps the first time the MINC is used to ensure reliable performance 3 11 3 Adjust the temperature set point e Press and hold one of the temperature selection touch pads The MINC will beep e The temperature will adjust in 0 1 C increments from 35 C to 40 C e The selected value appears in the temperature display for that chamber When the desired temperature setting is reached release the touch pad e After approximately one second the device will beep and the temperature display will revert to the actual chamber temperature The new te
10. 180 before pressing onto the Luer fitting and rotating clockwise to lock the filter in place This will ensure no kinking or twisting of the tubing occurs 3 Insert the gas lines into the centre slots on each side of the bay as per the diagram below Check to ensure that the gas lines are not kinked and are seated correctly into the slots to ensure they are not crimped when the lid is closed 1 Centre slot with gas lines inserted 3 9 K MINC 1000 Benchtop Incubator Logger Software The K MINC 1000 Benchtop Incubator Logger Software is a PC based program that monitors the operating state of up to 10 MINC incubators You may use this software to monitor the behaviour of the MINC over the incubation period The software cannot be used to control the device and does not affect the normal operation of the MINC Key features are Regular 5 minute logging of actual temperature temperature set points actual gas flow and gas set point e Immediate logging of events and errors such as lid opening and closing events set point changes activation of chambers and gas flow activation of the device gas flow supply errors and temperature errors e Graphical presentation of all data on screen e Data is logged to a CSV file for easy analysis with spreadsheet packages e Ability to hot swap connections of up to 10 MINC s e Ability to name individual devices for easy identification K MINC 1000 Instructions for Use English
11. 3 14 2 Loss of mains power e If the MINC is switched on and one or both heater chambers are active loss of mains power will cause the external alarm to activate if the power is still off after 2 minutes e If mains power is restored within the 2 minutes the external alarm will not activate and the MINC will recommence normal operation e If mains power is restored after the 2 minutes the external alarm will deactivate and the MINC will recommence normal operation e Also if the gas flow was active before the power was lost then the MINC will restart the flow sequence in purge mode when power is restored 3 14 3 Low inlet pressure The gas flow display will show a CO2 display and emit an audible alarm if the gas inlet pressure is too low to maintain flow the nominal inlet pressure to trigger this alarm is lt 50 kPa L E The external alarm contacts will close 15 minutes later if the correct inlet pressure is not restored The alarm will reset when a gas inlet pressure gt 60 kPa is restored 3 14 4 No gas flow or gas flow out of range The gas flow display will show an Err display and emit an audible alarm if the gas flow differs T from the set point by greater than 4 mL min including no gas flow for longer than 10 minutes The external alarm contacts will close 5 minutes later To reset alarm after rectification of cause of alarm condition toggle the gas flow start stop touch pad Allow at least
12. EWE OF OOO EE Ee 1 27 K MINC 1000 Instructions for Use English The following pictograms appear on the MINC Benchtop Incubator and the Sterile Sp Disposable Humidification Flask packaging A N Before connection read the manual Consult the operating instructions for CE Mark Approval Degree of enclosure protection from solid objects and liquids BH information needed for the proper use of the device N Soft UL Approval Marking 9 Standby On LISTED RoHS Compliance Mark art Stop SECH X Dispose of in accordance with WEEE Increase Decrease Set Point directive 2002 96 EC AAA sl Manufacturer Heater soto EC REP EC Representative CO Gas Flow Status Catalogue Code Q Gas Flow Meter Serial Number Temperature 1 Q Do not use if packaging is damaged Outlet gt fy Gas Cylinder We 1 AN Keep away from sunlight T sD eg Keep dry Inlet 1 Batch code _ Contacts oo USB Connections Note 1 Symbols are on Sterile Disposable Humidification Flask packaging only Warnings and Important Notes Throughout these Instructions for Use blocks of text may be accompanied by a pictogram and or printed in bold type These blocks are WARNINGS and IMPORTANT NOTES and they are used as follows A WARNING The personal safety of the patient may be involved Disregarding this information could result in injury to the operator device or the contents AN WARNING Biological hazard
13. Hubs Make Model Description DUB H7 7 Port USB 2 0 Hub FSU407 Hi Speed USB 2 0 4 Port Ultra Mini Hub 3 10 Activating the device e Connect the power cord to the mains power inlet and switch power on at the mains e The MINC s serial number should be displayed in the left and right temperature displays for approximately 2 seconds e The gas flow rate display should display the software version number for approximately 2 seconds e The device performs a self test e The device will then return to its last mains powered state either in standby or normal operation If the MINC was active before the mains power was disconnected then the device will then recommence operation using the previous temperature and gas flow rate settings When either lid is opened and closed or gas flow is started the chambers are automatically purged to re establish the appropriate gaseous environment quickly The automatic purge flow rate is preset and operates independently of the set flow rate When the MINC has just been turned on or when the temperature has been adjusted the temperature alarm is deactivated for 120 minutes to allow the device to reach stable conditions without constantly alarming The MINC will not be interrupted by a temporary loss of mains power The device can be placed in standby mode by pressing the standby touch pad 3 11 Chamber temperature selection When first turned on the MINC will default to a temperature of 37 0
14. accepts the product subject to all terms and conditions herein subject always to any contrary provisions which are necessarily implied by stature or law notwithstanding the within terms and conditions 10 2 Life of product The life of this product is deemed to be seven 7 years After this time Cook Australia will no longer be responsible for this product A D Activating the device EE 12 Device description WEE 4 Alarm conditions EE 13 Device placement osnossnssnssensseneerserrserserrsersrrrerrrrrsere 8 Alarm contact gd e ME EE 23 Dimensions atic ee e EE 23 Alarmi et e EE 25 Disposable Humidification Hack 11 Authorised service agent 21 Disposables eebe d eet Eege Ee bt ee 22 Automatic purge EE 12 E B Hecric shock hazad EE 3 Biannual functionality TEStING 5 use Ge ae EE ENEE EE AEN 20 Electric shock dere EE 23 BENOVe E 15 Electromagnetic compatibility ue gef ENEE EE RAR ANE de 7 24 Blanking PUG EE 10 Electromagnetic emissions guidance 24 Electromagnetic immunity guidance 24 C ee Elimination OF de EEN 25 SEENEN 22 WW 8 Environmental operating conditions 23 Chamber temperature capability ccc cece ccc e cence ence eenes 23 Err display gaS TlOWea casa omnes cence ees a4cssaneer Err ETIKO neS ekai 25 Chamber temperature selectlon 0 cece ccc e cece een eee e enn eees 12 Err display e 25 Change Over eer irie cen eae EEEIEE RAEO RRE A 10 E Explanation of NEIES ae Eeer eet 3 Changing internal filter ga
15. and concentration of the media the altitude at which the MINC is being operated and the humidification status of the atmosphere in contact with the media The correct percentage CO for the desired pH can be determined from the graph provided At sea level the Cook Culture System range of media will give an approximate pH of 7 4 if 5 0 CO is used and 7 3 if 6 0 CO is used in the gas mixture Cook Medical recommends the use of 6 0 CO as it promotes a more rapid recovery to an acceptable pH Cook Medical recommends a reduced oxygen concentration from the normal atmospheric concentration to a more physiological value of 5 8 in the atmosphere in contact with the media as this may reduce reactive oxygen species formation If using the MINC at an altitude other than sea level the following graph may be used to find the approximate CO percentage to achieve a pH of 7 3 CO required to maintain pH 7 3 vs altitude 15 _ _ CO in dry gas ech CH 3000 5000 6000 Metres above sea level 1000 2000 4000 If a different medium is used or a different pH is required then the end user will need to determine the appropriate gas mix for connection to the MINC K MINC 1000 Instructions for Use English A WARNING The gas inlet must be connected to a regulated pressure source set to 150 kPa tolerance of 15 kPa at the MINC to operate correctly E IMPORTANT NOTE Cook Medical strongly reco
16. authorised service agent K MINC 1000 Instructions for Use English Ty IMPORTANT NOTE To reduce the risk of damage to the MINC the use of an Uninterruptible Power Supply UPS with power conditioning capabilities is strongly recommended Furthermore to ensure uninterrupted device functionality the use of the following is also strongly recommended e An automatic gas cylinder changeover unit that can maintain a minimum pressure of 135 kPa e A remote alarm to alert staff to any failures in the gas or power supply E IMPORTANT NOTE It is important to retain packaging for future use Refer to 6 5 Return Procedure ic IMPORTANT NOTE This device has been certified by an independent testing authority for use with USB and Remote Alarm Cables of less than 3 metres in length A WARNING If connecting the MINC Benchtop Incubator to the External Electrical System via the USB cable ensure that the External Electrical System complies with the IEC 60601 1 safety standard or equivalent i IMPORTANT NOTE Items required but not supplied are listed here Ty IMPORTANT NOTE A non powered USB hub is suitable to connect multiple devices An installation and set up checklist has been included at the end of this section see 84 This may be used to help ensure correct preparation 3 1 Unpacking Please find the following items supplied User manual MINC Benchtop Incubator Pati
17. dish into the front inner corner of each chamber Fill the front inner well of each dish with 0 8 mL of media culture and thermally equilibrate Sp To measure the temperature immerse the tips of calibrated thermocouples into the culture media as shown below ensuring that the each thermocouple tip sits on the bottom of each well Close the chamber lid and allow enough time for the thermocouples to thermally equilibrate 1 Left chamber thermocouple well position 2 Right chamber thermocouple well position 3 Front of MINC The temperatures measured will be the user set temperature 0 2 C 6 3 2 Gas flow rate ic IMPORTANT NOTE This To test flow rate use an air calibrated gas flow meter connected to the Luer lock outlet beneath the bacterial filter functionality testing must be as shown below performed every six months 1 Luer Lock Outlet 2 Flow Meter The gas flow meter should have no further restriction on the outlet and be open to atmospheric pressure Start the gas flowing The gas flow meter should indicate twice the user set point value 15 Twice the user set point is observed because the display shows gas flow rate per chamber At each of the following set points check that the measured flow rate is within the corresponding acceptable range Flow Rate Set Point mL min BE Ee Range If measurements lie outside the acceptable ranges then contact your Cook Medical representative Gas flow rates for the MINC are calib
18. humidification flask to 35 C in step 4 and 2 Purging the system at least 3 times in quick succession as in step 5 This will allow immediate use of the device 6 2 Cleaning the device Before periodic cleaning of the MINC remove the contents of the incubation chambers Shut down device Refer to 5 7 It is recommended that the MINC be cleaned with aqueous 70 alcohol ethanol or isopropyl Moisten a cloth and wipe all internal and external surfaces of the device Do not immerse the device in the cleaning solution Clean the gas vents located in the centre of the front of the chamber lids by scrubbing the hole with a small pipe cleaner wetted with the aqueous 70 alcohol solution Following cleaning leave the lids of the unit open to allow sufficient time to ensure that all alcohol fumes have dissipated Purified water may be used to wipe device surfaces at times when the use of alcohol solution is not appropriate 6 3 Biannual functionality testing In order to preserve the MINC and maintain its safety regular inspections are necessary for early detection of possible malfunctions The user or a qualified technician must regularly test the device to assess its functionality The following must be tested on a biannual basis e Temperature e Gas Flow Rate e External Alarm Contacts K MINC 1000 Instructions for Use English 6 3 1 Temperature Set each chamber temperature to 37 C Place a NUNC four well
19. in standby Temperature settings not entered correctly Set temperature not achieved in time Lids open for extended periods Device is not operating in functional environmental conditions Gas supply not connected Gas supply empty Gas lines are kinked Gas cylinder change over unit incompatible with the MINC Resistance to gas flow from series connection of multiple devices is too high to allow multi unit purging Disposable gas lines flask and filter are incorrectly connected or occluded Disposable filter occlusion due to moisture Disposable gas lines are kinked or blocked 125 Elimination of error Check the power supply connection Turn on the mains power Refer to 3 10 Check that the Standby Indicator is illuminated green Press the Standby touch pad Refer to 3 10 Enter correct temperature settings Refer to 3 11 3 Turn heater bay off and on again Refer to 3 11 1 Do not leave lids open for extended periods Turn heater bay off and on again Refer to 3 11 1 Evaluate device placement Refer to 3 6 Check gas supply connection Refer to 3 7 3 The gas flow should recommence in purge mode when the gas supply is reconnected Check available remaining volume The gas flow should recommence in purge mode when the gas supply is re connected Check that gas lines are not obstructed The gas flow should recommence in purge mode when the gas supply is rec
20. is required during the purge cycle e The outlet fitting of the regulator is to be a Swagelok SS 400 1 4RT fitting to fit the connecting hose supplied with the MINC 3 7 3 Connection to gas cylinder Connection of the MINC to gas cylinder is achieved by use of the supplied braided connecting hose It has a non toxic low permeability PTFE lining which prevents the loss of CO content associated with high pressure use of more permeable materials such as silicone and PVC Silicone tubing is relatively porous to pressurised CO and must not be used anywhere in the connection from the gas cylinder as the correct gas concentrations may not reach the MINC chambers The MINC and connecting hose are fitted with Swagelok 14 series tube fittings The standard hose length is 3 meters Alternative lengths are available in 60 cm 100 cm 6 m 10 m or 20 m A union fitting is available to connect gas hoses Refer to your local Cook Medical representative for more information A pressure regulator with these fittings should also be used These fittings use a tapered ferrule to provide a leak free seal upon connection Backnut The ferrules on the connecting hose have been pre swaged before shipping Therefore any ferrule and backnut on the cylinder mounted regulator will be surplus to requirements K MINC 1000 Instructions for Use English It will be necessary to connect the hose to the regulator outlet fitting and also to the MINC in
21. of gas supply e A source of sterile distilled water A pressure manometer to measure the device input gas supply pressure This item is not required if the regulator has gas output display gauges e A 9 16 spanner e If a longer gas connecting hose is required contact your Cook Medical representative e A computer suitable to install and run the K MINC 1000 Logger Software on e A USB hub for connecting multiple up to a maximum of 10 MINC s to a single computer K MINC 1000 Instructions for Use English 3 3 Front of the device Standby touch pad Toggles the device between Active and Standby State Power indicator Green Indicates the power is connected to the device Off Power is disconnected Temperature display heater chambers Heating status indicator heater chambers Flashing Orange Below Set point Solid Green Set Point Reached Flashing Red Above Set Point Temperature selection touch pads heater chambers Adjust Set Point from 35 0 C to 40 0 C Heating start stop touch pad heater chambers Gas flow rate display Gas flow status indicator Flashing Orange Purge Cycle Flashing Red Outside Set Point Solid Green Set Point Reached Gas flow rate selection touch pads Adjust Set Point from 15 to 25 mL min Gas flow start stop touch pad Activates Gas Flow when one or both heater chambers are active Gas vent holes Patient identification plates
22. program continuously scans the USB port for connected devices The MINCs can be connected at any time Note For users running Windows 2000 the logger software must be closed before disconnecting any of the devices from the USB port Failure to do so may result in a system crash due to deficiencies in the way Windows 2000 handles USB devices For users running Windows XP Vista 7 or 8 the devices may be disconnected and reconnected at any time It is recommended to upgrade to Windows XP Vista 7 or 8 if the selected computer is running Windows 2000 5 6 Using the Logger Software 5 6 1 Logger working screen When the Logger Software detects a connected MINC three graphs will be shown for each device The first and last graph displays the left and right hand chamber temperatures respectively while the middle graph shows the gas flow The graph data is continuously updated approximately once a second and both the actual measurement and the set point are displayed The graphs will rescale as new data is collected A maximum of 3 days of logging information can be displayed on the screen After this the old data will be truncated from the end of the graph and cannot be viewed again in the Logger program All data logged may be reviewed via the CSV file refer to 5 6 3 K MINC 1000 Instructions for Use English An area of the graph can be zoomed in by clicking and dragging a rectangular region using the left mouse button Ho
23. shall be placed into biohazard bags All sharps should be disposed of in suitable puncture proof containers ic IMPORTANT NOTE During the filling process do not overfill the flask above the limit line and ensure that no water gets through to the bacterial filter If this occurs the filter will be blocked and no CO flow will be possible In such case replace the whole humidification flask assembly K MINC CTS S To avoid bacterial filter blockage and or spillage of water inside the unit remove the humidification flask assembly from the bay before moving the MINC i IMPORTANT NOTE Refer to 5 5 for limitations when running Windows 2000 operating system 3 8 Humidification flask The MINC uses a disposable humidification flask gas line and filter set re order code K MINC CTS S To prepare and install the humidification flask 1 Under laminar flow conditions and using aseptic techniques fill the humidification flask with 170 mL of sterile water Ensure the flask cap is pushed on in the correct orientation Failure to seal the cap may result in loss of gas flow to the chambers 1 Bacterial filter 2 Gas outlet 3 Disposable Humidification Flask 4 Front of device 5 Bay 2 Insert the flask into the appropriate position in the bay The tubing exiting the flask should face the rear of the MINC Connect the filter with the Luer fitting to the gas outlet as shown above Rotate the filter and tubing anticlockwise
24. the product for the intended use Cook Australia conducts a technical advisory service which can be consulted by a purchaser or intended purchaser on an advisory basis After one 1 year from the date of purchase this device will be repaired for a repair charge equal to the cost of parts labour and transport Before returning a product for any reason please contact your nearest Cook distributor for assistance and instructions Cook Australia reserves the right to change or discontinue this product without notice 10 1 Liability Because Cook Australia has no control or influence over the conditions under which this device is used over its method of use or administration or on handling of the product after it leaves its possession Cook Australia takes no responsibility for the results use and or performance of the product Cook Australia expects that use of the product will be confined to trained and expert users In no event will Cook Australia be liable for any direct or indirect damages including incidental consequential or special damages arising out of or in connection with the use or performance of the product If the manufacturer provides you with technical documentation this does not authorise you to perform repairs adjustments or alterations on the device or disposables No representative of Cook Australia and no vendor or lessor of the product is authorised to change any of the foregoing terms and conditions and the purchaser
25. 0 Hz 140 VA 2A 30VDC 18 C to 32 C 5 to 85 RH 700 hPa to 1060 hPa 5 C to 40 C 10 to 75 RH IEC 60601 1 1988 A1 1991 A2 1995 IEC 60601 1 2005 IEC 60601 1 2 2007 IEC 61010 1 2001 EN 61010 2 010 2003 UL 61010 1 AED CSA C22 2 No 61010 1 2ED CSA C22 2 No 61010 2 010 2ED Door closed 405 mm wide x 190 mm high x 265 mm deep Door opened 405 mm wide x 400 mm high x 315 mm deep 11 kg 24 3 Ib Blend of 6 CO 5 O 89 N Cook Culture System at sea level or high purity 6 CO in air recommended tolerances 0 2 150 kPa 15 kPa 21 8 psi 2 2 psi 1500 mbar 150 mbar 15 mL min to 25 mL min per chamber in 5 mL min increments Purge at 175 mL min per chamber for 3 minutes 15 of flow per chamber normal flow 18 mL min per chamber purge 35 0 C to 40 0 C in 0 1 C increments in an ambient temperature range of 20 C to 28 C At set point of 37 C the ambient temperature range is extended to 18 C to 32 C 0 2 C at calibration point Computer requirements for K MINC 1000 Benchtop Incubator Logger Software Operating system RAM Free hard disc space Processor Display I O ports K MINC 1000 Benchtop Incubator logger software specifications Maximum connected MINC s Logging interval range Maximum logging time period Log file format Graph Update Interval Maximum displayed time period on screen Temperature resolution Gas flow resolution Note 1 Not recommende
26. 12 23 46 PH i 12 23 46 PEK 12 23 46 PE Gas gege is Left Temperature 32 7 Left Set Point 37 Right Temperature 35 1 Right Set Point 37 Gas Flow 0 Gas Sec Point 15 Left 3et Point 37 Right Set Point 37 Gas Flow D Gas Sec Point L Left Temperature 35 6 Left Set Point 37 Right Temperature 35 9 Right Set Point 37 Gas Flow O Gas Set Point 15 Lett Temperature 36 7 Left Set Point 37 Right Temperature 37 Right Set Point 37 Gas Flow D e Select the relevant program management application to uninstall the software eIn the list of currently installed programs select K MINC 1000 Benchtop Incubator Logger and then click the appropriate icon to uninstall and follow the instructions 5 7 After Use 1 Use the Standby Touch Pad to place the MINC in standby mode 2 Remove the humidification flask gas supply and power cord K MINC 1000 Instructions for Use English 6 1 Changing filter gas lines amp humidification flask A WARNING To guarantee safe operation it is necessary to carry out proper care and maintenance of the MINC and disposables Regular checks to confirm correct functioning of the device are recommended New and repaired products must be prepared and tested according to the user manual before use WARNING BIOLOGICAL HAZARD Do not use a contaminated humidification flask in the MINC It is recommended that the sterile humidification flask be replaced each tim
27. 3 seconds between toggled off then on again 3 14 5 Temperature out of range When the MINC has just been turned on or the set temperature has been adjusted the temperature alarm is deactivated for 120 minutes to allow the device to reach stable conditions _ without constantly alarming After this time the temperature display will show Err emit an audible alarm and the external alarm will be activated if the set temperature differs by greater than 0 4 C for longer than 2 minutes To reset alarm toggle heater chamber start stop touch pad Note This will deactivate alarm for 120 minutes If any alarm condition is unable to be rectified contact your local Cook Medical representative or authorised service agent Check the following for installation of the MINC L The chamber temperatures and flow rate have been adjusted to desired values L All items have been supplied L The packaging has been safely stored for future use L The MINC has been left to operate for 24 hours to ensure any residual out gassing of components LJ All non sterile items have been removed from is complete plastic covers Check the following for installing the K MINC 1000 L The power cord is correct for your region L The MINC has been placed in a suitable location LJ The appropriate gas mixture has been determined L An appropriate gas regulator has been sourced J The gas regulator has been set to 150 kPa L The ga
28. 803560 ve sonras Kullan c El Kitab L tfen cihaz kullanmadan nce g venlik talimat n renin Bu cihaz sadece uygun teknik vas flara sahip doktorlar ve t bbi yard mc lar taraf ndan kullan labilir K MINC 1000 Instructions for Use English Copyright A WARNING READ THIS MANUAL Please familiarise yourself with the contents of the manual before using the device Failure to comply with these instructions may result in damage to device device contents and or patient or user injury This device should only be used by qualified personnel AN WARNING ELECTRIC SHOCK HAZARD The equipment is to be used only with electrical systems complying with all IEC CEC and NEC requirements Ab WARNING Any adjustment modification or repairs to the equipment should be carried out by persons authorised to perform them m Disposal of this product must be undertaken with regard to the WEEE directive 2002 96 EC This manual contains information that is subject to copyright All rights reserved This manual should not be photocopied duplicated on microfilm or otherwise copied or distributed completely or in part without the approval of William A Cook Australia Pty Ltd Some of the parts and equipment referred to in this manual bear registered trademarks but are not identified as such It should therefore not be assumed that the absence of the trademark indicates that any given designation is not subject to tr
29. Gas Supply 3 7 for details 3 5 Electromagnetic compatibility The MINC Benchtop Incubator has been tested and found to comply with the electromagnetic compatibility EMC limits for medical devices as specified by IEC 60601 1 2 2007 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation Medical electrical equipment requires special precautions regarding EMC and must be installed and operated according to these instructions It is possible that high levels of radiated or conducted radio frequency electromagnetic interference EMI from portable and mobile RF communications equipment or other strong or nearby radio frequency sources could result in performance disruption of the MINC Evidence of disruption may include erratic readings equipment ceasing to operate or other incorrect functioning If this occurs cease using the MINC and contact your Cook Medical authorised service agent For guidance and manufacturer s declaration on electromagnetic emissions and immunity of the MINC refer to 8 K MINC 1000 Instructions for Use English A WARNING The MINC should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the device should be monitored to verify normal operation in the configuration in which it will be used WARNING EXPLOSION HAZARD Do not use the device in the presence of flammable gases J WARNI
30. IMPORTANT NOTE Users must have Administrator privileges to install software AN WARNING ELECTRIC SHOCK HAZARD Internal circuitry is energised whenever the MINC is connected to mains power irrespective of whether the device is on or in standby E IMPORTANT NOTE Ensure that gas supply is available to the MINC i IMPORTANT NOTE For the gas flow to be active one or both of the chambers must be active 3 9 1 Software installation Note The Logger Software and drivers should be installed before connecting the MINC to the PC To install this software 1 Insert the CD marked K MINC 1000 Benchtop Incubator Logger Software 2 Run KMINC1000 setup exe from the root directory of the CD For installation on Windows 2000 use KMINC1000 Legacy setup exe located in the Legacy Installer directory Follow the instructions on screen to complete the installation 3 9 2 Connecting USB cables For connection of multiple MINC s it is recommended that a USB hub be used not supplied mn 2m USB A B cables USB HUB Computer Once connected the software will automatically detect the connected MINCs The MINC does not consume any power from the USB port so un powered USB hubs are suitable for connecting up to 10 devices Daisy chaining of USB hubs is not recommended Each hub should be connected to a separate USB port on the computer The MINC has been successfully tested with the following USB
31. LEATION AND SET UP EEN 1 5 SR ale et le ee ee E ee ee ee E eee fee ee ree ee Te ee ee ee ee a reer et ern ee eee er err eee re 1 5 D2 VOU Me cG WO To ON eebe EE 1 5 SE FO OR E oa ca ese ick SEIE E on head cee COs aes tO ee OE eR Tw EE 1 6 34 Rear of the device Eternal 1 7 3 5 LieEChOmadmelic COmpPatiDIty EE 1 7 3 6 DEVICE placement EE 1 8 BF AS EE 1 8 3 2 ola rege EE 1 11 3 9 KMINC 1000 Benchtop Incubator Logger Software EE 1 11 SA UAN e EV aeei eE E r EE E eg 1 12 3 11 Chamber temperature selection EE 1 12 sI ads e ET e EE 1 13 SEN ln 1 13 RCR EE in E EE 1 13 4 INSTALLATION ANISET ORCHESTER Eeer deet ENEE ont eieeeneraen 1 14 Bb OPERATION OF THE DEVICE fg ios 54 acs Hoon 646 Ra esa eh eee ee ee Se E eh 1 15 RR te EE 1 15 52 sermon orne CUCS ESSren rierren Eet 1 15 EECHER dE ENES EFE REENEN ee 1 15 5A POssible condensate e ane BEE 1 15 SS Starring tae Loger e 1 16 ee Beete te age ele i ee oe ee ne ee ee ee ee eee ee ee ee er eT er rer 1 16 57 AIEr EE 1 19 6 SERVICE AND MAINTENANCE e A dad EEN EEN ERAN dee Gb ne DEER oN 44S EE Bed EES Age 1 20 6 1 Changing filter gas lines amp humidification Task EE 1 20 SOAS E E EE 1 20 6 3 Biannual functionality testing EE 1 20 64 Inspection by an authorised service agent EE 1 22 6 5 Retuimn ee UE 1 22 TIDUS PO SABES EE 1 22 SEENEN Eege 1 23 ERKENNEN 1 25 TOLIMITEDWARRANTY ice eros hance Ee Eege 1 27 ONDE Cio se ne a ee ee re ee ee enn ree nn ee ee ere er te ee ee ee ee ee ere rer Trey 1 27 TOs
32. NG ELECTRIC SHOCK HAZARD Do not immerse the device Ab WARNING Ensure that the appropriate high purity gas mixture is selected to suit the altitude above sea level of use and the culture media being used IMPORTANT NOTE When using the Cook Culture System at sea level a 6 CO 5 O and 89 N blend high purity gas mixture is recommended 3 6 Device placement The MINC should be placed on a level secure surface away from heaters coolers air conditioning outlets mists splashes and exposure to direct sunlight It must not be placed in the presence of flammable gases Position the MINC such that quick and easy disconnection of the power supply plug is not impeded It is recommended to allow a reasonable amount of space around each MINC to allow for natural air circulation A clearance of at least 10 cm is recommended around each device The ambient temperature range should be between 20 C and 28 C to maintain a device set point between the ranges of 35 C to 40 C At a device set point of 37 C the ambient temperature range can be extended from 18 C to 32 C 3 7 Gas supply 3 7 1 Gas mixture required To maintain the correct operating pH of 7 2 to 7 4 in bicarbonate buffered media the concentration of CO in the atmosphere in contact with the media must be strictly controlled The concentration of CO expressed as a percentage required to maintain the correct operating pH is dependent on the chemical composition
33. There should be direct contact between the base of the dish and the surface of the chamber base 5 3 Patient identification plates Use the magnetic Patient Identification Plates on the chamber lids to record culture dish contents with a marking pen Pen markings can be removed using an alcohol solution 5 4 Possible condensate formation During the normal usage of the humidification flask some condensation may naturally form in the tubing Normal Excessive Blockage There are several factors that can cause the formation of condensation e Repeated opening and closing of the humidifier chamber lid e Leaving the humidifier chamber lid open e Fluctuating ambient conditions e Draughts It is not recommended to obstruct any tubing in any manner K MINC 1000 Instructions for Use English ic IMPORTANT NOTE It is recommended that no other applications be running while the Logger Software is being used Other processor or memory intensive applications may prevent the proper operation of the Logger Software 5 5 Starting the Logger Software Once the software has been installed it can be run from the K MINC 1000 Logger icon on the desktop The program can also be started from the Start Menu under Program Files Cook Australia gt K MINC 1000 Logger After starting the Logger Software any MINC that is connected to the USB ports will be identified after a short delay then logging will commence The
34. ademark protection Users of William A Cook Australia Pty Ltd products should not hesitate to contact us if there are any unclear points or ambiguities in this manual This symbol indicates that this product may not be treated as municipal waste Please ensure that this product is properly disposed of as inappropriate waste handling of this product may cause potential hazards to the environment and human health For more detailed information about disposal of this product please contact your local city office or Cook Medical Representative Cook fulfills its legal obligations with regards to WEEE and Waste Packaging compliance through our own takeback initiatives and through national takeback schemes Please see http www cookmedical com businessPractice do id Environmental_Recycling for details on how to properly recycle WEEE or waste packaging in your country COOK 2013 Document No IFU MINC2 9 Service address Please refer to your local Cook Medical distributor for details of your nearest authorised service agent K MINC 1000 Instructions for Use English EXPLANATION OF PICTOGRAMS TEE 1 3 HOW TO USE THIS MANUAL TEEN 1 3 Warnings aac Bra eer en le 1 3 EE det ET 1 3 T SAPET el CT it e LEE 1 4 2 ABOUT THE MINC BENCHTOP INCUBATOR 6 55 csics census xa d0 bas exeea ex nie ba aoe buen wens EN ENEE baal Lad eh NE Rv NEON ads NS exes eege EN Sec 1 4 Pea Nee Ee CEET 1 4 SEENEN EE 1 4 23 Precautions POr GEVICE EE EEN 1 4 SINS TA
35. amaximum period of use being 4 weeks in order to avoid bacterial contamination of contents This section provides general information about the use of the MINC and Logger Software Only the clinician embryologist can evaluate the clinical factors involved with each patient and determine if the use of this device is indicated The clinician embryologist must decide on the specific technique and procedure that will accomplish the desired outcome 5 1 Before use Prior to commencing the culturing procedure carry out the following steps e Use the temperature selection touch pads to select the desired chamber temperature see 3 11 3 e Install the humidification flask filled with sterile water as detailed in 6 1 e Confirm humidification flask and gas lines are correctly installed e Activate the required chambers as per 3 11 1 e Use the gas flow selection touch pads to select the desired gas flow see 3 12 4 e Activate the gas flow see 3 12 1 Ensure that gas bubbles are observed in the flask during both the purge cycle and normal flow e Wait a minimum of 4 hours before using to allow for equilibration 5 2 Insertion of the culture dishes The MINC has been designed to be used with NUNC four well dishes or NUNC and FALCON 35 mm and 60 mm single round culture dishes Four well dishes or single round dishes may be placed on the chamber base Ensure that they sit securely in the grooves designed to accept them
36. ble If connecting multiple devices use the approved USB hubs Start by connecting one MINC at a time to isolate the fault If the USB drivers have installed correctly the MINC will appear in Windows Device Manager under Universal Serial Bus controllers as USBXpress Device when connected Ensure the file name of the MINC is a valid filename Refer to 5 6 2 Check that the log file directory is correct Refer to 5 6 3 If the name of the MINC is changed the data is not logged to the new filename until the software is started again Free up some disc space by deleting unnecessary files Zoom in to spread the labels apart Refer to 5 6 1 Alternately load the CSV file and scroll down to the time in question Refer to 5 6 3 Pan the graph up using the right mouse button The flow axis is scaled to give satisfactory viewing of normal flow rates Refer to 5 6 1 Pan the graph sideways using the right mouse button or use a longer time period on the View menu Refer to 5 6 1 Create the directory if it doesn t already exist Refer to 5 6 3 Close the other application and start the logger again Change the logging directory to begin writing a new log file Refer to 5 6 3 Remove the offending characters from the MINC name Refer to 5 6 1 Archive the specified log file and move it to another folder Refer to 5 6 3 K MINC 1000 Instructions for Use English
37. d Windows Vista Windows XP Windows NT Windows 7 Windows 8 or Windows 2000 1 256 Mb minimum 10 Gb minimum Pentium 4 1 6 GHz or better 1024 x 768 256 colour or better USB port 1 1 or 2 0 compliant 10 Adjustable from 1 to 10 minutes Only limited by free disc space Comma Separated Values CSV 1 second 3 days 0 1 deg C 5 mL min K MINC 1000 Instructions for Use English Guidance and manufacturer s declaration electromagnetic emissions The MINC Benchtop Incubator is intended for use in the electromagnetic environment specified below The customer or the end user of the MINC Benchtop Incubator should assure that it is used in such an environment Emissions Test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Electromagnetic Environment Guidance The MINC Benchtop Incubator uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The MINC Benchtop Incubator is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Guidance and manufacturer s declaration electromagnetic immunity The MINC Benchtop Incubator is intended for use in th
38. dical com Sweden 46 858769468 se orders cookmedical com Switzerland French 41 448009609 fr orders cookmedical com Switzerland Italian 41 448009609 it orders cookmedical com Switzerland German 41 448009609 de orders cookmedical com United Kingdom 44 2073654183 uk orders cookmedical com www cookmedical com Americas EDI www cookmedical com edi do Phone 1 812 339 2235 800 457 4500 Fax 800 554 8335 E mail orders cookmedical com Australia Phone 61 734346000 1800777222 Fax 61 734346001 1800077283 E mail cau custserv cookmedical com poe Manufacturer WILLIAM A COOK AUSTRALIA PTY LTD 95 Brandl Street Brisbane Technology Park Eight Mile Plains Brisbane OLD 4113 AUSTRALIA EC REP EC Representative COOK IRELAND LTD O Halloran Road National Technology Park Limerick IRELAND COOK 2013 IFU MINC2 9
39. e electromagnetic environment specified below The customer or the end user of the MINC Benchtop Incubator should assure that it is used in such an environment Immunity Test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60Hz magnetic field IEC 61000 4 5 Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 0 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT 95 dip in UT for 5 seconds 3 A m 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 6kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 0 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT 95 dip in UT for 5 seconds 3 A m 3 Vrms 3 V m Note At 80 MHz and 800 MHz the higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people
40. e regulated pressure is stilla nominal 150 kPa with all series connected MINCs purging Silicone tubing must not be used in the connections of multiple devices To connect units in series 1 Remove the blanking plugs from the second gas connection point of all but the last unit in the sequence 2 Connect the hose of the last unit to the second gas connection point of the previous unit 3 Repeat step 2 until all units are linked The gas connecting hose can be ordered in different lengths to suit individual installation requirements Contact your Cook Medical Representative for further details 3 7 5 Other gas connections For other gas connections or existing gas delivery systems e g gas cylinder change over units or permanently installed gas supply systems it is recommended that the user contact the relevant gas equipment supply centre for installation advice e g BOC Gases or Air Liquide For gas connection information contact your Swagelok distributor www swagelok com K MINC 1000 Instructions for Use English L WARNING BIOLOGICAL HAZARD Do not use a contaminated humidification flask in the MINC It is recommended that the sterile humidification flask be replaced each time the sterile water needs replacing or regularly with a maximum period of use being 4 weeks Used sets are classed as infectious waste All infectious waste must be disposed of in a suitable biohazard container or bag No sharps
41. e the sterile water needs refilling or replaced regularly with a maximum period of use being 4 weeks in order to avoid bacterial contamination of contents eg WARNING ELECTRIC SHOCK HAZARD Do not immerse the MINC IMPORTANT NOTE This functionality testing must be performed every six months Proper service maintenance and storage must be provided to preserve the MINC and ensure its proper functioning To protect the patient from infection all disposable items that come into contact with human tissue such as test tubes and tubing must be sterile Disposables must be discarded after each patient use To change the filter gas lines and humidification flask 1 Ensure the gas flow is turned off 2 Lift both heater chamber lids and the centre chamber lid Detach and remove the old filter gas lines and humidification flask 3 It is recommended to clean the entire device prior to installing a new filter gas line and humidification flask Refer to 6 2 4 Prepare and insert a new flask as detailed in 3 8 5 To recommence operation of the MINC a Turn the gas flow on b Check that bubbles can be observed in the humidification flask c Check that the gas line supplying each chamber is not kinked or pinched d Close the lid of the centre chamber and adjust the flow rate if required 6 Allow 4 hours for the water to heat and saturate with CO This process can be accelerated by 1 Pre heating the aseptically prepared
42. ent identification plates 8 plates Disposable Humidification Flask K MINC CTS S Medical grade mains power cord External alarm connector on rear of device Braided Connecting Hose 3 metre length K MINC BCT 10 300 USB A B cable 2 metre length K MINC 1000 Benchtop Incubator Logger Software installation CD 10 MINC Introduction DVD VD CO N WN A W N Check the MINC and all items immediately upon receipt to make sure the contents are complete and that nothing is damaged The manufacturer will only honour claims for compensation which are forwarded immediately to the sales representative or the authorised service agent Remove all items from plastic covers except the Disposable Humidification Flask which needs to be handled under sterile conditions refer to 3 8 3 2 You need to supply e A clean source of mains power to supply the MINC Cook Medical strongly recommends the use of a UPS with power conditioning capabilities suitable for your local power supply system e Premixed medical grade gas cylinders All gas concentrations should be within 0 2 and cylinders should be supplied with a certificate of analysis refer to 3 7 1 e A single stage high purity gas regulator capable of supplying the gas listed above at 150 kPa 1 5 bar 22 psi to the MINC inlet refer to 3 7 2 e Automatic gas cylinder change over unit Cook Medical strongly recommends the use of automatic change over units to ensure continuity
43. evice Internal circuitry is energised whenever the MINC is connected to mains power irrespective of whether or not the displays are illuminated Always disconnect the device from mains power before cord replacement or cleaning Should any power cord or plug associated with the incubator become cracked frayed broken or damaged it must be replaced immediately To reduce the risk of electric shock do not remove covers Please refer all servicing to the manufacturer s authorised service agent Protect the MINC from being splashed by liquid Should any liquid enter the device discontinue use immediately Do not use the MINC in an area where flammable gases are present Use only the Braided PTFE lined gas connecting hose supplied with the MINC Benchtop Incubator to connect it toa gas supply The use of another tubing type may result in the loss of desired gas concentrations For your own safety use only original disposables see 7 2 1 Intended use The MINC Benchtop Incubator MINC is a microprocessor controlled gassed humidified incubator intended for use in cell culture 2 2 Device description The MINC is designed to maintain temperature accurately at a user specified temperature within the range of 35 to 40 C and to maintain accurate gas flow at a user specified flow rate within the range of 15 to 25 mL min The MINC utilises premixed gas to maintain optimum culture conditions within the incubation chambers All com
44. file is time and date stamped Alarms and other events are logged immediately The logging interval may be set from 1 to 10 minutes by selecting Set Logging Interval from the File menu bati K MINC 1000 Instructions for Use English ic IMPORTANT NOTE User will require Administrator privileges to remove programs The CSV data files may be opened in any text editor or in Microsoft Excel The log files may also be opened in read only mode while logging is in progress but might not have the most recent data Disconnect the MINC and close the Logger to flush and close the log files Microsoft Lacel RG DP MIMC 3 793403 cev 062005 1208 ones 120 Gas Sel Point 06 2008 12 13 Left Tem 1806 2008 1213 Laft Set Point 19 06 2008 12 13 Right Temperature enone 12 13 Right Set Pont 1805 2008 12 13 Gas Flow 4808 0008 12 13 Gas Set Point 19 06 2008 12 18 Left Temperature 18 06 2008 12 18 Left en 18062008 12 18 emperature Kette SE 1806 2008 12 23 Gas Flow 18 05 2008 12 23 Gas Set Point t zoss seo sees 5 6 4 Un installation of Logger Software we aan PE 12 03 46 PE 12 08 46 PE 12 03 46 PR 12 03 46 PE 12 08 46 PH 12 08 46 PE 96 12 13 46 PE 12 13 46 PH 12 13 46 PE gt 12 15 46 PE 12 13 46 PE Oe 12 13 46 PE 3 12 15 46 PE 108 12 16 46 PH 18 12 18 46 PE D 12 19 46 PE 12 18 46 PH 12 18 46 PE 3 12 23 46 PE 12 23 46 PE B
45. gh supply pressure Gas connections not secure or damaged Gas line damaged A lid is opened MINC is not powered MINC is not connected Invalid filename Incorrect or invalid log directory Name recently changed Disc full Many events or errors occurring in a short period Gas purge event Extended logging period The log directory is invalid or does not exists The file is already open in another application The user doesn t have sufficient privileges to append to a file that was created by another user The name of the MINC is used as part of the log filename so none of these characters can be used The specified log file is greater than 10 MB in size Large log files can slow the system down 126 English Elimination of error Check connections to Luer fitting in central chamber Refer to 3 8 Check flask lid is tight and flask is not cracked or damaged Refer to 3 8 Ensure that the inlet pressure to the MINC does not rise above 165 kPa Ensure all gas fittings from the cylinder to the MINC gas inlet are tight If error persists inspect all fittings for damage to seal surfaces and replace as necessary Replace the gas line Close the lid this feature is provided to help prevent the chamber from being left open for longer than is required Refer to 3 11 4 Ensure that the MINC has mains power present Connect the MINC to the PC using the supplied USB ca
46. ian e cence ences 22 SMD UU Eo eege e installation Eeler tee EE geg 5 Benes Tae test ee eee eee a Installation and set up checklist 32 vg s deeg Ae AER EE EN 14 EE a A User e Le DEE 25 PCIE RE 4 L U Ee EEN 22 27 Es m ee E Be EE 13 26 EES OSNA j Life of Tee HEEN 27 Eet be E T 11 EE 7 Logger Software working screen 16 W et ele EE 18 Warnings and important notes 3 LOW IMEL EE 14 25 Warranty IMME EE 27 LOW OF NO Gas OW ET 25 Gs a eer ee ee eer a eT eee E E ee 23 M WV ICIS Ping autn ier close pvasenued evens incew E tes 7 Mains power inlet EE 7 Y ET E e D DIE 3 You need to supply ee et Eeer 5 IE e PEE EE EE E E EAA 8 Multiple K MINC 1000 devices cece ccc cect een eee tenn eeeneenee 10 N COOb MEDICAL Customer Service EMEA EDI www cookmedical com edi do Distributors 353 61239240 ssc distributors cookmedical com Austria 43 179567121 oe orders cookmedical com Belgium 32 27001633 be orders cookmedical com Denmark 45 38487607 da orders cookmedical com Finland 358 972519996 fi orders cookmedical com France 33 171230269 fr orders cookmedical com Germany 49 6950072804 de orders cookmedical com Hungary 36 17779199 hu orders cookmedical com Ireland 353 61239252 ie orders cookmedical com Italy 39 0269682853 it orders cookmedical com Netherlands 31 202013367 nl orders cookmedical com Norway 47 23162968 no orders cookmedical com Spain 34 912702691 es orders cookme
47. l medyczny posiadaj cy odpowiednie kwalifikacje techniczne Beie dite UC K MINC 1000 Desde o n de s rie A803560 Manual do Utilizador Antes de utilizar este dispositivo familiarize se com as instru es de seguran a Este dispositivo apenas pode ser utilizado por m dicos e auxiliares com a forma o t cnica apropriada Pazgen PY CCK 7 O GI K MINC 1000 C cepunHoro N A803560 PykoBogcTego no kcnnyataynn Nepeg npumeHennem ycTponctBa N3yYnTe NHCTPYKUMN NO TEXHNKeE Ge30NacHOCTH JLaunoe YCTPONCTBO MOXET NpDNMEHATbCA NCKIIOYMNTENbHO Bpayamn n NOMOLHNKaMN Bpaya C COOTBETCTBYIOLeN TEXHUYECKON KBannonkayne Cast e SEMI hg yeasts css evans sotetgsea E EA E E E E E A AER K MINC 1000 Od s riov ho sla A803560 Pou vate sk pr ru ka Pred pou it m tohto zariadenia sa obozn mte s bezpe nostn mi pokynmi Toto zariadenie m u pou va len lek ri a zdravotn asistenti s pr slu nou technickou kvalifik ciou SUONI EE K MINC 1000 Sarjanumerosta A803560 l htien K ytt opas Perehdy turvaohjeisiin ennen laitteen k ytt Laitetta saavat k ytt vain sellaiset l k rit ja avustajat joilla on asianmukainen tekninen asiantuntemus SENSI E K MINC 1000 Fr n serienr A803560 Anv ndarhandbok G r dig f rtrogen med s kerhetsinstruktionerna innan apparaten anv nds Endast l kare och sjukv rdspersonal med l mpliga tekniska kvalifikationer f r anv nda denna apparat K MINC 1000 Seri No A
48. lding the right mouse button will pan the graph around To return to the original graph scale double click the left mouse button Use the View menu to select the timescale of the graphs There is a choice of displaying the last 6 hours 12 hours 24 hours or 3 days of data on the scrolling graphs The last 12 hours of data will be shown by default The items in the Window menu can be used to arrange the graph windows as desired The program will first arrange the graphs by tiling them horizontally If the application window is resized select this option again to refit the graphs to the main window a hifi af Tt i att ms 799403 Right Temperate e 2R amp D MINC 3 793403 Gas Flow e 3R amp D MINC 3 793403 Left Temperature 5 6 2 Selecting and naming devices If there is more than one MINC connected the set of graphs for a specific device can be displayed by choosing the desired device icon shown below located in the banner area along the top of the window R D MINC 3 793403 Only one MINC can be selected at a time The icons are arranged in alphabetical order according to their name To re name the selected MINC select MINC Name from the Edit menu R MAIHL 1000 Henc hto The name must be less than 128 characters and must not contain lt gt or The MINC s name is used to construct the CSV filename so it must contain valid filename characters K MINC 1000 Instructio
49. lectromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol D a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the MINC Benchtop Incubator is used exceeds the applicable RF compliance level above the MINC Benchtop Incubator should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the MINC Benchtop Incubator gt Over the frequency range 150 kHz to 80MHz field strengths should be less than 3 V m K MINC 1000 Instructions for Use English Recommended separation distance between portable and mobile RF communications equipment and the MINC Benchtop Incubator The MINC Benchtop Incubator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the MINC Benchtop Incubator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications eq
50. let fitting The IMPORTANT NOTE Firmly instructions below must therefore be performed on each end of the connecting hose Following these instructions tighten the connecting hose s to should ensure a reliable leak proof seal every time the connection is made the MINC fitting and ensure that the blanking plug is also firmly tightened if used 1 Ensure that the fitting body tube end and ferrules are free of any foreign materials To connect the hose to a fitting 2 Insert the tube adaptor with pre swaged ferrules into the fitting body until the front ferrule seats 3 Tighten the backnut firmly by hand Using a 9 16 spanner tighten the nut slightly usually 1 8 turn or less Check the seal is gas tight by covering with soapy water and looking for the presence of bubbles If bubbles are observed disconnect and repeat from step 1 tightening the nut further if no foreign material is found in the fitting The blanking plug shown above must be tightened onto the unused gas connection 3 7 4 Series connection of devices A important NOTE keep your unused blanking plugs securely In situations where multiple MINCs are to be operated from a single gas supply point sequential connection stored in the event that independent of the units is possible operation of the units is required in 2 the future 2 AL Ensure that your pressure regulator is capable of flowing sufficiently for your needs If in doubt check th
51. low rate display e When the desired gas flow rate setting is reached release the touch pad e After approximately one second the MINC will beep and the gas flow rate display will switch back to show the gas flow rate The new gas flow rate set point will be saved 3 13 First time use Leave the MINC to operate with both heater chambers at 37 C and gas flow at 15 mL min for a minimum of 24 hours to ensure that any residual out gassing of components is complete Test each chamber for pH maintenance using culture media containing phenol red indicator 15 ug mL Adjust the gas flow to 15 mL min and place the culture media in culture wells in both incubation chambers After overnight incubation observe that the phenol red indicator is the correct colour salmon pink The MINC is now successfully installed and commissioned 3 14 Alarm conditions 3 14 1 External alarm The MINC has the facility to connect to an external alarm monitor that will alert staff of activated alarms out of hours This external alarm is normally an open circuit that can close under the following conditions e Loss of mains power e Low inlet gas pressure e No gas flow or gas flow out of range e Temperature out of range See 8 Technical Data for the alarm contact rating Customer requirements for the external alarm monitor should be referred to a company that specialises in this type of equipment K MINC 1000 Instructions for Use English
52. mmends the use of automatic gas cylinder change over units to ensure continuity of gas supply A WARNING Use only a suitable medical gas grade pressure regulator set to a nominal 150 kPa Do not use flow restrictors or flow regulators in the gas stream A WARNING Silicone tubing must not be used in the connection between gas cylinder and the MINC or in series connections of multiple devices 3 7 2 Gas cylinder regulator recommendations The following information is a recommended guide for the selection of a gas cylinder regulator used with the MINC Following these guidelines will provide a reliable gas connection between a gas cylinder and the device The gas regulator chosen in conjunction with the MINC is an important part of the gas delivery system and must be designed and manufactured to carry medical gases As the gas specified to be used with the MINC is of high purity and accuracy it is important that the regulator used does not contaminate the gas stream Please specify the information below when ordering your gas regulator e Single stage high purity regulator e Metal to metal diaphragm seal e Stainless Steel diaphragm which doesn t contaminate high purity gas streams e Dual scale gauges optional e Fully configured for a special blend medical grade gas cylinder e Delivery pressure of 150 kPa 15 kPa at the MINC gas inlet e A minimum flow without undue supply pressure sag capability of 350 mL min per MINC
53. mperature set point will be saved 3 11 4 Open lid l e Opening the lid will cause the temperature display for that chamber to display L IL instead of the chamber temperature A beep will be emitted from the MINC approximately every 30 seconds to alert the user to an open lid e Closing the lid will cause the temperature display to revert to the actual chamber temperature and the beeping will cease 3 12 Gas flow rate selection When first turned on the MINC will default to a gas flow set point of 15 mL min per chamber The front panel display will show actual gas flow per chamber in millilitres per minute mL min 3 12 1 Turn the gas flow on e Press and release the gas flow start stop touch pad e The MINC will begin purging for approximately 3 minutes and then go into normal flow operation 3 12 2 Turn the gas flow off e Press and release the gas flow start stop touch pad e The gas flow will turn off 3 12 3 Display the gas flow rate set point e Press and release one of the gas flow rate selection touch pads e The MINC will beep and display the gas flow rate set point e After approximately one second the gas flow rate display will revert to show the gas flow status 3 12 4 Adjust the gas flow rate set point e Press and hold one of the gas flow rate selection touch pads the MINC will beep e The gas flow rate will adjust in 5 mL min increments from 15 mL min to 25 mL min e The selected value appears in the gas f
54. ns for Use English 5 6 3 Logging data Logging of the data to a CSV file begins as soon as a MINC is detected The logging function cannot be turned off A separate data file is written for each connected device and these files are created in the data file folder To view the current folder choose Select Data File Folder from the File menu bator Lopper 8 emperatuy bam Bop e D s S LES d B SA il ren SA d From here a new data file folder may be selected or created The files are named with the MINC s name followed by its serial number The data in these files is appended so that they may contain data from several different runs To clear the data select Clear Logged Data from the File menu Data is cleared only from the actively displayed MINC If data files are to be kept for individual cycles it is recommended to copy the specific MINC data file to an archiving area and rename the copied file prior to clearing logged data files The copied file will contain all logged data from start up or the last time the file was cleared to the time the file was copied If the MINC is not disconnected and the logged data is cleared subsequent data will continue to be written to the cleared file The files may also be deleted or renamed with the Windows File Manager By default measurements are logged to file at an interval of 5 minutes Each line of the
55. onnected Ensure that the inlet pressure to the MINC does not fall below 135 kPa The gas flow should recommence in purge mode when the gas supply is reconnected Check the regulated pressure is still a nominal 150kPa with all series connected devices purging Refer to 3 7 4 Check connections to Luer fitting in central chamber and check that disposable lines are not kinked Refer to 3 8 Turn flow off and on again Refer to 3 12 1 Replace the Disposable Humidification Flask gas tubing and filter set K MINC CTS S Refer to 3 8 Turn flow off and on again Refer to 3 12 1 Check that gas lines are not kinked or obstructed Refer to 3 8 Turn flow off and on again Refer to 3 12 1 K MINC 1000 Instructions for Use Error and alarm indicator Low or no gas flow from disposable gas lines without alarm present Excessive gas consumption Lid displayed and device emitting beep every 30 seconds Logger software fails to recognise a device No logged data Obscured event labels or graph trace Data extends beyond normal range of graph File Open Error Cannot Open filename csv message Invalid MINC Name The MINC s name cannot contain lt gt or message File filename csv exceeds 10 MB Consider archiving and deleting message Source of error Disposable flask and filter are incorrectly connected Disposable flask lid seal Hi
56. ponents in contact with the gas flow including external and internal gas lines have undergone rigorous testing to ensure a toxin free environment The MINC has the ability to accept NUNC four well culture dishes or NUNC and FALCON 35 mm and 60 mm single round culture dishes in two separate chambers The two chambers have individual temperature control whilst the single gas flow control applies commonly to both chambers The heater blocks under each culture dish are in direct contact with the bottom surface of the dish Whenever the chamber lid is opened and closed a rapid purge with the gas mix occurs to re establish the required environment The MINC enhances safety by continuously monitoring the critical functions Deviation from normal operation is immediately detected and the user is alerted to the detected fault The device can be connected to an external remote alarm to alert staff out of normal working hours to any problems that the device is unable to self correct in the allotted time The K MINC 1000 Logger Software is a PC based program that is used to continuously record the operating state of up to 10 devices The software monitors the behaviour of the MINC but will not control the device This software can only be used with MINC s with serial numbers from A803560 onward 2 3 Precautions for device use Should any electrical or mechanical fault occur while using the MINC stop using the device until it has been checked by an
57. rated at 22 C at sea level Temperature and atmospheric pressure must be taken into account when calculating the expected gas flow The table below shows the flow obtained with altitude when the MINC has been set at 15 mL min Flow variation vs altitude Flow mL min 0 1000 2000 3000 4000 5000 6000 Metres above sea level K MINC 1000 Instructions for Use English AN WARNING No user serviceable parts inside A WARNING BIOLOGICAL HAZARD The returned product must be clearly marked with a contamination warning and should be sealed in a plastic bag and sealed within a second plastic bag When shipping the MINC ensure that the humidification flask and all chamber contents are removed prior to transport E IMPORTANT NOTE When returning goods use the original packaging The manufacturer does not take responsibility for damage that has occurred during transportation if the damage was caused by inadequate transport packaging 6 3 3 External alarm contacts To test the external alarm contacts ensure at least one heater chamber is active and then disconnect the MINC from mains power The contacts should close approximately 2 minutes later Once the contacts close reconnect the device to mains power and allow to operate for 150 minutes Open an active chamber lid and mist the chamber with cold water During this period the temperature display should display Lid
58. s 13 S Gas flow selection reen eege geen Zeene EEN EE 6 LE e 4 Gas flow Starty stop touch pad rengen DEE AE Ee ens 6 ie Ee E 7 Gas TOW status indicato ET 6 Sequential Connection 10 Gas ul EE 7 Series connections Of GOVICOS ince ged Serbo hk oc bb koh dr So wee H OS 10 e 11 Service and Elei e lt a c0ndsvea eave caves edvaleete coda taed sewn 20 Gas MECUPETEQUNGH 4 rectersnerssiea0 closes ut kiin ens eeranesahonvs 8 S a o EEIE EE E E Ee 5 A SOUE epee EE 11 Software installation 0 cc cece cece eect e nent nee e eee teeta enes 12 Gas TE LEE EE 9 Specifications x scwacxcvervexcasencyennbisventvevieniedexeveewineaxbeows 23 Gas supply EE EEN 8 Standards manufacturing and d BEE 23 Gas SUP TE 23 Standby TOUCh Pad sie visesvadcekdieresy ys soeedsedensonsenesdeusaransides 6 Gas SUDPIY TEE 23 Starting Logger SEW ke E deg EN Hehe ed E eege 16 Gas vent EEN 6 Storage and transport directions 23 Grounding Lab ae Ee e ee eee eas 7 Swagelok 1 4 series tube fittings EEN 9 H T Heating start stop touch pad ra eege dee ee dree dE ga 6 US elt EE 23 Heating status EE ai egene de E ere gea 6 Technical documentati EE 22 H wtouse this manual EEN 3 Temperature EE 6 e Wie le Tale EE 11 22 Temperature Out Of range ccc cece cece eee e eee e teenie eaenes 14 25 Temperature SElECUION EE 12 Insertion of the culture dishes cece cece cece eee eee e eee enees 15 E EEN repeat ee eee i Inspection by an authorised service technic
59. s connections have been made and checked LJ The Humidification Flask has been filled and fitted U The MINC has been activated Logger Software optional The installation CD and USB cable has been supplied L A computer with the the appropriate specification is available to run the Logger application on LJ The Logger Software has been installed L The USB connections have been made and checked using USB hubs where required for multiple MINC connections LJ The MINC s have been activated K MINC 1000 Instructions for Use English A WARNING To guarantee safe operation it is necessary to carry out proper care and maintenance of the device and disposables Regular checks to confirm correct functioning of the device are recommended New and repaired products must be prepared and tested according to the manual instructions before use ic IMPORTANT NOTE The MINC measures gas flow internally prior to the gas entering the humidification bay There is no mechanism to verify correct gas flow into each chamber The user must visually ensure the correct installation of the humidification flask and gas lines to ensure unobstructed delivery of gas to each chamber WAN WARNING BIOLOGICAL HAZARD Do not use a contaminated humidification flask in the MINC It is recommended that the sterile humidification flask be replaced each time the sterile water needs refilling or replaced regularly with
60. s lines and humidification flask 20 Explosion EE 4 B E e EE 23 External ala Miers EE 13 Cleaning the device EE 20 CO disnl ao External alarm contacts unssennnsennnsrernsrrrnssrrsrerrsrrress 7 EE ee ae External alarm contacts test 22 Condensate eg Et ee EE 15 External alarm monitor EEN 13 CONCENtAION Of CO c0scsnsaecnns sehen E E E TT 8 Connecting gas E 9 Connecting USB Cables sca se03 snay bose orisii Era orire KE EENI EREDIENS 12 erte TEE 15 K MINC 1000 Instructions for Use English F O EE 11 Operation Of the device A Ae cess es os Eeer dee S EN ge Ee bards 15 First OME EE 13 riginal disposables Anen Zeg see geen tiri riu dE een Dees As 4 22 Flow Ee ET EE 23 Oxygen een DEE 8 FOW EE 21 Fourwell ln EE 15 SEN Patient identification plates 0 cc ccc cece cece eee e eee enneees 6 15 PRCQUCIIGY EE EE 23 Bai D SE GENEE 6 Petri dishes E e siete ts ace 15 Power Consumption E 23 G DEER he 6 Gas connections Othe ee 10 POWER KI 23 Gas cylinder regulator recommendations eee eneeees 9 Precautions for ee EN 4 EE Tei d TR EE 9 R Gas TOW out of range EEN 14 25 Rear of the device 0 cece ccc cece nec e ene nee n een ee een eeenenees 7 Gas flow rate adjustment EE 13 Eege te 6 Regular inspections 79 SEN EE ER RENE EE Eh oententasnsnabauwees 20 Return procedure ee GEES 22 Gas flow rate selection EE 13 Gas flow rate set point display i02 50soctasdecdsasvetenteasescderei e
61. uipment transmitters and the MINC Benchtop Incubator as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output power e 800 MHz to 2 5 GHz of transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 0 01 0 23 0 1 0 73 2 3 10 7 3 100 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 9 Troubleshooting IMPORTANT NOTE Should any errors persist contact your Cook Medical representative Error and alarm indicator MINC will not turn on Displays do not illuminate MINC will not heat to correct temperature Temperature out of range alarm Err displayed Low inlet pressure alarm CO displayed No gas flow or gas flow out of range alarm Err displayed Source of error Power supply cord is not connected Mains power is not turned on The device is

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