CulturePro
™ incubator
User manual
CulturePro incubator, software version 7.8
User manual, first issue 2021.08.02, revised 2022.06.01/230 V/English
Page 1: ...CulturePro incubator User manual CulturePro incubator software version 7 8 User manual first issue 2021 08 02 revised 2022 06 01 230 V English...
Page 2: ...upporting systems 19 3 1 Gas 21 3 2 ES server standard configuration only 22 3 3 External alarm output 23 3 4 Incubator data 23 3 5 USB connection for barcode printer stand alone configuration only 23...
Page 3: ...3 Notifications standard configuration only 69 8 2 Temporarily pausing alarms 70 8 3 Overview of the display colours of alarms warnings and notifications 71 8 3 1 Alarms 71 8 3 2 Warnings 71 8 3 3 Not...
Page 4: ...ce screen 98 13 2 2 Generating a monthly incubation report 99 13 2 3 VOC HEPA filter and sensor maintenance 100 14 Symbols and labels 103 14 1 Product information labels 103 14 2 Warning labels 104 14...
Page 5: ...al Users must be qualified to operate the device and qualified to perform procedures associated with device use in accordance with local qualification standards The product fulfils the requirements of...
Page 6: ...bator may not be used in a wet environment No fluids other than culture medium and oil and the cleaning agents specified in this user manual may be used in or near the incubator Never cover the vent h...
Page 7: ...he user s responsibility to validate the performance of the CulturePro incubator by performing quality control checks on the temperature CO2 and O2 levels every two weeks Only if the clinic incubates...
Page 8: ...PART 1 External equipment intended for connection to signal input signal output or other connectors must comply with the relevant IEC standard i e EN 60601 1 2006 Part 1 for medical electrical equipme...
Page 9: ...ation If this incubator does cause harmful interference to other instruments which can be determined by turning the incubator off and on the user is encouraged to try to correct the interference by on...
Page 10: ...URITY RECOMMENDATIONS Users are advised and expected to take the following measures to reduce cyber security risk in order to ensure that the device will work as designed in the intended user environm...
Page 11: ...ed to any accessory systems A standard configuration which can be connected to the ES server and communicate with other Vitrolife systems such as the EmbryoViewer software and share data with any avai...
Page 12: ...intain the desired gas concentrations inside the incubation chamber The gas is circulated through a VOC HEPA filter before entering the incubation chamber The same system also controls the temperature...
Page 13: ...door openings The removable frame surrounding the culture dish in load position combined with the fixed partitions between the culture dishes shield the dishes contained within the incubator from outs...
Page 14: ...yoViewer software In the stand alone configuration the barcodes can be printed from the Create Patient and Print Barcode screen Go to this screen by pressing in the bottom left corner of the screen St...
Page 15: ...nt only required if the clinic wants to incubate with reduced O2 concentration Medical electrical equipment requires special precautions regarding EMC and must be installed and put into service accord...
Page 16: ...the instructions contained in this user manual and only under the supervision of a person certified by Vitrolife 2 3 Starting up the CulturePro incubator In order to start up the CulturePro incubator...
Page 17: ...the PC home screen press the settings icon and select Shutdown 2 Select Remove all culture dishes and shut down and press OK The first culture dish is moved to the load door which is unlocked 3 Open...
Page 18: ...integrated PC will automatically restart when you press OK To manually restart the PC 1 Open the lid at the top of the incubator 2 Use a pointed object such as a pencil or a ballpoint pen to press th...
Page 19: ...ns certified by Vitrolife for establishing the relevant connections during installation Operators should never use or attach any tubing wiring to the incubator without supervision Main power switch Ma...
Page 20: ...turePro incubator 20 In addition a USB port that can be used by the clinic to extract monthly incubation reports see section 13 2 2 is available under the service lid at the top of the incubator USB p...
Page 21: ...k couplings that prevent the CO2 hose from being connected to the N2 inlet and vice versa The couplings are equipped with an automatic shut off valve that is activated when the couplings are removed f...
Page 22: ...y Ethernet cable and requires a special set up which must be performed by a person certified by Vitrolife The incubator may not be connected directly to an internet gateway ISP If the connection to th...
Page 23: ...o an external alarm system see section 8 10 3 4 Incubator data The CulturePro incubator is prepared for connection to an external logging system that can monitor the operation of the incubator The inc...
Page 24: ...ncubator screen controls the incubation conditions inside the incubator The incubator screen is used for Inspecting a range of incubation conditions current temperature CO2 concentration and O2 concen...
Page 25: ...een open Navigate on the incubator screen by pressing the buttons surrounded by a blue frame e g the temperature button on the home screen You can modify the set point of the incubation conditions or...
Page 26: ...ange set point mode To change between the home screen and the validation and calibration modes press the tool button Home screen Validation and calibration Tool button Press one of the incubation cond...
Page 27: ...the individual incubation conditions further details on the selected parameter are displayed If required you can change the set point of each parameter 4 1 2 Change set point mode When you press the...
Page 28: ...2 concentration The dotted green line displays the current set point It may be located behind the varying green graph The remaining graphs display the CO2 concentration varying green graph flow blue g...
Page 29: ...ormation on how to change set points 4 1 3 Validation and calibration mode The validation and calibration mode is used when you want to validate the incubation conditions and afterwards calibrate the...
Page 30: ...In the following example temperature sensor B is validated When the validation mode is opened the large PC screen displays a graph of the selected parameter in Live mode This graph is continually upd...
Page 31: ...this way the embryo temperature will correspond to the set point i e 37 0 C The other green line displays the current temperature as measured by the internal high precision thermometer When validatin...
Page 32: ...ration validation See sections 4 1 4 2 and 4 1 5 3 for information on how to calibrate the internal sensors 4 1 4 Controlling the incubator temperature 4 1 4 1 Changing the temperature set point 1 Pre...
Page 33: ...he temperature is calibrated The room temperature must be equivalent to normal laboratory temperature If the temperature reading made by an external high precision thermometer deviates from the curren...
Page 34: ...erature for sensor B in steps of 0 1 C or press to decrease the temperature in steps of 0 1 C until the displayed value matches the reading by the external temperature probe For example if the tempera...
Page 35: ...es and start a new calibration 4 After three minutes when the graph on the PC screen displays a stable temperature regulation validate the temperature by using the temperature probe a If the external...
Page 36: ...ress the blue framed Set Point button 3 Press to increase the gas concentration in steps of 0 1 or press to decrease the gas concentration in steps of 0 1 These are the minimum and maximum set points...
Page 37: ...ate gasses connected to ensure that full equilibrium is attained The room temperature must be equivalent to normal laboratory temperature Before you start make sure that the gas analyser is calibrated...
Page 38: ...cover from the gas sample port 5 Attach the tube from the gas analyser to the gas sample outlet The valve symbols differ between incubator models Cover to gas sample port Access to gas sample outlet...
Page 39: ...a sample The valve is open when the switch is turned to the left The screen displays the current CO2 O2 reading 7 Compare the reading made by the external gas analyser with the current reading displa...
Page 40: ...oncentration press 4 1 5 3 Calibrating the CO2 O2 concentration The CulturePro incubator must have been turned on for at least three hours to achieve full equilibrium before the gas concentration is c...
Page 41: ...een to increase the gas concentration in steps of 0 1 or press to decrease the gas concentration in steps of 0 1 to match the values on the external gas analyser For example if the concentration measu...
Page 42: ...e large calibration or press No to discard the changes and start a new calibration 5 After 10 minutes when the graph on the PC screen displays a stable gas regulation validate the concentration by usi...
Page 43: ...s that have been placed inside the incubator see the following screen shot Each patient may have more than one culture dish and thus be represented more than once in the overview From all other screen...
Page 44: ...use OR the culture dish contains one or more embryos selected for transfer Red The equilibration dish or culture dish is overdue and should be removed from the CulturePro incubator Running culture dis...
Page 45: ...e screen stand alone configuration In the standard configuration print one or more barcode labels for this patient from the Patient Details page of the EmbryoViewer In the stand alone configuration pr...
Page 46: ...bator will change from orange to a pulsating white colour indicating that the door is unlocked and can be opened 2 Open the load door and place the culture dish in the accessible position of the holde...
Page 47: ...der and do NOT want to insert the dish after all press the home icon Then remove the culture dish NOTE If the barcode cannot be read follow the instructions on the PC screen to manually enter the requ...
Page 48: ...ish Then reinsert the culture dish Insert the culture dish without a barcode and manually enter the patient information from the keyboard on the PC screen 2 There was a problem reading the barcode Ent...
Page 49: ...ew unique barcode for the treatment and place on the dish before inserting A culture dish with an identical barcode is running in the same or another incubator Print a new unique barcode from the Embr...
Page 50: ...sh holder in load position 3 When a message informs you that the incubator is ready press the unlock button at the front to open the load door 4 Remove the available culture dish and close the load do...
Page 51: ...u can resume culture in a culture dish if the incubator is connected to an ES server Culture can be resumed in the same incubator or in another compatible incubator If you attempt to insert a culture...
Page 52: ...n the system and initiate the emergency procedure see section 9 In the standard configuration you can also verify the connection to the server from this screen and re establish the connection if neces...
Page 53: ...er If the screen saver is disabled the text OFF is displayed under Screen Saver Press the arrow up to enable the screen saver Use the arrows to set the idle time period after which the screen saver wi...
Page 54: ...CulturePro incubator immediately after any media or oil spills 5 1 Periodic cleaning of the CulturePro incubator WARNING Never clean the CulturePro incubator with embryos inside Wearing gloves and us...
Page 55: ...inside the incubator If one or more dishes remain remove them as explained in the emergency procedure in section 9 7 Remove the load area frame 8 Moisten a lint free tissue wipe and clean all internal...
Page 56: ...70 ethanol and finally with distilled water again 13 Make sure that the load area frame is completely dry and that all traces of the used cleaning agent have evaporated The reinsert the load area fram...
Page 57: ...d using good handling techniques are important to successful cleaning Follow the below procedure to disinfect the CulturePro incubator in case of contamination and or spillage 1 On the PC screen press...
Page 58: ...n 5 Open the load door to the incubation chamber by pressing the white load door open button 6 Remove the load area frame 7 Clean all internal surfaces Apply clean distilled water to lint free tissue...
Page 59: ...free cotton buds Then wipe all surfaces as well as the culture dish holder and load area frame To do this follow steps 7 to 10 but use a disinfectant instead of distilled water 12 After 15 minutes of...
Page 60: ...person certified by Vitrolife or by clinic personnel in case the filter needs replacement outside service visits Always use a replacement filter delivered by Vitrolife This is the only filter that wil...
Page 61: ...cubator 61 4 Open the service lid at the top of the incubator to access the VOC HEPA filter 5 To remove the VOC HEPA filter follow the instructions on the following pages Grey quick connector White qu...
Page 62: ...CulturePro incubator 62 a Press the grey quick connector mounted in the filter tray and pull the filter to the left...
Page 63: ...CulturePro incubator 63 b Hold the VOC HEPA filter in upright position and press the white quick connector while pulling the filter upwards to release it...
Page 64: ...CulturePro incubator 64 6 Insert a new VOC HEPA filter by reversing the removal procedure a Insert the end of the VOC HEPA filter that has a red O ring into the white quick connector...
Page 65: ...5 b Insert the end of the VOC HEPA filter that has a grey O ring into the grey quick connector Always observe the flow direction indicated on the filter 7 Turn on the incubator by pressing the main po...
Page 66: ...r override the main fuses Follow this procedure to replace defective main fuses 1 Remove all culture dishes from the incubator and place them in a standard incubator by following the emergency procedu...
Page 67: ...A L 250 V You cannot insert the replacement fuses in the wrong direction 6 Close the fuse drawer by gently pushing it back into place 7 Attach the main power supply cord to the power inlet and switch...
Page 68: ...function All alarms are shown on the incubator screen and produce an audible signal that can be paused for three minutes All alarms activate an external alarm after a defined time delay see section 8...
Page 69: ...ory signal Only one of the redundant temperature sensors is not functioning Temperature control is handled by the remaining functioning temperature sensor 8 1 3 Notifications standard configuration on...
Page 70: ...he button which will continue to be pulsating red until the problem has been resolved The pause audio button will however be dimmed while the auditory signal is paused The auditory signal will automat...
Page 71: ...the incubator screen When the alarm has been reset the display will return to its default black colour Below is a graphical representation of the alarm colour scheme Default colour Incubator is in no...
Page 72: ...s alarms If multiple alarms occur at the same time the incubator screen will contain several red buttons on the incubator home screen Both an alarm and a warning may also be active for the same incuba...
Page 73: ...and reset in order to return to the default incubator home screen and enable operations such as changing set points or calibrating the sensors Only resolved alarms that are no longer active can be res...
Page 74: ...lly connected to the nitrogen inlet The incubator itself is not functioning correctly malfunction The power to the incubator has been cut off For a specification of the exact deviations required for t...
Page 75: ...screen Settings screen Shutdown button Then remove all culture dishes by following the instructions on the screen O2 CONCENTRATION Error condition 1 Error condition 2 Operator response O2 concentratio...
Page 76: ...s by following the procedure described in section 2 4 Immediately call Vitrolife support to schedule a service visit at your site O2 SENSOR ERROR Error condition 1 Error condition 2 Operator response...
Page 77: ...ator from the main power switch located on the back of the incubator Then remove all culture dishes by following the emergency procedure described in section 9 INCUBATOR MALFUNCTION Error condition 1...
Page 78: ...AL MOTOR HAS STOPPED Error condition 1 Error condition 2 Operator response An error has occurred that has caused the rotational motor to stop An action is required N A Follow the instructions on the P...
Page 79: ...ure is too low N2 inlet pressure is too low Check gas cylinders and supply lines to ensure adequate supply of gas at the required pressure see specifications LOAD DOOR OPEN Error condition 1 Error con...
Page 80: ...e support 8 8 Graphical overview of notifications and operator response standard configuration only A notification occurs when The connection to the ES server has been lost Below is a graphical repres...
Page 81: ...YES 2 Alarm O2 sensor error Red YES Details YES 0 YES 2 Alarm Incubator malfunction See 8 6 Details YES 0 5 YES 0 Alarm Power failure YES 0 YES 0 Warning Load door open Red YES Details YES 0 5 YES 2...
Page 82: ...to the external alarm system The external alarm system will only be activated when a number of pre defined errors occur see activation delays in section 8 10 2 Below you find a list of the errors tha...
Page 83: ...n the incubator itself For each type of error condition that may occur the table in section 8 9 specifies the total length of the delay until each type of error is sent to the external alarm system 8...
Page 84: ...all culture dishes can be terminated immediately by performing the following actions NOTE The emergency procedure may only be used when all other options to safeguard the running culture dishes have...
Page 85: ...the rest of the culture dishes by rotating the culture dish holder again and removing the next dish Repeat as many times as possible until you reach a hard stop Then rotate the holder counter clockwi...
Page 86: ...nt After the initial start up of the incubator there will be a grace period of 30 minutes before the temperature alarm is issued o CO2 concentration alarm Immediately displayed on the incubator screen...
Page 87: ...arm system will be activated within 60 minutes The exact delay depends on the specific situation o Load door warning Load door has been left open for more than 30 seconds o CO2 pressure warning Displa...
Page 88: ...um length External alarm Signal Unshielded 5 metres AC mains AC power Unshielded 3 metres Ethernet CAT6 Telecom Shielded 30 metres Barcode printer Signal Unshielded 5 metres Incubator data Signal Unsh...
Page 89: ...n case EMC immunity test levels are exceeded If the incubator is subjected to EMC immunity levels exceeding the levels tested malfunctions and instabilities may occur e g alarms and screen flickering...
Page 90: ...le contains the applicable information required for CISPR11 systems Guidance and manufacturer s declaration electromagnetic emissions The CulturePro incubator is intended for use in the home healthcar...
Page 91: ...to ground Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 2004 EUT...
Page 92: ...loser to any part of the CulturePro incubator including cables than 0 3 metres which corresponds to the distance of the test level applied Otherwise degradation of the performance of the CulturePro in...
Page 93: ...ople 1 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 pr...
Page 94: ...ower P of transmitter W Minimum separation distance d according to frequency of transmitter m Immunity test level E 3 V m 0 15 80 MHz Immunity test E 10 V m 80 2700 MHz 0 06 0 12 0 25 0 5 1 2 0 49 0 6...
Page 95: ...rating the incubator should be as least as accurate as the values displayed on the incubator itself or better i e Recommended accuracy for high precision thermometer in the range between 36 C and 39 C...
Page 96: ...n when it is time to change the filter O2 sensor 1 x sensor placed in the gas circulation unit 3 Certified service personnel UV light Internal UV light placed in the gas circulation unit UV light not...
Page 97: ...it 13 1 2 Routine calibration checks During each service visit service personnel certified by Vitrolife will also carry out routine calibration checks These checks are not a substitute for the regular...
Page 98: ...home screen and then press the Maintenance button The pin code on the right side of the screen provides access to advanced maintenance functions to be carried out in collaboration with Vitrolife pers...
Page 99: ...ator and press the Incubation Report button The following screen is displayed Select the month for which you want to generate an incubation report and press the Generate Report button A confirmation i...
Page 100: ...OC Filter button or the Sensor Validation button on the Maintenance screen PC home screen Settings Maintenance button Enable one or both options by pressing the corresponding radio button The interval...
Page 101: ...hidden for three days If you do not change the VOC HEPA filter within this period the warning will reappear You can press OK as many times as you like but the warning will reappear every three days un...
Page 102: ...ternal sensors If you press OK the warning will disappear and remain hidden for three days If you do not validate the sensors within this period the warning will reappear You can press OK as many time...
Page 103: ...pply See section 10 Declaration by the manufacturer that the device meets all of the applicable requirements in the Medical Device Regulation EU 2017 745 Medical device Unique device identifier Maximu...
Page 104: ...erial number Caution when discarded See section 15 Refer to the user manual 14 2 Warning labels Label Description Note Warns that the product is equipped with a UV light not connected in 100 V incubat...
Page 105: ...t of the CulturePro incubator The valve symbols differ between incubator models Alarm External alarm output socket See section 3 CO2 Inlet Pressure Max 1 Bar CO2 connection inlet See section 3 N2 Inle...
Page 106: ...r 106 14 4 Labels on the shipping crate Label Description Note Fragile This side up Keep dry Storage temperature Minimum 10 C Maximum 50 C C Humidity limitation Minimum 30 Maximum 80 Atmospheric press...
Page 107: ...011 65 EU which states that new electrical and electronic components do not contain lead mercury cadmium hexavalent chromium polybrominated biphenyls PBB or polybrominated diphenyl ethers It should ho...
Page 108: ...e hotline for support 45 7023 0500 available 24 hours a day 7 days a week E mail support support embryoscope vitrolife com response within two working days Vitrolife A S Jens Juuls Vej 20 DK 8260 Viby...
