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Leica BIOSYSTEMS 14 0493 80101, Instructions For Use Manual

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Leica BIOSYSTEMS 14 0493 80101 Instructions For Use Manual Download Page 78

78

Version 1.3, Revision D 

 

Operation

5

If the paraffin baths temperature is set to below 64 °C, or at 64 °C,  the melting time is approximately 
12 hours. If the paraffin baths temperature is set higher than 64 °C, the melting time takes longer, 
approximately 3 additional hours. For setting the paraffin baths temperature, see 

(

→

 P. 53 – 5.2.6 

System Setup)

.

For each paraffin bath, 2.8 kg-3.0 kg of the paraffin pellets are required. 
Fill the paraffin bath to the brim with pellets. The paraffin will need to be topped up with additional 
pellets within 6 hours.
Make sure that the paraffin has completely melted after being replaced, prior to use.

Note 

If pellets were added 6 hours after the initial paraffin refill, they may not be melted completely before 

use and an error message would be triggered which may cause the instrument to stop heating. 

Caution 

If the pellets were added, make sure that the paraffin is completely melted before starting a program.

Refilling paraffin

1.  Open the paraffin oven cover. A message pops up on the screen, and asks if you want to refill 

the paraffin.

2.  Press 

Yes

, the system will calculate the melting time. If it is to run a processing program, make 

sure that the time length before the paraffin step is longer than 12 hours. If the time length 
is less than 12 hours, the Formalin step will be delayed so that the melting time of 12 hours 
is completed. If the melted paraffin is added, press 

No

, and the system will not calculate the 

melting time. You must check the melting status of the paraffin, prior to use. 

Caution 

Press 

Yes

 first on the pop-up message box before adding the solid paraffin. 

There is a risk of blocking the instrument if the paraffin is not completely melted.

3.  Pull the paraffin bath out from the paraffin oven.

 Caution 

Proceed slowly and carefully when pulling out or removing a paraffin bath—never jerk it 

out. The paraffin inside is hot and can cause burns. The paraffin baths surface are also hot, 

therefore always wear chemical protective clothing, protective goggles, respirator, rubber 

gloves and all other necessary personal protective equipment during exchanging or adding 

paraffin.

4.  Drain the used paraffin into a bulk container and then refill the bath. The maximum and 

minimum levels for filling is in the interior wall of the paraffin bath.

Note 

Remove the residue of the paraffin or dirts before refilling the paraffin.

Summary of Contents for 14 0493 80101

Page 1: ... PEARL Tissue Processor Instructions for Use English Order No 14 0493 80101 Revision D Always keep this manual with the instrument Read carefully before working with the instrument Version 1 3 Revision D 08 2018 ...

Page 2: ......

Page 3: ...chnical details of the present Instructions for Use are not to be considered warranted characteristics of our products These are determined only by the contract provisions agreed between ourselves and our customers Leica reserves the right to change technical specifications as well as manufacturing processes without prior notice Only in this way is it possible to continuously improve the technolog...

Page 4: ... 3 2 Overcurrent protection 15 2 3 3 Overheating protection 15 3 Instrument Components and Specifications 16 3 1 Overview 16 3 2 Main features of the instrument 17 3 3 Technical Data 18 3 4 Compatible reagents 20 3 5 Recommended reagent handling 21 3 5 1 Cycle for changing reagents 21 4 Initial Operation 23 4 1 Installation site requirements 23 4 2 Standard delivery packing list 23 4 3 Unpacking a...

Page 5: ...stem 48 5 2 1 Languages 48 5 2 2 Regional Settings 48 5 2 3 Date Time 50 5 2 4 Alarm 51 5 2 5 Installation 52 5 2 6 System Setup 53 5 2 7 Data management 54 5 2 8 Maintenance 56 5 2 9 Event view 58 5 2 10 Network 58 5 3 Reagents 59 5 3 1 Reagent status 59 5 3 2 Groups 60 5 3 3 Stations 61 5 3 4 RMS 62 5 4 Program 66 5 4 1 Adding Editing programs 67 5 4 2 Favorite programs 72 5 5 Dashboard 73 5 6 R...

Page 6: ...ended cleaning reagents 92 6 3 Checklist for regular maintenance 92 7 Troubleshooting 94 7 1 Troubleshooting 94 7 2 Power failures 94 7 3 Malfunctions in the program sequence 95 7 3 1 Safe reagent 95 7 3 2 Crash or freeze of master software 96 7 4 Replacing a fuse 96 8 Ordering information 97 9 Warranty and Service 100 9 1 Warranty 100 9 2 Service information 100 9 3 Decommissioning and disposal 1...

Page 7: ...ious injury Note Indicates information which are important but not related to any risk Item numbers for numbering illustrations Fig 7 1 Numbers in red refer to item numbers in illustrations Save Software symbols that have to be pressed on the input screen are displayed as bold gray text Manufacturer Order number Serial number Manufacturer date Observe the Instructions for Use Caution consult the i...

Page 8: ... used in excess of the maximum permitted limit Symbol for alternating current PE terminal Power on Power off This warning symbol indicates the surfaces on the instrument that are hot during operation Avoid direct contact to prevent risk of burning Biohazard warning Solvents and reagents that are inflammable are marked with this symbol IPPC symbol Country code in accordance with ISO 3166 e g DE for...

Page 9: ...stem the shock dot shows impacts or shocks that are above a specified intensity through red colouration Exceeding a defined acceleration g value causes the indicator tube to change colour Tip n Tell indicator to monitor whether the shipment has been transported and stored in upright position according to your requirements With a pitch of 60 or more the blue quartz sand flows into the arrow shaped ...

Page 10: ...m Paraffin infiltration of histological tissue specimens The HistoCore PEARL must be operated exclusively with the reagents listed in the section of Compatible reagents P 20 3 4 Compatible reagents Caution Any other use of the instrument is considered Off Label use Failure to observe these instructions may result in an accident personal injury damage to the instrument accessories or specimens Prop...

Page 11: ...epair the instrument and access its internal components The instrument has been designed and constructed with the latest state of the art technology and according to recognized standards and regulations with regard to safety technology Operating or handling the instrument incorrectly can place the user or other personnel at risk of injury or can cause damage to the instrument or other property The...

Page 12: ...sport and Installation Caution Once unpacked the instrument must be transported only in an upright position Follow the unpacking instructions carefully to avoid damage to the instrument Prior to every transport in which it is possible for the instrument to be shaken tilted or lifted it must be cleaned including the tubing paraffin baths and reagent bottles otherwise the interior of the instrument ...

Page 13: ...rial and or toxic vapor please wear chemical protective clothing protective goggles respirator rubber gloves and all other necessary personal protective equipment Caution In exceptional situations e g accidental reagent spills it may be necessary to wear a respirator This depends on the specific local ambient temperature room volume additional load ventilation rate etc In case of doubt the laborat...

Page 14: ... is hot and may cause burns Also avoid personal contact with paraffin baths and retort walls they can be hot as well Caution When handling fixation dehydration or clearing reagents e g Formalin ethanol xylene etc wear Personal Protective Equipment lab coat protective goggles respirator rubber gloves etc When handling infiltration reagents e g paraffin etc wear Personal Protective Equipment lab coa...

Page 15: ...in baths and dry use ethanol to wipe clean the instrument exterior 2 3 Safety features on the instrument The HistoCore PEARL tissue processor is equipped with safety functions and with sophisticated software control mechanisms These ensure that the specimens remain undamaged in the event of a power failure or other malfunction during the program and that the program is completed successfully 2 3 1...

Page 16: ...nt components Fig 1 1 9 5 13 3 11 7 15 2 10 6 14 4 12 8 16 1 Active carbon filter 9 Caster 2 Specimen baskets 10 Condensate bottle 1 3 Retort 11 Paraffin drip tray 4 Lid latch knob 12 Paraffin oven 5 Paraffin baths 3 13 Basic instrument 6 Paraffin oven cover 14 Counter area 7 Reagent bottles 13 15 Display 8 Bottom tray 16 Retort lid ...

Page 17: ... of the program flow dashboard are for clarifying all menu steps The HistoCore PEARL can be operated using customized or pre installed validated tissue processing programs There are 3 pre installed non editable programs available including 1 Cleaning program 1 Overnight and 1 Biopsy 10 processing programs are freely configurable with up to 14 steps temperature time reagent pressure vacuum options ...

Page 18: ...Check function to ensure connecting status of reagent bottles In the event of a power failure the alarm system is triggered off The HistoCore PEARL will provide recovery measures after interruption In the event of an error an alarm is sound immediately The system will retry first to recover if this is unsuccessful the instrument will then fill the retort with a safe reagent to ensure the safety of...

Page 19: ...emperature cleaning reagents Ethanol 62 C Xylene 67 C Reagent bottles Reagent bottles 11 in reagent cabinet Condensate bottle 1 Cleaning bottles 2 Bottle volume Max 3 5 L Reagent Management System RMS RMS Processing program Cassettes Cycles Days Cleaning program Cycles Days Access levels Access levels Standard User Supervisor Service Password status Supervisor Service Type of password Alphanumeric...

Page 20: ...e HistoCore PEARL is permitted with the reagents specified in this section only These reagents must be validated before use i e tissue processing with patient tissue for diagnostics by the laboratory itself according to the local or regional accreditation requirements Reagents other than these listed here may cause severe damage to the components of the instrument Acetone benzene chloroform and tr...

Page 21: ... C The use of formalin reagents containing zinc chloride can cause corrosion of the instrument 3 5 1 Cycle for changing reagents Station Reagent Week 1 5 Cycles Week 2 Week 3 Week 4 1 Formalin Refresh each 600 cassettes 3 cycles Refresh each 600 cassettes 3 cycles Refresh each 600 cassettes 3 cycles Refresh each 600 cassettes 3 cycles 2 Processing water Refresh each 600 cassettes 3 cycles Refresh ...

Page 22: ...e to Station P3 P2 Paraffin Move to Station P1 Move to Station P1 Move to Station P1 Move to Station P1 P3 Paraffin Move to Station P2 Move to Station P2 Move to Station P2 Move to Station P2 12 Cleaning xylene Refresh Refresh Refresh Refresh 13 Cleaning ethanol Refresh Refresh Refresh Refresh On the condition that the instrument is running not more than 5 overnight program cycles per week and not...

Page 23: ...tilated and must contain no open flames The room in which the instrument is located must not be used as a permanent station for people Otherwise the room must be equipped with an exhaust device The installation location must be protected against electrostatic discharge Do not operate the instrument in rooms with explosion hazard To ensure proper function of the instrument it must be set up while m...

Page 24: ...k this first If one of the indicators is triggered the package was not handled as prescribed In this case please mark the shipping documents accordingly and check the shipment for damage Caution At least TWO persons are required when unpacking the instrument If the instrument is moved over stairs please call your local Leica Biosystems Technical Service who can safely transport it with appropriate...

Page 25: ...25 HistoCore PEARL Initial Operation 4 Fig 3 1 2 3 4 5 6 7 8 9 15 14 ...

Page 26: ...ath the instrument by pulling them towards you 8 Hook these rails into the groove on the left and right Fig 4 13 of the pallet so that they are flush with the wooden board that holds the instrument Fig 4 11 12 10 8 9 13 9 Push the instrument from the pallet Caution The instrument casters move very easily The empty weight of the HistoCore PEARL is 140 kg Therefore it is mandatory to have at least T...

Page 27: ...the casters 11 Remove the transport anchors Fig 6 1 2 Remove the packaging Fig 6 1 from behind the paraffin oven door along with the packaging Fig 6 2 covering the reagent bottles 12 Check the instrument and accessories for any visible transport damage All accessories are located in the small package box ...

Page 28: ...d To return the instrument follow the instructions above in reverse order 4 4 Basic instrument hardware 4 4 1 Installing the Display Installing the display L L The display is located along with all other accessories in the small packaging box Fig 7 1 2 3 4 5 1 Install the rubber pad Fig 7 1 on the instrument 2 Guide the cables of three terminals power supply USB port and display cable through the ...

Page 29: ...the hot surface wear chemical protective clothing protective goggles respirator rubber gloves and all other necessary personal protective equipment and keep your distance when opening the retort lid particularly if the reagents are heated Also avoid breathing in the vapors Level sensor and retort sieve Fig 9 1 2 There is a level sensor Fig 9 1 located at the right side wall of the retort It preven...

Page 30: ...he filter Fig 10 4 and on the instrument Fig 10 3 are at the same direction and then push the new filter in as far as it will go The date on which the filter has been inserted can be marked on the label Fig 10 3 on the front side 3 Close the top cover The instrument will calculate the time the active carbon filter has been in use When the time exceeds the warning threshold a warning pops up remind...

Page 31: ...spose of it with proper care according to the existing applicable local regulations 4 4 4 External exhaust system The instrument has been designed so that it can be connected to an external exhaust device The optional delivery includes the Extraction tube P 97 8 Ordering information for this purpose It is recommended to use an external exhaust system Fig 11 1 Attach one end of the extraction tube ...

Page 32: ...ns and baskets may drop down if they are not set down at the flat area of the counter 4 4 6 Cassette baskets Fig 13 1 2 3 4 The above figure Fig 13 shows the standard stainless steel basket Fig 13 1 The dividing spiral Fig 13 2 is used to align the cassettes in the basket accurately As shown with the dividing spiral the standard basket can be filled with up to 80 specimen cassettes Without a divid...

Page 33: ... a color LCD touchscreen A screen saver will turn off the screen display if no key has been pressed for 30 minutes Press any part of the touchscreen to restore the screen After having been restored the on screen functions will be non operational for a few seconds to avoid accidental touch of any keys The touchscreen is fastened to a stable base with four screws All terminals are protected from con...

Page 34: ...forcefully remove the paraffin baths when the instrument is cold Doing so can damage the instrument Caution Proceed slowly and carefully when pulling out a paraffin bath never jerk it out The paraffin inside is hot and can cause burns The paraffin baths surfaces handles and covers are also hot therefore always wear chemical protective clothing protective goggles respirator rubber gloves and all ot...

Page 35: ...s each other Fig 17 to facilitate filling and cleaning The maximum and minimum filling levels are located on the interior walls Make sure that the paraffin level is between these two marks There is a filter Fig 17 4 located in each paraffin bath which can be taken out for easy cleaning 4 4 9 The paraffin drip tray Fig 18 The paraffin drip tray Fig 18 is located below the paraffin oven It collects ...

Page 36: ...n the top with the reagent name in the middle and are displayed on the screen Fig 20 All reagent bottles have a max capacity of 3 5 L The maximum 3 5 L and minimum 3 3 L fill levels for filling are embossed on the front of each bottle Fig 21 2 1 3 4 Pulling out a reagent bottle 1 Grasp the front handle Fig 21 1 and pull out half of the bottle 2 Grasp the top handle Fig 21 2 and pull out the full l...

Page 37: ...s on the front side Regularly check and empty the condensate bottle P 90 Emptying the condensate bottle 4 4 11 The bottom tray Fig 22 1 The bottom tray is located below the reagent cabinet Fig 22 1 It collects reagents that have overflowed or spilled The bottom tray volumn is approximately 4 L The bottom tray must be regularly checked for signs of reagents that have leaked To do so use one hand to...

Page 38: ...lly Correspondingly all messages are classified according to their severity The HistoCore PEARL is equipped with 3 different alarm functions Instrument alarm This instrument alarm is generated from within the instrument itself for all alarm messages Local alarm This alarm is external to the instrument e g in the office of the instrument operator The local alarm is used when the instrument cannot c...

Page 39: ...ig 24 Normally open contact pin 3 Fig 24 Normally closed contact pin 2 Fig 24 Pin 4 Fig 24 and pin 5 Fig 24 shall be short circuited 4 6 Connecting the power supply Caution Observe the following instructions carefully to prevent damage to the instrument The instrument MUST be connected to a grounded power socket The power plug must be easily accessible so that it can be pulled out if required The ...

Page 40: ...ction we recommend connecting the HistoCore PEARL to a socket with a residual current circuit breaker Switching the instrument on 1 Connect the power cable to the power socket If applicable switch on the switch for the power socket 2 Switch On the ON OFF switch on the rear panel of the instrument 3 After being switched on the instrument will take a few minutes to initialize Fig 26 Fig 26 ...

Page 41: ...er A screen saver will turn off the screen display if no key has been pressed for 30 minutes Press any part of the touchscreen to restore the screen After having been restored the on screen functions will be non operational for a few seconds to avoid accidental touch of any keys Note When a program is running and the screen saver is active the message In processing is displayed on the screen ...

Page 42: ... 50 5 2 3 Date Time RemoteCare connection symbol Fig 28 3 Active user level symbol which have three levels Standard user default level Fig 28 4 Service Fig 28 5 Supervisor Fig 28 6 To switch between the user levels see Access levels P 47 5 1 Access levels Error button Fig 28 7 For more information see P 43 Message boxes Warning button Fig 28 8 For more information see P 43 Message boxes Program ru...

Page 43: ...manage data and access the service software User Fig 29 7 switch the user mode and change the password For more information see P 47 5 Operation Message boxes The system delivers messages in three different severity levels Information Fig 30 1 Warning Fig 30 2 Error Fig 30 3 Each message is displayed on the screen as shown below Fig 30 The message must be confirmed with OK Yes or No If an error oc...

Page 44: ...ed into each entry field however sometimes not all characters entered can be displayed Important keys Keys Description Escape Confirm Switch between upper lower case letters Switch between letters numbers and special characters Jump over the previous character Jump over the next character Delete the previous character Buttons Fig 32 1 2 The enabled button is highlighted Fig 32 1 the disabled butto...

Page 45: ...lease follow these steps Fig 34 1 2 3 Switching off the instrument Caution Do not switch off the instrument while a program is running L L Only supervisor or service user level can access the shut down button 1 Press the settings icon Fig 34 1 2 Press the icon of Maintenance Fig 34 2 3 Press Shutdown button Fig 34 3 The following message pops up Please note that the waiting hours in the message is...

Page 46: ...nt the power cord must be disconnected from the power supply and the instrument is cooled down Before moving the instrument make sure that no paraffin is in paraffin baths or the paraffin drip tray and the paraffin oven cover is closed to protect paraffin baths from dropping during transportation Or remove the paraffin baths from the instrument The retort lid must be sealed as well To avoid droppi...

Page 47: ...ns and additionally create programs and perform the initial setting functions The function buttons that can not be accessed by the Supervisor are grayed out Note The system will be automatically switched from Supervisor back to Standard user if no operation is performed within 10 minutes Service Fig 35 5 For service personnel only Fig 35 1 2 3 4 5 7 6 8 Switching from Standard user to Supervisor 1...

Page 48: ...e settings icon Fig 29 6 The settings menu has the following sub menus Languages Regional Settings Date Time Alarm Installation System Setup Data Mgm Maintenance Event View and Network 5 2 1 Languages Fig 36 1 2 3 Setting the Language L L Only Supervisor and Service user level can edit the system language 1 Press the icon of Languages Fig 36 1 2 Select a language from the list Fig 36 2 3 Press Sav...

Page 49: ...vice user level can edit it 1 Press the icon of Regional Settings Fig 37 1 2 Set the temperature unit C or F by pressing the two ends Fig 37 2 3 Set the time format 24h or 12h by pressing the two ends Fig 37 3 4 Toggle between the International format ISO format or US format Fig 37 4 5 Press Save Fig 37 5 ...

Page 50: ...me L L Only Supervisor and Service user level can edit it 1 Press the icon of Date Time Fig 38 1 2 Set the date by scrolling the wheels Fig 38 2 Note The date sequence is Day Month Year 3 Set the time by scrolling the wheels Fig 38 3 If the time format is set to 12h in the Regional Settings the time scroll wheel uses AM and PM Fig 38 4 The local time and date can only be changed to the value withi...

Page 51: ...ided Fig 39 4 5 Set the periodic time Fig 39 5 ranging from 0 10 minutes For example if it is set to 5 minutes the alarm rings one time per 5 minutes If the periodic time is set to 0 the alarm rings continuously The periodic time can be set to On or Off by using the slider Fig 39 6 If it is set to Off the periodic time is disabled 6 Press Test Fig 39 7 to play the select sound at the selected volu...

Page 52: ... Installation View the Instrument name Serial number and Software version Fig 40 1 2 Viewing the Installation Press the icon of Installation Fig 40 1 and the Instrument name Serial number and Software version are displayed on the right Fig 40 2 ...

Page 53: ...ended to set the paraffin baths temperature 2 C higher than the maximum paraffin melting point provided in the paraffin manufacturer s specification Otherwise the paraffin that is not completely melted may cause a blockage in the air liquid system If the paraffin baths temperature is set to above 64 C the melting time will take longer approximately 15 hours If the paraffin bath temperature is set ...

Page 54: ... check is interrupted for example by the power failure restart the Bottle Check when the power is restored 5 2 7 Data management Note The instrument only supports the USB disk with FAT32 format User export Fig 42 2 3 4 5 6 1 With this function the data relating to the instrument can be transferred to a USB disk The following data is saved Customized programs information of reagents status group st...

Page 55: ...ted files to your service engineer or customer support Service export L L Make sure that no program is running 1 Insert a USB disk in one of the USB ports on the instrument and press the icon of Data Mgm Fig 42 1 2 Press Service Export Fig 42 3 3 A display on the screen shows that data is currently being copied while the files are being transferred When all data has been successfully transferred a...

Page 56: ...5 Or press Remote SW Update Fig 42 6 after the RemoteCare server is connected and the button is activated 3 A display on the screen shows that data is currently being copied while the files are being transferred When all data has been successfully transferred a completion message appears Note If power failure occurs when updating the master software restart the instrument When the power restores c...

Page 57: ... the yearly preventive maintenance Active carbon filter The instrument calculates the time of the active carbon filter in use When the time exceeds the default warning threshold a warning pops up reminding you to replace a new active carbon filter When the time exceeds the default alarm threshold the alarm rings with a warning message Reset the active carbon filter L L The default warning threshol...

Page 58: ...44 1 2 3 4 Viewing log file 1 Press Event View Fig 44 1 2 Select a log file you want to view Fig 44 2 3 Press Open Fig 44 3 and the Event Viewer window pops up 4 Press Close Fig 44 4 to close the Event Viewer window 5 2 10 Network View and edit remote care parameters Fig 45 1 2 3 4 5 ...

Page 59: ...ng Remote Care parameters L L Only Supervisor and Service user level can edit Remote Care parameters whilst there is not a program running L L Make sure that the instrument is connected to the network 1 Press Network Fig 45 1 2 Uncheck Direct Connection Fig 45 2 and the proxy parameters fields are enabled Fig 45 3 3 Edit the parameters 4 Check Enable Remote Care Events Fig 45 4 5 Press Save Fig 45...

Page 60: ...selected row is highlighted with red Fig 46 2 3 Press Set as Empty Fig 46 3 or Set as Full Fig 46 4 or Reset Data Fig 46 5 as needed 4 A message pops up asking if you want to run a Bottle Check or not When editing the paraffin status no messages will pop up Note If the instrument is in heating the Bottle Check function is disabled for about 30 minutes 5 The reagent status is updated both in this w...

Page 61: ...n the table Fig 47 2 3 Press Edit Fig 47 3 and the color palette pops up The system provides 12 predefined colors 4 Select a color Fig 47 4 5 Press OK Fig 47 5 The new color will be used on all stations to represent the reagent 5 3 3 Stations This window shows a list of all stations with the allocated reagents defined in the instrument Allocation of the reagents Stations 1 11 can only be assigned ...

Page 62: ...hat ensures optimized reagent consumption and the best possible tissue processing results The Reagent Management System is controlled via warning threshold values that display the reagent replacement For each reagent a value of this type can be defined depending on the use RMS mode The RMS is divided into 2 groups Processing Reagents and Cleaning Reagents For Processing Reagents the following 4 mo...

Page 63: ...eded bottle turns to red and blinks The operator is notified that the reagent has exceeded and can replace this reagent before the program starts However it is possible to start the program if logged in at Supervisor level Always replace the reagents when the threshold is reached The exceeded bottle turns to red and flashes at the end of a program after the cleaning You can go directly to the reag...

Page 64: ...s steps of how to edit the RMS of a processing reagent To edit the RMS of a cleaning reagent select a RMS mode in the cleaning reagent setting area 4 Press Edit Fig 49 4 and the Edit Reagent window pops up 5 To change the reagent name press the reagent name button Fig 49 5 To change the warning threshold value press the button Fig 49 6 6 Press OK Fig 49 7 The warning threshold value on the Status ...

Page 65: ...rea 3 Press New Fig 50 3 and the New Reagent window pops up 4 Select a reagent group Fig 50 4 5 Enter a name for the new reagent Fig 50 5 Enter the warning threshold value Fig 50 6 Please refer to the warning threshold value P 63 Threshold Value otherwise the tissue processing quality may be impacted 6 Press OK Fig 50 7 The new reagent is displayed on the Status window Deleting a reagent L L Make ...

Page 66: ...l or when a program is running the menu Program is in view mode At the Supervisor or Service level and if no program is running the menu Program is in edit mode The customized programs can be added deleted or edited by Supervisor Note HistoCore PEARL is normally used in sequential mode which means that the instrument uses one bottle after the other Note The pre installed processing programs and Cl...

Page 67: ...tics according to the local or regional accreditation requirements Fig 52 1 2 3 4 5 6 7 Creating a new program L L Make sure that no program is running L L Make sure that the number of programs is less than 10 L L Only Supervisor and Service user level can create edit delete customized programs 1 In the Program window Fig 52 select a program Fig 52 1 as similar as possible to the program you wish ...

Page 68: ...racters and can not consist of all spaces 4 Press the icon button Fig 52 4 The Select Icon window pops up 5 Select an icon Fig 52 5 6 Press OK Fig 52 6 7 Check the steps of the program If no change is to be made press Save Fig 52 7 and the new program is displayed at the end of current program list If changes are to be made to program steps go on with steps in Editing program steps Editing a progr...

Page 69: ...Select the step that is to be changed Fig 54 3 and press Edit Fig 54 4 The Edit Program Step window pops up 3 Make sure that the step which is to be changed is selected Fig 54 5 Set the duration of the time the temperature and the Pressure Vacuum type Fig 54 6 Note To change the temperature unit see Regional Settings P 48 5 2 2 Regional Settings 4 Press Save on the Edit Program Step window Fig 54 ...

Page 70: ...ram is running L L Make sure that the program has less than 14 steps L L Only Supervisor and Service user level can create edit delete a new program Fig 55 1 5 3 7 2 6 4 8 1 Select the program that is to be changed Fig 55 1 and press Edit Fig 55 2 The Edit Program window pops up 2 Press New Step Fig 55 3 The New Program Step window pops up ...

Page 71: ... 6 Press Save on the Edit Program window Fig 55 8 Deleting a program step L L Make sure that no program is running L L Only Supervisor and Service user level can create edit delete a new program Fig 56 1 2 3 4 5 1 Select the program that is to be changed Fig 56 1 and press Edit Fig 56 2 The Edit Program window pops up 2 Select the step Fig 56 3 that you want to delete and press Delete Fig 56 4 The...

Page 72: ...firmation message box pops up 2 Press Yes to delete the selected program 5 4 2 Favorite programs Favorite programs are displayed on the Program List Panel on the dashboard Up to 5 programs can be selected as favorite programs Setting a favorite program L L Only Supervisor and Service user level can set a program as a favorite program ...

Page 73: ...ogram name Fig 58 1 5 5 Dashboard Fig 59 1 5 3 2 4 On the dashboard displays the retort status Fig 59 1 paraffin baths status Fig 59 2 reagents status Fig 59 3 a list of favorite programs Fig 59 4 and program running status buttons of start pause abort Fig 59 5 and shows the seal unseal status of retort lid ...

Page 74: ...empty during draining Caution Do not open the retort when the program is running It may damage the specimens Paraffin baths status Fig 61 1 3 2 4 The paraffin baths are filled with paraffin group color and named with Paraffin 1 Paraffin 2 and Paraffin 3 The paraffin baths have the following status Empty Fig 61 1 The paraffin bath is empty Partially filled Fig 61 2 The retort is sucking draining th...

Page 75: ...ning a reagent Reagent bottle filling decreases from full to empty when the retort is sucking a reagent reagent bottle filling grows from empty to full when the retort is draining the reagent back Pipe connection Fig 63 1 When the retort is sucking a reagent from one station the connection from the station paraffin baths and reagent bottles to the retort is highlighted with the pipe filled with th...

Page 76: ... reagents or paraffin directly into the retort Doing so will cause an overflow from reagent bottles or paraffin baths during filling or draining which could result in instrument malfunction or potentially a fire accident 5 6 1 Filling draining reagents Caution The following steps should only be carried out by trained laboratory personnel experienced in handling reagents Always wear chemical protec...

Page 77: ...the reagent bottle on flat ground To do so keep your eye sight and the reagent level at the same level and make sure that the volume of the reagent is not either more than the max level or lower than the min level The insufficient reagent may cause the specimen to dry out due to the specimen not being covered by sufficient reagents 5 Place the filled reagent bottle back in the reagent cabinet When...

Page 78: ... the system will calculate the melting time If it is to run a processing program make sure that the time length before the paraffin step is longer than 12 hours If the time length is less than 12 hours the Formalin step will be delayed so that the melting time of 12 hours is completed If the melted paraffin is added press No and the system will not calculate the melting time You must check the mel...

Page 79: ...ue samples after transportation or moving the instrument perform a test run to ensure the suitability of the instrument and the program used Either use a pre installed program or combine this activity with the validation of your own protocols Only process patient tissue samples for diagnostic purpose after all above checks have been performed successfully If any of the previous steps failed contac...

Page 80: ...make sure that the retort is empty clean and dry Otherwise the contamination in retort may occur and impact the tissue processing quality 3 Put the baskets in the retort Note Use the basket during processing Do not put the specimens into the retort directly Carefully handle the specimens and place into a cassette to avoid dropping into the retort sieve holes 4 Select a program in the program list ...

Page 81: ...ou want the program to end Note The date sequence is Day Month Year 8 Press OK Fig 67 3 Note If the first reagent in the program belongs to the fixation group programs can be started up to 7 days in advance If the program is ended at a defined date time the delay step is lengthened accordingly Or if you do not set the end time press ASAP Fig 67 4 and then press Run Fig 67 3 The program starts The ...

Page 82: ... Note If you want to add more cassettes when the program is running and the tissue is soaking in Formalin pause the program and make sure to wear chemical protective clothing protective goggles respirator rubber gloves and all other necessary personal protective equipment to add the cassettes The Standard user can only pause the program at the first 3 steps and abort the program at the first step ...

Page 83: ...nd time Fig 68 5 Program Details button Fig 68 6 Press Program Details to view the program details Fig 69 Pause button Fig 68 7 At the Standard user level the pause button is only enabled during the first 3 program steps at Supervisor Service level the pause button is enabled at any time within the program Abort button Fig 68 8 Abort Program button Fig 69 10 At the Standard user level the Abort bu...

Page 84: ...nnot be resumed Please press the OK button then press the Abort button to abort the program Caution Make sure that the retort lid is sealed when the program starts Do not open the retort lid when a program is running 5 8 Ending a program When a program is completed a message pops up indicating that The program is finished Would you like to drain the paraffin Press OK and the instrument starts to d...

Page 85: ...ol 80 0 40 45 5 Ethanol 95 0 40 45 6 Ethanol 100 1 00 45 7 Ethanol 100 1 00 45 8 Ethanol 100 1 00 45 9 Xylene 1 00 45 10 Xylene 1 00 45 11 Xylene 1 00 45 12 Paraffin 1 00 65 V 13 Paraffin 1 00 65 V 14 Paraffin 1 30 65 V Biopsy approximately 2 hours 40 minutes Step Reagent Duration Temperature P V 1 Formalin 0 15 37 P V 2 Processing Water 0 02 3 Ethanol 70 0 05 45 4 Ethanol 80 0 05 45 5 Ethanol 95 ...

Page 86: ...86 Version 1 3 Revision D Operation 5 Note The Duration is the time of soaking infiltration The two pre installed programs above cannot be edited or deleted they can be copied ...

Page 87: ...e Vacuum 1 Cleaning xylene 10 7 67 Ambient 2 Cleaning ethanol 3 3 62 Ambient Dry step Empty retort 3 Vacuum step 10 80 Vacuum 4 Ventilation step 20 Ambient Ambient Indicating the duration of soaking Running Cleaning program The Cleaning program skips any steps not required to complete the cleaning of the retort If the last step of a processing program is Formalin Processing Water or Ethanol the Cl...

Page 88: ...nd the cleaning program starts The procedure is displayed graphically on the Dashboard After the cleaning program has been completed a message appears on the screen if the temperature in the retort is high Open the retort lid and wait for a few minutes to let it cool down Cleaning reagent warning message If RMS is enabled the following indicates that the warning threshold values have been exceeded...

Page 89: ... the plastic scraper provided when cleaning the retort lid and seal to avoid damage to the retort lid seal Do not damage the edges of the seal with the scraper Cleaning the retort Wipe the retort using a lint free cloth moistened with solvent xylene or ethanol or mild detergent Remove residues of paraffin and reagent from the retort inside wall higher than the reagent level area and the area aroun...

Page 90: ...ue to liquid paraffin Pull out the paraffin drip tray Empty the paraffin drip tray with the supplied scraper If necessary place it in the laboratory oven on cellulose and clean with xylene substitute 6 2 2 Weekly cleaning and maintenance Cleaning the paraffin baths Caution Work carefully and wear gloves Be careful as the walls of the paraffin baths are very hot and may cause burns Wipe the paraffi...

Page 91: ...ning and maintenance Replacing the active carbon filter The life of the active carbon filter will depend on the reagent types used and the frequency of vacuum cycles The filter should be replaced every 45 60 days 45 days warning threshold 60 days alarm threshold After replacing the filter open the maintenances menu to reset the filter threshold For additional information see P 56 5 2 8 Maintenance...

Page 92: ...net wipe the stainless steel inner walls of the reagent cabinet with a lint free cloth moistened with a mild detergent Cleaning the paraffin oven Caution Switch off the instrument before cleaning the paraffin oven Work carefully and wear chemical protective clothing protective goggles respirator rubber gloves and all other necessary personal protective equipment Be careful as the walls of the para...

Page 93: ...e of the paraffin baths Check the filter of the paraffin baths Check and empty the condensate bottle Clean the inlet openings Check the retort sieve for tissue or paraffin residue Check the retort lid seal and clean it Clean the display Check the status of the active carbon filter Clean the reagent bottles from the inside Lubricate the O rings of the reagent bottles and check them for damage Make ...

Page 94: ...g a fuse Note If you cannot identify the problem by carrying out the above listed steps call Leica Biosystems Technical Service Caution If the instrument detects a power failure the heaters and the display are immediately switched off The objective in case of power failure is to secure the tissue samples in a currently running program The main emphasis is on the safety of the tissue samples not th...

Page 95: ...ted following any power outage or malfunction where the processing program cannot be automatically finished A processing program that has been started and cannot be finished automatically leads to a safe specimen state being initiated The safe reagent process ends with one of the following results Safe reagent filling process has been completed successfully The specimens are being protected by saf...

Page 96: ... replacing a fuse switch the instrument off and pull out the power plug Use ONLY the fuses with correct value Fuse rating T15 A 250 V AC Fuse Order No 14049354395 Fig 75 1 Replacing a fuse L L A suitable flat head screwdriver must be used to prevent damage to the fuse holders 1 Unscrew the two fuse holders Fig 75 1 at the rear panel of the instrument with a flat head screwdriver and check for dama...

Page 97: ...643 Maintenance kit 14049353391 Reagent bottle assembly 14049350465 Funnel 255 mm D 250 mm 14047643631 Connector male 5 pole 14049351429 Extraction tube 14049544881 Silicone pad 14049350559 Active carbon filter 200X100mm 36mm 14049350629 Main control fuse 14049354395 Reagent bottle label kit Order No 14049353389 Fig 76 Paraffin scraper Order No 14039353643 Fig 77 ...

Page 98: ...98 Version 1 3 Revision D Ordering information 8 Maintenance kit Order No 14049353391 Fig 78 Funnel Order No 14049355900 Fig 79 Extraction tube Order No 14049544881 Fig 80 ...

Page 99: ...99 HistoCore PEARL Ordering information 8 Optional silicone plate kit Order No 14049353396 Fig 81 Active carbon filter Order No 14049350629 Fig 82 ...

Page 100: ...nty terms of your Leica Biosystems sales organization or the organization from which you have purchased the contractual product shall apply exclusively 9 2 Service information If you are in need of technical customer support or spare parts please contact your Leica Biosystems representative or the Leica Biosystems dealer where you purchased the instrument Please provide the following information M...

Page 101: ... LeicaBiosystems com within the product menu This template has to be used for gathering all required data When returning a product a copy of the filled and signed confirmation has to be enclosed or passed on to the service technician The responsibility for products that are sent back without this confirmation or with an incomplete confirmation lies with the sender Returned goods that are considere...

Page 102: ...ww LeicaBiosystems com Version 1 3 Revision D 08 2018 Leica Biosystems Nussloch GmbH Heidelberger Str 17 19 D 69226 Nussloch Germany Tel 49 0 6224 143 0 Fax 49 0 6224 143 268 Web www LeicaBiosystems com ...

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