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IFU-10891[C] HemaPRO 

User 

Manual 

Page 30 of 33

 

13.0

 

Safety Data Sheets 

Safety Data Sheets (SDS) for any associated reagents kits can be found at 

www.HardyDiagnostics.com/SDS/

. 

 
 

14.0

 

References 

1. 

Samples for Hematology

. 2014. Cornell University College of Veterinary Medicine, 

Ithaca, NY.

 

 

2.  Lee, S.H., et al. 2008. ICSH Guidelines for the standardization of bone marrow 

specimens and reports. 

International Journal of Laboratory Hematology

.  

Содержание QuickSlide HemaPRO

Страница 1: ...IFU 10891 C HemaPRO User Manual Page 1 of 33 ...

Страница 2: ... Preparation 10 8 1 Blood Specimen and Bone Marrow Specimen 10 8 2 Methanol Fixation 10 9 0 Unit Installation 11 10 0 User Operation 14 10 1 The Staining Process 14 11 0 Menu Navigation 17 11 1 Altering Timing for Stain and Buffer 17 11 2 Sound Settings 18 11 3 Exiting the Menu Options 19 12 0 User Maintenance 20 12 1 Reagent Kit Installation 20 12 2 Stain Activation Module 21 12 3 Tubing Kit Repl...

Страница 3: ...ompany s manufacturing establishments are registered and its medical devices are listed with the FDA In addition Hardy Diagnostics quality management system is certified to ISO 13485 for medical devices Our devices for the medical laboratory are developed produced and distributed according to the requirements of ISO 13485 Unpacking and Inspecting Carefully unpack the HemaPRO and accessories Check ...

Страница 4: ...n 16 32 Degrees C 60 90 Degrees F Humidity 0 to 95 without condensation Operator Adjustments Individual adjustable stain times on both blood and marrow stain cycles Adjustable sound volume control Operator Entry Keypad overlay Standards IEC 61010 1 2010 Third Edition EN55022 CISPR 22 Ed 6 0 2008 Class A CFR 47 Part 15 Subpart B Class A 2011 ICES 003 Issue 4 2004 CAN CSA CIE IEC CISPR 22 02 Class A...

Страница 5: ...er cord The power supply is a Class I supply that must be connected to an earthed grounded main power outlet Failure to connect the HemaPRO as specified will prevent the electrical safety protection features to function as designed The HemaPRO has one waste tube which drains all of the waste fluids The HemaPRO drain line can be placed into a customer designated disposal container to accommodate th...

Страница 6: ...ch The cuvette holds one slide at a time The chamber is sequentially filled with stain buffer and rinse by use of peristaltic pumps under the front cover Once staining and rinsing has been completed the slide quality will be best when promptly removed from the cuvette and blotted or air dried Operator Responsibility Safety Instructions The HemaPRO ensures safe operation when installed operated and...

Страница 7: ...it HP1RT ProSlide Frosted Microscope Slides PF72P Cuvette Cleaning Swabs QS1001 Bibulous Paper 28511007 Methanol 32oz VMT032 Coplin Jars VCJ001 Microscope Lens Cleaner Z97 Lens Paper 52846001 Immersion Oil Z95 Microscope MRP5000 5 0 Ordering Information If additional supplies are needed Reagent Stain Kits and Tubing Kits can be ordered through Hardy Diagnostics Customer Service Call 800 266 2222 o...

Страница 8: ...l information on this error please refer to Section 12 2 We offer two alternatives of Hematology stain based on traditional and improved versions of Wrights Giemsa formulations HP1SK Wright Giemsa Stain Kit Improved Provides our users with a modified Wrights Giemsa stain formulation to show enhanced color of the leukocytes with well defined red blood cell morphology 6 1 1 1 Wrights Giemsa Stain wi...

Страница 9: ...cess Power Cord Input The power cord plugs into the left side of the machine Pump Cover Covers the reagent supply and waste drain pump rollers and tubing Reagent and Waste Line s These lines wrap around the left side to the back of the unit The HemaPRO Reagent Kit sits behind the instrument on the designated platform Stain Activation Module Input The Stain Activation Module included with the Quick...

Страница 10: ...be stained immediately and will be stored long term the practice of methanol fixation is highly recommended Methanol Fixation Procedure Air dry the specimen at room temperature Heat blocks are not recommended since it is extremely important that the specimen does not get damaged by excessive heat Once fully dried fix by submerging the slide in the Coplin jar filled with methanol for 30 seconds Ple...

Страница 11: ...nit will need to be powered off and you will need to have a HemaPRO Reagent Kit on hand Remove the two thumb screws to open the front panel that is covering the pump tube rollers Attach all four orange pump tubes around their pump rollers Open the HemaPRO Reagent Kit Cat No HP1SK Remove the cap from each reagent bottle and pierce the induction seal on the opening of each bottle with a sterile need...

Страница 12: ...move the Stain Activation module the short cord that resembles a phone cord from the HemaPRO reagent kit box Connect the Stain Activation module to the receptacle on the right hand side of the instrument NOTE If the Stain Activation module is not plugged in when the unit is turned on the message SELF TEST FAILURE Pack not connected will appear Turn unit off connect Stain Activation module and turn...

Страница 13: ...ill need to F1 Prime the unit twice NOTE For every new tubing kit that has been installed on the HemaPRO a double Prime will be required This is to ensure that all reagent lines are properly filled and ready for staining Hardy Diagnostics Rev 2 m COPYRIGHT 16 SYSTEM SELF TEST in process SYSTEM SELF TEST pass Draining Cuvette Evaluation RPM B GG B in house burnin Cycles Remaining 125 F1 Prime F4 Co...

Страница 14: ...The unit s Tubing Kit Cat No HP1RT is to be replaced every six 6 months Refer to User Maintenance for step by step procedure for replacing the tube kit Do not leave the stained slide in the cuvette for an extended period of time as this could result in an altered stain quality The Staining Process Main Menu Press F4 Cont to continue to the Slide Type screen Choose your slide type by pressing eithe...

Страница 15: ...tely press the Stain The unit will proceed to stain the slide followed by the buffer and quick rinse of the slide When the staining process is complete promptly remove the slide from the cuvette and press the F4 Cont to continue to the Main Menu NOTE DO NOT leave the slide in the cuvette after staining The stain quality is best when the slide is promptly removed from the cuvette and allowed to air...

Страница 16: ... HemaPRO User Manual Page 16 of 33 Wipe the back side of the slide and let it completely air dry before viewing the slide under the microscope Alternatively you can use bibulous paper for blotting Cat No 28511007 ...

Страница 17: ...second press of the Menu button will allow you to alter Stain times for either F1 Blood or F4 Bone Marrow Menu 2 A third press of the Menu button will allow you to alter the Buffer times for either F1 Blood or F4 Bone Marrow Menu 3 IMPORTANT The default factory setting for blood specimen is a 30 second stain and a 30 second buffer The default factory setting for bone marrow specimen is a 255 secon...

Страница 18: ...s A fourth press of the Menu button will bring you to the sound setting options menu Press the F1 button to turn the alerts off or the F4 button to keep the alerts on Menu 4 NOTE It is not recommended that the systems sound be turned off as these alerts are meant to inform the technician when the machine needs attention NOTE After the sound setting has been saved the screen will prompt you to Choo...

Страница 19: ...in Menu you will need to cycle through the Menu screen until you arrive at the final Exit Menu screen below Menu 5 Pressing F4 Yes will direct you back to the Main Menu by first showing the following screen Main Menu Exit MENU F1 No F4 Yes Evaluation RPM B GG B in house burnin Cycles Remaining 125 F1 Prime F4 Cont ...

Страница 20: ... Module sold by Hardy Diagnostics to ensure optimal results The instrument is calibrated only for these reagents The use of other stain reagents or solutions will produce unreliable results and will void the warranty Reagent Kit Installation The Wright s Giemsa reagents Stain Rinse and Buffer are supplied to the unit through the tubing s cannula connected to the individual containers Each tube can...

Страница 21: ...ert Turn unit off connect Stain Activation module and turn unit on to continue Power the instrument back on The instrument will continue with its normal boot cycle and will land upon the Main Menu below Main Menu Before using the instrument you will need to F1 Prime the unit twice NOTE For every new reagent kit and tubing kit that has been installed on the HemaPRO a double Prime will be required T...

Страница 22: ... if the Stain Activation Module is not plugged into the HemaPRO This screen will also be accompanied by a steady audio alert This screen may be addressed by ensuring the Stain Activation Module is plugged into the unit If you receive this warning while the Stain Activation Module is plugged into the unit please power the unit off and unplug the Stain Activation Module Make sure there is no blockag...

Страница 23: ...re the line labeled Waste remains in the waste container after it has been emptied Remove the three reagent cannulas labeled Stain Buffer and Rinse from their respective bottles and wipe each cannula with an isopropyl alcohol wipe Hold them all at the opening of the empty waste container NOTE The three reagent cannulas should not be placed in the waste container as they may pull back in the fluid ...

Страница 24: ...ce that all elbow connection labeled as Shorter connect to the bottom of the cuvette Remove the orange pump tubes off of each roller so that they are hanging off of the roller but still held inside of the black metal bracket Cut the four 4 zip ties that are holding the clear tubing together One 1 may be found between Pump 3 and Pump 4 and three 3 are located along the back of the instrument Pump 1...

Страница 25: ...l hypotube at the base of the cuvette Wiggle the clear lines down off the hypotubes at the same time you are using the hemostat or forceps to completely remove the clear tubes from the machine DO NOT PULL using excessive force on the clear tubing as this may cause the metal hypotubes to break from the cuvette DO NOT USE a lubricant to remove or replace clear tubing This will cause poor friction to...

Страница 26: ...zip ties to maintain good tubing management so the tubing does not get in the way of the pumps One 1 may be placed between Pump 3 and Pump 4 and three 3 are to be placed along the back of the instrument Power the instrument on The unit will now need to be primed twice Press F1 Prime to begin the priming process Once the first cycle has completed you will need to prime once more NOTE For every new ...

Страница 27: ...UWF10Jhs Fill levels set without a 1 x3 x2mm slide inserted in the cuvette during programming will result in incorrect fill levels This will lead to overflow of the reagents onto the operating area This can lead to possible damage of the unit s surroundings Ensure the unit has been primed twice as explained in Tubing Kit Replacement step 14 before resetting fill levels Power the instrument off Pla...

Страница 28: ...down rather than a press and release Begin with the setting the Stain calibration With the slide still in cuvette press and hold the F2 Stain button until the cuvette fills up to the desired level Release the F2 Stain button when the desired Stain fill level has been met Once you release the button the screen will then revert back to the F1 Drain or F4 Fill screen below The cuvette will currently ...

Страница 29: ...evels by pressing the MENU button The unit will automatically save the fill levels and cycle back to the Main Menu Purging the Stain Line The HemaPRO operates as intended when the Stain line is completely empty and the Buffer and Rinse lines are primed with their respective reagents Normal operation of the HemaPRO will pull stain fresh from the bottle for every cycle and purge the Stain line when ...

Страница 30: ...d reagents kits can be found at www HardyDiagnostics com SDS 14 0 References 1 Samples for Hematology 2014 Cornell University College of Veterinary Medicine Ithaca NY 2 Lee S H et al 2008 ICSH Guidelines for the standardization of bone marrow specimens and reports International Journal of Laboratory Hematology ...

Страница 31: ...de by Buyer ii any neglect by Buyer or end users iii Buyer s or end users use of products not in compliance with published specifications which are not for their intended purposes iv Buyer s or end users modifications or alterations of products v damage from Buyer or end user misuse or operation outside of the environmental specifications for the products vi any other act or failure to act not in ...

Страница 32: ...s to Buyer as of the date of such shipment shall conform in all material respect to the specifications last published at www HardyDiagnostics com before the time of shipment of the products HARDY DAIGNOSTICS MAKES NO OTHER WARRANTIES TO BUYER EXPRESS OR IMPLIED AND HEREBY EXPRESSLY DISCLAIMS ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE How Long Coverage Lasts This warranty l...

Страница 33: ...9 0 ______ HemaPRO Reagent Kit installation with Stain Activation Module Section 12 1 Section 12 2 ______ Specimen Slide Preparation Section 8 0 ______ Operation Guidelines Section 10 0 ______ Menu Navigation Section 11 0 ______ Alter Timing for Stain and Buffer Section 11 1 ______ Stain Activation Module Section 12 2 ______ Tubing Kit Replacement Section 12 3 ______ Setting Fill Levels Section 12...

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