User`s Manual
Contents
1. ready indicator e located on the start button the indicator signals that the DiffSpin is ready to process the next specimen there is a brief delay between cycles See Figure 1 on the following page acceleration amp duration control dials e adjust the acceleration and the duration of the cycle They are located on the side of the instrument and are usually set at their mid point the letter C for all blood samples Setting C should provide adequate films for normal hematocrits Turn either control toward E to increase the spin duration or the acceleration These adjustments may be necessary for blood samples from patients with disease states that result in major changes in their blood flow characteristics Duration 0 4 3 0 seconds Acceleration Final rotational speed is inconsequential Acceleration of the platform cradle is responsible for the quality of the blood film 3 1 Controls and Indicators cont NOTE Some laboratories prefer acceleration setting of D To adjust the acceleration control to a slower setting first change the control to the desired setting Then discharge the memory of the previous setting Do this by placing a Slide Holder with slide inside the DiffSpin Close the cover and press the start button Spin only the slide and Slide Holder with no specimen during this reset cycle The next cycle will now operate at the new speed and2. THERE IS NO WARRANTY OF MER CHANTABILITY OR OF FITNESS FOR ANY INTENDED PUPOSE AND THAT THERE ARE NO OTHER REMEDIES OR WARRANTIES EXPRESSED OR IMPLIED WHICH EXTEND BEYOND THE DE SCRIPTION ON THE FACE OF THIS AGREEMENT NO AGENT OR EMPLOYEE OF STATSPIN IS AUTHORIZED TO EXTEND ANY OTHER WARRANTY OR TO ASSUME FOR STATSPIN ANY LIABIL ITY EXCEPT AS SET FORTH ABOVE 19 Stat Spr An IRIS Company 85 Morse Street telephone 800 782 8774 Norwood Massachusetts 781 551 0100 02062 USA fax 781 551 0036 http www statspin com
3. one hour of preparation with either a Romanowsky stain containing fixatives or fix within one hour with water free i e lt 3 water methanol for later staining 4 2 Operation 1 Insert a clean slide Product No SL72 frosted edge out into a disposable Slide Holder Product No SC01 Place the Slide Holder with slide onto the cradle by placing the holes in the tabs located on the sides of the Slide Holder over the silver colored mounting posts and press down gently until the Slide Holder comes to rest flush on top of the cradle See Figure 2 IMPORTANT The labeled end of the slide should rest between the slide retaining posts on the Cradle With a StatSpin Transfer Pipette Product No PD50 place a single drop of blood into each of the two holes located on the top of the Slide Holder See Section 3 2 The two drops must pool together to ensure uniform coverrage this takes a second or two Be careful not to leave any blood on the outside of the disposable Slide Holder before spinning Spin the slide immediately after adding the blood Close cover firmly until it latches Press start button The cycle is less than 3 seconds When unit comes to a stop squeeze the latch on the cover lift upward to open See Figure 3 below Figure 3 4 2 4 3 Operation cont 7 Remove the disposable Slide Holder containing the slide 8 Remove the slide and air dry or oven dry as your lab procedures
4. products and believes that the quality utility and value we build into each instrument will provide complete customer satisfaction StatSpin warrants to the original purchaser that this instrument will be free from defects in material or workmanship under normal and proper use for a period of one year from the date of installa tion StatSpin will at its option repair or replace any unit covered under this warranty returned to StatSpin with shipping costs prepaid Repaired or replaced instruments supplied under this warranty will carry only the remaining portion of the original warranty For warranty terms and conditions outside the United States contact your Autho rized StatSpin Distributor StatSpin shall not be responsible for damage to a StatSpin instrument resulting from misuse negligence accident or resulting from unautho rized repairs alterations or improper installation Additionally StatSpin shall not be liable for any claims losses or damages of any third party or for lost profits or indirect or consequential damages of any kind even if StatSpin has been advised of the possibility of such damages The purchaser shall be deemed liable for any and all claims losses or damages incurred by the use or misuse of the StatSpin instrument by the purchaser its employees or others following receipt of the instrument THIS WARRANTY IS GIVEN EXPRESSLY AND IN LIEU OF ALL OTHER WARRANTIES EXPRESSED OR IMPLIED THE PUR CHASER AGREES THAT
5. when assembled 10 REFERENCES 1 Blood Sample Preparation for Automated Differential Systems Rogers Charles H American Journal of Medical Technology Vol 39 No 11 435 442 November 1973 2 The Automated Differential Pattern Recognition Sys tems Precision and the Spun Smear Kingsley Thomas C Blood Cells 483 487 1980 3 The Use of Wedge and Spun Blood for Reference WBC Differential Counts Abstract presented at International Society of Laboratory Hematology 6th International Symposium on Technological Innovations in Laboratory Hematology Berend Houwen et al Santa Fe New Mexico March 1993 4 Causes for Poor Leukocyte Distribution in Manual Spreader Slide Blood Films Steine Martin E A American Journal of Medical Technology Vol 46 No 9 May 1980 5 Automation and Laboratory Hematology Impact on Quality and Cost Effectiveness B Houwen et al American Society of Clinical Pathology College of American Pathologists Hematology Seminar Orlando Florida October 19 1993 6 Flow Cytometric White Blood Cell Differential A Pro posed Alternative Reference Method L Lebeck et al Sysmex Journal International 3 61 69 1993 7 A Critical Evaluation of the Manual Visual Differential Leukocyte Counting Method Koepke J A et al Blood Cells 11 173 186 1985 1 15 02 54 002663 001 Rev B 18 11 0 WARRANTY FOR THE DIFFSPIN CENTRIFUGE StatSpin takes pride in its
6. DiffSpin Operator s Manual Stat Spin An IRIS Company Operator s Manual for DiffSpins Slide Spinner Model Number M700 10 M700 12 M700 22 Covered under one or more of the following US patents StatSpin and accessories 4 846 974 4 981 585 DiffSpin Slide Spinner 5 326 398 Other patents applied for StatSpin is a registered trademark of StatSpin Inc an IRIS Com pany International Remote Imaging Systems Copyright 2002 Printed in U S A 10 11 TABLE OF CONTENTS INTRODUCTION AND THEORY OF OPERATION 1 1 Introduction 1 2 Clinical Utility UNPACKING AND INSTALLATION 2 1 Check for damage sustained during transport 2 2 Check for complete packaging 2 3 Installing the DiffSpin slide spinner 2 4 Power connection WORKING WITH DIFFSPIN 3 1 Controls and indicators 3 2 Safety features and precautions INSTRUCTIONS FOR USE 4 1 Collection and preparation of blood sample 4 2 Operation 4 3 Sample Volume 4 4 Analysis of the slide 4 5 Typical results 4 6 Slides MAINTENANCE 5 1 Cleaning instructions SERVICE TECHNICAL DATA NOTES 8 1 Safety Warning 8 2 General Note TROUBLESHOOTING GUIDE REFERENCES WARRANTY FOR THE DIFFSPIN Www w OA O ON 12 12 13 14 14 15 15 16 18 19 Warranty Card Inside back cover UNIVERSAL PRECAUTIONS Universal Precautions should be followed on all specimens regardless of whether a specimen is known to contain an inf
7. MPORTANT The DiffSpin contains components which have a potential SHOCK HAZARD The unit should only be opened by trained and qualified personnel 7 TECHNICAL DATA Power Requirements Product DS02 10 100 VAC 50 60 Hz DS02 12 120 VAC 50 60 Hz DS02 22 240 VAC 50 60 Hz Running Time 0 4 to 3 0 seconds Slide Holder Disposable accepts 1 x 3 inch microscope slides Dimensions 6 5 inches 16 5 cm diameter by 4 5 inches 11 4 cm high Weight 3 7 pounds 1 7 kg 14 8 1 8 2 8 NOTES Safety Warning This DiffSpin left the factory in perfect order from the point of view of work safety To keep it that way and to ensure safe operation the user must follow the instructions and warnings given in this operating manual General Note The data and information provided in this manual correspond to the state of knowledge existing at the time of printing this manual Any important changes will be taken into account in the next edition of this manual or with the Package Insert sheet included with the Slide Holders In every case the respective package insert should be regarded as definitive 9 TROUBLESHOOTING GUIDE DESCRIPTION POSSIBLE CAUSE OPERATOR RESPONSE Power light not lit Power cord Verify that the power unplugged from cord is plugged DiffSpin or from securely into the outlet outlet and into the DiffSpin Non functioning Verify that outlet is outlet functioning properly LED burned out Verify Diff
8. Spin is still operational Cradle does not Start button not Retry by pushing rotate depressed fully start button Cover not closed Verify that cover is properly closed tightly Unit not ready Verify ready light is lit before initiating cycle Poor Quality Unclean slides Verify that slides are Blood Films without dust and or fingerprints See Section 4 6 Slides Inappropriate Verify sample volume sample volume refer to Section 4 3 16 DESCRIPTION POSSIBLE CAUSE Poor Quality Blood Films Time and speed settings not correct Excessive amount of blood Blood escapes Slide Holder Blood on outside of holder Slide Holder does Slide holder not not lay flat on Cradle positioned correctly Slide and or Holder dislodges during spinning Slide holder not Smear area covers Slide placed frosted edge of slide incorrectly into Slide Holder 17 positioned correctly OPERATOR RESPONSE Verify position of time and speed knob at recommended C mark for average hematocrit levels Verify drops only large enough to cover slide Verify that no blood is present on exterior of slide holder after pipetting blood onto slide Check Figure 2 Section 3 2 and verify Slide Holder and slide are oriented properly on cradle Check Figure 2 Section 3 2 and verify Slide Holder and slide are oriented properly on cradle Verify that frosted edge of slide protrudes from Slide Holder
9. ectious agent Universal Precautions have been stated by Center for Disease Control in 1987 and updated in 1988 and are reprinted in National Committee for Clinical Laboratory Standards proposed guidelines Protection of Laboratory Workers From Occupationally Acquired Infections Approved Standard NCCLS Document M29 A2 2001 NCCLS National Office 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 1 1 1 2 1 INTRODUCTION AND THEORY OF OPERATION Introduction The DiffSpin Slide Spinner is a special purpose instrument for produc ing uniform monolayer blood smears or films on microscope slides DiffSpin is compact and easy to use allowing the user to rapidly pre pare reliable blood smears that are technique insensitive The benefits of DiffSpin are 1 it s ability to produce consistent monolayer smears and 2 the convenience and safety of disposable Slide Holders which collect and contain the excess spun off blood and minimize aerosols IMPORTANT Insure the DiffSpin is on a level surface Clinical Utility The differential white blood cell count has long been recognized as being useful in the diagnosis and prognosis of disease and the monitor ing of therapy There are five potential sources of error or methodological variables in making the differential count 1 Errors in interpretation or classification of the cells 2 Statistical sampling errors 3 Non random or non uniform distribution of cell
10. ilable for count ing Depending on the aperture of the microscope there will be over 20 000 high power fields 100x available to the user This area is always larger than the feathered area used on the wedge smear Red blood cell morphology varies with the method of preparation 2 Spun films may display slightly different morphology in some areas of the slide than smears prepared by the wedge method However similar as with the wedge method the user will easily identify those areas that enable accurate identification of red cell morphology Distribution of white blood cells is uniform through out a spun blood smear 1 The uniformity of blood smears prepared by DiffSpin depends on the quality of the microscope slides Slides The uniformity of blood smears prepared with either manual or automated systems depends on the quality of the microscope slides For best results use StatSpin microscope slides Prod uct Number SL72 StatSpin slides are clean dustfree and de hydrated which is a prerequisite for consistent results Other various commercially available pre cleaned slides may result in inadequate blood films if the slide surface is covered with dust or debris particles or if the slides have been exposed to humid storage conditions Always use clean desiccated slides and handle them carefully Avoid touching slide surface Oil from fingers on the slide sur face will result in a non uniform film 12 4 6 5 1 S
11. in Slide Preparation Kit Product Number DSPK Installing the DiffSpin Slide Spinner Place the DiffSpin on any level surface acceptable for a laboratory instrument Position the DiffSpin away from direct sunlight and sources of heat and cold Power Connection Before connecting the DiffSpin to the power please check that the nominal voltage V and frequency Hz specified at the rear of the DiffSpin matches your outlet voltage and frequency If it does not please contact your supplier WARNING If the voltages do not match do not connect the DiffSpin to the power source If the voltages match connect the DiffSpin to a grounded outlet using the cable provided This protective grounding must not be neutralized by using an extension cord without a ground lead Once the DiffSpin is connected to the power it is ready for use The DiffSpin does not have an ON OFF switch 3 1 3 WORKING WITH DIFFSPIN Controls and Indicators stop open button e interrupts the cycle and stops the centrifugation The stop open button is rarely used as the cycles are short It can be used to release an accidentally latched cover power indicator e green LED illuminated when the DiffSpin is connected to a power source The DiffSpin is not provided with an on off switch The unit is normally left plugged in and on The cover is usually left down but not latched start button e initiates a spin cycle
12. indicate When slide is dry it may be stained or processed in the usual manner Dispose of the contaminated Slide Holder as you would other biohazardous material IMPORTANT Use Slide Holders only once The Slide Holders are designed for single use only NOTE There is a built in time delay between cycles Wait until the ready indicator is lit before initiating the next cycle See Figure 1 Section 3 1 A new cycle can not be initiated until the time delay has elapsed Sample Volume For best results use 50 ul of whole blood placed in each of the holes in the slide holder The drops should pool to create a bar formation This bar formation will adequately cover the slide and provide good viewing area The density of the cellular layer depends on the sample s viscosity cell content and surface tension of the glass slide The volume applied to the slide also affects the cell density on the blood film Operator s preference of volume varies greatly Sample Volume continued next page 4 3 Sample Volume cont The following are some suggestions for sample volumes e For lower cell density some laboratories report best results with total volume of 40 ul i e 0 040 ml of blood pipetted into each hole of the slide holder With small quantities of blood the slide will not be uniformly coated with a film however the spacing between the cells will be greater something that may be preferred for faster cell recognition e Fo
13. lides cont Slides must be fresh Non uniform slide coverage e g streaking or fingering is a result of poor quality slides that have degraded resulting in increased surface tension e g glass slides stored for months without protection from humidity and temperature This increased surface tension is found with poor quality slides slides which were exposed to humidity or slides stored for excessive lengths of time If this condition persists try a new box of StatSpin slides Product Number SL72 5 MAINTENANCE Cleaning Instructions The DiffSpin requires no maintenance beyond routine cleaning Prior to cleaning the power cord should be disconnected Clean the exterior surface and inner surface or bowl area with a 10 bleach solution on a damp cloth Never have liquid inside the bowl Do not use abrasives or solvents Clean the clear cover with a glass plastic cleaner if required Any machine or accessory containing accumulated blood and or other chemical deposits must be cleaned prior to shipment to the manufacturer distributor for service This decontamination is required by Federal Law Title 48 and 49 of the Code of Federal Regulations and in accordance with the E P A s Regulations for Biohazard Waste Management This decontamination cannot be performed by StatSpin personnel 13 6 SERVICE The DiffSpin has no user serviceable parts Should the instrument require service please consult your Warranty for instructions I
14. n was developed to eliminate aerosol formation while pro viding the higher quality of a spun slide Using the DiffSpin when the slide rotates the excess blood is captured by the slide holder When used according to the instructions independent studies indicate there is no detectable aerosol generation 5 In addition because of the eccentric spinning platform slides prepared with the DiffSpin are not completely covered with blood Therefore prepared specimen slides are readily handled and easily labeled for identification When the slide rotates the excess blood is thrown off and captured by the Slide Holder The remaining blood wets the slide and the thickness of the layer left behind depends on the sample s viscosity cell content and surface tension Though the density of the cellular layer may depend on the sample s viscosity cell content and surface tension of the glass slide the volume applied the the slide also affects the cell density See Section 4 3 Sample Volume 2 1 2 2 2 3 2 4 2 UNPACKING AND INSTALLATION Check for Damage Sustained During Transport The DiffSpin Slide Spinner and its accessories are delivered in one package Save the shipping carton in the event the instrument needs to be returned for service Notify the carrier and your DiffSpin distribu tor if damage in shipment is evident Check for Complete Packaging e Centrifuge e Line Cord e Operator s Manual w Warranty Card e DiffSp
15. r higher cell density and a larger area of the slide to be covered some laboratories apply 2 x 65 ul i e 2 x 0 065 ml drops of blood Although this produces a more fully covered slide this much surface area is not really necessary Do not exceed 75 ul per drop as blood will exit the slide holder and cause excessive aerosols Examination Area shown below is best for viewing red cell morphology Figure 4 Examination Area Representation of 2 x 50 ul drops NOTE The two drops of blood must merge or pool together to ensure uniform coverage Sample Volume continued next page 10 4 3 Sample Volume cont e The amount of blood added to create a monolayer film with the DiffSpin is a matter of preference The smaller volumes create a more spread out cell monolayer under the microscope but may not have the same slide coverage as larger volumes Also other cell suspensions may also be used to create a mono layer on a microscope slide Pipettes For best results use StatSpin pipettes with a premeasured drop size of 50 ul Order StatSpin Product Number PD50 11 4 4 4 5 4 6 Analysis of the Slide The peripheral blood smear made with your DiffSpin slide spinner should be read according to your laboratory protocol Typical Results About 70 of the slide will be covered with a monolayer of blood cells The areas covered on typical DiffSpin slides are shown in Figure 4 Nearly all of these covered areas are ava
16. s on the slide 4 Distortion of blood cell morphology by inappropriate anticoagulant blood storage and handling 5 Blood film preparation technique The spinner technique addresses the third and fifth sources of these potential errors Amore complete explanation follows 1 2 Clinical Utility cont The traditional technique to prepare the microscope slide the manual wedge smear introduces a source of error as it causes non random distribution of cells which is dependent on cell size 1 This gener ally results in an under reporting of monocytes 7 and a slight over reporting of lymphocytes This phenomenon is not surprising with the visually apparent non uniform distribution gradient established using the wedge technique The slide spinner technique addresses both the non uniform distribu tion of cells and preparation technique By using a slide spinner all areas covered by cells are good no searching for a good area Total time to achieve accurate results is less Indeed the results achieved with spun slides are more accurate than those prepared using the wedge smear technique 6 Slide spinners were first developed in association with automated differential counters to produce uniform monolayers independent of operator skill 1 Using these early generation slide spinner instru ments produced superior quality slides however the advantages were offset by the hazards associated with aerosol generation The DiffSpi
17. setting Figure 1 DiffSpin Front View is SN S Q Ready Indicator Power STOP OPEN START FiK a Vo Stop Open Start Button Button 5 Control Dials 3 2 Safety features and precautions e The DiffSpin slide spinner incorporates an interlock mechanism This mechanism prevents the DiffSpin from being operated unless the cover is closed IMPORTANT Do not attempt to defeat this safety feature of your DiffSpin instrument e The DiffSpin prepares blood smears for microscopic examination Use of the DiffSpin places a responsibility upon administrative personnel to insure adequate training of operators Do not open the DiffSpin until the slide has stopped rotating WARNING Any rotating device can generate a mechanical safety hazard For the user s protection the unit will NOT operate when the cover is open e Donot leave any blood on the outside of the disposable Slide Holder before spinning e The DiffSpin is not explosion proof Do not use in a potentially explosive atmosphere e StatSpin slides 1 x 3 inch Product No SL72 e Mount the Slide Holder so that it lies flat on the Cradle Check that the tabs are securely over the mounting pins Failure to ensure the Slide Holder is mounted properly may break the slide and or result in damage to the instrument See Figure 2 below Holes for Blood Microscope Slide Figure 2 Frosted or Label End Rear Retaining Pos
18. ts Slide Cradle Mounting Posts for Slide Holder 4 1 4 INSTRUCTIONS FOR USE Collection and Preparation of Blood Sample The National Committee for Clinical Laboratory Standards NCCLS publication Reference Leukocyte Differential Count Proportional and Evaluation of Instrumental Methods Approved Standard NCCLS Document H20 A Vol 12 No 1 NCCLS National Office 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA indicates the following for visual differential count Use whole venous blood collected in anticoagulanted tubes with tripotassium ethylenediamine tetra acetate K EDTA 1 5 0 15 mg in liquid or powder form per mL see NCCLS document H3 A4 Note the specimen condition Macroscopically visible clots are cause for rejection of the specimen for analysis Microscopically visible platelet clumps consisting only of platelets are acceptable provided their presence is noted Slides are to be prepared within 4 hours of blood collection in K EDTA Blood samples are to be stored at room temperature until blood smear has been prepared Use StatSpin Slides Product No SL72 Make sure that the blood is well mixed Use a blood tube rocker or similar device if there is any delay in preparing the blood smear Manual mixing is allowable as long as the blood tube is inverted completely at least 20 times This will mix the blood and minimize artifacts such as rouleaux formation Stain the film within
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