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QuickSlide HemaPRO
User's Operation Manual
23 pgs888.81 Kb0

Hardy Diagnostics QuickSlide HemaPRO User's Operation Manual

TableofContents
SPECIFICATIONS............................................................................................................................................4
1.0 INTRODUCTION.................................................................................................................................5
OperatorResponsibility–SafetyInstructions........................................................................................5
2.0 WORKAREAREQUIREMENTS...........................................................................................................6
4.1GeneralInformation...........................................................................................................................7
4.2OrderingInformation..........................................................................................................................7
4.3ReagentKitInstallation.......................................................................................................................7
5.0 OPERATIONSOVERVIEW/PREPARATION........................................................................................8
5.1InstrumentDiagram............................................................................................................................8
5.2SpecimenSlidePreparation................................................................................................................9
5.3InstrumentPreparation(FirstTimeSet‐up).....................................................................................10
6.1GeneralGuidelines............................................................................................................................12
6.2StainProcedure.................................................................................................................................12
7.0 SYSTEMSOFTWARE/MENUNAVIGATION.....................................................................................
7.1AlterStain/BufferTiming................................................................................................................14
7.2SoundSettings..................................................................................................................................15
8.0 HEMAPROUSERMAINTENANCE....................................................................................................16
8.1TubeKitReplacement.......................................................................................................................16
8.2SettingFillLevels...............................................................................................................................17
8.3HardyDiagnosticsQuickSlide™ServiceRequest..............................................................................20
14
10.0REFERENCES....................................................................................................................................
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Congratulations!
You have made an excellent choice for your Lab. Hardy Diagnostics thanks you for the trust you have placed in our products and services.
This operating manual has been designed to help you gain an understanding of the operation and application of our HemaPRO. For optimal utilization of all functions, we recommend that you thoroughly study this manual prior to beginning operation.
This manual has been prepared as an aid for all operations and maintenance, which can be carried out in your facility.
The QuickSlide™ Quality Management System
This product is supplied by Hardy Diagnostics in accordance with its quality management system, which complies with the U.S. Food and Drug Administration's (FDA's) Quality Systems Regulation (QSR) and current Good Manufacturing Practices (cGMP) contained in Title 21 Part 820 of the Code of Federal Regulations (CFR).The company's manufacturing establishments are registered, and its medical devices are listed with the FDA.
Unpacking and Inspecting
Carefully unpack the HemaPRO and accessories. Check for damage incurred during transit. Keep all packing material until you are sure the unit operates properly. Any damage to the shipping box should be reported to the responsible carrier. These instructions must be followed for us to guarantee our full support of your claim.
Important: Keep this operating manual for future use.
©2016AllRightsReserved QuickSlide 800‐266‐2222
www.HardyDiagnostics.com www.QuickSlide.com Sales@HardyDiagnostics.com
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SPECIFICATIONS
Dimensions/Weight
Width 30.48 cm (12 in.) Height 26.67 cm (10.5 in.) Depth 27.94 cm (11 in.) Weight 4.5 kg (10.00 lbs.)
Power Requirements
Input 100-240V, 50-60 Hz, 0.8 A Standard power cords are supplied to meet local standards.
Temperature, Ambient Operation
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
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 EN61326-1: 2010
Warranty
OneYearStandard(seepage21).
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1.0 INTRODUCTION
This Operation Manual is provided to guide the user in all aspects of unit set-up, operational use, and user-level maintenance of the QuickSlide stainer unit.
The HemaPRO microscope slide stainer is capable of automatically performing a hematology stain (Wright Giemsa) sequence on a slide containing a biological specimen for in vitro diagnostic use. This instrument accepts standard thickness 1”x3”x1mm glass slides that are frosted and pre-cleaned.
Two settings are programmed – a setting for blood smears and a setting for bone marrow smears – with specific stain durations that are customizable for each. A 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. After staining and rinsing have been completed, the slide quality is best when promptly removed from the cuvette and dried.
Operator Responsibility – Safety Instructions
The HemaPRO ensures safe operation when installed, operated, and maintained according to common safety regulations. This section explains the potential dangers that may arise when operating the HemaPRO.
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HemaPRO Automated Hematology
It is the operator’s responsibility to be properly qualified to operate the HemaPRO. The operator and laboratory personnel are advised to refer to this Operating Manual and the set­up letter that is packaged with the unit.
In addition, the operator must be familiar with good laboratory practices and safety precautions when processing specimens with potential blood borne pathogens.
ExplanationofSymbols
| - Power On
Caution – Refer to marked paragraphs in this manual for details.
O - Power Off
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2.0 WORK AREA REQUIREMENTS
IMPORTANT!
The HemaPRO unit requires a level counter top surface of 12 inches wide by 11 inches deep with a vertical height of 10.5 inches. The Reagent Supply Kit should be positioned at the same level as the instrument on the counter immediately beside or behind the instrument and is connected with tubing. Do not place reagents above or below the
instrument.
The HemaPRO has one tube that drains all of the waste fluids. The HemaPRO drain tube should be placed into a waste container or in a drain according to your local city and county regulations.
The HemaPRO uses an external power supply module that is be supplied with 50-60 Hz, 100-240V, 0.8 A. This unit requires power from a grounded outlet.
The HemaPRO is assembled with tubing sets to connect the instrument to the reagents. Place the correct cannulas (opaque rigid tubes) into the corresponding reagent supply containers. Labels attached to the cannula lines indicate which reagent is to be used with each line.
In addition, the reagent module cord supplied with the reagent kit must to be plugged into the right side of the machine in order to use a new reagent kit.
3.0 RECEIVING AND UNPACKING
Unpacking and set-up assistance for the HemaPRO may be obtained by calling the Technical Service Department of QuickSlide of 8 a.m.to 5 p.m. Pacific Standard Time, Monday through Friday.
The HemaPRO should only be used with the provided external power supply. The external 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.
TM
at (800) 266-2222 (option 2) during the hours
4.0 MATERIALS REQUIRED BUT NOT PROVIDED
Standard microbiological supplies are required, but not provided. If additional supplies are needed, reagents and tubing kits can be ordered through Hardy Diagnostics Customer Service. Call (800) 266-2222 (option 1), or go to www.HardyDiagnostics.com. Alternatively, you can contact your preferred distributor.
Wright-Giemsa Stain Kit (HP1SK) HemaPRO Replacement Tubing Kit
(HP1RT)
ProSlide™ Frosted Microscope Slides
(PF72P)
Cuvette Cleaning Swabs (QS1001)
Methanol 32oz. (VMT032) Coplin Jars (VCJ001) Microscope Lens Cleaner (Z97) Lens Paper (52846001) Immersion Oil (Z95) Microscope (MRP5000)
Bibulous Paper (28511007)
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4.1 General Information The HemaPRO offers consistent results by systematically staining, buffering, and rinsing
the provided biological specimen. It is critical for the success of this automated process that these unique reagents are obtained from QuickSlide™.
NOTE: For quality control purposes, Reagent Supply Kits are labeled with a Kit Number,
Lot Number, and Expiration Date. These values are used to track and identify the Reagent Supply Kit used in the unit. The machine tracks the number of stain cycles that a reagent kit performs through the reagent kit module that is included with each reagent kit. Be sure to plug the module into the right side of the machine with each new reagent kit.
4.2 Ordering Information The HemaPRO reagent module regulates the consumption of the Reagent Supply Kit.
When starting each stain cycle, the system displays a count of the remaining number of stain cycles available in the current kit. The remaining count should be carefully monitored so that fresh reagents may be ordered and available when needed. Call Hardy Diagnostics Customer Service
at 800-266-2222 (option 1) to order supplies.
4.3 Reagent Kit Installation The HemaPRO reagents are supplied to the unit through cannulas connected to the
individual reagent containers. Each tube cannula is clearly labeled, and must be inserted into the correct reagent container. The waste tube should be placed in awaste container or in a drain according to your local city and county regulations. Use care to ensure each line is properly connected before powering on the HemaPRO unit.
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