Hematek Slide Stainer Operating Manual Rev A April 2004

© 2003 Bayer HealthCare LLC. All rights reserved. No part of this manual or the products it describes may be reproduced by any means or in any form without prior consent in writing from Bayer HealthCare LLC. Hematek is a trademark of Bayer HealthCare LLC.

The information in this manual was correct at the time of printing. However, Bayer HealthCare continues to improve products and reserves the right to change specifications, equipment, and maintenance procedures at any time without notice. If the system is used in a manner differently than specified by Bayer HealthCare, the protection provided by the equipment may be impaired. See warning and hazard statements.

Contents Section 1: Introduction... 1-3 General Description and Intended Use...1-3 Theory of Operation ...1-4

Physical Characteristics ...1-5

Circular Bubble Level ...1-5 Levelers ...1-5

Slide Transport System...1-6

Conveyor Spirals ...1-6 Platen ...1-7 Slide Drying System ...1-7 Slide Drawer ...1-7 Waste Tank ...1-7

Staining System ...1-8

Volume Control Panel ...1-8 Solution Pumps ...1-8 Pump Tubing and Cannulas ...1-9 Sensing Switches ...1-10

Electrical System ...1-11 Operating Lever ...1-11 POWER Light ...1-12 LOW STAIN Light ...1-12 Power Module ...1-12 Line Cord Receptacle ...1-13 Fuse Holder ...1-13 ON / OFF Switch ...1-13

Specifications ...1-13 Disposal of System Waste and Supplies ...1-14

Section 2: Installation... 2-3 Overview ...2-3 Environmental Factors ...2-3 Unpacking ...2-4 Instrument Setup ...2-5

Level the Instrument ...2-5 Plug the Line Cord into an Outlet ...2-6 Performance Check (Prior to Installing Tubing) ...2-6 Install the Pump Tubing ...2-7 Install the Stain Pak ...2-10 Inspect Waste Tank and Slide Drawer ...2-11 Familiarize Yourself with the Instrument ...2-11 Check Pump Volumes ...2-11 Fill Out and Mail Warranty Registration Card - U.S. Only ...2-11

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Contents

Section 3: Operating Instructions ... 3-3 General Guidelines for Optimal Staining ...3-3 Operating Procedures ...3-3

Start the Instrument ...3-3 Prime the Tubing ...3-4 Load the Blood Smear Slides ...3-5 Stain the Smears ...3-6 Clean the Tubing after Use ...3-7 Turn the Instrument Off at the End of the Day ...3-7

Stain Pak Replacement ...3-7

Section 4: Specimens... 4-3 Overview ...4-3 Peripheral Blood Smears ...4-3 Bone Marrow Smears ...4-5

Section 5: Maintenance ... 5-3 General Cleaning ...5-3 Daily Cleaning ...5-3 Cleaning the Platen ...5-3 Cleaning the Stain Tubing and Cannula ...5-4 Emptying the Waste Tank ...5-6

Weekly Cleaning ...5-7 Cleaning Drain Troughs and Rear Guide Rail ...5-7

Decontamination and Removal from Operation ...5-10

Section 6: Minor Replacements and Adjustments ... 6-3 Fuse Replacement ...6-3 Replacement of Light Assemblies ...6-4 Replacement of the Pump Tubing ...6-7 Replacement of the Underplaten Tubing ...6-11 Pump Volume Adjustment ...6-14

Check and Correct Instrument Operation Prior to Pump Volume Adjustment ...6-15 Adjust the Stain, Buffer, and Rinse Volumes ...6-15

Volume and Ratio Determination ...6-17 Sensing Switch Fingers Adjustment...6-18

Section 7: Troubleshooting ... 7-3 Checklist for Quality of Stained Blood Smears ...7-3 Troubleshooting Chart...7-4

Contents

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Section 8: Service, Supplies, and Replacement Parts ... 8-3 When to Call for Service ...8-3 For Service ...8-3 Bayer Authorized Representative ...8-3 Bayer Offices Worldwide ...8-4

Returning the Instrument for Repair, Exchange, Replacement, or Loaner ...8-6 Supplies and Replacement Parts ...8-7 Hematek Stain Pak – Modified Wright’s Stain ...8-7 Hematek Stain Pak – Modified Wright-Giemsa Stain ...8-7 Hematek Cannula Set ...8-7 Hematek Pump Tube Set ...8-7 Hematek Underplaten Tubing ...8-8 Ordering Information for Supplies and Replacement Parts ...8-8

Appendix A: List of Symbols ... A-1 Symbols Used With This System ...A-1

Appendix B: Hematek Preservice Checklist... B-1 Appendix C: Hematek Manufacturer’s Warranty ... C-1 Hematek Slide Stainer Manufacturer’s Warranty ...C-1

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Contents

Contents

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Section 1: Introduction... 1-3 General Description and Intended Use...1-3 Theory of Operation ...1-4

Physical Characteristics ...1-5

Circular Level ...1-5 Levelers ...1-5

Slide Transport System...1-6

Conveyor Spirals ...1-6 Platen ...1-6 Slide Drying System ...1-7 Slide Drawer ...1-7 Waste Tank ...1-7

Staining System ...1-8

Volume Control Panel ...1-8 Solution Pumps ...1-8 Pump Tubing and Cannulas ...1-9 Sensing Switches ...1-10

Electrical System ...1-11 Operating Lever ...1-11 POWER Light ...1-12 LOW STAIN Light ...1-12 Power Module ...1-12 Line Cord Receptacle ...1-12 Fuse Holder ...1-13 ON / OFF Switch ...1-13

Specifications ...1-13 Disposal of System Waste and Supplies ...1-14

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Section 1: Introduction, Page 1-1

Page 1-2, Section 1: Introduction

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Section 1: Introduction General Description and Intended Use The Hematek® Slide Stainer, shown in Figure 1-1. Hematek Slide Stainer is a fully automated, bench-top instrument designed specifically for the staining of hematology slides for in vitro diagnostic use. This self-contained precision instrument accepts, conveys, fixes, stains, and delivers dry blood smear preparations that are spread on standard thickness 25-mm x 75-mm or 1” x 3” glass slides. The slides are stained at the rate of one slide per minute. Two conveyor spirals move the slides along the platen. Three sensing switches are triggered sequentially as the slide moves along the platen. Each switch activates its respective solution pump, which meters and delivers the stain, buffer, or rinse into the capillary space between the slide and platen. After staining and rinsing have been accomplished, the slide is dried by a flow of air from a low velocity blower and it is then deposited in a slide drawer. Optimal results with the Hematek Slide Stainer are obtained by using one of the Hematek Stain Paks. The Stain Pak consists of one bottle each of stain, buffer, and rinse solutions, and is designed for easy installation and removal from the instrument. NOTE

Only Hematek Stain Paks should be used with the Hematek Slide Stainer. Use of other stain packs or solutions may void the warranty.

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Section 1: Introduction, Page 1-3

Theory of Operation The Hematek Slide Stainer is designed to produce stained slides of consistent quality in a continuous process. This is accomplished by having a fixed length of time in each of the three phases of stain, buffer, and rinse, as well as a predetermined ratio of stain-to-buffer volumes in the buffer phase. A properly stained slide is the result of an interactive process involving the pump volumes, the mixing process, and the stain-to-buffer ratio. A minimum ratio of 1:2 is recommended; however, if the platen is filling properly, good mixing is occurring, and the stained slides are acceptable under the microscope, the stain-to-buffer ratio should not be adjusted.

Figure 1-1. Hematek Slide Stainer

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Physical Characteristics Figure 1-2. Circular Bubble Level and Leveling Feet, shows the physical characteristics of the Hematek Slide Stainer, including the circular bubble level and the leveling feet.

Figure 1-2. Circular Bubble Level and Leveling Feet 1 2

Circular Bubble Level Leveling Feet

Circular Bubble Level CAUTION

Do not move the circular bubble level from its location directly behind the operating lever. Proper leveling is essential for optimal mixing of the stain and buffer. The circular bubble level is a water bubble gauge with an inscribed circle that can be observed through the clear plastic lid of the instrument. The level is located on the instrument panel to the left of the reagent pumps, directly behind the operating lever. It is used to ensure the Slide Stainer is in a level position.

Levelers The feet under the front corners of the instrument act as levelers and may be adjusted to raise or lower the instrument to a level position. Observe the circular bubble level to verify that the feet have been properly adjusted and the instrument is level.

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Section 1: Introduction, Page 1-5

Slide Transport System Figure 1-3. Slide Transport System and Figure 1-4. Slide Transport and Staining System show the slide transport system, including the conveyor spirals, the platen, the platen guide rails, and the slide drawer.

Figure 1-3. Slide Transport System 1 Conveyor Spirals 2 Platen 3 Platen Guide Rails 4 Slide Drawer

Conveyor Spirals The conveyor spirals are two parallel spirals with opposing grooves. Slides to be stained are fitted separately into the opposing grooves, which move the slides across the staining surface. When loading slides onto the instrument, the side covered by the blood smear is faced to the left of the operator, with the feathered edge to the back of the instrument. Slides are moved by the conveyor spirals side by side, from right to left, first at the vertical plane, then at the horizontal plane with the blood smear facing downward toward the platen.

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Platen The platen spans the entire front of the instrument, between the conveyor spirals. The outside ridges of the platen are elevated guide rails, which give support to the slides as they are moved along the platen. It is a precision-machined component made from a highperformance plastic polymer material and is designed specifically for two main functions: 1. It maintains the exact volumes of the required solutions within a capillary space between the platen and the slide. 2. It provides a mixing system for the stain and buffer. The platen also provides the necessary time interval after the rinsing step for proper drying of the slides before they are deposited in the slide drawer. A trough around the perimeter of the platen allows for drainage of used solutions into the waste tank below.

Slide Drying System The dryer is a blower type fan that runs continuously when the instrument is in operation. The airflow serves to cool the mechanical components inside the Slide Stainer, as well as to dry the slides.

Slide Drawer The slide drawer is located below the left end of the platen. It receives the slides as they drop from the platen after being stained, rinsed, and dried. The drawer will hold 100 slides. See Figure 1-4. Slide Transport and Staining System .

Waste Tank The waste tank is located underneath the platen and collects used and overflow staining solutions. The waste tank should be emptied and rinsed once each day and whenever a new Stain Pak is installed. Refer to Section 5: Maintenance for more information.

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Section 1: Introduction, Page 1-7

Staining System Figure 1-4. Slide Transport and Staining System , Figure 1-5. Staining Systems, and Figure 1-6. Sensing Switches, illustrate the staining system, including the volume control panel, pump assemblies, pump cap, pump arm, pump tubing, and cannula.

Figure 1-4. Slide Transport and Staining System 1 2 3

Slide Drawer Waste Tank Volume Control Panel

Volume Control Panel The volume control panel tips out from the right front corner of the instrument and contains three graduated adjustment knobs. The volume of reagent being delivered can be adjusted by rotating the respective control dial clockwise to increase the volume or counterclockwise to decrease the volume.

Solution Pumps The instrument has three pump assemblies, one for each solution. Each assembly consists of a pump motor, four rollers that are attached to the underside of a pump cap, and a pump arm. All work together to maintain a constant metering speed to provide consistent volumes of stain, buffer, and rinse, even though the line voltage may fluctuate. The amount of solution pumped is electronically adjusted through the use of the volume control knobs.

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Figure 1-5. Staining Systems 1 2 3 4 5

Pump Assemblies Pump Cap Pump Arm Pump Tubing Cannula

Pump Tubing and Cannulas CAUTION

Use only the Hematek Pump Tube Set with the Hematek Slide Stainer. Use of other tubing may result in incorrect measurement and improper staining, buffering, and rinsing. The pump tubing is provided as a set of three separate pieces of tubing. Notice that each pump tube is identified with a number and symbol, which corresponds to the reagent carried by the tubing: • 1 for stain • 2 for buffer • 3 for rinse Each tube has a clear plastic cuff that fits snugly up to the pump arm and holds the tube in position without slippage. The tubing is a special type of rubber that is resistant to leaching and brittleness. The special diameters and lengths of the tubing assure precise measurement of solutions. Each pump tube is connected to a cannula that is inserted into the appropriate bottle in the Stain Pak. Three cannulas are provided with the Hematek Slide Stainer. With proper routine cleaning, the cannulas can be used for an extended period of time.

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Section 1: Introduction, Page 1-9

Sensing Switches The sensing switches are three finger-like devices located just above the back edge of the platen. When contacted, the respective sensing switch is activated, which tells the instrument that a slide is in position for the pump to run. After a specific time delay, the pumping motor for the specific reagent is activated. The solution pumps are set so that precise volumes of stain, buffer, and rinse are delivered to their respective areas on the platen. Each reagent is delivered through its respective cannula and tubing network to the platen orifice. The capillary space between the slide and the platen is then filled with the measured volume of reagent.

Figure 1-6. Sensing Switches 1

Sensing Switches

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Electrical System Figure 1-7. Electrical System and Figure 1-8. Electrical System–Rear of Instrument illustrate the components of the electrical system.

Figure 1-7. Electrical System 1 2 3

Operating Lever Power Light Low Stain Light

Operating Lever The operating lever is a multiple function, bar-shaped lever located at the front left side of the instrument, near the top. The three positions of the lever are labeled and their related functions are as follows: • UNLOCK releases the pressure of the reagent pump arms against the pump tubing. • LOCK locks the reagent pump arms into their proper position against the pump tubing. • PRIME provides an override control to allow the pumps to run continuously so the tubes can be primed with solutions and cleared of air bubbles. The lever must be held continuously in the PRIME position. When released, it returns automatically to the LOCK position.

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Section 1: Introduction, Page 1-11

POWER Light The green POWER light is located at the right side of the instrument near the top. When the instrument is turned on, the light illuminates.

LOW STAIN Light The yellow LOW STAIN light is to the left of the POWER light. It is off under usual operating conditions; however, when the Hematek Stain Pak contains sufficient reagents to stain only about 20 slides, a weight-sensing device activates the circuit and illuminates the light. The Stain Pak should be replaced at this time.

Power Module The power module is located on the rear of the instrument; on one side of the module is the panel that contains the line cord receptacle, fuse, and power switch. The power module converts the line current coming into the instrument to 12 volts DC, which is the voltage within the instrument.

Figure 1-8. Electrical System–Rear of Instrument 1 2 3 4

Power Module ON / OFF Switch Fuse Holder Line Cord Receptacle

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Line Cord Receptacle The line cord connects into the line cord receptacle, which is located at the top of the panel on the power module.

Fuse Holder The fuse holder, in the center of the panel, holds the fuse that protects against serious electrical overload. A spare fuse is also located in the fuse holder.

ON / OFF Switch The ON / OFF Switch is located at the bottom of the panel and controls all power to the instrument.

Specifications Power Requirements

100 - 230 VAC + 10%, 50/60 Hz, 0.75 Amps

Fuse Rating

250 Volt, 1.0 Amps, 5mm x 20mm, Type T

Line Leakage Current

<5 milliamperes Testing protocol and allowable limits as specified by the safety standards for laboratory equipment outlined in UL 1262 and CSA 22.2 No. 151.

Dimensions

Depth - 43.4 cm (17.1 in) Width - 47.0 cm (18.5 in) Height - 19.0 cm (7.5 in)

Weight

17.7 kg (39 lbs)

Throughput

Stains 1 slide per minute

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Section 1: Introduction, Page 1-13

Disposal of System Waste and Supplies Laws and regulations enacted to protect the environment and to encourage resource conservation require the disposal of hazardous and biohazardous wastes in a specified manner. Some of the wastes from the Hematek Slide Stainer can be classified as hazardous or biohazardous wastes. It is essential that the laboratory take appropriate steps to determine the laws and regulations applicable to their disposal and to effect compliance. If it is necessary to sample instrument wastes and effluent in order to evaluate compliance with applicable regulations, the laboratory should contact a local licensed biohazardous waste disposal firm for assistance. The principal wastes associated with the use of the Hematek Slide Stainer are pump and underplaten tubing, effluents from the staining operation, and the container for stain, buffer, and rinse. Slides with human specimens, control materials, and all reagents, should also be handled and disposed of in accordance with the prevailing regulations and guidelines of agencies with jurisdiction over the laboratory. Refer to the product label and to Material Safety Data Sheets for details concerning any special precautions related to the handling of Hematek Stain Pak containers. Material Safety Data Sheets are available from Bayer. BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Appendix A, page A-1 for recommended precautions when working with biohazardous materials.

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