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User defined modifications are not supported by Siemens as they may affect performance of the system and test results. Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str.
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Chapter overview Chapter overview Introduction Safe handling Life cycle Description Operating Cleaning Performing maintenance Troubleshooting Appendix Addendum to the instruction manual ® Hematek 3000 System – Instruction Manual – Version 1.3...
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Chapter overview ® Hematek 3000 System – Instruction Manual – Version 1.3...
Table of contents Table of contents 1 Introduction About this manual Orientation tips Service Warranty Ordering information 2 Safe handling Intended use General safety information 2.2.1 Operator qualification 2.2.2 Electrical safety 2.2.3 Mechanical safety 2.2.4 Operational safety 2.2.5 Safe handling of glass slides and consumables Safety messages 2.3.1 Signal words in safety messages...
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Table of contents Non-operation De-installation Transport Disposal 3-10 4 Description Slide stainer 4.1.1 Fluid delivery components 4.1.2 Slide transport components 4.1.3 Electrical components 4.1.4 Leveling components 4-12 4.1.5 4-12 Consumables and spare parts 4-12 4.2.1 Hematek Stain Pak - Modified Wright’s Stain 4-12 4.2.2 Hematek Stain Pak - Wright-Giemsa Stain...
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Table of contents Cleaning the exterior surfaces Cleaning the stain tube and cannula Cleaning the platen Cleaning the waste tank Cleaning the drain troughs and the rear guide rail 7 Performing maintenance Periodic maintenance Installing the Hematek Stain Pak Replacing the pump tubing 7.3.1 Removing the pump tubing 7.3.2...
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Table of contents 9 Appendix Principle of operation Staining process 9.2.1 Example for the calculation of the stain-to-buffer ratio Technical specifications Index IX-1 Addendum to the instruction manual 1 ® Hematek 3000 System – Instruction Manual – Version 1.3...
1 Introduction Introduction This chapter gives orientation tips for using this manual and information about service and warranty. About this manual This manual describes the use of the Hematek 3000 System in clinical laboratories. Orientation tips Bullets Bullets indicate a list.
Siemens service refers to both, the Siemens service or any local representative authorized by Siemens. You will receive information about how to reach the Siemens service when the system is installed, or visit www.siemens.com/diagnostics to find contact information. The scope of agreed service is included in your service contract.
• Always follow the instructions in this manual. • Only use the system as intended. If the system is not used as intended, Siemens disclaims all liability for any personal injury and property damage. • Always follow good laboratory practice.
2 Safe handling 2.2.2 Electrical safety Risk of electric shock when contacting live parts. Even when the system is switched off, some components, for example, capacitors, can be live as they can still be electrically charged. Death or serious injury can result. To avoid this hazard: •...
• Only carry out maintenance and repair work or replace parts as described in this manual. • Only use Siemens spare parts. 2.2.5 Safe handling of glass slides and consumables Risk of infection by potentially infectious material. Blood and bone marrow smears and parts of the system which have come into contact with this material are potentially infectious.
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• Do not use glass slides of variable thicknesses. • Do not use bevel-edged glass slides. • Only use approved Siemens consumables. • Do not use consumables after their expiry date. • Be sure to read and observe any instructions for use that are supplied with the consumables.
2 Safe handling Safety messages All safety messages must be observed to avoid hazardous situations which can result in death, injury or damage to the equipment. 2.3.1 Signal words in safety messages The following explains the signal words and their meaning. Signal word Meaning Indicates a hazardous situation which, if not avoided, will result in death...
2 Safe handling Symbols on the slide stainer and consumables This chapter describes the symbols used on the slide stainer and on the consumables used with the slide stainer. Symbol Meaning Consult instructions for use Caution, consult accompanying documents In vitro diagnostic medical device CE mark Manufacturer Authorized representative in the European Community...
2 Safe handling Symbol Meaning Biological hazard The labeled area can come into contact with potentially infectious material. The safety instructions regarding infectious material must be observed, see Chapter 2.2.5. Content is toxic if swallowed, inhaled, or in contact with skin Content is flammable Content is harmful if swallowed, inhaled, or in contact with skin Batch code...
2 Safe handling Obligations of the system owner The system owner takes on the obligations arising from the national legislation about the operation of in vitro diagnostic medical devices. ® Hematek 3000 System – Instruction Manual – Version 1.3...
10. Retain the transport container, plastic bag, and foam packing. If the system needs to be transported, these will afford the best protection. 11. Check the content for completeness, see Chapter 3.1.2, and intact condition. 12. If anything is missing or damaged, inform the Siemens service immediately. ® Hematek...
• 1 Hematek 3000 slide stainer • 1 Hematek Pump Tube Set • 1 Hematek Cannula Set • 1 Hematek 3000 System Instruction Manual (language-specific) • 1 Power cord (country-specific) Note: A Hematek Stain Pak is required for operation, but is not included in the delivery and must be ordered separately.
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3 Life cycle 6 Platen 7 Leveling feet 8 Sensing switch fingers 9 Slide drawer 10 Waste tank Figure 3-1 Installing the system (continued) 1. Make sure that the electrical and environmental conditions are met, see Electrical on page 9-3 and Environmental on page 9-3. 2.
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Install pump tubing 22. Install the pump tubing, see Chapter 7.3.2. Install underplaten tubing 23. Install the underplaten tubing, see Chapter 7.4. Note: When first delivered by Siemens, the underplaten tubing is already installed. ® Hematek 3000 System – Instruction Manual – Version 1.3...
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3 Life cycle Install Hematek Stain Pak 24. Install the Hematek Stain Pak, see Chapter 7.2. Start system 25. Start the system, see Chapter 5.1. 26. Prime the pump tubing, see Chapter 5.2. NOTICE If glass slides are not placed correctly in the grooves of the conveyor spirals, this can cause them to break Damage to the system can result.
• Refer to the Hematek Stain Pak labeling and to Material Safety Data Sheets for more information on first aid measures. Material Safety Data Sheets are available from Siemens. WARNING Risk of burns by combustion of flammable liquids. The Hematek Stain Pak contains methanol which is highly flammable.
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• Refer to the Hematek Stain Pak labeling and to Material Safety Data Sheets for details concerning any special precautions related to the disposal of Hematek Stain Paks. Material Safety Data Sheets are available from Siemens. Remove glass slides 1. Remove processed glass slides from the slide drawer. If glass slides are being processed, do not attempt to remove them from the platen.
3 Life cycle Clean platen 10. Clean the platen, see Chapter 6.4. Clean waste tank 11. Clean the waste tank, see Chapter 6.5. Clean exterior surfaces 12. Clean the exterior surfaces, see Chapter 6.2. De-installation To de-install the system, proceed as follows: 1.
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3. In the pocket at the rear of the slide stainer, screw in the knurled thumb screw retained with the transport container. If you have lost the knurled thumb screw, order from the current Siemens product catalog or contact the Siemens service 4.
2012/19/EU on waste electrical and electronic equipment (WEEE), and corresponding national transpositions. Siemens is committed to taking back and recycling electrical and electronic equipment in areas where the above mentioned directive is enforced. In areas where the above mentioned directive is not enforced, contact the Siemens service with regard to disposal of the system.
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To dispose of the system, proceed as follows: 1. De-install the system, see Chapter 3.4. 2. Contact the Siemens service with regard to disposal of the system. 3. Dispose of the system according to national and local standards and regulations.
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3 Life cycle ® Hematek 3000 System – Instruction Manual – Version 1.3...
4 Description Description This chapter describes the operation and the functions of the system. Slide stainer The slide stainer is displayed in Figure 4-1 and Figure 4-2. 1 Circular bubble level 2 Power switch with green power light 3 Yellow low stain light 4 Red waste tank light 5 Slide transport components 6 Fluid delivery components...
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4 Description 1 Lid 2 Power module 3 Fixed foot 4 Air inlet 5 Leveling feet Figure 4-2 Rear view of the slide stainer ® Hematek 3000 System – Instruction Manual – Version 1.3...
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4 Description 1 Pump tubing release knob 2 Sensing switch fingers 3 Waste tank Figure 4-4 Fluid delivery components, front view Pump assemblies and The slide stainer has three pump assemblies, one for each fluid. An adjustment knobs adjustment knob that controls the rotating speed of the respective pump is located next to each pump assembly.
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4 Description Each pump assembly consists of a pump motor and four rollers that are attached to the underside of a pump cap. A pump arm that presses the stain, buffer, or rinse tube against the pump is situated next to each pump assembly.
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4 Description When the priming button is pressed, the green light in the priming button goes on, the three pumps start rotating and fluid is delivered through the pump tubing as long as the pump tubing release knob is in the lock position, see Pump tubing release knob on page 4-6.
4 Description 4.1.2 Slide transport components The slide transport components are displayed in Figure 4-7. 1 Platen 2 Conveyor spirals 3 Mixing grooves 4 Slide dryer 5 Slide drawer Figure 4-7 Slide transport components ® Hematek 3000 System – Instruction Manual – Version 1.3...
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4 Description Platen The platen spans the entire front of the slide stainer, between the conveyor spirals. The outside ridges of the platen are elevated guide rails, which provide support to the glass slides as they are moved along the platen. The functional areas of the platen are displayed in Figure 4-8.
4 Description Mixing grooves The two mixing grooves are located in the mixing area of the platen. As buffer is pumped onto the platen from the channel right of the mixing grooves, stain and buffer move around the mixing grooves and hence fully intermingle.
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4 Description 1 Power module Figure 4-10 Electrical components of the slide stainer, rear view 1 Service button Figure 4-11 Electrical components of the slide stainer, service button Power switch with green power The power switch is located on top of the slide stainer, at the right side. light When the main switch, see Main switch on page 4-11, is set to position I and the power switch is pressed, the green power light in the power switch goes...
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4 Description Red waste tank light The red waste tank light is located at the right side of the slide stainer, next to the rear conveyor spiral and below the yellow low stain light. It is off under normal operating conditions. A sensor activates the red waste tank light when the waste tank is full or removed from the slide stainer.
Consumables and spare parts This section lists the consumables and spare parts for the slide stainer. For more details, for example, order numbers, refer to the current Siemens product catalog or contact the Siemens service. Instructions for using the consumables are given in the respective procedures in this manual.
4 Description The Hematek Stain Pak - Modified Wright’s Stain contains a polychrome methylene blue-eosin stain and specially prepared buffer and rinse. The Hematek Stain Pak is contained in a single carton that fits easily into the pocket at the rear of the slide stainer and requires no additional preparation and opening.
4 Description 4.2.4 Hematek Pump Tube Set A pump tube is displayed in Figure 4-16. Figure 4-16 Pump tube The Hematek Pump Tube Set consists of three tubes, each labeled with an identifying number specific to the fluid carried by the tube: •...
4 Description 4.2.6 Glass slides A glass slide is displayed in Figure 4-18. Figure 4-18 Glass slide The dimensions of the glass slides are 75mm x 25mm x 1mm (L x W x H). 4.2.7 Line fuses A line fuse is displayed in Figure 4-19. Figure 4-19 Line fuse Two line fuses are inserted into the fuse compartment.
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4 Description ® Hematek 3000 System – Instruction Manual – Version 1.3...
5 Operating Operating This chapter describes how to operate the system, from starting the system to switching off the system. Starting the system To start the system, proceed as follows: 1. Inspect the waste tank and slide drawer for proper positioning below the platen.
5 Operating 5. If the pump tubing does not prime easily, pinch the tubes several times with your fingers in the area between the cannula and the pump. Otherwise skip this step. 6. Press the priming button. The green light in the priming button goes off and the pumps stop rotating.
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5 Operating 1. Prime the pump tubing, see Chapter 5.2. The pump tubing is free of air bubbles. NOTICE If glass slides are not placed correctly in the grooves of the conveyor spirals, this can cause them to break Damage to the system can result.
5 Operating 8. Before processing more glass slides, prime the pump tubing, see Chapter 5.2. CAUTION Injury to fingers and hands by broken glass slides Minor or moderate injury can result. • Wear appropriate protective equipment. • Handle smeared glass slides in accordance with good laboratory practice.
6 Cleaning Cleaning This chapter describes how to clean the system. WARNING Risk of very serious irreversible effects through inhalation of methanol, through contact with skin, and if methanol is swallowed Death or serious injury can result. • Wear appropriate personal protective equipment; that is, gloves, protective clothing, safety glasses and mask.
6 Cleaning Periodic cleaning Periodic cleaning actions are listed in Table 6-1. Interval Action Daily, end of shift, or if necessary Clean exterior surfaces Chapter 6.2 Daily, end of shift Clean stain tube and cannula Chapter 6.3 Daily, end of shift, or if no glass slides are to be Clean platen Chapter 6.4 processed for one hour or more...
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6 Cleaning Rinse stain tube and cannula 2. Place the stain cannula, with stain tube attached, into a small container with approximately 5mL of methanol. 3. Left of the pump assemblies, press the priming button, see Chapter 4.1.1. The green light in the priming button goes on and the pumps start rotating.
6 Cleaning Cleaning the platen To clean the platen, proceed as follows: NOTICE Breakage of glass slides due to stained front rail of the platen If using frosted-end glass slides, the stain can spread across the frosted portion of the glass slide to the front rail. If allowed to accumulate, this can cause the glass slides to break.
• Refer to the Hematek Stain Pak labeling and to Material Safety Data Sheets for more information on first aid measures. Material Safety Data Sheets are available from Siemens. WARNING Risk of burns by combustion of flammable liquids. The content of the waste tank contains methanol which is highly flammable.
Sheets for details concerning any special precautions related to the disposal of Hematek Stain Pak fluids. Material Safety Data Sheets are available from Siemens. 1. Carefully pull the waste tank away from the system, supporting the bottom of the waste tank to hold it level. The red waste tank light goes on.
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6 Cleaning 3. Remove the middle cover from the system, see Figure 6-1. The rear trough and guide rail are completely exposed and easily accessible. 1 Lid 2 Middle cover Figure 6-1 Removing the middle cover Clean drain troughs and rear 4.
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6 Cleaning 5. Wipe from right to left along the length of the drain troughs and the rear guide rail with the cotton swab to remove the entire excess residue, see Figure 6-2. 1 Drain troughs 2 Rear guide rail Figure 6-2 Cleaning the drain troughs and rear guide rail 6.
• Refer to the Hematek Stain Pak labeling and to Material Safety Data Sheets for more information on first aid measures. Material Safety Data Sheets are available from Siemens. ® Hematek 3000 System – Instruction Manual – Version 1.3...
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• Refer to the Hematek Stain Pak labeling and to Material Safety Data Sheets for details concerning any special precautions related to the handling of Hematek Stain Paks. Material Safety Data Sheets are available from Siemens. To install the Hematek Stain Pak, proceed as follows: 1. Raise the lid.
7 Performing maintenance 12. With the cannula, make a second hole in the top of the bottle, near the indentation. 13. Push the cannula down through the first puncture until the guard at the top touches the plastic container. 14. Repeat step 9 to step 13 for each bottle. 15.
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7 Performing maintenance WARNING Risk of burns by combustion of flammable liquids. Methanol is highly flammable. Death or serious injury can result. • Do not use methanol in the proximity of sources of ignition, for example, ovens, hot plates, burners, radiators, or open flames. •...
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7 Performing maintenance 8. Dispose of the disposable, absorbent cloths. Remove pump tubing 9. Left of the pump assemblies, turn the pump tubing release knob to the unlock position, see Chapter 4.1.1. 10. Disconnect each tube from its cannula. 11. On the rear of the middle panel, disconnect the tube from the nipple. An example pump assembly is displayed in Figure 7-1.
7 Performing maintenance 16. If you want to install a new Hematek Pump Tube Set, go to Chapter 7.3.2. 7.3.2 Installing the pump tubing You will need: • 1 new Hematek Pump Tube Set • Optional: 1 new Hematek Cannula Set To install the pump tubing, proceed as follows: Each tube is identified 1.
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7 Performing maintenance 6. Make sure that you push each tube until it is flush against the guard of the cannula. Thread tubes through pump arms 7. Left of the pump assemblies, turn the pump tubing release knob to the unlock position, see Chapter 4.1.1.
7 Performing maintenance 14. Make sure that at least 7mm (1/4in) of the tube is connected to the nipple. 15. Execute step 9 to step 14 for each tube. 16. Left of the pump assemblies, turn the pump tubing release knob to the lock position, see Chapter 4.1.1.
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7 Performing maintenance WARNING Risk of very serious irreversible effects through inhalation of methanol, through contact with skin, and if methanol is swallowed Death or serious injury can result. • Wear appropriate personal protective equipment; that is, gloves, protective clothing, safety glasses and mask. •...
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7 Performing maintenance 1. Raise the lid. Empty underplaten tubing 2. Remove the three cannulas from the Hematek Stain Pak. 3. Place the tips of the cannulas on a disposable, absorbent cloth to soak up fluids. 4. Left of the pump assemblies, press the priming button, see Chapter 4.1.1.
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7 Performing maintenance Disconnect underplaten tubing 10. On the middle panel, disconnect the rinse, buffer, and stain tubes from the nipples. 1 Middle panel 2 Nipples 3 Rinse tube 4 Buffer tube 5 Stain tube 6 Tube clamps Figure 7-5 Disconnecting the underplaten tubing from the nipples 11.
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7 Performing maintenance 14. Reach underneath the platen through the waste tank area, see Figure 7-6. 1 Spouts 2 Rinse tube 3 Buffer tube 4 Stain tube 5 Rear conveyor spiral 6 Waste tank area 7 Platen 8 Slide drawer Figure 7-6 Waste tank area, bottom view 15.
7 Performing maintenance 7.4.2 Installing the underplaten tubing You will need: • 1 new Hematek Underplaten Tubing Set To install the underplaten tubing, proceed as follows: Connect tubes to nipples 1. On the middle panel, connect one of the new tubes of the underplaten tubing to each nipple.
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7 Performing maintenance 6. Thread each tube between the middle panel and the rear conveyor spiral until it extends under the platen, see Figure 7-8. 1 Spouts 2 Tubes 3 Middle panel 4 Rear conveyor spiral Figure 7-8 Connecting the underplaten tubing to the spouts Connect tubes to spouts 7.
This chapter lists possible problems relating to electrical and mechanical operations that could occur during system operation together with probable causes and corrective measures. If the measures recommended do not solve the problem, contact the Siemens service. Problem Probable cause...
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Fill level detector is not operating Contact the Siemens service. correctly. Red waste tank light goes on. Waste tank is full. Empty, rinse and replace the waste tank, see Chapter 6.5.
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Chapter 8.5.2. decrease stain intensity because of an incorrect stain-to-buffer ratio. Glass slides stick together because Glass slide drying system does not Contact the Siemens service. they are not dry. operate properly. Conveyor spirals do not operate. – Contact the Siemens service.
8 Troubleshooting Leveling the system To level the system, proceed as follows: 1. Place the system on a firm, level work surface. 2. Raise the lid, see Figure 8-1. 1 Lid 2 Circular bubble level 3 Leveling feet system Figure 8-1 Leveling the 3.
8 Troubleshooting Checking the adjustment of the sensing switch fingers You will need: • 4 spare glass slides To check the adjustment of the sensing switch fingers, proceed as follows: 1. Start the system, see Chapter 5.1 to Chapter 5.2. NOTICE If glass slides are not placed correctly in the grooves of the conveyor spirals, this can cause them to break...
8 Troubleshooting Adjusting the sensing switch fingers The sensing switch fingers must be properly positioned in order to accurately activate the pumps. You will need: • 1 spare glass slide To adjust the sensing switch fingers, proceed as follows: 1. On top of the system, at the right side, press the power switch. The Switch off system green power light in the power switch goes off, and the fan and the conveyor spirals stop.
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8 Troubleshooting • If so: Go to step 7. • If not: Go to step 5. 1 Sensing switch fingers 2 Sensing switches 3 Back trough 4 Platen Figure 8-3 Checking sensing switch fingers Adjust sensing switch fingers 5. Support the sensing switch finger that is not upright near the center of the wire with one hand.
Chapter 8.3. 13. If the adjustment of the sensing switch fingers does not result in correct timing, contact the Siemens service. Set middle cover back in place 14. Set the middle cover back in place. 15. Close the lid.
8 Troubleshooting 8.5.2 Correcting the pump volumes You will need: • 5 priming slides • 15 spare smeared glass slides To correct the pump volumes, proceed as follows: NOTICE If glass slides are not placed correctly in the grooves of the conveyor spirals, this can cause them to break Damage to the system can result.
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8 Troubleshooting • If the stain overflows on either side of the smeared glass slide, turn the stain adjustment knob counter-clockwise, see Figure 8-4. 1 Rinse adjustment knob 2 Buffer adjustment knob 3 Stain adjustment knob 4 Rear conveyor spiral Figure 8-4 Adjusting the pump volumes 5.
8 Troubleshooting • If the second mixing groove is completely flooded with the stain and buffer mixture, turn the buffer adjustment knob and the stain adjustment knob counter-clockwise slightly, see Figure 8-4. Adjust amount of rinse 9. Examine the stained glass slides under a microscope. Note: Any change in the rinse setting can cause a slight color change due to the small amount of methanol in the rinse.
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• Refer to the Hematek Stain Pak labeling and to Material Safety Data Sheets for more information on first aid measures. Material Safety Data Sheets are available from Siemens. WARNING Risk of burns by combustion of flammable liquids. The Hematek Stain Pak contains methanol which is highly flammable.
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8 Troubleshooting Disconnect tubes 2. Reach underneath the platen through the waste tank area, see Figure 8-5. 1 Spouts 2 Rinse tube 3 Buffer tube 4 Stain tube 5 Service button 6 Platen 7 Waste tank area 8 Slide drawer Figure 8-5 Waste tank area, bottom view 3.
8 Troubleshooting 8. Place the free end of the rinse tube into a 25mL graduated cylinder. NOTICE If glass slides are not placed correctly in the grooves of the conveyor spirals, this can cause them to break Damage to the system can result. •...
If the rinse volume deviates significantly from 10mL for 10 blank glass slides and/or the stain-to-buffer ratio is not between 1:2 and 1:3, proceed as follows: 1. If you already corrected the pump volumes, contact the Siemens service. 2. Otherwise, connect the tubes to the spouts under the platen. The tube from the stain pump must lead to the right spout.
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5. Carefully remove the fuse holder. 6. Remove the used line fuses. NOTICE Damage to the slide stainer due to inadequate line fuses Slide stainer can break down. • Only use Siemens spare parts. ® Hematek 3000 System – Instruction Manual – Version 1.3...
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8 Troubleshooting Replace line fuses 7. Insert new line fuses into the fuse holder. 8. With the lid facing in the direction of the main switch, put the fuse holder back into the fuse compartment. Push in all the way. Connect power source 9.
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8 Troubleshooting ® Hematek 3000 System – Instruction Manual – Version 1.3...
9 Appendix Appendix This chapter describes the principle of operation of the system and the technical specifications of the system. Principle of operation As the glass slides move along the platen, with the smeared side down, the system performs the following steps: Staining glass slides When a glass slide contacts the first of three sensing switch fingers, the respective sensing switch is activated.
9 Appendix Staining process The system produces stained glass 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.
9 Appendix Technical specifications Physical Dimensions (L x W x H) 46.0cm x 54.0cm x 22.0cm (18.1in x 21.3in x 8.7in) Required space for ventilation 10cm (3.9in) on all sides Weight 20kg (44.1lbs) Sound level 60dBA at operator’s position Glass slide capacity Input: 23 glass slides in the grooves of the conveyor spirals Output: approximately 65 glass...
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9 Appendix ® Hematek 3000 System – Instruction Manual – Version 1.3...
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Index Index system 6-1 waste tank 6-5 consumables glass slides 4-15 Hematek Cannula Set 4-13 Hematek Pump Tube Set 4-14 adjust Hematek Stain Pak - Modified Wright’s Stain 4-12 pump volumes 8-9 Hematek Stain Pak - Wright-Giemsa Stain 4-13 sensing switch fingers 8-6 Hematek Underplaten Tubing Set 4-14 adjustment knob line fuse 4-15...
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Index exterior surfaces, clean 6-2 pump tubing 7-6 system 3-2 underplaten tubing 7-13 intended use 2-1 feet, description 4-12 international standards 2-7 fluid delivery components, description 4-3 fuse description 4-15 replace 8-15 level system 8-4 leveling feet, description 4-12 lid, description 4-12 life cycle 3-1 general safety information 2-1 lights...
Addendum to the instruction manual Addendum to the instruction manual If you obtain an addendum to the instruction manual, file it with this instruction manual. ® Hematek 3000 System – Instruction Manual – Version 1.3...
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Addendum to the instruction manual ® Hematek 3000 System – Instruction Manual – Version 1.3...