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CellaVision RAL SmearBox Instructions For Use Manual

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RAL SmearBox
Instructions for Use
RAL Diagnostics
Site Montesquieu
33650 Martillac
France
+33 (0) 557 960 404
www.ral-diagnostics.fr

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Summary of Contents for CellaVision RAL SmearBox

  • Page 1 RAL SmearBox Instructions for Use RAL Diagnostics Site Montesquieu 33650 Martillac France +33 (0) 557 960 404 www.ral-diagnostics.fr...
  • Page 3 ® CellaVision is a registered trademark of CellaVision AB. All other trademarks used in this document are the property of their respective owners. No part of this document or the products it describes may be reproduced or transmitted by any means or in any form without prior consent in writing from RAL Diagnostics.

  • Page 5: Table Of Contents

    1.5.2 Back view 1.5.3 Control panel 1.5.4 RAL SmearBox Slide Spreader 1.6 Patents 2 INSTALLATION 2.1 Unpacking and set-up of the RAL SmearBox 2.1.1 Check the box 2.1.2 Unpack the device 2.1.3 Check the contents of the box 2.1.4 Set up the device 2.1.5 Start the device...
  • Page 6 5.1.8 Disposal 5.2 Performance specifications 5.2.1 Performance specifications per device cycle 5.3 Consumables and spare parts 5.3.1 RAL SmearBox Slide Spreader 5.3.2 RAL SmearBox spare parts 5.3.3 Slides 5.3.4 Blood tubes 5.3.5 Decontamination solution 6 CLEANING AND MAINTENANCE 6.1 Change the waste bin 6.1.1 Change waste bin procedure...
  • Page 7 8 APPENDIX 8.1 Examples of Blood tubes compatible with RAL SmearBox Revision history INDEX PM-11056-01 Revised: 2023-06-07...

  • Page 9: Introduction

    1  Introduction 1 INTRODUCTION RAL SmearBox is an automatic blood smearing device, for use in combination with a RAL SmearBox Slide Spreader. It produces standardized blood smears, suitable for both manual microscopy and digital image analysis systems, directly from a closed whole blood sample tube.

  • Page 10: Symbols

    1  Introduction Alerts Explanation Can cause personal injury. Warning! Risk of infection. Warning! Can cause damage to the system. Caution! Can cause misleading results. Important! 1.3.2 Symbols Depending on the product, you may find the following symbols on the device or the packaging material.
  • Page 11 1  Introduction Symbol Meaning Catalog number. Indicates the manufacturer's catalog number so that the medical device can be identified. Serial number. Indicates the manufacturer's serial number so that the medical device can be identified. Manufacturer. Indicates the medical device manufacturer. Date of manufacture.

  • Page 12: General Safety

    Allow only trained and authorized personnel to operate or service the device. Do not use chipped or broken glass slides. Use only RAL SmearBox original, or by the manufacturer approved, consumables. Use only RAL SmearBox original spare parts. Do not modify or tamper with the device.

  • Page 13: Electrical Safety

    Declaration of conformity. 1.4 Theory of operation RAL SmearBox uses a disposable one-piece consumable RAL SmearBox Slide Spreader to automatically pierce a closed, anticoagulated whole blood sample tube, deposit a blood drop on a glass microscope slide, and spread it to make a blood smear. The RAL SmearBox Slide Spreader is then ejected into the internal disposable waste bin.

  • Page 14: Overview Of The Ral Smearbox

    1  Introduction 1.5 Overview of the RAL SmearBox 1.5.1 Front view 1 Lid (open position) 4 Control panel 5 Glass slide receptacle 2 RAL SmearBox Slide Spreader receptacle 6 Disposable waste bin receptacle 3 Blood tube holder 1.5.2 Back view 7 USB port...

  • Page 15: Control Panel

    1 Needle - Function: Piercing the blood sample tube 2 Spreader - Function: Smearing the blood drop 3 Dropper - Function: Drop making 1.6 Patents RAL Diagnostics owns the following patents for the RAL SmearBox and RAL SmearBox Slide Spreader. Other patents pending: PM-11056-01 Revised: 2023-06-07...
  • Page 16 1  Introduction Patents no. FR 1552214 US 10746636 B2 PM-11056-01 Revised: 2023-06-07...

  • Page 17: Installation

    2  Installation 2 INSTALLATION 2.1 Unpacking and set-up of the RAL SmearBox Warning - Risk of personal injury! To prevent injury due to improper handling: Place the device on a stable surface, such as a desk or workbench. Allow only trained and authorized personnel to operate or service the device.

  • Page 18: Check The Box

    Acclimatize the device to operating conditions before taking it into use. For specifications of operating conditions, see 2.1 Unpacking and set-up of the RAL SmearBox on the previous page. PM-11056-01...
  • Page 19 2  Installation 1. The device should be placed out of direct sunlight. Make sure that the work area fulfills all laboratory standards. A work area 50 cm x 50 cm, near a mains power outlet, is needed for the installation. 2.
  • Page 20 2  Installation 4. Turn the waste bin over, tear the tabs along the side perforations, and fold them outwards. 5. Use the outer box to store the unused RAL SmearBox Slide Spreader consumables. When empty, reuse it to cover the filled waste bin, as described in 6.1 Change the waste bin on page 43. 6.

  • Page 21: Start The Device

    2  Installation 8. Connect the cord from the 24 V DC / 2.5 A power supply to the back of the device and connect the power supply to the 100 to 240 V AC outlet. Only use the power supply provided. 2.1.5 Start the device When the device is powered up, by connecting it to the power outlet, the start-up sequence runs automatically: a.
  • Page 22 2  Installation 3. Open the lid and put a blank slide in the slide receptacle. Note: Do not put a RAL SmearBox Slide Spreader or a blood tube in the device. 4. Close the lid. PM-11056-01 Revised: 2023-06-07...
  • Page 23 2  Installation 5. Press and hold the start button for a minimum of 10 seconds. All mode LEDs turn blue and the status LED flashes green. The running-in cycle begins. 6. After about 30 minutes, status LED turns solid green and the running-in cycle is complete. 7.

  • Page 25: Operating Procedure

    3  Operating procedure 3 OPERATING PROCEDURE 3.1 Operation of the RAL SmearBox Warning - Risk of personal injury! To prevent injury due to improper handling, allow only trained and authorized personnel to operate or service the device. Warning - Risk of electric shock!

  • Page 26: Operation Mode Selection

    Use only blood tubes and glass slides specified in this documentation. 3.1.1 Operation mode selection The RAL SmearBox is programmed with five selectable operation modes. To cycle between modes, press the Change mode button. The three icons Short smear, Standard smear, and Mixing light up in blue, in different combinations, to indicate the selected mode.
  • Page 27 If in doubt, contact your local vendor. Refer to the 8.1 Examples of Blood tubes compatible with RAL SmearBox on page 57. The list is not exhaustive, so vacuum tubes of different brands, but with the same dimensions, may also be compatible.
  • Page 28 3  Operating procedure 2. Put a glass slide in the slide receptacle with the frosted or label side up and towards you. Note: The lid must be opened to insert the slide. 3. Put a RAL SmearBox Slide Spreader in the RAL SmearBox Slide Spreader receptacle. PM-11056-01 Revised: 2023-06-07...
  • Page 29 3  Operating procedure 4. Close the lid. 5. A solid blue indicator light shows that the device is active. If the device is in standby mode (solid white indicator), press the Change mode button on the control panel to exit standby mode. PM-11056-01 Revised: 2023-06-07...
  • Page 30 3  Operating procedure 6. Press the Change mode button until the desired mode is selected. The selected modes will light up in blue. Note: The default settings are Standard smear and Mixing. 7. Press the Start button. A flashing green Status LED shows that the operation proceeds normally. A flashing blue Status LED shows that the blood smear is complete.

  • Page 31: Evaluate The Blood Smear

    The gradual transition in smear thickness and the forming of a monolayer suitable for analysis. The relative absence of grainy streaks, troughs, ridges, holes, or bubbles. The following illustration is an example of a well-formed blood smear, showing the typical "flame shaped" smear produced by the RAL SmearBox: PM-11056-01 Revised: 2023-06-07...
  • Page 32 3  Operating procedure Deviations and corrective actions RAL SmearBox is designed to produce standardized blood smears of uniform quality. If the blood smear is too long, make another smear as described in 3.1.2 Make a blood smear on page 26 but this time press the Change mode button until Short smear is selected.

  • Page 33: Troubleshooting

    4  Troubleshooting 4 TROUBLESHOOTING This section describes issues that can occur during operation, along with possible causes and suggested solutions. If an issue arises: 1. Observe any unusual circumstances concerning the issue. 2. Note any Status LED indications. 3. Follow the relevant troubleshooting steps. 4.

  • Page 34: The Slide Does Not Fit The Receptacle

    4  Troubleshooting To select the mode, press the Change mode button. Make sure that the Mode icon for either Standard smear or Short smear is lit, together with the Mixing icon. If only the Mixing icon is lit, the device will not produce a smear. A flashing red Status LED indicates that no blood was dropped on the slide.

  • Page 35: The Slide Is Stuck In The Receptacle

    4  Troubleshooting Use only slides specified in 5.3 Consumables and spare parts on page 41. If the slide is stuck in the receptacle, see 4.1.4 The slide is stuck in the receptacle below . 4.1.4 The slide is stuck in the receptacle 1.

  • Page 36: The Stack Of Consumables In The Bin Blocks The Operation Of The Device

    4  Troubleshooting 4. Close the lid and connect the power supply. The tube holder returns to its initial position and releases the blood tube. If the tube holder has been damaged, see 6.5 Parts replacement on page 49. 4.1.8 The stack of consumables in the bin blocks the operation of the device When the RAL SmearBox discards the used RAL SmearBox Slide Spreader in the bin, it is possible that the stack of RAL SmearBox Slide Spreader consumables blocks the operation of the device.

  • Page 37: The Blood Smear Has The Wrong Shape Or Structure

    4  Troubleshooting 4.2.3 The blood smear has the wrong shape or structure Morphological deviations include blood smears that are uneven, asymmetrical, or perforated, as well as blood smears that fail to spread. Poorly formed blood smears can have various causes. To rule out an error in the blood smearing process: Make sure that the slide is clean.

  • Page 39: Technical Information

    5  Technical information 5 TECHNICAL INFORMATION 5.1 System specifications 5.1.1 Storage and handling specifications Specification Limitations Temperature: -20 °C to +60 °C Relative humidity: 10 % to 70 %, non-condensing Follow the instructions in the enclosed Quickstart guide when unpacking the device. Save the packaging material, including the wheel stopper transport protection, for future transport needs.

  • Page 40: Physical Specifications

    5  Technical information 5.1.4 Physical specifications Specification Properties Weight: 2.2 kg, without power supply Width: 235 mm Height: 233 mm Depth: 238 mm Other: 1 USB flash drive port 1 power supply port 5.1.5 Electrical specifications Specification Properties Power source rating: 100 to 240 V AC, 50/60 Hz, 2.5 A Power supply unit output: 24 V DC / 2.5 A, 60 W maximum Surge category:...

  • Page 41: Performance Specifications

    The lid, the plate that covers the slide receptacle and, the tube holder are available as spare parts. Replacement spare part Reference number Quantity S4100034 Plate S4100030 Tube holder S4100031 5.3.3 Slides RAL SmearBox accepts glass slides that conform to the ISO 8037/1-1986 specifications. PM-11056-01 Revised: 2023-06-07...

  • Page 42: Blood Tubes

    Blood sample tubes with dimensions exceeding 13 x 82 mm will not fit the tube holder! Other limitations related to certain brands, dimensions, and designs may apply. If in doubt, contact your local vendor. See 8.1 Examples of Blood tubes compatible with RAL SmearBox on page 57. Blood tube specifications Specification...

  • Page 43: Cleaning And Maintenance

    6  Cleaning and maintenance 6 CLEANING AND MAINTENANCE 6.1 Change the waste bin Warning! To avoid contact with potentially infectious blood from used consumables: Wear protective disposable gloves, protective clothing, and face protection when handling potentially infectious materials. Dispose of consumables according to laboratory standards and applicable national and local regulations in force.

  • Page 44: Change Waste Bin Procedure

    6  Cleaning and maintenance 6.1.1 Change waste bin procedure 1. Remove the waste bin from the side of the device. 2. Put the empty Outer box (3) upside down over the Waste bin (4). Make sure that the Bio-hazard symbol (5) is visible in the cut-out. The folded Tab (6) should catch inside the box, to prevent it from being accidentally opened again.

  • Page 45: Scheduled Cleaning

    5. Open a new box of RAL SmearBox Slide Spreader consumables and insert the new waste bin in the device. For details, see 2.1 Unpacking and set-up of the RAL SmearBox on page 17. 6. To reset the internal counter and make the device ready for use again, press and hold the Start button (2) for ten seconds.

  • Page 46: Corrective Maintenance And Cleaning

    6  Cleaning and maintenance We recommend that you clean both the interior and exterior surfaces of the unit regularly: 1. Wipe off any blood stains, using a soft, lint-free cloth or absorbent paper soaked in water. 2. Decontaminate the unit, using a soft, lint-free cloth dampened with rubbing alcohol. See: 5.3 Consumables and spare parts on page 41.

  • Page 47: Internal And External Decontamination Of Blood Spills

    6  Cleaning and maintenance Corrective maintenance can be necessary in some situations: If the Status LED indicates an error; see 7 Buttons, icons, and indicators on page 53. If blood is not smeared correctly. If glass dust is found inside the device. Note: Glass dust becomes an issue mainly if glass slides with cut edges and 90°...

  • Page 48: Glass Dust Inside The Device

    2. Place the new BSMxxx.hex software on a FAT 32 formatted USB flash drive. 3. Disconnect the power cord at the back to power OFF the RAL SmearBox. 4. Insert the USB flash drive in the port next to the power connector, at the back.

  • Page 49: Parts Replacement

    6  Cleaning and maintenance 6.5 Parts replacement Service and repairs should be performed by a service technician. However, parts replacements described in this section can be done by the user. 6.5.1 Change the lid 1 Lock-plug 2 Plug 3 Washer 1.

  • Page 50: Change The Slide Receptacle Cover Plate

    6  Cleaning and maintenance 6.5.2 Change the slide receptacle cover plate 1. Twist the two plastic plugs a quarter of a turn by hand, or with a flat screwdriver. 2. Remove the plugs, then pull the plate towards you and remove it. 3.

  • Page 51: Change The Tube Holder

    6  Cleaning and maintenance 6. Make sure that the pressure sensor protrudes through the hole in the plate, so that it is not stuck. 6.5.3 Change the tube holder 1. Insert a slide into the slide receptacle and start a cycle. 2.

  • Page 53: Buttons, Icons, And Indicators

    7  Buttons, icons, and indicators 7 BUTTONS, ICONS, AND INDICATORS The interface of the RAL SmearBox, located in the control panel on the right side of the lid, consists Change mode button, for selection of mixing and blood smear setting.

  • Page 54: Led Colors Of The Interface

    7  Buttons, icons, and indicators 7.1.1 LED colors of the interface Status Activation Icon color Indication Standby Device inactive for more than 5 minutes Solid Active Start or Change mode button pressed Solid Cycle in Start button pressed after setup and mode selection Flashing progress Cycle...
  • Page 55 7  Buttons, icons, and indicators Standard Solid smear Short smear Solid Mixing Solid Select mode button + Start button Standard smear + Solid Mixing Short smear Solid + Mixing PM-11056-01 Revised: 2023-06-07...
  • Page 57 8  Appendix 8 APPENDIX 8.1 Examples of Blood tubes compatible with RAL SmearBox Important! Blood sample tubes with dimensions exceeding 13 x 82 mm will not fit the tube holder! Other limitations related to certain brands, dimensions, and designs may apply. If in doubt, contact your local vendor.
  • Page 58 8  Appendix (cont.) Supplier Reference Note Volume EDTA Dimensions 454052 VACUETTE 1 mL 13 x 82 mm 454034 VACUETTE 1 mL 13 x 82 mm 454024 VACUETTE 2 mL 13 x 82 mm 454047 VACUETTE 2 mL 13 x 82 mm 454087 VACUETTE 2 mL...

  • Page 59: Revision History

    "Do not overload the power socket." and "Only use the power supply cord provided with the device/by your distributor." 1.5 Overview of the Updated illustration to include label. RAL SmearBox on page 14 2.1 Unpacking and set- Added reference to running-in cycle. up of the RAL SmearBox on page 17...
  • Page 60 8  Appendix Section Change Added note that the tube needs to be inserted into the tube holder 3.1.2 Make a blood bottom first, and updated illustration to indicate this. smear on page 26 Added note that lid needs to be closed when inserting slide. Updated instructions to say that mode settings do not need to be changed prior to making a smear.
  • Page 61 8  Appendix Revision 2022-05-23 Section Change Whole document First version of document created. PM-11056-01 Revised: 2023-06-07...
  • Page 63 Index indicators 53 INDEX Infection risk 12 Intended use 9 LED colors - Key 54 Bio-hazard waste 40 Blood smear 26 Blood smear - Requirements 31 Maintenance 43 Blood tubes - List 57 Maximum altitude 39 Buttons 53 Mixing 26 Change mode 29-30 Operation 13, 25 Change waste bin 43...
  • Page 64 Index Spare parts 41 Standard smear 30 Storage 39 Symbol 10 Technical information 39 Temperature 39 Transport 39 Troubleshooting 33 Update system software 48 User safety 12 Warning 12 Waste bin 19 Weight 40 Width 40 PM-11056-01 Revised: 2023-06-07...

  • Page 66: Pm-11056-01

    Document: PM-11056-01 Revised: 2023-06-07...