SIL. Part Number: RAN711A. ABX SPS / ABX SPS Evolution / ABX SPS Evolution wave 5 3 month periodical maintenance kit modification

Transcription

1 Tn SIL Part Number: RAN711A ABX SPS / ABX SPS Evolution / ABX SPS Evolution wave 5 3 month periodical maintenance kit modification QUAL-QA-TEMP-0220_rev15 Date: 25/10/13 ECR: 5308

2 3 month periodical maintenance kit modification SIL: RAN711A Objective The staining mixing tubbing kit is added in the 3 month periodical maintenance kit Intervention information Intervention priority For information - As needed - Mandatory on next visit - Immediate and mandatory Tracking number SIL-RAN711A Intervention estimated duration: xhxx User process impact YES NO Potential patient result impact YES NO User training needed YES NO User documentation update YES NO Applied in factory on instrument serial # since instrument serial # Note history Note index Reason for change A to B Software version Note index Previous New Mini. requirements A to B B to C C to D New parts Parts designation Previous New Reason for change 3 month maintenance kit XEA933BS Kit to order: XEA933CS Add of XEC115AS New adjustments Adjustments Previous New Reason for change New documents Documentation Previous New Reason for change SPS 3 month maintenance procedure RAS563A RAS563B Add of XEC115AS replacement, linked to this note Additionnal requirements Designation Part number Link Part details kit or Assy Designation Component p/n Component designation Qty available for order 2/4

3 3 month periodical maintenance kit modification SIL: RAN711A Subject The staining mixing tubbing kit (XEC115AS) is added in the 3 month periodical maintenance kit. XEC115AS To EV26-2 To EV13-1 To Dilution Stain 2 chamber #2 The 3 Month maintenance procedure RAS563 is updated and includes this replacement. This procedure is linked to this note. 3/4

4 3 month periodical maintenance kit modification SIL: RAN711A 4/4

5 ABX SPS Evolution RAS563B 3 month maintenance RAS563B: 3 month maintenance Concerns 3 month maintenance Required tools Hexagonal keys Brush Plastic pipette Professional desinfection wipes (ex : WIP'ANIOS wipes) Soft paper and precision wipes (ex : Kimberly Clark KIMTECH SCIENCE Precision Wipes) Required products Ethanol (70% denatured alcohol) Sodium hypochlorite (bleach) Tap water Silicone grease (XEA019A) Oil (XEA821A) Grease (LAM017A) Intervention time 1 h 30 mn Frequency Every 3 month Specific kit or consumables 3 month maintenance kit: XEA933CS Disposable gloves, eyes protection and lab coat must be worn by the operator. Local or national regulations must be applied in all the operations.

6 3 month maintenance ABX SPS Evolution 3 month maintenance kit: XEA933BC Part number Designation Qty XEA850AS Black neopren tubing 4 x LG=12 mm 1 FAA067A O ring, syringe D=2.4 5Diff / SPS 2 GBG042A Syringe, crosspiece P60 / SPS 1 XDA622A O ring, reagent syringe. + Washer 5 GBC030A Piston 5 GBH0004 Piston d=12 staining syringe 1 XEA626B Sampling line + drop needle 1 FAA040A O ring, 12.1x CAE024A Vertical slide detection switch 1 XEC115AS Kit, tubing staining line Carrier Use a brush to remove the glass particles from the carrier 2. Rails Use a brush to clean the rail: RAS563B - 2 RAA036AEN

7 ABX SPS Evolution 3 month maintenance 3. Slide loader To access to the slide loader parts, remove the protection by unscrewing the 2 CHC screws. When installing the protection back, make pass wirings and tube by the apertures envisaged for this purpose. D Use a brush and a soft paper to remove the glass particles from slide loader parts: - Ball bearing way (A) - Axis (B) - Rolls (C) - Endless screw (D) Put one drop of oil (XEA821A) on the endless screw (D). B A C 4. Stainer and wells The use of Methanol is proscribed as emanations are dangerous for health. Use only Ethanol to clean the wells Remove all the wells from the stainer then plunge them into a container full of Ethanol. Leave them for about 5 mn then clean the well with tap water. RAA036AEN RAS563B - 3

8 3 month maintenance ABX SPS Evolution Throw the used Ethanol in the staining waste container. Use a soft paper to clean the stainer plate. Re install the empty staining wells, then: Enter: Menu \ SPS \ Misc cycles \ Methanol filling Enter: Menu \ SPS \ Misc cycles \ Methanol drain 5. Rinsing chamber Use tap water and soft paper to clean the drop needle s bracket (A) (see "Fig.5: rinsing chamber"). Pour Minoclair in the rinsing chamber then wait for 5 minutes. Drain and rinse the rinsing chamber. A 6. Cleaning stain marks Marks of stain on INOX or metallic surfaces (without painting) can be cleaned with ethanol using precision wipes. Marks of stain on painted covers can't be cleaned with ethanol : the painting might be dammaged. RAS563B - 4 RAA036AEN

9 ABX SPS Evolution 3 month maintenance 7. Important recommendations Never use Sodium hypochlorite (bleach) to clean or desinfect parts or surfaces of the device: oxydation might be created. Only internal part of the rinsing chamber and drop needle can be cleaned with sodium hypochlorite using a plastic pipette. In case it is needed to clean blood on the smearer wedge, only use WIP'ANIOS wipe to clean and desinfect it. 8. Hydraulic parts Check all tubings and fittings to detect possible leaks or potential sources of leakage. if necessary, solve the problem and clean up. 9. Sampling syringe 9.1. Location RAA036AEN RAS563B - 5

10 3 month maintenance ABX SPS Evolution 9.2. O ring & piston replacement (1x XDA622A + 2x FAA067A + 1 GBC030A + 1 GBG042A) Remove reagent tray (see " RAS550A: Pentra analyzer / ABX SPS Evolution separation"). Remove the 3 tubings connected on the syringe block. Unscrew the 2 syringe fixation screws. A Remove reagent block and empty the syringe by moving the two pistons, then unscrew the three CHC and two FHC screws. Remove the plate and remove the old O rings. Clean the block. Replace pistons, O rings and washers by new ones from the yearly maintenance kit. Use one drop of silicon grease in between two fingers to lubricate O rings. Reassemble in reverse order. Use a dynamometric screw driver to tighten the syringe. Put one drop of silicone grease on the metalic plate (A on previous page) maintening the pistons. TORQUES: - 4 x CHC M3 x 12: 400m N.m (56.8 Ozf.in) - 2 x FHC M 3 x 12: 400m N.m (56.8 Ozf.in). After Startup and priming, make sure there is no leakage. RAS563B - 6 RAA036AEN

11 ABX SPS Evolution 3 month maintenance 10. Reagent syringe location The reagent syringe is located at the right rear corner. To access to this syringe block: Remove the rack output tappet (A), unscrew the FHC screw located in the middle of the rack output plate (B) then turn the plate on the right side. B A Unscrew the 4 CHC screws to turn the cover in the same way. Take advantage of this dismantling to clean the endless screw (C). C As the endless screws is teflon coated, NO grease or oil must be applied. RAA036AEN RAS563B - 7

12 3 month maintenance ABX SPS Evolution Remove the atmospheric tubing from the dilution stain chamber, inlet 3, and replace it by a silicon one. Clamp this silicon tubing. Remove the five tubings connected on the staining syringe block. Unscrew the 2 fixation syringe screws and carefully remove the staining syringe block O ring & piston replacement (4 x XDA622A + 1 x FAA040A + 4 x GBC030A + 1 x GBH0004) Push several times the pistons over the staining waste container to drain the syringes. On a piece of absorbant paper, open the syringes by unscrewing the bottom plate Be careful with stain 1 and stain 2 not to damage any parts and/or clothes. RAS563B - 8 RAA036AEN

13 ABX SPS Evolution 3 month maintenance Washer O ring Replace pistons, O rings and washers by new ones from the yearly maintenance kit. Use one drop of silicon grease in between two fingers to lubricate O rings. Reassemble in reverse order. Put one drop of silicone grease on the metalic plate (A) maintening the pistons (exept if new stainless steel plate). Put back each tubing in position A TORQUES: - 4 x CHC M3 x 12: 400m N.m (56.8Ozf.in) - 2 x FHC M 3 x 12: 400m N.m (56.8 Ozf.in). Remove the clamp from the dilution stain chamber and reconnect the teflon tubing back. When installing back the rack output plate, ensure to correctly install the sensor wire under the metallic plate (B). B 11. Sampling line (1 x XEA626B) Please, refer to RAS553 (see "2.2. Needle replacement procedure"). RAA036AEN RAS563B - 9

14 3 month maintenance Staining tubing line 2 ABX SPS Evolution 12. Staining tubing line 2 (1 x XEC115AS) Remove the staining tubing line 2 and replace by the XEC115AS kit provided in the kit. XEC115AS To EV26-2 To EV13-1 To Dilution Stain 2 chamber #2 13. Grabber (1 x XEA850AS) Remove the 4 black tubings on the fingers then replace them by the 4 new. RAS563B - 10 RAA036AEN

15 ABX SPS Evolution 3 month maintenance Staining tubing line Endless screws Clean the vertical endless screws (A), vertical axis (B) and guiding plate (C) with brush and soft paper. Put one drop of LAM017A grease on the slide transfer endless screw and on the needle plate endless screw. C B A B A 15. Wedge Remove the smearer ribbon then use a softpaper with Ethanol to clean the wedge (See User manual, Section Maintenance & troubleshooting). 16. Eccentric bearings adjustment STA Y bearing Use a soft paper to clean the horizontal rail (A). Loosen the CHC screw located on the side of the assembly (B). C A Gently push on the opposite side of the assembly. Use a flat screwdriver to adjust the eccentric (C) just in touch with the rail then tight the CHC screw (B): Push B RAA036AEN RAS563B - 11

16 3 month maintenance Staining tubing line 2 ABX SPS Evolution STA Z bearing Use a soft paper to clean the vertical rail (A). Loosen the CHC screw located on the right side of the assembly (B). Gently push on the left side of the assembly. Tight the CHC screw (B). Push A B RAS563B - 12 RAA036AEN

17 ABX SPS Evolution 3 month maintenance Staining tubing line Examining the instrument for chemical build up Purpose Providing instructions for examining the internal electronic components of the instrument for chemical deposits that may be present Description It has been reported that chemical deposits have been observed accumulating on certain internal electronic components. If not removed, these deposits can create a risk of electrical and/or mechanical malfunction. The following describes the required preventive maintenance procedure for examining components for chemical build-up Prepare the instrument for examination BIOHAZARD: All products or objects that come in contact with human or animal body fluids should be handled, before and after cleaning, as if capable of transmitting infectious diseases. Wear facial protection, gloves, and protective clothing. The operator should follow the recommendations to prevent the transmission of infectious agents in health-care settings as recommended by the Clinical and Laboratory Standards Institute (formerly NCCLS) in Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - Third Edition CLSI Document M29-A3. This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety. ELECTRICAL HAZARD: To prevent electrostatic discharge damage when handling PCBs or other ESD sensitive devices, use an antistatic pad or wrist straps to allow for proper grounding. As an absolute minimum, before touching these devices, you must ground yourself by physically touching an unpainted or conductive surface on the instrument connected to ground. 1- Turn off the instrument To avoid damaging the two slide detectors when removing slides from the stacker, lift the slides up from the front corners at an angle and remove them from the stacker. RAA036AEN RAS563B - 13

18 3 month maintenance Staining tubing line 2 ABX SPS Evolution 2- Remove all slides from the slide dispenser. 3- Open the front door and remove the metal guide from the slide dispenser. 4- Open the manual inlet door. 5- Remove the metal rack dispenser to gain access to the upper top cover thumbscrew. 6- Loosen the thumbscrew and raise the upper top cover. 7- Remove the three screws that secure the reagent tray. Keep the screws and remove the reagent tray Examine the instrument When cleaning electrical components, ensure that they are completely dry and free of lint or any cleaning material before reinstallation. With the instrument turned off, thoroughly examine the thirteen Motor Command electronic boards, the Main PCB board, the Printer board and the Pelletier board. If any of the boards, cables or connectors are corroded and/or have chemical deposits, clean/repair/ replace them as needed. Cleaning is best performed using distilled water and/or alcohol prep pads Return the instrument to Operation 1- Replace the reagent tray and secure with the three retained screws. 2- Tighten the thumbscrew and replace the metal rack dispenser. 3- Close the manual inlet door and replace the slide dispenser metal guide. 4- Replace the slides in the slide dispenser. 5- Turn on the instrument. 18. Verification see " RAS566A: Check up after intervention" RAS563B - 14 RAA036AEN