Leica ST5010 Instructions for Use, V2.4, RevF

Leica AutoStainerXL Leica AutoStainerXL, V 2.4 06/2016 14 0456 89102 G

备案号 / 产品技术要求编号 : 国械备 20151320 产品名称 : 染色机 产品型号 :Leica Autostainer XL (ST5010) 备案人 / 生产企业名称 :Leica Biosystems Nussloch GmbH 住所 :Heidelberger Strasse 17-19 69226 Nussloch Germany 生产地址 :Heidelberger Strasse 17-19 69226 Nussloch Germany 备案人 / 生产企业联系电话 :+49 62 24 143-0 生产日期 : 见产品英文铭牌 使用期限 : 无 代理人及售后服务机构 : 徕卡显微系统 ( 上海 ) 贸易有限公司 代理人及售后服务地址 : 中国 ( 上海 ) 自由贸易试验区富特北路 127 号 3 楼 C 部位联系电话 :021-63876606 传真 :021-63876698 说明书编制或修订日期 2016 6

Leica Biosystems Nussloch GmbH () Leica Biosystems Nussloch GmbH Leica Biosystems Nussloch GmbH Leica Biosystems Nussloch GmbH Heidelberger Str. 17-19 D-69226 Nussloch Germany +49 6224 143-0 +49 6224 143-268 http://www.leicabiosystems.com Leica AutoStainer XL 3

1....6 1.1... 6 1.2... 8 1.3... 8 2....9 2.1... 9 2.2... 9 3.... 10 3.1... 12 3.2... 14 3.3... 15 4.... 16 4.1... 16 4.2... 16 4.2.1... 16 4.2.2... 17 4.3 UPS ()... 18 4.4 ()... 19 4.5... 19 4.6... 19 5.... 20 5.1... 21 5.2... 22 5.3... 23 5.4... 24 5.4.1... 25 5.4.2... 26 5.4.3... 26 5.4.4... 27 5.4.5... 27 5.4.6... 27 5.4.7... 28 5.4.8... 29 5.4.9... 29 5.5... 31 5.6... 31 4 V 2.4 06/2016

5.7 ()... 32 5.8 ()... 33 5.9... 33 5.9.1... 34 5.9.2... 34 5.9.3... 35 5.9.4... 35 5.9.5... 36 5.9.6... 36 5.9.7... 37 5.9.8... 38 6.... 39 6.1... 39 6.1.1... 39 6.1.2... 39 6.1.3... 39 6.1.4... 39 7.... 40 7.1... 41 7.2... 42 7.2.1... 42 7.2.2... 42 7.2.3... 43 8.... 44 9. ()... 45 10.... 47 1... 49... 49 2... 50... 50 3... 52... 53... 54 Leica AutoStainer XL 5

1. 2 1.1 (5) ( 5) Leica AutoStainer XL 1 3.3 6 V 2.4 06/2016

1. 1 ROHS WEEE RoHS WEEE WEEE (ElektroG 7 ) CE CE EC Leica AutoStainer XL 7

1. 1.2 - AutoStainer XL - - 1.3 - AutoStainer XL - AutoStainer XL 8 V 2.4 06/2016

2. 2.1 2.2 CE www.leicabiosystems.com DIN EN 1717:2011-08 (2013 8 ) Leica AutoStainer XL 9

3. AutoStainer XL AutoStainer XL 11 ( 30 ) AutoStainer XL AutoStainer XL 10 V 2.4 06/2016

3. Leica AutoStainer XL 11

3. 3.1 1 20 2 19 18b 18a 3 16 17 4 5 6 7 8 15 14 11 9 13 10 2 12 12 V 2.4 06/2016

3. 21 3 27 26 25 34 29 24 30 31 23 32 33 28 22 1. 2. 3. 4. 5. 6. ON/STOP ( ) 7. 8. 9. LED 10. 11. 12. 13. 14. LED 15. 16. () 17. LED 18a. 18b. 19. 20. 21. 22. 23. ( ) 24. () 25. 26. (ON/OFF ( )) 27. 28. 29. 30. 31. 50 V 1 A 32. 33. 34. Leica AutoStainer XL 13

3. 3.2 1 Leica ST5010 (100-120 V / 50-60 Hz) 1 ( 2)... 1 (0456 35660) 22... 14 0475 33659 5... 14 0456 35268 5... 14 0456 33919 2... 14 0475 34486 1... 14 0411 34604 1... 14 6844 01005 1... 14 0422 31972 1... 14 0475 33669 1 3/4 V... 14 0456 36101 1... 14 0474 32273 1... 14 0456 35240 1 ( ) ()... 14 0456 35216 1 ( )... 14 0456 35459 1... 14 0474 32325 1... 14 0475 35748 1... 14 0456 89102 1 ( ) 14 V 2.4 06/2016

3. 3.3... 200 ( 600 )... 11...30...26... 18...450 ml... 5... 1... 30 C 65 C...0 99 59... 1...15 25...15 C 35 C... 80 % ( x x )... 109 cm x 67 cm x 51 cm...81 kg...100 V 120 V 50 Hz 60 Hz 230 V 240 V 50 Hz 60 Hz Leica AutoStainer XL 15

4. AutoStainer XL () 4.1 AutoStainer XL ( 1090 mm 670 mm ) 3 m AutoStainer XL 110 V 8 A 240 V 4 A AutoStainer XL 4.2 4.2.1 ( 3 27) ( 3 34) ( 3 29) 16 V 2.4 06/2016

4. 1. 2. ON/STOP ( ) STOP ( ) 3. ON/OFF ( ) ON ( ) 4. ON/STOP ( ) ON ( ) 3 Main Menu ( ) ON/STOP ( ) STOP ( ) ON/OFF ( ) ON ( ) 4.2.2 3/4" Leica AutoStainer XL 17

4. 4.3 UPS () (UPS) 4 UPS UPS 200 VA 5 UPS UPS UPS 4 18 V 2.4 06/2016

4. 4.4 () ( UPS ) ON/STOP ( ) STOP ( ) ON ( ) UPS 1 A 50 V (6.25 mm) 4.5 ( ) ( 2 18b) 4.6 Leica AutoStainer XL 19

5. AutoStainer XL AutoStainer XL LED LOAD () LED EXIT () LCD LOAD () LED AutoStainer XL 11 ( ) 15 20 V 2.4 06/2016

5. 5.1 AutoStainer XL LOAD () UNLOAD () LED LCD LED LCD [F1] [F4] 4 4 LED LED UNLOAD () LED ( ) ( ) STAIN () LED () ALARM () LED () POWER () LED () (ON/OFF ( ) ON/STOP ( ) ON ( )) Leica AutoStainer XL 21

5. LOAD () EXIT () LOAD () EXIT () LED 35 37 5.2 ON/STOP ( ) ON ( ) Main Menu ( ) 3 AutoStainer XL V2.00 Main Menu Stain Edit SetUp PC AutoStainer XL V2.00 PC Stain () Edit () SetUp () () PC 22 V 2.4 06/2016

5. 5.3 INSERT (blank step) () DELETE (all steps) () BLANK (steps removed) ( ) STAIN SELECT PROGRAM LOAD EXIT UNLOAD PAUSE SELECT PROGRAM COPY EDIT VIEW STAIN ABORT RACK MAIN MENU SET STEP, STATION, TIME AND EXACT MORE NEXT (step) () ERASE (step) () QUIT MORE CHECK (compatibility) ( ) SAVE PROGRAM EDIT SET UP PC CONTROL PC OVEN DIPS (agitation) () 5 MAIN MENU Leica AutoStainer XL 23

5. 5.4 AutoStainer XL 15 1 15 25 () 1 23 24 V 2.4 06/2016

5. 5.4.1 1. Main Menu ( ) [F2] Edit () 2. 3. [F2] Edit () 4. 1 25 [F2] Next ( ) 5. 00:00 6. 4 5 7. ( 27 ) Leica AutoStainer XL 25

5. 5.4.2 5.4.3 1. ( 25 1 3) 2. ( 25 4) 3. [F3] Erase () 4. ( 27 ) 1. ( 25 1 2) 2. [F2] Edit () 3. () 4. [F1] More () 5. [F1] More () 6. [F1] Insert () 7. [F1] Yes ( ) 3 25 8. 9. ( 27 ) 26 V 2.4 06/2016

5. 5.4.4 1. ( 25 1 2) 2. [F2] Edit () 3. [F1] More () 4. [F1] More () 5. [F3] Blank () 6. [F1] Yes ( ) 7. ( 27 ) 5.4.5 1. Edit Program () [F4] Quit () ( [F1]) ( [F2]) ( [F4]) 2. [F1] 3. [F2] 4. [F4] 5.4.6 1. ( 25 1 2) 2. [F2] Edit () 3. [F1] More () 4. [F1] More () 5. [F2] Delete () 6. [F1] Yes ( ) 7. ( ) Leica AutoStainer XL 27

5. 5.4.7 1. ( 25 1 2) 2. [F1] Copy () 3. 4. [F1] Copy () 5. 3 4 6. [F4] Cancel () 28 V 2.4 06/2016

5. 5.4.8 1. ( 25 1 2) 2. [F3] View () 3. [F4] 5.4.9 ( ) 1 2 1 1 2 3 3 2 1. ( 25 1 2) 2. [F2] Edit () 3. [F1] More () 4. [F2] Check () 5. 6. [F2] Check () 7. [F4] 8. 5 6 Leica AutoStainer XL 29

5. 9. [F4] 1 3 30 V 2.4 06/2016

5. 5.5 5.6 AutoStainer XL ( 46 1) () () 35 65 C ( ) 1. Main Menu ( ) [F3] SetUp () 2. [F1] Oven () 3. [F1] [F2] 4. [F4] SetUp () 5. [F4] Main Menu ( ) Leica AutoStainer XL 31

5. 5.7 () () 1-20 1. Main Menu ( ) [F3] SetUp () 2. [F2] Dips () 3. [F1] [F2] 4. [F4] SetUp () 5. [F4] Main Menu ( ) () ( ) 32 V 2.4 06/2016

5.8 () ( 1) 1. Main Menu ( ) [F3] SetUp () 2. [F3] Move () 3. [F1] Dip () [F2] Up () [F3] Down () 4. 5. 3 4 6. [F4] SetUp () 7. [F4] Main Menu ( ) 5. 5.9 AutoStainer XL 29 Leica AutoStainer XL 33

5. 5.9.1 5.9.2 450 ml ( 2 18a) AutoStainer XL 8 L/min 34 V 2.4 06/2016

5. 5.9.3 5.9.4 AutoStainer XL 1. Main Menu ( ) [F1] Stain () Abort () [F1] Stain () 2. ([LOAD] () LED ) 3. [LOAD] () [LOAD] () LED 4. 2 3 Leica AutoStainer XL 35

5. 5.9.5 [EXIT] () LED 30 1. 2. [EXIT] () LED [EXIT] () 5.9.6 [UNLOAD] () LED 1. [F1] Unload () 2. ( ) 3. [F4] Cancel () 36 V 2.4 06/2016

5. 4. [F1] Unload () 5. [F1] Done () 6. 2 5 5.9.7 (SetUp ()) 1. Abort () [F4] Pause () Main Menu ( ) 2. 38 3. [F1] Stain () 4. [F4] Main Menu ( ) Main Menu ( ) (SetUp()) Main Menu ( ) [F1] Leica AutoStainer XL 37

5. 5.9.8 1. Staining () [F4] Pause () 2. [F2] 3. 4. [F2] Abort () 5. [F1] Done () 6. 3 5 7. [F4] Cancel () Abort () 8. [F1] [F4] Main Menu ( ) 38 V 2.4 06/2016

6. 6.1 5 % ( ) 6.1.1 6.1.2 6.1.3 6.1.4 Leica AutoStainer XL 39

7. AutoStainer XL [F1] Quiet () [F2] Pause () 40 V 2.4 06/2016

7. 7.1 Mains Power fail () Power Supply fail ( ) Make sure that the head is free of obstruction ( ) Head stalled ( ) Fume system blocked () Oven failure () Oven overheating () Remove obstruction and replace rack on hook ( ) UPS 18 1. 2. 3. 4. () Leica AutoStainer XL 41

7. 7.2 7.2.1 Program (x) cannot be used for staining ( (x) ) Program (x) is not compatible with programs in use ( (x) ) Ensure a rack is in the Load drawer and close the drawer ( ) Ensure the Exit drawer is empty and close the drawer ( ) 0 () 29 7.2.2 Station (x) and Station (y) are in reverse order ( (x) (y) ) The steps after Exit will be ignored (Exit () ) Program (x) is in use for staining and cannot be altered ( (x) ) Exit () Exit () 42 V 2.4 06/2016

7. 7.2.3 SetUp lost. Default SetUp used. ( ) Battery backed RAM Failure! Service is required. ( RAM ) Caution: increasing Dips might extend some station times ( ) () Leica AutoStainer XL 43

8. Leica Biosystems Nussloch GmbH 44 V 2.4 06/2016

9. () 亲爱的客户 : 任何要退回 Leica Biosystems 或要现场维修的产品, 都必须按正确的方法进行清洗和消毒 由于朊病毒的污染, 如 CJD BSE CWD 等不能消除, 因此, 接触过包含朊病毒的样品的设备不能退回 Leica Biosystems 进行维修 只能由经过风险培训且佩戴个人防护装备的现场维修工程师根据相关机构的政策和处理步骤的指导现场维修污染了朊病毒的设备 在完成相关消毒工作后, 必须将该证明书与仪器放在一起, 将其固定到装运箱外部或直接递交给维修工程师 在公司或维修工程师收到合格的证明书之前, 不打开箱子, 也不会执行维修工作 若公司认为退回的货物有危险, 会立即将其退还客户, 费用由客户承担 注意 : 切片机的刀片必须装在盒子里 必填信息 : 标有 * 的区域为必填项 根据仪器是否受到污染, 请继续填写 A 部分或 B 部分 铭牌信息型号 ( 参见铭牌 )* SN ( 参见铭牌 )* REF ( 参见铭牌 )* A B 是 是 否 1 如果符合, 请在方框 A 中打勾 否则请根据要求或实际情况提供进一步的信息, 完成 B 中所有内容 该设备未接触过非固定生物样品 本设备内部或外部曾经接触过如下所述的危险物质 : 血液 体液 病理样品 请在此提供更多详细信息 : 其它生物危险品 有害健康的化学药品 / 物质 其它危险品 放射性物质 是 否 2 该设备已清洗并消毒 : 若选 是, 请给出具体方法 : 请在此提供更多详细信息 : 若选 否 **, 请说明理由 : 是 否 3 ** 未获得 Leica Biosystems 的书面同意, 此类设备不可退回 该设备已做好准备, 确保可以安全搬运 / 运输 请尽可能使用原来的装运箱 / 盒 Leica AutoStainer XL 45

9. () 避免拒收的重要提示 : 在仪器打包或移送维修工程师之前请放入一份复件, 若送往徕卡的物品无适当的消毒文件, 其退回费用由客户承担 如果您有任何其它问题, 请致电当地的徕卡机构 徕卡内部使用 : 如适用, 请给出相应的作业号和 RAN-/RGA 号 : 作业单号 : BU 退还核准号 : SU 退还核准书 : 签名 / 日期 * 机构 * 姓名 * 职衔 * 部门 * 地址 * 电子邮箱 * 电话 * 传真 Leica Biosystems Nussloch GmbH Heidelberger Str. 17-19 69226 Nussloch, Germany 电话 : ++49 (0) 6224 143 0 传真 : ++49 (0) 6224 143 268 www.leicabiosystems.com 46 V 2.4 06/2016

10. 产品中有毒物质的名称及含量 Names and Contents of the Hazardous Substances 部件名称 Part Name 有害物质 Hazardous Substances AXL 230-240V/50-60Hz 14045635136 铅 (Pb) 汞 (Hg) 镉 (Cd) 六价铬 (Cr(VI)) 多溴联苯 (PBB) 多溴二苯醚 (PBDE) 印刷电路板 Printed circuit boards 电子元器件 Electronic components 机械部件 Mechanical parts 电缆 Cables 本表格依据 SJ/T 11364 的规定编制 This table is prepared in according with the provisions of SJ/T 11364. : 表示该有害物质在该部件所有均质材料中的含量均在 GB/T 26572 规定的限量要求以下 Indicates that said hazardous substance contained in all of the homogeneous materials for this part is below the limit requirement of GB/T 26572. : 表示该有害物质至少在该部件的某一均值材料中的含量超出 GB/T 26572 规定的限量要求 Indicates that said hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirement of GB/T 26572 Leica AutoStainer XL 47

10. 产品中有毒物质的名称及含量 Names and Contents of the Hazardous Substances 部件名称 Part Name 有害物质 Hazardous Substances AXL 230-240/50-60 TS5015 14045638879 铅 (Pb) 汞 (Hg) 镉 (Cd) 六价铬 (Cr(VI)) 多溴联苯 (PBB) 多溴二苯醚 (PBDE) 印刷电路板 Printed circuit boards 电子元器件 Electronic components 机械部件 Mechanical parts 电缆 Cables 本表格依据 SJ/T 11364 的规定编制 This table is prepared in according with the provisions of SJ/T 11364. : 表示该有害物质在该部件所有均质材料中的含量均在 GB/T 26572 规定的限量要求以下 Indicates that said hazardous substance contained in all of the homogeneous materials for this part is below the limit requirement of GB/T 26572. : 表示该有害物质至少在该部件的某一均值材料中的含量超出 GB/T 26572 规定的限量要求 Indicates that said hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirement of GB/T 26572 48 V 2.4 06/2016

1 0-30 0-11 18 0-18 5 0-5 1 1 1 1 1 0-1 15 15 25 25 ( ) 0 59 99 ( 0 ) () ± 1 () 0 ( ) / 30-65 C () / 1-20 / 2 1-4 () 9 4-9 () 2 2-4 () Leica AutoStainer XL 49

2... 14 0474 32273 (IRAM 2073 / IEC 60320-C19)... 14 0411 55671 (AS/NZS 3112 / IEC 60320-C19)... 14 0411 55672 (NBR 14136 / IEC 60320-C13)... 14 0411 47869 (GB 2099 / IEC 60320-C19)... 14 0411 51038 (AFSNIT107-2-D1 / IEC 60320-C19)... 14 0411 55673 (CEE7/7 / IEC 60320-C13)... 14 04111 3558 (BS 1363 / IEC 60320-C13)... 14 0411 27822 (SI 32 / IEC 60320-C19)... 14 0411 55674 (CEI 23-50 / IEC 60320-C13)... 14 0411 13561 (SEV 1011 CH-Type J / IEC 60320-C13)... 14 0411 13560 (SABS164-1 / IEC 60320-C19)... 14 0411 55675 (NEMA 5-15 / IEC 60320-C13)... 14 0411 13559 Leica TS5015 -... 14 0506 38050... 14 0475 37647... 14 0475 34524... 14 0475 34525... 14 0456 27069 30... 14 0456 33919... 14 0456 35268... 14 0456 35434 30 ( 30 )... 14 0475 33750 30 5... 14 0475 33643 Sakura ( 140474 33463)... 14 0475 34515 50 V 2.4 06/2016

2 Medite 20... 14 0475 34516 Medite 30... 14 0475 34517 Shandon... 14 0475 34518 Microm 30... 14 0475 34943... 14 0475 33659... 14 0475 34488... 14 0475 34486 12... 14 0475 33644 ( )... 14 0456 35445 ( )... 14 0456 35393 2.50 m 3/4"... 14 0474 32325 4 m... 14 0475 35748 2 m... 14 0475 35762 4 m... 14 0475 35763 ( )... 14 0456 35216 3 x 2 mm FKM ( )... 14 0253 35822 7.65 x 1.78 mm FKM ( )... 14 0253 34214 V 3/4" 40/22 H6 ()... 14 0456 36101... 14 0456 35459... 14 0456 30906 Leica AutoStainer XL 51

3 1 H&E 2 Papanicoleau 1 10:00 1 2 2:00 2 3 2:00 100 % 3 4 2:00 100 % 4 5 2:00 70 % 5 6 1:00 1 1:30 1 7 2:00 2 2:00 6 8 5:00 3 3:30 2 9 2:00 4 2:00 HCl 7 10 0:02 5 0:05 3 11 3:00 6 2:00 Scott 8 12 3:00 7 4:00 4 13 3:00 8 2:00 95 % 9 9 1:30 OG 6 10 10 2:00 95 % 11 11 1:30 95 % 12 12 1:30 EA 50 13 13 2:30 14 14 2:00 95 % 15 15 0:30 14 1:30 100 % 16 16 2:00 15 1:30 100 % 17 17 2:00 16 1:30 100 % 18 18 2:00 17 1:30 19 18 1 4 () 51 52 V 2.4 06/2016

3 1 H&E 5 Hx 1 10:00 1 2 2:00 2 3 2:00 100 % 3 4 2:00 100 % 4 5 2:00 70 % 5 6 1:00 1 7 2:00 6 8 5:00 1 5:00 2 9 2:00 2 2:00 HCl 7 10 0:02 3 0:02 3 11 3:00 4 3:00 Scott 8 12 3:00 5 3:00 4 13 3:00 6 3:00 14 14 2:00 95 % 15 15 0:30 100 % 16 16 2:00 7 2:00 100 % 17 17 2:00 8 2:00 100 % 18 18 2:00 9 2:00 19 10 Leica AutoStainer XL 53

LCD LED PC UPS () LCD IBM LCD x y z () 54 V 2.4 06/2016

1 () Leica AutoStainer XL 55

() () 25 x 75 x 1 mm 56 V 2.4 06/2016

www.leicabiosystems.com Leica Biosystems Nussloch GmbH Heidelberger Strasse 17-19 D- 69226 Nussloch +49 6224 143 0 +49 6224 143 268 http://www.leicabiosystems.com