CM1950 Instructions for Use, V 1.8, RevI

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1 Leica CM1950 Leica CM1950 V 1.8, I

2 / Leica CM1950 / Leica Biosystems Nussloch GmbH Heidelberger Strasse Nussloch Germany Heidelberger Strasse Nussloch Germany / C

3 Leica Leica Biosystems Nussloch GmbH () Leica Biosystems Nussloch GmbH Leica Biosystems Nussloch GmbH Leica Biosystems Nussloch GmbH Heidelberger Str D Nussloch Germany Leica CM1950 3

4 ( ) ( ) ( ) ( ) ( ) ( ) CE V 1.8 I

5 CM ( ) UVC LED Leica CM1950 5

6 (5) ( 5) UVC 98/79/EC (IVD) (ElektroG) 7 ElektroG RoHS CSA (ANSI) (UL) (CSA) (NSF) (IVD) 6 V 1.8 I

7 ( 1 ) Leica CM1950 UV ( ) % 1.4 CM1950 UV ( ) ( ) CM1950 (IVD) Leica CM1950 7

8 CE UV V 1.8 I

9 CM1950 LED Leica CM ( ) 3.5 m 4 Leica CM1950 9

10 2. 2 ( 3 1) ( 3 ) ( 3 2) ( 4 4) ( 4 3) ( 4 5) ( 4 6) ( 4 7) ( ) V 1.8 I

11 ( 5 7) ( 6 6) L ( ) R ( ) ( 6a 10) ( 6a 11) ( 6a 12) a ( 6 9) ( 6 10 ) (6) ( 6 8) Leica CM

12 ( ) ( ) UV UV 12 V 1.8 I

13 2. CE CN CN-Z CE (1) (2) () 9 Leica CM

14 UV Leica Cryofect ( Cryofect ) Cryofect ( ) ( ) CE CN CN-Z Leica Biosystems Division 14 V 1.8 I

15 UVC UVC UVC UV Leica CM

16 (±10 %) 100 VAC 120 VAC 230 VAC 50/60 Hz 60 Hz 50 Hz 1500 VA 1500 VA 1500 VA 5 35 A eff. 35 A eff. 25 A eff. I I I T15A M3 T15 A T1 T10 A T II II II ( ) 1900 J/s 1900 J/s 1900 J/s CE CE/c_CSA_us CE IEC-1010 UL 3101 ( ) 700 mm µm ( ) 835 mm () 850 mm µm ( ) 1215 mm µm ( ) 1025 mm 25 mm + 1 mm 59 mm 0.5 mm ( ) 193 kg 20 µm () () 185 kg 50 x 80 mm () 183 kg 0 50 / 0 85 / / () ( ) ( ) 175 kg 165 kg 145 kg 8 (x Y ) 18 C 35 C 60 % 300 µm/s 900 µm/s 18 C 35 C +5 C +55 C 60 % 35 < 60 % V 1.8 I

17 3. CM Hz CM Hz 20 C 0 C 35 C ± 5 K 1 K 20 C 0 C 35 C ± 5 K 1 K 25 C 5 h 5 h 35 C 8 h 8 h 690 W 690 W * 300 g (± 5 g) R-404A* 300 g (± 5 g) R-404A* * 0.6 L EMKARATE RL22S ICI* 0.6 L EMKARATE RL22S ICI* ( ) ( ) C 5 C 42 C (+5 K) 35 C 42 C (+5 K) 35 C Peltier K 35 C 17 K 35 C C ± 3 K C ± 3 K 320 W 320 W V/50 Hz 130 g (± 5 g) R-404A* 100 V/50/60 Hz 140 g (± 5 g) R-404A* 120 V/60 Hz 140 g (± 5 g) R-404A* * 0.4 L 22 Kyodo* 0.4 L 22 Kyodo* ( ) CECOMAF45 C 25 C *) Leica CM

18 mm xxxxx ml OCT 125 ml M * CM1950 DVD A * 100 V 50/60 Hz 1 S ( ) 1 ( ) (5 ) CM V 1.8 I

19 4. () mm xxxxx ml OCT 125 ml M * CM1950 DVD A * 100 V/50/60 Hz 1 S ( ) () 1 ( ) (5 ) CM1950 Leica CM

20 5. () ( UV ) () 12 ( ) V 1.8 I

5. 5.1 1 1 2 2 () 3 3 () 1 7 4 6 10a 15 16 5 10b 14 10 11 2 3 10c 8 9 13 12 4 ( ) 10c CE 5

21 () 3 3 () a b c ( ) 10c CE 5 Peltier ( 2 ) ( ) 8 ( ) 14 9 ( ) () 10 CE (a) 16 10b CE 17 Leica CM

22 x 850 mm - 8 m 3-18 C 35 C - 5 C 55 C - 60 % () - < 60 % m A < = 70 db (A) - 15 cm - 30 cm - 15 cm 22 V 1.8 I

23 ( 30 ) (2) ( ) 13 ( ) (1) ( ) () ( 29 E) 1 2 Leica CM

24 6. (13 mm) (1) ( 12) (1) (2) (4) (4) V 1.8 I

25 (1) (2) ( ) ( ) 18 ( ) ( 5 ) 3 E-STOP ( ) LED ( ) Leica CM

26 A 35 A ( 1) 1 (1) V 1.8 I

27 ( ) 3 (1) 1 (2) (3) 2 (2) ( ) (3) (2) (3) 3 20 Leica CM

28 ( ) 1 ( ) 2 21 (1) (2) 4 (1) ( ) (1) 3 (3) ( (2) ) A (a) V 1.8 I

29 ( ) 1 4 ( 24 1) ( ) ( ) ( 25 1) (2) ( ) (2) (3) Leica CM

30 6. 4 (2) (4) (5) ( ) ( 26) ( ) ( 26) 2 A 26 5 (2) (a ) 26 ( 3 ) 30 V 1.8 I

31 ( ) ( ) A L 3a 3 (1) (A) (3) (3a) ( ) ( 28 2) (E) E 29 Leica CM

32 ( ) CE B G F E 30 H (A) 1 (B ) 2 (C D F) (D) (E) (F) (G) (H) A C D ( ) ( 31 ) ( 31 I) (K) 2 (H) (F) 31 C K D I B A 32 (D) ( 11.1 ) 32 V 1.8 I

33 CM ( ) Peltier +/ +/ ( 50 C) +/ +/ UVC ( ) ( ) 34 1 () E-Stop ( ) LED E-Stop ( ) LED (Single) (Cont.) Leica CM

34 7. 35 A B 12 6 VAC VAC LED A B Peltier PE Peltier 36 5 C Peltier ( ) Peltier 10 Peltier 10 ( ) 34 V 1.8 I

7. 7.1.2 2 TRIM ( ) SECT ( ) (LED ) 3 on ( ) off ( ) ( ) + off ( ) = 0 on ( ) = 20 µm ( 8 2 ) off ( ) 1 2 37 LED 12 3 ( ) ( ) 20 µm 20 µm 200 µm - 2 1-100 µm 1.0 µm 5.0 µm 0.5 µm 5.0 µm 20.0 µm 1.0 µm 20.0 µm 60.

35 TRIM ( ) SECT ( ) (LED ) 3 on ( ) off ( ) ( ) + off ( ) = 0 on ( ) = 20 µm ( 8 2 ) off ( ) LED 12 3 ( ) ( ) 20 µm 20 µm 200 µm µm 1.0 µm 5.0 µm 0.5 µm 5.0 µm 20.0 µm 1.0 µm 20.0 µm 60.0 µm 5.0 µm 60.0 µm µm 10.0 µm µm () 1.0 µm 10.0 µm 1.0 µm 10.0 µm 20.0 µm 2.0 µm 20.0 µm 50.0 µm 5.0 µm 50.0 µm µm 10.0 µm µm µm 50.0 µm () 10 µm 20 µm 30 µm 40 µm Leica CM

36 µm/s 300 µm/s 1 ( ) LED (1) ( ) LED (1) ( ) 20 µm 2 20 µm LED (2) LED (2) ROCK ( ) (LED ) ( 1/4 ) ( ) ( 12 3 ) 36 V 1.8 I

37 ( ) ( CUT MODE ) ( CONT ) ( SINGLE ) ( ) (0-100 %) E-STOP ( ) LED ( ) M-STOP ( ) LED ( ) 0 50 / 0 85 / / Vmax ( ) 38 (SINGLE) (CONT.) ROCK ( ) ( ) (LED ) (6 ) 1. 2 RUN/STOP ( ) ENABLE ( ) BRAKE ( ) ( BRAKE ( ) ) 3 RUN/STOP ( / ) ENABLE ( ) 4. BRAKE ( ) BRAKE ( ) Leica CM

38 UVC UVC 30 UVC 1 ( 4 ) sectioning/cryosectioning/details/product/leica-cm1950/ downloads/ UVC 20 C Leica CM1850 UV CM1900 UV CM1950 ( 1 I. Maier) (CM1850 UV/CM1950) (CM1900 UV) ( ) 4log10 (99.99 %) 30 (CM1850 UV/CM1950) 40 (CM1900 UV) ( H5N1) 5log10 ( %) UVC UV UVC ( ( ) Cryofect* ) UV UVC () UV UV UV * Leica Cryofect 38 V 1.8 I

39 ( ) ( ) ( ) Leica CM

40 LED ( ) 5 ( LED ) / V 1.8 I

41 / C Peltier ( 50 C) 50 C LL 44 +/ ( ) 45 Leica CM

42 / + LED C 5 C ( ) 5 K () C ( Peltier ) V 1.8 I

43 8. 47 ( ) + (12 ) 10 C 5 C ( ) ( ) + 45 C 15 + = = Leica CM

8. (1-600 µm) (10 20 30 40 µm) TRIM/SECT ( )

44 8. (1-600 µm) ( µm) TRIM/SECT ( ) 50 TRIM/SECT ( ) LED TRIM ( ) 2 + ( 7 2 ) TRIM/SECT ( ) LED SECT ( ) 2 + ( 7 2 ) 51 TRIM/SECT ( / ) 3 2 LED ( ) ( ) + 20 µm 44 V 1.8 I

45 (12 ) 52 Peltier Peltier Peltier 53 ï 1 (2) (2) (1) (3) Leica CM

46 8. 55 ( ) E ( ) ( ) ( 56a) ( ) 56a 56b 56c 46 V 1.8 I

47 8. C K I D B ( 57 ) ( 57 I) A 57 ( 62 ) VAC (1 2) RUN/STOP ( ) ENABLE ( ) A 58 B VAC VAC LED A B Leica CM

48 (VAC LED ) VAC 59 E 2. (E) ( ) ( ) ( 28) 60 () VAC (1 2) RUN/STOP ( ) ENABLE ( ) () 48 V 1.8 I

49 8.4.3 VAC (VAC LED ) ( ) 8. 1 VAC VAC VAC () 0.5 cm Leica CM

50 8. ( ) () ( ) ( ) ( ) ( ) 3 ( 61) Cryofect UVC 61 Leica Cryofect 50 V 1.8 I

51 ( ) Leica CM

52 9. ( ) (c d ) 52 V 1.8 I

53 Leica CM

54 9. LED UV UV UV V 1.8 I

55 C 20 C 11 C 10 C 15 C 20 C 15 C 10 C 15 C 10 C 15 C 10 C 15 C 10 C 15 C 10 C 15 C 20 C 18 C 20 C 15 C 20 C A* 20 C E* 20 C A 20 C E 20 C 30 C 20 C E 20 C 15 C E 20 C 15 C 20 C A 15 C 20 C 19 C 32 C 40 C 19 C 21 C 25 C 10 C 15 C 20 C 15 C 15 C 10 C *E *A=*E= Leica CM

56 mm mm mm mm x 50 mm O (10 ) 20 mm O (10 ) 20 mm O (10 ) 30 mm O (10 ) 30 mm O (10 ) 40 mm O (10 ) 40 mm O (10 ) 55 mm O (10 ) 55 mm CE-BB µm µm µm mm mm CN CN CN CN CN-Z mm V 1.8 I

57 x 37 mm x 28 mm Dr.Peters ( ) / Leica Cryofect 4 x 350 ml M S CM ( ) Leica CM

11. CE ( (LP) (HP)) 6 1 5 4 9 12 3 4 2 7 8 63 (1) (2) 4 (5) ( ) 2 5 (4) (6) (7) (8) (9) (3) ( 66 7a)

58 11. CE ( (LP) (HP)) (1) (2) 4 (5) ( ) 2 5 (4) (6) (7) (8) (9) (3) ( 66 7a) 63a (CE ) (10) 2. (11) (12) ( 14) (11) 4. (13) (11) () V 1.8 I

59 ( ) (1) (2) 4 ( 2 5 ) ( 66 6a) (8) ( 66 7a) 5 CE (LP HP ) ( ) 7a 2.5 (6a) 2.5 6a Leica CM

60 11. CE CE (4) (11) ( ) 2. (10) 3. (9) 4. (10) 5. (11) (4) ( ) (12) (10) (2) V 1.8 I

61 11. ( 68) 68 CE 8 1. (8) ( 3 ) 2. (8) 69 69a CN Leica CM

62 11. (1) 1 CE 70 I II I III II III III III ( 10 µm) 62 V 1.8 I

63 CE (33) (34) 2. (35) 3. (36) () 36 Leica Cryofect 71 CN T 72 ( Leica Cryofect) 15 Leica Cryofect Leica CM

64 11. CN 1 50x80 mm 5 µm ( ) 3a 3a 2 (80x50 mm) CN 16 cm C 64 mm 84 mm (1) (2) 4 (4) (5) (6) (3a) (3) (3a) V 1.8 I

65 CN (18) (19) 22 cm ( 84 mm ) (16) (17) 74 CNZ 3a (3a) ( 1 mm ) Leica CM

66 mm ( ) 70 mm - 50 µm< 4 µm 70 mm µm5 µm - 50 µm 70 mm µm> 50 µm 77 CE µm ( ) CE ( ) 78 (7) CE ( 59 49) CE 350/ () V 1.8 I

67 11. (25 ) A (A) B A G E D A - B - ( ) C - ( D F) D - 4 (E) G - () 81 F C ( ) ( 28 ) 82 Leica CM

68 x 80 mm 5 µm ( ) 50x80 mm ø 55 ø 40 ø 30 ø 20 mm A 83 O 20 mm ( ) mm ( ) mm ( ) mm ( ) 10 A B B 84 C 37x37 mm Dr. Peters D 28x28 mm 85 ( D) Dr. Peters 3 L ( ) x W ( ) x H ( ) 30 x 30 x 7 mm 4 L ( ) x W ( ) x H ( ) 24 x 24 x 6 mm 4 L ( ) x W ( ) x H ( ) 18 x 18 x 6 mm 68 V 1.8 I

69 CUT MODE ( ) CONT ( ) SINGLE ( ) ( 37 38) CONT ( ) SINGLE ( ) E-STOP ( ) LED ( 38) (CONT ( ) SINGLE ( )) Leica CM

70 CE V 1.8 I

71 ( ) ( 73 UVC ) Leica Cryofect ( ) (1) Leica CM

72 12. (1) 1 90 UV ( 7 ) Leica Cryofect ( Cryofect ) T ( 20 10) () 72 V 1.8 I

73 UVC UVC UVC UVC 9000 ( ) 1 UVC (2) (1) Leica CM

74 UVC (3) (4) (5) (8) (6) (7) ( 93) (7) ( 93) (5) UVC 30 UVC UVC 94 UVC 74 V 1.8 I

75 12.4 LED 12. LED 77 Leica CM

76 13. Leica Biosystems 76 V 1.8 I

77 14. Leica Biosystems Nussloch GmbH UV Leica CM

78 15. 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 CM1950 有害物质 Hazardous Substances 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 的规定编制 This table is prepared in accordance with the provisions of SJ/T : 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 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 : 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 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 V 1.8 I

80 Leica Biosystems Nussloch GmbH Heidelberger Strasse D Nussloch, Germany Phone: Fax: Internet:

CM1950 Instructions for Use, V 2.0, RevM

CM1950 Instructions for Use, V 2.0, RevM Leica CM1950 Leica CM1950 V 2.0, 2018 11 14 0477 89102 M 医疗器械备案凭证编号 / 产品技术要求编号 : 国械备 20161067 号备案人 / 生产企业英文名称 :Leica Biosystems Nussloch GmbH 备案人 / 生产企业中文名称 : 徕卡生物系统 ( 努斯洛赫 ) 有限公司住所 :Heidelberger Strasse