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 17-19 69226 Nussloch Germany 生产地址 :Heidelberger Strasse 17-19 69226 Nussloch Germany 联系方式 :www.leicabiosystems.com 生产日期 : 见产品中文铭牌代理人 / 售后服务单位 : 徕卡显微系统 ( 上海 ) 贸易有限公司住所 : 中国 ( 上海 ) 自由贸易试验区富特北路 127 号 3 楼 C 部位联系方式 :4006580692
Leica Leica Biosystems Nussloch GmbH ( ) Leica Biosystems Nussloch GmbH Leica Biosystems Nussloch GmbH Leica Biosystems Nussloch GmbH Heidelberger Strasse 17-19 69226 Nussloch Germany +49 6224 143-0 +49 6224 143-268 www.leicabiosystems.com Leica CM1950 3
1.......6 1.1.... 6 1.2.... 7 1.3.... 7 1.4.... 7 2.......8 2.1.... 8 2.2.... 8 2.3.... 9 2.4... 9 2.5.... 12 2.6.... 13 2.7.... 14 2.8.... 15 2.9... 15 2.10.... 15 3....... 16 4....... 18 5....... 20 5.1...... 21 6....... 22 6.1.... 22 6.2.... 23 6.3.... 24 6.3.1.... 25 6.3.2 ( )... 25 6.4.... 26 6.5... 27 6.5.1 ( )... 27 6.5.2 ( ).... 28 6.5.3.... 28 6.5.4 ( ).... 28 6.5.5 ( ).... 29 6.5.6.... 29 6.5.7.... 31 6.5.8.... 31 6.5.9 ( ) CE...... 32 4 V 2.0 M 2018 11
7....... 33 7.1 CM1950.... 33 7.1.1 1.... 33 7.1.2 2... 35 7.1.3 3 ( )... 37 8....... 39 8.1.... 39 8.2.... 39 8.3.... 40 8.4.... 45 8.4.1.... 45 8.4.2 1..... 46 8.4.3...... 49 9....... 51 9.1...... 51 10....... 55 11.... 56 11.1....... 56 12....... 71 12.1.... 71 12.2... 73 12.3 UVC.... 73 12.4 LED...... 77 13....... 78 14....... 79 15....... 80 Leica CM1950 5
1. 1.1 (5) ( 5) UVC 98/79/EC (IVD) (ElektroG) 7 ElektroG RoHS CSA (ANSI) (UL) (CSA) (NSF) (IVD) 6 V 2.0 M 2018 11
1. 1.2 3 1.3 Leica CM1950 UV ( ) 99.99 % 1.4 CM1950 UV ( ) ( ) CM1950 (IVD) Leica CM1950 7
2. 2.1 CE UV www.leicabiosystems.com 2.2 8 V 2.0 M 2018 11
2. 2.3 CM1950 LED Leica CM1950 2.4 ( 6 6.1 ) 3.5 m 4 Leica CM1950 9
2. 2 ( 3 1) ( 3 ) ( 3 2) ( 4 4) ( 4 3) ( 4 5) ( 4 6) ( 4 7) ( ) 4 6 2 5 3 4 7 1 3 8 4 10 V 2.0 M 2018 11
2. 9 10 6 8 7 5 6 6 ( 5 7) ( 6 6) L ( ) R ( ) ( 6a 10) ( 6a 11) ( 6a 12) 10 12 11 6a ( 6 9) ( 6 10 ) (6) ( 6 8) Leica CM1950 11
2. 2.5 () ( ) UV UV 12 V 2.0 M 2018 11
2. CE CN CN-Z CE 2.6 12 6 7 (1) (2) 1 2 8 ( ) 9 Leica CM1950 13
2. 2.7 UV Leica Cryofect ( Cryofect ) Cryofect ( ) () CE CN CN-Z Leica Biosystems Division www.leicabiosystems.com 14 V 2.0 M 2018 11
2. 2.8 2.9 2.10 3 UVC UVC UVC UV Leica CM1950 15
3. -3 (±10 %) 230 V~ 50 Hz 1500 VA 5 25 A eff. I T10 A T1 2 II ( ) 1900 J/s CE IEC-1010 UL 3101 () 700 mm 1 100 µm () 835 mm () 850 mm 10 40 µm ( ) 1215 mm 1 600 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 / 85 90 / () () () 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 % 6.1 16 V 2.0 M 2018 11
3. CM1950 50 Hz CM1950 60 Hz 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 25 25 3 3 * 300 g (± 5 g) R-404A* 300 g (± 5 g) R-404A* * 0.6 L EMKARATE RL22S ICI* 0.6 L EMKARATE RL22S ICI* 20 C 0 C 35 C ± 5 K 1 K () () 24 24 12 12 5 C 5 C 42 C (+5 K) 35 C 42 C (+5 K) 35 C 15+2 15+2 Peltier 2 2 17 K 35 C 17 K 35 C 10 50 C ± 3 K 10 50 C ± 3 K 320 W 320 W 25 25 3 3 230 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* () 15 15 CECOMAF 45 C 25 C *) Leica CM1950 17
4. 1...14 0477 41346 5 3 mm...14 0477 40044 1...14 0477 40062 1...14 0477 40080 1...14 0477 43763 1...14 0436 43463-1...14 0183 28642-1...14 0183 40426-1 1.5...14 0222 10050-1 2.5...14 0222 04137-1 3.0...14 0222 04138-1 4.0...14 0222 04139-1 4.0...14 0222 32131-1 5.0...14 0222 04140-1 5.0...14 0194 04760-1 6.0...14 0222 04141-1 13...14 0330 33149-1 16...14 0330 18595 1...14 0441 xxxxx 1 407 50 ml...14 0336 06098 1 OCT 125 ml...14 0201 08926 1 M *...14 0340 29011 1...14 0477 89102 1 CM1950 DVD...95.10696 A * 100 V 50/60 Hz 1 S (14 0340 40859) 1 ()...14 0477 43300-1...14 0477 40293-2...14 0477 40294 -...14 0477 40295 -...14 0477 43302 -...14 0477 43304 -...14 0477 43779 - (5 )...14 0477 43792 www.leicabiosystems.com CM1950 18 V 2.0 M 2018 11
4. ( ) 1...14 0477 41347 5 30 mm...14 0477 40044 1...14 0477 40062 1...14 0477 40080 1...14 0477 43763 1...14 0436 43463-1...14 0183 28642-1...14 0183 40426-1 1.5...14 0222 10050-1 2.5...14 0222 04137-1 3.0...14 0222 04138-1 4.0...14 0222 04139-1 4.0...14 0222 32131-1 5.0...14 0222 04140-1 5.0...14 0194 04760-1 6.0...14 0222 04141-1 13...14 0330 33149-1 16...14 0330 18595 1...14 0441 xxxxx 1 407 50 ml...14 0336 06098 1...14 0443 30420 1 OCT 125 ml...14 0201 08926 1 M *...14 0340 29011 1...14 0477 89102 1 CM1950 DVD...95.10696 A * 100 V/50/60 Hz 1 S (14 0340 40859) ( ) 1 ()...14 0477 43300-1...14 0477 40293-2...14 0477 40294 -...14 0477 40295 -...14 0477 43302 -...14 0477 43304 -...14 0477 43779 - (5 )...14 0477 43792 www.leicabiosystems.com CM1950 Leica CM1950 19
5. ( ) ( UV ) ( ) 12 ( ) 10 20 V 2.0 M 2018 11
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 Peltier ( 2 ) 11 6 15 12 7 13 ( ) 8 ( ) 14 9 ( ) () 10 CE (a) 16 10b CE 17 Leica CM1950 11 21
6. 6.1-835 x 850 mm - 8 m 3-18 C 35 C - 5 C 55 C - 60 % () - < 60 % - 2000 m A < = 70 db (A) - 15 cm - 30 cm - 15 cm 22 V 2.0 M 2018 11
6. 6.2 ( 30 ) (2) ( ) 13 ( ) (1) ( 6.5.8) 1 12 2 2 () ( 29 E) 1 2 Leica CM1950 23
6. (13 mm) (1) ( 12) 13 6.3 (1) (2) 1 2 4 6 (4) (4) 14 24 V 2.0 M 2018 11
6. 6.3.1 12 6 1 2 15 16 12 6 (1) (2) ( ) 17 6.3.2 ( ) 18 ( ) ( 5 ) 3 E-STOP () LED ( ) Leica CM1950 25
6. 6.4 4 25 A 35 A ( 1) 1 (1) 19 26 V 2.0 M 2018 11
6. 6.5 6.5.1 ( ) 3 (1) 1 (2) (3) 2 (2) ( ) (3) (2) (3) 3 20 Leica CM1950 27
6. 6.5.2 ( ) 1 ( ) 2 21 (1) (2) 4 (1) 1 6.5.4 ( ) (1) 3 (3) ( (2) ) 2 3 22 6.5.3 A (a) 23 28 V 2.0 M 2018 11
6. 6.5.5 ( ) 1 4 ( 24 1) ( ) ( ) 24 6.5.6 ( 25 1) (2) () 2-5 4 (2) (3) 3 1 5 2 25 Leica CM1950 29
6. 4 (2) (4) (5) ( ) ( 26) ( ) ( 26) 2 A 26 5 (2) (a ) 26 ( 3 ) 30 V 2.0 M 2018 11
6. 6.5.7 27 ( ) ( ) 6.5.8 1 2 A L 3a 3 (1) (A) (3) (3a) ( ) ( 28 2) (E) 28 1. 2. 3. E 29 Leica CM1950 31
6. 6.5.9 ( ) CE B 30 G (A) 1 (B ) 2 (C D F) (D) (E) (F) (G) (H) H A E F C D ( ) ( 31) ( 31 I) (K) 2 (H) (F) 31 C K I D B A 32 (D) ( 11.1 ) 32 V 2.0 M 2018 11
7. 7.1 CM1950 7.1.1 1 33 1-5 ( ) Peltier +/ +/ ( 50 C) +/ +/ UVC ( 30 180 ) ( ) 34 1 ( ) E-Stop () LED E-Stop () LED (Single) (Cont.) Leica CM1950 33
7. 35 A B 12 6 VACVAC LED A 12 6 6 12 12 3 3 6 6 12 B Peltier PE10 10 4 4 Peltier 36 5 C Peltier ( ) Peltier 10 Peltier 10 ( ) 34 V 2.0 M 2018 11
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 60.0 µm 5.0 µm 60.0 µm 100.0 µm 10.0 µm 1 600 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 100.0 µm 10.0 µm 100.0 µm 600.0 µm 50.0 µm ( ) 10 µm 20 µm 30 µm 40 µm Leica CM1950 35
7. 900 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 2.0 M 2018 11
7. 7.1.3 3 ( ) ( CUT MODE ) ( CONT ) ( SINGLE ) ( ) (0-100 %) E-STOP () LED ( ) M-STOP () LED () 0 50 / 0 85 / 85 90 / Vmax () 38 (SINGLE) (CONT.) ROCK ( ) () (LED ) (6 ) 1. 2 RUN/STOP ( ) ENABLE ( ) BRAKE ( ) ( BRAKE ( ) ) 3 RUN/STOP ( / ) ENABLE ( ) 4. BRAKE ( ) BRAKE ( ) Leica CM1950 37
7. 39 30 180 UVC UVC 30 UVC 1 ( 4 ) 180 http://www.leicabiosystems.com/specimen-preparation/ 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 (99.999 %) UVC UV UVC ( ( ) Cryofect* ) UV UVC ( ) UV UV UV * Leica Cryofect 38 V 2.0 M 2018 11
8. 8.1 () ( ) ( 6.5.2 21) 40 11 8.2 5 41 Leica CM1950 39
8. 8.3 5 LED ( ) 5 ( LED ) + 42 + + / + 1 5 10 40 V 2.0 M 2018 11
8. 43 + + / + 1 5 5 C Peltier ( 50 C) 50 C LL 44 +/ + + 1 ( ) 45 Leica CM1950 41
8. 46 24 + / + LED 15 + + 1 10 C 5 C () 5 K ( ) 4 + +10 C ( Peltier ) 12 42 V 2.0 M 2018 11
8. 47 ( ) + (12 ) 10 C 5 C ( ) 10 48 49 ( ) + 45 C 15 + = = Leica CM1950 43
8. (1-600 µm) (10 20 30 40 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 2.0 M 2018 11
8.4 8.4.1 8. (12 ) 52 Peltier Peltier Peltier 53 ï 1 (2) 2 3 54 (2) (1) (3) Leica CM1950 45
8. 55 () 8.4.2 1. 56 E ( ) ( ) ( 56a) ( ) 56a 56b 56c 46 V 2.0 M 2018 11
8. C K I D B ( 57) ( 57 I) A 57 ( 62 ) VAC (1 2) RUN/STOP () ENABLE ( ) A 58 B VACVAC LED A 12 6 6 12 12 3 3 6 6 12 B Leica CM1950 47
8. 5 1 (VAC LED ) VAC 59 E 2. (E) ( ) ( ) ( 28) 60 ( ) VAC (1 2) RUN/STOP () ENABLE ( ) ( ) 48 V 2.0 M 2018 11
8.4.3 VAC (VAC LED ) ( ) 8. 1 VAC VAC VAC ( ) 0.5 cm Leica CM1950 49
8. () ( ) ( ) () ( 6.5.8 ) ( 6.5.7 ) 3 ( 61) Cryofect UVC 61 Leica Cryofect 50 V 2.0 M 2018 11
9. 9.1 ( ) Leica CM1950 51
9. ( ) (c d ) 52 V 2.0 M 2018 11
9. - - - Leica CM1950 53
9. LED UV UV UV 62 54 V 2.0 M 2018 11
10. 15 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 CM1950 55
11. 11.1. 20 mm... 14 0477 43739 30 mm... 14 0477 40044 40 mm... 14 0477 40045 55 mm... 14 0477 40046 80 x 50 mm... 14 0477 43714 O (10 ) 20 mm... 14 0477 43247 O (10 ) 20 mm... 14 0477 43248 O (10 ) 30 mm... 14 0477 43247 O (10 ) 30 mm... 14 0477 43248 O (10 ) 40 mm... 14 0477 43249 O (10 ) 40 mm... 14 0477 43250 O (10 ) 55 mm... 14 0477 43251 O (10 ) 55 mm... 14 0477 43252... 14 0477 40351 CE-BB... 14 0477 43005... 14 0477 42488... 14 0477 40387 70-50 µm... 14 0477 42491 70-100 µm... 14 0477 42492 70-150 µm... 14 0477 42493 70 mm... 14 0477 42497 50 mm CN... 14 0419 33816... 14 0477 42359 CN... 14 0477 42358 CN... 14 0477 42380 CN... 14 0477 42370 CN-Z... 14 0477 42363 50 mm... 14 0419 33981... 14 0477 41039... 14 0477 43737... 14 0477 43126 56 V 2.0 M 2018 11
11.... 14 0477 40062... 14 0477 43036... 14 0477 42618... 14 0477 43037... 14 0477 40080... 14 0477 43763 37 x 37 mm... 14 0477 42603 28 x 28 mm... 14 0477 42604... 14 0477 42600... 14 0477 42601... 14 0477 42602 Dr.Peters... 14 0477 41338... 14 0201 39119 8... 14 0201 39127... 14 0477 42832 ()... 14 0477 43300 350/5865... 14 0477 40296 5... 14 0477 44469 25... 14 0477 44307 Leica Cryofect 4 x 350 ml... 14 0387 42801 M... 14 0340 29011 S... 14 0340 40859 CM3050... 14 0443 30420 (8030442)... 14 0710 34911... 14 0505 33888... 14 0712 40150... 14 0712 40151... 14 0712 40152... 14 0712 40153... 14 0712 40154... 14 0712 40161 GB2099 (16A) C19... 14 0411 49617 Leica CM1950 57
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) 63a (CE ) 10 1. (10) 2. (11) (12) 6 11 10 3. ( 14) (11) 4. (13) (11) 13 14 4 () 64 58 V 2.0 M 2018 11
11. 1 6 2 4 3 65 7 8 ( ) (1) (2) 4 ( 2 5 ) ( 66 6a) (8) ( 66 7a) 5 CE (LP HP ) ( ) 7a 2.5 (6a) 2.5 6a 1 2 66 Leica CM1950 59
11. CE CE 4 9 8 11 10 1. (4) (11) () 2. (10) 3. (9) 4. (10) 5. (11) (4) () 12 6. (12) (10) (2) 2 67 60 V 2.0 M 2018 11
11. ( 68) 68 CE 8 1. (8) ( 3 ) 2. (8) 69 69a CN Leica CM1950 61
11. (1) 1 CE 70 I II I III II III III III ( 10 µm) 62 V 2.0 M 2018 11
11. 35 CE 33 34 35 1. (33) (34) 2. (35) 3. (36) ( ) 36 Leica Cryofect 71 CN T 72 ( Leica Cryofect) 15 Leica Cryofect Leica CM1950 63
11. CN 1 50x80 mm 5 µm () 3a 2 3a (80x50 mm) CN 16 cm C 64 mm 84 mm 3 4 4 5 4 (1) (2) 4 (4) (5) (6) (3a) (3) (3a) 6 73 64 V 2.0 M 2018 11
11. 19 18 19 17 16 CN (18) (19) 22 cm ( 84 mm ) (16) (17) 74 CNZ 3a (3a) ( 1 mm ) 75 76 Leica CM1950 65
11. 70 mm () 70 mm - 50 µm < 4 µm 70 mm - 100 µm 5 µm - 50 µm 70 mm - 150 µm > 50 µm 77 CE 50 100 µm ( ) CE (14 0477 43005) 78 (7) CE ( 59 49) CE 350/5865 1 3 ( ) 79 66 V 2.0 M 2018 11
11. (25 ) A (A) 14 0477 44307 80 B A G E D A - B - () C - ( D F) D - 4 (E) G - ( ) 81 F C () ( 28 ) 82 Leica CM1950 67
11. 50 x 80 mm 5 µm () 50x80 mm ø 55 ø 40 ø 30 ø 20 mm A 83 O 20 mm () 10 30 mm () 10 40 mm () 10 55 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 2.0 M 2018 11
11. 86 CUT MODE () CONT () SINGLE () ( 37 38) CONT () SINGLE () E-STOP () LED ( 38) (CONT () SINGLE ( )) Leica CM1950 69
11. 87 CE 88 89 70 V 2.0 M 2018 11
12. 12.1 ( ) ( 73 UVC ) Leica Cryofect ( ) (1) Leica CM1950 71
12. (1) 1 90 UV ( 7 ) Leica Cryofect ( Cryofect ) T ( 20 10) () 72 V 2.0 M 2018 11
12. 12.2 12.3 UVC UVC UVC UVC 9000 ( 30 180 ) 1 UVC 1 2 91 (2) (1) Leica CM1950 73
12. CM1950 UVC UVC UVC UVC 1 2 ( 91a-1) 2 UVC ( 91a-2) 1 2 91a 2 4 ( 91b-1) 4 UVC ( 91b-2) 2 1 91b 74 V 2.0 M 2018 11
12. 4 3 5 UVC (3) (4) (5) (8) (6) (7) ( 93) 6 7 8 92 93 (7) ( 93) (5) UVC 30 UVC UVC 94 UVC Leica CM1950 75
12. UVC UV 2 14 0477 43192 95 UV 4 14 0471 57385 96 76 V 2.0 M 2018 11
12.4 LED 12. LED 79 Leica CM1950 77
13. Leica Biosystems www.leicabiosystems.com 78 V 2.0 M 2018 11
14. Leica Biosystems Nussloch GmbH UV 7 Leica CM1950 79
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 11364 的规定编制 This table is prepared in accordance 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 80 V 2.0 M 2018 11
www.leicabiosystems.com Leica Biosystems Nussloch GmbH Heidelberger Strasse 17-19 69226 Nussloch Germany Phone: +49 6224-143 0 Fax: +49 6224-143 268 Internet: http://www.leicabiosystems.com