TEEx Transducer User Guide

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堰娩萧
7 years ago
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1 TEEx c0086

2 SonoSite, Inc th Drive SE Bothell, WA USA SonoSite Ltd Alexander House 40A Wilbury Way Hitchin Herts SG4 OAP UK M-Turbo MicroMaxx SSeries SonoSite SonoSite SonoSite, Inc. SonoSite SonoSite D D D D D D D D D D AU AU CA CA CN ZL CN ZL CN ZL CN ZL DE DE DE DE DE DE DE FR FR FR FR FR FR GB GB GB GB GB GB IT IT IT IT KR KR NO NO NZ RCD SP SP SP P / SonoSite, Inc. ii

3 TEEx TEEx iii

4 TEEx/8-3 MHz iv

5 1 TEEx/8-3 MHz TEEx SonoSite M-Turbo, S Series MicroMaxx TEEx SonoSite TEEx TEEx TEEx TEEx TEEx TEEx 1 1

6 TEEx (2D) M (M Mode) (Color) (PW) (CW) TEEx 2 1

7 TEEx 12 SonoSite TEEx SonoSite SonoSite SonoSite Support 1 3

8 +44-(0)

9 2 TEEx SonoSite SonoSite / 1 TEEx 2 3 TEEx TEEx TEEx TEEx 1 TEEx 2 5

10 TEEx TEEx TEEx SonoSite 3 TEEx 6 2

11 TEEx TEEx

12 TEEx 3 3 TEEx TEEx TEEx 1 2 TEEx 4 8 2

13 U 2 9

14 TEEx

16 TEEx

17 SonoSite 3 SonoSite U SonoSite 3 13

18 TEEx TEEx ALARA TEEx (Medical Alert on Latex Products, FDA 1991) CIVCO TEEx SonoSite TEEx SonoSite

19 TEEx CIVCO TEEx TEEx SonoSite SonoSite

20 16 3

21 4 TEEx SonoSite TEEx TEEx 1 a 8 1 b TEEx (ETO) 4 17

22 1 2 3 / TEEx TEEx X 0 C +45 C / -40 C +70 C TEEx 18 SonoSite 18 4

23 SonoSite SonoSite 4 19

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25 5 TEEx SonoSite TEEx 93/42/EEC IIA TEEx CAN/CSA C22.2, No M90:1990, Canadian Standards Association, Medical Electrical Equipment Part 1. General Requirements for Safety 1 Medical Device Directive, 93/42/EEC. 93/42/EEC IEC :1988 Medical Electrical Equipment-Part1 IEC : EN :1990, European Norm, Medical Electrical Equipment-Part1. EN : IEC 1157/EN61157:1994, Requirements for declaration of the acoustic output of medical diagnostic ultrasonic equipment. IEC 1157/EN61157: 1994 EN :2001, Medical Electrical Equipment-Part 2. Collateral standard; Electromagnetic Compatibility, Requirements and tests. EN : EN :2001, European Norm, Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment EN : 2001 UL :2003, Underwriters Laboratories Medical Electrical Equipment-Part1. UL :2003 (UL) 1 TEEx

26 TEEx TEEx SonoSite SonoSite 4 21 CFR TEEx TEEx 43 C 22 5

27 41.0 C 42.5 C 41.0 C OK 42.5 C 42.0 C FREEZE UNFREEZE 17.5 C 17.5 C 18.0 C FREEZE UNFREEZE 1 (2D) (Doppler) (2D) 2D (2D) Res Gen (PW Doppler) PRF / (CW Doppler) CW (Color) 5 23

28 22 +/- 0.1 C /- 0.1 C +/- 0.5 C 2 TEEx (Triple Transducer Connect) 3 FREEZE 4 10 cm /-0.5 C / 7 Warning 22 SonoSite SonoSite TEEx SonoSite IEC :1988 Medical Electrical Equipment - Part 1. General Requirements for Safety. 1 TEEx EN /IEC Type BF Applied Part BF 9g NaCl 40 cm 24 5

29 SonoSite EN >10M Ω 4 5 Ω V/Ω Com g NaCl / 1 L H 2 O 1 >25 cm 2 Cu TEEx

30 9g NaCl/1 L 25 cm 2 40 MOhm NIST - 1 TEEx 40 cm > 40 MOhm MOhm 10 MOhm SonoSite 26 5

31 6 TEEx/8-3 MHz 10.5 mm 110 cm mm* 14 mm x 12.5 mm BF UL CSA IEC ±0.5 C C 42.5 C 17.5 C 5.0 MHz 2 m TEEx / ISO C C 15% 95% hPa * 6 27

32 28 6

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TEEx Transducer User Guide

TEEx Transducer User Guide TEEx c0086 SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021 USA +1-888-482-9449 +1-425-951-1200 1+-425-951-1201 SonoSite Ltd Alexander House 40A Wilbury Way Hitchin Herts SG4 OAP UK +44-1462-444800