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 +44-1462-444801 M-Turbo MicroMaxx S Series SonoSite SonoSite SonoSite SonoSite SonoSite 5722412 5817024 5893363 6135961 6203498 6364839 6371918 6383139 6416475 6447451 6471651 6569101 6648826 6575908 6604630 6817982 6835177 6962566 7169108 7449640 7534211 7549961 7588541 7591786 7604596 7643040 D456509 D461895 D509900 D538432 D544962 D558351 D559390 D591423 D592750 D592760AU727381 AU730822 CA2372158 CA2373065 CN ZL 97113678.5 CN ZL 98106133.8 CN ZL 98108973.9 CN ZL 200830007734.8 DE60021552.0, DE60029777.2 DE60034670.6 DE69730563.5 DE6980539.6 DE69831698.3 DE60 2004 23 816.3-08 FR0815793 FR0875203 FR0881492 FR1175713 FR1180970 FR1589878 GB0875203 GB0881492 GB1175713 GB1180970 GB1180971 GB1589878 IT0815793 IT0881492 IT1175713 IT1589878 KR528102 KR532359 NO326202 NO326814 NZ542968 RCD000897368-0001 SP0815793 SP0881492 SP1589878 P05924-02 03/2010 2010 SonoSite ii
1... 1... 1 TEEx... 1... 2...3... 3... 3 2... 5... 6... 7 TEEx... 8... 8...10...11 3...13...14...14...15...15 4...17...18...18...18...19...19 5...21...21...22 (thermal safety)...23...23...23...24 iii
... 24... 24... 25... 26 6 TEEx/8-3... 27 iv
1 SonoSite M-Turbo SSeries MicroMaxx TEEx/8-3 TTEx TEEx SonoSite TEEx TEEx TEEx TEEx TEEx (electronically steered phased array) (sealed tip) TEEx (scanplane) 1 1
0 90 2 90 2 2 1 180 (conic imaging volume) 4 (deflection control wheels) 1 2 4 5 3 1 1 90 2 90 3 4 1 90 5 2 90 TEEx (2D) M (M Mode) (color Doppler) (pulsed wave, PW) (continuous wave, CW) TEEx 2 1
TEEx TEEx SonoSite 12 SonoSite (sheath) (biteguard) (tip cover) www.civco.com SonoSite SonoSite +1-877-657-8118 +1-425-951-1330 +1-425-951-6700 service@sonosite.com www.sonosite.com 1 3
+44-(0)1462-444-800 uk.service@sonosite.com +81-3-5304-5337 sonositejapan@sonosite.com 4 1
2 TEEx SonoSite SonoSite 1 TEEx 2 3 TEEx TEEx TEEx (3) (3) (3) (3) TEEx 1 TEEx 2 5
TEEx TEEx TEEx 8 10 10 12 (Leakage test) 24 SonoSite 3 TEEx 6 2
TEEx (cable) (connector) 2 1 4 9 11 5 6 10 2 3 7 8 2 TEEx 1 (Flexible endoscopic shaft) 7 2 (Articulation section) 8 3 9 (Scanplane control buttons) 4 (Deflection brake) 10 (Attachment ring) 5 11 6 (Neutral marker) 2 7
TEEx 3 3 TEEx TEEx TEEx 1 2 TEEx 2 2 // 4 / 8 2
1 2 3 4 5 6 4 1 50 10 2 50 10 3 50 10 4 125 5 5 6 U 2 9
TEEx 1 4 7 2 2 3 / / 5 / 1 2 3 4 5 5 1 4 2 5 3 1 2 3 4 5 6 1-5 10 2
6 1 6 1 2 3 4 2 3 4 7 0 0 180 7 2 11
1 5 10 2 180 0 (acoustic window) 6 22 112 162 72 1 TEEx 2 1 3 0 180 180 0 6 4 7 12 2
3 3 10 5 8 10 10 12 24 25 17 SonoSite 3 SonoSite U SonoSite 3 13
TEEx TEEx ALARA 2 ( ) TEEx (Medical Alert on Latex Products) (FDA 1991) (high level disinfection) CIVCO TEEx SonoSite TEEx 3 SonoSite 1 14 3
TEEx CIVCO TEEx TEEx (acoustic coupling) SonoSite SonoSite 1 2 3 4 5 6 1 2 3 15
16 3
4 TEEx SonoSite TEEx TEEx 1 a 8 b 2 8 1 3 TEEx 1 (Ethylene-Oxide, ETO) 4 17
1 2 3 / 1 5 8 3 TEEx 1 17 2 3 TEEx x 0 C +45 C / 18 4
-40 C +70 C TEEx 18 SonoSite SonoSite SonoSite 4 19
20 4
5 TEEx SonoSite TEEx 93/42/EEC (Medical Device Directive 93/42/EEC) IIA TEEx CAN/CSA C22.2, No. 601.1-M90:1990, Canadian Standards Association, Medical Electrical Equipment Part 1. General Requirements for Safety CAN/CSA C22.2, No. 601.1-M90:1990 Medical Device Directive, 93/42/EEC 93/42/EEC IEC 60601-1:1988 Medical Electrical Equipment-Part1. General Requirements for Safety IEC 60601-1:1988 EN 60601-1: 1990, European Norm, Medical Electrical Equipment-Part1. General Requirements for Safety EN 60601-1:1990 (EN 60601-1: 1990, European Norm, Medical Electrical Equipment-Part1 IEC 1157/EN61157: 1994, Requirements for declaration of the acoustic output of medical diagnostic ultrasonic equipment IEC 1157/EN61157:1994 EN 60601-1-2: 2001, Medical Electrical Equipment-Part 2. Collateral standard; Electromagnetic Compatibility, Requirements and tests 60601-1-2:2001 EN 60601-2-37: 2001, European Norm, Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment EN 60601-2-37:2001 UL 60601-1:2003, Underwriters Laboratories Medical Electrical Equipment-Part1. General Requirements for Safety UL 60601-1:2003 1 TEEx 24 24 5 21
TEEx TEEx SonoSite 13 15 25 (coupling gel) SonoSite 4 21 CFR 801.437 (21 CFR 801.437, User labeling for devices that contain natural rubber) TEEx TEEx 22 5
(thermal safety) 43 C 2 41.0 C 42.5 C 41.0 C 1 OK 42.5 C 42.0 C FREEZE UNFREEZE 17.5 C 17.5 C 18.0 C 1 Res Gen PRF / (sample gate) (sample linie) 5 23
1 23 (thermal safety) (water bath) +/- 0.1 C 1 41.8 +/- 0.1 C +/- 0.5 C 2 TEEx 3 4 10 5 6 41.8 +/-0.5 C / 7 23 (thermal safety) SonoSite SonoSite TEEx SonoSite (IEC 60601-1:1988 Medical Electrical Equipment-Part1. General Requirements for Safety) 24 5
EN 60601-1/IEC 60601.1 19 BF 9 40 SonoSite EN 60601-1 2 >10 4 5 Ω V/Ω Com 3 6 1 50 >25 1 2 2 1 4 TEEx 2 5 3 6 5 25
1 1 9 25 40 [NIST] 1 TEEx 40 2 2 3 > 40 4 2 10 10 SonoSite 26 5
6 TEEx/8-3 10.5 110 120 130 40 60 40 60 180 5 180 90 (biocompatibility) 35 * 14 x 12.5 BF UL CSA IEC ± 0.5 C 35 45 C 42.5 C 17.5 C (Center Frequency) 5.0 2 TEEx / ISO 10993-1 -35 +65 C 0 +45 C 15 95% 700 1060 0.7 1.05 * 6 27
28 6
P05924-02 *P05924-02*