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all published data at t case = 25c unless otherwise indicated esd: electrostatic discharge sensitive device?observe handling precautions! PTFB193404F confidential, limited internal distribution data sheet ? draft only 1 of 13 rev. 04, 2011-02-07 thermally-enhanced high power rf ldmos fets 340 w, 30 v, 1930 ? 1990 mhz description the PTFB193404F is a 340-watt ldmos fet intended for use in multi- standard cellular power ampli? er applications in the 1930 to 1990 mhz frequency band. features include input and output matching, high gain and thermally-enhanced package with earless ? ange. manufactured with in? neon?s advanced ldmos process, this device provides excellent thermal performance and superior reliability. rf characteristics two-carrier wcdma measurements (tested in in? neon test ? xture) v dd = 30 v, i dq = 2.6 a, p out = 80 w average, ? = 1990 mhz, 5 mhz spacing, 3gpp signal, channel bandwidth = 3.84 mhz, peak/average = 7.5 db @ 0.01% ccdf characteristic symbol min typ max unit gain g ps 17.5 19 ? db drain efficiency d 28.5 30 ? % adjacent channel power ratio acpr ? ?31 ?29 dbc features ? broadband internal matching ? wide video bandwidth ? typical single-carrier wcdma performance, 1990 mhz, 30 v - output power = 125 w - ef? ciency = 31% - gain = 17 db - par = 5.5 db @ 0.01% ccdf - acpr @ 5 mhz = ?35 dbc ? increased negative gate-source voltage range for improved performance in doherty ampli? ers ? capable of handling 10:1 vswr @ 30 v, 340 w (cw) output power ? integrated esd protection ? excellent thermal stability ? pb-free and rohs compliant PTFB193404F package h-37275-6/2 two-carrier wcdma 3gpp drive-up v dd = 30 v, i dq = 2.6 a, ? = 1990 mhz, 3gpp wcdma signal, par = 8 db, 10 mhz carrier spacing, bw = 3.84 mhz -60 -55 -50 -45 -40 -35 -30 -25 -20 36 38 40 42 44 46 48 50 52 average output power (dbm) imd, acpr (dbc) 0 5 10 15 20 25 30 35 40 drain efficiency (%) efficiency im d up imd low acpr
data sheet ? draft only 2 of 13 one rev. 04, 2011-02-07 PTFB193404F confidential, limited internal distribution rf characteristics (cont.) two-carrier wcdma characteristics (not subject to production test?veri ed by design/characterization in in neon test xture) v dd = 30 v, i dq = 2.6 a, p out = 80 w average, ? 1 = 1980 mhz, ? 2 = 1990 mhz, 3gpp signal, channel bandwidth = 3.84 mhz, peak/average = 7.5 db @ 0.01% ccdf characteristic symbol min typ max unit gain g ps ? 18 ? db drain efficiency d ? 29 ? % intermodulation distortion imd ? ?33 ? dbc two-tone characteristics (not subject to production test?veri ed by design/characterization in in neon test xture) v dd = 30 v, i dq = 2.6 a, p out = 265 w pep, ? = 1990 mhz, tone spacing = 1 mhz characteristic symbol min typ max unit gain g ps ? 19 ? db drain efficiency d ? 36 ? % intermodulation distortion imd ? 30 ? dbc dc characteristics characteristic conditions symbol min typ max unit drain-source breakdown voltage v gs = 0 v, i ds = 10 ma v (br)dss 65 ? ? v drain leakage current v ds = 28 v, v gs = 0 v i dss ? ? 1.0 a v ds = 63 v, v gs = 0 v i dss ? ? 10.0 a on-state resistance v gs = 10 v, v ds = 0.1 v r ds(on) ? 0.05 ? operating gate voltage v ds = 30 v, i dq = 2.6 a v gs 2.3 2.8 3.3 v gate leakage current v gs = 10 v, v ds = 0 v i gss ? ? 1.0 a maximum ratings parameter symbol value unit drain-source voltage v dss 65 v gate-source voltage v gs ?6 to +10 v junction temperature t j 200 c storage temperature range t stg ?40 to +150 c thermal resistance (t case = 70c) r jc 0.2 c/w
data sheet ? draft only 3 of 13 two rev. 04, 2011-02-07 PTFB193404F confidential, limited internal distribution typical performance (data taken in production test ? xture) ordering information type and version package outline package description shipping PTFB193404F v1 h-37275-6/2 ceramic open-cavity, earless push-pull tray PTFB193404F v1 r250 h-37275-6/2 ceramic open-cavity, earless push-pull tape & reel, 250 pcs two-carrier wcdma 3gpp drive-up v dd = 30 v, i dq = 2.6 a, 3gpp wcdma, p ar = 8 db, 10 mhz carrier spacing , bw = 3.84 mhz -60 -55 -50 -45 -40 -35 -30 -25 36 38 40 42 44 46 48 50 52 average output power (dbm) imd (dbc) 1990 1960 1930 s uuu im 3 low im3 up two-carrier wcdma 3gpp drive-up v dd = 30 v, i dq = 2.6 a, ? = 1990 mhz, 3gpp wcdma signal, pa r = 8 db, 10 mhz carrier spacing, bw = 3.84 mhz 16 17 18 19 20 36 38 40 42 44 46 48 50 52 average output power (db m) gain (db) 0 5 10 15 20 25 30 35 40 efficiency (%) gain efficiency
data sheet ? draft only 4 of 13 one rev. 04, 2011-02-07 PTFB193404F confidential, limited internal distribution typical performance (cont.) two-tone broadband performance v dd = 30 v, i dq = 2.6 a, p out = 52 dbm 10 20 30 40 50 60 1840 1900 1960 2020 2080 frequency (mhz) -50 -40 -30 -20 -10 0 gain efficiency return loss imd3 return loss (db) / imd (dbc) gain (db) / efficiency (%) two-tone drive-up v dd = 30 v, i dq = 2.6 a,, ? 1 = 1989 mhz, ? 2 = 1990 mhz -65 -55 -45 -35 -25 39 44 49 54 output power, pep. (dbm) imd (dbc) 0 5 10 15 20 25 30 35 40 45 efficiency (%) 3rd order imd efficiency two -ton e drive-up v dd = 30 v, i dq = 2.6 a , ? 1 = 1989 mhz, ? 2 = 1990 mhz 15 16 17 18 19 20 40 44 48 52 56 output power, pep (db m) gain (db) 0 7 14 21 28 35 42 efficiency (%) gain efficiency two -ton e drive-up (over tempera tur e) (p out -max 3rd order imd @ ?30 dbc) v dd = 30 v, i dq = 2.6 a , ? 1 = 1959 mhz, ? 2 = 1960 mhz 16 17 18 19 20 21 39 41 43 45 47 49 51 53 55 57 output power, pep (dbm) gain (db) 0 10 20 30 40 50 efficiency (%) +25c +85c ?30c efficiency gain
data sheet ? draft only 5 of 13 two rev. 04, 2011-02-07 PTFB193404F confidential, limited internal distribution typical performance (cont.) two-tone drive-up at selected frequencies v dd = 30 v, i dq = 2.6 a, tone spacing = 1 mhz -70 -60 -50 -40 -30 -20 39 41 43 45 47 49 51 53 55 57 output power, pep (dbm) imd 3rd order (dbc) 1990 mhz 1960 mhz 1930 mhz intermodulation distortion vs. output power v dd = 30 v, i dq = 2.6 a, ? 1 = 1989 mhz, ? 2 = 1990 mhz -75 -65 -55 -45 -35 -25 -15 39 41 43 45 47 49 51 53 55 57 output power, pep (dbm) imd (dbc) 3rd order 7th 5th int ermodulation di stortion vs. tone spacing v dd = 30 v , i dq = 2.6 a, ? = 1930 mhz, p out = 317 w (pep) -70 -60 -50 -40 -30 -20 -10 1 10 100 two tone spacing (mhz) imd (dbc) imd7 im d5 imd3 imd lower imd upper single-c arrier wcdma driv e-up v dd = 30 v, i dq = 2.6 a, ? = 1990 mhz, 3gpp wcd ma signal, tm1 w/16 dpch, 43% clipping, p ar = 7.5 db, 3.84 mhz bw -60 -50 -40 -30 -20 36 38 40 42 44 46 48 50 52 av erage output power (db m) 0 5 10 15 20 25 30 35 40 drain efficiency (%) adjacent channel power ratio (db) efficiency acpr up acpr low
data sheet ? draft only 6 of 13 one rev. 04, 2011-02-07 PTFB193404F confidential, limited internal distribution typical performance (cont.) single-carrier wcdma drive-up v dd = 30 v, i dq = 2.6 a, ? = 1990 mhz, 3gpp wcd ma signal, par = 7.5 db, bw = 3.84 mhz 2 6 10 14 18 22 26 36 38 40 42 44 46 48 50 52 54 average output power (dbm) -70 -50 -30 -10 10 30 50 efficiency (%) / acp (dbc) acp parc @ .01% ccdf efficiency gain parc (db) / parc gain (db) single-c arrier wcdma drive-up v dd = 30 v, i dq = 2.6 a, ? = 1960 mhz, 3gpp wcd ma signal, par = 7.5 db, bw = 3.84 mhz 2 6 10 14 18 22 26 36 38 40 42 44 46 48 50 52 54 av erage output power (dbm) -70 -50 -30 -10 10 30 50 efficiency (%) / acp (dbc) parc (db) / parc gain (db) acp parc @ .01% ccdf efficiency gain single-carrier wcdma drive-up v dd = 30 v, i dq = 2.6 a, ? = 1930 mhz, 3gpp wcdma signal, par = 7.5 db, bw = 3.84 mhz 0 4 8 12 16 20 36 38 40 42 44 46 48 50 52 54 average output power (dbm) -60 -40 -20 0 20 40 60 efficiency (%) / acp (dbc) acp parc @ .01% ccdf efficiency gain parc (db) / parc gain (db) single-carrier wcdma broadband v dd = 30 v, i dq = 2.6 a, p out = 125 w, 3gpp wcdma signal -5 5 15 25 35 1840 1900 1960 2020 2080 frequency (mhz) -40 -30 -20 -10 0 return loss (db) / acp (dbc) acp parc @ .01% ccdf efficiency gain gain, parc (db) / efficiency (%) . irl
data sheet ? draft only 7 of 13 two rev. 04, 2011-02-07 PTFB193404F confidential, limited internal distribution broadband circuit impedance (measurements taken on full part, both sides) g d g s d pp- fet c o mp l e t e _12- 1 6- 2010 z load z source frequency z source z load mhz r jx r jx 1900 1.21 ?3.60 0.73 ?2.08 1930 1.21 ?3.53 0.72 ?2.01 1960 1.20 ?3.47 0.72 ?1.94 1990 1.20 ?3.41 0.72 ?1.87 2020 1.19 ?3.35 0.72 ?1.81 see next page for circuit information
data sheet ? draft only 8 of 13 one rev. 04, 2011-02-07 PTFB193404F confidential, limited internal distribution reference circuit 1 2 3 tl101 tl102 tl103 tl104 tl105 r802 1300 ohm r803 10 ohm r804 1200 ohm c803 1000 pf tl106 tl107 tl108 tl109 tl110 tl111 tl112 tl113 tl114 tl115 c101 1000000 pf tl116 tl117 tl118 tl119 s c b e 1 2 3 4 s2 1 2 3 s1 c801 1000000 pf c802 10000000 pf c102 1000000 pf r103 10 ohm l101 22 nh l102 22 nh r104 10 ohm c103 10000000 pf c104 10000000 pf c105 18 pf c106 18 pf c107 1.5 pf c804 10000000 pf tl120 12 3 tl121 1 2 3 4 tl122 tl123 12 3 tl124 r801 100 ohm port 1 1 2 34 5 6 7 8 s3 rf_in b 1 93 4 0 4f - v1 _ b d o ut _1 2 - 1 6 - 2 0 10 gate dut (pin g1) gate dut (pin g2) reference circuit input schematic for ? = 1990 mhz = 3.48 h = 20 mil ro/ro4350b1 r
data sheet ? draft only 9 of 13 two rev. 04, 2011-02-07 PTFB193404F confidential, limited internal distribution reference circuit output schematic for ? = 1990 mhz reference circuit assembly dut PTFB193404F test fixture part no. ltn/ptfb193404ef pcb rogers ro4350, 0.508 mm [0.020?] thick, 1 oz. copper, r = 3.48copper find gerber les for this test xture on the in neon web site at http://www.in neon.com/rfpower transmission electrical dimensions: w, l (mm) dimensions: w, l (mils) line characteristics input tl101 0.017 , 47.12 w1 = 1.270, w2 = 1.270, w3 = 1.524 w1 = 50, w2 = 50, w3 = 60 tl102 0.039 , 47.12 w = 1.270, l = 3.553 w = 50, l = 140 tl103 0.023 , 47.12 w = 1.270, l = 2.055 w = 50, l = 81 tl104 0.013 , 47.12 w = 1.270, l = 1.168 w = 50, l = 46 tl105 0.122 , 7.29 w = 12.700, l = 10.160 w = 500, l = 400 tl106 w1 = 0.010, w2 = 1.168, offset = 5.893 w1 = 10, w2 = 46, offset = 232 tl107 w1 = 0.010, w2 = 1.168, offset = ?5.893 w1 = 10, w2 = 46, offset = ?232 tl108 0.007 , 34.08 w = 2.032, l = 0.635 w = 80, l = 25 tl109 0.012 , 34.08 w1 = 2.032, w2 = 1.034 w1 = 80, w2 = 41 tl110 0.055 , 53.60 w = 1.034, l = 5.029 w = 41, l = 198 tl111 0.023 , 47.12 w = 1.270, l = 2.111 w = 50, l = 83 tl112 0.017 , 47.12 w = 1.270, l = 1.524 w = 50, l = 60 tl113 0.023 , 47.12 w = 1.270, l = 2.055 w = 50, l = 81 table continued on page 9 reference circuit (cont.) tl201 tl202 c201 0.8 pf 1 2 3 tl203 tl204 tl205 tl206 tl207 tl208 tl209 tl210 tl211 tl212 dcvs v2 dcvs v1 1 2 3 tl213 1 2 3 tl214 1 2 3 tl215 1 2 3 tl216 1 2 3 tl217 tl218 tl219 c202 100000000 pf tl220 c203 100000000 pf 1 2 3 tl221 1 2 3 tl222 1 2 3 tl223 1 2 3 tl224 1 2 3 tl225 tl226 tl227 port 1 c204 18 pf c205 18 pf c206 4700000 pf c207 4700000 pf c208 4700000 pf c209 4700000 pf c210 10000000 pf c211 10000000 pf c212 10000000 pf c213 10000000 pf b193404f-v1_bd out_12- 16-2010 rf_out v dd v dd drain dut (pin d 1) drain dut (pin d 2) drain v dd (pin v 1) drain v dd (pin v 2) = 3.48 h = 20 mil ro/ro4350b1 r
data sheet ? draft only 10 of 13 one rev. 04, 2011-02-07 PTFB193404F confidential, limited internal distribution reference circuit (cont.) transmission electrical dimensions: w, l (mm) dimensions: w, l (mils) line characteristics input (cont.) tl114 0.013 , 47.12 w = 1.270, l = 1.168 w = 50, l = 46 tl115 0.122 , 7.29 w = 12.700, l = 10.160 w = 500, l = 400 tl116 0.068 , 47.12 w = 1.270, l = 6.170 w = 50, l = 243 tl117 0.032 , 47.12 w = 1.270, l = 2.875 w = 50, l = 113 tl118 0.024 , 47.12 w = 1.270, l = 2.131 w = 50, l = 84 tl119 0.017 , 47.12 w = 1.270, l = 1.524 w = 50, l = 60 tl120 0.084 , 53.60 w = 1.034, l = 7.671 w = 41, l = 302 tl121 0.014 , 53.60 w1 = 1.034, w2 = 1.034, w3 = 1.27 w1 = 41, w2 = 41, w3 = 50 tl122 0.014 , 47.12 w1 = 1.270, w2 = 1.270, w3 = 1.270, w1 = 50, w2 = 50, w3 = 50, w4 = 1.270 w4 = 50 tl123 0.032 , 47.12 w = 1.270, l = 2.896 w = 50, l = 114 tl124 0.014 , 47.12 w1 = 1.270, w2 = 1.270, w3 = 1.27 w1 = 50, w2 = 50, w3 = 50 output tl201 w1 = 1.577, w2 = 1.046 w1 = 62, w2 = 41 tl202 w1 = 2.263, w2 = 1.577 w1 = 89, w2 = 62 tl203 0.009 , 31.48 w1 = 2.263, w2 = 2.263, w3 = 0.762 w1 = 89, w2 = 89, w3 = 30 tl204 0.139 , 31.48 w = 2.263, l = 12.299 w = 89, l = 484 tl205 w1 = 0.001, w2 = 13.335, offset = ?6.223 w1 = 1, w2 = 525, offset = ?245 tl206 w1 = 3.048, w2 = 2.263 w1 = 120, w2 = 89 tl207 0.009 , 25.04 w = 3.048, l = 0.762 w = 120, l = 30 tl208 0.266 , 40.78 w = 1.577, l = 23.889 w = 62, l = 941 tl209 0.160 , 6.97 w = 13.335, l = 13.335 w = 525, l = 525 tl210 0.160 , 6.97 w = 13.335, l = 13.335 w = 525, l = 525 tl211 0.151 , 53.21 w = 1.046, l = 13.774 w = 41, l = 542 tl212 0.120 , 31.48 w = 2.263, l = 10.617 w = 89, l = 418 tl213 0.024 , 19.85 w1 = 4.064, w2 = 4.064, w3 = 2.032 w1 = 160, w2 = 160, w3 = 80 tl214 0.026 , 19.85 w1 = 4.064, w2 = 4.064, w3 = 2.286 w1 = 160, w2 = 160, w3 = 90 tl215 0.026 , 19.85 w1 = 4.064, w2 = 4.064, w3 = 2.286 w1 = 160, w2 = 160, w3 = 90 tl216 0.024 , 19.85 w1 = 4.064, w2 = 4.064, w3 = 2.032 w1 = 160, w2 = 160, w3 = 80 tl217 0.026 , 19.85 w1 = 4.064, w2 = 4.064, w3 = 2.286 w1 = 160, w2 = 160, w3 = 90 tl218 0.116 , 19.85 w = 4.064, l = 10.008 w = 160, l = 394 tl219 0.052 , 19.85 w = 4.064, l = 4.470 w = 160, l = 176 tl220 0.116 , 19.85 w = 4.064, l = 10.008 w = 160, l = 394 tl221 0.024 , 19.85 w1 = 4.064, w2 = 4.064, w3 = 2.032 w1 = 160, w2 = 160, w3 = 80 tl222 0.026 , 19.85 w1 = 4.064, w2 = 4.064, w3 = 2.286 w1 = 160, w2 = 160, w3 = 90 tl223 0.026 , 19.85 w1 = 4.064, w2 = 4.064, w3 = 2.286 w1 = 160, w2 = 160, w3 = 90 tl224 0.026 , 19.85 w1 = 4.064, w2 = 4.064, w3 = 2.286 w1 = 160, w2 = 160, w3 = 90 tl225 0.024 , 19.85 w1 = 4.064, w2 = 4.064, w3 = 2.032 w1 = 160, w2 = 160, w3 = 80 tl226 0.052 , 19.85 w = 4.064, l = 4.470 w = 160, l = 176 tl227 w1 = 0.001, w2 = 13.335, offset = 6.223 w1 = 1, w2 = 525, offset = 245
data sheet ? draft only 11 of 13 two rev. 04, 2011-02-07 PTFB193404F confidential, limited internal distribution reference circuit assembly diagram (not to scale) component id description suggested manufacturer p/n c101, c102 chip capacitor, 1 f atc nfm18ps105r0j30 c103, c104 capacitor, 10 f digi-key 490-4393-2-nd c105, c106, capacitor, 18 pf atc 800a180jt c204, c205 c107 capacitor, 1.5 pf atc 800a1r5bt c801 capacitor, 1 f digi-key 490-4736-2-nd c802, c804 capacitor, 10 f digi-key 587-1818-2-nd c803 chip capacitor, 1000 pf digi-key pcc1772ct-nd l101, l102 inductor, 22 nh digi-key 0805w220jt r101, r102 resistor, 1000 digi-key p1.0kect-nd r103, r104 resistor, 10 digi-key p10gtr-nd r801 resistor, 100 digi-key p100gtr-nd r802 resistor, 1300 digi-key p1.3kgtr-nd r803 resistor, 10 digi-key p101gtr-nd r804 resistor, 1200 digi-key p1.2kgtr-nd s1 potentiometer digi-key 3224w-202ect-nd s2 transistor digi-key bcp56-nd, bcp56 s3 voltage regulator digi-key lm780l05acm-nd, 7805 c201 capacitor, 0.8 pf atc 800a0r8bt c202, c203 capacitor, 100 f digi-key pce4442tr-nd c206, c207, capacitor, 4.7 f digi-key 490-1864-2-nd c208, c209 c210, c211, capacitor, 10 f digi-key 587-1818-2-nd c212, c213 b193404f-v1_cd_12-16-2010 c209 rf_out rf_in c207 c210 c203 c202 c212 c208 c102 c101 c211 c201 c204 r104 r802 c105 c801 c104 c206 c106 c107 r803 c803 c103 c205 l102 c104 r801 r103 c802 r804 s2 .020 v dd v dd s3 ptfb193404 _in_01 ptfb193404_out_01 + s1 c213 l101 .020 (60) ro4350, .020 (63) v dd ro4350, reference circuit (cont.)
data sheet ? draft only 12 of 13 one rev. 04, 2011-02-07 PTFB193404F confidential, limited internal distribution pinout diagram package h-37275-6/2 pin description v1 v dd device 1 v2 v dd device 2 d1 drain device 1 d2 drain device 2 g1 gate device 1 g2 gate device 2 s source ( ange) v2 s = 1g2 d1 d2 v1 -37275-6-2_pd_07-22-2010 see next page for package outline speci cations
data sheet ? draft only 13 of 13 two rev. 04, 2011-02-07 PTFB193404F confidential, limited internal distribution package outline speci cations package h-37275-6/2 diagram notes?unless otherwise speci ed: 1. interpret dimensions and tolerances per asme y14.5m-1994. 2. primary dimensions are mm. alternate dimensions are inches. 3. all tolerances 0.127 [.005] unless speci ed otherwise. 4. pins: d1, d2 - drain, devices 1 & 2; g1, g2 - gate, devices 1 & 2; v1, v2 - v dd , devices 1 & 2; s - source ( ange). 5. lead thickness: 0.127 0.051 [.005 .002]. 6. gold plating thickness: 1.14 0.38 micron [45 15 microinch]. find the latest and most complete information about products and packaging at the in neon internet page http://www.in neon.com/rfpower v1 g1 g2 d2 d1 v2 32.258 [1.270] 1.626 [0.064] 10.160 [.400] 4x 11.684 [.460] 2x 45 x 1.19 [45 x .047] 2x 1.143 [.045] 16.612.500 [.654.020] 9.398 [.370] c l 13.716 [.540] 9.144 [.360] 2x 3.175 [.125] 2x 30 31.750 [1.250] 2x 2.032 [.080] ref 2.134 [.084] sph 3.2260.508 [.127.020] 31.2420.280 [1.230.011] 4.585 +0.250 -0.127 [ .180 +.010 -.005 ] s 4x r0.508 +.381 -.127 [ r.020 +.015 -.005 ] c l c l c l c l h- 37275- 6- 2_po _07- 21- 2010
data sheet ? draft only 14 of 13 rev. 04, 2011-02-07 PTFB193404F v1 con dential, limited internal distribution revision history: 2011-01-24 data sheet previous version: 2010-12-16, data sheet page subjects (major changes since last revision) 1, 2 rf tables revised for clarity. we listen to your comments any information within this document that you feel is wrong, unclear or missing at all? your feedback will help us to continuously improve the quality of this document. please send your proposal (including a reference to this document) to: highpowerrf@in neon.com to request other information, contact us at: +1 877 465 3667 (1-877-go-ldmos) usa or +1 408 776 0600 international edition 2011-01-24 published by in neon technologies ag 81726 munich, germany ? 2010 in neon technologies ag all rights reserved. legal disclaimer the information given in this document shall in no event be regarded as a guarantee of conditions or characteristics. with respect to any examples or hints given herein, any typical values stated herein and/or any information regarding the application of the device, in neon technologies hereby disclaims any and all warranties and liabilities of any kind, including without limitation, warranties of non-infringement of intellectual property rights of any third party. information for further information on technology, delivery terms and conditions and prices, please contact the nearest in neon technologies of ce ( www.in neon.com/rfpower ). warnings due to technical requirements, components may contain dangerous substances. for information on the types in question, please contact the nearest in neon technologies of ce. in neon technologies components may be used in life-support devices or systems only with the express written approval of in neon technologies, if a failure of such components can reasonably be expected to cause the failure of that life-support device or system or to affect the safety or effectiveness of that device or system. life support devices or systems are intende d to be implanted in the human body or to support and/or maintain and sustain and/or protect human life. if they fail, it is reasonable to assume that the health of the user or other persons may be endangered.

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