Final Test Data Sheet for Force 2-PCH aS ee coe nai? eee SE Yrapee Dale cairtenconpiied ae Lae | Sone Sg Post Cycled By (Signature) BAO LUC ) Me 723102) oo 4. Initial inspection Ce ee A ee eee ana oe es a (See deat nee owe wean te Coes a ane pe Ae fone Sioec veg eae a eps ave — ae ee A. Correct Mode Waveforms B. Maximum RF Pulse Width (C. Minimum RF Pulse Wieth ‘A. Supply Frequency B, High Voltage Idle High Voltage DC Supply (voc CC. High Votage Current Limit 5 ‘Monopolar Output Power C2 HV Clamp 120 Watt Page tof -1vE0) a | (Toonsec -300nsec)_796.00 nsec [—_] (G0 nsec -350nsec)_100.00 nsec [——] (92 KHe-48KH2)_30.70KHz [] (oce)__ Ys [J] (ocep)___y [J] (425 vp -485 ve)_440.00v_ [~~] Electronic Final Test Data Sheet FORCE 2°CH ows Rev 944360085, A10. 1" 12. Page 2018 Return Electrode Monitor (REM) 8. EREM Voltage (975 v0e-svoc)__44sv_ [——} . REM Frequency (120 KHe- 160 kHa)_197.80 Kt [——] D. REM Pulse - Duty Cycle (88 msee-10.2 msec)_10.00 msec [——] Endurance Test ‘A. Cut3 Minute Test - 300 ohm LOAD Initial Current 1007.00 ma Final Current 968.00 mA, % Change (<= 5%) 2h B. Coag 2.5 Minute Test - Open Circuit Co nd Life cycle Test Time In__11:00 AM. Time Out 12:50 PML inal Test Proced Keyboard and Reatuta lo Monopolar Output Power ‘A. Cut Accessory - 300 ohm LOAD 1 Watt (40 mA- 100 mA) _ 59.00 ma 75 Watt (481 mA -§38 mA) 518.00 mA 300 Watt (622. ma. 1072 mA) 896.00 mA. BB Blend Accessory - 300 chm LOAD Blend 11 Watt (40 mA- 100 mA) _61.00 mA 75Watt (461 mA -§36 mA) — 519.00 ma 250 Watt (842 mA - 979 mA) 916.00 mA Blend 21 Watt (40 mA-100 mA) _ 66.00 mA 75 Watt (481 mA -§38 mA) 519.00 mA 200 Watt (753 mA - 876 mA) 815.00 mA Blend 3.1 Watt (40 mA 100 mA) _61.00 ma 75 Watt (481 mA -538 mA) 513.00 mA 150 Watt (652 mA -758 mA) 702.00 mA Electronic Final Test Data Sheet OWS REV FORGE 2-°CH| ‘944950063 A8 “4 18 Page 3016 C. Coag Accessory - 300 ohm LOAD Coag 1 Watt (4omA-100 ma) _57.00 mA 30 Watt (289 rea - 242 mA) 328.00 mA 120 Watt (683 mA - 878 mA) — 636.00 mA Low Voltage Coag 99 Watt (630A - 816 mA) _587.00 mA D. Simultaneous Cog - 300 ohm LOAD (x2) 120 Watt (385mA-516 ma) _447.00ma [——] E, Bovie Output (accep) Ys [J] (recep) YJ F. Remote (Power Control) Handswitch G. Handswitch Output Power - 100 ohm LOAD Cut 300 Watt (L7A-1.8A)__4.758 Blend 1 250 Watt (144-18 A)__1548 Coag 120 Watt (0.7 A-1.1A)_1.06A. H. Power Alarm (ceed) se Velina [rama] Bipolar Output Power 1Watt 100 ohm LOAD (70mA-141 mA) _92.00mA 7 Watt 100 ohm LOAD (G48 mA - 489 mA) 307.00 ma 7OWatt 100 ohm LOAD (771 ma - 887 mA) — 846.00 mA 40 Watt 50 ohm LOAD (250 me - 1200 ma) 1728.00 mA 40 Watt 300 ohm LOAD (180mA - 960 mA) — 265.00 mA Waveforms and Peak to Peak Voltages ‘A. Correct Mode Waveforms -Matched Load (Accept) s[_] 8. Crest Factors - Coag 60 Watt - 300 ohm LOAD (600 Vp - 1600 Vp) (Accept) Ys CC. Maximum Peak to Peak Voltage - Open Cirut cut 300 Watt (<= 9500 Vpp) _ 2640.00 V Blend 1 250 Watt (<= 3800 Vpp) 3080.00 Blend2 200 Watt (<= 4000 Vpp) 3440.00 Blend3 180 Watt (<= 4000 Vpp) 3560.00 V Coag 120 Watt 7000 Vpp) 6040.00 Bipolar 70 Watt (<= 1200 Vpp) 624.00 High Impedance Power Electronic Final Test Data Sheet FORCE 2-PCH ows Rev ‘94350083 AA. Cat (max power) ‘3000 ohm (= 238 mA) _ 262.00 mA +4000 ohm 83.00 mA B. Blend 2 (max power) | 3000 ohm 215.00 mA +4000 ohm 90.00 mA ©. Coag (max power) ‘3000 ohm 171.00 mA +4000 ohm 97.00 mA 18, Gross Coupling A Handswitch Current Accessory Active (OmA-150mA)_ 35.00 mA Bipolar Active (Oma. 150 ma) 8.70 mA 8 Accessory Current Handswitch Active (OmA-160 mA) _38.00 ma Bipolar Active (mA. 150 ma) 880 mA c. Bipolar Current Accessory Active (OmA-150mA)_2.20 ma Handswiteh Active (Oma 150 mA) 1.90 ma 17, High Frequency Leakage A. Bipolar RF Leakage 70 Watt (OmA-65 ma) (hecept)_ oy B. Monopolar Patient Retum RF Leakage Bt. Cut Mode 15Watt (mA 150 mA) 20 Watt (0 mA- 150 ma) 30Watt (0 mA- 150 ma) 300 Watt (O.mA~ 150 mA) 2, Blend 3 Mode 30Watt (0 mA- 150 ma) 40 Watt (0 mA- 150 mA) 45Watt (0 mA- 150 mA) 50 Watt (0 mA- 180 mA) 3. Coag Mode Page 4 ot6 Electronic Final Test Data Sheet pws REV FORCE Z°CH ‘sea360083 A40Watt (0 mA-150 ma) (Accept) ___¥. 15 Watt (0 mA 150 ma) (Accept) __¥ 25 Watt (0 mA 150 ma) (Accent) —__¥. 120 Watt (0 mA- 180 mA) (Aecept) —¥ CC. Monopolar Accessory Active RF Leakage Cut 300Watt (0 mA- 150 ma) (Accent). Coag 120Watt (0 mA-150 mA) (Accept) —¥ 48, Return Electrode Monitor (REM) A. High REM Trip (190 ohm «140 ohm) _ 135.00 Ohm [———]} BL REM Trip Points Ba 40 ohm - OFF (Accept) B2 ——1200hm-OFF (Accept B3 —1500hm-ON (Accopt Ba 60 ohm - OFF (Accept BS 1000hm-ON (Accept BS 30 ohm - OFF (Accept Br 10 ohm - OFF (Accept Ba 3.ohm -ON (Accept . Non-REM Trip Points 24 ohm - ON (Accep)__¥ ‘ohm - OFF (Accept) _¥ D. Keyed REM (Acces) 18. Torque Seal (Accept) __¥ 20. High Line / Low Line Output Power A. ARC Test « 85 Volt Accept). 135 Vott (ecept) B. Low Line Output - Matched Load - Maximum Power Setings (85 Volt) cut (200 mA 1100 mA) _ $96.00 mA Blend 1 (700 mA - G80 mA) 833.00 mA. Blend 2 (680 mA - 890 mA) 767.00 mA. Blend 3 (450 mA - 750 ma) 857.00 mA Coag (650 mA -690 mA) 647.00 mA. Page Sof Electronic Final Test Data Sheet ows REV FORCE Z°CH 94360063 Aa. 2. 23. Pages ofS Bipolar Cover Unit Safety Testing (700mA-800.ma)_844.00ma [——] ere Y_ 7} (Attach a copy of Safety Tester data printout to data sheet) A. High Potential Tests B, Ground Continuity Test C. Low Frequency Leakage Tests Final Inspection A. Keyboards and Readouts B. Keying and RF Indicator Responses ‘75 Watt Cut into 300 ohm Load is - 520 -525mA, Handswitch Keying - All Modes Footswitch Keying - All Modes RF Indicator Resp - All Modes. ©. Tone and Volume Power-Up Tone Normal Volume level Range and Carty Mode Tones Normal D. REM Alarm ‘Alarm Activates Two Waming Tones @ Max Volume E, Workmanship / Cosmetics No Scratches or Dents on Unit ‘Top Cover Siksereen Legible- Proper Cover installed All Sorews Inserted and Secured Feet Installed and Secured on = Bottom of Unit Proper Front Panel LED Alignment F. Documentation ‘econc Final Test Dat Sheet FORCE 2-PCH Accept) (Accept) (Accept) Accent) ys [] (Accept) (Accept) YY] (Accept) ¥) (Accept) TY (Accept). (Accept) TY (Accept) TY. (Accept) (Accept) TY (Acoep)_Y. (Accept) —¥. = (Accept) _¥ 1944950083 ows REV ASW607 Test Data Report Gomi formation Company TYCO HEALTHCARE Contact ‘Address 5920 Longbow Orie Phone: Boulder co 9020-320 Fax. Project Information Project # FORCE 22 PCH Date Started 1182002 Model # FORCE22CH Completion Date 18/2007 Description _—_Elecko Surgical Generator ProjectTime: 2 minutos Manufacturer VALLEYLAB Equiptment Type su Technician Q) ee 7/23/08 Notes Unit Regustory Approvals: ULS44; CSA 22.2 No. 125 Soral# F26415857 Tested By OTLE606 UnitPIF Pass Model # FORCE2-2°CH Time Spent 6.00 mintes seq 1 5 Testinfo Test# 1 Reading 1108 ACVols PassiFall Pass Test Name AC LINE(MAINS) VOLTAGE Los 160501 Pie Min 118.00 Vots Test Notes Set AC Soureato 120 VAC PIFMax 12200 Vail a Delay 0 See Meter Mode AC FEGnd Open PL1 No PLE No Line Polarity Of PLGnd Open PL2 No PLT No Single Faut None Sink Rev Nermal PL3 No PLB No Gnd Select 5. Gnd Ene. Gnd Open PLA No PLO No. ‘ce.Gnd_ O96 PLS_No PLI0_No. 2 Reading 29uAmps—PassiFail Pasa S.GND LEAKAGE CURRENT Load 160801 PIF Min S000 Ntexoam PIF Max 10000 Kteoam Delay 6 Soe Motor Mode AC*OC FEGnd Open PL1 No PLE No Line Potarty Normal PLGnd —Ciosed PL2 No PLT No Single Fauit None Sink Rov Norma PL3 No PLA No Gnd Select S.God Ene.Gnd Oren PL4 No PLO. No Ace. Gnd Oyen PLS No PLIO_ NoSerial # F2G41595T Tested By OTLES66, Unit PIF Pass Model # FORCE 2-2 PCH Time Spent 6.00 minutes Last Tested 7123/2002 seq 1 Paget 2 ofS Printed 72872002 Testinto Test t 3 Reading 0.0 uAmps —Passifail Pass ‘TestName — PATIENTLD ALL TO GND Lead ICO: PIF Min 0,00 Mcraam Test Notes PIF Max 10,00 Meron Settings Delay 0 See, Mater Mode ACHDC FEGnd Open PL1 Yor PL Yor Line Polarity Norms! PLGnd Open PL2 Ys PLT No Single Fault Nove ‘Sink Rov Normal PL3. Yes PLE No Gnd Select S.Gnd Ene.Gnd Open PLa Yes PL No ‘Ace. Gnd _Open PLS Yes PLIO_No Test into Test 4 Reading 17 uAmps —PaseiFail Pass TTestName PATIENTLD ALL TO GND Lead 10801 PIF Min 0.50 Microam Test Notes PIFMax 10.00 Microam pour Delay 0 See. Mater Mode ACHOG FEGnd Open PLi Yes PLE Yes Line Polarity Normal PLGnd Open PL2 Yes PLT No ‘Single Fault Open 8. Gnd Sink Rov Nocral PL3 Yes PLE No Gnd Select S.Gné Ene. Grd Open PLA Yes PLO. No ‘Ace. Gnd Open PLS Yes PLI0_No Testinto Test 5 Reading 6.4 uAmps —PassiFall Pass TTestName PATIENTLDSINKEACHTOGNO Load IEC501 PIF Min 3.00 Mcroam ‘Test Notes PIF Max 10.00 Meroam ‘Settings Delay 1 Sec, Mater Mode ACO FEGnd Open PLi Yes PLE Yes Line Polarity Norma PLGnd Open PL2 Yes PLT No ‘Single Fault None Sink Rev Normal PL3 Yes PLB No Gnd Select S.Gad Ene. Gnd pen PLA Yes PLO. No ‘ce. Gnd__Dpen PLS Yes _PL10_No i Test 6 Reading 0.0 uamps Passa Pass ‘Test Name PATIENTLD ALL TO GND Load IEC801 PIF tin 0.00 Microam Test Notes PIF Max 20.00 Microam seninas Delay 0 See, ‘Mater Mode ACYDC FeGnd — 2pen PL1 Yes PLE. Yos Line Polarity Normal PLGnd —Spen PL2 Yes PLT No Single Fault Open Neutral ‘Sink Rev Normal PLA Yes PLE. No Gnd Select 5S.Gnd Ene.Gnd 2pen PLA Yes PLO. No ‘Ace.Gnd _Dpen PLS Yes PLIO_ NoSerial F2G41595T Tested By OTLS686 UnitPIF Pass Model# FORCE 2.2 PCH Time Spent 5.00 minutes Last Tested 7/2872002 Seq 1 Paget 3 of 5 Printed 7/28:2002 Testinfo Test 7 Reading S2uAmps —PassiFail Pass TestNeme S.GNO LEAKAGE CURRENT Load 1EC50% PIF Min 25:00 eros Tost Notes PIF Max 100.00 Mieroam ae Deiay 0 See, ‘Meter Mode AC+DC FEGné Open PL1 No PLE No Line Polarity Normal PLGne Closed PL2 No PLT No Single Fault Open Neutral ‘Sink Rev Normal PL3 No PLE No Gnd Select S. Grd Ene. Grd Open PL4 No PLO No. ‘Ace. Gnd Open PLS No PLIO_No Testinfo Test # 8 Reading S2uAmps —PassiFall Pass ‘TestName_S.GND LEAKAGE CURRENT ‘Load 1EC60: PIF Min 25.00 Microam Test Notes PIF Max 100.00 Microam pea Dey 0 See, Meter Mode ACYDC FEGné Open PL1 No PLE No Line Polarity Reverse PLGne Closed PL2 No PLT No Single Fault Open Neural ‘Sink Rev Normal PL No PLE No Gna Select S.Gnd Ene. Grd Open PL4 No PLO No ‘Ace.Grd Open PLS No PLIO_No Test info Test 3 Reading 0.0 uAmps ——PassiFall Pass Test Name PATIENTLDALLTO GND ‘Load 1EC601 PIF Min 0.00 Mieroam Test Notes PIF Max 20.00 Meroam tons Delay 0 Sec. Meter Mode AC+OC FEGné Open PL1 Yes PLE Yes Line Polarity Reverse PLGne Open PL2 Yes PLT No Single Fault Open Neutal ‘Sink Rev Normal PLa Yes PLE No Gnd Select S.Gnd Enc. Gnd Open PLa Yes PLO. No ‘Ace. Gnd_Open PLS Yes PLI0_No Tests 0 Reading 0.0 uAmes —PasaiFall Pass Test Name PATIENTLD ALL TO GND ‘Load 1EC601 PIF in 0.00 Nicxoam ‘Test Notes PIF Max 10.00 Nleroam ‘settings Delay 8 See Meter Mode ACDC FEGné Open PL1 Yes PLE Yes Line Polarty Reverse PLene Open PL2 Yes PLT No ‘Single Fault Nene Sink Rev Normal PL3 Ys PLE No Gnd Select S.Grd Ene.Gnd Open PL4 Yes PLO. No ‘Acc. Gad_ Open PLS Yes PLI0_ No.Senal# F26s%6957 Tested By DTL8596 UnitPIF Pass Model # FORCE 22PCH Time Spent 6.0) minutos Last Tested 772372002 seq 1 Poet 4 of 5 Printed 72372002 Testinto Test# " Resting 64.uAmps Pass/Fail Pass TestName PATIENTLO SINKEACH TOGNO Load IEC80t PIF Min 3.00 Micraam ‘Test Notes PIF Max 10.00 Micrnam Settings : Delay 1 See Meter Mode AC*DC FEGnd Open PL1 Yes PLE Yes Line Polarity Reverse PLGnd Open PL2 Yes PLT. No Single Fault Nove ‘SinkRRev_Nermal PLS. Yes PLB No Gnd Select 5. Gnd Enc.Gnd Open PL4 Yes PLO No. ‘cc. Gnd_Open PLS Yes PLIO_No Testinfo Test# a eating 15uAmps —PassiFall ‘Pass TestName —PATIENTLD ALL TOGND Load Ieo8ot PIF Min 050 Microm Tost Notes PIF Max 10.00 Microm a Delay 0 Se. Meter Mode AC*OC FEGnd Open PL1 Yes PLO Yes Line Polaty Rovers0 PLGné Open PLZ Yes PLT No Single Fault Open. Grd Sink Rev Normal PLS. Yes PLE No Gnd Select 5.Grd Enc.Gnd Open PLA Yes PLO No. ‘Acc. Gnd_Open PLS Yes PLI0_No. ‘Testinfo Test # 13 Reacing 25 uAmps —«PassiFall——Pass TestName S.GND LEAKAGE CURRENT Load lost PIE Min s000Meroam Tost Notes PIP Max 10000 Micra a: Delay 0 Sec. Meter Mode AC*DC FEGnd Open PL1 No PLE No Line Potarty Reverse PLGnd —Ciosed PL2 No PL? No Single Fault None Sink Rev Normal PL. No PLO No Gnd Select 5.God Ene. Gnd Open PL4 No PLO No ‘ec. Gad_ Open PLS No PLI0_No. Testinto Test# “4 Rescing 1198 ACVols Passa! Pass Test Name AG LINE(WAINS) VOLTAGE aad IECEOt PIF Min 11600 Vots Test Notes DUT Power Down PIPMax 12200 Vota extn Delay 0 Sec Meter Mode AC FEGnd Open PL1 No PLE No Line Polarity Of PLGnd Open PL2 No PLT No Single Fault None Sink Rev Normal PL3. No PLB No Gnd Select 8. God Ene. Gnd Open PLA No PLO No ‘ec. Gnd_Onen PLS_No_PL10_No.‘Seral# F2G41505T Tested By DTLS685 Unit PIF Pass Model # FORCE22CH Time Spent 6.00 minutos Last Tested 7/2372002 Seq Paget 5 ofS Printed 7/2872002 Testinto Test 7 Reading 13858 millohms Pase/Fail Pass ‘Test Name GROUND INTEGRITY Dey 0 ‘Test Notes Plug DUT nto JUNCTION BOX receptacle ‘Setings Frequency 60 He current 25 Amps “Test Time 5.00 see, Min Resistance 50.00_m Ohms MaxResistance 200.00 Ohms Te 16 Reading 700.77 Miro Amps PassiFall Pass TestName AC VOLTS DIELECTRIC Deyo ‘Test Notes ‘Sattings Voltage 4,500 Volts Max Current 4.50. m Amps TestTime 60.00 sec Slow Rate 1000 Volisisec. Min Currant 100.00 u Amps Current Sense TOTAL Frequency 60_Hz Tea info Taye 7 Reading 154.74 Miro Amps PassiFail Pass TestName AC VOLTS DIELECTRIC Deyo ‘Test Notes Switch JUNCTION BOX to APPLIED PART Voltage 3.000 Vots| Max Curent 4.50. m Amps TestTime 1.00 sec Slew Rate 1000 Volisisec. Min Currant. ©1000 u Amps Cur Frequency 60_Hz sat Sense TOTAL