Technical Service ManualContents om 1a na 13) 20 22) 23) 24) 240) 242) 243) 24a) 245) 240 247, Performance test forthe StimPod NMS410/450, Povformance ests athe site of use Nerve Locating Mede Combined Nerve MappingNerve Locating Mode Neuromscular Blocking gent Mode (NMBA Mode M5450 on) “Test Instructions forthe safety checks (ST) Mosrng fuipent Checking the extemal contion ofthe dice Performance Texting Checking and measuring he Stimpod Output Fs Wid test Locate de, Locating cable) Frequency test (Locate moe, Insert Locating cable) Stimulus current est Locate Mode, srt Locating cable) Stimulus curent test ocate Mode, nsrt Mapfccating cate) Stirs curent est Mapping Mode Inset Mapiocating cable) Sirus current est (NMBA Mose, srt NMBA cable) Detaut Settings Replacing the electrode cable Repair address ‘Appendix: Report Template Manufacturer evant Tenlogy TVLTD) 169 Garstfontein Road shee Garde, 0081 Pretoria, South ica e427 (0 12755 5451 Fac +27 (0.85547 0026, Ema: suppor@arant.com eb swiaxavant.com Legal Representative inthe EU marge Gow 15 Molestrat, 2513H, The Hague “he Nethertands ‘e431 70345 8570, a 431 70346 72991. Performance test for the StimPod NMS410/450 Bofre operating and wing the device a pertermance tat must be cared cout at these of use n compliance wih § 5 MPBeveb 1.1 Performance teste atthe ste of use «Inert the bates nd teh on the deve The flowing seen should apposed fotomed by aaa 1.14. Nerve Locating Mode 1 Inert te Nene Locating Cable Th flowing screen shuld appeson the dsl ‘©The LED should fash RED and no auc fecack shouldbe hea The folowing seen shoul spear onthe display 0.00mA "cata ‘+The LED shoul fash GAEEN and sound is enabled nthe menu a beep ‘Should behead each te a stimuli Severed 4s Stmutesnoud occur athe et equency (12 Or 5H) 1 Use the adjusting whos and slowly increase the cent to 500m 1 Monter thatthe stimulating waveform, measired and displayed inthe Ahognoste wedoa square and ha the ep part a the square oe touches the dated ne, which represents the cert seting ae shown bela. 1.12. Combined Nerve Mapping/Nerve Locating Mode « Inert the Combined Nerve MappingNerve locating Cable The folowing scsen shold appear on the dl \\ “+The LED shou fash RED and no aude fecack shouldbe head «Shorter the Newe Mepping probe and the £6 connector, The allowing seen shoul pear onthe dsp ‘The LED shoud fash GREEN and sound enabled in the mena beep ‘hod be hea ach te a stimu divered, 1 Stulus shod occur atthe se Requeny (1.2 or He ‘se the asting wheel and iow nrease the eet to 20mA 1 Montortnt te stimulating waveform, messed ara displayed in he ‘agro windou quar and that the top part of he square wave touches the dotted ine which represents the uent sting Incrder tts the Neve Locating connection and dove fanctnalty follw he tutors in 11 1.13. Neuromuscular Blocking Agent Mode (NMBA Mode) (NMS450 onb) Inst th NMEA Cable, The folowing saeen shoud appear onthe clay Ensue thatthe once bn TOP meds Short rc the red and lack lca connector ‘Use the adjusting whee and ineeas the current to BOA 1 pres the playa’ buon whe shaking the acelerometet ‘The NMSe50 should respond ae follows: 1 "The LED should fash GREEN in accordance withthe four stimsations 1 ach stimulation should be accomporsed by on aut ‘bee { InvDiagnstie window four bars ot afferent heights shoud nda hat the aceleometer detected movement. “Monitor be actual cen elvred to ensue thatthe wating sgn foes nat ape « Seprate the ed and back lectode connectors to cause an open cet betwesn them = ress he playpause' burton The follwing screen sould appear on the apy. oma" “a OFen Gout ‘+The LED shoud fash RED and no austefedack shouldbe hea 1¥ the STAAPOD malfunctions in any one ofthese performance test, IRshould be checked by the relevent technical department in ‘ccordance with te following test instructions.2. Test instructions forthe safety checks (STK) Seton 6 ofthe MPBeveB) species that safety checks should be perormed by he user Thasalety check shoud be perormed by qualifed ttt (5.6, pan MPbetrbv) mn accordance vith the folowing ‘rin the Report Template 2.1 Measuring Equipment The folowing measuring and testing equipments requted «Sora Oxiloscone 1 2011Chim messing rsstor 1 -4skohm measuring ester 3 ayaanbatenee 22 checking the external condition ofthe device (Check the fling and tek the coespenng check toxin the Report Tempe) 1 Check thatthe housing! connectors and cables are intact and ean (Brine the howsng! connectors and cables the are contaminated wth loo or medestion} (© Check thatthe keypad legible Check thatthe ater cover ‘slegbe Sth unt on and verity that the dspay working. Connect locate cable and very that tho current can be Ireeased sing the keypad aa, Verity thatthe pulse with canbe charged wing use ‘wah burn onthe keypad Very thatthe frequency ean bechanged wing be “fequeney button onthe ep. Very thatthe menu canbe accessed usng theme’ button. nme lace cable Verify tha he pause button operated when proved 1+ Check thatthe encase, screen, keypad sean 1 Check thatthe Claw operates covet 1 Inspect he Keypad to erste that: ven and at on the font cove 23 Performance Testing ‘Cary out perormance test according to 1.3 and 1.2 224 Checking and measuring the Stimpod Output; 224.1. Pulse Width tet (Locate mode, Locating cable) Scope settings areas fellow © Channel settings | © Coupling DC © Probe 1 vtage © Inv of «= Probe 10x ‘+ Horizontal Seting © 25,57 1 Vortial Setting Insert the Locate Cable Cont» 20K0 fo ‘Adjust the Curent to Sma ‘ust the Frequency t 5H ‘gust the Pulbe Width 1 0.5 Record the Pe Width on the Report Tenpita, ijt th Pulse Width Record he Pulse Width onthe sor Tomate 242. Frequency test (Locate mode, Insert Locating cable) Scope settings areas follow: ‘Channel 1 settings ~ coupling DC © Probe 10K vtage ey © ner of Probe Horizontal Setting © 100msD Vertical Setting Connect» 20K0 tos, Adjust the Crrent io Sma ‘just Frequency 05H ‘just the Pbe With 20-1 Record the Frequeney onthe fepor Tope "| 0.1m apon and 1.ons option must be selected inthe SETUP Mi PULSE WioTH2.43, Stimulus current test (Locate Mode, Insert Locating cable) Scope settings area follow © Channel settings Coupling DC 8 robe TIX vlogs © Inverts «* Probe on10x 1 Horizontal Setting 8. 750,00 = Vertical setting -500nVDN Connect 20K load across the nee and the EC cia camnetor. Adjst the Frequency to He 1 Achat the Pls With at Ir ‘ahst the Curent Ome Tak Tk ee, waa neame 24 Stimulus current test (Locate Mode, insert Maplocating Scope settings are a follow: © Channel settings Coupling DC 2 Bete fa ms + Hot Stig ican \\ tlio er ' Connect» 20K load across the nel and the ECG clip connactor. {Adjust the Frequency to SH 1 Aajst he Current oa ‘check hat there na stmuatig ue, IW apuses present eco the Voltage onthe Report ate Caleate the curt Curent = BE, 1 Recrd the Cumenton the Rept Tete Scope settings area follow: © Channel 1 settings © Coupling OC 8 robe TAX vage © Invert oft « Probe 10K Horizontal setting 2.250.900 = Vertical Setting 200/DW Connect» 20K lad Adjust the Fequeny to SH 1 Aaja the Plo Wath at I 1 Achat the Current oS sco the Voltage onthe feprt empat Calcite the caren: Curt = a8 eco the cum on the hepart erblate ecard the Re Time onthe Report Tpit Aecod the Fall Te onthe Report Tera 1 Check that there's no stmuating pute 1 putes present: 1 Record the Votage onthe por erate 1 Calate the cura Curent BE sco the Cunt on the Scope settings are a follow: © Channel 1 settings © Coupling 9 robe 0X vtone 2 Inver ot = Probe OK 1 Horizontal Stting >. 250,508 = Vertical setting 2.2040 Connect #2080 bad ‘Adjust he Frequency to Siz ‘at the Puse Wan at Irs 1 Record the Votage on the Fep 1 Record the Current on the Res eco the Rie Time ont eco the Fall Time othe Fp245. Stimulus current test (Mapping Mode, Insert MaplLecatng cable) Scope settings are a follow: © Channel settings © Coupling DC 9 robe TX vtage © nero « Probe o-10x Horizontal Setting 2.250.008 = Vertical setting °-S00nVON 1 Connect a 20K load across the Mapping Pobe and ECG comectoc 1 Aajst he Fequeney 0 St ‘ht the Pune Wn at Ines dhs he current 0 a Tok Tk ey recs | as Pe oe ie 1 hack that there ino stmuating pe, Ir apube s present fcr he Votoge othe Rear ete. fC te are Curt ey 1 Record the Curent on the Rept erp Scope settings areas follow: 1 Channel 1 settings © Coupling oc © robe 2X vatage © Invert © Probe «= Horizontal Setting ©. 250,80 1 Vertical setting 1 Connect» 2040 load 1 Ada the Frequeney to Sk 1 Aahst the Pale Wt at I 1 Aas the Current 0 Sm eco the Voltage onthe Ropar ampat. Cale the caren: Curt = Fecal the current on te hep rate eco he Abe Time onthe Report Tope sco the Fall Time onthe Rept Trp 2.46. Stimulus current test (MBA Mods, Insert NBA cab) ‘timpod settings areas fllowe 1 Make se the made of opestions TH 1 oquency set at 5 He Scope settings are a follow: 1 Channel 1 setungs Coupling DC © Probe 0X vtlone iver off = Probe onux 1 Horizontal Setting 5. 250,8D0 1 Vertical Setting o-s00mi/O%" 1 Connect 24 5ka load acts the two ECG connectors ‘dst the equeney to Sa ‘jst the Curent 1 OA 1 Check that there iro stimuating pul Wa pute present ‘Record the Voltage onthe por elate cite the cure: Curet 1 Record the Currant cn te Repo Spite ‘Scope settings are a follow: 1 channel 1 settings 1 Coupling DC © robe 0X vtiane Invert off robe onax 1 Horizontal Setting 100,409 1 Vertical Setting > S0VDN 1 Connect 4 5KA lord, 1 Adjust the Cunret o Bam 4 fecrd te vortage on te Repo rae. 1 Catto th cre Curent 1 Record the Currant on the Repo Tle. Record the Rie Time onthe Reper! Tope Recor he Fall Time onthe Rept Tt.2 Default Settings Ensure that the devices eset 0 the folowing default stings afer esting eset Pulse Width cpins fo 0s and 0 ns 3. Replacing the electrode cable ‘A taut acwode cable can be easly laced on ste with anew one The polarized cnmecor prevents the wang connection of the elect cable 4. Repair address Manufacturer avant Tedneoay PYLID) 09 castfontan Road Jshlea Gaders, 0081 Pretoria, South ic ek 42700 12755 5401 Fac 12710) 86 547 0026 Email: support@xaventcom ‘Web wwaxrantcomReport Template ‘Checking the external condition ofthe device rt papa 22) Check thatthe housing’ cect and cables ate intact and ean, Check thatthe keypads ogi Check thatthe battery coer lege Swsch unt on and ery tat he asp working Connect locate cable and vert thatthe cuent an be increased using the keypad da ‘eat that the pulse wth can be changed sing pulse wi” bution on the keypad ‘ery tha the rua can be changed using he "requency butt onthe keypad ‘ny hat the menu canbe aces sng the ‘menu buon Connect locate cable Verity tha the pause button operated when pressed, (Check thatthe ences, scren, keypad dean Check thatthe Claw operates correct, Inspect he keypad to ensire that is even and lt on the font eve. Performance Testing vr pxogsph 23) ‘Cary out performance test according to 1.1 and 1.2 oo ‘come 82042 lad and setthe arent Svan equecyto Hz Connect a2 alan set the cent Sma quency oz (eet peagm 741 Pulse wih test (Lat mode Laat cable) ‘ir pepo 242) Frequency tert (Laat mode Loa cle) expected ates Voronce Expected values Vorionce Seting me) Messed (ms) Mins) Maxims) Pas Fall Setting te) Measured (He) in Ha) Max a) Passa on 0.095.105 HH 5 amo 5250) LI ‘Connect a 20k load and set the pulse width of 1.0ms fr tpapeh 2.42) Locate Cable (Locate Mode) Stimulus CurrenRising/ Falling Edges Expected volves verlance 5x xpecte values Sting (mA) Messured(V) Caelated (A) Min (a) Max (DA) Pas Fall Seng (mA) Measured (us) Mins) Max us) Pass oll ou ‘ouo "0.000 “Tabing £6pe (us) soo 47505280 si om om OC “ating Kage (us) maeas St on aC) ‘Connect a 20 load and set the pulse width of 1.0ms rt pxapeh 2.44) "MapyLocate Cable (Locate Mode) Stimulus CurrenRsing/ Falling Edges Expected values Variance os expected Values Seting mA) Measured (¥) Calculated (mA) Min (mA) Max (nA) Pass Fall Setting mA) Measured (us) Min (us) Max (us) Pass Fall ao 0000000 “sing Edge (us) 500 47505250 sma a a Bp “Fling Edge us) - Sma om 0 OC ‘Connect 20k Toad and set the pulse width of 1.0ms rr tpxancph 245) 'MapyLocate Cable (Mapping Mode) Stimulus CurentiRsing/aling Edges Expected values Variance 3% Expected Values Setting (mA) Measured (V) Calculated (mn) Min (mA) Max mA) Pass. Fail Setting (mA) Measured (us) Minus) Max (us) Pass. Fail 00 0000000 “Ring Edge (us) a 2000 ao 21.000 {7} 20m on 0 CC) “alin Edge (us) 2m on Connect 4.52 Toad ie o para 245) [NMEA Cable (NMBA Mode) Stimulus Curen/Rsing/aling Edges Expected values variance 3% expected values Setting (mA) Measured (V) Calculated (mA) Min (mA) MaximA) Pass. Fall Setting (mA) Measured (us) Min (us) Max (us) Pass. Fall 00 0000000 “Rising dg (9) 20m 76000 84000 ma a 0 OC) “Ling Edge os) - 80mA 01 vo OO Default Settings tr para 24.7) Reset pulse width options to 0. ms and 0.3m. ovo