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nGenuityTM 8100E Series Vital Signs Monitor Service Manual

Contents

1.
2. 2m REV DATE ECN 1 1 1 44 0 12 26 06 15pF MODE 6 128K FLASH 50 T 1102 N 7 B C14 C22 623 2 c52 4 e MA O 19 780 1 RU n T 010 15 M9 2 1 7 jui A E T MELASHt car 111111 888888 MAO VAT S
3. SVREF 5 U35A OP296GS 2 0 50 WT 5D R207 40K A D 18 MELASH2 Place this buffer closest to CPU 2 MFLASH2 isc DNI c42 R203 C163 CPU2CLK 2 XTAL E 88888 2 R41 4 CRA16 S JE 229292 pag22RO6 50 a 102 0 2 0 PAS AZ1IRQS 0 ESE 5 5 A0 IRESETCPU2 TRUE 2 RESETCPUT 418 PA2IA18 22 32 6 A17 8 A d IRES 21 3 5 2 4 16 0 2 100K R245 10K 15 16 20 E18 02 2 2 a PBIMS 18 2 1 AM BLA31AG601SN4D kn ALES A a JBOOT2 1 CRA 86 ro GASWAITISREOO PBOIAI4 147 3 6 5 3
4. te ECG BANDWIDTH 100 Ez dq 9 GAINS R27 470M E R12A R128 1 SVREF m R153 5VREF el 100 nz 5VREF ANE T C135 1 9 100 100 9 R128 C30 1 4 99K 1 gt Mi 2 5VREF bal 68PF 68PF 30 1K 4 om 18 4 E LEAD OPEN DETECT CKT C159 1451 1498 T T TPAD pect 1 1 R146 SIN GT SMD1812150 100 R145 R131 1 all 1 62 178K 1 482 4 7 com DNI E 2 6 4 1 facie 2136 HI G 2000 o 52 T 7 J maxo X 12 5 GAIN 1 48416 R120 R120 I d qua 3 6 4 5 10K E oov _ m FILTERCLK 9102 100KxaP 7 100 ECG1 c2 x c2 10 10 E ins ECG CHANNEL 1 ECG2 peat H 68PF 68PF R28 5 HIRST1 lo sHz ps 18 pe ECGV 2 470M lcs o 9 C166 lt 2 5VR
5. tet ete Calibration Tools Needed Before You Begin DEDE Disassembly E Disconnect the Battery oF Check Replace the CO A 11 Replace the External Module A 12 Replace the Internal Module 12 Troubleshooting A 13 Verification Checklist enne nre A 14 nGenuity 8100E Series Service Manual Criticare Systems Inc Warranty Workmanship amp Materials Exemptions Safety Reliability amp Performance In Case of Emergency Contact Criticare Systems Inc Criticare Systems Inc CSI warranties new equipment to be free from defects in workmanship and materials for a period of two 2 years from date of shipment under normal use and service The following exceptions apply to this statement and the warranty period as indicated Internal Batteries one 1 year O2 Cells and CO2 Absorbers six 6 months 940 Series Multi Site and Y style SpO2 sensors six 6 months CSI s obligation under this warranty is limited to repairing or replacing at CSI s option any part which upon CSI s examination proves defective EXCEPT AS DESCRIBED IN THE PARAGRAPH ABOVE CSI MAKES NO WARRANTIES EXPRESS OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE
6. DRAWN CHECK ENG BY L SOROKA BY ar L SOROKA 3 7 06 QA 12 27 2005 DA appr KAPLAN 3 8 06 1 2 DO SCALE PRINT Av J SLOLYGA 3 7 06 TOLERANCE UNLESS OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL 020 INFORMATION AND MAY NOT BE COPIED OR DIVULGED 005 WITHOUT WRITTEN CONSENT OF CRITICARE SYSTEMS INC ANGLES 1 DEGREE TITLE PART NO REV CHASSIS BOTTOM ASSEMBLY 92799 A001 7 302 SHEET or SPACER 4 PL CUP WASHER 4 PL TORQUE 6 IN LB APPLY THREAD LOCKER SEE NOTE 1 4 PL SEE NOTE 2 REVISIONS REV DATE DESCRIPTION 1 04 17 07 SEE 9166 SIRIP CUT 1 2 LONG NOTES 1 USE SEMI PERMANENT THREAD LOCKER ITEM 7 TO PREVENT SCREWS ITEM 5 FROM LOOSENING 2 VERIFY INSULATING VARNISH ON SVR1 OF POWER SUPPLY RELEASED DOCUMENT SW CRITICAIR SYSTEMS INC DRAWN eC CHECK ENG BY BY APPR 5 Coogan 02 28 07 RELEASE QA DATE 12 20 06 DATE APPR Penton 03 01 07 scale 1 1 DO NOT SCALE PRINT Hawver 03 01 07 TOLERANCE UNLESS OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL 020 INFORMATI
7. ANGLES 1 DEGREE L SOROKA Am L SOROKA 3 7 06 oat 01 06 2006 Ed wre KAPLAN 3 8 06 1 2 DO NOT SCALE PRINT s J SZOLYGA 1 9 06 TOLERANCE UNLESS OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL 020 INFORMATION AND MAY NOT COPIED OR DIVULGED 005 WITHOUT WRITTEN CONSENT OF CRITICARE SYSTEMS INC TITLE FINAL ASSEMBLY 8100EP PART NO 93979 A002 302 SHEET 6 409958001 TORQUE 6 IN LB TORQUE 8 IN LB REFERENCE P N 40180B002 2 REFERENCE P N 42731B001 2 7 8 9 i 4 A DETAIL B A REVISIONS REFERENCE P N 40496B001 RELEASED REFERENCE P N 40995B003 DOCUMENT NOTES 1 Remove the 2 screws for the Battery Door 2 screws near the power inlet 2 screws for the printer cover 6 six screws on the bottom including insulator and 8 screws securing the rear encloser then remove rear enlcosure 2 Modify the rear enclosure as shown using drill fixture T3314 Make sure that the enc
8. DS 107 TCLKC TIOCB1 P013 P15 PE3 D3 MD2 uss MDZ o A2 10 PDAS PDT 32132 PD10 3213 MDT DB2 Pikoy ze M00 0548 25 2 UDSE 53 1_ Be MHZ 106 TIOCA2 PO14 P16 PEZID2 8 2 6 Ed 9 MM MDT PD 33 50 33 MDO mi UD6B A BD UD7B 0 2105 TCLKD TIOCB2 PO15 P47 PE1 D1 MD4 o A H m MDS PD15 0 34 34 DBO UE 40 H 34 4 x L Nc vec MDE 9 7 9 35 GND 35 p x ANLGOUT2 102 AN7 PA7IDA1 E12 BLASMAGEOISNAD N 08 Ao MAT JETHCE 1 e TDI 7 AUDIOGAIN 101 AN6 P46 DA0 AWR 5D MD7 21 07 MDI 2 553 37 37 37 RD WR FPD1 Tat m R230 00 D88 1 nene 8 3 55 38 Wet 2 X8 ANA PFAIHWR pit enw T RD 45 ee Man POS 32 io 905 337 38 WEO Feos Ha oo y PFSIRD 082 3 5 AE SOUA 510 81 23 40 PDS 40 RD gq UDi e TON p82 CRAT 512K55NS vo 10 REG 41 41 PDT pi BS EPDS a6 UD2 _ DN CD BATTLVL2 PSTICSTIRGS 28 2 1 gwar TORD 4B ETHCET 42 CONNECTOR HITACHI PASSIVE 57018037 ZORD 43 m BATTLVL1 it 2 Revr 2 8 3 2091 NORD 4144 NORD 43 RESET 88 ips 31 EA pe 16 m IMEMWR 44 FPD9 i
9. 7 A pt es Po 419 3 T ovr voc 49 MMBT2222A 1 1 U19D gt 2 Po ejes 5D ii 5 50 Acc 3 3 2 vss 16 R35 R224 10107 66 R225 PD 66 A 4 r ENCA lt gt 40k GND 67 1 202 67 105 GND 7 124 L SND 68 68 GND R181 5 1 t DNI R193 R197 HD64F2357TE 4 1 55 4 ss SZ DNI DNI OSC 24 576MHZ 2 80K SR186 MSD te nde 12 R254 3 74HC14 016 AD1 Bis 1 IRESET v A000004 R12 VCON A cast 11 DS 10K ETHERNET CARD SLOT 10K L 1 FB X 10 ENCB MDi2 as Hid WR on A 5 _ ROTENCON MOIS 2 ADS RW 50 DNI MD14 19 BLA31AG601SN4D R8 D 4 MD15 ADS R251 330 oh 1 9 14 ADT 456 PIER sug bers ttn TRSGRD BQ3285S 002 ho 818 R105 ENCKEY ctp 57 101 4 t2 6 LD2B DNI TGD5 TGD6 us 01 CAN LD2 6 143 1Y3 R1 12 4 18 _ TRSGRD TRSGRD u28 E uz 103 Bl qnd 0008 DNI Gi eMe 2200 Y 13 1 1 9 cH CANH 1 on 21 2 R104 5BL gt CANL p Aa 2Y2 19028 4 CRAZ4 E Rio JEXTRAM M2 Tar 9999 26 ADU T 392 820250 PRS 2 002 15 23 23 H 8 00 BLAMAGBDISMD pagg P CRA28 1KX4 CRA23 400KX4 A6 AD6 05 x UD3 tT 2 4 23 7 400KX4 100KX4 400K ZO 34148 aps 28 aot 27 05 Bw S3 CN 4 CON W 4 DNI BRIGHT CRA27 1KX4
10. _2 95 RI 0008 10 i NURSECALL XION 400000 1 1 4 TWR 78 xion 48 8 44 uL duc Cio AA m 4 ja M MED IMRD X20N 3 X3ON y RD gt 20 60 nSec 9 13 MATT 69 Fi 2 X4ON E 7 4 0028 18 MATS A19 Fag 1 8 1 BKLTON 4 4 1 one wait state BLAS1AG601SN4D R121 igo 15 ENCKEY 18 A18 X50N ol 49 to get WR gt 60 nSec E26 1 EM a1 BDO R237 0 OHMS 1 These gates are used to create time delays FLMB DNI LCD O HOSEL NOSEL 32 Bt 14 to match the timing requirements of 5241000 2 62 7 6 jaa 2 d t SW 4 4 4 19501 1 202 03 Cc E 1 2 74 JDISPOFFB 00K yp AcrIELCDCON GRNLED eS c Sus mre pr 87 ic2b1 BD4 EXTERNAL RACK CONN CAN 1 4 re 1 102 BD4 05 X20N X4ON m DNI 8125 4 q 1 1 4 4 J 4 4 4 4 q 76107 use Bos 28 ps oot XTON 22 H x d VW d 29 Bo E BD6 7 DNI 1 2 11 o m 1 bottom side on y 120pf 3 X Orient pin 1 bottom MDO 2 807 _ 85 56 2 2 4 tit e o 00 10 1 5D Ci34 C133 C 40 C132 C139 C131 C138 C129 C137 C130 2510 71288 1 coniu 3 Suco il L OM ic tel mS C227 2 1 1 1 4 i 4 4 4 4 4 M2 102 CONUD ine 4 Tvs4 Tvs3 16 vec Mio E 3b 8
11. FH m CT 660ms 12989105 C 4 5 DNI PWR_SW GND vm R208 57 DNI 1 JSVREF 5 Eu 2 5VREF 8 80F 50 DC Wake A d E wea A 127F 100 DC MGR TOS ADU 01 180H44A C82 C73 C96 Slo a LAN 4 E sa 9 5 220 25V Z20uF 25V Zia 77 2 R150 Di 845K TSR540 ces 58 9 b 1800 16V A BATTERY LEVEL INDICATOR BATTI 7 c179 4 us m 38V 45A 11 TPAD Id Rus 1 TP46 2 24 2o 11 60 m OP296GS PWR_SW 1 P vss ud BATTLVLI R21 249K gt gt BATTLVLI ONIOFF 100K uza io m ON OFF Vout BATT 10 0 R108 D FKE ia R91 100 gm 0 D31 221 E ON SW 12 mm 2 330 2 5VREF R252 als isb o 330 g 0 LOADBAT R58 1 U16A DT EE ANL 249K 74HC132BATT E SEP 2 R111 m o 2 5VREF 14M MD914 R2 1 106 DTE 42 5 VREF DNI JBOOM 3 1 2 1 RIS IBOOT gt NET alp 8 meg OET Keser 150K 4 mm VRI 7 100K ee LTI004CS8 2 5 woo 4 PFI tipsat mq 4 wo 05 amp R116 R19 49K 57 PWR 10 4V 165K 1 1 BATT2 ERE li Pug 10 tev 6 10K 2 1 J MAX705 74HC132BATT 71 utec si 4 Bici 33 zx 2 02
12. RXO DOUT RESP BW PATIPOTITIOCBSITMOt 3 je 44 1 0 00003 TFFEFH an 82 P26lPOG TIOCAS TMOO PD7IDIS Let jot 2 po 0 2 0 P2SIPOSITIOCBA TMCIT PD6 D14 Mig TXOSETUPIN 24 4 4 PD5 D13 42 a 4 884 23 204 012 de rn uz 52 22 2 0 PD3 D11 50 10K nd 10 p2uPOiTIOCSS 45 ma This is PLD statemachine interface for ios 4 d nm i f IRESET LH 20 1 44 i A Addr Data Mur NUES 2 4 am 2 DINCKIOTOCAOIPOS P10 ron to match the timing requirements 5281000 zi la A SETRA 4 1 11 ru 2 5 2 Di IRESET A AN HH TCLKATTIOCCOIPOTOIPI2 SANT 2 i T1 1 t 1 PWMOUT 108 1 preach PWMOUT 08 TIOCA1 PO12 P14 005 ob ops oe H 1I TCLKC TIOCB1 PO13 P15 ATXA alt RB471E TIOCAZIPO14 P 16 DNI 6107 C98 JPACERST 105 EDITIOCB2 PO15 PAT 74 74 74HC14 WwW eoor 4 4 4 da m E 50 ANG PAG DAO I R CLEAN METALLIS wm ISOLATED uus 109 ANEP Aa ME KEEP ISO BARRIER CLEAN OF METALLISATION 0 3 WIDE Ur 99 AN4 P44 8
13. Instrument Dropped Software Download Annual Safety Test Field Calibration Procedures Page 6 2 5 2 x 9 c 49 o v v v v v v v v v v v v lt lt lt lt lt lt lt lt lt lt lt lt Ground Continuity Test 5 5 lt lt lt lt lt lt lt Functional Testing lt lt lt lt 5 lt lt lt lt lt lt Gas Flow CO2 Verification Some of the following procedures require specialized equipment that could be available only to larger service facilities Criticare recommends that NIBP calibration and calibration of the ECG Analog Board be performed at CSI authorized service facilities NOTE For testing and calibration of the module see Appendix A Service nGenuity 8100E Series Service Manual Criticare Systems Inc Performance Testing Programming the SmartSat Analyzer Test Procedure Criticare Systems Inc Section 6 Service Testing and Calibration This test requires a SmartSat Pulse Oximetry Analyzer Model SS 100A The SmartSat is a programmable simulator and probe analyzer The SmartSat is the recommended device for testing the SpO module The SmartSat model SS 100A is available from Clinical Dynamics Corp of Wallingford CT The SmartSat comes standard with Lemo style connections The Cat No 913A adapter that converts Lemo to DB 9 style SpO c
14. SEE NOTE 2 I9 IPM 2 125V N 15 D16 C72 R68 DDI 002 8 5 p Uto E em os c74 3 R69 S gt c E SI B 017 018 e 5 918 e 5 E 2 J m R76 grus 8 E 027 5 Bes w 8 B amp gl8 8 z R83 C95 0 bl g E g m g T eos d REB R86 098 09 Zoe a IE Wn Ses E 0 eels Ipis 09 C107 C108 RM 5 2 p um gpus ei pus BIB js ms 2 g m e Bo 2 9 3 m 12 R102 RI03 e 2 5 Bow ER 020 a 021 REJE mos Spg CS EE amp B CRM 5 022 VRI COMPONENT SIDE C127 Rif CHO 52 di om me 0 5 o ie a m 8 im R25 E 2 8 s H qm R30 gt s ane R40 3988 eur cus R136 T ee 8 7 R155 zg wl Les ge g 1P23 HIS ES 161 8153 159 P6 C165 NOTES COMPONENT SIDE SOLDER T 1 91542 005 USES BARE BOARD 836028003 2 THE FOLLOWING COMPONENTS ARE TO BE ENCAPSULATED IN RTV ADHESIVE DOW CORNING 3145 46146 CSI PN 409948002 OR EQUIVALENT C7 C8 07 08 09 010 012 015 016 017 018 C143 C146 R155 AND C161 3 ALL TEN 10 LEADS OF T2 ARE TO BE TOTALLY INCAPSULATED WITH ADHESIVE DOW CORNING 3145 PN MIL A 4614
15. eet ee 5 21 Nurse 5 21 Battery and Power Testing iocis 5 22 ore recent nde AS 5 22 Functional and Safety Testing 5 23 Section 6 Service Testing and Calibration Field Service Testing Safety Field Service Test Matrix Field Calibration Procedures sess 6 2 SpO Performance 6 3 Programming the SmartSat Analyzer 6 3 Test 6 3 5 Board Test Values 6 4 NIBP Calibration 6 5 Installing the PC Service 6 5 Configuring the Ports i X EE rrr netter teen re nn nerd Temperature Input Check Monitor Fault Testing Power Supply Board Test sse Main Board Testing tamen ibit eren 6 12 Section 7 Disassembly 5 7 1 Tools Needed rnt 7 1 Before You Bein c ccvivecescccurecousecivecsucuccorvontansevesebeacnsuctesacdvedtecatenstecetwervecentendos 7 1 Service 1 7 1 Electrostatic Discharge Protection Disconnecting and Replacing the Battery s 7 2 R
16. CSI s obligation or liability under this warranty does not include any transportation or other charges or liability for direct indirect or consequential damages or delay resulting from the improper use or application of the product or the substitution upon it of parts or accessories not approved by CSI or repair by anyone other than a CSI authorized representative This warranty shall not extend to any instrument which has been subjected to misuse negligence or accident any instrument from which CSI s original serial number tag or product identification markings have been altered or removed or any product of any other manufacturer Criticare Systems Inc is not responsible for the effects on safety reliability and performance of the 8100E Series Patient Monitor if assembly operations extensions readjustments modifications or repairs are carried out by persons other than those authorized by Criticare Systems Inc or the 8100E Series Patient Monitor is not used in accordance with the instructions for use or the electrical installation of the relevant room does not comply with NFPA 70 National Electric Code or NFPA 99 Standard for Health Care Facilities Outside the United States the relevant room must comply with all electrical installation regulations mandated by the local and regional bodies of government CRITICARE SYSTEMS INC Telephone 262 798 8282 20925 Crossroads Circle Tech Support 800 458 2697 Waukesha
17. LD1B TPRNSTRE 1 65 25 Ey MD14 RST 56 NC ei psu DNI TE BAT 21 20 our BAIS 2 20 C125 DTS yg 0814 Mois M 39 015 Nc H LD25 1 28 LD3B SIPOS TIOCBA TMCIT 8 MD13 T IWR a NC WooG rong 34 SL EA POATTIOCAAITMRIT Posi Pai Ed 0 a AUR az qm 92 21 T pas 2 999 5 8 Hb 68 PD4 D12 8 b 23 WE a ta Poi maco Tici 8 1 m o ik S m Pog E 21024 21 pon Eoee 2 6 0 PD2 D10 6 MD9 4 PD6 25 25 DB9 3 NWE 11 12 SCL 3 201 09 22 3 MDB BLA31AG601SN4D 1 28 25 8___23 DBs WE R244 zug 146 1 T0KX4 PSEL D AICIKIO TIOCAD POBIP10 3 4 8 MD7 ddp 1 MDT 27 97 28 DB7 JDISPOFF 10K 15 16 CRA DACKT TIOCBO POSIP11 41 2 MDE C228 MDZ m 2 28 28 25 BS DB6 LCDPWR LCD v BP i ICA FI 19 CPUZAK EN TCLKA TIOCCO PO10 P12 PEGID6 740 313 amp MD5 MD3 m PDS 20 29 28 59 MD4 DBS FPFRAME 13 5 UDOB ENCE TCKB TIOCDO PO11 P13 PESIDS 390 4 MD4 BLA31AG601SN4I EE MDZ 30 30 30 g 084 La UDE 21 22 UD2B OCLK 10MHZ SDA 108 TIOCA1 PO12 P14 PE4 D4 8 4100 5 2 MDS U48 NOT U PD12 31131 809 130 8 pgs FPLINE 77 co HOR 246
18. M R81 woos lt lt MD914 E 1 R15 e ds BATTLVL2 100K DNI gt gt BATTLVL2 Laj DN j 1M R82 jd Vout BATT2 10 0 1 NZ R117 R165 DNI 0167 Vv 1 2 DNI DNI 25VREF 2 9 57 a LOADBAT Notes C103 All resistors are 1 4 40W DNI unless otherwise noted All capacitors are in uF unless otherwise noted 47 7 913408005 REV Q CREATION DATE Monday May 10 1999 TTE 8100 1 1 MAINBOARD LAST MODIFIED DATE Wednesday January 31 2007 SHEET SIZE DIST 306 SHEET 3 3 5 3 I 3 2 T REMSIONS SEE NOTE 2 p NOTE 4 AND DETAIL A 2 REV DATE DESCRIPTION BY 1 05 15 06 8845 RWK 2 7 24 06 8897 DBL 3 11 13 06 SEE 8988 RWK 23 4 04 01 08 10202 RWK i s EM cs at e 3 ET e cj 7 oT ee wee 4 Hz l4 N feb ALAN bd co 15 E 2 JP RO 5 2 2888 amp E E mn mmn rn C25 C26 C28 xa sk 91342 003 ag Wen ses CM CRITICARE SYSTEMS INC ue E 81190018 80662 8 xm 2188 2 2 Made USA 07 p 855 C40 OS 2121810 A C45 z T 2 88222 22222 cz uec 21218 se 5 2828812 s 8125285 9 feq
19. supply 15 3 VDC 0 1V Proceed to the next step if the voltage is within specification If it is a new board under test it might not be calibrated The trim potentiometer on calibrated boards should be varnished or otherwise sealed Reassemble the monitor Criticare Systems Inc nGenuity 8100E Series Service Manual Page 6 11 Section 6 Service Testing and Calibration Main Board Testing Page 6 12 Test the following conditions without batteries in the monitor 1 Connect a 15 3VDC 3A power supply to connector PS2 on the Main Board 2 Insert an ammeter inline at PS1 on the Main Board 3 Verify the quiescent current the power is applied but the power control is in the OFF state is less than 1ma This quiescent current decreases to less than 1ma in a very short period of time This must be done at the Battery connector Remove the ammeter Connect a speaker to J20 on the Main Board Connect a membrane switch to J7 on the Main Board Attach a menu knob to the main board at J8 on the Main Board Verify that the monitor turns on after pressing the ON OFF key and that the following voltages are present Test Point Signal Value TP21 PWRUNSW 415 3V x0 5VDC TP4 50 5 0 0 1VDC TP18 5 45 0V x0 1VDC TP1 3 3D 3 3V 0 05 0 17 48V 48 0V 0 25VDC TP7 5 5 0V x0 25VDC T13 46 8 46 8V 0 32VDC TP9 5 5 0 0 3 0 TP14 45 0V
20. 2 PL GIHERWSE SPECIES CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL XX 020 INFORMATION AND MAY NOT BE COPIED OR DIVULGED no d WITHOUT WRITTEN CONSENT OF CRITICARE SYSTEMS INC 4 07 LOCTITE 425 ASSURE TO THREADS TE ET ENG m 4 AA CO2 MODULE 92811 001 5 RELEASED DOCUMENT INTERNAL 75 LONG 2 PL 2 PL PUMP OUT PUMP IN 3 LONG Q4 PUMP OUT A TO P2 HOLE PUNCH CIRCLES BEFORE APPLYING LABEL REVISIONS REV DATE DESCRIPTION 03 10 07 SEE 9139 1 2 04 19 07 SEE 9166 3 02 16 08 SEE 10061 4 09 19 08 10240 5 2 17 09 10343 DBL ITEM DESCRIPTION gt 1 1 TO ACCUMULATOR PUMP PUMP IN RIGHT SIDE 2 P2 TO PUMP OUT RIGHT SIDE 3 P3 EXHAUST TO ACCUMMULATOR EXHAUST BOTTOM 4 PA WET TO PNEUMATIC RECEPTACLE PLATE AY WET BOTTOM 5 5 DRY TO PNEUMATIC RECEPTACLE PLATE AY DRY BOTTOM 6 P6 CAL TO PNEUMATIC RECEPTACLE PLATE AY CAL BOTTOM 7 P7 NEEDLE VALVE AY ON TOP OF BLOCK LEFT SIDE 8 PB TO SENS1 PSI DETECTOR MOUNTED ON PCB LEFT SIDE 9 P9 TOPIO TOP 0 PIO 9 TOP p11 TO P12 REAR 2 12 11 REAR 3 VENT FRONT 4 vi VALVE 1 MOUNT LOCATION FRONT 5 V2 VALVE 2 MOUNT LOCATION F
21. CALIB 400 50 GNDANL 4 100K L 3 5VREF E J 4 OUT eek un i vec D 5 1 a 4 56 alt TEMPSELA cH 2 Fae M 1 CALIB 400 xd x TEMPSELB 5 xl R118 CALIB 700 M 83 TEMPSELC t c2 J 203 74 14 74HC14 TVs2 PROBET TEST 2 us A MMBZ15VALT 1 PROBE 1 READ M 54 50 LP2951ACM BARE 836028003 PROBE2 TEST 16 Notes a PROBE2 READ 9 5 m A11 resistors are 18 1 10W 7 5 unless otherwise noted PROBE2 TEST m PROBE2 mu Q4A CALIB 700 M 1 capacitors are in uF siesspv 599250 ai 4 E unless otherwise noted a d SI9925DY j 74HC237 9 C118 ELECTRONIC FILE NAME JAPERM 507EDX HW191342A00X191342A003 91342S003R1 91342S3RV1 DSN v Md 400 SYSTEMS INC CONFIDENTIAL This document contains confidential information and may not usta 74 20925 Crossroads Circle Waukesha WI 53186 be copied or divulged without written consent of CRITICARE SYSTEMS INC ap U22E U22F DRAWN BY DJR ENG APPR E m 2 as 1 CREATION DATE David Rieck 5 09 06 913425003 1 APPR T4HC14 LAST MODIFIED DATE THE 8100 ECG ANALOG BOARD gt A Tuesday June 20 2006 Alex Kaplan 5 10 06 XY CHECKED BY MFG APPR E SHEET SIZE D DIST 306 SHEET 1 OF 3 Keith Hawver 5 10 06
22. CRITICARE SYSTEMS INC PDR DBL Bue 77 7 D RIECK 6 7 00 D RIECK 6 7 00 8 23 88 aA KAPLAN 6 8 00 DO NOT SCALE PRINT As SCHMITZ 6 7 00 TOLERANCE UNLESS OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL 020 INFORMATION AND MAY BE COPIED DIVULGED XXX 005 WITHOUT WRITTEN CONSENT OF CRITICARE SYSTEMS INC ANGLES 1 DEGREE nu 9133900 5 4 3 2 1 The following resistor values are used when 91418A001 is DATE R2 10K R3 130K R1 R2 7 10 00 6419 oe iis 10 25 07 10108 C1 xis G2 10T 1 DRGATE 1 x R3 42 2 Q1 TN2106 TP5 6 SHIELDING TIE POINTS 0 DCLK I U3A A 8 SH 4 DOUT EDSST DVALID GUARD INPUT 7 5 6 JOFLOW WITH GND TRACE C3 OFLOW 0 01 R1 R2 a R5 R6 1 5AO VREFIN 24 9K 1K VBUFD 2MHZ I 5 8 5 1 10T src JT RSTSYS I 9 DNI VR1 0 I LT1004 2 5 R7 RSTSETUP 1 TP1 27 50 TESTIN I O 10 Oximeter A2D Module 5 91418A001 or DDC 101U V 1 8W Lx RD SETUP o 5A 9 EN 70553 0005 IRSTSETUP LEDDR 1 50 O 155 c12 10T 2 Q3 HEADER 13X2 R9 MMBT4403 AD822AR R10A R10B External Cable OUO 8 15 Schematic p m Ps 100 i TANT u
23. RA RESP R16 40 1 1 90 13 10K 1 GAINe1 48416 Les o g RESP RA RESP 3 32K C69 HO v 2 FILTERCLK cm ond LL RESP 4 1 io d U48D 1 SETRA OVERRIDE seTRA_OVERRIDE J usa 5 HIRST2 0 5 2 Fus 161 cas 5 3 Se d ECG CHANNEL 2 i o 4 USA 1 H 4 2 5VREF 2 5VREF 1 1 0 10 10 MAX352 mel u20 J gt 86096 4 d 7 GAIN12 VAA vss 1 ADSI 2 Qe 0160 2 5VREF VDD 50 E af 52520 1 R76 vo 8 A E en ER g g 10 o 150 SN 6 1 2 1 G1 12455 A2 18 SETA R116 C48 2 2 16 SETLA 033 R43 R32 s199 243K 56 1 SETLL R109 6 81 1 95 8 G2 57 HE 5VREFO 1 1 1 10K rud REF H 58 EN 2 3 249K 19 6K 4 0047 d cA EUM 249K AD620AR B cz 7 ADG408BR 5 HEH 5 10 GAINSV For 3 lead support SETRA converts II to III C49 40 022 1 R155 CHA 2 ps DRIVEN RL CKT 117 10 4 90K 4 D5 a t C110 TP22 4 1 a 73 xi C 61 276143 1 J 4 1 7 R142 06 U32A R141 R129 R18 CMPZ5235B CMPZ5235B 43 vv d 10K 4 10 10 FR 114 SEE i A E RI7 C38 NY a u29 num 1 AA 2 a zl o o R15 o m 2 viN M Jd 10 u eH R92 vo 10 o MAX352 NS 1 64 oO 3 _ M J R m ae rorem v FILTERCLK T 12 5 8 NY M
24. REVISIONS REV DATE DESCRIPTION BY 1 2 25 09 10251 DBL 1 00 LONG p gt 9 25 LONG 75 LONG i 1 4 A q 9 25 LONG 1 gt TOP VIEW 2 00 LONG POSITION NUMBER WIRE INSERTED ITEM 18 PINOUT PUMP POSITIVE ITEM 1 RED WIRE PUMP NEGATIVE ITEM 1 BLACK WIRE VALVE 1 ITEM 2 SEE DRAWING VALVE 1 ITEM 2 SEE DRAWING VALVE 2 ITEM 2 SEE DRAWING VALVE 2 ITEM 2 SEE DRAWING NOTES 2 3 4 5 o 1 ATTACH FOAM TAPE ITEM 14 TO THE PUMP ITEM 1 AND MOUNT PUMP ITEM 1 ONTO THE BRACKET ITEM 4 SECURE THE PUMP TO THE BRACKET USING CABLE TIES ITEM 12 MOUNT BOTH VALVES ITEM 2 TO THE BRACKET USING SCREWS ITEM 7 TORQUE IS SPECIFIED ON THE DRAWING SER ore THREAD LOCKER ITEM 20 ON THE REWS 2 TWIST ALL VALVES WIRES TOGETHER PUT WIRES FROM PUMP ND VALVES ITEMS 1 AND 2 THROUGH FERRITE BEADS ITEM 6 AND SHRINK TUBING ITEM 17 UT SHRINK TUBING ITEM 17 OVER FERRITE BEADS ITEM 16 ND HEAT SHRINK IT FERRITE BEADS SHOULD BE POSITIONED 25 25 FROM THE CONNECTOR HOUSING ITEM 18 AND ENTERED IN THE SHRINK TUBING OR INSERTING WIRES INTO HOUSING ITEM 18 SEE TABLE 5 INSTALL HOLDER TIE WRAP ITEM 11 ONTO THE BRACKET ITEM uo
25. 0 025 0 5B 5 0V 0 25 0 nGenuity 8100E Series Service Manual Criticare Systems Inc Section 7 Disassembly Before You Begin Tools Needed The following tools are needed to perform these procedures Before You Begin 1 0 phillips screwdriver 1 phillips screwdriver 2 phillips screwdriver 3 16 flat blade screwdriver 11mm deep dish socket and wrench Turn the monitor off Disconnect the AC Mains power cord and remove the battery NWARNING N The procedures presented in this section are intended to be implemented by qualified biomedical engineering or field service personnel for PCB assembly replacement The procedures presented in this section are not intended to be used for component level trouble shooting and repair of the PCB assemblies Only CSI service personnel are authorized to perform component level repair Possible safety hazard Read the battery safety information provided in Safety on page 1 16 NCAUTION A Opening a monitor and breaking the quality seal can void your manufacturer warranty Before breaking the seal on a CSI monitor contact the CSI service department The repair procedures for the monitor are included here for the determination of damaged or unusable assemblies CSI does not recommend attempting the field repair of the circuit boards Service Safety NDANGER N The monitor contains an internal AC power supply that contains potentially lethal volta
26. 005 ANGLES 1 DEGREE CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION AND MAY NOT BE COPIED OR DIVULGED WITHOUT WRITTEN CONSENT OF CRITICARE SYSTEMS INC TITLE ASSEMBLY 81 91 542 00 5 PART NO REV 4 DIST SHEET 2 OF 2 CSIO390 Rev 0 uso TEM WRELS 1 6 20 06 8897 5D MIC5203 3 3BM5 330 R95 50 50 Sin veur 100K 45004 ous OXIMETER OPTIONS 117 3 CRITICARE Leave 51 and S2 open cus NELLCOR Close 51 Heg l 4 MASIMO Close 52 EI 4 10KX2 si SSH 9 4 R94 C105 C104 of 3 6 113 DNI 4 a uet T T SWDIP4 500 1 2 4 4 5D BEAD 50 9101 2 1 GND 5 d Ride cas 10K F
27. 8100E Series Service Manual Page 6 3 Section 6 Service Testing and Calibration 4 Even if the monitor fails only one level rerun the sequence after 30 seconds Only if the monitor is successful the second time do you pass the monitor 5 If the monitor fails again contact the CSI service department SpO gt Board Test Values While the SpO Board is in operation it should conform with the following test values The operational current draw of the board should be less than 50 ma Use 4 as ground for each measurement Test Point Signal Value 5A 5V 0 05V 9 10 10 x0 20V 2 50 0 05V VR1 4 2 5 2 5V 0 03V 1 If the any of these values fail to test correctly isolate the problem to either the SpO Board or the power supply circuits 2 Remove the SpO gt Board from the monitor 3 Test the equivalent signals on the ECG Analog Board circuits 5A 10 50 2 5VREF See Assembly Tests on page 7 9 4 If the values return to normal with the SpOs Board removed replace the SpO Board NOTE The ECG Analog Board provides power to the SpO Board The SpO Board be replaced as a serviceable component The downloadable software settings associated with the gt module are stored on the ECG Analog Board No calibration or SpOs Board preparation is required Page 6 4 nGenuity 8100E Series Service Manual Criticare Systems Inc NIBP C
28. Auto calibrating Auto calibrating Manual Calibration Selectable percent only 0 to 3 13 6 25 12 5 or 25 0 to 99 mmHg 0 to 12 596 0 to 12 5 kPa 0 to 99 Torr 1 mmHg 0 196 0 1 kPa 0 1 Torr 2 mmHg 0 3 vol 0 3 kPa 2 Torr 200 ml min amp RR lt 120 Br min Manual On Off 200 ml min 200 ml min 10 20 ml 1 25 seconds 200 ml min using an 8 ft sample line 170 milliseconds 200 ml min 10 90 1 08 seconds 15 sec including auto calibration to first reading 1 min to full accuracy 35 dBa maximum 1 meter Temperature Channels 1 Range 68 113 F 20 45 C Accuracy 0 1 C over entire range Display Resolution 0 1 C Probe Type YSI 400 or YSI 700 nGenuity 8100E Series Service Manual Page 1 11 Section 1 Introduction Page 1 12 Alarms Characteristics Indication Levels Settings Alarm Modes Volume Silence Trend Reports Types Trend memory Tabular Intervals Graphical Span Data Types Printer Optional Recorder Type Data Formats Paper Speed Controls Screen Resolution Waveforms Waveform Display Gain Waveform Sweep Speed Keys Rotary knob Languages System Outputs Com Ports Nurse Call Defibrillation Sync Video Port nGenuity 8100E Series Service Manual EN 475 Adjustable Audible Visual High Medium Low Informational User Defaults Hospital Defaults Factory Defaults Adult Pediatric Neona
29. Defective valve Defective main board Replace Cuff Replace Hose Re seat tube or replace pneumatics Contact CSI Service Department Contact CSI Service Department NIBP not functioning Pump disconnected Pump motor failure Main Board pump driver bad NIBP calibration error Reconnect pump to P2 on Main Board Contact CSI Service Department Contact CSI Service Department Contact CSI Service Department Criticare Systems Inc nGenuity 8100E Series Service Manual Page 8 1 Section 8 Troubleshooting Symptom Problem Solution SpO not functioning Board disconnected Defective SpO Cable ECG S1 switch set wrong Main board malfunction Reconnect to P5 on ECG Analog Board and check the connection at P1 on SpO Board Replace cable Adjust switches to correct module 1 4 OFF for SpO Contact CSI Service Department ECG noise or intermittent function Poor electrode placement Bad wrong ECG Cable Line Frequency Filter wrong ECG connection worn Cable to ECG Analog Board bad Defective analog PCB Reposition replace electrodes Replace ECG cable Check ECG settings Replace ECG port Replace cable assembly at P1 on ECG Analog Board Replace Analog board 5 is noisy Sensor may be bad Receptacle may be damaged The connection between Main Board J12 and ECG Analog Board P4 is loose or disconnected Can be verifie
30. Inc nor the rights of others Criticare Systems Inc does not assume any liability arising out of any infringements of patents or other rights of third parties PROPERTY OF CRITICARE SYSTEMS INC ALL RIGHTS RESERVED nGenuity vital signs monitor DOX Digital Oximetry ComfortCuff NIBP SHELL and Multi Site 5 Sensors are trademarks of Criticare Systems Inc Page ii nGenuity 8100E Series Service Manual Criticare Systems Inc Contents n di ciere ert PE RE e Pe P EYE EP ERU P EE TED TEE RE ii Contents iii Warranty 22 Service Return 4 40 0000 viii EG Declaration of Conformily ani rte er e ea eode dpe ix Section 1 Introduction BIETET Srle DRE 1 1 Irntended Use retire eterne 1 1 nGenuity 8100E Series Options enne 1 1 Pulse Oximetry Measurement 5 1 2 Definition 22 DOX Digital Oximelty rre CE Menge HORE 1 2 1 2 SpO Clinical Testing and Accuracy Heart Rate ECG Measurement S bin Mec E Stability iiic riter pest Pacemaker Pulse 21 4 4 3 Non Invasiv
31. LCD ACTVE TFT 10 4 NEC 59 DISPLAY CABLE 8100E ASY CABLE MAIN BOARD TO INVRTR BACKLIGHT INVERTER MEMBRANE SWITCH BRACKET DISPLAY MOUNT TAPE MICROFOAM ADH BACKED ROTARY ENCODER WASHER SHIELDED ENCODER WASHER FLAT ENCODER FOAM GASKET 9 25 x 25 x 060 TUBING SILC BLU 040X 140 5 4 40 25 SEMS 4 40 PHMS SEMS PHILLIPS STANDOFF F F 2 56 NYLON 5 LNG ASSEMBLY PATIENT CONNECTORS CSI Part 87284B001 90860A001 90872A005 42014B001 40284B005 41458B001 40086B001 90817A005 Description INSERT PATIENT CONNECTORS AY CBL 8100 SPO2 TO DB9 ASSEMBLY CABLE TEMP CONNECTOR FITNG QUICK CON HH NIBP NUT 10 32 KEPS PL P H M S 4 X 250 HI LO WASHER FLAT PL 125X 219 AY CBL 8100 ECG TO OUT nGenuity 8100E Series Service Manual Page 9 11 Section 9 Drawings and Schematics Page 9 12 Shielded Analog 91353 003 AY SHIELDED ANALOG BRD Board Assembly Printer Item 01 02 03 04 92804A001 01 02 03 04 nGenuity 8100E Series Service Manual CSI Part 91342A003 41785B004 40995B011 40086B001 83358B001 83434B001 40284B001 40431B001 40884B001 Description ASSEMBLY ANALOG PCB 8100 SHLD ANALOG BRD 8100 P H M S 4 40 X 438 SEMS WASHER FLAT PL 125X 219 INSULATOR ECG SHIELD CIRCUT BRD ECG SHEILD NUT 4 40 KEPS PL WIRE 18AWG 300V GREEN YELLOW SPACER 4 2500D 125L PL AY PRINTER MODULE CSI Part 45184B001 45186B001 84005B001 91341A003 45188B001 45189B001 40418
32. No affect when tested to IEC 60068 2 64 standards 35W typical 100 240 VAC 50 60 Hz 1 sealed lead acid batteries 3 hr typical w o CO 2 5 hr typical w CO 4 5 hours 59 95 F 15 35 23 122 F 5 50 C 15 to 90 non condensing Class Equipment Ilb EU Class Equipment Type CF Defibrillator Proof IPX1 1 000 10 000 feet All specifications are subject to change without notice Specifications related to the ST and Arrhythmia option are found in the Arrhythmia and ST Analysis appendix in the 8100E operator s manual nGenuity 8100E Series Service Manual Page 1 13 Section 1 Introduction Symbols Symbol 1 14 nGenuity 8100E Series Service Manual Definition Refer to Operator s Manual for Information Shock Hazard Equipotential Terminal European Community Mark Electrical Testing Laboratories ETL Mark Do not dispose of in municipal waste Wheeled bin symbol indicates separate collection for electrical and electronic equipment WEEE Directive 2002 96 EEC Type CF Equipment defib proof Identifies the degree of protection against fluid as drip proof Input Output port Output only port Alarm port Nurse call External display port Criticare Systems Inc Criticare Systems Inc o lt 3 gt Section 1 Introduction Definition Fuse Gas Scavenging Air Intake Alternating
33. This fixture may be created by using the schematic below 1 8 Mini stereo plug J2 Batt P I IM 12 Batt Pos J11 pins 1 and 2 1 gt gt 1 2 LED LED LED LED 2 CON1 12V Batt Neg 311 4 CON2 Connect the Smart Sat and monitor all levels Connect the Nurse Call fixture into the back of the monitor while the Smart Sat simulator runs Create an alarm state with the Smart Sat and verify that the lights on the Nurse Call fixture go on Press the Alarm Silence button and verify that 2 minutes appears at the top of the display and the lights on the Nurse Call fixture go off and remain so for two 2 minutes while the in the alarm state Press and hold the A arm Silence button The Nurse Call fixture should go off and remain off regardless of changing alarm states NOTE While in the 2 minute Alarm Silence if the alarm states change the Nurse Call fixture lights will come back on While in permanent alarm silence the lights on the Nurse Call fixture should remain off regardless of changing alarm states nGenuity 8100E Series Service Manual Page 5 21 Section 5 Preventative Maintenance Battery and Power Testing Page 5 22 Test the Battery This procedure provides a method of testing the power regulation and battery charging circuits of the main board This test does not require you to open the monito
34. 09 08 SEE ECN 10207 RWK 4 5 23 08 SEE ECN 10233 OBL 4 47 5 7 8 09 10463 2 25 3 67 R Rias REG Ru 2o p m 1 FD 915404005 ep o 2 SEE NOTE 6 E UU ms STRAT 90000 al p n Q 1 di 13 dh o 00 1 94 N BOO 2 2 22 TYP 2 5 amp a TYP ETE eg 2 Be e 22 8 pam 5 18 77 8 Es 4 ra 1 NES al Q ITEM 6 8 8 8 z AL 8 g Bom 8 1 x ye 9 5 1 8 88 as _ E j 1 7 ELI jo ITEM 7 VE P 77 Sou ita g s b gt a 2 B rg 8 cm 3 Tn wo non 8 8 5 i Cas m E7 E4 1 55 a 2 E 2 1 zm NS DES a VES s 8 or i 40 Ze 8 nct P1 r 58 i i HER l 5 B Em m m E n cn 8 8 s 8 5 SEE NOTE 47 10 i E ag C 2 1 B 7 T a 5 Pes i 5 E eee 1 5 cus P 804 E cie los bd 1 GEJ Tia e x cRAITL 11 g se 8 E Lt e i 3 50 7 vo sm 3 00 SEE DETAIL A 3 85 8 52 BO as 1 75 2 2 1 00 B a 1 vs 3 50 m 1 00 MOUNTING HOLE 5 50 4 75 SOLDER SIDE COMPONENT SIDE NOTES 1 FINISHED BOARD SHALL MEET CURRENT 610 STANDARDS CLASS 2 BARE BOARD 835998005 TO BE USED ON ASSEMBLY 913404005 3 CSI RESERVES
35. 12 1 IHIPRESS 7 4 4 COZFULLON HH TCLKAmIOCCOPO10 P12 pees 41 m c19 109 TCKB TIoCDO PO 1 13 PESIDS 40 Coo OFF R146 R62 74H074 TU BES neon J x g tm eu soon 1 1 15 pesos iH 5A 01 m VALVEL HIGHLOWRNG 2 16 PEZD2 35 0 232V 15mm pak VALVEZ eS TCLKD TIOCB2 PO15 P17 PEUD 34 0 158V 5mm 1 CLRERR BPPUMP 102 Peano R140 a JNMINIBP 9 MS 101 ANGPAGDAO E17 BLA31AGB01SN4D ce em du 5 10 1 ANSIPAS pB8 1e 124K R59 100K BPVALVE1 9158 CO2REF 71 ANAIPA4 pat MRD 50 gt 2 0 __ 100 1 sise2spy IE 8 8 PFSIRD UA al b mweour R139 NIBPDC 3 6 t 2 42 PREAS p CRA25 10KX4 1 n IRESETCPU2 4 5 1 95 AND 29 1 8 Si TLC352CD 100K R191 5VREF addant JHIPRESS 2 wy TLC352CD 100 19 1KX4 9 9 Pe6 CSellRQ2 31 TIMEOUT 6 5VREF 1 cn 5A R192 1 c200 c203 13 avcc 6 31 1 A R52 7T 100 0 8 100K D 43 94 AVSS usec 221M cid 5 VREF POODREQUCS4 D OFAT i 8 4 0 55 E z ai VW TOCPUZTX 2 PS50 TXD2 RENT 88 MUXEN 4 16 TO
36. 2 re 2 300 VERY SHORT TRACES ON THESE RESISTORS d oZ eu slao 9 4 M e 4 afao 14 aaa 5 16 5 L10 R213 100 uH 150uH 196K u33 R179 a E x MD914 171108 58 6 D18 C60 6 cteg 171108098 022 224K 5 5 028 4 TS 1007 lt 107 2 CMSH1 40 C95 cet 400T R214 OVER CHG TRICKLE 18 2K p noe A TP9 mm che EN 42 100 25 YN us SEES R215 T 22830 50 _ 9 5v Q 100ma UC39000W sic I LA 24 TP3 5V 150ma Hu 549K 5 5 8 5 gl u26 58 00 ud cao 4 8 8 88 8 E J 1 8 IN jour 31 58 TP14 R101 100E25V 7 588 and TP 107 02 amp Hum 2 b RAM GRNLED mE _ o 2 5VREF 5V 100 uc cus dios 1M 475 n 5 OHMS P s SENS J H i TO BATTERY 1 o Tap ACIN K CHRGDIS CHGOFF sD 5 T F2 Socket 1 Ries R110 LOADBAT czs 301k pus 1 1 247002 mie Nol 5 4 Q4 PWR_SW Socket Socket lt 1 2N7002 SMBJI5A u2 cus 9 FM CHRG1 DIS pu 1 26765 5 0 a umi s7 58 PWR PWR_SW 4 F4 curctois TP23 s19435DY asp 5V 20A 4 VIN Cb 2 1 14 100K 21 6 T 35 C36 33uH A 57 TA 220uF 25V 220 uF 25V 9 ves E Hina t 4
37. 3 06 12 06 SEE ECN 8886 LBS 4 09 13 06 SEE 8941 RWK 5 01 22 07 SEE 9079 sc 6 4 30 08 10136 DBL 7 7 29 08 SEE 10466 DBL BACK VIEW ITEMS 11 15 AND 34 ARE NOT SHOWN FOR CLARITY E 3 IN LB BROWN WIRE FROM ITEM 6 NOTES 1 POSITION BATTERY SLIDE ITEM 32 ON THE BOTTOM OF THE BATTERY COMPARTMENT LINED UP WITH THE FRONT EDGE OF THE BATTERY COMPARTMENT AND AT EQUAL DISTANCES FROM THE SIDE WALLS 2 POSITION FOAM PAD BATTERY ITEM 16 ON THE TOP AND SIDE WALLS OF THE BATTERY COMPARTMENT CENTERED FROM SIDE TO SIDE AND FROM TOP TO BOTTOM AS SHOWN N ON THE BACK VIEW CLOSE TO THE REAR WALL COVER EACH OF THESE PADS WITH BATTERY SLIDE ITEM 32 AND STICK OVERLAPPING PARTS OF THE BATTERY SLIDES TO THE A WALLS IN FRONT OF THE FOAM PADS 3 TO CUSHION FERRITE OF THE CABLE ITEM 6 FROM THE CHASSIS ITEM 1 PUT FOAM TAPE ITEM 34 ON THE FERRITE SIDE FACING CHASSIS 4 VERIFY FOR NO ELECTRICAL CONTINUITY BETWEEN POWER INPUT MODULE ITEM 8 AND CHASSIS ITEM 1 BEFORE CONNECTING THE CABLE ITEM 6 TO THE POWER INPUT MODULE ITEM 8 5 ROUTE WIRES FROM THE BATTERY CABLE ITEM 7 OVER BATTERY BRACKET ITEM 15 MAKE SURE WIRES ARE NOT PINCHED UNDER FOAM PAD ITEM 33 RELEASED DOCUMENT SW CRITICAR E SYSTEMS INC
38. 3 months without periodic charging At the end of its useful life you can dispose of the monitor and its accessories according to your institution s policies and procedures for disposal of patient contact medical waste Alternately you can return the monitor and its accessories to Criticare Systems Inc for safe disposal The shipping address is Criticare Systems Inc 20925 Crossroads Circle Suite 100 Waukesha WI 53186 nGenuity 8100E Series Service Manual Page 5 5 Section 5 Preventative Maintenance Electrical Safety Perform this test each time you open the monitor housing and before Testing you use the monitor on patients NWARNING A e Shock Hazard Because dangerous and lethal voltages are present during the withstanding voltage leakage and ground AN continuity test all leakage and voltage testing must be done with the monitor housing in place For complete information about the proper operating and safety procedures refer to the nGenuity 8100E Series Patient Monitor Operator s Manual Equipment Needed The following are needed to complete this procedure Kikusui TOS 8750 Withstanding Voltage Tester or equivalent Hi Pot tester Withstanding Voltage The following test and set up is for the Kikusui TOS 8750 9 9 Hi Pot Test Equipment Withstanding Voltage Tester If you use an equivalent tester use the and Setup factory recommended test for that tester 1 Test the Withstanding Voltage Tester by conn
39. 44 5 come 2 cet 1 J MLSS100 8 4 n 8 1 L cw TP6 ton C100 TP12 220 35 22035V uz2c ET TPAD 100 25V 0 68uF TP SM 15 019 4 KAA WRFLSH 330uH 20 5 DNI Rot NY GNDPWR A soos Lon 3 01K R125 74 14 JECGON 221 d co 4 LLO RAO E 2 SPO2 INTERFACE OPTIONAL CSI 4 ECGV R149 RESP_BW RESP BW UNS 221 PACER VRI 2MHZ 1 1 BASEIMP BASEIMP AN R137 2 P5 RESP_GAIN RESP GAIN psc 10 1 5VREF ross 4 5 JOFLOW em m n d 3 4 GAIN2 SETLA 402K LM385M3 1 2 RSTSYS RESPOUT 5VREF Ci54 RDISETUP gs 5 FIETEROUK pat 47pF R139 ZC5800E TRSTSETUP 220 ANA 022 Bo U41B EAMT 913 14 HIRSTV 10 x 15 16 150 1N914 LMC6482 R114 C155 50 9 17 18 TO 450 P3 gt au d19 20 Te w 50 MMBZ15VALT 1 0 66ma TEMP 4TpF AD 921 2 Ed 1 bacc 923 24 SVREF 2 Nout c156 1 426 26 GNDANL 2 t DNI Qa 28 IRESET M 5 920 30 re 2 2 5 TRING BRRREL 2 R138 RO 1 7 8 01 135K To 5 4 SVREF VDD VCC 50 4 y 9 MMBZ15VALT 1 d 5 4 5VREF lt 5 TEMPERATURE PROBE SEN eme 4 HEADER 20x2 50 PROBE1 TEST 2 m PROBE1 REAI qu Q5B i o jS 59250 siso2spv 4 J d si9925DY lt VW se a pa TPAD Y VN TP23 SPO2 INTERFACE OPTIONAL NELLCOR m E R9 TEAN da
40. 50 m3 1105 CONINC CONCS 50 5 ZX Aww Wow 26 GND FB 4 15 DNI R6 1 CONCS 35 ORS T 6 Leao 4 4 4 4 05 92 os PCMRST1 H6 __iFemerstt 1 ERRO ERRI 1K 7 74 244 A 3 30 S Qv 4 4 1 az 2 4 E V lt eu ANLGOUT2 MDT M 9 IPCMRST2 19 PRNPS panes ye 7 9 8 A6 80 me o 2 20 PSEL 2 3 Ry R29 4 4 4 MDS 97 08 exts DNI lt gt 89 C90 C78 C83 C68 C69 C74 O10 100 or DN cur A CHRG1 DIS c CHRG1_DIS R238 5 uou A 011 CARDDET1 BDS 225 4 E Wb n X Lo N pt DNI 013 n CARDET2 ARDET Uter R14 BDS 4 014 IL 014 85 1 KENT eed 5VREF 50 dd MD15 O15 evint 200 1 50 5VREF 9 oe ae E n 8V0 NT 2 5 The No 81 010 PRNTCON2 ICONINC 5 1 TR T M 8 TDO 73 NC Hax SEIKO PRINTER LTP1245 CON es VL OKA NC MFLASH1 A IRESETS 9999999 FNR 1500V AC isolation 500mW max Power Dissipation L 4 PTH on RIGHT TOP CORN DNI agp 9 P 55555555 PLD EQUATIONS Do not exceed 800 m load current Te 8 sg 0K 58 ZR 2 mE 50 EXTROM 20000H 9FFFFH m 1 Qi E EXTRAM A0000H DFFFFH And 100000 1FFFFFH A vH o INKEYS E0000H FFFFFH NURSECALL 1 6 3o 1 CONCS o E e R24 OPTIONSON ECGON NU
41. 6 32 keps nuts pn 40284 002 6 Attach the speaker wire to J20 on the Main PCB Label and remove the hoses from the NIBP fitting and Main PCB Disconnect cable from Main PCB P2 Remove the four 4 screws PHMS 4 40 X 0 250 SEMS pn 40995B005 holding the NIBP chassis to the bottom chassis 3 Remove the NIBP chassis Position and place the new NIBP chassis assembly pn 927974001 onto the four 4 stand offs of the riveted bottom chassis assembly pn 92798A001 Secure the NIBP chassis assembly with four 4 screws removed earlier Reattach connector P2 on the Main PCB and hoses on Main PCB and NIBP fitting Label and disconnect the power supply cable from PS2 on the Main PCB 2 Disconnect cable CN1 from power supply 3 Disconnect groundwire from JP1 and Power Supply nGenuity 8100E Series Service Manual Page 7 7 Section 7 Disassembly Testing Page 7 8 8 9 Remove the two 2 screws PHMS 6 32X0 25 SEMS pn 40496B002 from the bottom of the chassis that hold the power supply bracket in place Disconnect cable from J5 Remove the existing power supply from the chassis Connect cable to J5 on new Power Supply Position and place the new power supply onto the riveted bottom chassis assembly pn 92798A001 Insert the two 2 screws removed earlier through the bottom of the chassis and into the power supply bracket Secure the assembly with the screws A
42. 60 Hz and 50 Hz bands that reduce electrical interference from the AC mains power sources User selectable filters are also available The accuracy of the ECG analog output bandwidth is equal to the frequency response specified in the ECG specifications The variable gain control is x200 x400 or x800 according to the ECG Sensitivity setting The propagation delay is 1000 milliseconds The accuracy of the synchronizing pulse amplitude is equal to 500 times that of leadview II The pulse shape and duration match those of leadview II The output impedance is 1000 ohms and propagation delay is less than 6 6 milliseconds With the pacemaker detector turned ON in the 8100E P Series the system detects and rejects pacemaker pulses ranging from x2 to 700 mV amplitude and 0 1 to 2 0 ms duration Heart rates properly display over this range of pacemaker operation Pacer pulse markers are present if pace detect is on and appear in the ECG analog output as narrow positive spikes at the point of pace detection NCAUTION Ambient noise sources may induce artifactual triggers of the pacemaker pulse detector and display Respiration is measured via the ECG electrodes The ECG uses the impedance measurement based off of lead 11 When determining respiration from the ECG the monitor measures patient respiration by impedance pneumography As the patient s chest changes size and shape during inspiration and expiration the resistance between
43. 82004B001 for the battery input at PS1 There is one 1 replaceable 4A fuse 82004B010 for the power supply module at PS2 F4 protects the supply output If you replace the Main Board you are required to cal check the NIBP module NIBP pneumatics assemblies and Main Boards may not be changed unless re calibrated Except for fuses the Main Board is not a field repairable component Replacement Main Boards are pre tested programmed and calibrated nGenuity 8100E Series Service Manual Page 8 5 Section 8 Troubleshooting Power Module A Fuse Replacement A AC Power Components Page 8 6 N The power module pn 95710A002 consists of the battery compartment bulkhead and chassis the fan cable assemblies and the Power Supply Board The Power Supply Board AC to DC converter is not a field repairable component If the board is damaged or fails test replace the entire assembly NDANGER N High Voltage Repairing and testing the power supply requires working with dangerous voltages The power supply module should only be serviced by experienced electrical repair technicians The main fuses pn 82013B002 for the power module is located in an external compartment above the AC power cord connection Replace only with 1A 110 230 volt Time Lag fuses pn82013B002 Check the monitor ID label to determine which voltage the unit uses You do not have to open the monitor case to change the main pow
44. CO2 Service EXHAUST TEST 1 Place the flow meter on the Exhaust Port and measure the flow The flow must be greater than 250 ml min 2 Remove the flow meter VERIFICATION 1 Check that the CO2 measurement is displayed in PERCENT If not set in the Parameters menu PARAMS 2 Using the regulator CAT 623 and regulator bleed tube CAT 613B connect the 10 CO gas canister to the sample line 3 Turn on the 10 gas by turning on the knob on the regulator Allow the gas to run for 30 seconds Verify that the reading is 6 9 4 to 10 6 Turn off the gas when finished and disconnect from the sample line NOTE The 6 accuracy is derived from the test tolerance of 496 combined with the 2 accuracy of the gas canister Testing Checklist Verification Checklist is at the end of this appendix This checklist should be added to the Functional and Safety Testing Checklist in Section 5 Page A 6 nGenuity 8100E Series Service Manual Criticare Systems Inc Calibration Appendix A CO2 Service Tools Needed The following equipment is needed to perform this procedure WaterChek 2 Water Trap CAT 938F NC Sample Line CAT 625N Calibration Gas 10 CO with accuracy 2 622 Regulator CAT 623 Regulator Bleed Tube CAT 613B Breath Rate Simulator CAT 1466 NCAUTION A Calibration kits contain compressed gas cylinders Read and obey all precautions listed on the
45. GAIN as 1 0 SWEEP as 25MM SEC and size The size might not be changeable on some waveforms Select Exit and verify that a non symmetrical sine wave displays on the window 12 Set the Dynatech MED SIM300 to a heart rate of 300BPM Verify that the ECG HR reads 300BPM 1 13 Turn off the simulator and verify that the message ECG LOST appears at the top of the window 14 Turn the simulator back on and set the simulator for 60 LEAD II and verify that the gain settings are effective at x 5 x2 and x4 for 1mv ECG input 15 Select on the simulator for ECG performance Cursor through the menu until you obtain and execute twice the PACED RYTHMS Verify that PACE is turned on in the menu screen of the 8100 You should see white spikes on the waveform and 75BPM 16 Select ECG on the simulator select base then BPM and 60 This gives a normal sinus rhythm at this time Select ECG then ARRH then VNT2 and then VFIB The unit should detect an erratic baseline and display the message ECG LOST ECG Analog Output Test You need a MedSim 300 patient simulator to perform this procedure 1 Connect BNC cable with 0 1uf CAP signal to ground from the ECG BNC on the monitor to an input channel on an oscilloscope Select and press the PARAMS softkey Set Filterto Diagnostic and ECG Sensitivity to Medium Select and press the DISPLAY softkey Set Waveform 1 for ECG Lead II ECG IN on the screen Set the MedSim 300 pa
46. Manual Controls Check Alarm Verification Vital Sign Modules Verification e ECG SpOs NIBP Temperature Internal Printer Communications Battery and Power Criticare recommends that you run a serviced monitor for 24 hours before you perform the tests listed above and place the monitor back into service Repaired modules could require more extensive testing than what is shown in this list A Always follow ESD precautions when performing a procedure discussed in this section NWARNING Because test procedures require working with exposed electrical circuits only experienced electrical or biomedical technicians should perform the procedures After a monitor is altered through repair or hardware adjustment you must fully test it before use Page 5 2 nGenuity 8100E Series Service Manual Criticare Systems Inc Equipment and Tools Accessory Testing Criticare Systems Inc Section 5 Preventative Maintenance The following procedures assume that the technician has an ESD safe workbench a set of electronic hand tools and a digital multimeter with a 10 amp setting At the beginning of each test special equipment can be listed A variety of customized cables clips and test fixtures are also needed to complete the tests For more information contact the CSI Service Department Check patient cables e g temperature cables printer cables monthly for damage loose wires connections l
47. NZ SMBJI2CA doo Ey 5 J D4 C40 c154 834 FPS 68uF 40V a uF 10V ZR 4 PS 1 2 Vovercharge 14 6v 22 2 R33 d Mies PWR_SW Note Parts from the 052 circuit have been Mickie m TP24 H 4 removed from the artwork to accomodate the t hU SM q C186 PWRCON 0 11206 TP 107 02 012 heatsink SHROUDED MALE CONNECTOR 9 i TP18 d 81 32 ON OFF 5 DNI DNI T 1 MN ob L11 S Hook for LCD chassis connection R217 e 124 C120 i rukav 11 9 imm 1 4 E x DNI 0 pi 4 5 5 5 2 015 1 3 012 0122 ont MODE CHOKE DNI S 35534 10V 68uF 10 4 perte dar lir 100K R218 2 9 over che TRICKLE Ht DNI TO BATTERY2 E mH os cHe en 2 v vgs 5A 5A 140ms R161 m nis vi V SENSE ET 280ms DNI sic Hw y ii w x E wok 4 3 M 14257233 1 TP 3 3 600 Analog and Digital Grounds are CHRGDIS je 2N7002 589 8 SZ 2 2 ei 330 connected at 6 R220 amp To Thermistor T 5 Cb I 13 C207 4 4 1 5P 024 a SN 33uF 35 cue TT CM 8 L8 Loo 4 7j D3 C145 R9 029 1 NI CMSH240 S F Ds EN DE Y 68uF 10 C209 4 5 19 CHGOFF 9 x Ne 8V 9 R151 R152 IsD bu 1 VOD DNI 1 00K 5 62K isp EO 3 en our Hya 9
48. ON THE FRAME MAIN ITEM 1 THE BOTTOM MOUNTING HOLES SHOULD BE IN FRONT OF THE FRAME AND THE TOP HOLE BEHIND THE FRAME 3 PLUG ECG CABLE ITEM 6 INTO THE SHIELDED ANALOG BOARD ITEM 3 BEFORE MOUNTING THE BOARD ROUTE CABLE BETWEEN SHIELDED ANALOG BOARD ITEM 3 AND MAIN ITEM 2 4 FOR TORQUE VALUES SEE THE DRAWING 5 WITH A PERMANENT MARKER COPY THE SERIAL NUMBER OF THE MAIN PCB ITEM 2 ONTO BOTH SIDES OF SHIELD ITEM 8 THE SERIAL NUMBER MARKING SHOULD BE NEAR THE EDGE THAT IS VISABLE AFTER ASSEMBLY THE FIRST SHOULD BE BELOW THE PRINTER CABLE CONNECTOR THE SECOND ON THE OPPOSITE SIDE NEAR THE RS232 CONNECTOR ZX 6 CONNECT THE REMAINING CABLES FROM ITEM 6 REMAINING CONNECTORS SW VG CRITICAR E SYSTEMS INC w LSOROKA L SOROKA 2 16 06 va 01 03 2006 Ed KAPLAN 3 8 06 SAE 1 4 DO NOT SCALE PRINT A J SZOLYGA 1 9 06 TOLERANCE UNLESS OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL 020 INFORMATION AND MAY NOT COPIED OR DIVULGED XXX 005 WITHOUT WRITTEN CONSENT OF CRITICARE SYSTEMS INC ANGLES 1 DEGREE TITLE PART NO REV CHASSIS MAIN ASSEMBLY 92801 A001 7 302 SHEET or SEE PINOUT TABLE AT RIGHT HEAT SHRINK 1 50 LONG 2 50 LONG 75 LONG CHECK VALVE ORIENTATION SYMBOL ee DETAIL A SCALE 2 1 5
49. PWR SUPPLY TO MAIN 06 90968A004 CBL AY INLET GROUND 07 95768A001 CABLE AY BATTERY TO MAIN PCB 08 80243B002 PWR ENTRY MODULE FILTERED 09 80130B001 PWR RECPT FUSE DRAWER 10 82013B002 FUSE T TIME LAG 1A L 250V 5X20 12 45193B001 INSULATOR POWER INPUT 13 42633B001 PLATE SPEAKER MOUNTING 14 45187B001 INSULATOR SPEAKER 16 42643B003 FOAM PAD BATTERY 17 41537B001 FOAM DISK 1 38 DIA 25THK 18 41158B001 TERMINAL EQUIPOTENTIAL 19 40995B005 5 4 40X 25 SEMS 20 40496B002 P H M S 6 32X 250 SEMS 21 41297B001 F H M S 4 40X 375 PL PH 22 40284B001 NUT 4 40 KEPS PL 23 40284B002 NUT 6 32 KEPS PL 24 41164B001 NUT M6 X 1 0 KEPS PL 25 42353B001 SHOULDER WASHER 4 26 42448B001 1 4 20 55316 SPRNG LOCK 27 40500B003 WASHER FLAT 6 NY 062THK 28 40294B001 HOLDER TIE WRAP ADH BK SM 29 40067B001 CABLE TIE 4 0 30 40067B002 CABLE TIE 5 6 32 42402B002 BATTERY SLIDE 8100EP 33 40132B001 TAPE MICROFOAM ADH BACKED 34 41955B001 FOAM TAPE 1 0 X 2 12 nGenuity 8100E Series Service Manual Criticare Systems Inc Section 9 Drawings and Schematics Power Supply with Brackets 95710 003 AY POWER SUPPLY WITH BRACKETS Item 01 02 03 05 06 07 08 09 CSI Part 86523B001 42368B002 42369B002 40995B003 40887B002 41157B001 42501B002 42499B002 Description POWER SUPPLY 60W BRACKET RIGHT PS BRACKET LEFT PS P H M S 4 40X 500 SEMS SPACER NY 6 250D 250L THRDLOCK ASSURE SURF CUR GROMMET STRIP WITH ADHES WASHER CUP NYLON 4 Main Chassis Asse
50. TEMP INVALID appears on the display Repeat steps 1 3 for temperature simulator TP700 5 Switch off the power Disconnect all cables nGenuity 8100E Series Service Manual Criticare Systems Inc Section 6 Service Testing and Calibration Monitor Fault Testing The following procedures are used to determine whether boards and assemblies are damaged New boards and mechanical assemblies should be tested as part of any replacement repair Board level tests require opening the monitor housing which can void your product warranty Always follow ESD precautions when performing these procedures A Power Supply Board Test 1 NDANGER N High Voltage Board testing requires working with dangerous voltages The rear assembly that contains the power supply module should only be serviced by experience electrical technicians Remove the batteries from the monitor 2 Open the case Follow the disassembly procedures refer to Disassembly in Section 7 in this manual to expose the power module Do not remove the power module Disconnect the DC power cable at PS2 of the Main Board Leave the other end attached to the Power Supply Board Using a controlled AC source apply 115 VAC at 60 Hz to the AC receptacle The source should be able to supply a minimum of 3 amps Use a power cable that has suitable connections to the AC source Measure the DC power cable end The power module should
51. THE RIGHT TO INSPECT THIS ITEM AT THE VENDORS FACILITY VENDORS INSPECTION SYSTEM AND MANUFACTURING HS1 Q12 PROCESS ARE SUBJECT TO REVIEW APPROVAL VERIFICATION AND ANALYSIS BY AUTHORIZED CSI REPRESENTATIVES ALL CHANGES IN DESIGN COMPONENTS PROCESSES OR FABRICATION MUST BE AUTHORIZED IN WRITING BY CSI PRIOR TO IMPLEMENTATION ALL DEVIATIONS FROM DRAWINGS SPECIFICATIONS OR OTHER REQUIREMENTS MUST BE REPORTED TO CSI FOR APPROVAL PRIOR TO TORQUE TO SIN LB SHIPMENT ALL RAW MATERIALS USED TO PRODUCE THIS PART SHALL BE TRACEABLE TO AT LEAST A LOT LEVEL ALL ITEM 5 ITEM 4 TRACEABILITY AND INSPECTION RECORDS MUST BE IDENTIFIABLE TO THE RAW MATERIALS PARTS ASSEMBLIES OR DEVICES TO WHICH THEY APPLY AND SHALL BE AVAILABLE UPON REQUEST OR AUDIT BY CSI REPRESENTATIVE co FIRST ARTICLES MUST BE INSPECTED AND ACCEPTED BY A CSI QUALITY REPRESENTATIVE PRIOR TO A PRODUCTION SHIPMENT UNLESS OTHERWISE AUTHORIZED BY CSI THE FIRST ARTICLES MUST BE INSPECTED AND OR TESTED FOR COMPLIANCE TO THE REQUIREMENT OF APPLICABLE ENGINEERING DRAWINGS AND SPECIFICATIONS FIRST ARTICLES MUST SO MARKED AND IDENTIFIED WITH A PART NUMBER ANY MAJOR TOOLING PROCESS OR COMPONENT CHANGE WILL REQUIRE A NEW FIRST ARTICLE EVALUATION _ _ _ VENDOR SHOULD COMPLY WITH THE FOLLOWING CSI QUALITY EACH LOT OF PARTS SHALL BE ACCOMPANIED BY A LEGIBLE COPY OF A CERTIFICATE OF COMPLIANCE LISTING THE DRAWING L REQUIREMENTS Q1 Q2 Q4 Q5 Q6 Q7 010 Q11 AND Q16 SPEC
52. bpm or 1 ECG whichever is greater 3 bpm maximum Selectable On Off ECG primary 6 to 150 breaths minute ECG 0 to 120 breaths minute 1 breath minute 1 or 1 breath minute whichever is greater 1 99 1 70 99 range 2 50 69 range 3 lt 50 unspecified Statistical represents one st dev 66 of clinical samples Plethysmograph Numerical Audible pulse tone pitch varies with SpO Dual wavelength LED Adult Pediatric Neonate Continuous Use 660nm 905nm 80mW Criticare Systems Inc Criticare Systems Inc NIBP Technique Measurement Time Automatic Measurement Cycles Inflation Pressure Range Resolution Transducer Accuracy STAT mode Capnometry CO3 Units Display Method Calibration Waveform Scale Range Resolution Accuracy N50 Flow Rate Flow Tolerance System Response Time Rise Time Delay Time Time from cold start Pneumatic Sound Pressure Section 1 Introduction Oscillometric measure upon inflation 40 seconds average standard adult cuff 2 3 5 10 15 30 min 1 2 4 hrs Adult 0 to 300 mmHg Pediatric 0 to 300 mmHg Neonatal 0 to 150 mmHg 1 mmHg x 2 mmHg or 2 of reading whichever is greater 5 min of consecutive readings mmHg Percent kPa Torr Inspired CO Expired CO End Tidal Numerical values capnogram and breath by breath ETCO bar graph Non dispersive Infrared
53. gas cylinder labels Before You Begin Make sure the CO calibration gas cylinders are not depleted or nearly depleted The pressure meter should be above zero and you should not hear a hissing sound when in use WARNING Never attach intravenous tubes to gas sample connections because the gas sampling lines could inadvertently be connected to intravascular fluid systems thus allowing air into a blood vessel NCAUTION Calibration kits contain compressed gas cylinders Read and obey all precautions listed on the gas cylinder labels Do not use if the calibration gas cylinder is beyond its expiration date Check the accuracy of the test gas The gas must be within the accuracy stated above to ensure proper calibration NOTE Make sure the monitor is not in STAND BY mode before proceeding with the following procedure Criticare Systems Inc nGenuity 8100E Series Service Manual Page A 7 Appendix A CO2 Service Procedure PREPARATION Page A 8 1 Insert a water trap CAT 938F NC and sample line CAT 625 on the 8100E1 monitor Connect the other end of the sample line to PORT 2 on the Breath Rate Simulator CAT 1466 2 Turn the 8100E1 monitor on and allow to run for 30 minutes Using the rotary knob highlight PARAMS Press the knob to enter the Parameters menu Verify that CO2 is ON If the parameter is off highlight CO2 using the rotary knob and press the knob Turn the knob until YES is disp
54. gt gt gt gt gt gt x gt Neonate Reading on STAT MODE 4 readings Criticare Systems Inc nGenuity 8100E Series Service Manual Page 5 23 Section 5 Preventative Maintenance Functional and Safety Testing Checklist Page 2 of 2 PASS Monitor powers up on Battery only ON Current Base 1400mA Verify that charging works on BATT Verify GREEN BATTERY ICON Verify YELLOW BATTREY ICON Verify BLACK BATTERY ICON Verify SHUTDOWN 10 0 0 5 VDC If active is connected full view is readable Verify that the display meets the criteria Verify SPO2 NO SENSOR Verify SPO2 HIGH AMBIENT VerifySPO2 SENSOR Verify SPO2 Readings with HR Verify PULSE TONE Verify SPO2 SEARCH OR LOST Verify Temp Accuracy 20 to 45 degrees C TP400 Verify Temp Accuracy 20 to 45 degrees C TP700 Verify Temp NVALID for both Verify baselines are set x4 and no more than 3 pixels Verify LEADS OFF message Verify 3 Lead operation for LEAD I Il verify 60bpm and 20bpm for respiration Correct leads off message in Lead II Correct Lead off messages for five lead Verify 5 lead operation for 11 IIl AVL AVR AVF V Verify Respiration 9 20 BPM Verify Respiration waveform Verify the HR 9300 BPM Verify that the gain works 5mv 2mv amp 4mv Verify Pace detect is functional 75BPM Verify ECG LOST is detected from VFIB Verify that ECG out works from J11 Verify Sine wave lt 5 decrease Verify sine wave in Monitor Mode Verify sin
55. is transparent to CO and other gases typically found in the medical industry The signal from the reference channel is processed similarly to that of the CO measurement channel The CO and reference detectors work by an effect known as pyroelectric Pyroelectric effect works by changing energy levels either increasing or decreasing that are imposed on a sensing element The detector is outfitted with an optical bandpass filter that passes only a narrow band of a determined wavelength of infrared energy The infrared source is modulated at 15 hertz Hz to provide varying energy for the detector and amplifier circuits Correction for temperature and pressure effects on the sample is implemented to maintain accuracy over a wide temperature and atmospheric pressure range nGenuity 8100E Series Service Manual Criticare Systems Inc Appendix CO2 Service Block Diagram The following block diagram aids in tracing the connections for the CO module co2 Board Pump Motor L 1 1 1 1 1 1 828 Es I 3 S amp 1 3 i 1 1 1 e ITI 1T 1L 1 gt 1 1 S I dbi 24 Thermistor E 5 Power lt lt BC om Module 2 2 hri Assembly H 1 Hem fome 8 Main Board Solder Side Download Connector Rotary Encode
56. manometer The cuff pressure should be within 0 5 mmHg of each other Use the up and down arrows to adjust the gain unit until the pressures match each other Click Finish LI x r Software Cal Burn in file path Cancel C PROGRA 1 Csi T ools Nibpsve ncalbum Browse Help Adjust gain up and down with arrows Click Finish to accept calibration mmHg 2155 0 Gain adjust 6 NIBP Module 71 Fact controlled inflation Figure 6 8 Finish Calibration 11 A window will appear on the screen indicating that data is being stored Downloading C PROGRA 1 Sending record 24 0 Estimated time remaining Figure 6 9 Storing Data Page 6 8 nGenuity 8100E Series Service Manual Criticare Systems Inc Section 6 Service Testing and Calibration 12 A Positive Confirmation message will appear Click Done NIBP Performance 1 Unit Calibration E Software Cal Burn in file path Cancel C APROGRA 1NCsAToolsWWibpsvchncalbum Browse Help Calibration results Positive Confirmation Cutt mmHg 0 5 o 4 Gain adjust 71 Fact controlled inflation 50643 NIBP Module Figure 6 10 Positive Confirmation Message NOTE If a confirmation fails power cycle the monitor and recalibrate If the zero base point is out of range manually set the NIBP module Restart the service pr
57. on the front panel to turn on the 2 Rotate the menu knob to highlight CONFIG in the main menu and press the knob once to select it The CONFIG window appears DAY 11 Freeze timeout Alarm tone warning Language Line Frequency Restore Factory Defaults Enter Service Mode Enter Simulation Mode Patient size MM DD YYYY MONTH JUN 17 47 2 minutes ON ENGLISH 60 NO NO NO Adult YEAR 2007 Figure 2 1 CONFIG Configuration Window 3 Rotate the menu knob to highlight Enter Service Mode and press to select The value EXIT Date Format Date Time Freeze timeout Alarm tone warning Language Line Frequency Restore Factory Defaults DAY 11 Enter Service Mode Enter Simulation Mode Patient size NO is highlighted MM DD YYYY MONTH JUN 17 47 2 minutes ON YEAR 2007 ENGLISH 60 NO NO NO Adult Figure 2 2 Enter Service Mode Highlighted nGenuity 8100E Series Service Manual Page 2 1 Section 2 Service Windows 4 Rotate the menu knob to highlight YES and press to select The Enter Service Mode dialog box appears Enter Service Mode gt gt gt CAUTION lt lt lt All monitoring Will be stopped Enter password Figure 2 3 Password Window for Service Mode 5 To enter the service mode enter the password PIA418 by doing the following e Rotate the menu knob to select a character e Press the menu knob to enter each character e Ifa mistake is ma
58. reading is between 10 0 and 10 1 power cycle the monitor and perform the CO Verification earlier in this appendix If the EXP CO reading is above or below this range proceed with the remaining steps Select CO2 Zero Cal with the rotary knob turn the knob until Abort CO2 Zero Cal is displayed and press the knob to abort the CO Zero Cal Using the rotary knob highlight CO2 Gain Adjustment and press to select Turn the rotary knob clockwise to increase the reading and counter clockwise to decrease the it until the reading is as close to 10 096 as possible Go back to Step 4 and repeat until the EXP CO reading is between 10 0 and 10 1 at the end of the CO Zero Cal When the EXP CO reading is between 10 0 and 10 1 power cycle the monitor and perform the CO Verification earlier in this appendix nGenuity 8100E Series Service Manual Page A 9 Appendix A CO2 Service Disassembly NOTE The CO Calibration and Gas Flow CO Verification in this appendix are required after replacing the CO absorber or external or internal modules NOTE Perform appropriate safety tests listed on the Field Service Test Matrix in Section NOTE Before any disassembly of the monitor the battery must be disconnected Follow the procedure below Disconnect the Battery 1 Follow all ESD procedures as stated in Electrostatic Discharge in Section 7 Disassembly 2 Remove the two screws PH
59. table and the schematics in Drawings and Schematics in Section 9 to identify and locate components that malfunction Symptom Problem Solution Unit won t power up On Off LED is dark Battery is not connected Battery is discharged AC power cord is not securely connected to monitor AC outlet off or unpowered Fuses are blown Located below AC connection Main Board is disconnected Bad membrane Main Board fuse blown Fully seat battery connection Connect AC power cord Connect AC power cord to monitor Connect power cord to a live outlet Replace AC fuses pn 80131B002 Reconnect DC power cable at PS2 on Main Board Replace the keypad membrane Replace F2 on Main Board for battery or F4 for Power Source Cannot activate hardkey function or turn on monitor with AC power On Off LED is green Membrane panel is not securely connected Keypad membrane is bad Inverter is bad Main board is bad Reconnect ribbon cable to J7 on Main Board Replace keypad membrane panel Replace the inverter Contact CSI Service Department Display is blank or not readable Video screen cables to Main Board are disconnected or loose Inverter malfunction Inverter is bad Reconnect data and inverter cables to connectors on Main Board J2 J3 J4 and or J5 Make sure all Inverter connections are secure Replace the inverter NIBP air leak Defective cuff Defective hose Pneumatic tube leaks
60. the following lead configurations for following items heart rate 60 BPM RESPIRATION RATE of 20 2 breaths per minute and correct waveform ouod i II m 111 5 14 7 Use the Electrode status error messages the CRT to perform a lead off check in LEAD II a LL Red LL LEAD OFF b LA Black LEADS OFF c RA White RA LEAD OFF Connect all the leads back on the simulator and select ECG to 5 lead Set the monitor for LEAD Il waveforms Disconnect the following leads one at a time and look for the proper status error message and for the waveform to continue or flatline Reconnect the lead and the message should disappear and the waveform should return if it flatlined a 1 Brown V LEADS OFF b LL Red LL LEADS OFF C LA Black LA LEADS OFF d White RA LEADS OFF e RL Green LEADS OFF nGenuity 8100E Series Service Manual Criticare Systems Inc Section 5 Preventative Maintenance 9 Check the following lead configurations for following items Heart rate 60 BPM resp rate 20 x2 BPM and correct waveforms aVR 10 Verify that the respiration rate changes from 20 to 30bpm when changing on the MED SIM 300 Criticare Systems Inc nGenuity 8100E Series Service Manual Page 5 15 Section 5 Preventative Maintenance 11 Rotate the menu knob to highlight Display and press to select Under waveforms 3 6 Select RESP as TYPE
61. the red lead of the Hi Pot to Hot Neutral and the black lead to SpO Set up the Hi Pot per table above to Memory 21 Verify Hi Pot is now set to a Trip Current of 1mA and test 4242VDC for 1 second 5 Connect the red lead of the Hi Pot to Hot Neutral and the black lead to BNC Set up the Hi Pot per table above to Memory 21 Verify Hi Pot is now set to a Trip Current of 1mA and test 2500VDC for 1 second 6 Connect the red lead of the Hi Pot to Hot Neutral and the black lead to Nurse Call Set up the Hi Pot per table above to Memory 21 Verify Hi Pot is now set to a Trip Current of 1mA and test 2500VDC for 1 second Criticare Systems Inc nGenuity 8100E Series Service Manual Page 5 7 Section 5 Preventative Maintenance Leakage Test Equipment Perform all testing with the cover on The following test requires a and Setup Dynatech 232D leakage tester or equivalent 1 Perform a self test if applicable on the DYNATECH 2320 by plugging it into 110 VAC outlet Turn on the leakage tester Set the mode switch to self test Display should read 1000 20 and the CURRENT SOURCE ACTIVE lamp should be on NCAUTION If these conditions are not met do not continue with this test Set the mode switch on the Dynatech 232 to L1 L2 line voltage The display should read the line voltage 10 Set the mode switch to L1 GND The display should read no more than 596 of L1 L2 on a grounded power system Set the mode switch to L2
62. this point is equal to the patient s diastolic pressure which is stored by the monitor As cuff pressure continues to increase the pulse waveform as measured from BP cuff pressure fluctuation becomes stronger reaching its maximum at the patient s mean arterial pressure i e when cuff pressure mean BP The monitor stores this value as mean pressure As cuff pressure increases further it approaches the patient s systolic pressure and the cuffs pulse waveform decreases in amplitude The cuff pulse waveform disappears at the point where cuff pressure is equal to the patient s systolic pressure When the monitor determines that the cuff waveform has decreased to zero amplitude it stores the cuff pressure value as the systolic pressure and releases the pressure from the cuff This typically occurs at about 10 mmHg over the patient s systolic pressure The cuff then rapidly deflates Dynamic Measurement Ranges Systolic mmHg Diastolic mmHg MAP mmHg Adult 50 280 30 225 35 245 Pediatric 50 280 30 225 35 245 Neonate 50 135 20 100 30 120 Page 1 6 nGenuity 8100E Series Service Manual Criticare Systems Inc NIBP Clinical Testing and Accuracy Cuff Inflation and Pressure Protection Pressure in mmHg Section 1 Introduction This device was clinically tested per the requirements of EN 1060 and AAMI SP 10 The NIBP module as installed in the 8100E Series monitor has been tested to meet the performance specificati
63. two chest or abdomen ECG electrodes changes Respiration rate is calculated from this change in resistance The user may select ECG which uses the impedance measurement based off the lead or the respiration that is based off the capnogram There is also a selectable smart respiration function that can automatically switch sources if there is an interruption of waveform data The CO data is the primary source for the smart respiration function and it defaults to the CO source if it is available nGenuity 8100E Series Service Manual Page 1 5 Section 1 Introduction Non Invasive Blood The monitor uses ComfortCuff technology to determine non invasive Pressure NIBP blood pressure by means of oscillometry The oscillometric method detects volume displacements within the artery and senses pressure variations within the blood pressure cuff during inflation The monitor uses cuffs ranging in size from neonate cuffs to thigh cuffs Comfort Cuff ComfortCuff technology measures NIBP while the cuff inflates Technology Consequently a measurement is obtained more quickly and with less discomfort than with monitors which measure NIBP during cuff deflation Description of NIBP The NIBP cuff begins to inflate at the beginning of the NIBP Measurement measurement cycle As the cuff pressure approaches the diastolic pressure of the patient the cuff pressure waveform begins to indicate the pulse waveform The cuff pressure at
64. 01 onto the rotary encoder Place and secure the lock washer and the nut which is part of the rotary encoder onto the encoder Reassemble the monitor Attach the four 4 pieces that make up the foam gasket pn 43614B001 to the display pn 81520B001 Align the new display over the stand offs of the display chassis Secure the new display with four 4 screws Page 7 6 nGenuity 8100E Series Service Manual Criticare Systems Inc Bottom Chassis Repair Disassembly Speaker Replacement NIBP Chassis Replacement Power Supply Replacement Criticare Systems Inc Section 7 Disassembly Follow all ESD procedures as stated in Electrostatic Discharge Protection in this section Remove the battery following the instructions in Hemove the Battery in this section Remove the two 2 screws PHMS 6 32 X 0 375 SEMS pn 40180B002 from the rear enclosure pn 45179B001 Refer to Front Chassis Disassembly earlier in this section Remove the rear enclosure pn 45179B001 from the front enclosure assembly pn 45178B001 Label and disconnect the speaker wire from J20 on the Main PCB Remove the speaker assembly pn 95257A002 and the speaker mounting plate pn 426338001 from the chassis bottom Position and place the speaker assembly over the speaker insulator Position and place speaker mounting plates pn 42633B001 onto chassis speaker studs 5 Secure speaker with
65. 05 07 12 DO NOT SCALE PRINT KHAWVER 03 05 07 TOLERANCE UNLESS OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL 020 INFORMATION AND MAY BE COPIED OR DIVULGED XXX 005 WITHOUT WRITTEN CONSENT OF CRITICARE SYSTEMS INC ANGLES 1 DEGREE E PARTNO FINAL ASSEMBLY FNAL 93979A011 4 302 or REV DATE DESCRIPTION BY 1 04 17 07 SEE 9166 sc 2 12 19 07 SEE 10053 RWK 3 5 1 08 SEE 10136 DBL 4 8 21 09 10416 DBL E d 9 i ees DETAIL B A REFERENCE P N AN 404968001 REFERENCE P N 40995B001 TORQUE 6 IN LB TORQUE 8 IN LB REFERENCE P N 40180B002 ge TORQUE 8 IN LB NOTES 1 Remove the 2 screws for the Battery Door 2 screws near the power inlet 2 screws for the printer cover 6 six screws on the bottom including insulator and 8 screws securing the rear encloser then remove rear enlcosure 2 Modify the rear enclosure as shown using drill fixture T3314 Make sure that the enclosure is pressed firmly and completely against the fixture before drilling Secure two 2 standoffs Item 5 42431B002 to the rear enclosure using two 2 KEPS nuts Item 6 40284B002 REFERENC
66. 06 14 2006 SEE 8891 185 3 5 1 08 10136 DBL 4 8 20 09 10416 DBL A 1 TIGHTEN SCREWS ITEM 8 FLUSH AND DO NOT OVER TIGHTEN USE 93979 ASSEMBLY PROCEDURE SEE 8100 DRAWING FOR LABEL PLACEMENT OF 95773AXXX LABELS SW 24 ANGLES 1 DEGREE SYSTEMS INC W LSOROKA 1 SOROKA 3 7 06 oat 01 06 2006 Ed A KAPLAN 3 8 06 1 2 DO NOT SCALE PRINT A J SZOLYGA 1 9 06 TOLERANCE UNLESS OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL 020 INFORMATION AND MAY NOT COPIED OR DIVULGED 005 WITHOUT WRITTEN CONSENT OF CRITICARE SYSTEMS INC TITLE FINAL ASSEMBLY 8100E PART NO 93979 A001 4 302 SHEET or TORQUE 6 IN LB NOTES A 1 TIGHTEN SCREWS ITEM 8 FLUSH AND DO NOT OVER TIGHTEN REVISIONS REV DATE DESCRIPTION 1 5 12 06 SEE 8842 2 06 14 2006 SEE 8891 185 3 5 1 08 10136 DBL 4 8 20 09 10416 2 USE 93979 ASSEMBLY PROCEDURE ADD PAPER ITEM 4 TO PRINTER 4 SEE 8100EX DRAWING FOR LABEL PLACEMENT OF 95773AXXX LABELS SW CRITICARE SYSTEMS INC
67. 0pF 1KV Se 001 3 C158 Bz 10 0 l 1 0uF Ta U24A 7 LMC6482 MC34072 i Ras 016 432K 5VREF 2 5VREF 4 SVREF NY 2 5VREF SVREF R74 10K 17 1 lt 2 5VREF RB 8 RESPOUT LL RESP L RESP 243K IN gt lLREP lt ES 1 RA RESP RESP COM yas BARES RESP BW a RESP BW RESP Bw SHON osl BASEIMP BASEIMP RESP GAIN RESP GAIN RESPOUT ESPOUT 5VREF RESP GAIN 450 0 80 Ua SO o uso MAX4514 8 40 o lt 10 a 2 510 10 1 o 9 2 5VREF 2 5VREF 5 5 o_o vec VDD S 50 50 VSS GND X GNDANL NY ELECTRONIC FILE NAME JAPERM 507EDX HW191342A00X 91342A003 91342S003R1 91342S3RV1 DSN CRITICARE SYSTEMS INC CONFIDENTIAL This document contains confidential information and may not y 20925 Crossroads Circle Waukesha WI 53186 be copied or divulged without written consent of CRITICARE SYSTEMS INC DRAWNBY DJR ENG APPR ai PART NUMBER REV CREATION DATE 913428003 1 ITHO Q A APPR LAST MODIFIED DATE TITLE Tuesday June 20 2006 8100 ECG ANALOG BOARD CHECKED BY MFG APPR SHEET SIZE D DIST 306 SHEET 3 OF 3 3 AFTER SOLDERING SECURE PCB WITH CSI P N 400468001 OR EQUIV AS SHOWN N A SEE NOTE 4 98 2 9 5 BB SEE NOTE 2 CRITICARE SYSTEMS INC 913394001 REV MADE IN USA COMPONENTI SIDE SOLDER SIDE NOTES 1 ASSE
68. 1 Section 1 Introduction Pulse Oximetry Measurement SpO Definition DOX Digital Oximetry Method Page 1 2 The monitor uses Digital Oximetry DOX technology to measure blood oxygen saturation SpO Hemoglobin exists in the blood in several forms e Oxygenated Oxyhemoglobin Reduced Deoxyhemoglobin Dyshemoglobins carboxyhemoglobin and methemoglobin In the monitor SpO pulse arterial oxygen saturation is the ratio of oxygenated hemoglobin to the sum of oxygenated hemoglobin plus hemoglobin which is available for binding to oxygen as expressed in the following formula oxyhemoglobin oxyhemoglobin deoxyhemoglobin Un percent oxygen saturation Dyshemoglobins such as carboxyhemoglobin and methemoglobin are not directly measured and therefore are not factored into the measurement The monitor does not use analog circuitry for signal processing Digital signal processing in the microprocessor results in lower noise from circuitry components resulting in a cleaner signal and better performance under low perfusion conditions There is also improved rejection of noise from the patient and environment due to the availability of the true unfiltered sensor signal for digital signal processing The digital pulse oximeter measures oxygen saturation and pulse rate using the principles of spectrophotometry and plethysmography The sensor is completely non invasive and there is no heat sourc
69. 19 vet CRITICARE TORQUE 8 IN LB A TYSTEMS INE Ww LSOROKA SOROKA 2 16 06 pate 01 05 2006 Mena 3 A KAPLAN 3 8 06 sae 1 2 DO NOT SCALE PRINT me J SZOLYGA 1 9 06 TOLERANCE UNLESS OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL 020 INFORMATION AND MAY BE COPIED OR DIVULGED 005 WITHOUT WRITTEN CONSENT OF CRITICARE SYSTEMS INC ANGLES 1 DEGREE RELEASED DOCUMENT Tor 7 ASSEMBLY MAIN MONITOR 8100E EP 92800A00 1 7 Ds s or 7 TORQUE 8 IN LB SEE DETAIL A SEE DETAIL A TORQUE 8 IN LB TORQUE 6 IN LB TORQUE 8 IN LB 19 18 TORQUE 8 IN LB REVISIONS REV DATE DESCRIPTION BY 1 5 15 06 2 06 14 2006 SEE ECN 8842 DBL ECN 8891 185 11 29 2006 9026 185 4 8 18 09 SEE ECN 10416 DBL d lt Pd A N 2 SAC TORQUE 8 IN LB 27 TORQUE 5 IN LB A RELEASED DOCUMENT TORQUE 6 IN LB ATTERY INSTALL WITH TERMINALS UP q DETAIL SCALE 1 1 SLIDE FLAT PRINTER CABLE FROM CHASSIS ASSEMBLY ITEM 1 THROUGH THE SLOT IN THE ENCLOSURE REAR ITEM 3 BEFORE AA INSTAL
70. 1A PF2 LCASANATTIBREQO PBSIAI3 A 05 5 H AS 45D BOOT2TX BOOTS 2 WFUASHZ 1 1 110 4 E16 06 6 BOOT2RX Too 38 88 PFO BREQ PB3 A11 o AT U32A BLA31AG601SN4D 27 28 2 10 a 27 A 74HCTA MUXED 400KX4 TQ 9 4PUMP ABSPRESS CRA30 reece E15 10 AT is 4 4 1 a BOOT2RX sg BLA31AG601SN4D P33 RXD1 12 Hs ATS D25 H AE Tex sir 3 L6 H P31TXD1 PCA AA A gt E14 ICSRAM2 22 cer ale 4 58 Paorrxbo PONAS BLA31AG601SN4D IMRD2 24 15 A16 Er A 2 THWR2 29 16 50 15 ano PC1 A1 Ree aA cg 00 399250 57 O2BNCHHT 1 A18 L NEONRTE 64 P27IPOTITIOCBSITMO1 Pag 5 Nc m us 82 P26 POG TIOCAS TMOO U31B 2 D B ERR SS P2SIPOS TIOCBA TMCHI PD6 D14 BLASTAGSDTSNA R256 DNI R51 5 2 67 p4poAmTIOCAA TMRH 205 13 137K R185 GAR P23 PO3 TIOCD3 TMCIO PD4 D12 i 50 100 i 4 BPVALVE2 70 22 2 BLA31AG601SN4D F257 45D li 3 IRSRCEDRV IS 15HZ 50 IRSRCEDRV P2tPOVTIOCS 9 U36A 2 438V 316mm U40A 74H02 C161 4 Eo BOOT 1 P20POU TIOCAS 1 9 0 CO2BOOT 112 edi 0109 4 5 74H 1279V 158mm 4 5 CORIALVET 1H D AICIK ITIOCAO POB A PE REIL DACK TIOCBOIPOSIPI I
71. 4 7 h 18 EXTAL 25559 PANADIRQS 2L 51 BOOT 115 0 PA5 A21 RQ5 JDVALID u15 500 H5 2 PASIA20 IROS 22 SVALID __ ni 4 MD1 PA3IA19 H _ TRESET 118 MODE 6 paints 2 ADT 27 AAA a owe Vv REEL lio res 1 1 at Ae 5 z 8 392 5 RN2 100KX2 Sol 16 MB ADDR A15 9 4 245 d 38D g 7 SPACE 1 4 PB6 A14 18 4 31 ADS 26 sd TX 9 cH CANH 3 17 1 32 ADZ 2 gt a 5D DRGATE DEOR WAITIBREQO PDA 16 12 BLA3216B601SG4 CRA6 47X4 33 ADT 24 AD C45 8 1 4 SETRA OVERRIDE WRFLSH 88 pro BREQ PB3 A11 14 1 8 1 8 34 ADO 5 23 Apo 002 1 ae 5 4165 ESL 3 128KB FLASH PB2IA10 13 9 i 5 3 a 21 5 7 EUM 2 100 250 4 DG 889 P3sisck1 PB1 AO 45 AR ALEJAS 1 4 1 4 11 4 8 4 5 RD A 34 o 1 5 TWRCAN ROIE yone 5 302 820250 R87 4 NA 10 RT oor 8 9 E4 32168601504 47 4 19 18 pps T zo 1 1 459 3 pesas mca x g 2 I TXUSETUPIN 4 31 1 PCAIAA 2 1 2 H xu 8 HS P30 TXDO 2 i 8 3 2090 V xn2 RST TP 6 of TO POT a ATF1500AL R104 SJA1000T J 9 lt 7 m E
72. 4 2 M ps RESPOUT 4 5 98 3 RD TPAD 43 PFSIRD ECGV 3 6 97 82 4 5 ALE 4 ANZIPA2 PFG AS mE 2 96 AN1 P41 id RIS 1 95 ANO P40 P67 CS7 IROS 29 pene tw 4 5VREF PGG CSG IRQ2 20 3 2 Te HIRSTI 1 100K 10 C108 C99 103 POSIRQT 52 TEMPSELC 1 8 054 a AVSS P64 IRQO 50 POWER 4 H VREF ICSCAN 10KX4 RN12 PS1 PS2 PGO DREQU CS4 82 OUT n HE 22 lt Pe1 TENDO CSS 61 La l 1 4 MAIN BOARD CONNECTOR SENS 44 P62 DREQT Fas TEMPSELB P4 CHAP 8 tm 4 PGS TEND1 FORE 5 sp 2 AMP 13 CANL 91 c75 POWER 9 E u25 4 9 Ao A LP2951ACM 5 9 9 Zen 120 JEXTROM C16 R11 ECGON 10KX2 CSOIPG4 149 RSTSYS TP8 PLM250S50 T oo Vv 1 4 TX2 89 CSi PG3 TPAD EcGPwM 77 t 1 T 8 2 18 wen 3 T 220pF 100 ROATE 80 P51 RXD2 CSS PG1 PA do 22 52 3 2 _ 116 RSTSETUP 15 1 1 74 10 P53 ADTRG 22290999 CASIPGO PTH 1801 51 222220202 NM p 9 99 CMsH1 60 C58 HEADER 10 RNB oc R106 moez cu 10K DOWN LOAD CONNECTOR mo o 475 v 2 TP BLACI I2 1 pu SMBJ33AT3 R100 4 IECGON HD64F2357TE FRPP di i Ja 417 100K Ri51 iB S DNI 1 92 CMSH2 40 RI 93 ION POINT 1 4 015 t ds GROUNDS U23 1 47X2 0914 LM2586S ADJ v 1 o 50 i 2 d7 po vo 4 O POWER 9 8 4
73. 5 Section 7 Disassembly Display Assembly Display Removal 1 Membrane Replacement 1 Display Installation 1 Follow all ESD procedures as stated in Electrostatic Discharge in this section Remove the battery following the instructions in Remove the Battery described in this section Remove the front main chassis as described previously in this section Remove the four 4 screws PHMS 4 40 X 0 312 SEMS pn 40995B001 that hold the chassis to the front enclosure Remove the monitor chassis assembly pn 92803A001 from the front enclosure Remove the four 4 screws pn 409958006 that hold the display to the assembly Tilt display forward and disconnect all connectors Remove the Display assembly from the front chassis Remove the rotary encoder shaft using 11mm wrench Carefully press the membrane switch from the chassis Retain silicone tubing from membrane studs Position the membrane switch pn 45177B001 over the display chassis 42637B001 Align the four 4 threaded studs the membrane switch with the four 4 holes on the display chassis Push on the membrane switch and place silicone tubing onto the four 4 threaded studs Slide the encoder shoulder washer 42640B001 onto the rotary encoder pn 42140B001 Insert the rotary encoder through the rear of the display chassis so that it protrudes through the membrane switch Slide the encoder flat washer pn 42641B0
74. 53186 be copied or divulged without written consent of CRITICARE SYSTEMS INC o 6 DRAWN BY DJR ENG APPR REV 4 M CREATION DATE 913425003 1 6 QA APPR us an S ne LAST MODIFIED DATE TTE 8100 ECG ANALOG BOARD 12 Y Tuesday June 20 2006 v aR a CHECKED BY MFG APPR 74HC221 SHEET SIZE D DIT 306 SHEET 2 OF 3 5 z 3 2 1 5 I a I 3 1 TPS 10 VOLTS ANALOG so u2 180 LP2951 50 EL emi SQ c2 cs 10uF 10T E T 47 R2 DNI ZS on 180 CMSH240 10 VOLTS C20 v TP7 ANALOG 480 791 05 001 vo 5A R21 R20 400 1 2 1 nH i Y 49 9K 49 9K d ca LI ca at A a TN2106 Ta titus c pi Ae d AAA 1K MC34072 V NY R24 10K 1 0180 L 4 tour lt Respiration R36 5VREF ANALOG GND DIGITAL GND 012 raw 2 5800 pi LL RESP n INCL BASEIMP J 10 0k 7 R57 footprint RARESP rp SOXFMR 27
75. 6 CSI 409948002 OR EQUIVALENT INSULATING THE TOP IN BETWEEN DETAIL A AND UNDER EACH LEAD TO ENSURE ISOLATION REQUIREMENTS INSULATING THE TOP IN BETWEEN AND UNDER EACH LEAD TO ENSURE ISOLATION 4 SOLDER 165 169 TO TO TOPS OF TZ1 TZ5 5 FINISHED BOARD SHALL MEET CURRENT 600 6012 STANDARDS RELEASED DOCUMENT 6 FINISHED BOARD THICKNESS SHALL BE 062 010 VENDOR SHOULD COMPLY WITH THE FOLLOWING CSI QUALITY 7 011 MUST BE A NATIONAL LM358M P N 600568002 REQUIREMENTS Q1 Q2 Q4 Q5 Q6 Q7 Q10 Q11 AND Q16 IN ADDITION THE QUALITY REQUIREMENTS 09 Q13 AND 017 APPLY SEE 8 BOARD ASSEMBLY HOUSE IS TO PROVIDE SERIALIZATION OF EVERY BOARD CSI WEB SITE www csiusa com pdf QA_Requirements pdf FOR THE DEFINITION OF THE QUALITY REQUIREMENTS 9 CSI RESERVES THE RIGHT TO INSPECT THIS ITEM AT THE VENDORS FACILITY VENDORS INSPECTION SYSTEM AND MANUFACTURING PROCESS ARE SUBJECT TO REVIEW APPROVAL VERIFICATION AND ANALYSIS BY AUTHORIZED CSI REPRESENTATIVES ALL CHANGES IN DESIGN COMPONENTS PROCESSES OR FABRICATION MUST BE AUTHORIZED IN WRITING BY CSI PRIOR TO IMPLEMENTATION ALL DEVIATIONS FROM DRAWINGS C RITICAR E SPECIFICATIONS OR OTHER REQUIREMENTS MUST BE REPORTED TO CSI FOR APPROVAL PRIOR TO SHIPMENT ALL RAW MATERIALS USED TO PRODUCE THIS PART SHALL BE TRACEABLE TO AT LEAST A LOT LEVEL ALL TRACEABILITY AND INSPECTION RECORDS MUST BE IDENTIFIABLE TO THE RAW MATERIALS PARTS ASSEMBLIES OR DEVICES TO WH
76. 78B001 92810A001 42127B005 87285B001 87277B002 45182B001 42141B002 42431B011 40995B001 40995B003 40496B001 40180B002 40083B002 42731B001 40067B001 83338B002 42115B001 42431B007 41955B001 40067B003 40294B001 42634B002 42643B002 80519B001 40283B002 Description AY CHASSIS MONITOR ENCLOSURE FRONT AY REAR ENCLOSURE 8100EP WINDOW FILTER 8100E INSERT EXTERNAL CONNECTORS FOOT 7 16 OD X 5 82 HIGH BATTERY DOOR KNOB ROTARY ENCODER CUSTOM STANDOFF M F 6 32 X 1 5 P H M S 4 40X 312 SEMS P H M S 4 40X 500 SEMS 5 6 32X 375 SEMS 5 6 32X 375 PL PH F H M S 8 32X 375 PH PL 5 8 32 X 5 PL INTERNAL SEM PHILLIPS CABLE TIE 4 0 DISPLAY FILM SCREW FH 4 3 8 HI LO PH STANDOFF M F 6 32 X 7 8 FOAM TAPE 1 0 X 2 12 CABLE TIE 8 HOLDER TIE WRAP ADH BK SM BRACKET BATTERY LOCK FOAM PAD BATTERY BATTERY SLA 12V 5AHR WASHER FLAT 4 NY 032 Criticare Systems Inc Section 9 Drawings and Schematics Main Monitor with 92800A002 ASSEMBLY MAIN MONITOR W CO2 CO Assembly Criticare Systems Inc Item 01 02 03 04 CSI Part 92803A001 45178B001 92810C001 42127B005 87285B001 87277B002 92811A001 928114002 45182B001 42141B002 42431B011 40995B001 40995B003 40496B001 40180B002 40083B002 42731B001 40067B001 83338B002 42115B001 42431B007 42431B009 40284B002 42634B002 42643B002 80519B001 40283B002 41955B001 40067B003 40294B001 Description AY CHASSIS MONITOR ENCLOS
77. 9 SC 3 6 19 09 SEE ECN 10416 DBL TORQUE 5 IN LB ALIGN EDGE OF INSULATOR ITEM 5 WITH EDGE OF BOARD AS SHOWN 60006606 CRITICAR SYSTEMS INC GROUND WIRE DRAWN DBL wa L SOROKA 2 24 06 STRIP 25 EACH END 2 24 06 mm 55 M LARSEN 2 24 06 ER TEM 43 FIRST SCALE 1 1 DO NOT SCALE PRINT AK HAWVER 2 24 06 THEN TO ANALOG 52 CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL BOARD ITEM 1 AT XX 020 INFORMATION AND MAY NOT BE COPIED OR DIVULGED TO RQ UE 5 IN LB LOCATION P6 jr WITHOUT WRITTEN CONSENT CRITICARE SYSTEMS INC A TITLE PART NO ANALOG BOARD ASSEMBLY WITH FLEXIBLE SHIELD 91353A003 3 pis 302 SHEET or RELEASED DOCUMENT TORQUE 4 IN LB TORQUE 4 IN LB REVISIONS REV DATE DESCRIPTION 1 5 15 06 SEE 8842 2 1 18 07 SEE 9079 SW x CRITICAIR E SYSTEMS INC W LSOROKA 5 Am L SOROKA 3 7 06 oat 01 05 2006 Ed KAPLAN 3 8 09 SAE 1 2 DO NOT SCALE PRINT A J SZOLYGA 3 9 06 TOLERANCE UNLESS OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL 020 INFORMATION AND MAY NOT COPIED OR DIVULGED 005 ANGLES 1 DEGREE WITHOUT WRITTEN CONSENT OF CRITICARE SYSTEMS INC TITLE PRINTER MO
78. A003 and set on an ESD safe mat If only the Printer PCB needs to be replaced go to step 4 If the print head needs to be replaced a Remove the three 3 screws pn 41458B001 and the two 2 brackets 45188 001 and pn 45189B001 holding the print head in place b Remove the print head 840058001 c Place the new print head into the printer assembly d Reattach Ribbon Cables J2 and 43 e Reattach the brackets with the three 3 screws removed earlier Place Printer PCB in the assembly and fasten with the three 3 screws removed earlier Position the printer module assembly pn 92804A001 over the main monitor assembly Connect the ribbon cable to the printer module and insert the module into the main monitor assembly with etch facing PCB Insert the two 2 screws PHMS 4 40 x 0 312 SEMS pn 40995B001 and secure Criticare Systems Inc nGenuity 8100E Series Service Manual Page 7 3 Section 7 Disassembly Front Chassis Repair Disassembly 1 Remove and retain encoder knob from front unit by rotating and prying the knob off Remove and retain four 4 nylon screws pn 42654B002 and clear plastic insulator pn 40083B002 from bottom of unit Remove and retain two 2 phillips flat head screws from bottom of unit Remove and retain two 2 phillips flat head screws from rear of unit near power entry module Remove and retain two 2 phillips pan hea
79. ALOG BOX After setting the patient size e g NEONATE start from the main window to access and set the defaults for your facility s custom profile 1 Press and hold the DEFAULT button on the front panel for approximately two seconds The Set Unit Defaults dialog box appears NOTE If the Set Unit Defaults dialog box that prompts you to enter a password did not appear you did not hold the button in properly In this case with the menu knob highlight and select CANCEL or you could lose the settings you just created 2 Enter the password LIA608 by doing the following Rotate the menu knob to select a character Press the menu knob to enter each character f you make a mistake advance to the end of the password and start over After you press the menu knob for the last character of the password the monitor indicates acceptance of the password by displaying the Set Unit Defaults window When the Set Unit Defaults window displays both SELECT and CUSTOM DEFAULTS are highlighted Set Unit Defaults Set current configuration and alarm settings as new unit default settings SELECT EDIT CUSTOM DEFAULTS ACCEPT ALTERNATE CARE STD DEFAULTS STD DEFAULTS STD DEFAULTS CANCEL Figure 2 11 Set Profile Before Modifications Criticare Systems Inc nGenuity 8100E Series Service Manual Page 2 11 Section 2 Service Windows ENTERING THE NEW PROFILE TITLE 1 With both SELECT and CUSTOM DEFAULTS highlighte
80. AM PAD 8100E PUMP 27 40496B001 P H M S 6 32X 375 SEMS 28 40893B001 WASHER FLAT 8 PL 29 41371B001 TAPE INSUL KAPTON 2 30 41557B001 THRDLOCK ASSURE SURF CUR 31 40067B001 CABLE TIE 4 0 nGenuity 8100E Series Service Manual Page 9 9 Section 9 Drawings and Schematics External Module 92811A002 CO2 MODULE AY EXTERNAL 8100E P Assembly Item CSI Part Description 01 45205B001 ENCLOSURE EXTERNAL CO2 02 91785A001 AY PLATE PNEUMATIC PLUGS 03 91782A004 AY MANIFOLD WT W TRAP DETECT GREY 04 95780A001 AY TRAP DETECT 8100E 06 42686B001 SHOULDER SCREW 07 42687B001 CLIP MANIFOLD 08 41458B001 P H M S 4 X 250 HI LO 09 40570B004 ABSORBER IBENCH 10 42299B001 RETAINER TRAP DETECT 11 42300B001 MOUNTING BLOCK TRAP DETECT 12 42064B005 F H M S 4 40X 500 PH PL 13 41002B002 TYGON TUBING 063 ID X 125 OD 14 42692B001 PAD 1 00 X 25 15 40995B001 5 4 40X 312 SEMS 16 40596B001 ADHESIVE EPOXY HYSOL E 90FL 17 42496B001 WASHER FLAT 4 BRASS Page 9 10 nGenuity 8100E Series Service Manual Criticare Systems Inc Section 9 Drawings and Schematics Display Chassis Assembly 92802 001 ASSEMBLY CHASSIS DISPLAY Assembly Patient Connectors Criticare Systems Inc Item 01 02 03 04 957674001 Item 01 CSI Part 42637B001 81520B001 40614B001 90859A005 83265B003 45177B001 45181B001 40132B001 42140B001 42640B001 42641B001 43614B001 40296B001 40995B005 40995B006 42652B001 Description CHASSIS DISPLAY
81. AND BE SIGNED OFF BY THE VENDORS QA REPRESENTATIVE VENDOR SHALL FURNISH A COPY OF ACTUAL INSPECTION TEST RESULTS ASSOCIATED WITH EACH SERIALIZED ITEM INSPECTION AND TEST PARAMETERS OPERATIONAL MECHANICAL ELECTRICAL ENVIRONMENTAL ETC SHALL BE DEFINED BY CSI MANUFACTURING ENGINEERING EACH ASSEMBLY SHALL BE IDENTIFIED WITH THE CSI PART NUMBER AND REVISION FOR THE ASSEMBLY AND A UNIQUE SERIAL NUMBER IN HUMAN READABLE FORMAT SERIAL NUMBERS SHALL NOT BE DUPLICATED THE FORMAT FOR THE SERIAL NUMBER SHALL CONTAIN AT LEAST 2 ALPHABETICAL PREFIX CHARACTERS THAT ARE RELEVANT TO THE VENDOR TO DISTINGUISH BETWEEN MULTIPLE VENDORS THE ASSEMBLY PART NUMBER REVISION AND SERIAL NUMBER SHALL ALSO BE LABELED ON THE PCB ASSEMBLY IN BARCODE FORMAT USING CODE 39 PREFERRED OR CODE 128 EACH INDIVIDUAL ASSEMBLED PCB SHALL BE PACKAGED IN CONDUCTIVE STATIC SHIELDING BAGS OR CONTAINERS AND IDENTIFIED WITH ESD WARNING LABELS IF CSI P N 68005B001 IS NOT AVAILABLE REFER TO INSTRUCTION SHEET CSI P N 91339A1 ALT FOR ALTERNATE BUILD IF ALTERNATE BUILD IS IMPLEMENTED MARK THE REVISION AS REV 7A ON THE PCB AND ALSO NOTE THIS ON THE CERTIFICATE OF COMPLIANCE REMSIONS RELEASED DOCUMENT VENDOR SHOULD COMPLY WITH THE FOLLOWING CSI QUALITY REQUIREMENTS Q1 Q2 Q4 Q5 06 07 010 011 AND Q16 IN ADDITION THE QUALITY REQUIREMENTS 09 Q13 AND 017 APPLY SEE CSI WEB SITE www csiusa com pdf QA Requirements pdf FOR THE DEFINITION OF THE QUALITY REQUIREMENTS
82. ARE SYSTEMS INC 8 INSERT SCREW ITEM 4 THROUGH HOLES 012 AND HS1 AS SHOWN IN DETAIL A ADD KEPS NUT ITEM 5 AND TORQUE TO 5 IN LB RELEASED DOCUMENT E em 9 INSERT WIRE WITH TERMINAL ITEMS 6 amp 7 INTO HOLE ABOVE J11 8100E1 EP1 ASSEMBLY 91340A005 5 MAIN PCB BOARD SED F CSI0391 Rev 0
83. AX352 10 10 HIRSTV 0 5 2 15 o bs m 40k gt n NY SETRA OVERRIDE AD620AR Le CH2 e 2 5VREF 9 cuo 4 4 i 2 LA RA 4 4 2 5 ECG CHANNEL cH MAX352 GAINIV MAX352 1K 7 2 5VREF 40 R14 kei u320 4 610 1 1 LL R107 ms 9 1K 5VREFO 1 1 3 1 249K alt sas 10 249K se SETLL 5 MAX352 10K s MAX352 3 LEAD SUPPORT R38 1410 1151 LA 15 4 14 MAX352 NOTES 8 R39 ES 1 All resistor values are in OHMs and SETLA ECGDIS 1 108 1 8MD unless otherwise wrt 1 25 noted 10K 2 All capacitor values are in uFd UNLESS NOTED 10 10 C103 i a PACER DETECT CKT NY COMPLETE SHIELDING 5D 50 EXCEPT ON POWER SUPPLY UK 1 50 R67 44 1 301K GEXT SH2 SH3 U12A PTHs PTHs PTHs PTHs Co5 5 P6 ECGSIG 4 UnA R64 REXTICEXT GND PIN 1 1 PACETRG a id 4 PACETRG 212 an m 453 274K d ale 3d Bin a JECGDIS 27AK i P13 4 221 HIGH PASS FILTER 5 100K 50 TPAD JPACERST AAC GAIN X7 8 Sw 1K SVREF PACER IPACEDIS COMPARATOR R152 33 2K Uc UNUSED PARTS ELECTRONIC FILE NAME JA PERM 507EDX HW191342A00X191342A003 91342S003R1 91342S3RV1 DSN 2 w CRITICARE SYSTEMS INC CONFIDENTIAL This document contains confidential information and may not iilo mE V188 74 20925 Crossroads Circle Waukesha WI
84. Appendix A CO2 Service Gas Flow CO Verification TOOLS NEEDED Criticare Systems Inc Flow Meter e Vacuum Gauge 0 25 inches of mercury WaterChek 2 Water Trap CAT 938F NC Sample Line CAT 625N e Calibration Gas 10 CO with accuracy 2 CAT 622 Regulator CAT 623 Regulator Bleed Tube CAT 613B NCAUTION Calibration kits contain compressed gas cylinders Read and obey all precautions listed on the gas cylinder labels Do not use if the calibration gas cylinder is beyond its expiration date Check the accuracy of the test gas The gas must be within the accuracy stated above to ensure proper verification NOTE Make sure the monitor is not in STAND BY mode before proceeding with the following procedures PREPARATION 1 Insert a water trap CAT 938F NC and sample line CAT 625 on the 8100E1 monitor 2 Turn the 8100E1 monitor on and allow to run for 30 minutes FLOW VERIFICATION 1 Connect a flow meter to the end of the sample line and measure the flow The flow should be 200 ml min 10 20 0 ml min 2 Disconnect the flow meter from the sample line OCCLUSION TEST 1 Connect a vacuum gauge to the sample line There should be more than 12 5 inches of mercury of vacuum 2 Verify that CO2 OCCLUSION appears on the monitor and that the pump turns on 3 Disconnect the vacuum gauge from the sample line nGenuity 8100E Series Service Manual Page A 5 Appendix A
85. B001 41458B001 40995B005 45209B001 Description ENCLOSURE PRINTER DOOR PRINTER PRINTER SEIKO PCB AY SEIKO PRINTER BRACKET PRINTER BRACKET PRINTER SMALL DOWEL PIN 125 D X 2 0 L P H M S 4 X 250 HI LO 5 4 40X 25 SEMS INSULATING DOT 1 4 INCH Criticare Systems Inc Appendix Service Service Windows Monitors with CO will have additional items in the Service Mode window The additional items are highlighted below Enter NIBP Service NO Enter C02 Service NO Software Download No action taken Permanent Alarm Silence Enable ST Arrhythmia Keycode Invalid Keycode Current Software Revisions Main Display Processor Rev 2 0 NIBP Processor Rev 6 6D Vital Signs Processor Rev 6 2A 02 Processor Rev 0 3B Unit Serial Number 111111111 Unit Part Number 93979AXXX Keycode Base Number 00000000 Figure A 1 Service Mode Window Operating Mode User Mode Zero Cal Abort CO2 Zero Cal Gain Adjustment Turn to Incr Decr Press to Save Factory Defaults No Action compensation OFF Figure A 2 CO2 Service Window Criticare Systems Inc nGenuity 8100E Series Service Manual Page A 1 Appendix A CO2 Service Theory of Operations Capnometer Module Page A 2 The capnometer contains the circuitry for monitoring the sidestream level by actively sampling from the patient s airway It contains provisions for interfacing with galvanic oxygen monitoring option sub modules No electr
86. B001 LABEL CSI MON BAR CODE 10 46426B004 LABEL HARDWARE REVISION 4 nGenuity 8100E Series Service Manual Criticare Systems Inc 8100E1 With 939794011 Item 01 02 03 04 Section 9 Drawings and Schematics FINAL ASSEMBLY 8100E1 CSI Part CAT 8100E 92811A001 928114002 40496B001 42431B009 40284B002 46547B001 46162B001 46426B004 46599B001 Description NGENUITY MONITOR CO2 MODULE AY NGENUITY CO2 MODULE AY EXTERNAL 8100E P P H M S 6 32 375 SEMS STANDOFF M F 6 32 X 1 25 NUT 6 32 KEPS PL LABEL SERIAL NUMBER ENG LABEL CSI MON BAR CODE LABEL HARDWARE REVISION 4 LBL DEFIB SYMBOL 8100EP1 With 939794012 FINAL ASSEMBLY 8100EP1 and Printer Criticare Systems Inc Item CSI Part CAT 8100EP 92811A001 928114002 40496B001 42431B009 40284B002 46547B001 46162B001 46426B004 46599B001 Description NGENUITY MONITOR WITH PRINTER CO2 MODULE AY NGENUITY CO2 MODULE AY EXTERNAL 8100E P P H M S 6 32X 375 SEMS STANDOFF M F 6 32 X 1 25 NUT 6 32 KEPS PL LABEL SERIAL NUMBER ENG LABEL CSI MON BAR CODE LABEL HARDWARE REVISION 4 LBL DEFIB SYMBOL nGenuity 8100E Series Service Manual Page 9 3 Section 9 Drawings and Schematics Main Monitor Assembly 928004001 AY MAIN MONITOR Page 9 4 Item 01 02 03 04 05 06 09 10 12 14 15 16 17 18 19 21 22 23 24 25 26 27 28 29 30 31 nGenuity 8100E Series Service Manual CSI Part 92803A001 451
87. CPU2RX S gt TOCPUBRX 90 050 TOCPU2SCK 5 T0CPUZCLK PSDSCKD _ CRA29 10 4 1 82 PSSADTRG vec Best emp o sores 120 8 R68 4 643V 300 4 SIA estes 118 Mx 2 T 2 14 66nV mmig 52 62 0 1229 onmag 494 BPVALVE2 0 2 2 32 vedU0nalig Sn E 7 33nV mnlig Ki 99000000 Lis COzBNCHON oe comp 6 a aus 25992599 NMI Nc 7 sisgzspy 7 7 R182 190 HD64F2357TE R205 1 1 100K 100K 10K 4 ley NY eus 7 DNI L 0805 1010 R167 R178 R168 22986 CO2 CONNECTOR sr c n OP296GS DNI CRA32 13 3K 93 1K it 1 99 2 10T 4 010 8 C12 C108 C187 R176 MUXB Li 0 10 gt aR 2s A458 R169 R149 TP12 3 7 ne 10108 3 RAUK 7 32K 82 5K 5 4 R73 JDPOTICS NY 82 5K CRA34 507265 X 2 DNI CR3 JDPOT3CS 3 4 ad L s 45 6 CO2BNCHON 1 8 COZ OFF 8 1 7 8 wn sw H TN2106 Sre R148 R72 2 F 3 COZRXD 81 10 9 4 200 CR35 COZTXD 6 3 15K 1M HGHLOWRNG 4 a COZ BOOT 4 COZPUMPSPD 1 8 R177 SD 1 8 CRA36 IRSRCEDRV 2 JO2FLAG NEONATE NEOB _74HC4066 c87 DNI f 5 5 7 PES PWR_SW 1 1 oH O2ZERO 4 5 CRAS JDPOT CS 6 3 9 crass ICOZFLAG 1 4 R175 475K 150 pF DNI CO2PU
88. Component Side AC Line EE Isolation Board Not Used Active LED Not Used Not Used x c 3 4 nGenuity 8100E Series Service Manual Criticare Systems Inc Section 4 Cleaning and Disinfecting Cleaning and Disinfecting Pulse Oximeter Sensors Blood Pressure Cuffs Criticare Systems Inc NWARNING N e Shock Hazard Before cleaning a monitor and sensor turn the power off and disconnect the AC power cable Shock Hazard Never immerse the monitor because the monitor has an internal power source that is active even when the unit is unplugged Do not use abrasive cleaners on the monitor or on any sensors or probes Abrasive cleaners damage the monitor sensors and probes With the exception of the display screen wipe clean the exterior surface of the monitor with alcohol Dry it with a soft dry cloth Because paper towels or tissues can scratch the surface of the display use a cotton cloth to clean the monitor Do not use full strength alcohol on the display screen Repeated use of strong cleaners damages the screen Clean the display window by wiping it clean with a soft lint free cloth sprayed with common glass cleaner however do not spray glass cleaner directly on the display NCAUTION Do not immerse any Criticare pulse oximeter sensor connector in any liquid because it damages the connector The SpO sensor can be wiped clean with alcohol Disi
89. Current AC Technical Support Phone Number Serial Number Part Reference Number Placement of cuff over the brachial artery Blood Pressure Cuff Single use device only Do not reuse Recyclable cardboard paper packaging nGenuity 8100E Series Service Manual Page 1 15 Section 1 Introduction Safety Definitions Definitions for Warning and Caution symbols Warnings Page 1 16 Designates a possible dangerous situation NWARNING Non observance may lead to death or the most severe injuries Designates a possible dangerous situation NCAUTION A Non observance may lead to minor injuries or damage to the product NWARNING N Read this manual entirely before attempting clinical use of the monitor Inspect For Damage User should inspect the system for signs of damage Do not use the system if failure is evident or suspected Possible explosion hazard Do not use the monitor in the presence of gas mixtures which may be flammable Do not use this device in conjunction with flammable anesthetics such as cyclopropane and ether The monitor can sample from pure oxygen environments but the monitor itself should never be placed inside an oxygen rich environment such as an oxygen tent or gas containment apparatus When not in operation this device is not intended to be connected to any pressurized source containing an enriched oxygen environment All cords must have hospital grade plugs and be plu
90. D 17 40041B022 TUBING SHRINK 75 CLEAR 18 87151B006 HOUS SOCKET 098 LOCKING 20 41157B001 THRDLOCK ASSURE SURF CUR 21 41700B002 TUBE POLYU 125 X 250 85DU 22 40324B009 T CON 3 32 X 3 32 X 1 8 23 40324B015 TEE CONNECTOR PLASTIC 093 X 125 X 125 24 40325B002 STRAIGHT CONN 1 8 TO 1 8 25 40633B001 FILTER 130U RED NY ELEM Page 9 8 nGenuity 8100E Series Service Manual Criticare Systems Inc Internal Module Criticare Systems Inc Assembly Section 9 Drawings and Schematics 92811 001 CO2 MODULE AY NGENUITY Item CSI Part Description 01 91783A001 AY PNEUMATICS CO2 02 91784A001 AY PLATE PNEUMATIC RECEPTACLES 03 914074001 AY PCB 2 04 42689B001 CHASSIS CO2 INTERNAL 05 94254A004 AY PUMP W CONNECTOR 3 WIRE 06 41188C201 CO2 DETECTOR 07 83304B001 GASKET DETECTOR IR SOURCE 08 40995B005 5 4 40X 25 SEMS 09 40496B002 5 6 32X 250 SEMS 10 40496B004 P H M S 6 32X 500 SEMS 11 42643B001 FOAM PAD BATTERY 13 42688B001 FITTING ELBOW 1 8 1 16 14 41002B002 TYGON TUBING 063 ID X 125 OD 15 40320B001 TYGON TUBING 1251DX 150D 16 40887B002 SPACER NY 6 250D 250L 17 42691B001 WASHER SHOULDER 6 40 LONG 18 46597B001 LBL MANIFOLD CONNECTIONS 19 46598B001 LBL PNEUMATICS RECPTACLES 20 90903A002 AY CABLES VALVES CO2 21 40283B002 WASHER FLAT 4 NY 032 22 40132B001 TAPE MICROFOAM ADH BACKED 23 95787001 ACCULULATOR PVC 11 INCH 24 40067B003 CABLE TIE 8 25 90926A002 CABLE AY NIBP TO MAIN BOARD 26 42155B001 FO
91. DOCUMENT SW 2 pcs as shown on print Lock tabs must be towards the outside edge must snap into place 2 Insert mating part 91784A001 to Item 2 in RI ICAR E order to center the male crimp pin of Item 4 SYSTEMS INC Check that the lock tabs are still holding tabs must DRAWN SC CHECK ENG be towards the outside edge must snap into place 2208 DATE 01 04 07 QA DATE APPR L Penton 03 01 07 3 Add adhesive Item 16 with a syringe to the mem MFG NIS DO NOT SCALE PRINT 01 openings of Item 2 from where the wires stickout ares of Item 2 fill to the end of the cavity 2 places TOLERANCE UNLESS OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL 020 INFORMATION AND MAY NOT COPIED OR DIVULGED 4 After adhesive is tack free 4 hours remove XXX 005 WITHOUT WRITTEN CONSENT OF CRITICARE SYSTEMS INC 91784A001 and install remaining items ANGLES 1 DEGREE TITLE PART NO VENDOR SHOULD COMPLY WITH THE FOLLOWING CSI QUALITY ADD ADHESIVE ITEM 16 HERE AFTER INSERTING PIN DETAIL A REQUIREMENTS Q1 Q2 G4 Q5 Q6 7 010 Q11 AND 016 CO2 MODULE 928 1A002 5 SEE NOTE 3 2 ASSEMBLY EXTERNAL FOR THE DEFINITION OF THE QUALITY REQUIREMENTS DIST SHEET or CSI 0384 Rev 0 A TORQUE 4 IN LB 4 PLACES SE
92. DULE ASSEMBLY PART NO 92804A001 302 SHEET 1 REVISIONS REV DATE DESCRIPTION BY 1 3 15 07 9135 DBL 6 25 l 2 8 15 07 SEE 10032 DBL 3 04
93. E NOTE 1 2 e TORQUE 6 IN LB DID ae 10 TORQUE 6 IN LB NUT AND LOCK WASHER ARE PARTS OF ROTARY ENCODER ITEM 9 CUT TUBING PIECES 25 LONG 1 4 LONG 2 PLACES A 1 25 LONG NOTES ZX 1 CONNECT CABLE FROM DISPLAY ITEM 2 TO BACKLIGHT INVERTER ITEM 5 AT THE TOP OF THE BOARD GRAY WIRE TOWARDS INSIDE POSITION 2 ATTACH 1 4 INCH TUBING ITEM 15 TO ALL FOUR THREADED STANDOFFS LOCATED ON THE MEMBRANE Z 3 USE 92802P001 ASSEMBLY PROCEDURE N A SESS CUT TUBING PIECES A A S e 1 4 LONG 2 PLACES SEE NOTE 1 9 di d dd P dii TORQUE 2 IN LB A A TORQUE 2 IN LB A 8 I REVISIONS REV DATE DESCRIPTION 1 5 15 08 SEE ECN 8842 2 06 13 08 SEE ECN 8888 3 10 04 06 8932 4 01 22 07 SEE ECN 9079 5 04 17 07 SEEECN 9166 6 19 09 SEEECN 10416 TLE GY CRITICARE SYSTEMS INC ANT SOROKA SOROKA 02 16 06 01 03 2006 nore M LARSEN 02 16 06 sae 1 2 DO SCALE PRINT A J SLOLYGA 01 6 06 TOLERANCE UNLESS OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL XX 020 INFORMATION AND MAY NOT BE COPIED OR DIVULGED XXX 005 WITHOUT WRITTEN CON
94. E P N 3 Remove 2 screws on each side of the chassis assembly to 40995B003 drop the front Install the CO2 cable into J16 of the Main PCB Install the CO2 internal assembly Item 2 and secure it using four 4 screws Item 4 404968001 4 Re install the rear enclosure including insulator battery A cover and printer cover using previously removed hardware Reference current released 92800A001 and 93979 001 002 P documentation for screw information 5 Carefully line up and install the external CO2 Module Item 3 92800 002 and secure using two 2 screws Item 4 40496B001 Do not force the connection 6 Add defib label PN 45699B001 part of label set PN 95773A001 over the water trap manifold as shown 7 Print barcode label Item 8 containing CAT part and serial Place behind clear window on serial number label em 7 A 8 Place current revision Item 9 onto the serial tag Item 7 SW REFERENCE P N 427318001 vet CRITICARE SYSTEMS INC EG CHECK mc E 5 COOGAN 03 05 07 5 RUE 01 16 06 DATE nee AKAPLAN __ 03 05 07 1 2 DO NOT SCALE PRINT KHAWVER 03 05 07 TOLERANCE UNLESS OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL 020 INFORMATION AND MAY BE COPIED OR DIVULGED XXX 005 WITHOUT WR
95. E QUALITY REQUIREMENTS Q9 013 AND Q17 APPLY SEE CSI WEB SITE www csiusa com pdf QA_Requirements pdf S W FOR THE DEFINITION OF THE QUALITY REQUIREMENTS COMPARTMENT AND APPROXIMATELY 2 INCHES FROM RIGHT SIDE ND TO THE MAIN BOARD GROUND TEMS INC sys w LSOROKA A L SOROKA 3 7 06 owe 1 5 2006 RELEASE DATE KAPLAN 3 8 06 1 2 DO NOT SCALE PRINT MG r J SZOLYGA 1 9 06 TOLERANCE UNLESS OTHERWISE SPECIFIED 020 INFORMATION AND XXX 005 ANGLES 1 DEGREE CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL WITHOUT WRITTEN CONSENT OF CRITICARE SYSTEMS INC MAY NOT BE COPIED OR DIVULGED TE ASSEMBLY CHASSIS MONITOR 92803001 5 p se or CSI 0386 Rev 0 SSP IRI TORQUE 8 IN LB DAES gt M 742524 NS e CE 27 DEJ QTO 2 TORQUE 20 IN LB 5 LONG AA n LB A 2 lt GROUND GREEN YELLOW WIRE FROM ITEM 6 CONNECT BLUE WIRE FROM ITEM 6 20 TORQUE 8 IN LB 1 75 13 1 44 13 REVISIONS REV DATE DESCRIPTION BY 1 03 20 06 SEE 8715 LBS 2 05 15 06 SEE 8842 DBL
96. E SERIAL NUMBER IN HUMAN READABLE FORMAT SERIAL NUMBERS SHALL NOT CONSE OR RTT CARE STEMS ING BE DUPLICATED THE FORMAT FOR THE SERIAL NUMBER SHALL CONTAIN AT LEAST 2 ALPHEBETICAL PREFIX CHARACTERS THAT ARE RELEVANT TO THE VENDOR TO DISTINGUISH BETWEEN MULTIPLE VENDORS THE ASSEMBLY PART NUMBER REVISION AND SERIAL NUMBER SHALL ALSO BE LABELED ON THE PCB ASSEMBLY IN BARCODE FORMAT USING CODE 39 PREFERRED OR CODE 128 ASSEMBLY 8100 91342 A003 4 EACH INDIVIDUAL ASSEMBLED PCB SHALL BE PACKAGED IN CONDUCTIVE STATIC SHIELDED BAGS OR CONTAINERS AND IDENTIFIED WITH ESD WARNING LABELS ANALOG BOARD DIST o 510390 Rev 0 SOLDER SIDE 856028005 012 3 2 NOTE TRIM EXCESS LEADS ON TP1 2 TP4 TPS AND 8 REMSIONS REV DATE DESCRIPTION BY SEE SHEET 1 VENDOR SHOULD COMPLY WITH THE FOLLOWING CSI QUALITY REQUIREMENTS 01 Q2 Q4 Q5 Q6 Q7 Q10 Q11 AND Q16 IN ADDITION THE QUALITY REQUIREMENTS Q9 Q13 AND 017 APPLY SEE CSI WEB SITE www csiusa com pdf QA Requirements pdf FOR THE DEFINITION OF THE QUALITY REQUIREMENTS CRITICARE SYSTEMS INC By By APPR pate 12 19 05 AD APPR scale 1 1 5 DO NOT SCALE PRINT Aes APPR TOLERANCE UNLESS OTHERWISE SPECIFIED XX 020 XXX
97. EF 680PF a 4 MAX352 2 5VREF GT SMD1812150 40 8 7 9 57 GAIN11 2 5VREF Lo 10 R111 SVREF R13A 1 240K R112 249K NY 2 1 5 2 5VREF 20KRV 100Kx4P juss 7 HIRSTV 2 032 o8 68PF 68PF 1 4 2 High voltage levels under defib conditions C167 123 GAIN 52 RI 20K 5 680 INST AMPR GT SMD1812150 4 Jumper straight R3 2005 10 2 5VREF 2 5VREF across CHKl pads DCC2 C68 C147 1 5VREF 10 10 Pt 20K596 R154 5VREF ECG FILTERCLK 100 10 p TH tN eet kA o 10 H 2 KR 2 2 1 RA RESP 1 RA YY M ute A R127 VS GND 2 1 2 1 LL 4 9K 1 gt 2 5VREF cuo pim 1 1 DNI 2130 RABF 2 ow x T a 304K qd TP20 V SARAN 45 1 1 RL 822 Reg 6160 4 1 4 4 5VREF TPAD 6 RI3D LBF 2 1 4 FILTERCLK 2 R7 205 3 4 5 ACT 61 R144 FILTERCLK _ FILTERCLK ini P CAO 1 2 43 5 100 R143 R130 1 1 0 2 SPACING S 100KX4P 100kx4P DNI e 5 1 62M 178K 8 PACER C1687 c27 c2 7 LABF al REF gt 680 68 T er MIN gt S ECG Gain M 7 E 2 lo G 500 es a m AD620AR o MAX352 6 HI 6 2000 BETIS MN 0047 if GAIN 19 25 o o M 410 680PF GT SMD18121 prior E 10 1 304K SEU 10 9 10 1 34 21020 21 Sty 2 R23 77 4
98. Er T 1 Te 1 1 4 1 1 100K 100K 1 R39 1 EE w CRITICARE SYSTEMS INC CONFIDENTIAL This document contains ct v H 2 3 to 2 5V 74 20925 Crossroads Circle Waukesha WI 53186 be copied or divulged without written consent d M 3 220 2 IBOOT1 74HC14 1 4 3 MFLASH2 C43 C234 Gi 3 MFLASHT cies DNI 0 033 DRAWNBY KRISHNAN K ENG APPR PART NUMBER 40S005 REV 4 5 bil 01 5VREF TGD2 V bb Smith 5 15 06 91 3 4 ADMAD2E 57 4 R241 g TRSGRD CREATION DATE Robb Sm 0 3 Tida 7 gt pmucoss 116 Si aw MEM EG 8100E1 EP1 MAINBOARD 74HC14 LAST MODIFIED DATE 5 BOOTITX THIN TIOUT TX3 COM2CON 1K R133 Alex Kaplan 5 15 06 7 1 1 2 NI Bootz BOO HEX T20UT Bonn RE _ con nw MMBZSV6ALT 1 ee 5 171004 38 25 5 5 Wednesday January 24 2007 ETRA 12 9 RIIN F3 5 9 100K Wire to BATT CHECKED BY MFG APPR SHEET SIZE DIST 306 SHEET 1 OF 3 BOOT2RX gt gt BOOTARK 9 E R 1 T SHORT PIN 8 GND FOR 1 a Jon Szolyga 5 15 0 SHORT PIN 1 TO GND FOR 2 FOR FLASH DOWN LOAD IN BOOT MODE 2 3 v 5 4 g 7 z
99. GND NOTE This should read about the same as the L1 L2 reading for a grounded system Leakage Test Procedure The monitor must be powered up during all of the isolation tests 1 Set the mode switch on the Dynatech 232 to L1 L2 The display should read the line voltage 1096 Set the mode switch to L1 GND The display should read no more than 5 of L1 L2 line voltage on a grounded power system Set the mode switch to L2 GND This should read about the same as the L1 L2 reading for a grounded system Turn the mode switch to CASE LEAKAGE GROUND CONDUCTOR Connect the AC cord from the Dynatech 232D to the 8100E P and turn on the unit With the POLARITY switch in the NORMAL position Press OPEN GROUND and monitor the readout for less than 500 pA Verify that the green AC LED lights up on the front membrane NOTE The 8100E Series monitor must be powered up during all of the isolation tests Change the polarity switch to the REVERSE position press OPEN GROUND and monitor the meter for less than 500 pA With the POLARITY switch in the NORMAL position press OPEN NEUTRAL and OPEN GROUND switches and monitor the meter for less than 1 mA Change the POLARITY switch to the REVERSE position and press the OPEN NEUTRAL and OPEN GROUND switches and monitor the meter for less than 1 mA Page 5 8 nGenuity 8100E Series Service Manual Criticare Systems Inc Section 5 Preventative Maintenance 6 Connect a Dy
100. ICH THEY APPLY AND SHALL BE AVAILABLE UPON REQUEST OR AUDIT BY CSI SYSTEMS INC REPRESENTATIVE Br By APPR D RIECK 02 23 06 FIRST ARTICLES MUST BE INSPECTED AND ACCEPTED BY A CSI QUALITY REPRESENTATIVE PRIOR TO A PRODUCTION SHIPMENT UNLESS OTHERWISE AUTHORIZED BY CSI THE FIRST ARTICLES MUST BE INSPECTED pate 12 19 05 BATE APER A KAPLAN 02 23 06 AND OR TESTED FOR COMPLIANCE TO THE REQUIREMENT OF APPLICABLE ENGINEERING DRAWINGS AND SPECIFICATIONS FIRST ARTICLES MUST BE SO MARKED AND INDENTIFIED WAIT A PART NUMBER ANY MAJOR SCALE 1 1 5 DO NOT SCALE PRINT 9 JSZOLYGA 02 23 06 TOOLING PROCESS OR COMPONENT CHANGE WILL REQUIRE A NEW FIRST ARTICLE EVALUATION EACH LOT OF PARTS SHALL BE ACCOMPANIED BY A LEGIBLE COPY OF A CERTIFICATE OF COMPLIANCE LISTING THE TOLERANCE UNLESS DRAWING SPECIFICATION PROCESS AND APPLICABLE REVISOIN TO WHICH THE PARTS COMPLY AND BE SIGNED OFF BY THE VENDORS QA REPRESENTATIVE VENDOR SHALL FURNISH A COPY OF ACTUAL INSPECTION OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL TEST RESULTS ASSOCIATED WITH EACH SERIALIZAED ITEM INSPECTION AND TEST PARAMETERS OPERATIONAL MECHANICAL ELECTRICAL ENVIROMENTAL ETC SHALL BE DEFINED BY CSI MANUFACTURING 020 INFORMATION AND MAY NOT BE COPIED OR DIVULGED ENGINEERING EACH ASSEMBLY SHALL BE IDENTIFIED WITH THE CSI PART NUMBER AND REVISION FOR THE ASSEMBLY AND A UNIQU
101. IFICATION PROCESS AND APPLICABLE REVISION TO WHICH THE PARTS COMPLY AND BE SIGNED OFF BY THE VENDORS QA IN ADDITION THE QUALITY REQUIREMENTS Q9 Q13 AND Q17 APPLY REPRESENTATIVE SEE CSI WEB SITE www csiusa com pdf QA Requirements pdf FOR THE DEFINITION OF THE QUALITY REQUIREMENTS EACH ASSEMBLY SHALL BE IDENTIFIED WITH THE CSI PART NUMBER AND REVISION FOR THE ASSEMBLY AND A UNIQUE SERIAL DETAIL A E NUMBER IN HUMAN READABLE FORMAT SERIAL NUMBERS SHALL NOT DUPLICATED THE FORMAT FOR THE SERIAL NUMBER DETAIL A CRITICARE SHALL CONTAIN AT LEAST 2 ALPHABETICAL PREFIX CHARACTERS THAT ARE RELEVANT TO THE VENDOR TO DISTINGUISH BETWEEN MULTIPLE VENDORS THE ASSEMBLY PART NUMBER REVISION AND SERIAL NUMBER SHALL ALSO BE LABELED ON THE PCB SYSTEMS INC ASSEMBLY IN BARCODE FORMAT USING CODE 39 PREFERRED OR CODE 128 RAW HECK BGR SMITH 2 8 07 BY BY APPR 4 CONNECTOR J9 J10 J11 J13 AND J15 MUST BE MOUNTED STRAIGHT AND FLUSH TO PCB 9 12 06 DATE oa KAPLAN 2 19 07 5 ORIENT J11 CONNECTOR AS SHOWN 1 1 DO NOT SCALE PRINT MS HAWVER2 19 07 6 INSERT SCREW ITEM 2 INTO HOLE OF 089 CONNECTOR AS SHOWN TORQUE TO 5 IN LBS OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL 020 INFORMATION AND MAY NOT BE COPIED OR DIVULGED 7 INSERT WIRE ITEM 1 INTO HOLES ABOVE J15 AND TO THE RIGHT OF LOWER MOUNTING HOLE AS SHOWN Xt 005 gece MTHOUT WRITTEN CONSENT OF CRITC
102. ITTEN CONSENT OF CRITICARE SYSTEMS INC ANGLES 1 DEGREE RELEASED DOCUMENT 939794012 4 302 or REVISIONS REV DATE DESCRIPTION BY 1 5 15 06 SEE ECN 8842 DBL 2 06 14 2006 SEE ECN 8891 LBs 3 11 29 2006 SEE 9026 LBs 4 01 26 07 SEE ECN 9079 sc 6X 16 TORQUE 8 IN LB s sno SEE ECN 10136 4 3 09 SEE ECN 10407 DBL 7 7120 09 SEE 10416 DBL TORQUE SIN LB A TORQUE SEE DETAIL A AA SEE DETAIL A AA BATTERY INSTALL WITH TERMINALS UP A DETAIL A SCALE 1 NOTES A 1 SLIDE FLAT PRINTER CABLE FROM CHASSIS ASSEMBLY ITEM 1 THROUGH THE SLOT IN THE ENCLOSURE REAR ITEM 3 BEFORE INSTALLING ENCLOSURE REAR 2 AFTER MOUNTING ENCLOSURE FRONT ITEM 2 ON THE CHASSIS ASSEMBLY ITEM 12 SECURE THE SPO2 CABLE TO THE CABLE TIE HOLDER ON THE CHASSIS USING CABLE TIE ITEM 21 np EM FRONT SCREEN SURFACE USING DISPLAY FILM ITEM TORQUE 5 IN LB ZX 4 SECURE THE CHOKE OF THE ECG CABLE TO THE FRAME MAIN A USING FOAM TAPE ITEM 25 AND CABLE TIE ITEM 26 A 5 USE 92800P001 ASSEMBLY PROCEDURE 24 TORQUE 8 IN LB
103. LD 1 ABs 8 02 9 PB2 A10 MAS 9 09 32 u21 23 9 ABA 43 110 A4 Het o 6 6 34 MDD A3 8 ERR sane x ER mem Ed ovr 10KX4 COMIDIR 87d bay ecko J 27 11 on WB1 12 4 MATO 11 C ey MAT FL oo A6 VAT 1 CRAB 4 A12 Hes 2 14 MATT BATI 12 112 12 12 1 6 1 H 93 1 BOOTIRX 56 PClAG 2 2 6 MAS A13 H A 3 MATS MATZ BA12 9 13 BAIS 343 48 VDS 31 R27 10 0 92 1 P32 RXDO posas i i MAL JptastAGeots Na MATS A14 O14 28 ois JEXIRAM 22 cer ais 31 RE MATS BAT TEM MEM 14 MDO VOTO 33 99 21 3 6 4 XD1 4 8 A15 015 IMRD E 15 JMEMWR 44 O10 1 COMTIX 53 PO3 A3 48 416 TET EOM 29 9E 16 30 MATS BAIS JPCMCINTI 318 15 15 44 341010 ms RAS poe BKLTCON 4 2 MAT MAT 22 E 8 Mann MATS E 7 asp 17 wor P4238 101 8 BRIGHT 10 47X4 1 1 BLA31AG601SN4D 16 Nc gt R234 MATT 18 5 8 na MD15 MD12 ag 37 28 UCAS ORE IPRNRST 1 84 P27 PO7 TIOCBS TMO1 2 2 MDT 4500 Jnc 899 10 e ONIOFF PDO zE 12 19 ND 3191 0815
104. LING ENCLOSURE REAR 2 AFTER MOUNTING ENCLOSURE FRONT ITEM 2 ON THE CHASSIS ASSEMBLY ITEM 12 SECURE THE SPO2 CABLE TO THE CABLE TIE HOLDER ON THE CHASSIS USING CABLE TIE ITEM 21 FRONT SCREEN SURFACE USING DISPLAY FILM ITEM 4 CONNECT CO2 CABLE TO MAIN BRD J16 A 5 SECURE THE CHOKE OF THE ECG CABLE TO THE FRAME MAIN USING FOAM TAPE ITEM 32 AND CABLE TIE ITEM 33 ZA 6 USE 92800P002 ASSEMBLY PROCEDURE SW TH CRITICARE SYSTEMS INC DRAWN w SC wt 5 2 28 07 RELEASE 01 12 07 DATE 1 PENTON 3 01 07 1 2 DO NOT SCALE PRINT K HAWVER 3 01 07 TOLERANCE UNLESS OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL 020 INFORMATION AND MAY NOT COPIED OR DIVULGED 005 WITHOUT WRITTEN CONSENT OF CRITICARE SYSTEMS INC ANGLES 1 DEGREE mE PARTNO REV ASSEMBLY MAIN MONITOR 8100EC E2 92800A002 4 ser or A SEE DETAIL E FOR TORQUE 8 IN LB SEE DETAIL A WIRING CONNECTIONS MAIN BOARD EE NOTE WIRE SEE NOTE 3 SEE NOTE 2 A TORQUES IN LB Su id 1 4 I E GREEN YELLOW WIRE BLUE WIRE ex E Hl 97 x g
105. M 4 For laptops using a USB adapter select COM4 or an alternate COM port as necessary nGenuity 8100E Series Service Manual Page 6 5 Section 6 Service Testing and Calibration Calibration 1 Connect a serial download cable P N 90840A004 from the PC serial port to J10 on the Main Board COM2 2 Open the service tool on the computer Select Start gt Programs gt CSI NIBP Service gt NIBPSvc Close the disclaimer dialogue box 3 Select COM for the port and select 8100 Integrated NIBP for the model Click on OK 4 Click on Connection and select Open in Service Mode 5 Press the nGenuity 8100E monitor ON OFF key to start the monitor 6 Connect a 700cc dummy cuff and manometer to the NIBP fitting on the unit Page 6 6 nGenuity 8100E Series Service Manual Criticare Systems Inc Criticare Systems Inc Section 6 Service Testing and Calibration 7 Click on the Calibrate button to calibrate the NIBP module CSI NIBP Service Support Program 8100 Integrated NIBP B ioj xj Connection View Help i 350 Un Signals Clear 50 105107 0 A Lr ES 35 LOIS I MES Host made Service mode Mode Systolic mmHg Bownloa Service m Mean mm 7 Sta 9 Accuracy LEN pee Heart Rate bpm ee tu aa um Elapsed Time sec Speed Inflate T 7 Peak Pr sem Unt 0000 Peak Press
106. MBLY 91339A001 USES BARE BOARD 836038001 2 WRITE OR LABEL BOARD WITH CURRENT BUILD REVISION 3 CSI RESERVES THE RIGHT TO INSPECT THIS ITEM AT THE VENDORS FACILITY VENDORS INSPECTION SYSTEM AND MANUFACTURING PROCESS ARE SUBJECT TO REVIEW APPROVAL VERIFICATION AND ANALYSIS BY AUTHORIZED CSI REPRESENTATIVES ALL CHANGES IN DESIGN COMPONENTS PROCESSES OR FABRICATION MUST BE AUTHORIZED IN WRITING BY CSI PRIOR TO IMPLEMENTATION ALL DEVIATIONS FROM DRAWINGS SPECIFICATIONS OR OTHER REQUIREMENTS MUST BE REPORTED TO CSI FOR APPROVAL PRIOR TO SHIPMENT ALL RAW MATERIALS USED TO PRODUCE THIS PART SHALL BE TRACEABLE TO AT LEAST A LOT LEVEL ALL TRACEABILITY AND INSPECTION RECORDS MUST BE IDENTIFIABLE TO THE RAW MATERIALS PARTS ASSEMBLIES OR DEVICES TO WHICH THEY APPLY AND SHALL BE AVAILABLE UPON REQUEST OR AUDIT BY CSI REPRESENTATIVE FIRST ARTICLES MUST BE INSPECTED AND ACCEPTED BY A CSI QUALITY REPRESENTATIVE PRIOR TO A PRODUCTION SHIPMENT UNLESS OTHERWISE AUTHORIZED BY CSI THE FIRST ARTICLES MUST BE INSPECTED AND OR TESTED FOR COMPLIANCE TO THE REQUIREMENT OF APPLICABLE ENGINEERING DRAWINGS AND SPECIFICATIONS FIRST ARTICLES MUST SO MARKED AND IDENTIFIED WITH A PART NUMBER ANY MAJOR TOOLING PROCESS OR COMPONENT CHANGE WILL REQUIRE A NEW FIRST ARTICLE EVALUATION EACH LOT OF PARTS SHALL BE ACCOMPANIED BY A LEGIBLE COPY OF A CERTIFICATE OF COMPLIANCE LISTING THE DRAWING SPECIFICATION PROCESS AND APPLICABLE REVISION TO WHICH THE PARTS COMPLY
107. MPON 400K m j Ea PWR SW m 4 ES cz gt s 5 4 1 2 100uf 25V 3 4 lt gt 38 o sz R157 p 24 9K NIBP PUMP MOTOR DRIVER T 5P sA i R170 o 100K SHRGI DIS J Tesco d PWR SW O C220 4 SPKR 5VREF R90 R74 B 100K aa 2 I AAA 2 VW mu SPKR i BPPUMP_CTL S i o gt H asa 9 HA AUDIOGAIN lt 5 0 VOLT OP296GS 5 7 k 100K 9229663 19 pao 0914 bui 0229663 sa OA R222 RIS C106 5 0 4 11 2 1 MMBT4401 604K 7 5 5 R173 w 825 453 9 58 9 R172 13 3K Lo 5D E C27 TONE 2 D C219 NY EM l e 50 4 lt 50 lt 7 VSS GND cos D19 220327 Mose 14 Moma GND U54B z 5 R221 UM SHUTDWN gt P DRV TOTEMPBUFF 9 24 Q9 PUMP TEMP 1 047 9 Riso 999390 RI 330 6 1 P GATE pS ae 0 1 OHM m 0 335 E 1 INT VCC 021 2 100 uH zx 74 02 10 1 3 C191 M D E INT VCC NI 4 T 10075 W ie 023 Vv ITH sense 8 5 CMSH1 40 cat N GATE 1 cies Notes 2 2 2 All resistors are 1 1 10 a 6 TH unless otherwise noted 7 K Q 0800 001 All capacitors are in uF J PI unless otherwise noted C100 7 CRITICARE PART NUMBER 1340S Note Switcher signal ground and power 74 SYSTEMS INC 9 3 0 005 ww ground are tied toge
108. MS 4 40 x 500 SEMS pn 409958003 from the battery door 3 Remove the battery door pn 451828001 from the rear monitor enclosure pn 45179B001 4 Disconnect the cables from the battery 5 Reassemble in reverse order Page A 10 nGenuity 8100E Series Service Manual Criticare Systems Inc Check Replace the 1 Absorber 7 8 Appendix CO2 Service Follow all ESD procedures as stated in Electrostatic Discharge in Section 7 Disassembly Remove the two 2 screws PHMS 6 32 x 375 SEMS 40496B001 from the external module pn 928114002 Carefully pull the external module away from the monitor Once the external module is disconnected from the monitor check the condition of the CO absorber 40570 004 If the absorber is in good condition reassemble in reverse order and perform the Gas Flow CO Verification in this appendix If the absorber must be replaced continue with this procedure Disconnect the absorber Disconnect tubing Absorber Figure A 3 Disconnect CO Absorber Replace absorber Reassemble in reverse order Criticare Systems Inc nGenuity 8100E Series Service Manual Page A 11 Appendix A CO2 Service Replace the External Absorber Replace the Internal Page 12 Module Follow all ESD procedures as stated in Electrostatic Discharge in Section 7 Disassemb
109. ON AND MAY NOT BE COPIED OR DIVULGED 005 WITHOUT WRITTEN CONSENT OF CRITICARE SYSTEMS INC ANGLES 1 DEGREE TITLE PART NO REV POWER SUPPLY 957 10A003 WITH BRACKETS Dist 302 SHEET OF APPLY 1 0 PIECE OF TAPE WRAP AROUND EDGES OF SHIELD AS SHOWN 3 PL A 2 LONG 3 PL TORQUE 5 IN LB A TORQUE 5 IN LB 4 PLACES RELEASED DOCUMENT WRAP AROUND OUTSIDE EDGE OF SHIELD ITEM 3 CHECK ECG CONNECTOR KEY TO VERIFY POSITION AS SHOWN DETAIL A NTS 12 TORQUE 8 IN LB REVISIONS REV DATE DESCRIPTION BY 5 15 06 SEE ECN 8842 DBL 2 6 09 06 SEE ECN 8882 LBS 09 05 06 SEE ECN 8946 RWK 4 01 26 07 SEE 9079 SC 5 04 18 07 SEE ECN 9166 SC 6 05 04 07 9190 5 7 6 20 09 10416 DBL SEE DETAIL A A 1 WRAP SHIELD ITEM 8 AROUND MAIN ITEM 2 AND LOCK TABS INTO THE SLOTS OF THE SHIELD MAKE SURE ALL CONNECTORS ON THE PCB ARE LINED UP WITH THE OPENINGS IN THE SHIELD CLOSE THE GAPS ON THE TOP AND BOTTOM OF THE SHIELD BY BRINGING FRONT AND REAR OF THE SHIELD TOGETHER AND SECURE THEM IN THIS POSITION WITH ELECTRICAL TAPE ITEM 18 PER ASSEMBLY PROCEDURE ALSO SECURE THE TABS WITH THE ELECTRICAL TAPE ITEM 18 PER ASSEMBLY PROCEDURE 2 WHEN INSTALLING MAIN PCB ITEM 2
110. OUS ES m 2 m AB 222222 Maz es __ 100KX2 9 67 PBUSY 50 R20 4 X ABUS VD8 1 rama 4 I8 N 2 CTS 50 1246123 107 109 110 118 117 17 MA4 VAS 22888 PAS AZZIROS SOMBER DNI DNI DNI DNI DNI DNI DNI MATS 115 AB16 5 HE VAS 0 15KX4 OCLK PFTIOCLK PASIA21 IRQS_ 28 ao BLA31AG601SN4q RRA gt MATS 116 MAS et ie MD2 PASIA20IROS 28 MAAL 5 1 12 NA 14 58 VAB cis ses e t DN us zo gg oo es ajo 8 SD i ru uen vas HE dg 4 001 o l PA2IA18 8 MAI M 25 01 MDZ MD10 1 10 MAO 220 1 1 MATT 120 12 L59 y 37 SW JRESET IRES Hii BLA31AG601SN40N o2 H3 Mos MDT 7 02 2 rs MA4 MAT BAT 212 PD 211 i 11 MATO u22 5 SW R31 DNI 46 20 4 MA4 MA5 2 AB10 E RAMS 100 R247 10K TRY POAT a MAS 3 H MAG MA2 413 BB8 H 3 ABO 256Kx16EDODRAM m 1289 LION 6 14 18 2 MAG 0 5 05 MD14 6 BAG 5 PD14 ABB 16 6 2 MDS 20 6 BDu y MAT v5 3 4 0 JAT L E53 M88 EE Ris 8 ia BEA 8 e gt E 88 S HL f i BACK 4 8 3o vD a ooo 1 Tab FEAST Br PEMBACK Pega 5 fo 28 BAT oA 8 BA
111. RONT 6 NI NEEDLE VALVE MOUNT LOCATION TOP 7 LI LAMP AY MOUNT LOCATION TOP NOTES 1 APPLY 2 4 LONG PIECES OF FOAM TAPE ITEM 22 ALONG EDGE OF CHASSIS ITEM 4 AS SHOWN ASSEMBLE ITEM 25 amp 29 CHECK FOR FIT TRANSFER TO CONVERSION DEPT CUT 3 LEADS OF DETECTOR 6 TO 100 LONG FROM BOTTOM EDGE OF DETECTOR USE TOOL 110008 VENDOR SHOULD COMPLY WITH THE FOLLOWING CSI QUALITY REQUIREMENTS Q1 Q2 Q4 Q5 Q6 Q7 Q10 Q11 AND Q16 IN ADDITION THE QUALITY REQUIREMENTS Q9 Q13 AND Q17 APPLY SEE CSI WEB SITE www csiusa com pdf QA Requirements pdf FOR THE DEFINITION OF THE QUALITY REQUIREMENTS SW CSI 0385 Rev 0 REVISIONS REV DATE DESCRIPTION BY 1 04 17 07 SEE ECN 9166 SC 2 05 18 08 SEE 10227 RWK 3 12 17 08 SEE 10343 DBL SEE DETAIL A 4 4 1 09 SEE 10252 DBL PHS 2 PL TORQUE TO 5 5 29 09 SEE 10439 DBL 3 IN LBS 2 PL TORQUE TO 3IN LBS TIGHTEN UNTIL FULLY INSERTED FLUSH DO NOT OVER TIGHTEN VERIFY TUBING 2 PCS IS INSTALLED HERE PART OF ITEM 3 TORQUE TO 3 IN LBS AN ADD LOCTITE ASSURE 425 AFTER ASSEMBLY LOCK TABS TOWARDS FROM THE BACK SIDE OUTSIDE EDGE Recommended Build Sequence 1 Item 4 male crimp pin ends install into Item 2 RELEASED
112. RSECALL SON 20 Y 13 co NM DNI SHUTLED Yy suum cp 1 VE 92 1 750 20XXXXH 21XXXXH MD8 co E TONE VCC VDD Sd 4 T 04 P ds PRINTER DTASTRB BRR TDR ee MD8 15 4 n i mw ar ONZ gt gt TONE d 9 6 TRL 24 T2 EXT 2 ADM207 x 9gs 7 P m METRI ONCE CONINC CONU D PCMRST1 PCMRST2 EXT1 3 NURSECALLCON pour e DNI AUDIOGAIN gt gt AUDIOGAIN gp 50 X RS v m ISRAEL RE Rectore are 1 10W e SP 2AXXXXH 2 X h JTAGCON DATA COINCIDENT WITH or MRD TN TOU L 1 8 unless othenyise noted ON OFF gt gt ONOFF OMDR 1 All capacitors are in 4 IB e JCOMIDTR 8 T30UT ted gt gt SYINT KEYI amp KEY2 amp 12 AQV212 1 24 6 unless otherwise noted IRESI m KE info 11128 5000047 t 35 3 Bare board 835998005 VW DNI 7 CARDDET1 Cibi amp C1D2 N 2 p 202 BLA31AG601SN4D 1 CARDDET2 C2D1 C2D2 SS m COM 4 33D o R36 R2OUT 28 i 10K JCOMIDSR R3OUT 16 JBOOT2 IBOOT2 JM vto o 0 DSN Ae Br iA uv ECGOUTG N ELECTRONICFILENAME JAPERM 8100E P NGENUITY MAINBOARD 91340AQ051REV 019134050058 S Fron optocoupler o 1 5 Rande
113. SENT OF CRITICARE SYSTEMS INC ANGLES 1 DEGREE RELEASED DOCUMENT CHASSIS DISPLAY ASSEMBLY PART NO 92802A001 6 302 seg or A NUT PART OF ITEM 3 WASHER PART OF ITEM 3 NOTES OLERANCE ESS TIGHT SIDE SURFACE OF THE TEMPERATURE CONNECTOR c MEN CO HOULD BE PARALLEL T E OF THE INSER 24 THE WASHER PART OF THE ITEM 3 SHOULD BE INSTALLED ON THE CONNECTOR BEFORE THREADING IT INTO THE NUT FOR TORQUE VALUES SEE DRAWING ASSEMBLY PATIENT CONNECTORS 95767A001 3 pis 302 SHEET or INSERT NUT PART OF ITEM 3 INTO THE CORRESPONDING RECESS OF THE INSERT PATIENT CONNECTORS ITEM 1 AND THREAD IN TEMPERATURE CABLE ITEM 3 HAND REVISIONS DESCRIPTION SEE 8842 REV DATE 1 05 15 2006 2 05 16 2006 1 3 01 26 2007 SEE 8850 9079 AS SHOWN POSITION ECG CONNECTOR KEY DETAIL A NTS SW YOK CRITICAIRIE SYSTEMS INC DRAWN SOROKA ie LAE 2210 27 pate 01 04 2006 Le SOROKA 1 6 06 DATE A KAPLAN 2 16 06 scae 1 2 DO NOT SCALE PRINT Aw J SLOLYGA 1 6 06 1 REV DATE DESCRIPTION BY SERIAL NUMBER THIS 1 05 15 06 SEE ECN 8842 DBL pore 2 01 26 07 SEE ECN 907
114. SPO2 HIGH AMBIENT appears by introducing a higher than normal amount of ambient light on the SPO2 sensor detector Verify the message disappears within 10 seconds after you remove the ambient light Verify that the message SPO2 SENSOR appears when you plug the finger sensor in but without a finger actually inserted into the sensor Use an SpO finger sensor and verify that the heart rate and plethysmograph operation display on the LEDs within 15 seconds Verify that gt error messages do not appear alarm violations can occur depending on individual readings and monitor set up Verify the LCD displays a plethysmograph waveform Connect cable CAT 931A to 2 Plug BNC A of the cable into a oscilloscope channel In the CONFIG window ANALOG OUT SELECT select PLETH Use the SpOz finger sensor to verify that the SpO waveforms appear on the scope The waveform should be centered on 0 volts and register 1 volt peak to peak Remove the CAT 931A cable Verify that the pulse tone increases as you change the tone from 1 to 10 in the Alarm Setting window Use an optical load to simulate a small signal and verify that the message SPO2 SEARCH or LOST appears after search delay time 5 seconds An optical load that can be used for this test is a foam peanut used for packing Page 5 18 nGenuity 8100E Series Service Manual Criticare Systems Inc Section 5 Preventative Maintenance NIBP Verificat
115. Section 2 Service Windows Service Settings Several settings on the CONFIG window are password protected You should not change these functions during use and only biomed technicians or supervisory personnel should adjust the settings These functions include Alarm Tone Warning Line Frequency e Enter Service Mode Enter Simulation Mode To set the functions listed above do the following 1 Rotate the menu knob to highlight CONFIG in the Main menu and then press the knob once to select it The CONFIG window appears Date Format MM DD YYYY Date DAY 11 MONTH JUN YEAR 2007 Time 17 47 Freeze timeout 2 minutes Alarm tone warning ON Language ENGLISH Line Frequency 60 Restore Factory Defaults NO Enter Service Mode NO Enter Simulation Mode NO Patient size Adult Figure 2 9 CONFIG Parameters window 2 Rotate the menu knob to highlight the service function that you want and press to select Service Password enter the service mode enter the password P1A418 by doing the following 1 Rotate the menu knob to select a character 2 Press the menu knob to enter each character 3 If a mistake is made advance to the end of the password and start over Criticare Systems Inc nGenuity 8100E Series Service Manual Page 2 7 Section 2 Service Windows Alarm Tone Warning Set the Alarm Tone Warning value to ON to allow the monitor to Page 2 8 Line Frequency produce a low pitched double beep every 2
116. Shock Hazard Because a monitor is an AC powered device an immersed monitor presents a danger to anyone who attempts to handle the device Immediately perform the following steps following an accidental wetting of equipment 1 Turn the power off Disconnect the AC power cord from the monitor 2 If the monitor is monitoring a patient transfer the patient to another monitor as quickly as possible 3 Use a clean dry towel or cloth to remove the liquid from the monitor housing 4 A service technician should inspect the monitor as soon as possible 5 If the internal mechanism is saturated allow the liquid to drain out for 24 hours before shipping 6 If liquid has entered the monitor it must be dried and cleaned internally Full testing is required before you can use the monitor Contact the CSI service department as soon as possible Time is critical The longer any liquid remains in the monitor the more damage it can do It is important to service the monitor immediately after any liquid is spilled into it Page 4 4 nGenuity 8100E Series Service Manual Criticare Systems Inc Section 5 Preventative Maintenance Incoming Inspection You must inspect monitors coming back from service for shipping damage before you place them into operation just like newly purchased monitors The monitor should be free from dents cracks or other physical damage The quality inspection seal of the monitor should be unbroken indic
117. THE WIRES TO THE HOLDER WITH CABLE TIE ITEM 13 6 USE 92797PA002 FOR ASSEMBLY A VENDOR SHOULD COMPLY WITH THE FOLLOWING CSI QUALITY REQUIREMENTS Q1 Q2 04 Q5 Q6 07 010 Q11 AND 016 IN ADDITION THE QUALITY REQUIREMENTS 09 AND Q17 APPLY SEE CSI WEB SITE www csiusa com pdf QA Requirements pdf SW OR THE DEFINITION OF THE QUALITY REQUIREMENTS CRITICAR E SYSTEMS INC TORQUE TO 3 IN LB DRAWN CHECK ENG BY SC BY APPR QA t 08 09 07 a APPR MFG SCALE 11 DO SCALE PRINT APPR TOLERANCE UNLESS OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL 020 INFORMATION AND MAY NOT BE COPIED OR DIVULGED XXX 005 WITHOUT WRITTEN CONSENT OF CRITICARE SYSTEMS INC ANGLES 1 DEGREE TITLE PART NO REV RELEASED DOCUMENT ASSEMBLY NIBP CHASSIS 92797 A002 1 Dist sug A SEE NOTE 2 AA KAPTON TAPE CUT 5 LONG SEE NOTE 2 4 PL 7 IN LBS 4 LONG OUTSIDE EDGE SHOULD TOUCH INSIDE SURFACE OF CHASSIS END ITEM 4 ACCUMULATOR PUMP OUTER LOOP VG CRITICARE SYSTEMS INC ACCUMULATOR EXHAUST 7 ke m INNER LOOP PUMP IN BY SC BY APR 5 Coogan 01 31 07 01 11 07 AP Kaplan 02 02 07 TO P3 NTS DO NOT SCALE PRINT appr Hawver 02 02 07 2 A EXHAUST 28
118. Tools Accessory Testing e Fuse 5 4 Long Term Monitor and Battery 5 5 Monitor and Accessories Disposal 5 5 Electrical Safety Testing 5 6 Equipment 5 6 Withstanding Voltage Hi Pot Test Equipment and Setup 5 6 Withstanding Voltage Hi Pot Test 5 7 Leakage Test Equipment and Setup Leakage Test Procedure Ground Continuity Test je Functional Testing eere torri Interface Inspection nirai aiia ii Aii Manual Controls Check Alarms VerifiCatiOn iioii Printer Check i nee ete eet i ee Ret nGenuity 8100E Series Service Manual Criticare Systems Inc Criticare Systems Inc Module VerificatiOn 2 euer ECG Verification ECG Analog Output Test ondes nem ee EE RID eoe d 5 16 Diagnostic Monitor and ST Filter Mode 5 17 2 Verification esee nennen nennen nenne 5 18 NIBP VerifiCatiOi iioc eure rere pee reor ea Ua e erige Re eR Cx RE ERE 5 19 Temperature 5 20 Communication Testing sussana rd ede deve T ee
119. URE FRONT AY REAR ENCLOSURE 8100EP WINDOW FILTER 8100E INSERT EXTERNAL CONNECTORS FOOT 7 16 OD X 5 32 HIGH CO2 MODULE AY NGENUITY CO2 MODULE AY EXTERNAL 8100E P BATTERY DOOR KNOB ROTARY ENCODER CUSTOM STANDOFF M F 6 32 X 1 5 5 4 40X 312 SEMS 5 4 40X 500 SEMS P H M S 6 32X 375 SEMS F H M S 6 32X 375 PL PH F H M S 8 32X 375 PH PL P H M S 8 32 X 5 PL INTERNAL SEMS PHILLIPS CABLE TIE 4 0 DISPLAY FILM SCREW FH 4X3 8 HI LO PH STANDOFF M F 6 32 X 7 8 STANDOFF M F 6 32 X 1 25 NUT 6 32 KEPS PL BRACKET BATTERY LOCK FOAM PAD BATTERY BATTERY SLA 12V 5AHR WASHER FLAT 4 NY 032 FOAM TAPE 1 0 X 2 12 CABLE TIE 8 HOLDER TIE WRAP ADH BK SM nGenuity 8100E Series Service Manual Page 9 5 Section 9 Drawings and Schematics Chassis Assemblies 928034001 AY CHASSIS MONITOR Item 01 02 03 08 09 10 11 12 13 CSI Part 92799A001 928014001 92802A001 40496B002 40132B001 SHTM10005 40496B001 40294B001 40067B001 Description AY CHASSIS BOTTOM AY CHASSIS MAIN ASSEMBLY CHASSIS DISPLAY P H M S 6 32X 250 SEMS TAPE MICROFOAM ADH BACKED SUPPORT BRCKT NGENUITY 5 6 32 375 SEMS HOLDER TIE WRAP ADH BK SM CABLE TIE 4 0 Bottom Chassis Assembly 927994001 AY CHASSIS BOTTOM Page 9 6 Item CSI Part Description 01 92798A001 AY CHASSIS BOTTOM RIVETED 02 95710A003 AY POWER SUPPLY WITH BRACKETS 03 92797A002 ASSEMBLY NIBP CHASSIS 04 952574002 SPEAKER ASSEMBLY 05 90865A003 CBL AY
120. WI 53186 Orders 800 458 4615 USA Fax 262 798 8290 Internet www csiusa com nGenuity 8100E Series Service Manual Page vii Service Return Policy Return Procedure Page viii In the event that it becomes necessary to return a unit to Criticare Systems Inc the following procedure should be followed Obtain return authorization Contact the CSI Service Department at 800 458 2697 to obtain a Customer Service Authorization CSA number Outside the US call 001 262 798 8282 The CSA number must appear on the outside of the shipping container Return shipments will not be accepted if the CSA number is not clearly visible Please provide the model number serial number and a brief description of the reason for return Freight policy The customer is responsible for freight charges when equipment is shipped to CSI for service this includes customs charges Loaner service In the U S If it is necessary to provide a loaner unit to any U S customer CSI will ship the unit within one 1 working day if available by secure transport means For units under warranty a loaner unit if required will be made available upon request For units out of warranty in the event of a loaner unit being required after the product warranty has expired and no extended service contract is in place a charge will be applied to the customer s account Loaner units must be returned to CSI at the customer s expense within one 1 week afte
121. acy tables which were originally generated by monitoring desaturated human patients or volunteers and matching their displayed SpOs value to the value determined by sampling arterial blood and measuring functional SaO with a clinical laboratory grade multi wavelength optical oximeter i e CO oximeter The final SpOs calibration curve was then generated based upon numerous patients data over the range of 40 to 99 SaO All accepted data were taken from patients with dyshemoglobin i e carboxyhemoglobin methemoglobin concentrations near zero This oximeter is a two wavelength device which is calibrated to measure functional SpO only when dyshemoglobin concentrations are near zero The accuracy specifications of this device will not be met with high concentrations of dyshemoglobins Significant concentrations of carboxyhemoglobin results in a higher displayed SpO value than is actually present in the patient SpO clinical accuracy validation to CO oximeter SaO readings was performed for this sensor using a DOX compatible monitor The personal demographics of the study participants for the SpO clinical accuracy validation include a mix of adult males and females from 18 45 years of age All were healthy during the course of the study Physical characteristics and skin tone were by chance with a mix from slight to stout and light to dark Criticare Systems Inc nGenuity 8100E Series Service Manual Page 1 3 Section 1 I
122. age of the 4 readings and verify that each reading does not vary by more than 4 or 4 whichever is greater from the calculated average Each reading shall not vary more than 8 mmHg from the simulator setting nGenuity 8100E Series Service Manual Page 5 19 Section 5 Preventative Maintenance Temperature Verification This section requires the use of a Fogg TP400 700 simulator This simulator is available from Fogg Company Systems Inc Or an equivalent simulator may be used Page 5 20 1 Select Temperature ON from the PARAMS window and TEMP F C Centigrade Connect the temperature to TEMP on the monitor Insert the simulator TP 400 Verify that simulator settings correctly display for all temperatures that range from 20 C to 45 C with accuracy of 0 1 Verify that the message TEMP INVALID appears when the temperature is at 0 for TEMP Select Temperature ON from the menu setup and TEMP F C Centigrade Connect the temperature to TEMP on the unit Insert the simulator TP 700 Verify that simulator settings correctly display for all temperatures that range from 20 C to 45 C with accuracy of 0 1 C Verify that TEMP INVALID appears when the temperature is at O nGenuity 8100E Series Service Manual Criticare Systems Inc Communication Testing Nurse Call Criticare Systems Inc Section 5 Preventative Maintenance This test requires the use of a Nurse Call fixture
123. alibration Installing the PC Service Program Configuring the Ports Criticare Systems Inc Section 6 Service Testing and Calibration Equipment Required CAT 1320 kit which includes NIBP Service Program pn 97082A003 Rev 2 PC computer configured for use with CSI Service Software 8100 serial download cable CAT 1320 pn 90840A004 e 700cc dummy cuff ESD protected workbench Digital reference manometer Dynatech Nevada NIBP Analyzer The NIBP Service Program is provided on a self installing CD ROM disk pn 97082A003 Rev 2 If the CD ROM does not run automatically you may need to click on the CD ROM icon Run the auto installation disk The program NIBPSvc exe will be loaded into the Program Files directory The new folders CSI Tools will be created A launch icon will also be placed on the desktop of the computer The Service Program is designed to operate using a serial COM COMS or COM4 port If your computer uses USB ports instead of a serial port an adapter will be required The following adapters are recommended e Omega USB to Serial PDA Converter Cable GUC232A Keyspan USB Serial Adapter USA 19HS If COM1 COMG or COM 4 is not available as a free port the ports will need to be reconfigured in the computer s device manager Go to Control Panel System Hardware and select Device Manager Select Ports and reassign the alternate port or the USB to Serial Adapter to COM 1 or CO
124. and calibrated The monitor requires complete safety testing after reassembly NOTE Always check line frequency filter settings and the ECG lead cables as part of any ECG trouble shooting Always use the recommended simulators for performance testing There are three pots under the shielding at locations R112 R110 and R108 They are the baseline adjustments for ECG EGG Il and ECG V respectively These are factory set you should not adjust them Set the S1 switches off in the open position to allow communication with the DOX module See ECG Verification in Section 5 The ECG Analog Board contains its own on board software that is factory loaded The program is stored in non volatile memory on the ECG Analog Board Repair or improper handling of the ECG Analog Board can corrupt this software The respiration circuit is located on the ECG Analog Board There is no separate calibration or testing for the impedance respiration The temperature module is located on the ECG Analog Board There are no on board settings or service calibrations The temperature module is auto calibrating upon start up nGenuity 8100E Series Service Manual Criticare Systems Inc SpO Module Main Board Criticare Systems Inc Section 8 Troubleshooting The SpO module consists of a separate board that is attached above the ECG Analog Board There is a communication connection for a ribbon cable pn 90866A001 at the b
125. any of the BROWN ECG test terminals on the Dynatech Connect the other end to the SPO2 connector on the monitor under test MODE switch should be on ECG Change the LEADS switch to ISO Set the POLARITY switch to NORMAL Press the ISO button and monitor the meter for less than 20 pA For inline voltages of 264V meter for less than 50g A 14 Keep the power cord plugged into the monitor under test and the Dynatech Unplug the SpO cable from the 8100E Series monitor Unplug the test leads from the Dynatech Connect the Temp cable end to any of the BROWN ECG test terminals on the Dynatech Connect the other end to the TEMP connector of the monitor under test MODE switch should be on ECG Change the LEADS switch to ISO Set the POLARITY switch to NORMAL Press the ISO button and monitor the meter for less than 20 pA For inline voltages of 264V meter for less than 15 Verify the green LED lights up on the front membrane Criticare Systems Inc nGenuity 8100E Series Service Manual Page 5 9 Section 5 Preventative Maintenance Ground Continuity Test Page 5 10 This portion of the test requires a ROD L Model 25 Ground Continuity Tester or equivalent Do the following before turning on the ground tester 1 Set the ground continuity tester to the resistance trip point setting of 0 1 ohms Set test time of 6 seconds Set the tester to ground test only Set the test current to 25 AMP s 3 Turn on the
126. apa 22 6 eo HR t 3 41 2 ECGON 22 Lit R253 0 OHMS 17 2 d e 44 PTI 4 iau HS As i AD api vss H 98 PWMECG di PWMECG AD1 ADO 3 VDD2 Aie 4 TIVE KEY1 58 1 99999999 TEXTROM 44 ino 34 TCSCAN 4 0 1 9 E24 BLASTAGEO1SN4D ACTIVE 88888888 7 15 cs C50 10 4 KEYZ x 99999999 JEXTROM 201 D7 8 IMRD ALE 3 ALEJAS a T R134 LD4 5 1 6 3 t KEYS M ao as mo 06 IRD 9 RD E vss2 2 2 4 99K ECGBDCON m Hm LOSE 40 RODE 2 1 KEYS as Hi DS VET D5 MR Hi vons 105 1 2 1Y2 2 61068 3 ri 1 1 KEYS 52 DS T MB 9 ICSCAN jo TRDCAN TCANINT 16 int H 143 1 3 LD7B 4 4 4 KEYS 40 kc IDTASTRB 14 Wen 34 ps IRDCAN uj E IBP CONNECTOR 144 2 _4 UD4B Tee 5 6 3 KEYT 90 JOPTIONSON 13 CRA39 2H D2 ADDREN x IWRCAN yni 8 vss Hs Tt Rad R190 14 Ul J 11 21 2 UDSB 1088 6 1 KEYS 89 ISPARE 1X4 io 9 10K 121 UbS 13024 22 H IDOE 4 7 8 1 1 KEYS 81 ko IMCTRL 2 4 ECGON 0 0 9999 43 OCLK OMHZ R40 006 15 223 2 20078 BLA3TAG601SN4D m3 8 4 1 KEY10 80 k10 ECGON 3 8 IBP120N 6666 ck SJA1000T q RESET 4PWR SW 1 2Y4 2 4 E25 LD7B 9 i 2 58 IBPON 42 NURSECALL ATF1500AL MODE INTEL
127. ating that the monitor has been tested according to manufacturer s specifications If further incoming inspection or testing is required the manufacturer recommends that you use the Alarms Verification located in this section as an incoming inspection test You can perform additional electrical safety testing in this section as part of an incoming inspection in accordance with the policies of the health care provider Maintenance Schedule Every Patient e Clean and disinfect the sensor cables and sensor nspect the accessories and cables for damage Every Day Charge the monitors battery Every 3 Months Clean the exterior of the unit or clean as needed Every Year Perform the annual safety tests provided in this section NOTE For additional maintenance of the module see Appendix A Service Criticare Systems Inc nGenuity 8100E Series Service Manual Page 5 1 Section 5 Preventative Maintenance Monitor Safety Testing You can perform the following tests as part of a periodic safety check The following safety tests are designed so that the monitor s warranty seal does not have to be broken If the monitor fails any portion of these tests contact the CSI service department The contents of this section Preventative Maintenance include the following verifications and safety tests Withstanding Voltage Hi Pot Electrical Leakage Ground Continuity Interface Inspection
128. be 8VREF_O 8 avec PGS IRQT 32 jCANINT 4 JEXTRAM ats FAL MAS TCK 45 TOWR 45 MR epoi 0 106 AVSS 10KX4 JMRD A16 TDO 46 LK 3 o on RIGHT BOTTOM CORNER 94 VREF eo 1 8 329 OE o WAS R94 47 R99 m 2 Ube AQUAE wi E61 PCMICEN2 1 wc 48 48 S ae els Fepis 33 US 6 CARDDETZ 3 6 421K DNI 49 49 WAI Fpp14 94 906 PTH2 CARDDET1 4 BL 50 5 DNI 50 Les UD7 TOCPUZRX yy TOCPU2RX PSU TXD2 oF 1 54 18 5 FPD15 Wir a R260 750K TOCPUZTIX C TOCPUZTX P51 RXD2 CRAS 10 4 R228 x15 SPOT 215 1 susPEND 1071 1 TOCPU2SCK PS2ISCK2 D6 ER eus 53 TESTEN 1 77 25 55 IRESETCPU2 P53 ADTRG 1 54 54 lt 218 302 E27 RAIA 1004 50 55 DACVDD V Map S 1 8 T3 56 1 E DNI DACVDD LI2FB L13FB BLA31AG601SN4D 120 EXTI 50 56 AVCC 1 T 50 4 EL 7 51 57 57 DACVDD 1 1 2 ES 5 118 TSSCAN 3 6 7 4 3VBKUP 50 CMSH1 40 IM 58 IPCMCRST2 a DACVSS BLUE 1052 7 p MD914 52 62 HH 1355 5 4 CRAS1 oi R229 4 JMCWAT 59 59 MOWAT 60 DACVSS GREEN 100 LAWN Ev CS3 PG1 as 2M 82 60 22222222 L14 FB 2 2 2 4 77 10V IREG 61 60 NY 55555555 IREF E28 16 HITACHI 32 768KHZ 20 z 32k 23 61 61 4 d BLASTAGGO1SNAD 29999999 NMI S exrram 22x 62 62 330 an 1 229299925 2 63
129. bon cable at J1 on the internal module s PCB board Remove the four 4 screws PHMS 6 32 x 375 SEMS pn 40496B001 holding the internal module pn 928114001 to the chassis Replace the internal module Reassemble in reverse order nGenuity 8100E Series Service Manual Criticare Systems Inc Appendix A CO2 Service Troubleshooting SYMPTOM TRAP ERROR OR CO MALFUNCTION Problem Solution Trap is plugged or leaks Replace Trap Tubes to the trap manifold are Check manifold connections loose or pinched Bad valve or pump Contact CSI Service Department Criticare Systems Inc nGenuity 8100E Series Service Manual Page 13 Appendix A CO2 Service Verification Checklist Page A 14 Functional and Safety Testing Checklist This checklist may be copied as needed to record field testing Add this page to the Functional and Safety Testing Checklist in Section 5 of this manual Monitor Serial Number CO2 Processor Software Rev Gas Flow Verification Flow Calibration Occlusion Exhaust Test Test Certification of CO Verification Technician Date nGenuity 8100E Series Service Manual Criticare Systems Inc TORQUE 6 IN LB NOTES REVISIONS REV DATE DESCRIPTION BY 1 5 12 06 8842 DBL 2
130. culates the temperature in Fahrenheit or Celsius The conversion value displays on the video screen The monitor provides two patient isolated external RS 232 serial data ports TX RX and ground The DB 9 COM1 port is configured for compatibility with ASCII printer applications The DIN 8 COM port is custom configured with one pin reserved for analog output The main module drives a patient isolated external analog output It provides a 0 to 1 v output capable of driving a high level input such as a defibrillator or chart recorder The Main Board powers and controls the optional printer module The Main Board processes error messages from the Printer Board and displays them on the screen The internal printer module is a Sieko LTP1245 type mechanism nGenuity 8100E Series Service Manual Page 3 3 Section 3 Theory of Operation Block Diagram The following block diagram aids in tracing communication and data routes within the system Connection numbers are given to show the relationship between the boards The diagram is keyed to the theory of operations found on the previous pages 35 CRT Con c 5989 A5 o I1 ee ee 1 L m 8 5 2 Nurse lt 55 B Module l 2 I Assembly _ TECG Hoe Heo Main Board Solder Side Rotary Encoder
131. d by presence of CONM H W error Main Board or ECG Analog Board may be bad Replace the sensor Replace receptacle Reseat the connection Replace Board s No sound from speaker Volume turned down Main Board connection is disconnected or loose Speaker wire broken at speaker terminals Set volume higher in Configuration CONFIG window Reconnect J20 on Main Board Check speaker wires for breaks or bad crimp pins Speaker scratchy or unclear sound Metal debris on speaker Bad speaker Remove debris from speaker drum Replace speaker COM 1 serial interface doesn t work Set to internal printer Incorrect or bad cable Setting mismatch Connector is bad Reset monitor to external printer Replace with correct serial cable Reset baud rate and other settings Replace the Main Board No ECG trace displays ECG Cable may be bad The connection between Main Board J12 and ECG Analog Board P4 is loose or disconnected Can be verified by presence of CONM H W error Main Board or ECG Analog Board may be bad Replace with known good cable Reseat the connection Replace Board s Page 8 2 nGenuity 8100E Series Service Manual Criticare Systems Inc Section 8 Troubleshooting Troubleshooting and Before attempting to repair a damaged monitor the technician must Repair fully understand the functions of the monitor The service technician should have read and under
132. d in the Set Unit Defaults window rotate the menu knob to highlight EDIT and press to select As you rotate the menu knob CUSTOM DEFAULTS remains highlighted e The first letter of CUSTOM DEFAULTS is highlighted 2 Change the label CUSTOM DEFAULTS for example to the title FACILITY DEFAULTS by doing the following With the letter C highlighted the first letter of CUSTOM DEFAULTS rotate the menu knob to highlight the letter F the first letter of the example FACILITY DEFAULTS and press to select The next letter automatically highlights Continue for the remaining letters of the new title e After completing the last letter in the title in this example it would be the letter S press the menu knob until the entire label name highlights This indicates that the entry is complete but not accepted ACCEPTING THE NEW PROFILE TITLE 1 To accept the new label name rotate the menu knob to highlight ACCEPT and press to select The message Action Completed appears Set Unit Defaults Set current configuration and alarm settings as new unit default settings SELECT EDIT FACILITY DEFAULTS ACCEPT ALTERNATE CARE STD DEFAULTS STD DEFAULTS STD DEFAULTS CANCEL Figure 2 12 Set Profile After Modifications 2 Press the menu knob Your set of defaults are saved in memory 3 Press the ON OFF button on the front panel of the monitor to turn off the power to the monitor Page 2 12 nGenuity 8100E Series Servic
133. d screws and battery cover from rear of unit battery cover Remove and retain two 2 phillips pan head screws and either printer or printer cover from rear of unit Disconnect printer cable from printer Remove and retain six 6 phillips head screws from around edge of unit accessible from rear of unit Remove quality sticker from the unit PCB Replacement Spo PCB To replace the SpOs PCB assembly pn 91339A001 1 Label and disconnect the connectors at P1 and J1 on the SpOs PCB Remove the four 4 screws PHMS 4 40 X 0 500 40995B003 holding the SpOs PCB to the chassis assembly Remove the SpO PCB from the mounting plate pn 42636B001 Position the new 5 PCB over the bracket and connect it to the SpO to analog cable at P1 Reattach the SpO cable to the PCB at J1 Place the SpOs PCB on the SpO mount plate Secure the SpO PCB to the mount plate with the four 4 screws removed earlier Page 7 4 nGenuity 8100E Series Service Manual Criticare Systems Inc Section 7 Disassembly SHIELDED ANALOG PCB To replace the Shielded Analog PCB pn 91353A003 1 Remove the SpO PCB assembly as described in SPO2 on page 7 4 2 Label and disconnect all connectors Remove four 4 screws from the corners of the metal plate which the SpO Board is mounted on Remove the plate 3 Remove the four 4 spacers pn 40909B002 that hold the shi
134. de advance to the end of the password and start over When you enter the correct password the Service Mode window appears See the next step If you entered an invalid password the window below appears Check the validity or spelling of the password you entered and repeat the password entry Enter Service Mode gt gt gt CAUTION lt lt lt All monitoring will be stopped Enter password invalid password Figure 2 4 Invalid Password Window Page 2 2 nGenuity 8100E Series Service Manual Criticare Systems Inc Criticare Systems Inc Section 2 Service Windows 6 When you enter a valid password the Service Mode window appears Enter NIBP Service NO Software Download No action taken Permanent Alarm Silence Enable ST Arrhythmia Keycode Invalid Keycode Current Software Revisions Main Display Processor Rev 1 2F NIBP CO2 02 Processor Rev 6 5C Vital Signs Processor Rev 6 2A Unit Serial Number 111111111 Unit Part Number 93979AXXX Keycode Base Number 00000000 Figure 2 5 Service Mode Window From this point you can access all service mode functions and calibrations set operation values and perform tests All the following functions are accessed from the Service Mode window shown above NIBP Service Mode Processor Software Download Permanent Alarm Silence Arrhythmia and ST Analysis NOTE Monitors with monitoring will have additional items in the Service Mode w
135. dering or sterilizing the cuff Close the Velcro fastener before you launder the cuff Strong bleach solutions damage the cuff Temperatures over 275 F 135 C damage the cuff Soaking the cuff in dark colored solutions may stain or discolor the cuff Hand laundering as opposed to machine laundering prolongs the life of the cuff Wash the cuff in warm soapy water Rinse the cuff thoroughly After you clean the cuff allow the cuff to air dry then insert the inflation bag in the cuff You can clean the ECG cable and leads with alcohol Do not immerse the connections nGenuity 8100E Series Service Manual Criticare Systems Inc Section 4 Cleaning and Disinfecting Temperature Cable Clean the cable according to the hospital protocol for cleaning of reusable equipment cables Typically this protocol consists of the following steps 1 Disconnect the cable from the monitor and temperature sensor 2 Wipe the cable with a nonabrasive cloth moistened with a mild detergent and warm water or a disinfectant 3 Dry thoroughly 4 Do not use alcohol or solvents to clean the cable 5 Do not allow the cable connectors and contact points to come in contact with liquids 6 Do not fully immerse the cable in liquids 7 Do not autoclave or EtO sterilize the cable Criticare Systems Inc nGenuity 8100E Series Service Manual Page 4 3 Section 4 Cleaning and Disinfecting Accidental Wetting NWARNING A e
136. e Blood Pressure NIBP 555 Comfort Cuff M Technology iintindi iviena Description of NIBP NIBP Clinical Testing and Accuracy N Cuff Inflation and Pressure Protection 1 7 Capnography Measurement of CO 1 8 Method of Measurement eese enne nennen nter nenne innen 1 8 Conditions of Uses n coerente eee Stability of Accuracy us NJO Comperisation tette Temperature Cautions Leakage Current Voltage Fluctuations Equipotential Gro ng o t rere tate breed Software Error Related Hazard Mediation 1 18 Potential Interference 2 latex Content LT uincere bec r aaa ai Section 2 Service Windows Service Mode WiIDdOW bei er tta f dt te bie Lets Ne et Service Mode WitidOW nime peer NIBP Service MOd6e ee Processor Software Download 4 Permanent Alarm Arrhythmia and ST Criticare Systems Inc nGenuity 8100E Series Service Manual Page iii Page iv SEPvice Setting e Service Password Alarm Tone Warming tenti toin rr retten teni erinne
137. e Manual Criticare Systems Inc Section 3 Theory of Operation Power Module Main CPU and System CONM Module Vital Signs Module Speaker Driver Criticare Systems Inc The 8100E Series patient monitor employs a universal switching power supply for international use In order to monitor the status of the line power and condition of the battery pack the internal power supply circuitry drives several status lines available to the main module The power management watchdog circuit provides a low battery level detection mechanism and a hardware based check on software operation watchdog timer The microprocessor circuitry handles the Main Board computational functions and provides integrated I O functions including timers I O pins serial interfaces and analog I O The CONM module contains a microprocessor and associated circuitry for NIBP No electrical connection is made with the patient from the monitor for NIBP The vital signs parameters are passed to the main module using a serial channel The vital signs module is a single printed circuit board with connectors to the Main Board the ECG input leads the SPO connector and the temperature sensor The vital signs module contains a microprocessor and associated circuitry for pulse oximetry temperature ECG signals and TTI respiration ECG signals can be either 3 lead single channel or 5 lead triple channel Patient isolation for galvanic contact is required fo
138. e monitor should not be placed directly in the X ray beam which could damage the internal electronics of the monitor OTHER INTERFERENCE There is a negligible adverse effect to the monitor from electrocautery and electrosurgery infrared energy and defibrillation Biocompatibility patient contact or user contact materials in this monitor and it s accessories have passed ISO 10993 5 10 amp 11 biocompatibility tests or have been in use in clinical environments in large numbers over an extended period of time predating these standards Latex Content Criticare Systems Inc products including patient monitors and accessories are free from latex in any location that may result in patient contact DEHP Content Criticare Systems Inc products currently shipping are free of DBP and DEHP in any areas that would be intended for patient contact with blood mucous membranes or continuous skin tissue contact Criticare Systems Inc nGenuity 8100E Series Service Manual Page 1 19 Section 2 Service Windows Service Mode Window The monitor has a Service Mode window that is accessible through the CONFIG window of the monitor NWARNING N Criticare Systems Inc Never service a monitor while it is attached to a patient Never enter the service menu while monitoring a patient 1 Press the ON OFF button power to the monitor Service Mode Window To access the Service Mode located in the CONFIG window
139. e that could burn the patient The pulse oximeter sensor contains two types of LEDs Each type emits a specific wavelength of light Since oxygenated hemoglobin and deoxygenated hemoglobin absorb light selectively and predictably the amounts of these two compounds can be determined by measuring the intensity of each wavelength that passes through the measuring site nGenuity 8100E Series Service Manual Criticare Systems Inc Section 1 Introduction The light from the LEDs shines into a pulsating vascular bed A photodetector located opposite or alongside the LEDs measures the intensity of each wavelength transmitted through the monitoring site The light intensity is converted to an electrical signal which is input to the monitor The effects of skin pigmentation venous blood and other tissue constituents are eliminated by separating out the pulsating absorption data SpO is calculated with every pulse and averaged with the results from previous pulses to arrive at the current numeric display value The display is updated at least once per second with the numeric values that were calculated during the intervening period The plethysmographic pulse wave is not auto gained The amplitude display of the plethysmographic pulse wave is proportional to the pulse volume changes occurring in the tissue illuminated by the SpO sensor SpO Clinical Testing Criticare oximeters DOX compatible have SpO calibration and Accur
140. e to the Main Board Criticare Systems Inc nGenuity 8100E Series Service Manual Page 8 3 Section 8 Troubleshooting ECG Impedance Respiration Module Board Settings and Module Page 8 4 Software Respiration Temperature The ECG circuitry is located on the ECG Analog Board assembly pn 91353 003 that is attached to the metal chassis behind the main board The ECG Analog Board fits directly on to the Main Board through a socketed 10 pin connection on the left side of the board assembly There is also a shielded cable assembly that extends from the top of the board to the external ECG port Check each of these connection points if the monitor fails to produce an accurate ECG waveform The ECG Analog Board has a foil shield to reduce noise from other portions of the monitor Noise can be introduced by worn cable assemblies and degraded power supplies Test the analog ECG waveform signal and the input power where they enter the ECG Analog Board for interference noise There is a replacable 2 amp fuse 80004B003 at location F1 on the ECG Analog Board The fuse provides protection in the power circuit leading from the P4 connection to the Main Board Surface mount components on the ECG Analog Board are not recommended for field repair and replacement You can replace the ECG Analog Board assembly as a serviceable component Replacement ECG Analog Board assemblies pn 91353 003 are pre tested software loaded
141. e wave in ST filtering Measure the sine wave 05Hz In Monitor mode 5Hz Verify ST mode 05Hz Verify ECG LOST when the simulator is turned off Verify encoder works Verify time amp date are set Verify that FREEZE button is operational Verify that the TREND button works Verify that the STANDBY button works Verify that the DEFAULT button works Verify that printer paper feed works Verify that printer is operational Verify external monitor is functional Verify that serial number is correct Verify all hardware is tight and properly sealed CERTIFICATION THAT THE UNIT IS FUNCTIONING PROPERLY NAME DATE CERTIFICATION OF FUNCTIONAL AND SAFTEY TESTING TECHNICIAN DATE This checklist may be copied as needed to record field testing Page 5 24 nGenuity 8100E Series Service Manual Criticare Systems Inc Section 6 Service Testing and Calibration Field Service Testing Safety Criticare Systems Inc NWARNING N Service testing procedures require working with exposed electrical circuits and should only be attempted by experienced electrical or biomedical technicians When a monitor is altered through repair or hardware adjustment it should be fully tested before use NCAUTION A Always follow ESD precautions when performing any procedure discussed in this section The manufacturer recommends that a serviced monitor be allowed to run for 24 hours before the monitor is placed back into op
142. eakage current limits required by medical safety standards for patient connected devices A hazard caused by the summation of leakage currents is possible when several pieces of equipment are interconnected Connecting any external equipment to signal input signal output or other connectors forms a system and this new system must comply with the requirements of IEC 60601 1 1 If in doubt contact qualified technician or local representative Voltage Fluctuations When operated in the line voltage range specified in this manual any fluctuation will have a negligible effect Very low line voltage will cause the monitor to revert to battery power Very high line voltage may cause damage to the charger circuits The monitor is designed with circuitry that turns the unit off before spurious readings can be caused by a low battery condition Equipotential Ground Health care providers and patients are subject to dangerous uncontrollable compensating currents for electrical equipment These currents are due to the potential differences between connected equipment and touchable conducting parts as found in medical rooms The safety solution to the problem is accomplished with consistent equipotential bonding The monitor is fitted with a connecting lead made up with angled sockets to the equipotential bonding network in medical rooms Connection Lead Equipotential Socket 23 Terminal Equipotential Main Connector Body 4 Ear
143. ecting the red and black lead together Set the voltage to 1000 VAC 2 Set timer for 1 second and cutoff current for 1 milliamp 3 Press the Test button The NG light should come on NCAUTION N e f the NG light does not come on do not continue with this test You must repair or replace the withstanding voltage tester Page 5 6 nGenuity 8100E Series Service Manual Criticare Systems Inc Section 5 Preventative Maintenance Withstanding Voltage NOTE For the following tests set the Hi Pot unit as follows Hi Pot Test Procedure Memory 20 Memory 21 Arc Fail OFF OFF Arc Sense 5 5 Ramp HI OFF OFF Charge LO 0 0 pA 0 0 uA Dwell Time 1 0 sec 1 0 sec Ramp Time 1 0 sec 1 0 sec LO Limit 0 0 0 0 pA HI Limit 1000 A 1000 Voltage 2 500 KV 4 242 KV 1 Connect the red lead of the Hi Pot to Hot Neutral and the black lead to Chassis Ground EPT Set up the Hi Pot per table above to Memory 20 Verify Hi Pot is now set to a Trip Current of 1mA and test 2500VDC for 1 second 2 Connect the red lead of the Hi Pot to Hot Neutral and the black lead to ECG Set up the Hi Pot per table above to Memory 21 Verify Hi Pot is now set to a Trip Current of 1mA and test 4242VDC for 1 second 3 Connect the red lead of the Hi Pot to Hot Neutral and the black lead to Temperature Set up the Hi Pot per table above to Memory 21 Verify Hi Pot is now set to a Trip Current of 1mA and test 9 4242VDC for 1 second 4 Connect
144. egulations concerning the disposal of spent Lead acid batteries or contact Criticare for assistance Risk of electrical shock Do not remove cover Refer servicing to qualified personnel e U S Federal law restricts this device to sale by or on the order of a physician Cautions NCAUTION Use the monitor only with recommended accessories Use of unapproved accessories may cause inaccurate readings Equipment accuracy may be affected at extreme temperatures Do not store equipment at extreme temperature Temperatures exceeding specified storage temperatures could damage the system A possible explosion hazard exists Do not use the monitor in the presence of flammable anesthetics Do not press on the keys with surgical instruments or other tools Sharp or hard objects could damage the keys Use only your fingertips to press on the keys Do not allow the conductive parts of the patient electrodes to contact other conductive parts including ground earth Changes or modifications not expressly approved by Criticare Systems Inc may void the user s authority to operate the equipment and may also void the warranty Always monitor patients with a pacemaker very closely since the 8100E may count at the pacemaker rate during cardiac arrest or some arrhythmias Criticare Systems Inc nGenuity 8100E Series Service Manual Page 1 17 Section 1 Introduction Leakage Current The monitor complies with l
145. elded analog PCB assembly 4 Disconnect cables from P1 ECG Cable and P5 Ribbon to SpO Board 5 Remove the Shielded Analog PCB 6 Reassemble in reverse order certain when installing the Shielded Analog PCB that P4 is fully seated to the main PCB e If not seated properly the unit will display a CONM H W error shortly after Power Up MAIN PCB To replace the Main PCB pn 91340A004 1 Remove the four 4 screws PHMS 4 40 X 0 312 SEMS pn 40995B001 that hold the chassis to the front enclosure Remove the monitor chassis assembly pn 92803A001 from the front enclosure 2 Label and disconnect all connectors from rear Main PCB 3 Remove the two 2 screws PHMS 6 32 x 0 500 pn 40496B004 and standoffs F F 6 32 X 0 625 HEX pn 42639B001 from the upper section of the main frame and the upper section of the Main PCB Retain the screws and standoffs for reassembly 4 Remove the four 4 screws PHMS 6 32 X 0 250 pn 40496B002 and the four 4 standoffs F F 6 32 X 0 625 HEX pn 42639B001 from the middle and lower sections of the main frame and the Main PCB Retain the screws and standoffs for reassembly 5 Remove the Main PCB shield pn 45192B001 from the main frame pn 42635B001 6 Label and disconnect all connectors from front Display of main PCB 7 Remove the Main PCB from the shield 8 Reassemble in reverse order Criticare Systems Inc nGenuity 8100E Series Service Manual Page 7
146. emove the 7 2 Reconnect or Replace the 7 2 Printer 2 7 3 Removing Printer Assembly Replacing Printer Components 7 3 Reattach the Printer Assembly 7 3 Front Main Chassis 7 4 Disassembly 352 aede e Dt v eg 7 4 Display Assembly irent een ne T aere 7 6 Disassembly 7 6 Membrane Replacement 7 6 Display Installation 7 6 Bottom toa n teret aeta cta o t ir dee 7 7 22 e nn eoe nni eee er eee en ees 7 7 Speaker Replacement 7 7 NIBP Chassis Replacement 7 7 Power Supply Replacement 2 7 7 EE 7 8 Assembly Tests iro rite rro Ar EHE 7 9 nGenuity 8100E Series Service Manual Page v Page vi Section 8 Troubleshooting Troubleshooting and ComfortCuff NIBP Module meet ECG Impedance Respiration Module s Board Settings and Module Software sss 8 4 Respiration e 8 4 Temperature 8 4 SpO Module 8 5 Main Board 8 5 Power err en n ne e np iere or ona etie 8 6 Fuse Replacement rne nette nete
147. er fuses See Fuse Removal Replacement in Section 5 NWARNING N Shock hazard Substitution of fuses or jumping the fuse contacts can endanger the patient and damage the monitor The power entry module pn 80243B002 when replaced must remain electrically isolated between the chassis and power entry module ground The AC power entry module requires a fuse drawer pn80130B001 Replace broken cracked or loose AC receptacles Replace the receptacle if the external pins are bent or broken Do not attempt to remove or modify the ground pin Check the cables and chokes for heat damage before power module replacement Remove the assembly from the housing and inspect the back side of the board for scorching or damaged solder connections Replace the entire assembly if there are any signs of high current damage nGenuity 8100E Series Service Manual Criticare Systems Inc Section 9 Drawings and Schematics List of Drawings Assembly BOMs and Drawings PCB Drawings and Schematics Criticare Systems Inc Title Final Assembly 8100E without printer Final Assembly 8100EP with printer Final Assembly 8100E1 w no printer Final Assembly 8100EP1 w CO and printer Main Monitor Assembly Main Monitor with Assembly Chassis Assemblies Bottom Chassis Assembly Power Supply with Brackets Main Chassis Assembly NIBP Chassis Assembly Internal Module Assembly CO External Module Asse
148. eration Modules and PCBs that have been repaired may require more extensive testing than what is described in this manual The pre assembly testing of printed circuit boards PCBs is not covered in this manual Disassembly of surface mounted components on PCBs is not recommended Tests provided here are only for the identification of damaged or degraded PCBs nGenuity 8100E Series Service Manual Page 6 1 Section 6 Service Testing and Calibration Field Service Test Matrix Field Service Testing Required Test v Recommended Test No Fault case opened Any time you open a monitors case you must perform electrical safety tests before you return the monitor to operation If you service the monitor you should also perform the functional tests You should perform additional tests that are specific to modules and assemblies when you service adjust calibrate or disassemble assemblies See the following table ECG Verification SPO Verification NIBP Verification CO2 Absorber Verification Temperature Verification Communication Testing SpO2 Performance Test NIBP Module Calibration CO Calibration Temperature Check Main Board Testing NIBP Pump SPO2 Board ECG Analog Board D oO X oO 9 pum o e 9 e e CO2 Absorber CO2 Board Main Board Display Inverter Board Membrane Key Pad Printer and or Board Power Module
149. ges High Voltage If the power supply is defective replace the entire Power Supply assembly Criticare Systems Inc nGenuity 8100E Series Service Manual Page 7 1 Section 7 Disassembly Electrostatic Discharge Protection Disconnecting and Replacing the Battery Remove the Battery Reconnect or Replace Page 7 2 the Battery The procedures in this section require handling of electrostatic sensitive components Microprocessors and other electronic components can be permanently damaged by attempting repairs at an unprotected workbench Use all electrostatic discharge ESD protection as described Perform the disassembly procedure on an antistatic mat that is grounded Check the ground cable to insure that it is connected to a good earth ground Use a grounded soldering iron Wear a wrist grounding strap Connect the wrist strap and mat through a resistor 1 megohm typical to the same ground source Test the wrist ground straps on a daily basis Temporarily store components in metal or antistatic containers Do not store components in plastic dishes Store circuit boards in sealed antistatic bags or cover them in antistatic boxes Do not store electronic boards directly in cardboard boxes Follow all ESD procedures as stated in Electrostatic Discharge Protection on page 7 2 Remove the two 2 screws PHMS 4 40 x 500 SEMS pn 40995B003 from the battery door Remove t
150. gged into hospital grade outlets The electrical installation of the relevant room must comply with NFPA 70 National Electric Code or NFPA 99 Standard for Health Care Facilities Outside the United States the relevant room must comply with all electrical installation regulations mandated by the local and regional bodies of government Cables cords and leadwires may present a risk of entanglement or strangulation Verify safe and proper positioning of these items after patient application Leakage currents may increase if other equipment is interconnected to the patient The increased leakage currents may present a hazard to the patient nGenuity 8100E Series Service Manual Criticare Systems Inc Section 1 Introduction NWARNING N High Frequency HF surgical equipment may affect ECG operation The ECG waveform will return to normal momentarily after the HF source is removed Ensure that electrodes and sensors are not placed near the HF source Unapproved modifications to the monitor may cause unexpected results and present a hazard to the patient Unapproved use of the accessories can also result present a hazard to the patient or affect monitor performance Donotre use accessories labeled as single use Risk of patient contamination may occur mproper disposal of batteries may result in explosion leakage or personal injury Do not open batteries Do not dispose of batteries in a fire Follow all local r
151. ground tester Plug in the AC cord from the ground continuity tester to the monitor being tested Connect the ground cable to the chassis ground on the rear of the monitor 6 Press the Reset button on the tester Press the Start button 7 The monitor passes if the Fail Light does not come on or if the resistance does not exceed 0 1 ohms during the test nGenuity 8100E Series Service Manual Criticare Systems Inc Functional Testing Section 5 Preventative Maintenance Interface Inspection This procedure is for the monitors TFT active display Manual Controls Check Criticare Systems Inc 1 i Verify that a readable screen displays For a guide to proper screen layout refer to the nGenuity 8100E Series Patient Monitor Operator s Manual for sample screens Verify that the screen display is clear and bright when you directly face the monitor Verify that rotating the menu knob moves the cursor through the menu items Verify that when you press the menu knob on a highlighted menu item the monitor displays a sub menu Use the menu knob to enter the CONFIG window and set the date and time for the real time clock Press the FREEZE key Verify that you get an audible response from the speaker Press the FREEZE key again to unlock the waveforms Press the TREND key Verify that you get an audible response from the speaker A Trend window appears on the display Press the TREND key aga
152. he battery door pn 45182B001 from the rear monitor enclosure pn 45179 001 Unscrew battery bracket pn 42634 002 5 Label and remove the battery cables from the battery Connect the battery cable to the battery Negative lead black to the negative terminal of the battery Positive lead red to the positive lead of the battery Replace battery bracket Wires must not route between battery and bracket Place the battery door pn 451828001 onto the rear enclosure 451798001 Insert the two 2 screws 4 40 x 500 SEMS pn 40995B003 into the battery door and secure nGenuity 8100E Series Service Manual Criticare Systems Inc Removing Printer 1 Assembly Section 7 Disassembly Follow all ESD procedures as stated in Electrostatic Discharge Protection on page 7 2 Remove the battery following the instructions in Hemove the Battery on page 7 2 Remove the two 2 screws PHMS 4 40 x 0 312 SEMS pn 40995B001 holding the printer assembly pn 92804A001 to the monitor 4 Label and remove the ribbon cable from the printer module 5 Remove the module from the main monitor assembly Replacing Printer 1 Components Reattach the Printer 1 Assembly Remove the three 3 screws pn 409958005 holding the Printer PCB to the assembly Disconnect Ribbon Cables J2 and J3 Remove the Printer pn 91341
153. he gas sample d Distance measured through the sample The Beer s Law calculation is performed by the monitor s software nGenuity 8100E Series Service Manual Criticare Systems Inc Conditions of Use Stability of Accuracy Compensation Temperature Measurement Criticare Systems Inc Section 1 Introduction The 8100E Series monitor has been calculated with dry NIST traceable calibration gases at room temperature and pressure 21C 740mmH g Given the small effect of water vapor upon the CO measurement and the unit s built in temperature and pressure measurements and compensations this monitor s method of gas analysis is best described as ATPS Ambient Temperature and Pressure Saturated 21C 750mmHg 100 Humidity Saturated The monitor is suitable for sustained pressure breathing circuit monitoring environments and has been tested per clause 51 101 Measurement Accuracy of EN 21647 2004 The monitor has an internal barometer and thermistor that allow compensation for changes over a range of temperature and atmospheric pressures The monitor complies with EN 21647 standards for cyclical pressure and testing found negligible drift of accuracy The module as installed in the 8100E Series monitor has been clinically tested for performance with a variety of patients The monitor has a manual 0 compensation feature for a fixed value is 60 The user may select compensation when 40 80 N5O is
154. he permanent alarm silence feature with the menu knob highlight Permanent Alarm Silence and press to select Enable is highlighted 2 Rotate the menu knob to highlight Disable and press to select 3 Press the ON OFF button on the front panel of the monitor to turn off the power to the monitor NOTE Read about the override capability of the Permanent Alarm Silence function over the Alarm Tone Warning function in Alarm Tone Warning on page 2 8 NCAUTION Before you disable this safety feature contact your local distributor because the Permanent Alarm Silence tone is required in certain countries Arrhythmia and ST Analysis Arrhythmia and ST Analysis software extension has the capability to measure ST segment deviations and generate arrhythmia alerts for common ventricle arrhythmia conditions The arrhythmia and ST features are available through keycode activation on all nGenuity 8100E Series monitors The feature can be purchased from Criticare Systems Inc NOTE Unless instructed DO NOT enter a keycode In case of accidentally selecting the keycode simply turn off the monitor without completing the keycode entry The keycode will not be over written unless you enter the complete keycode 8100E Series models that do not include the arrhythmia and ST analysis feature will have the message nvalid Keycode appearing next to the setting Page 2 6 nGenuity 8100E Series Service Manual Criticare Systems Inc
155. ical connection is made with the patient from the monitor for capnometry The CONM module controls the capnometer The CO Board contains an assembly known as a bench This bench contains the optics IR source detector sample cell and optical filters The purpose of this bench is to convert CO levels in a gas sample to electrical signals The bench assembly utilizes the principle of infrared absorption spectrometry to measure to the amount of CO in patients breath Infrared absorption spectrometry is widely used in gas analysis Using a phenomenon explained in Beers Law gas absorbs certain wavelengths of infrared energy with the amount depending on the amount of CO gas A detector outfitted with an infrared bandpass filter only allows a certain wavelength of infrared energy that the gas absorbs As the concentrations in the sampled air passes through the sample cell the detector senses the infrared energy changes and converts them to an electrical signal This electrical signal is then amplified and conditioned and sent to a microprocessor for processing and then sent to a display The CO Board also uses a reference channel The purpose of this reference channel is to cancel the effects of IR source changes sample cell contamination temperature etc The only difference from the CO channel is that the detector is outfitted with an optical filter that is tuned to a band in the infrared spectrum that
156. ice Manual Criticare Systems Inc Pulse Oximeter Module SpOj Temperature Communications Printer Criticare Systems Inc Section 3 Theory of Operation The pulse oximeter is based upon the principle of dual wavelength photoplethysmography Red and infrared LEDs are alternately driven to illuminate some relatively well perfused tissue site and a photo detector receives either the transmitted or reflected light resulting in a current flow This input signal is demultiplexed with sampling in the monitor to separate the red and infrared components The wavelengths are chosen to permit discrimination of oxygenated and deoxygenated hemoglobin based on the difference in their absorbance spectra In a pulse oximeter a high passed AC component is extracted from each of the red and infrared signals and digitally processed to detect the pulsations corresponding to blood flow in the illuminated tissue The AC and DC components in red and infrared measured near the time of pulsation are combined in a relatively simple ratiometric formula obtained with many assumptions by solving Beer s law equations with empirically derived coefficients to yield a figure proportional to SpO The pulse rate is also calculated from the pulse intervals detected The temperature module measures probe resistance and uses an internal data table for looking up temperature conversions Depending on the user s selected settings the monitor cal
157. in to close the Trend window Or optionally press and hold the TREND key to open the TYPE INTERVAL SCHEEN menu that you close by selecting EXIT Press the STANDBY key Verify that you get an audible response from the speaker A standby confirmation menu should appear Highlight NO and press menu knob to exit Press the DEFAULT key Verify that you get an audible response from the speaker The Custom Default menu appears Select CANCEL and then press menu knob when No action taken is highlighted to exit nGenuity 8100E Series Service Manual Page 5 11 Section 5 Page 5 12 Preventative Maintenance Alarms Verification verify the alarm circuitry for SpO perform the following procedure 1 In the PARAMS window turn off all monitoring modules except for SpOs Set the display to show a plethysmograph waveform In the PARAMS window set the SpO2 Low Limit Alarm setting to HIGH This sets the alarm priority for only this alarm parameter Use an SpO simulator to set the monitor to display the plethysmograph waveform Confirm the heart rate and saturation reading In the ALARMS window adjust the SpO low alarm level above the saturation reading to cause an alarm condition Verify that the message LOW 5 2 appears at the top of the waveform channel in red letters Verify that you get an audible response The alarm should be a high priority alarm tone consisting of 3 beeps followed shortl
158. in use Body temperature is measured by the monitor using a thermistor temperature sensing elements in the temperature probe The thermistor can sense change in body temperature by changing electrical resistance Unusual fast artificial variations in temperature readings may occur with accompanying applications of an electrocautery system Electrical leakage current of the cable when used with the monitor and sensor comply with IEC 601 1 EN 60601 1 The monitor is compatible with any YSI 400 or YSI 700 series temperature probe nGenuity 8100E Series Service Manual Page 1 9 Section 1 Introduction Specifications Page 1 10 ECG Connectors Lead Selection Gain Selection ECG Sensitivity Frequency Response Electrosurgery Protection HF Equipment Protection Defibrillator Protection Pacer Detection Rejection Heart Rate Source Range Accuracy Pulse Tone Respiration Source Rate Range Resolution Accuracy SpOs Range Resolution Accuracy Indications Method Modes Operation Sensor Wavelength Sensor Power nGenuity 8100E Series Service Manual 3 or 5 Lead Standard AAMI 3 Lead Il Ill 5 Lead Il aVR aVL aVF V 0 5 1 0 2 0 4 0 Low 0 5 Medium 1 0 High 2 0 Auto Diagnostic 0 05 100 Hz 3db Monitor 0 50 40 Hz 3db Yes Yes Yes Yes Smart Switching ECG primary Pleth NIBP 20 300 bpm ECG Pleth 30 240 bpm NIBP 1
159. indow See Appendix A Service for service screens NOTE After you perform each service mode function you must turn off power to the monitor Press the ON OFF button on the front panel of the monitor nGenuity 8100E Series Service Manual Page 2 3 Section 2 Service Windows NIBP Service Mode From the Service Mode window do the following NOTE To service the NIBP module you need specified equipment See Section 6 Service Testing and Calibration for details 1 To run a high time or pressure test for adults or infants or to run an inflate deflate speed test with the menu knob highlight Enter NIBP Service and press to select The value NO is highlighted 2 Rotate the menu knob to highlight YES and press to select The NIBP Service Mode Parameters window to service NIBP appears RESULT Run Leak Adult High Time Test Run Infant High Time Test NO Run Adult High Pressure Test NO Run Infant High Pressure Test NO Run Infl Defl Speed Test NO ELAPSED TIME MAX PRESSURE 0 Figure 2 6 NIBP Service Mode Parameters Window 3 Rotate the menu knob to highlight the test you want to run and press to enter The test value NO is highlighted 4 Rotate the menu knob to highlight YES and press to begin the test When the test is executing the following message appears on the bottom of the NIBP service window Test in progress select NO to cancel 5 Press the ON OFF button to exit the NIBP Ser
160. ing both on the PCB and external to it reduces the impact of ESU noise on signal quality and heart rate calculation The following issues were important in the design of the ECG module Diagnostic quality signal bandwidth reliable beat detection and heart rate calculation ESU noise rejection pacemaker pulse detect and artifact rejection The ECG module uses a differential amplifier to extract surface ECG activity from a pair of electrodes Input to the amplifier is protected against damage from excessive voltages Passive filtering reduces high power RF interference from electrosurgical devices Hardware under software control performs filtering for monitor vs diagnostic modes lead selection lead off detection and pacer pulse detection Software performs gain control notch filtering to remove line frequency interference pacer artifact handling noise detection beat detection heart rate calculation and serial CAN bus communications The TTI respiration circuit uses a transformer to generate a low current high frequency stimulus through the Lead electrodes The resulting voltage variations reflect impedance variations across the thorax which in turn reflect respiration activity as well as other phenomena including cardiogenic artifact and motion artifact The TTI respiration software performs low pass filtering high pass filtering breath detection and calculates breath rate nGenuity 8100E Series Serv
161. ion The NIBP verification requires Dynatech Nevada NIBP Analyzer equivalent Criticare Systems Inc Connect the 8100E Series monitor to a Dynatech Nevada NIBP Analyzer set for the following operation 4 NIBP Analyzer Settings Adult 120 80 90 Heart Rate 80 bpm Neonate 80 50 62 Heart Rate 80 bpm Pressure Adjustments Gain 10096 Shift 4 Use the T connection with the dummy cuffs for these tests Connect them to the 0 300 mmHg port of the NIBP analyzer Connect the monitor to an AC mains power source and turn on the monitor Press the monitor s NIBP CYCLE STAT key The monitors cycle time window appears Select the NIBP Cycle Time to two minutes 120 80 OPERATION SETTING 1 In the monitors ADM DIS window set the Patient Size to Adult mode 2 Connect the NIBP hose to the fitting on the monitor 3 Press and hold the NIBP key 4 Allow the monitor to take at least four 4 readings Calculate the 5 average of the four 4 readings and verify that each reading does not vary by more than 4 or x4mmHg whichever is greater from the calculated average Each reading shall not vary more than 8 mmHg from the simulator setting Recalibrate the monitor if necessary 80 50 OPERATION SETTING 1 Set the monitor to the Neonate mode 2 To verify STAT mode operation press and hold the NIBP CYCLE STAT key Allow the monitor to take at least four 4 readings Calculate the aver
162. l 300 simulator or equivalent Criticare Systems Inc 1 Select the menu to set up for ECG PARAMS to 5 Lead ECG ON Filters MONITOR SENSITIVITY to HIGH Insert a shorted ECG cable into the ECG connector Use the menu knob to enter the DISPLAY window Set the following and use the current defaults for the size They are 25MM except waveform 3 Waveform 1 ECG I x 4 0 25 0 e Waveform 2 ECG II x 4 0 25 0 e Waveform 3 ECG V x 4 0 25 0 Exit the DISPLAY window Verify that the baselines are centered Verify that the base line signal is no greater than 3 pixels in height Select the most solid line as the reference line and verify that this reference is less than 3 pixels from the ECG y axis center line If they are not adjust pots R12 Waveform 1 R110 Waveform 2 and R108 Waveform 3 Remove the shorted cable Verify that the message LEADS OFF appears at the top of the window when no cable is connected Connect the 3 lead ECG patient cable CAT 1075 S to the ECG cable assembly and use a Dynatech Nevada Model 300 simulator to turn on ECG normal sinus 6 amp 1 0mV axis int Respiration rate 20 and the impedance set for 0 5 ohms and base impedance for 2K nGenuity 8100E Series Service Manual Page 5 13 Section 5 Preventative Maintenance 6 Rotate the menu knob to select PARMETERS and press to enable the menu Select ECG for 3 LEADWIRE Set the monitor for LEAD II waveforms Check
163. larms and alerts The monitor also prints strip chart recordings and stores tabular trends for review The 8100E Series monitor is intended to monitor physiological parameters of patients within clinical care settings It is intended that the user is a professional health care provider Physiological data system alarms and patient data analysis are available to the care provider from the monitor The user is responsible for the interpretation of the monitored data that is made available Physiological data should be reviewed by a qualified clinical personnel prior to any medical intervention The monitor is designed to be used with only one patient at a time The monitor including accessories is capable of monitoring a full range of patients from neonate to adult The nGenuity 8100E Series monitor comes standard with 5 Lead ECG ComfortCuff NIBP SpO and one temperature channel for monitoring Options include internal printer and CO monitoring A color TFT screen with a six waveform display is standard on all nGenuity 8100E Series models The nGenuity 8100E Series monitor is also available with ST and Arrhythmia analysis as an option Catalog Number Printer Additional Features 8100E No Standard 8100E ST No ST Arrhythmia 8100E1 No COs 8100E1 ST No ST Arrhythmia 8100EP Yes Standard 8100EP ST Yes ST Arrhythmia 8100EP1 Yes 8100 1 5 Yes Arrhythmia nGenuity 8100E Series Service Manual Page 1
164. layed and press the knob to save selection Press the knob once more to skip the color choice Highlight Unit of Measure underneath CO2 and press the knob to select Rotate the knob until PERCENT is highlight press the knob to save selection Highlight EX T and press the rotary knob to exit the Parameters menu Highlight CONFIG and press the rotary knob to enter the Configuration menu In the Configuration menu highlight Enter Service Mode using the rotary knob Press the knob to select Rotate the knob so that YES is highlighted Press the knob to enter Service Mode The Enter Service Mode password box appears Enter password 418 and press the rotary knob The Service Mode window will appear nGenuity 8100E Series Service Manual Criticare Systems Inc Criticare Systems Inc Appendix A CO2 Service CALIBRATION 1 Highlight Enter CO2 Service and press the rotary knob to select Rotate the knob to YES and press the knob to enter CO2 Service Using the regulator CAT 623 and regulator bleed tube CAT 613B connect the 10 gas to PORT 1 on the Breath Rate Simulator Turn on the Breath Rate Simulator and the 1096 CO gas 3 Highlight CO2 Zero Cal and press the knob to select 4 Turn the rotary knob until Hequest CO2 Zero Cal is displayed Press the knob to begin a CO2 Zero Cal Wait for the calibration to complete about one 1 minute If the EXP
165. losure is pressed firmly and completely against the fixture before drilling Secure two 2 standoffs Item 5 424318002 to the rear enclosure using two 2 KEPS nuts Item 6 402848002 3 Remove 2 screws on each side of the chassis assembly to drop the front Install the CO2 cable into J16 of the Main PCB Install the CO2 internal assembly Item 2 and secure it using four 4 screws Item 4 40496B001 4 Re install the rear enclosure including insulator battery cover and printer cover using previously removed hardware Reference current released 92800A001 and 93979A001 002 documentation for screw information 5 Carefully line up and install the external CO2 Module Item 3 92800A002 and secure using two 2 screws Item 4 40496B001 Do not force the connection 6 Add defib label PN 45699B001 part of label set PN 95773A001 over the water trap manifold as shown 7 Print barcode label Item 8 containing CAT part and serial number Place behind clear window on serial number label Item 7 A 8 Place current revision Item 9 onto the serial tag Item 7 and above the address REV DATE DESCRIPTION BY 1 04 17 07 SEE 9166 5 2 12 19 07 10053 RWK 3 5 1 08 SEE 10136 DBL 4 8 20 09 SEE 10416 DBL SW vet CRITICARE SYSTEMS INC EG CHECK mc E 5 COOGAN 03 05 07 5 RUE 1 16 06 DATE note AKAPLAN __ 03
166. ly Remove the two 2 screws PHMS 6 32 x 375 SEMS 40496B001 from the external module pn 928114002 Carefully pull the external module away from the monitor Replace external module Reassemble in reverse order Follow all ESD procedures as stated in Electrostatic Discharge in Section 7 Disassembly Remove the printer module pn 92804A001 or printer cover pn 45183B001 from the rear enclosure a Remove the two 2 screws PHMS 4 40 x 312 SEMS pn 40995B001 holding the module or cover to the rear enclosure b If the monitor has a printer module label and remove the ribbon cable from the printer module Remove the external module pn 928114002 following the instructions above Remove the rear enclosure pn 92810C001 a Remove the four 4 nylon screws PHMS 8 32 x 375 NYLON pn 42654B002 on the bottom of the enclosure NOTE The plastic insulator bottom pn 45194B001 will come off when the screws are removed Do not lose b Remove the two 2 screws FHMS 8 32 x 375 PH PL pn 40083B002 located under the insulator c Remove the two 2 screws PHMS 4 40 x 500 SEMS pn 40995B003 from the back of the battery door d Remove the two 2 screws FHMS 6 32 x 375 pn 40180B002 from the power area e Remove the six 6 screws PHMS 6 32 x 375 SEMS pn 40496B001 holding the rear enclosure to the front enclosure Disconnect the rib
167. mbly Display Chassis Assembly Assembly Patient Connectors Shielded Analog Board Assembly Printer Title Main Board 8100E 8100EP Main Board 8100E 8100EP Schematic Analog Board 8100 Analog Board 8100 Schematic SpO Board SpO Board Schematic nGenuity 8100E Series Service Manual Drawing Number 93979A001 93979A002 93979 011 93979 012 92800A001 92800A002 92803A001 92799A001 95710A003 928014001 927974002 928114001 928114002 92802A001 957674001 91353A003 92804A001 Drawing Number 91340A005 913408005 91342A003 913425003 91339A001 913395001 9 1 Section 9 Drawings and Schematics Final Assembly 8100E Without Printer 8100EP With Printer Page 9 2 93979A001 FINAL ASSEMBLY 8100E Item CSI Part Description 01 92800A001 AY MAIN MONITOR 02 45183B001 COVER NO PRINTER 03 40995B001 5 4 40X 312 SEMS 05 95773A001 LABEL SET 8100E EP ENGLISH 06 41891B002 DB9 COVER PLATE 07 41891B003 PLATE COVER MINI DIN 08 40123B004 5 4 40X 250 NY WHT 09 46162B001 LABEL CSI MON BAR CODE 10 46426B004 LABEL HARDWARE REVISION 4 93979A002 FINAL ASSEMBLY 8100EP Item CSI Part Description 01 92800A001 AY MAIN MONITOR 02 92804A001 AY PRINTER MODULE 03 40995B001 5 4 40X 312 SEMS 04 40065B002 PAPER THERMAL 2 283 WIDE 05 957734001 LABEL SET 8100E EP ENGLISH 06 41891B002 DB9 COVER PLATE 07 41891B003 PLATE COVER MINI DIN 08 40123B004 5 4 40X 250 WHT 09 46162
168. mbly 92801A001 AY CHASSIS MAIN Item 01 Criticare Systems Inc CSI Part 42635B001 91340A005 91353A003 91339A001 42636B001 95767A001 90866A002 45192B001 82569B001 42642B001 40496B002 40496B005 42639B001 40909B002 41955B001 40067B003 42501B002 40035B001 83111B002 40995B003 41371B001 nGenuity 8100E Series Service Manual Description FRAME MAIN ASSY MAIN PCB 8100E1 EP1 AY SHIELDED ANALOG BRD ASSEMBLY PCB 8100 SPO2 BOARD PLATE SPO2 MOUNT 8100E EP ASSEMBLY PATIENT CONNECTORS CABLE SPO2 TO ANALOG SHIELD MAIN PCB FERRITE BEAD SPACER MAIN PCB 5 6 32 250 SEMS P H M S 6 32X 750 SEMS STANDOFF F F 6 32 X 625 HEX SPCR HEX 6 32X 625 NY M F FOAM TAPE 1 0 X 2 12 CABLE TIE 8 GROMMET STRIP WITH ADHES TAPE ELECTRICAL BLK 75 8100 PRINTER CBL P H M S 4 40 500 SEMS TAPE INSUL KAPTON 2 Page 9 7 Section 9 Drawings and Schematics NIBP Chassis Assembly 92797A002 ASSEMBLY NIBP CHASSIS Item CSI Part Description 01 95576A005 AY PUMP WITH WIRES 02 95596A004 AY OKEN VALVE WITH CRIMPS 04 42629B001 BRACKET NIBP 06 42081B002 ORIFICE RESTRICTOR 0125 07 42111B001 SCREW M2 4X3 PH BINDER 08 41700B001 TUBING POLYU 0941DX 1870 09 40296B002 TUBING SILC BLU 125X 250 10 42069B001 TUBING 1 4X1 8 POLYU COIL 11 402948001 HOLDER TIE WRAP ADH BK SM 12 40067B002 CABLE TIE 5 6 13 40067B001 CABLE TIE 4 0 14 41955B001 FOAM TAPE 1 0 X 2 12 15 41579B003 CHECK VALVE 16 80111B001 FERRITE BEAD EMI SHIEL
169. minutes after a new alarm activates Set the Alarm Tone Warning value to OFF to allow the monitor to suspend any audible alarm remain silent after a new alarm activates Thus you can silence alarms with a long push held in for 2 seconds on the monitors SILENCE key NOTE As a safeguard measure the Permanent Alarm Silence function Service Mode window can override the Alarm Tone Warning function The Disable value of the Permanent Alarm Silence function can prevent the ability of the Alarm Tone Warning function s OFF value to suspend audible alarms In this case pushing the Silence button has no effect the monitors full audio alarm would continue Set this safeguard according to your facility protocols and according to local safety regulations for medical devices Override from the Configuration Window Service Mode Window Alarm Tone Warning Permanent Alarm Silence ON OFF ENABLE double beep always silent DISABLE full audio alarms full audio alarms In the CONFIG menu the frequency which is rejected is either 50 Hz or 60 Hz Set the frequency to the local AC mains power which is 60 Hz in the U S and 50 Hz in most of Europe Contact your local distributor for more information The password to change the frequency is PIA418 nGenuity 8100E Series Service Manual Criticare Systems Inc Section 2 Service Windows Simulation Mode Simulation software is only used for demonstrations and not intended f
170. n 2 3 112106 j R11 ji C9 100 10K R12 T MMBT4403 1K AD822AR LED CT LMT 40MA R10D 1 1 SH1 SH2 SH3 SH4 5 5 PTHs PTHs PTHs PTHs PTHs LED PWR COMMON ANODE IRLED RLED 131 pis R14 047 4 75K ELECTRONIC FILE NAME JAPERMY81001HWA91339RV2191339RV2 DSN s 4 IRGATE CRITICARE SYSTEMS INC CONFIDENTIAL This document contains confidential information and may not SI9925DY 20925 Crossroads Circle Waukesha WI 53186 be copied or divulged without written consent of CRITICARE SYSTEMS INC DRAWN BY DJR ENG APPR PART NUMBER David Rieck 6 05 00 91339S001 YW APPR LAST MODIFIED DATE TIE Circuit Schematic 8100 9100 SpO2 Thursday November 01 2007 Alex Kaplan 6 08 00 CHECKED BY MFG APPR RELEASED DOCUMENT SHEET SIZE B DIST 306 SHEET 4 OF 1 BARE PCB 83603B001 REV 0 Ken Schmitz 6 08 00 5 3 e
171. nGenuity 8100E Series Vital Signs Monitor Service Manual Cat No 1448 Part No 39166B101 Date 09 09 Revision 2 Copyright COPYRIGHT CRITICARE SYSTEMS INC 2006 2009 CRITICARE SYSTEMS INC Criticare owns all rights to this unpublished work and intends to maintain this work as confidential Criticare may also seek to maintain this work as an unpublished copyright This publication is to be used solely for the purposes of reference operation maintenance or repair of Criticare equipment No part of this publication may be reproduced in any manner or disseminated for other purposes In the event of inadvertent or deliberate publication Criticare intends to enforce its rights to this work under copyright laws as a published work Those having access to this work may not copy use or disclose the information in this work unless expressly authorized by Criticare to do so All product specifications as well as information contained in this publication are subject to change without notice All information contained in this publication is believed to be correct Criticare Systems Inc shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing performance or use of this material This publication may refer to information and products protected by copyrights or patents and does not convey any license under the patent rights of Criticare Systems
172. natech 232 or equivalent to the 8100E Series monitor using the 5 lead ECG cable marked Cat 1075 5 Change the MODE switch to ECG For the rest of the Leakage test insure that the leads are dressed away from the ground planes and the AC power cords and the chassis Set the LEADS selector switch to ALL TO GND Set the POLARITY switch to NORMAL Monitor the meter for less than 5 pA 7 Set the POLARITY switch to REVERSE and monitor the meter for less than 5 pA 8 Set the POLARITY switch to NORMAL and press the OPEN NEUTRAL switch and monitor the meter for less than 10 pA 9 Set the POLARITY switch to REVERSE and press the OPEN NEUTRAL switch and monitor the meter for less than 10 pA 10 Set the POLARITY switch to NORMAL and press the OPEN GROUND switch and monitor the meter for less than 10 pA For inline voltages of 264V meter for less than 20pA 11 Set the POLARITY switch to REVERSE and press the OPEN GROUND switch and monitor the meter for less than 10 pA For inline voltages of 264V meter for less than 20pA 12 Turn the LEADS selector switch to the ISO Position Turn the POLARITY switch to NORMAL press the ISO TEST button and monitor the meter for less than 20 pA For inline voltages of 264V meter for less than 50pA 13 Keep the power cord plugged into the unit under test and the Dynatech Unplug the 8100E Series ECG cable from the 8100E Series monitor Unplug the ECG test leads from the Dynatech Connect the SpO cable end to
173. nfect the SpO sensor by placing the paddles and cable in a 2 glutaraldehyde solution Only the sensor paddles and cable are placed in the solution You can clean the reusable blood pressure cuff by wiping it with a damp cloth or sponge If necessary disinfect the cuff by wiping it with 7096 alcohol mild bleach solution or other disinfectant Disposable blood pressure cuffs are for single patient use and are not intended to be disinfected You can sterilize the cloth cuff and neoprene bag with commercially available disinfectants such as ethylene oxide EtO Rinse thoroughly to remove residual disinfectants Do not allow liquids to enter the neoprene bag The cloth cuff can also be sterilized in an autoclave nGenuity 8100E Series Service Manual Page 4 1 Section 4 Cleaning and Disinfecting ECG Cable Page 4 2 If the cuffs become grossly soiled with blood or other body fluids you should launder the cloth cuffs by hand or machine You can launder or sterilize the dacron cloth cuff by first removing the neoprene inflation bag Feed the inflation tube back through the hole and then pull out the cloth flap Flap Figure 4 1 Remove Inflation Bag from Cuff Roll up the inflation bag and slide it out the open slot in the cloth cuff The following laundering precautions apply only to non disposable cuffs You should not launder disposable cuffs and neoprene inserts Remove the inflatable bag from the cuff before laun
174. ntroduction Heart Rate ECG Measurement Page 1 4 Method The heart rate is determined primarily from the ECG waveform data A beat detection algorithm is used to identify QRS beats The monitor has a user selectable smart heart rate function It automatically uses alternate sources to determine heart rate if the primary source becomes unmeasurable The plethysmograph SpO waveform is used if the ECG heart rate is unavailable In the absence of SpO and ECG data the NIBP oscillometric data is the final default source for a heart rate measurement Response times for the ECG heart rate meter change from 80 BPM to 40 BPM and from 80 BPM to 120 BPM is less than or equal to 10 seconds The alarm for tachycardia is less than or equal to 10 seconds per EC 13 The pulse rate accuracy for SpO is the root mean square rms difference between paired pulse rate data recorded with the pulse oximeter and a reference method NOTE The accuracy of the heart rate depends upon the source The range of the measurable NIBP based heart rate does not extend as far as the range available in other modules used by the smart heart rate feature NOTE The NIBP based heart rate is not a continuous measurement and is only current during an NIBP measurement The electrocardiogram ECG or EKG records the changing potential generated by electrical activity of the heart To obtain an overall view of the heart s electrical activity three or five electr
175. odes attached to lead wires detect electrical impulses from the patient s heart to the skin The monitor calculates the difference in electrical force between two electrode sites Electrode polarity positive negative or ground depends on the cable receptacle the lead wire is attached to and the lead selected on the monitor screen The ECG design uses the standard conventional bipolar limb leads leads Il using 3 lead or 5 lead cable accessory With the 5 Lead cable accessory leads aVR aVL aVF and V lead may also be viewed The monitor has user selectable automatic lead switching capability when using the 5 lead settings If a lead becomes detached or is unmeasurable the monitor can automatically display an alternate lead view using the remaining leads nGenuity 8100E Series Service Manual Criticare Systems Inc Section 1 Introduction Stability of Accuracy monitor is equipped with pacemaker detection and user Pacemaker Pulse Rejection Respiration Criticare Systems Inc selectable pacer rejection There are no known safety hazards due to the operation of a cardiac pacemaker or other electrical stimulators when used with this vital signs monitor The accuracy of the monitor is not affected by arrhythmia or other physiological conditions where the electrocardiogram amplitude and heart rate are within the detectable limits specified for the monitor The monitor has user selectable signal filtering in the
176. ogram on the PC Select Start gt Programs gt CSI NIBP Service gt NIBPSvc Close the disclaimer dialogue box Turn the monitor s power on again and establish a new communications link between the monitor and the PC service program To perform the service test for speed click on the Speed button then click on Start When the unit passes the speed test press Done To perform the service test for leakage click on the Leak button then click on Start When the unit passes the leakage test press Done To perform the service test for inflation safety click on the Safety button then click on Start When the unit passes the safety test press Done Turn the monitor off Click on Abort if an error message appears on the computer once the monitor is off Exit the service program on the computer Remove the download cable Click No to exit the program click Yes to save the data to a user specified location Criticare Systems Inc nGenuity 8100E Series Service Manual Page 6 9 Section 6 Service Testing and Calibration Temperature Input Check Page 6 10 Connect the temperature simulator TP400 to the TEMP connector Verify the Temperature on the display is within 0 1 C for temperature simulator settings of 20 25 30 35 36 37 38 39 40 and 45C Disconnect the Temperature simulator from the TEMP CONNECTOR and verify that the Temperature on the display is Verify
177. onnections is needed for the 8100E Series The analyzer also has a custom port designed for testing DOX SpO sensors The SmartSat can be used for spot checking 5 values using the manual settings The manufacturer recommends using a timed and programmed sequence to ensure that there is optimal performance For older revisions of SmartSat Analyzer that does not have a program for the Model 8100E monitor program the SmartSat as specified below Verify that the monitor s display value matches the corresponding value in the test procedure not the program settings AUTO SEQ MODEL 8100E Oximeter DOX Step Time Mod Setting Rate 1 185 5 00 99 40 2 205 5 00 96 60 3 205 5 00 89 80 4 205 5 00 73 100 5 20s 5 00 52 120 6 20s 5 00 42 180 7 20s 5 00 26 300 8 END Recent versions of the SmartSat Analyzer are pre loaded with a different program but utilize the same test 1 Verify the SpO module For verification refer to 2 Verification on page 5 18 2 Attach the monitor to the SmartSat 3 Start the SmartSat programmed sequence SmartSat Auto Sequence Verify that the monitor s reported 5 values are within the limits specified LevelSaturation Limits Heart Rate Limits 1 99 97 99 40 bpm 39 41 bpm 2 96 94 98 60 bpm 59 61 bpm 3 90 88 92 80 bpm 79 81 bpm 4 78 76 80 100 bpm 99 101 bpm 5 61 58 64 120 bpm 119 121 bpm 6 52 49 55 180 bpm 179 181 bpm 7 40 37 43 300 bpm 297 303 bpm nGenuity
178. ons listed in this manual The maximum cuff inflation rate is 15 mmHg sec The software limits inflation to 300 mmHg adult 300 mmHg pediatric or 150 neonate A secondary circuit limits maximum possible cuff pressure to 330 mmHg in adult pediatric mode and 165 mmHg in neonatal mode Cuff pressure is allowed to remain above 30 mmHg for a maximum of two minutes The monitor automatically deflates the cuff if the time limit is violated The monitor contains hardware protection for overpressure conditions pressure transducer failures or microprocessor and pump control circuit failures B P Cuff Inflation Pressure Shown during inflation Systolic Pressure Actual Blood Pressure Waveform A Diastolic Pressure ip i lt Cuff deflates rapidly 50 i after monitor determines systolic pressure 20 i 10 0 1 m Time gt Pulse Waveform Measured from Cuff h Pressure Fluctuation Diastolic Mean Systolic Pressure Pressure Pressure Figure 1 1 NIBP Cuff Pressure and Pulse over Time Criticare Systems Inc nGenuity 8100E Series Service Manual Page 1 7 Section 1 Introduction Capnography Measurement of Method of Measurement Page 1 8 The 8100E Series monitor uses the sidestream method of measuring CO Gas is aspirated through a nasal cannula or a ventilation circuit adapter The gas sample enters from a sampling tube into a
179. oose connectors cracked housing etc Check the electrical safety of the power cord as part of the monitor safety testing Check the cuffs for leakage as part of the NIBP verification nGenuity 8100E Series Service Manual Page 5 3 Section 5 Preventative Maintenance Fuse Removal There are two 2 AC power fuses located at the rear of the monitor Replacement directly below the AC power entry socket United States monitors use 1A 250V Time Lag fuses nternational monitors used in 220 240 volt environments use 1A 250V Time Lag fuses 1 Remove power cord 2 Press in the side clips at the same time with a tool and lift out the access cover The two 2 fuse sockets are visible Clips Figure 5 2 Remove the Fuse Cover Figure 5 3 Fuses Exposed Page 5 4 nGenuity 8100E Series Service Manual Criticare Systems Inc Long Term Monitor and Battery Storage Monitor and Accessories Disposal Criticare Systems Inc Section 5 Preventative Maintenance 3 Gently pull the fuses out of the fuse cover assembly Figure 5 4 Fuses Pulled 4 Reassemble in reverse order For more information about troubleshooting power problems refer to Troubleshooting in Section 8 No special preparation is necessary for long term storage of the monitor Although you do not have to remove the battery from the monitor for long term storage the battery drains to an unrecoverable state after
180. or servicing the monitor The service password is required to activate this demonstration function The words S MULATION MODE appear in large letters on the monitor screen when in use In the sample window shown below all function parameters are active and reflected in the waveforms and numerical values that could be useful for a demonstration or training session The screen only displays functions that are available on the unit ECG BPM 205 MAP mmHg CYCLE OFF AGE min ALARMS PARAMS DISPLAY ART1 HIGH DIA 96 4 V000 NO ADMIT ADM DIS CONFIG PRINT Adult NOV 07 05 14 12 59 Figure 2 10 Example of the Window in Simulation Mode NOTE Simulation Mode can only be exited by pressing the ON OFF button and turning off the monitor NOTE To exit the menu navigate to EX T and press SELECT Criticare Systems Inc nGenuity 8100E Series Service Manual Page 2 9 Section 2 Service Windows Custom Profiles Setting Patient Size Page 2 10 The monitor has a set of default settings that you can configure to the needs of the facility These default settings are password protected The monitor is designed to look at the patient size information selected in the ADM DIS or ALARMS windows and determine whether the monitor should use one of the following alarm settings while monitoring e Adult Pediatric Neonatal When you change the patient size in the ADM DIS window or the ALARMS wind
181. ottom edge of the ECG Analog Board The ribbon cable extends to the SpO Board There is also a short cable to the ECG Analog Board pn 90866A002 The plethysmograph input signal enters the SpO Board through shielded cable that runs between the boards and metal chassis to the opposite side of the monitor The SpO module is composed of digital components that are not effected by noise There is also no signal degradation or loss of calibration due to analog components Interference or noisy signal can be due to a worn cable assembly or DB 9 connector Replace the connector and cable assembly if necessary Always check the sensor when intermittent problems are reported Stretched or otherwise damaged sensor cables must be replaced NOTE The line frequency setting of the monitor must be set correctly for optimal SpO s monitoring The Main Board pn 91340A004 contains the primary processors storage memory NIBP circuitry communication interfaces audio driver vital signs module connections power regulation battery charge circuits video generation and keypad inputs User The Main Board has an adjustable pot R92 that you set during NIBP calibration There are two CPUs on the Main Board that you must program from a CSI Service Download Station The programmable settings remain in non volatile memory Repair or improper handling of the Main Board can corrupt this software There is one 1 replacable 3 amp fuse pn
182. ow the monitor determines which window appears when you select the ALARMS window When the user changes patient size the user effectively changes all the alarm limits for all of the following e 5 ECG NIBP Temperature Respiration Maximum NIBP pressure limit To enter patient size do the following 1 Rotate the menu knob to highlight ADM DIS or ALARMS and press to select 2 Rotate the menu knob to highlight Update select YES and press to select You can now select the patient data field 3 Rotate the menu knob to highlight Patient Size and press to select 4 Rotate the menu knob to highlight Adult Pediatric or Neonate as required Optional Enter a value for unit label only if you use central station communication 5 Select EXIT to return to the Main window 6 Exit the ADM DIS or ALARMS window nGenuity 8100E Series Service Manual Criticare Systems Inc Section 2 Service Windows Creating Custom Profiles The default mode you last completed is the default patient size for custom defaults If you want a different default size mode change the order in which the monitor saves alarm limits In the example below the first patient size setting created is NEONATE Update the custom default alarm limits for the pediatric and adult modes by repeating the steps in this procedure two more times once for PEDIATRIC and once for ADULT as the patient size setting ACCESSING THE DEFAULTS DI
183. r Hi GND Component Side AC Line Isolation Board D 5 gt 9 8 5 52 2 z o o z Criticare Systems Inc nGenuity 8100E Series Service Manual Page A 3 Appendix A CO2 Service Preventative Maintenance Maintenance Schedule Absorber Verification Page 4 Perform these maintenance tasks in addition to those listed in the Maintenance Schedule in Section 5 EVERY PATIENT Change the gas sampling device and sampling line EVERY WEEK Change the water trap or as needed EVERY 3 MONTHS Clean the exterior of the unit or as needed EVERY YEAR e Verify the CO auto calibration Calibrate if necessary Check the absorber Change if necessary Check the gas flow rate Adjust if necessary The granules in the absorber are normally white indicating good absorber If the granules remain violet or blue the absorber is spent and needs to be replaced NOTE The absorber can change color during use but should always return to its original white color when not in use Verifying the state of the CO absorber requires removing the external module from the monitor See Check Replace the Absorber located under Disassembly later in this appendix for instructions on removing the external module from the monitor nGenuity 8100E Series Service Manual Criticare Systems Inc
184. r housing and break the warranty seal 1 NWARNING N Shock Hazard Do not attempt to power the monitor with an external DC source while sensors are attached to a person Always use vital signs simulators when using alternate power Sources during testing If voltages exceeding those listed are applied permanent damage will occur Set a power supply to 13VDC 0 25VDC Attach the power supply module to the battery terminals of the monitor under test Turn on the monitor under test and verify that the green battery icon is present Lower the voltage with the adjustment of the power supply to a voltage of between 11 55 and 11 40 VDC and verify a yellow battery icon appears Lower the voltage to between 11 30 and 10 50 VDC and verify that a black battery icon appears Continue to decrease the voltage and verify that the unit shuts down at 10 2 VDC x0 5VDC nGenuity 8100E Series Service Manual Criticare Systems Inc Section 5 Preventative Maintenance Functional and Safety Testing Checklist Functional and Safety Testing Checklist Page 1 of 2 SERIAL NUMBER Tester DATE SOFTWARE REV MAIN SOFTWARE REV CONM SOFTWARE REV VSM PASS FAIL Verify 1 Amp fuses Verify Ground Continuity Verify Hi Pot Hot Neutral to EPT 2500VDC Hot Neutral to ECG 4242VDC Hot Neutral to Temperature 4242VDC Hot Neutral to Spo2 4242VDC Hot Neutral to BNC 2500VDC Hot Neutral to Nurse Call 2500VDC Verif
185. r receipt of the repaired goods If the unit is not returned to CSI within that time the customer will be invoiced for the full purchase price of the equipment Outside the U S No loaners are available from CSI internationally Contact your local CSI representative nGenuity 8100E Series Service Manual Criticare Systems Inc EC Declaration of Conformity nGenuity 8100E Series Patient Monitor Representative in the European Union Criticare Systems Inc To view the Declaration of Conformity visit the Criticare website at www csiusa com A copy of the Declaration can also be faxed Contact Criticare s customer service department at 262 798 8282 to obtain a faxed copy of the Declaration Criticare Systems Limited c o Wright Hassall 9 Clarendon Place Leamington Spa Warwickshire CV 32 5QP United Kingdom T 0044 0 1926 886688 F 0044 0 1926 885588 For the Attention of Ref 45 or Mr L A Heizler nGenuity 8100E Series Service Manual Page ix Section 1 Introduction Description Intended Use nGenuity 8100E Series Options Criticare Systems Inc The nGenuity 8100E Series monitor interprets and displays real time physiological data including waveforms and numerical data The monitor is designed for multi parameter measurements including ECG NIBP SpOs temperature and respiration Optional monitoring is also available For all these vital parameters the 8100E Series monitor has limit a
186. r the temperature and ECG functions Patient isolation for non galvanic contact is required for the pulse oximetry sensor A CAN bus passes the vital signs parameters to the main module The main module sends the vital signs module control information and the vital signs module sends the main module waveforms and hardware status The communication cycle is 20 Hz for the vital signs information from the VS module twice a second for the status of the VS module and as needed for the control information from the main module The speaker drive circuit is a DAC controlling speaker volume and an output pin to control frequency A software controlled timer generates a square wave signal that drives the speaker Hence any drive frequency has harmonic components and generates no pure tones Applicable standards recommend against the use of pure tones in alarm situations to reduce the risk of an individual with a notch hearing deficit missing an alarm nGenuity 8100E Series Service Manual Page 3 1 Section 3 Theory of Operation ECG Module Impedance Respiration Page 3 2 The ECG module monitors from either three lead or five lead surface electrode configuration providing one or three concurrent ECG leadviews respectively The ECG module processing includes heart rate ECG lost pacer pulse and leadoff detection The main software is able to control lead gain scale and filter selection as well as pacer mode operation Shield
187. rientra dena 8 6 ACG Power Components d dr tre erige 8 6 Section 9 Drawings and Schematics List of Drawings roin a ei rh d cea n Assembly BOMs and Drawings PCB Drawings and Schematics Final 8100E Without 8100EP With Printer nter tnnt teen tnr renis 8100E1 With CO 8100EP1 With and Printer Main Monitor Assembly P Main Monitor with Assembly ne 9 5 Chassis Assemblies Bottom Chassis Assembly ys Power Supply with Main Chassis NIBP Chassis Assembly Internal Module Assembly CO External Module Assembly n Display Chassis Assembly aiiin eii Assembly Patient Connectors essere nennen Shielded Analog Board Assembly S IT LE L 9 12 Appendix A Service Service Windows Theory of Operations 52 Capnometer Module tenente tette tata tnn A 2 Block Diagram eene t tnr terrm tenet di ne A 3 Preventative Maintenance A 4 Maintenance Schedule A 4 Absorber Verification A 4 Gas Flow CO tns A 5
188. rn nud 2 8 deiner net meet mee ier eee edite 2 8 Simulation Mode 2 9 Custom Profiles 2 10 Setting Patient Size 2 10 Creating Custom Profiles eese 2 11 Section 3 Theory of Operation EE 3 1 Main CPU and Systelri s ucc int nee tt rented Dep reci Dee b vare vada 3 1 ee ois 3 1 Vital Signs Module 3 1 Speaker Driver 3 1 ECG 3 2 Impedance 3 2 Pulse Oximeter Module 0 00 0 3 3 Communications Printer 0 LL Section 4 Cleaning and Disinfecting Cleaning and DISINGGCtIAG 0 cc ccveciecanenseeecssenvccsnesceusentarvoveeyectecactessbevoustececusbasertenateadtes 4 1 Pulse Oximeter 4 1 Blood Pressure 4 1 ECG Cable 5 Temperature Cable 5 nea nece te 4 3 Accidental Wettirig terreri teen da ree rb e reete etr 4 4 Section 5 Preventative Maintenance Incoming Inspection rere rere etenim rebns Maintenance Schedule icit cunt eec eec Dieta tpe dota Monitor Safety Testing Equipment and
189. stood all the previous sections of this manual You must fully repair calibrate and test all damaged monitors before you use them on patients The monitor must meet the original operating specifications before you use it on a patient A Always follow ESD precautions when performing any of the procedures discussed in this section ComfortCuff NIBP The NIBP module consists of a pneumatic pump assembly Module pn 95576A003 and control circuitry located on the Main Board pn 91340A004 The pneumatics assembly is mounted on the back side of the metal chassis plate A large diameter tube pn 41602B001 connects to the Quick Connect hardware fixture and the transducer on the Main Board The transducer port faces out the back side of the Main Board through a hole The remaining pneumatics links connect the two control valves pn 95596A004 the pump pn 95576A005 and the check valve 41579 003 As the tubing ages it may lose its seal Old tubing can be re seated or replaced as necessary When any major pneumatic component such as a pump or valve is replaced the NIBP module must be re calibrated as in NIBP Calibration in section 6 of this manual The manufacturer recommends that the monitor be returned to a CSI authorized service facility if pump replacement is required The transducer 1 and the zero point calibration pot R92 are not field serviceable components Improper replacement can result in permanent damag
190. t 5 3 lt gt ws SS gt sks n E IE S LE gt BROWN WIRE 5 DETAIL SCALE 1 1 N PCB CONNECTIONS GROUND WIRE SEE NOTE 3 DETAIL C SCALE 1 1 SEE NOTE 3 AND IL B DETA AA SEE NOTE 1 TORQUE 8 IN LB REVISIONS DATE DESCRIPTION BY 5 15 06 SEE ECN 8842 DBL 4 12 08 SEE ECN 8885 185 1 22 07 SEE ECN 9079 sc 4 30 08 SEE ECN 10136 DBL 6 23 09 SEE ECN 10416 DBL CHECK ECG CONNECTOR KEY TO VERIFY POSITION AS SHOWN DETAIL A AA RELEASED DOCUMENT DETAIL D SCALE 1 1 A 2 00 2 00 DETAIL B A 1 AFTER ATTACHING CHASSIS MAIN AND INSTALL TOP SCREWS 2 BEFORE ATTACHING CHASSIS DISPLAY ITEM 3 CONNECT LL CABLES TO THE PCB 3 CUT 2 INCHES OF FOAM TAPE ITEM 9 AND APPLY TO THE WHITE IRE REMOVE THE PAPER FORM T zz OTTOM ITEM 1 USING BOTTOM SCREWS ITEM 8 PLUG IN ALL ELECTRICAL CONNECTIONS TO THE MAIN PCB LIFT CHASSIS MAIN RE APPROXIMATELY 2 INCHES DOWN FROM THE TOP OF THE BATTERY ITEM 2 TO THE CHASSIS HE TAPE AND SECURE THE GROUND SEE DETAIL B CONNECT THE GROU WIRE CONNECTOR A 4 USE 92803P001 VENDOR SHOULD COMPLY WITH THE FOLLOWING CSI QUALITY REQUIREMENTS Q1 Q2 Q4 Q5 Q6 Q7 Q10 Q11 AND 016 IN ADDITION TH
191. te High and low limit settings for each mode User Adjustable 1 10 Yes 2 minutes or permanent Tabular and Graphical 24 hours 30 sec 1 2 5 10 15 30 min 1 2 4 hrs NIBP user selectable 2 4 8 12 or 24 hours BPM HR SpO Temp Resp NIBP Systolic Diastolic Mean Internal thermal line printer Single or dual waveform Tabular 12 5 or 25mm sec continuous Snapshot at 50mm sec 10 4 active color TFT 640 x 480 pixels 6 maximum 0 5 1x 2x 4x user selectable 6 25 12 5 25 or 50 mm sec selectable 9 membrane activated Push and rotate 24 steps turn English French German Portuguese Spanish Italian Russian RS 232 compatible digital DB9 COM 1 mini DIN8 COM 2 Contact switch audio jack 1 8 inch 24V Q 100 ma maximum switching BNC connector Serial VGA Compatible Criticare Systems Inc Criticare Systems Inc Mechanical Electrical Weight Size Mechanical Shock Vibration Power Requirements Voltage Number of Batteries Battery Life Recharge time Environmental Operating Temperature Storage Temperature Operating and Storage Humidity Medical Device Electrical Protection Degree of Protection Protection against ingress Altitude Section 1 Introduction 13 2 Ib 6 kg no CO2 14 Ib 6 4kg with CO2 11 0 H x 13 0 W x 10 3 D 28 0cm H x 33 1 cm W x 26 2cm D No affect when tested to IEC 60068 2 27 standards
192. th Ground Software Error Related Criticare Systems Inc has quality control practices and procedures Hazard Mediation in place to review potential hazards as they relate to software monitor is Year 2000 Compliant and utilizes a 4 digit year for all date time and leap year calculations Page 1 18 nGenuity 8100E Series Service Manual Criticare Systems Inc Section 1 Introduction Potential Interference This device has been successfully tested to IEC 601 1 2 specified levels for emissions of and resistance to electromagnetic energy fields External disturbances which exceed these levels may cause operational issues with this device Other devices which are sensitive to a lower level of emissions than those allowed by IEC 601 1 2 may experience operational issues when used in proximity to this device MAGNETIC FIELDS Use of the monitor in an MRI environment may interfere with MRI image quality Use of MRI may interfere with the monitor The 8100E Series patient monitor is not intended for use in MRI environments RADIO FREQUENCY INTERFERENCE The monitor conforms with IEC 1000 4 3 for radio frequency interference and will operate with negligible adverse effects CONDUCTED TRANSIENTS The monitor conforms with IEC 61000 4 4 and IEC 61000 4 5 for conducted transients and will operate with negligible adverse effects X RAY The monitor will operate with negligible adverse effects in an X ray environment However th
193. ther at a single point near the 1 1149 CREA TITLE Wednesday April 01 1998 8100E1 EP1 MAINBOARD LAST MODIFIED DATE SHEETSUE DST 306 SHEET 2 OF 3 Wednesday January 24 2007 3 z 3 z 5 5 T z 5 PWR_SW BATTERY C59 R160 CHARGERS 100 25027 221 Charge current Bulk 012 Heatsink 7121d Vovercharge 14 6V loct 114ma Vfloat 13 7V RATS R200 R199 NS Vtrickle 10V EET 3 Tz 3 4 0OHM 0 22 OHM R212 SER
194. tient simulator for tri 10 triangle waveform oa fF 7 Verify that the baseline is zero and signal is a peak to peak voltage of 1 2V 0 2 Page 5 16 nGenuity 8100E Series Service Manual Criticare Systems Inc Section 5 Preventative Maintenance Diagnostic Monitor and 1 In the PARAMS menu set FILTER to DIAGNOSTIC On the ST Filter Mode Tests simulator select PERF under ECG then WAVE and then s10 10 Hz sine wave Verify on the monitor that the S40 simulator sine wave signal displayed has amplitude no less than 0 95 X 10 10 Hz sine wave To accomplish this measure the peak to peak amplitude of the 10 Hz sine wave in waveform then measure the peak to peak amplitude of the 40 Hz sine wave There shall be no more than a 5 decrease 40 Hz amplitude or 0 95 X 10 Hz amplitude 2 Select MONITOR filtering The 40 Hz sine wave displayed on the monitor display shall be 0 70 X the input amplitude in mV when the simulator is set to s10 10 Hz sine wave Measure as described in the previous step 3 Select ST filtering The 40 Hz sine wave displayed on the monitor shall be 0 70 X the input amplitude when the simulator is set to 510 10 Hz sine wave Measure as described in the previous step Set FILTEH back to DIAGNOSTIC 4 On the simulator use the arrow to select s0 05 for a 0 05 Hz sine wave In the monitor s D SPLAY menu select a sweep speed of 12 5 mm sec The 0 05 Hz sine
195. ttach the power supply cable to J20 on the Main PCB Attach ground wire to JP1 on Power Supply 10 Attach power cable to CN1 on Power Supply Perform the annual safety tests and the electrical safety tests any time the monitor is opened for repair These tests are found in Preventative Maintenance in Section 5 nGenuity 8100E Series Service Manual Criticare Systems Inc Section 7 Disassembly Assembly Tests Field Service Assembly Testing Unit Serial Number _ __ Main Software Revision ___ Plug an AC cord into the unit The green AC light should be on Hit the Power key The display should show CSI with current revision of software Check for proper operation of pump by hitting the NIBP key To insure the membrane buttons are operable hit the following keys in sequence and listen for the beep FREEZE NIBP CYCLE STAT NIBP PRINT SILENCE DEFAULT TREND STANDBY Rotate the Encoder knob and verify the cursor moves Press the encoder and verify a menu is selected Press the encoder again to exit List of replaced or repaired modules Description Serial Number Certification of Proper Assembly Name Assembly Technician Name This checklist may be copied Criticare Systems Inc nGenuity 8100E Series Service Manual Page 7 9 Section 8 Troubleshooting This section lists the possible causes of monitor problems Use this
196. ure mmHg 1 E Leak r r eset lt F5 gt scr ow mw Disable FE Safety 00 mmHg ElpsedTime 0 0 we 8100 Integrated NIBP 70 Fact idle Figure 6 5 Select Calibrate 8 A box prompting you to attach the digital manometer and dummy cuff will appear Verify that the pressure at the cuff is OmmHg 2mmHg Click Next Unit Calibration xi Software Cal Burn in file path CAPROGRA 1NCsAToolsWibpsveNncalburn Browse Attach digital manometer and dummy cuff Cuff mmHg 0 5 0 Gain adjust 50643 NIBP Module 70 Fact idle Figure 6 6 Verify Cuff Pressure nGenuity 8100E Series Service Manual Page 6 7 Section 6 Service Testing and Calibration 9 Verify that the pressure at the cuff is OmmHg x2mmHg If the pressure is not x2mmHg of zero the main board must be replaced Click Next Unit Calibration Software Cal Burn in file path anual C PROGRA 1 Csi T 2357 Browse Help If pressure is off by more than 2 mmHg adjust the ZERO POT if equipped Otherwise wait for the Module to auto zero Cuff 0 Gain adjust 8100 Integrated NIBP 70 Fact idle Figure 6 7 Verify Cuff Pressure 10 Check the cuff pressure as indicated on the service screen of the computer with the pressure indicated on the digital
197. vice Mode Parameters window NOTE Pressing the ON OFF button will turn off the monitor Press the ON OFF button again to restart the monitor Page 2 4 nGenuity 8100E Series Service Manual Criticare Systems Inc Section 2 Service Windows Processor Software The Software Download parameter in the Service Mode window is Download used to download software for the following processors e NIBP CO Processor Vital Signs Processor Main Display Processor From the Service Mode window 1 Rotate the menu knob to Software Download and press to select 2 Rotate the knob to choose the processor you wish to download and press to select The value NO is highlighted Are you sure NO Figure 2 7 Initial Software Download Dialog Box 3 Rotate the menu knob to highlight YES and press to select The following window appears Are you sure YES Run PC Download Application Figure 2 8 Software Download Response Message If you choose not to select YES allow NO to remain selected and then press the menu knob to return to the Service Mode window The following message then appears next to the Software Download parameter No action taken 4 Press the ON OFF button on the front panel of the monitor to turn off the power to the monitor Criticare Systems Inc nGenuity 8100E Series Service Manual Page 2 5 Section 2 Service Windows Permanent Alarm Silence From the Service Mode window 1 To disable t
198. water trap which removes water vapor and particulate matter from the gas sample The gas then enters the detector where it is analyzed The monitor measures concentrations and displays them in a continuous waveform The monitor also detects end tidal and fraction Inspired CO levels displaying them numerically End tidal ETCO is defined as the maximum concentration at the end of expiration The monitor measures and displays this numerical value of concentration The ETCO value is updated continuously with each breath cycle The amount of in the gas mixture inhaled in by the patient is the fractional Inspired CO FICO The monitor measures CO using the principles of infrared absorption spectrometry An unknown concentration of gas CO is calculated by comparing its absorption of infrared light to that of a known standard The absorption of light is directly related to the concentration of gas As infrared light passes through the sample gas chamber the light transmitted is converted to a voltage signal The monitor converts the voltage to concentration and expresses it as mmHg percent 96 kPa user selectable or Torr Infrared analysis of the gas samples is done using Beer s Law The formula for Beer s Law 504 Infrared value of measured sample Infrared value of light source Exponential function 42 Extinction coefficient Concentration of t
199. wave shall be 0 70 X the input amplitude as displayed on the monitor when the simulator is set to 510 10 Hz sine wave Measure as described in the previous step 5 Select MONITOR filtering The 0 05 Hz sine wave is no longer present flat baseline On the simulator select 50 5 0 5 Hz sine wave and verify that a 0 5 Hz sine wave with amplitude equal to 0 70 X the 10 Hz sine wave amplitude is present Set the simulator back to 0 05 6 Select ST filtering The 0 05 Hz sine wave should have an amplitude equal to 0 70 X the 10 Hz sine wave amplitude Set the FILTER back to DIAGNOSTIC Select 10Hz on the simulator 7 Turn off the simulator Verify that the message ECG LOST appears at the top of the screen Criticare Systems Inc nGenuity 8100E Series Service Manual Page 5 17 Section 5 Preventative Maintenance SpO Verification following test requires a SmartSat analyzer If you service the monitor i e you open the housing use the longer SpOs Performance test For more information refer to SpO2 Performance Testing on page 6 3 NOTE For older revision SmartSat analyzers that do not have a Model 8100 selection use the general Criticare selection in the SmartSat simulator Check the SpO value of 52 3 with the analyzer set to 4296 1 Verify that the message SPO2 NO SENSOR appears when there is nothing connected to the SpO connector Verify that the message
200. y Leakage Self test 1000 20 Line voltage on Dynatech 232 Case leakage GND Con Ext OPEN GND lt 500 Case Leakage GND CON OPEN GND REVERSE 500 pA Open Neutral Open GND Normal lt 1 Open Neutral Open GND Reverse 1mA ECG Mode to GND Normal lt 5UA ECG Mode to GND Reverse lt 5UA Open Neutral Normal lt 10UA Open Neutral Reverse 10uA Open GND Normal 10uA for 120V input lt 20pA if line voltage is 264V Open GND Reversed 10pA for 120V input 20pA for 264V line voltage ISO test ECG Normal 20pA for120V input 50pA if line voltage is 264V ISO test SPO2 Normal lt 20pA for 120V input 50pA 264V line voltage ISO test Temp Normal 20pA for 120V input 50pA 264V line voltage Verify AC light is on Verify that the SPO2 Smart Sat is operational Verify that Nurse Call is operational Verify that Alarm Volume is increases Verify 2 min ALARM SILENCE ICON Verify ALARM OFF Verify correct software revision Verify correct serial number and software Connect to computer using COM 1 Connect download cable Cal 0 for NIBP Verify communication with Calibration Program Accepted calibration for 0 Accuracy readings are within 296 or 3 in hg Verify the Speed Test 12 15 s inflate 10 s deflate Verify that the Leak Test 4mmHg min Timeout for Adult Verify Leak Test Neonate 4mmHg min Verify timeout Neonate Safety Test Adult Safety Test Neonate Adult Reading on 2 min 4 readings gt gt gt gt gt gt
201. y by two beeps In the PARAMS softkey window change the SpO2 Low Limit Alarm setting to MEDIUM Verify that the message LOW 5 2 appears at the top of the waveform channel in yellow letters Verify that you get an audible response The alarm should be a medium priority alarm tone consisting of 3 beeps ALARM VOLUME TEST 1 From the ALARMS window vary the ALARM VOLUME through the ranges from OFF to 10 Verify that the speaker volume changes according to the setting of the ALARM VOLUME Press the alarm SILENCE key once Verify that the low heart rate alarm stops for 2 minutes and that the 2 minute Alarm Silence icon appears in the system status area of the screen Press and hold the alarm SILENCE key for at least 2 seconds Verify that the low heart rate alarm stops and the Alarm Suspend icon appears in the system status area of the screen Printer Check printer only prints if the green battery light is ON or the AC mains cord is plugged in 1 Lift the paper feed lever up and insert paper Close the lever and the paper should automatically feed 2 In the PRINT window set the Print Type to Tabular Press the PRINT key on the front of the monitor 3 Verify that the correct date and time print nGenuity 8100E Series Service Manual Criticare Systems Inc Module Verification Section 5 Preventative Maintenance ECG Verification This test requires a Dynatech Nevada Mode

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