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eQuality™ 506DN Vital Signs Monitor Service Manual

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2. REV DATE DESCRIPTION NOTE U4 MUST BE PROGRAMMED
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4. C63 30 u22 OUTS SHON 10uF eva GND 20 ADR391 External reference is quieter than internal gives 18bit noise free range with x32 oversampling From photodiode 003 002 DGND3 B 25vddonr d X7R10 9 8 3 3 1 924 8605 R74 m 301K Reg 1 52K3 1 i 100pF50V R68 5 COG 10K 1 Two 16bit ADCs driven in push pull for 17bit resolution without oversampling AV 2 AGND2 AVDD i i 8051 Core 4K RAM DGND1 P2 0 P2 1 P2 2 P2 3 P2 4 P2 5 P2 6 P2 7 P1 0 P1 1 P1 2 P1 3 P1 4 P1 5 P1 6 P
5. Pass gt gt BATT_PLUS 5834 TSA 125V INPUT TP42 gt gt AC LED R77 9 VDC NOMINAL Q10 104 Si4435BDY 499K N T3A 25V 4 2 i amp 4 BATT CHG 4 R78 1 SMF10A Sone 4 Us JMP implemented as 100K ES ont trace between lands 2 and MOLEX 43045 0216 LOWESR 27 100T of 011 on bottom side 46 1 EXT GND D13 16 1 4 5524 LOW ESR BLK 1 R82 2 LED s mounted PCB and not intended JMP1 100K to be seen by the user MOLEX 87427 0242 For testing and dianostic use only v C66 H n DNI 01 1 1 MPPS R83 0 21W 6V at 4 5 AH MINIMUM VIN STAT 1 STATO 4 4 4 4 BATT_RIN Battery wires to be 015 016 1 cer 18AWG PORA W 12066 4403 RT to reside a thermally 1 x isolated tab of the PCB STAR GROUND POINT These traces must RED GREEN E
6. Speed Test 1 Click on Speed ioli Connection View Help o E s gt J 350 300 r Signals 250 On 200 150 100 Clear 50 12 58 48 0 00 0 01 0 02 0 03 0 04 0 05 0 06 0 07 0 08 0 03 0 10 Host mode Service mode Systolic mmHg Service Bead Diastolic mmHg Calibrate Adult Y Pass ean mmi 3 Accuracy LEM Tt Deflate Heart Rate bpm Pas Fai m nil Elapsed Time sec Speed Inflate LI Deflate Cycle AT Reset F5 Peak Pressure mmHg 00 00 5 Adi Disable FB TUM Leak Time Le Infant 7 LI Adult mi Safet 0 mmHg Elapsed Time 0 sec NM Infant M 506N3 NIBP Module 26 Watchdog circuit fired 70 Fact idle 00 OK 00 OK Page 6 14 Figure 6 16 Select Speed 2 A Factory Speed Test window opens Click on Start Factory Speed Test Inflation Pass criterion Inflate at 5 mmHg sec Deflation Pass criterion Deflate at 17 mmHg sec Cancel Help 0 seconds 0 mmHg sec 0 seconds 0 mmHg sec Pass Fail Pass Fail 0 mmHg Start 50643 NIBP Module 70 Fact idle Figure 6 17 eQuality 506DN Service Factory Speed Test Window Manual Criticare Systems Inc Section 6 Service Testing amp Calibration 3 Verify that the nflation and Deflation indicates a Pass with checkmarks in the boxes Factory Sp
7. 10 ADHERE TO U4 SOLDER CURRENT PWB REVISION INSTALL ITEMS 1 AND 2 THIS SIDE 3 X AE RM coe C118 s 9 15 J O REV 0 34 E um c x 83663B001 O z a B E EJ B Hg 2 9 E SEE mE alent vj RM H E 8 2 Ett We A ry Ro og Jh e BEBE ERE E PLACE REVISION AND of B L CB s EEE S N LABELS HERE 5 B d s 8 EEE B E z ell sls E amies a 2 8 E 5 5 3 6 al b a amp i 5 Sie Beeg 2 BL BISIS 8 Be oj uj 10 i P c os E E EERE E C60 E E lal cu E Bl euis R2 hm mx zx ET NM t S B E E 1 Ea E c B S E E EE BE Ld L R60 2 5 8 Og g Hate Ogee BI NA iS 8 B og B E EEE 8 B EE m f Les TEM eus S e 18 E m 155 8 5 8 2 42 ree ey a mA CN Eee mu TA E m I 8 E P 02 9 u c S bg ha s 5 amp ERE Dig _ z 8 5
8. CRITICARE C SEE SHEET 1 FOR REVISION HISTORY POWER SUPPLY SECTIONS CONFIDENTIAL This document contains confidential information and may not be copied or divulged without written consent of CRITICARE SYSTEMS INC 20925 Crossroads Circle Von o 2008 w 914108001 mu CREATION DATE 20MARO7 THLE SCHEMATIC MAIN BOARD 506CN LAST MODIFIED DATE Thursday January 15 2009 SHEET SIZE D DIST SHEET 20 3 306 U2 25 PTB y 33D U26A PUMP 5V_ANL 74HC74D T PUMP C105 TALVCO2A TALVCO2A 33D pc
9. i Page 5 8 eQuality 506DN Service Manual Criticare Systems Inc Criticare Systems Inc Section 5 Preventative Maintenance HOT NEUTRAL TO GROUND HI POT FIXTURE Ground A Hot Neutral Note At Pont Hot Nuetral are soldered together NURSE CALL HI POT FIXTURE eQuality 506DN Service Manual Page 5 9 Section 5 Preventative Maintenance Electrical Safety Tests Perform this test whenever the monitor housing is opened before using the monitor on patients Withstanding Voltage Test Hi Pot NWARNING High Voltage The following test procedure requires working AN with exposed electrical circuits and should only be attempted by experienced technicians Equipment Needed This test requires a Kikusui 7512DT Associated Research or equivalent Hi Pot tester The tester should be rated for 4000 VAC maximum Setup Hi Pot Tester e Hi limit 1mA e Lo Limit 0 0uA Arc Fail OFF Arc Sense 5 e Ramp Hi Off Charge Lo 0 0 uA Ramp Time 1 second Dwell Time 21 second AC DC DC Page 5 10 eQuality 506DN Service Manual Criticare Systems Inc Section 5 Preventative Maintenance Hi Pot Performance Test NOTE Do not power up the 506DN monitor during the Hi Pot steps 1 Connect the 506DN monitor to the measurement receptacle of the Hi Pot tester Test Hot Neutral to Ground at 2500VDC 2 Install a screw into the roll stand mounting insert located on
10. 4 Quasar Connector 1 8 RLED Tw 33uF35V m o8 C34 lt 2 2 4 EDS A cy 9 2 4 47 ELOESR em 5 3 6 gt 1 LED PWR sai 2 Sour 10 4 8 10 i 50 92 IRLED 0 lt lt H I mou d o4 6 IOFL POS e La n POFLE JOFLOW All resistors are 14 1 10W oli t EUR unless otherwise noted d SDOUT ITEM01 otherwise noted DBS lana 5 unless otherwise noted x 2 z tc P C B BARE 4 i 5 J J Page 2 Connections Assembly Part number 91391A002 BLA3216B601SG4 Gio cas Bare PCB Part number 83646B002 J DN s x x gt ELECTRONIC FILE NAME JAPERM SPO2 MODULE DOX SCHEMATIC 91391A002 91391S002_RV0 DSN ZH CRITICARE SYSTEMS INC CONFIDENTIAL This document contains confidential information and may not 20925 Crossroads Circle Waukesha WI 53186 be copied or divulged without written consent of CRITICARE SYSTEMS INC DRAWNBY DJR ENG APPR PART NUMBER REV CREATION DATE ELECTRONICALLY SIGNED IN OMNIEY 913915002 0 RELEASED DOCUMENT M LAST MODIFIED DATE TITLE iai ELECTRONICALLY SIGNED IN oMNIFY Digital SpO2 Module Friday June 27 2008 E ps MA SHEET SIZE DIST SHET 1 OF 2 ELECTRONICALLY SIGNED IN OMNTFY 306
11. Tg 17 gjar 047 475K TN2106 2 8 pour 55 P32 RXD0 CPU pesas amp E sc 1 8 TSETUPIN3 P 5 A3 IRD 32 IRGATE PC2 A2 NR C ee TORXA M bis ps 380 4330 84 PzTIPOTITIOCBS TMO 2 85 Pae POG TIOCAS TMOO 207 015 81 128K X8 TSOP 4 mt 400KX2 tPs 68 P2SIPOSITIOCBA TMCH PD6 D14 505 Rig Rai 4 TP6 E2AIPOAITIOGMITMRIM 205013 42 pa 10 499K DNI ire AN Tr P23 PO3 TIOCD3 TMCIO PD4 D12 25 1 ev 4g Ds E P22 PO2 TIOCC3 PD3 D11 TPS mno pz 420000 42FFFF x 8 Installed part R22 us us 20 4 D KB x 8 Alternate wees DACK TIOCAO POB P 10 Poons 3 POPROM WRELSH 4 mE DACKT TIOCBO POB P11 PETID7 EPROM ds R23 41 110 12 51 EZ ROM DTA 1 30mA max 1 TCKB TIOCDO PO11 P13 PES D5 40 TN2106 pM 108 TIOCATIPOT2IP14 4 04 39 409 107 1 15 31 DD ee eu 3 106 TIOCAIPO14IP16 PE2p2 28 1 gt 105 TCLKD TIOCB2 PO SIP17 PE1 D1 35 NZ 74 PEo DO 34 P14 4 4027 LEDDR 102 TN2106 100 TP15 3 TP16 ANTE BLA3216B601SG4 100 IWR A TORRE 4 i ANSIPAS 2 Isolation Bar
12. 06 3 NIBP Module 10 Host disabled 2 Figure 6 25 Infant High Time Test Pass 7 If each Pass box has checkmark click on the Done button Page 6 18 eQuality 506DN Service Manual Criticare Systems Inc Section 6 Service Testing amp Calibration 8 The main screen displays checkmarks indicating a Pass of the Leak tests CSI NIBP Service Support Program 506N3 NIBP Module ni x Connection View 2 0 00 0 01 0 02 0 03 0 04 0 05 0 06 0 07 0 08 0 09 0 10 Host mode Service mode Mode Systolic mmHg Do Service Diastolic mmHg Calibrate Adult U 5 Pass Fail ean mml Infant 3 Accuracy Heart Rate bpm Pas Fal i Unit Elapsed Time sec Speed Inflate M M Reset F5 1 Peak Pressure mmHg ns Disable FB 21 Lea Time Infant LI Adi E 7 Safety Cuf 0 mmHg Elapsed Time 0 Infant 506 3 Module 70 Fact idle 100 OK 00 OK Figure 6 26 Leak Test Pass Criticare Systems Inc eQuality 506DN Service Manual Page 6 19 Section 6 Service Testing amp Calibration Accuracy Test 1 Click on Accuracy Connection View ie 5 350 300 m Signals 250 On 200 150 100 Clear 50 14 03 56 0 0 00 0 01 0 02 0 03 0 04 0 05 0 06 0 07 0 08 0 09 0 10 Host mode Service mode Mode Se
13. e Electrical Leakage S SpO2 Verification lt lt lt lt NIBP Verification lt lt lt lt Communication Testing The following procedures assume that the technician has available an ESD safe workbench a set of electronic hand tools and a digital multimeter with a 10 amp setting Servicing of the NIBP module requires a calibration work station At the beginning of each test special equipment may be listed A variety of customized cables clips and test fixtures may also be needed to complete all the tests Contact Criticare Service for additional information eQuality 506DN Service Manual Criticare Systems Inc Communication Testing Equipment Required Pinout Chart Procedure Criticare Systems Inc Section 6 Service Testing amp Calibration Windows compatible computer with DB 9 serial port NOTE If your computer uses USB ports instead of a serial port a USB Serial converter with software is needed to complete this procedure Install the converter and software on the computer as directed by the converter manufacturer The following adapters are recommended e Omega USB to Serial PDA Converter Cable GUC232A e Keyspan USB Serial Adapter USA 19HS Serial download cable pn 87016B002 A common computer terminal program Pinout Chart PIN SIGNAL CD Carrier Detect 0 0 o Figure 6 1 Pinout Chart 1 2 3 4
14. in as uryan Alarm Menu High Pulse Low Pulse High Systolic Low Systolic High Diastolic gt Low Diastoli asal rere erem OR rera aa Low MAP Contrast Brightness Reverse Video Language Communication Menu 2d On NIBP ziii ep e e one ese Od NUR MS Interval 4 Patient Data eis aro UR Serial eee oreet tet eh T e ee e ee nee Section 3 Theory of Operation System Architect re o m en 3 1 Module Architecture Main Board ah ente eene iere eae mein NIBP Module DOX SpO Module esee n etate sa 3 2 Block Diagram uuu a a a awak w WS ua 3 3 eQuality 506DN Service Manual Criticare Systems Inc Contents Section 4 Cleaning and Disinfecting Cleaning and Disinfecting essen 4 1 Pulse Oximeter Sehsols 5c e RECEN e qe 4 1 Blood Pressure inna eh Neal 4 2 Accidental Wetting corn treten ere tree et enden 4 3 Section 5 Preventative Maintenance Incoming INSPEClION Maintenance Schedule Long T rm Storage etae EA AE Service Checks z
15. 1653 652 es 77 vi pom 27 8 8 R53 560 Em m3 Rs U9 C54 nae e R59 13 Tl i gt R20 28 C cst B 2 i e B uo c2 03 pt L J f C22 R22 Dt D2 ia VEDI a m R32 Ct6 z 2 R27 e Cee cr e PAD2 Se b m R4 C RI CHH qe 8 RO 02 R6 06 R25 x ahe rasle D Vas e 19 R 7 09 R67 018 RH R26 P R35 R34 R36 08 Boo j i 29 m R24 R3 26 RIO I C20 00 ms as 2 R33 gt cat R29 a8 a mW e s 836468002 C u O R28 e Rage REV C0123 COMPONENT SIDE SOLDER SIDE SOLDER SIDE NOTES 1 THIS PCB ASSEMBLY SHALL MEET CURRENT 610 SPECIFICATION CLASS 2 2 FISHED BOARD THICKNESS SHALL 0624 0 UNLESS OTHERWISE AUTHORIZED BY CSI THE FIRST ARTICLES 3 BARE BOARD 836468002 TO BE USED ON ASSEMBLY 913914002 MUST BE INSPECTED AND OR TESTED FOR COMPLIANCE TO THE REQUIREMENT OF APPLICABLE ENGINEERING DRAWINGS AND 4 BOARD TO BE FABRICATED WITH RAILS OR IN MULTIPLE UP SPECIFICATIONS FIRST ARTICLES MUST BE SO MARKED AND RELEASED DOCUMENT PANELS TO AID AND OPTIMIZE COMPONENT ASSEMBLY CONTACT IDENTIFIED WITH A PART NUMBER ANY MAJOR TOOLING PROCESS CSI S CONTRACT MANUFACTURER FOR THE PREFERRED LAYOUT EUN T CHANGE WILL REQUIRE A NEW FIRST ARTICLE SESS e ds P ru Pe e ASIE RS TO APPROVE LAYOUT B
16. Criticare Systems Inc Symbol lt 2t o gt Section 1 Introduction Definition Non Invasive Blood Pressure Connection SpO Sensor Mounting Connection Communication Transmit Receive Port Not a Sensor Connection Alarm Port Nurse Call Serial Number Part Reference Number Placement of cuff over the brachial artery Blood Pressure Cuff Single use device only Do not reuse Recycle cardboard paper packaging eQuality 506DN Service Manual Page 1 11 Section 1 Introduction Safety Page 1 12 Definitions for Warning and Caution symbols Designates a possible dangerous situation NWARNING Non observance may lead to death or the most severe injuries Designates a possible dangerous situation NCAUTION Non observance may lead to minor injuries or damage to the product NOTE Indicates that important information follows a tip that can help you recover from an error or point you to related details in the manual NWARNING N Read this manual entirely before attempting clinical use of the monitor A possible explosion hazard exists Do not use this monitor in the presence of flammable anesthetics Cables cords and leadwires may present a risk of entanglement or strangulation Verify safe and proper positioning of these items after patient application Unapproved modifications to the monitor may cause unexpected result
17. HOUSING ASSEMBLY TO BATTERY DOOR IN THIS APPROXIMATE 2 PL LOCATION IN LBS BEZEL ASSEMBLY VENDOR SHOULD COMPLY WITH THE FOLLOWING CSI QUALITY REQUIREMENTS Q1 Q2 04 Q5 Q6 97 010 Q11 AND 016 IN ADDITION THE QUALITY REQUIREMENTS Q9 Q13 AND Q17 APPLY SEE CSI WEB SITE www csiusa com pdf QA Requirements pdf SW FOR THE DEFINITION OF THE QUALITY REQUIREMENTS YOK CRITICAR SYSTEMS INC DRAWN CHECK ENG BY SC BY APPR QA pate 04 04 08 a APPR MFG quy DO NOT SCALE PRINT APPR 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 TLE PART NO REV DIST _ sHeeT 4 CSI 0385 Rev 0 REVISIONS REV DATE DESCRIPTION BY CONNECTOR 16 VALVE AY HOUSING 2 PL RED PUMP BLK PUMP WHT V1 WHT V2 CONNECTOR HOUSING 87283B003 JST PHR 6 CONNECTOR WIRING DETAIL NOTES 1 REFER TO ASSEMBLY PROCEDURE FOR 95597P005 ASSEMBLY SEQUENCE AND INSTRUCTIONS INSTALL WITH 1 50 LONG ARROW POINTING LONG AWAY FROM PUMP 1 50 LONG VENDOR SHOULD COMPLY WITH THE FOLLOWING
18. The lead acid battery is contained in a compartment accessible with a tool The design of the compartment prevents the 506DN circuitry from being exposed when the battery compartment is opened Thus the 506DN does not require recalibration or functional testing due to a possible tampering of critical electronics External connectors consist of An RS 232 COM port AC Mains Power NIBP ComfortCuff pneumatic SpO Sensor Electrical isolation of patient connections observes EN60601 1 On this end isolated DC power supplies are contained by the DOX SpO2 technology Additional isolation is incorporated through a medical grade AC to DC power supply conforming to 4000VAC isolation and an isolated supply for the external COM function This supply conforms to 4000VAC isolation eQuality 506DN Service Manual Page 3 1 Section 3 Theory of Operation Module Architecture Page 3 2 Main Board pn 91410A001 NIBP Module pn 955974005 SpO Module pn 913914002 The hardware design of the 506DN monitor relies on multiple serial communication channels wherein the Main Board functions as the hub Signal and display processing is off loaded to the various vital signs technology modules the Display Board and the LCD Module The Main Board collects the vital signs information then stores formats and outputs the data either electronically through the external serial port or in hardcopy via the optional inter
19. 506DN Service Manual Page 5 1 Section 5 Preventative Maintenance Service Checks If the monitor shows any signs of physical damage contact the Criticare Service Department for repair Technical Service US 800 458 2697 International Customer Service 262 798 8282 Calibration No periodic calibration of the monitor is necessary It is recommended to perform an NIBP calibration verification as part of the annual safety testing Page 5 2 eQuality 506DN Service Manual Criticare Systems Inc Serviceable Components Battery Removal Replacement Criticare Systems Inc Section 5 Preventative Maintenance The only user serviceable parts inside the monitor are the battery and the fuses Refer all other maintenance inside the monitor to a qualified technician For more information about troubleshooting power problems refer to Troubleshooting in Section 8 BATTERY SAFETY Although the battery requires no maintenance you should allow the battery to fully charge at least once every three months For optimal battery performance the battery should never be left in a drained state for any period longer than 24 hours NCAUTION A Do not open the case Sensitive electronic components may be damaged by electrostatic discharge Opening the case requires an electrostatic discharge ESD protected work bench Shock hazard The interior of the case contains exposed circuitry Do not short ci
20. MR 0 PFO 44 100 265800 09 T74AC32 1 7 MAX708ESA T EMUL_MODE BATT_PLUS y 10 n R46 R47 me M T 2 100 3p FAL um JPWR DN 47538 uma 1 0800 12 74 2 4 338 R48 same R49 C45 tom tome 700608 6mm ISOLATION BARRIER S 338 10 16V R50 5 10 0K H NY U128 N 6 9 H a 5v 4 1006 VOLTS DNI TP6 3 38 T74AC32 TAAHCOB R53 U13B R55 TL V2451IDBV ss U15A R54 R57 100 i cat 124 R59 nd a 100K TAAHCOB 2 10 0K AY 3 3D bee N CALL 1 HARDWARE ITEM SW cLsD T 1111 4 ITEMT 4 40 x 3 8 STANDOFF MU 6 4 74HCO0D 400K un R62 d 243 4 Lag NURSE CALL 2 USED PER ASSY C54 x cg m 10 0K see RET 15 FAULT 7 comps voccs H2 ME 1 d 10 0K 100 EL 2 20 100 3 3B 3 16V C55 35mS 120mS FAIL 8 1 R64 249K IRF782 25V d B HARDWARE ITEM 80mS dd or bep ed LOWESR 3 ITEMZ 4 40 x 1 4 PEM SPACER NXV FAULT 5 3 pav 249K x TP7 R63 NY COMPA T 2 USED PER ASSY 100K 04 66 5 n e 4 Re 4 ET 444 Pwr SW 2 es 10 0K 12 utsB Bee on lt H AQV210EHA uisce U15D Fault Thresholds 017275 iG HARDWARE ITEM m 12V 10 18V 10 92V 10 55V NOM SPKR_DIS 74HCO0D FAIL 4 72V 5 18V 4 95V NOM l uus 74HC00D 10 74HC00D 5V 460 4 75V 4
21. a usta R202 TP25 155 49 9K 47 5K 27 4K 1 gt gt NIBPDC E o vies H lt BOOT DISABLE ADB22AR 24 dane QUA BPVALVE2 6 U31B Kh t 22 22 01 R203 ja SI9926BDY q 2 523K m 5 6124 5 1 4 99K J ey 9218 027 74AC32 39 2K gt 0 1 R156 F 81875 4 205800 ut8c HRE MA F160 Ee 4 R162 100 4 100K 74AC32 aie Took Took 100K 4 SVREF 4 4 C125 R163 Tail DNI 221 S t 5 01 27 7 xrPwosokPGR BP R165 i SENS1 13 3K cr ANL Ji 2 2 TA 10 109 ci 2 us2c 04 lt R166 a Ci201 74LVCO2A 7ALVCO2A gt Po poar 130 e ADS22AR TP28 6 comp 93 1K 93 1K J T Ll NY y wvDd w FT E das mm JNIBPAC NY C135 J 16V 4 99K 680pF C132 R168 R169 R170 01 R201 5 10 22 0 1 5 845 7 32 82 5K 499K NY 5 RI71 0 1 gt gt BOOTMODE NY NY 82 5K C136 4 028 T R172 BAT54C th az R173 TN2106 H 1 00M SV 15 0K 290 R176 C138 BRE NIBP FILTER 40 a Y T 100 NY R178 6 R179 10 0K 475 Fd 100K d NE BOOTMODE RESET lt lt 4 T4LVC1G14 5VREF 5VREF j 922 T b NIBP_GAIN_CTRL gt 72106 0229668 NY 20VREF SV 5 1T 5A gt 12 TP32 VCC VDD 33D or 5VREF a Py 3305 4 1 LP2951ACM gt OUT 2 4 SENS GND T cu
22. Hold the MENU key while you restart the monitor The reset to defaults message appears Depending on configuration of the unit this message may appear as USER DEFAULTS HOSPITAL DEFAULTS or ALT C DEFAULTS Press the MENU key and press the UP DOWN arrow keys to scroll to the CONFIGURATION menu Press the MENU key to enter the CONFIGURATION menu Press the UP DOWN arrow keys to scroll to CONTRAST Check the LCD CONTRAST setting Adjust the contrast as necessary Continue in the CONFIGURATION menu Ensure the time and date are correct eQuality 506DN Service Manual Criticare Systems Inc Speaker Performance Alarms Verification Power Supply Performance Criticare Systems Inc Section 5 Preventative Maintenance To verify alarm circuitry 1 2 Set the alarm volume to 10 in the ALARMS menu With no cuff attached press the NIBP START STAT STOP key The monitor attempts to inflate and responds with a message BP CHECK CUFF Listen for the low level alarm tone It is a burst of two pulses at the same pitch The bursts should repeat every 10 seconds Set the alarm level to 1 and cause another CHECK CUFF alarm The volume should be decreased but still audible Set the alarm volume to OFF and cause another CHECK CUFF alarm No alarm tone should be audible Confirm that the alarm bell indicator appears 6 Return the alarm volume setting to 4 7 Inthe CONFIGURATION menu turn on the
23. Pull out the power supply and bracket and disconnect the power supply cable P N 90927A003 from CON 2 on the power supply Disconnect the AC power inlet cable from CON 1 on the power supply Disconnect the ground wire from the AC inlet cable from the power supply bracket by removing the keps nut P N 40284B002 Disconnect the power supply from the bracket P N 45213B001 by removing the four 4 screws PHMS 4 40 X 438 SEMS P N 409958011 holding them together 8 Obtain a new power supply P N PWRS10000 9 Reassemble in reverse order See assembly drawings for torque instructions Perform the Completion of Service procedure at the end of this section eQuality 506DN Service Manual Page 7 11 Section 7 Disassembly Completion of Service 1 Verify all connections are secure 2 Reconnect the battery See Disconnect and Remove Battery on page 7 3 3 Perform the functional tests in Functional and Safety Testing in Section 5 4 Perform the electrical safety tests in Electrical Safety Tests in Section 5 Page 7 12 eQuality 506DN Service Manual Criticare Systems Inc Section 8 Troubleshooting Troubleshooting Guide Symptom Problem Solution Unit won t power up Battery is discharged No AC power at outlet Main power fuse is blown Poor keypad cable connect Bad keypad switch Bad Main Board Connect AC power cord Use alternate outlet Replace power f
24. 125 X 250 85DU 40324B013 TEE CONNECTOR PLASTIC 125 X 125 X 125 42749B001 FITTING ELBOW 1 8 TO 3 32 40633B001 FILTER 130U RED NY ELEM 87283B003 CONN CBL HSNG JST PHR 6 6 POS 2MM 42750B001 FITTING ELBOW 3 32 42751B001 FITTING DBL ELBOW 40067B001 CABLE TIE 4 0 MONITOR SPO2 NIBP DOX CSI Part Description 939874001 FINAL AY 506DN DOX 95795A001 LBL SET 506 DN CN ENGLISH 95795A005 LBL SET 506 DN CN SPANISH 46426B001 LBL MAIN PRODUCT REV 1 46158B002 LABEL QUAL SEAL OVAL WHT eQuality 506DN Service Manual Page 9 3 REVISIONS REV DATE DESCRIPTION BY 1 9 18 08 SEE ECN 10308 DBL 2 1 13 09 10359 DBL 2 PL 5 IN LBS VENDOR SHOULD COMPLY WITH THE FOLLOWING CSI QUALITY REQUIREMENTS Q1 Q2 G4 Q5 Q6 07 010 Q11 AND 016 IN ADDITION THE QUALITY REQUIREMENTS Q9 Q13 AND Q17 APPLY 5 IN LBS SEE CSI WEB SITE www csiusa com pdf QA_Requirements pdf SW FOR THE DEFINITION OF THE QUALITY REQUIREMENTS TH CRI TICARE SYSTEMS INC Fa SC Eran APPR QA DATE 04 04 08 a APPR MFG qui DO NOT SCALE PRINT APPR TOLERANCE UNLESS OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL XX 020 INFORMATION AND MAY NOT BE COPIED OR DIVULGED 005 WITHOUT WRITTEN CONSENT OF CRITICARE SYSTEMS INC ANGLES 1 DEGREE TI
25. ERR B TAP sp 6 FB 04 R187 Rigs GND_PWR 190K 150K 7 L pied 100K GND vss R191 GND 33V gt gt R190 2 100K U37B 2 00M EAA 3 BPPUMP_CTL gt gt 3 STR 0 2966 5VREF t R193 SCARE 100K 029005 604K 5 R194 82 5K NY R195 13 3K TALVCO2A NY NY 12 LM2672M 1 5 a PUMP 1 VIN Cb P T 17 33uH 13A 9 our a 8 ic og 2 DERE CRITICARE CONFIDENTIAL This document contains confidential information and may OI c 19 SVETIH RT not be copied or divulged without written consent of CRITICARE SYSTEMS INC 1 20925 Crossroads Circle R206 029 Waukesha WI 53186 PART NUMBER 914105001 REV 2 eM Copyright 2007 ee CREATION DATE BPPUMP 20MAROT 5 MAIN BOARD 506CN LAST MODIFIED DATE SHEETSIZE DIST 306 SHEET 3 Thursday January 15 2009
26. JEXT_IO SEE REF1 ON BOM FOR CORRECT G 11 28 2007 First prototype layout source sa SOFTWARE AND REVISION LEVEL pae CRA1 0 5 30 2008 Second prototype layout source i TO PIN 98 ATR 100pF and Pre Production Ali components and traces 01 TOPIN4 UR same side of PCB as processor 2 4 4 1 7 01 2008 Production Release Keep traces short URS a pele P5 5 5 JLCD SEL Ui 97 TAN 10 TLW 401 06 T S 744032 2 01 15 2009 SEE ECN 10359 Ri C t 4 saom 330 NE l 49 9 OHM 10pF NE 4 S Snai H IRD j 0 TE COM CTS A2 paz Ha us 32 LE ONES p osc ICOM_DSR 4 1 SCK 1 4433 74 32 JEXT IO m sl T i 96 9 999 31 RN2 A5 pas 4 MOS 2 1 SDA 2 D XTAL 9 999 PATIA23IIRQT 3n 40K x2 MDE vec H 4 4 330 DNI 10 0K EXTAL gt gt gt gt PAG A22 IRQ6 A6 16 MD7 10Kx2 94 A GS 29 1 4 AT 48 PFT CLKO PAS A21 IRO5 29 8 28 4 2 19 Ps 30 MDS 90 2 1 PA3 A19 26 MATE Her La 01 1 2 2 MATT bala Dai R4 AT24C64A NZ MAT6 35 d EMUL MODE 32 22 4 A MATS Data 36 MOIS e EEPROM 0xA0 WRITER gt DF2378RVFQ34V PB7 A15 27 Mu Ded Ez MD14 OxA1 READ NES REG se 31 ion 920 iRES PB6 A14 35 2 MATS 0914 pas
27. These procedures are not intended to be used for component level troubleshooting and repair of the PCB assemblies The repair procedures for the 506DN monitor are included here for the determination of damaged or unusable assemblies The manufacturer does not recommend attempting field repair of the printed circuit boards See the 506DN Final Assembly drawing in Section 9 NWARNING N The following procedures require working with exposed electrical circuits Repair should only be attempted by experienced electronics technicians Do not short circuit the battery terminals The resulting high current discharge can cause burns Remove the battery before disassembly to avoid electrical shock Electronic components are selected for specific performance characteristics Use of substitute replacement parts y cause inaccurate performance or damage the monitor Order replacement components by their catalog or part number from an authorized dealer Any time an electrical circuit board is altered through repair or adjustment it must be fully tested before use NCAUTION Replacement of surface mount components is beyond the scope of this manual Attempting to remove surface mount components with a soldering iron can result in the overheating of the board and damage to tracings Damaged laminated circuit boards cannot be repaired and require replacement Any electronic repair should be done in compliance with ANSI I
28. idle Figure 6 21 Leak and High Time Test Window Page 6 16 eQuality 506DN Service Manual Criticare Systems Inc Criticare Systems Inc Section 6 Service Testing amp Calibration 3 Verify that the Pass criterion indicates a Pass for the Leakage Test by having a checkmark next to it in the box Leak and High Time Test Leakage Tes High Time Test Elapsed time Elapsed time 80 sec Pass criterion Pass criterion _ Help No more than 4 mmHg min Time out within 110 and 160 seconds mmHg over 60 seconds Pass Adult Pass J Fail 2 mmHg min Fail Infant Pass J Fail Approximate actual timing is done in the monitor Timer starts when cuff exceeds 15 mmHg Cuff 238 0 mmHg Infant high time test only Start 50643 NIBP Module 7A Fact leakage test measurement 2 Figure 6 22 Leakage Test Pass 4 Verify that the High Time Test indicates a Pass for Adult with a checkmark in the box Leak and High Time Test rLeakage Test High Time Test Elapsed time 59 sec Elapsed time 127 sec Cancel Pass criterion Pass criterion Time out within 110 and 150 seconds Help No more than 4 mmHg min 2 mmHg over 60 seconds Pass Adult Pass Fail mmHg min Fail Infant Pass Fail Approximate actual timing is done in the monitor Timer starts when cuff exceeds 15 m
29. mode Cuff pressure is allowed to remain above 300 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 and microprocessor and pump control circuit failures B P Cuff Inflation Pressure Shown during inflation ___ Systolic Pressure Actual Blood Pressure Waveform Diastolic Pressure 4 Cuff deflates rapidly after monitor determines M systolic pressure Pressure in mmHg 28 Time Pulse Waveform Measured from Cuff ANNJ UV Pressure Fluctuation Diastolic Mean Systolic Pressure Pressure Pressure Figure 1 1 NIBP Cuff Pressure and Pulse Over Time Criticare Systems Inc eQuality 506DN Service Manual Page 1 3 Section 1 Introduction Heart Rate Page 1 4 Heart rate measurement is determined primarily by the plethysmographic SpO5 waveform When the oximeter is not in use heart rate is determined from the blood pressure data by using an oscillometric method that measures during inflation The unit of measurement is beats per minute Under conditions where the plethysmographic based heart rate and oscillometric heart rate are both beyond the detectable limits of the monitor no heart rate is reported Also no heart rate is reported where the amplitude of the plethysmograhic waveform an
30. 15 19 1 GND JLCD WR 1 R5 PB5 A13 20 a DIR vec 22 3 p3D ICD RD 6 LCD Version Level Chi ur 7 1 E AS 0x4XXXX0 LCD INSTR REG o m 4 Bo fersion Level Chart 10 0K PB3 A11 MATO wR x 9 B8 Di SW VER HW Function cols 1 a 86 pF2jIROTE LCASIDOML 210 H 2 z DM A16 0x4XXXX1 LCD DATA RAM wba A7 a7 2 3 amp PH A CONNECTOR Level 2 85 PFARQIA UCASIDQMU PB1 A9 15 vs 40 JUB MBIT 6 H 1 D3 10 3 8 84 PFOWAIT L UB 39 AB MAB B5 DF initial Design po7ia7 18 MAG 185 5 4 HS 05 12 JWDTOVF POBIAG 11 3 A MAS 58 43 08 m H 2 8 De 1s 4 ani wbTOVF PCBIAS 4 MAG 62WV12816BLL 55T Mo A B2 Ht D7 14 RN5 RN6 PEV E 1 1 8 128K x 16 B 33D B1 JLCD SEL 100K X4 ATKx4 HE 5508 gg 31 Di RNI9 47X4 TRST 1 8 ROWS 1 8 49 p47 POAS TIOCB2Z TCLKD EDRAK3 6 Teo 20mA vv 1 4 1 E 338 74LVC245ADW R196 100K I 2 ROW gt 4B P16 PO14 TIOCA2 EDRAK2 PCO AD 100K 4 i i i 8 E EXT RAM 0x200000 0x27FFFF NY ci 5514 LCD Busy RB 100 8 1 45 P13 PO11 TIODO TCLKB 512K T 22 S 8197 1 00K PTB Cr RN7 7 44 2 a 15 2 33v 4 CLRERR 10Kx4 8 FI BACKLIGHT P1POSTIOCBO 207 15 80 MD ES
31. 4 40 X 25 LG NYLON P N 42744B001 on the left side of the board differ from the two 2 screws PHMS SEMS 144 40 X 44 LG P N 40995B01 1 on the right side of the board Detach the insulator board P N 42740 001 by breaking the solder point between the insulator and main boards See 506DN assembly drawing in Section 9 Detach the PCB NIBP assembly from the bezel by removing the four 4 screws PHMS SEMS 4 40 X 25 LG P N 40995B005 10 Unlock the membrane tail from the connector at J2 on the main board 11 Disconnect the LCD display s ribbon cable from J1 on the main board 12 Remove main board from bezel 13 On the bezel assembly disconnect the speaker cable from J4 on the main board 14 Remove the speaker from the rail on the bezel 15 Remove the two 2 standoffs STANDOFF M F 4 40 X 375 Criticare Systems Inc LG NYLON P N 42742B001 and two 2 hex nuts HEX NUT 144 40 NYLON P N 42743B001 from the old main board eQuality 506DN Service Manual Page 7 7 Section 7 Disassembly 16 Obtain a new main board P N 91410A001 17 Reassemble in reverse order Refer to 506DN assembly drawing in Section 9 for solder point when connecting the main and insulator boards NOTE When reassembling after the NIBP module and SpO board are mounted route the NIBP tube as shown below It must be around the sensor and valves 672024 1 er Figure 7 2 NIBP Tubing Perform t
32. 5 6 7 8 9 1 Set PRINT TO to SERIAL the COMMUNICATION menu Set SERIAL to TEXT Connect the COM port to the serial port on the computer or the USB port with adapter on the laptop om 4 Start Hyper Terminal from the Accessories Communication menu on the PC Settings 19200 bps 8 N 1 or Auto Detect mp Accessories Communications A Adobe Entertainment gt Network and Dial up Connections Favorites gt office 2000 Games amp Phone Dialer Y Y Shut Down A 8 system Tools Documents EB Calculator Eh Settings B command Prompt Imaging E Notepad Is 9 Help y Paint J Windows Explorer Run e WordPad Figure 6 2 PC HyperTerminal 5 Press the SEND key on the monitor to initiate a print of data 6 Ensure data prints to the computer eQuality 506DN Service Manual Page 6 3 Section 6 Service Testing amp Calibration Page 6 4 Nurse Call This test requires the use of a Nurse Call fixture This fixture may be created by using the schematic below Alligator clips to connect to battery 3 5 mm stereo plug D2 D3 D4 J2 01 12 Batt Pos b gt b J11 pins 1 and 2 E 1 2 LED LED LED LED 2 CON II Connect the Smart Sat and monitor all levels Connect the Nurse Call fixture into the side of the monitor while the Smart Sat simulator runs Create an alarm state with the Smart Sat and verify that
33. 5 16 in nutdriver 1 4 in nutdriver eQuality 506DN Service Manual Criticare Systems Inc Section 7 Disassembly Disconnect and The battery must be disconnected and removed from the monitor Remove Battery before any further disassembly of the monitor may be performed 1 Follow the caution for static sensitive devices in Electrostatic Discharge Protection on page 7 2 2 Open the battery door by unscrewing the two 2 screws PHMS 4 40 X 25 GEM Gray P N 42745B001 securing it to the back of the monitor 3 Pull the battery P N MISC10004 from the door and disconnect the battery cables from the terminals 4 Reassemble in reverse order Torque to 5 in lbs Detach Bezel Assembly To open the monitor for repairs detach the bezel assembly from the from Housing Assembly housing assembly 1 Follow the caution for static sensitive devices in Electrostatic Discharge Protection on page 7 2 2 Detach the bezel assembly from the housing assembly remove the four 4 screws PHMS 6 32 X 50 LG SS P N 42435B002 securing them together 3 Disconnect the battery cable from J6 the main board on the bezel assembly 4 Disconnect the cable from J5 on the main board 5 Reassemble in reverse order NCAUTION When reattaching the bezel and housing assemblies make sure the AC and battery cable wires do not get pinched between the two assemblies This will damage the wires Do not allow the battery c
34. 68 16V 400K a mor Cp vv T1 gt y T v Bank D 4 010 sPKR al 1 Reg 3 38 me MD914 d 1 924 JSW PULSE 100K rd HHJ FDN337N JSTB 28 PH SM4 TB 1 16V 200 MAIN DIGITAL SECTION POWER CONTROL AND VOLTAGE MONITORS us i TP10 4 1 U13D WC 4 SYS_ONOFF lt 4 rn ELECTRONICFILENAME JAPERMYIQUASARIHWASCHEMATICI91410S001 REV 21914108001 R2 DSN 1 00M AUDIO VOL 1 a NE 7 A T4AHC08 788 p kp rese r 1 R73 CRITICAR Puede miri CONFIDENTIAL This document contains confidential information and may not TONE aukesha be copied or divulged without written consent of CRITICARE SYSTEMS INC cui tH SYSTEMS INC Copyright 2008 E zT PCBNUMBER 836638001 R1 ENG APPR PART NUMBER 91410S001 REV 2 R72 v Pis v Sv DRAWN BY Engineering gt 100K 1 VOLTS AC POWER lt U12D J 20MARO7 QA APPR RIS LAST MODIFIED DATE 9 lt QA Approval gt TITLE SCHEMATIC MAIN BOARD 506CN ursday January 15 a p e RELEASED DOCUMENT 100 CHECKED BY MFG APPR PWR 16 0K SHEET SIZE DST 306 SHEET 1 OF 3 SPEAKER VOLUME CONTROL lt Mfg Approval gt I 11
35. Figure 6 9 Finish Calibration 6 The cal information will be downloaded into the E2 and Calibration Complete should appear Page 6 10 eQuality 506DN Service Manual Criticare Systems Inc Section 6 Service Testing amp Calibration Safety Test 1 Using the mouse click on the Safety test button Il xl Connection View Help 0 00 0 01 0 02 0 03 0 04 0 05 0 06 0 07 0 08 0 09 0 10 Host mode Service mode Mode Systolic mmHg Service Diastolic mmHg Calibrate Adult Pass Fail ES mmHg fi 22 Accuracy Deflate Heart Rate bpm Pass Unit Cycl Elapsed Time sec Speed Inflate Reset FB E eset F5 Peak Pressure mmHg 00 00 Adult Disable FB bn T m isable Time Infant LI Adult Safety 0 mmHg Elapsed Time 0 sec EM Infant 7 Li 506 NIBP Module 70 Fact idle 00 00 Figure 6 10 Select Safety 2 A High Pressure Safety Test window opens Click on Start High Pressure Safety Test Pass criterion Unit hardware must release pressure before peak pressure Cancel exceeds 320 mmHg Hel Pass ZER lt untested gt Fail Pass Infant lt untested gt Fail Test infant mode Cuff 0 0 mmHg Peak Pressure mmHg 50643 NIBP Module 71 Fact controlled inflation Figure 6 11
36. High Pressure Safety Test window Criticare Systems Inc eQuality 506DN Service Manual Page 6 11 Section 6 Service Testing amp Calibration 3 The cuff pressure should increase until approximately 300 315 mmHg Verify that the Pass box for Adult contains a checkmark High Pressure Safety Test E Pass criterion Unit hardware must release pressure before peak pressure Cancel exceeds 320 mmHg Hel Pass _ Heb Adult Pressure released at 314 0 mmHg Fail Pass Infant lt untested gt Fail Test infant mode Cuff 1 mmHg Peak Pressure 314 0 mmHg 50643 NIBP Module 10 Host NIBP disabled Figure 6 12 Adult Test Pass 4 Click on the Test Infant Mode A checkmark should appear in the box before it Click Start High Pressure Safety Test Pass criterion Unit hardware must release pressure before peak pressure Cancel exceeds 160 mmHg Hel Pass Hep Adult Pressure released at 314 0 mmHg Fail Pass Infant lt untested gt Fail Cuff 0 mmHg Peak Pressure 314 0 mmHg 10 Host NIBP disabled Figure 6 13 Test Infant Mode 06 3 NIBP Module 6 12 eQuality 506DN Service Manual Criticare Systems Inc Section 6 Service Testing amp Calibration 5 Verify that the Pass box in the nfant field contains a checkmark High Pressure Safety Test Pass criterion Unit hardware mus
37. ITEM 24 4 PL 5 IN LBS 7 IN LBS CUT 2 LONG 2 PL 5 IN LBS GND GRN YEL ITEM 24 CABLE AY BRN ITEM 24 DETAIL A CST CRITICARE NTS SYSTEMS INC aen oum WIRING OF AC INLET EE SA 04 04 08 DATE APPR Scale 14 DO NOT SCALE PRINT APPR TOLERANCE UNLESS OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL XX 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 FINAL ASSEMBLY 93987 A001 2 596DN DIST _ sHeet 4 pun pn NOTE 1 2 PL IN LBS EM Seu s e REVISIONS REV DATE DESCRIPTION BY SEE DETAIL A FOR WIRING FUSE 2 PL cQ c TERMINALS UP AS SHOWN 2 PL 3 IN LBS NOTES 1 APPLY LOCTITE ITEM 47 TO FOOT MOUNTING SCREWS ITEM 12 2 PL 2 USE PROCEDURE 93987 TO ASSEMBLE UNIT VENDOR SHOULD COMPLY WITH THE FOLLOWING CSI QUALITY REQUIREMENTS Q1 Q2 04 Q5 Q6 97 010 Q11 AND 016 IN ADDITION THE QUALITY REQUIREMENTS Q9 Q13 AND Q17 APPLY SEE CSI WEB SITE www csiusa com pdf QA Requirements pdf SW FOR THE DEFINITION OF THE QUALITY REQUIREMENTS CSI 0385 Rev 0 REVISIONS REV DATE DESCRIPTION BY APPLY FOAM PAD
38. Normal Polarity Open GND lt 25 lt 50uA Isolation test 5 25 50uA Criticare Systems Inc eQuality 506DN Service Manual Page 5 19 Section 5 Preventative Maintenance NAME Functional Tests Alarm Functions Display Functions Powerup Function NIBP Function SpO Functions Functional and Safety Testing Checklist Page 2 of 2 PASS FAIL Verify Pulse volume operation from 0 to 10 Verify Alarm volume operation from 0 to 10 Verify 2 minute Alarm Silence function Verify permanent Alarm Silence function Verify Nurse Call lights up when alarm is triggered Verify Green Charge LED w AC power connected Verify unit powers up with AC plug in Verify unit powers up on battery Simulator set to Adult mode 120 80 1 min cycle Each reading does not vary by more than 4 or 4mmHg whichever is greater from the calculated average Average Simulator set to Neonate mode 80 50 Stat mode Each reading does not vary by more than 4 or 4mmHg whichever is greater from the calculated average Average f Seal Test Verify SPO2 NO SENSOR condition Verify SPO2 SENSOR condition Verify SPO2 HIGH AMBIENT condition Take SPO2 amp HR readings Verify LED Bargraph Sensor symbol operation Verify SPO2 LOST condition CERTIFICATION THAT THE UNIT IS CALIBRATED AND FUNCTIONING PROPERLY COMMENTS Page 5 20 eQuality 50
39. The factory default value is 200 for Adult and Pediatric modes and 140 for Neonate mode Select the low alarm limit for systolic blood pressure Choices are 50 through 150 mmHg and off The factory default value is 50 for all patient modes Select the high alarm limit for diastolic blood pressure Choices are 50 through 180 mmHg and off The factory default value is 100 for Adult and Pediatric modes and 80 for Neonate mode Select the low alarm limit for diastolic blood pressure Choices are 15 through 50 mmHg an off The factory hospital default is 30 for all patient size modes The factory alternate care default is 40 for Adult and Pediatric modes and 30 for Neonate mode Select the high alarm limit for mean arterial blood pressure Choices are 70 through 200 mmHg and off The factory hospital default value is 150 for Adult and Pediatric modes and 100 for Neonate mode The factory alternate care default value is off for all patient size modes Select the low alarm limit for mean arterial blood pressure Choices are 25 through125 mmHg and off The factory hospital default value is 50 for Adult and Pediatric modes and 40 for Neonate mode The factory alternate care default value is off for all patient size modes eQuality 506DN Service Manual Criticare Systems Inc Configuration Menu Time Hour Minute Day Month Year Contrast Brightness Reverse Video NIBP SpO Units Language Criticare Systems Inc
40. Volume Pulse Volume Enable MAP Press the MENU key to enter the Main Menu Use the arrow keys to select the main settings and submenus and press the MENU key to access them Use the arrow and MENU keys to change settings as desired The patient size can be set to Adult Pediatric Ped and Neonate Neo The alarm volume can be set from 1 to 10 and off If the volume is set to off or 1 it returns to 2 if the monitor is power cycled The factory default is 4 The pulse volume can be set from 1 to 10 and off The pulse volume setting will remain if the monitor is power cycled The NIBP MAP display can be turned on and off in the main menu eQuality 506DN Service Manual Criticare Systems Inc High Pulse Low Pulse High SpO Low SpO Criticare Systems Inc Section 2 Service Menus Press the MENU key to enter the Main Menu Use the arrow keys to highlight ALARM MENU and press the MENU key to access it Use the arrow keys to move through the alarm submenu and highlight the setting you desire to change Press the MENU key to access the settings for the desired item When the setting is changed as desired press the MENU key to save the setting Alarm limits are set separately for adult pediatric and neonatal modes and are saved independently To set adult alarm limits enter the ALARM MENU while in adult mode Patient size mode is set in the Main Menu Confirm that ADULT appear
41. by 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 eQuality 506DN Service Manual Page 1 1 Section 1 Introduction Non Invasive Blood Pressure NIBP ComfortCutf Technology Page 1 2 Description of NIBP Measurement The 506DN monitor uses ComfortCuff technology to determine non invasive 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 adult thigh cuffs ComfortCuff technology measures NIBP while the cuff inflates Consequently a measurement is obtained more quickly and with less discomfort than with monitors which measure NIBP during cuff deflation The NIBP cuff begins to inflate at the beginning of the NIBP 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 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 patie
42. is desired the manufacturer recommends you use Speaker Performance Alarms Verification in this section as an incoming inspection test You may perform additional electrical safety testing with Electrical Safety Tests 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 NIBP cuff and the SpO cable as needed nspect the accessories and charger for damage Every Day Charge the monitors battery as necessary Every 3 Months Clean the exterior of the unit or clean as needed nspect the monitor and AC mains cord for damage Every Year Perform the annual safety tests that are described in this section Long Term Storage No special preparation is necessary for long term storage of the monitor Although the battery does not have to be removed from the monitor for long term storage the battery does drain to an unrecoverable state after 3 months without periodic charging Disposal At the end of its useful life the monitor and its accessories may be disposed of according to your institution s policies and procedures for disposal of patient contact medical waste Alternately the monitor and its accessories may be returned to Criticare Systems Inc for safe disposal The shipping address is Criticare Systems Inc 20925 Crossroads Circle Waukesha WI 53186 Criticare Systems Inc eQuality
43. monitor or on any sensors or probes Abrasive cleaners can damage the monitor and accessories The exterior surface of the monitor except for the display screen you may wipe clean with alcohol and dry with a soft dry cloth It is best to use a cotton cloth to clean the monitor Paper towels or tissues can scratch the surface of the display Do not use full strength alcohol on the LCD display Repeated use of strong cleaners can damage the screen Clean the display window by wiping it with a clean soft lint free cloth sprayed with common glass cleaner Do not spray glass cleaner directly on the display NCAUTION N Do not immerse any Criticare pulse oximeter sensor connector in any liquid Doing so may damage the connector The SpO sensor may be wiped clean with alcohol The SpOs sensor may be disinfected by placing the paddles and cable in a 296 glutaraldehyde solution Place only the sensor paddles and cable in the solution eQuality 506DN Service Manual Page 4 1 Section 4 Cleaning and Disinfecting Blood Pressure Cuffs Page 4 2 To clean the reusable blood pressure cuff wipe it with a damp cloth or sponge If necessary disinfect the cuff 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 Sterilize the cloth cuff and neoprene bag with commercially available disinfectants such as ethylene oxide EtO R
44. 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 eQuality Vital Signs Monitor DOX Digital Oximetry ComfortCuff NIBP and Multi Site 5 0 Sensors are trademarks of Criticare Systems Inc Page ii eQuality 506DN Service Manual Criticare Systems Inc Contents ERE ii Contents iii Warranty zs Service Return nennen viii EG Declaration of Conformily teni rete e e ix Section 1 Introduction Description xerit eerie hm eo EPOR ER EP PO E E 1 1 Intended Use 1 1 Non Invasive Blood Pressure NIBP 21 2 ComfortCuff amp Technology enne 1 2 Description of NIBP 1 2 NIBP Clinical Testing and Accuracy 1 3 Cuff Inflation and Pressure Protection 1 3 Heart Hate ener ten 1 4 DOX Pulse Oximetry Measurement 5 1 5 De PINION MEE DOX Digital Oximetry ats Mu SpO Clinical Testing and Accuracy sss 1 6 1 7 Software Error Related Hazard Mediation 1 14 Potential Interference n
45. the MODE switch to L2 GND This reading should be the same as the first reading 5 VAC Criticare Systems Inc eQuality 506DN Service Manual Page 5 11 Section 5 Preventative Maintenance Leakage Procedure NOTE The monitor must be on throughout the leakage test This test should be performed at a supply voltage of 230VAC If supply voltage is 120VAC then acceptable leakage current limits are one half the value stipulated NOTE If attaching acceptable leakage measurements to the check sheet check PASS on each step completed 1 Connect the monitor to the measurement receptacle of the leakage tester 2 Configure the leakage tester to test internal case leakage Dynatech 232D MODE CASE LEAKAGE GROUND CONDUCTOR Record measurements on the check sheet for the following Normal Polarity 50uA 100uA Reverse Polarity 50uA 100uA Normal Polarity Open Ground 250uA 500uA Reverse Polarity Open Ground 250uA 500uA 3 Configure the leakage tester to test external case leakage Dynatech 232D MODE CASE LEAKAGE EXT LEAD Clip the external leakage test lead to the DB9 shell of the monitor Record measurements on the check sheet for the following Normal Polarity 50uA 100uA Reverse Polarity 50uA 100uA Normal Polarity Open Ground 250uA 500uA Reverse Polarity Open Ground 250uA 500uA Page 5 12 eQuality 506DN Service Manual Criticare Systems I
46. 2 E F2 m 2 S fe zi s 2o Hr E s am EJE B E CT f g es o Er d a eum g BEERE E m MOD WIRE dec 221112181818 H euet E B s TPH s mam 5 ow pa n 1 J2 L 67 _ DETAIL A SEE DETAIL A _ SIDE BOT OM SOI DER SID NOTES ASSEMBLY FILES 1 THIS PCB ASSEMBLY SHALL MEET CURRENT 610 SPECIFICATION CLASS 2 DESCRIPTION EE EI E 2 APPLIED LABELS MUST BE NON CONDUCTIVE TOP STENCIL PASTE 91410A001 R1 TSP PHO 3 PLACE REVISION AND SERIAL NUMBER LABEL S ON COMPONENT SIDE NOT COVERING ANY MOUNTING HOLES OR SOLDER JOINTS BOTTOM STENCIL PASTE 91410A001 R1 BSP PHO BOTH NUMBERS MAY APPEAR ON THE SAME L BEL PLACEMENT CENTROID 91410A001 R1 PLC 4 REFER TO BILL OF MATERIAL FOR COMPLETE LISTING OF COMPONENTS NOT INSTALLED DNI 5 MICROPROCESSOR MUST BE PROGRAMMED WITH SOFTWARE PRIOR TO FUNCTIONAL TESTING OF PCB ASSEMBLY FIRMWARE REVISION LABEL MUST BE AFFIXED TO MICROPROCESSOR 6 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 VENDOR SHOULD COMPLY WITH THE FOLLOWING CSI QUALITY NUMBERS SHALL NOT BE DUPLICATED THE FORMAT FOR THE SERIAL NUMBER SHALL CONTAIN AT LEAST 2 ALPHABETICAL PREFIX CHARACTERS THAT ARE RELEVANT TO THE REQUIREME
47. 2 506DN Revisions Menu eQuality 506DN Service Manual Criticare Systems Inc Section 2 Service Menus Test Menu The TEST MENU contains the monitor s NIBP Seal self test TEST MENU NIBP SEAL OFF Figure 2 3 506DN Test Menu To perform the NIBP SEAL self test 1 Press the MENU key to shift the cursor to OFF 2 Press the either arrow key to change OFF to ON 3 Press the MENU key to begin the test The following message will appear START TO SEAL XXXX X mmHg The valves close so that the pneumatic circuit can be checked for leaks This provides a simple field test for verifying the safety and static pressure accuracy of the NIBP transducer The current pressure is displayed on the second line of the message displayed on the LCD screen pressures from 0 to 300 mmHg have an accuracy of 2 The message format allows for the display of negative numbers to indicate negative zero offsets Press the MENU key a second time to terminate the test Criticare Systems Inc eQuality 506DN Service Manual Page 2 3 Section 2 Service Menus Default Setups The DEFAULT SETUPS menu contains options for setting the default values which will take effect when the monitor is turned on with the MENU key pressed and held during power up DEFAULT SETUPS USER STORE USER NO CONFIRM NO AUDIO OFF YES LINE FREQ 60 Figure 2 4 506DN Defaults Setup Menu CONFIG USER This selects the which type of confi
48. 30 to 300 mmHg Neonate 20 to 150 mmHg Adult 300 Pediatric 150 Neonate 150 30 to 240 1 mmHg x1 bpm or 1 5 min of consecutive readings SP10 2002 Less than 5 mmHg Less than 6 93 mmHg 2 mmHg Plethysmograph or oscillometric NIBP data 30 to 240 for all parameters 1 bpm or 1 for all parameters Page 1 7 Section 1 Introduction Alarms Characteristics Indication Minimum Duration of Alarm Conditions for Indication Levels Alarm Modes Volume Silence Communications Com Port Nurse Call Displays Controls Display Status Indicators Keys Languages Trend Reports amp Memory Types Trend Report Length Review Mode Interval Review Mode Data Types Page 1 8 eQuality 506DN Service Manual EN 475 Adjustable Audible Visual At least 1 second for Audible and Visual alarms High Medium Low Informational Adult Pediatric Neonate User Adjustable Yes 2 minutes or permanent RS232 serial port Contact switch audio jack 3 5 mm 24V Q 100 ma maximum switching LCD 3 25 in W x 2 4 in H Alarm Silence Battery Status Sensor AC Power Patient Size 9 membrane activated English Spanish Tabular Mini Trend Report 24 hours max selectable intervals On panel review of trend reports Every valid NIBP measurement NIBP Systolic Diastolic Mean SpO percent Heart Rate Criticare Systems Inc Criticare Systems Inc Mechanical Elect
49. 403 AD822AR R56A R56B o ESERI 330 1 i x J 10 5 1206 1 1004 15pF 1 1 JL1 1 10KX4 al 014 i 32 PIN TSOP 4 VW PACKAGE TN2106 24 59 Z NU dd ie C L2 343311 gt ELLAS E RSS 20 88888 28 renew AT 2 22 01 TS AD822AR 8 19 B xia 80 EAA 7727 28 wia D2 LED CT IMT 40MA 330 2 115 Moe D 25 A3 1 des D3 R56D I 4 4 114 3 6 04 4 RID Ria 113 0 22 18 5 15 0427 05 Ga DNI 499 499K TRESET Taq MOO MODE 6 ee A6 14 45 105 28 beg 330 4 10000 00000 PAQ A16 20 16 13148 29 57 E RN3 100KX2 3 30 O 75 19 15 3 R59 STEY 3FFFFH 256K PBTIAIS 15 8 RAM 150 i 2 86 PF2ILCAS WAITIBREQU pesata LL 0 3 At0 D sate R14 mV R13 L DRGATE a DE Beck PBGAS 12 11 4 410 ma 1 3 3v WRFLSH 4 38 PFO BREG i Alt 12 12 A12 LED PWR COMMON ANODE TP4 R16 rg 1 1 R15 Logic Icc 100mA max PB2 A10 13 10 _ 4149 IRLED 1 T TN2106 DNI 1006 2 3 Bq P35 SCK1 pp 92 9 100 330 1 4 701035879 A15 Q4 34 mS P34 SCK0 11 7 e Has E PC7IAT 10 i 16 4 5 Na 10 RXt B amp
50. 6DN Service Manual Criticare Systems Inc Section 6 Service Testing amp Calibration Monitor Testing Service Checks Field Service Testing A Criticare Systems Inc If the monitor fails any portion of these tests contact the Criticare Service Department for additional information See Functional and Safety Testing in Section 5 for functional and electrical safety tests Monitoring module verifications are also located in Service Checks in Section 5 If the monitor shows any signs of physical damage return it to Criticare for repair NWARNING N fthe unit fails any tests contact Criticare Do not use the monitor for patient monitoring until you fix the problem No user serviceable parts exist inside the monitor Do not remove the cover Refer all servicing to a qualified technician NWARNING N Service testing procedures require working with exposed electrical circuits and only experienced electrical or biomedical technicians should attempt these procedures Any time a monitor is altered through repair or hardware adjustment you should fully test it before use NCAUTION A Always follow ESD precautions when you perform any of the procedures discussed in this section The manufacturer recommends that a serviced monitor be allowed to run for 24 hours before you place the monitor back into operation Modules and PCBs that you have repaired may require more extensive testing t
51. ANEL FITING QUICK CON HH NIBP 5 4 40 X 438 SEMS NUT 10 32 KEPS PL BEZEL 506CN MEMBRANE 506CN DISP LCD PNL GRAPHIC 320X240 WINDOW FILTER 506CN EMI SHIELD 5 4 40 X 25 SEMS SPEAKER CABLE AY 1 5 DIA CABLE ASSY BATTERY TO MAIN BRD HOUSING 506CN FOOT 50 OD X 19 H NUT 4 40 KEPS PL AC POWER INLET FUSE TIME LG 500MA L 250V 5X20 5 4 40 X 312 PH PL CABLE AY AC INLET TERMINAL EQUIPOTENTIAL NUT M6 X 1 0 KEPS PL CABLE AY POWER SUPPLY TO MAIN BD PWRSUP 40W 9VDC 90 264VAC 47 63 HZ BRACKET POWER SUPPLY SHOCK PAD 75DIA X 188TH P H M S 6 32 X 375 31655 BATT LA 6V 4 5AH 70X48X110MM BATTERY DOOR 506CN F H M S 4 40 X 25 COATED GREY NUT 6 32 KEPS PL CABLE TIE 4 0 HOLDER TIE WRAP ADH BK SM TAPE MICROFOAM ADH BACKED THRDLOCK ASSURE SURF CUR DUST COVER CLEAR DB9P 5 4 40 X 625 SEMS Criticare Systems Inc Module 506DN Monitor Criticare Systems Inc Section 9 Drawings and Schematics 95597A005 NIBP MODULE 6 PIN CONN 506DN X Item 01 02 03 CSI Part Description 40067B002 CABLE TIE 5 6 40296B002 TUBING SILC BLU 125 X 250 41700B001 TUBING POLYU 09410 X 1870 41579B003 CHECK VALVE 42069B001 TUBING 1 4 X 1 8 POLYU COIL 42081B002 ORIFACE RESTRICTOR 0125 42104B003 BRACKET 42111B001 SCREW M2 4X3 PH BINDER 95576A007 ASSEMBLY PUMP WITH WIRES 95586A006 AY OKEN VALVE WITH CRIMPS 40132B001 TAPE MICROFOAM ADH BACKED 41700B002 TUBE POLYU
52. B CONFIDENTIAL This document contains confidential information and may not SYSTEMS INC 2006 be copied or divulged without written consent of CRITICARE SYSTEMS INC PCB NUMBER 83646B002 RO ENG APPR PART NUMBER DRAWN BY ELECTRONICALLY SIGNED IN OMNIFY 91391S002 DJR APPR DOX A D Processor CHECKED BY MFG APPR ELECTRONICALLY SIGNED IN OMN Y SHEET SIZE DIST 306 SHEET 2 OF 2 REVISIONS REV DATE DESCRIPTION BY 0 6 06 2008 PRE PRODUCTION ISSUE JEG 1 6 30 2008 INITIAL RELEASE JEG 2 8 26 08 10277 DBL 3 1713709 10359 DBL ITEM 3 POSITION OVER P5 ALIGN OVER COMPONENTS AS SHOWN PRESS
53. 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 SW FOR THE DEFINITION OF THE QUALITY REQUIREMENTS lt 2 CRITICARE SYSTEMS INC rox SC P ud APPR 50 04 04 08 DA AR LONG DO NOT SCALE PRINT APPR 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 DIST _ SHEET or CSI 0385 Rev O LABEL MODEL SERIAL NO LABEL si E COUNTRY OF ORIGIN LABEL NIBP SPO2 LABEL ELEC RATING LABEL BATTERY INSTALL REVISION LABEL REVISIONS REV DATE DESCRIPTION 1 14 09 SEE ECN 10359 LABEL FRONT LOGO LABEL MODEL LABEL LANGUAGE MENU USED ON ENGLISH VERSION NOTES 1 NOT SHOWN ITEM 4 SHIPPING ASSEMBLY PACKAGING ITEM 5 46036B101 CSI LOGO QUALITY SEAL LABEL LABEL SERIAL PORT 2 LABEL WARNINGS VENDOR SHOULD COMPLY WITH THE FOLLOWING CSI QUALITY REQUIREMENTS Q1 Q2 04 Q5 Q6 07 010 Q11 AND Q16 IN ADDITION THE QUALITY REQUIREMENTS Q9 Q13 AND Q17 APPLY SEE CSI WEB SITE www csiusa c
54. DREQTIRQS 82 PA VE R25 Pi SPA ___138 P3 SCKOISCKA SDAO 475 1 00K NSS Gl 10K x2 y 139 P33 RxD1 SCL1 SPO2 TXD 3 4 a Gun lt 6 100 141 P S2 RxD0 IrRxDISDA1 TSPO2_BOOTT 5 GND 33V XLI s COM TXD lt P31 TxD1 L 162 JPEE T eiai E 7 2 sp s 142 p30 TxD0 IrTxD eae ao SPO2 ON OFF 470 R29 475 S 89 475 Raz L 163 m ie 3 3V_LOGIC NBD 100K X4 P85 IRO5 SCK3 EDACKS TSPOZ BOOT 100K 470 pF 4 00K GROUND R33 RI 4 80 SP02 RXD i ASP 115311 04 4 1 PLLVec gt AAA P83 IRQ3 RxD3 ETENDS ACLED gt 2 2 2 5 2 TXD D3 04 05 MODULE LOGIC 21 PB81 IRQTyTxD3 EDREQ3 2 2 8 3 30 SPO2 RXD D4 y MMBZSVGALT1 GROUND PEO IRCOYEDREG 2 4 m s SPO2 MODULE CONNECTOR 2 4 10Kx4 04 3D R36 PLLVss e 9 x 100K R35 gt 41 RTS SPO2 ON OFF 10 0K 2299099299 COM DTR EL 25555055 No Code Turn off en on m Timer 5 BV 85 9 330 ni 176S Mi 2104 fe x 73 S Max cn t 01 4 R37 3s NIBP_ZERO 4 C34 04 01 4 Took Ei 200K cag cous ep D R42 MES 24 C30 10 gt ZC5800E b6 07 1 00M ot 4 16V 20 0K 100 3 4 2 4 wn H 33D R43 8 SPKR DIS MMBZSV6ALT1 ZC5B00E DB 22T7T Sasu FDN337N iud ae ilm pols
55. EAS LOT LEVEL ALL _ ALSO BE LABELED ON THE PCB ASSEMBLY IN BARCODE FORMAT XXX 005 WITHOUT WRITTEN CONSENT OF CRITICARE SYSTEMS INC TO THE RAW MATERIALS PARTS ASSEMBLIES OR DEVICES TO _ TITLE PART NO REV WHICH THEY APPLY AND SHALL BE AVAILABLE UPON REQUEST 7 AFTER THE BOARD HAS BEEN TESTED ATTACH ITEM 02 SHIELD ASSY DIGITAL SPO2 OR AUDIT BY CSI REPRESENTATIVE AND SOLDES AND PROS 91591 002 2 DOX MODULE DIST _ _ 1 F 1 510590 Rev O 330 330 330 330 VW 9 REV DATE 1 WRFLSH PWR R51 R52 7 4 1 1 LEDDR R3 R4 JUMPER 330 330 o 499KQ DNI 9 105 1206 1 00K 4 sv Install jumper for emulation mode alt C56 A T 57 DNI LED Current 8 5 ma 47 a 4 R53 R5 U20A 3 2 AAA 6 330 1 m TN2106 9 Q12 2 2M 100 24 PWR R54 R55 MMBT4
56. EFORE FABRICATION i ADDITION THE QUALITY REQUIREMENTS 09 013 AND 017 APPLY SEE EACH LOT OF PARTS SHALL BE ACCOMPANIED BY A LEGIBLE CSI WEB SITE www csiusa com pdf QA Requirements pdf FOR THE 5 LABELING MUST NON CONDUCTIVE COPY OF A CERTIFICATE OF COMPLIANCE LISTING THE DRAWING DEFINITION OF THE QUALITY REQUIREMENTS SPECIFICATION PROCESS AND APPLICABLE REVISION TO WHICH THE PARTS COMPLY AND BE SIGNED OFF BY THE VENDORS QA REPRESENTATIVE i Z CRITICARE PROCESS SUBJECT TO REVIEW APPROVAL VERIFICATION AND EACH ASSEMBLY SHALL BE IDENTIFIED WITH THE CSI PART NUMBER ET RXRIEM 8 4 LN ANALYSIS BY AUTHORIZED CSI REPRESENTATIVES ALL CHANGES AND REVISION FOR THE ASSEMBLY AND A UNIQUE SERIAL NUMBER ay DBL BY APPR M DESIGN COMPONENTS PROCESSES R IN HUMAN READABLE FORMAT SERIAL NUMBERS SHALL NOT BE pate 4 25 08 DATE S APPR DEVIATIONS FROM DRAWINGS SPECIFICATIONS OR OTHER DUPLICATED THE FORMAT FOR THE SERIAL NUMBER SHALL CONTAIN SCALE 1 1 5 DO NOT SCALE PRINT MEG REQUIREMENTS MUST BE REOR ED o CA FOR PROV AE AT LEAST 2 ALPHABETICAL PREFIX CHARACTERS THAT ARE RELEVANT iti TO THE VENDOR TO DISTINGUISH BETWEEN MULTIPLE VENDORS THE TOLERANCE UNLESS OTHERWISE SPECIFIED CONFIDENTIAL THIS DOCUMENT CONTAINS CONFIDENTIAL 1 TO PRODUCE THIS PART ASSEMBLY PART NUMBER REVISION AND SERIAL NUMBER SHALL XX 020 INFORMATION AND MAY NOT BE COPIED OR DIVULGED SHALL BE TRACEABLE TO L
57. ING DRAWINGS AND SPECIFICATIONS FIRST ARTICLES MUST BE SO MARKED AND IDENTIFIED WITH A RELEASE DATE 06 09 2008 DATE OMNIFY appr SEE OMNIFY PART NUMBER ANY MAJOR TOOLING PROCESS OR COMPONENT CHANGE WILL REQUIRE A NEW FIRST ARTICLE EVALUATION SCALE NONE DO NOT SCALE PRINT MES SEE OMNIFY TOLERANCE UNLESS 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 AND BE SIGNED OFF BY THE VENDORS QA REPRESNTATIVE TOLERANCE UNLESS a INFORMATION AND MAY NOT BE COPIED OR DIVULGED VENDOR SHALL FURNISH A COPY OF ACTUAL INSPECTION TEST RESULTS ASSOCIATED WITH EACH SERIALIZED ITEM INSPECTION AND TEST PARAMETERS OPERATIONAL ees MGR Wa LN CONSENT SYS TENE ING MECHANICAL ELECTRICAL ENVIRONMENTAL ETC SHALL BE DEFINED BY BY CSI MANUFACTURING ENGINEERING ANGLES 1 DEGREE TITLE PART NO REV 8 EACH INDIVIDUAL ASSEMBLED PCB SHALL BE PACKAGED IN CONDUCTIVE STATIC SHIELDING BAGS OR CONTAINERS AND IDENTIFIED WITH ESD WARNING LABELS ASSY 506CN MAIN BOARD 91410A00 DIST _ __ SHEET 1 OF 1 510390 Rev 0 Aoa SEE DETAIL LIFT 18 14 AND SOLDER WIRE 3OAWG 40577B001 TO PIN 14 AND JUMPER U21 3 RELEASED DOCUMENT 1 2 s I rj I z I
58. IRESET Wg TN2106 ilasa vola 12 poops 78 6 E6 21 osco veat 3 TP2 20 20 RM 20 Molex 52610 2271 RNB 100KX4 4 MD12 BLA31AG102SN4D RN8C 8 8 P27 PO7ITIOCBSI IRO15 204 012 IL 8 SDA 12w TO XA PAT PAL 2 P26 POS TIOCAS IRQ14 PD3 D11 MD1O JEXT RAM SCK amp scr 3 amp AN 4 m P25 POSITIOCBANIROT3 2 Z amp E7 vss 4 me 8 1 ILCO RST P24 POAITIOCAA RXDA IRQ12 PD D9 74 4 MDE RTC 0xD0 WRITE RTC Calibration 1 Q2 1 54 P23IPOSITIOCD3 TXDA IRQA1 73 5 7 OxD1 READ FON337N amp 3 3 P22 POZ TIOCC3 IRQ10 PETID7 MDE d NY 8 4 5 4 TONE 2 P21 PO1 TIOCB3 IROS 68 1 05 500 Ha 100 1 P20 POO TIOCAS IRQ8 PESiD5 88 3 Variable 4 R205 R204 2 5VREF RN9 peapa 57 5 10Kx4 R14 PE3 D3 88 8 ape m MD D 15 v PE2ID2 eq MDT d PE1 D1 RN1o 10 4 10 0K 6 4 MDO ACPOWER 3 10 127 BSTIANISIDAS 3 6 P96 AN14 DA4 AWR OFFION 2 128 P9S AN13 DA3 PF3 LWR 8 1 a t 1 uza 33D 5 P ANT2IDA2 PFAHWR B 67780 2 RN11 124 P 3 AN11 PFS RD 5 5 123 P92 AN10 PFG AS 904 nee 5 FARES VCC VDD 33D SW VER 121 DANS cask BLA31AG102SN4D_ i TOT 2 T AUDIO VOL 129 ROV ANG Saa 40 s 33D NIBP ZERO 119 ANG PAG DAO R17 100 3 8 TUB RN17 VAN Pus BATSTATI 117 ANSP45 42 I
59. IT P0 0 P0 1 SCLK 50 SDOUT u12 5A LP2985 3 3 Ty 4 VOUT Cer BYP GND 40V 1uF 20 80 co 10nF 16v 10 xmi 3D 33A R75 10R 1 C68 10uF 6V3 Single ground plane junction the pcb analog 5V For lowest noise this system is powered from P0 0 SPI SCLK 32K Flash VoD Monitor u23 C8051F067 AGND3 P0 2 P0 4 POS P0 6 P0 7 RsT MONEN TCK TMS TDI gt TDO NC1 NC2 NC3 NC4 NC5 TDXMIT TFDS TOFL_POS TOFL_NEG 44 ADVALID 1 30 P0 1 SPI Master in Slave out P0 2 SPI Master out Slave in INTO 20 4 INTI C8051F027 IO Crossbar settings TDO TDI TCK CEEL CEEL bbk TMS 7 v 212 XTAL2 20 xrAL1 JTAG Debug Samtec CLP 2x4x0 05in SMT vert pass thru AGND 5 50 gt 08 yy DCLK JDXMIT lorow gt IOFL_POS IOFL NEG SDOUT 50 R76 10K 1 1 Connections ELECTRONIC FILE NAME JAPERM SPO2 MODULE DOX SCHEMATIC 91391A002 91391S002_RV0 DSN LAST MODIFIED DATE Wednesday June 18 2008 ELECTRONICALLY SIGNED IN OMNIFY TITLE CRITICAR M W
60. NTS 01 Q2 04 Q5 Q6 07 010 a js Q16 IN VENDOR TO DISTINGUISH BETWEEN MULTIPLE VENDORS THE ASSEMBLY PART NUMBER REVISION AND SERIAL NUMBER SHALL ALSO BE LABELED ON THE PCB ASSEMBLY IN ADDITION THE QUALITY REQUIREMENTS Q9 013 AND Q17 APPLY SEE BARCODE FORMAT USING CODE 39 PREFERRED OR CODE 128 1 Au CSI WEB SITE www csiusa com pdf QA_Requirements pdf FOR THE 7 CSI RESERVES THE RIGHT TO INSPECT THIS ITEM AT THE VENDORS FACILITY VENDORS INSPECTION SYSTEM AND MANUFACTURING PROCESS ARE SUBJECT TO REVIEW APPROVAL VERIFICATION DEFINITION OF THE QUALITY REQUIREMENTS 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 CRITICAR E 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 SYSTEMS INC 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 DRAWN JEG CHECK ENG SEE BE INSPECTED AND OR TESTED FOR COMPLIANCE TO THE REQUIREMENT OF APPLICABLE ENGINEER
61. P Board amp reconnect Replace pump Replace Main Board and software Replace NIBP Board and software Criticare Systems Inc eQuality 506DN Service Manual Page 8 1 Section 8 Troubleshooting Symptom Problem Solution 5 not functioning Using incorrect sensor SpO module turned off Bad sensor 5 board disconnected Bad SpO board Bad Main Board SpO Cable Verify the correct sensor is used for the monitor Turn in the CONFIGURATION menu or ensure the proper setting is selected for the SPO2 setting in BOARD SETUPS in the service menu Replace sensor Reconnect SpO board Replace SpO board Replace Main Board SpO Cable Unit intermittently missing blood pressure measurements Cuff size changed Wrong cuff size or poor loose cuff placement Poor connection of NIBP module Incorrect Patient Size selected Unit adapts to cuff size on next attempt Check cuff selection and placement Check pins and clean connection of the NIBP module to the Main Board or replace module board if necessary Change patient size No sound from speaker Speaker wire disconnected Speaker wire broken Bad Main Board Reconnect Replace speaker Replace Main Board No communications Serial settings not correct Bad serial cable external Bad Main Board Check MENU settings Replace external serial cable Replace Main Board Page 8 2 eQuali
62. PC A 610 manufacturing standards for medical equipment Failure to use standard ANSI IPC assembly practices can result in permanent damage to the monitor eQuality 506DN Service Manual Page 7 1 Section 7 Disassembly Electrostatic Discharge Page 7 2 The procedures in this section require the handling of electrostatic Protection sensitive components Microprocessors and other electronic components can be permanently damaged by attempting repairs at an unprotected workstation Use all electrostatic discharge ESD precautions as described below yon 1 Perform the disassembly procedures an antistatic mat that is grounded Check the ground cable to insure that it is connected to a good earth ground 2 Always use a grounded soldering iron 3 Wear a wrist grounding strap 4 The wrist strap and mat should both be connected through a resistor 1 mega ohm typical to the same ground source Wrist ground straps should be tested on a daily basis Components should be temporarily stored in metal or antistatic containers Never store components in plastic dishes Circuit boards should be stored in sealed antistatic bags or covered antistatic boxes Never store electronic boards directly in cardboard boxes Tools Needed The following is a list of tools needed for disassembly and reassembly of the eQuality 506DN monitor Set of hand tools Up to 7 in torque screwdriver with accessories 10 socket
63. PI6 V RAIL LP2950CDT 3 3 3 38 E13 i Standby Power Supply BLM21BD222SN1B VANE 2 E14 k BLM21BD222SN1B 10T AN 17 33D u22 4 um g ewlt IO gt 2 3 330 TO 252 Package 4 ViN gt sw 2 5 cat LM2651MTC 3 3 DT3316P 473 019 C82 2 avin 9 018 220EL AN 3514 AN gt 04 8514 25V Diode protects against output voltage 16 10 comp LOW ESR being pulled below ground through the LOW ESR synchronous FET undervoltage 8 ssso 252 REL 2 input situation R115 1 Design Specs ys 15 0K 3 3 Volt at 400 mA step down Vin 5 25 to 13 2 Volts V_BATT 917 Si4435BDY Le R19 10 0K 68uH ce SW_VRAJL 1 cos mes 7 100 12V 25V 117 21 LOW ESR 20 0 TP 9 5 5V 400ma Ron FM cor AE p a 15 5 ANALOG VOLTAGE 2 1 t t T T vin 8 10000 1 2 D I qi s ow J ds var e n 6 4 100 uH 100 uH um 15 up Design Specs 04 OND c90 DT1608 aig R121 107 AN gn Specs 25v LM2594M 5 0 D22 208 2 01 7T 04 400 KHZ 5 16 12 Volt at 1 amp step LOW ESR 8514 25v 16V IRF7821 step up 7 ps 110K LOW ESR LOW ESR PS 403 OHM Vin 5 25 to 9 2 volts em R122 QI 4 42 T 2 cowe isen 1 2 3 C101 8 s r C102 1 R125 022 13 0K R128 e R127 02 OHM 4 75
64. SEE VIEW A originate from R4 R88 RSET ws bi gt lands bj R87 9 5 gt gt R86 200K RSET 8 our I 200 R89 2 R90 16 i 4 R10 cst NCOBOSKH103J 30 1K cs LZ SENSE ces ww R92 914 3 92K RM R94 TN2106 g 1 U l E SES T t STATO CHGENB LJ 28 0K AC Power STATA RS Sense Input To R95 R96 ROVC2 va L2 R97 CPU 3 92K 2 6 19k 4 VLOGIC Vi BATSTATI 1 100K R98 RS2 8 R99 VBATT_MON 0 V TO 2 50 V wrt TP26 1 BATSTATO amp 0 1 oirik STATLV 562K FOR BATT_PLUS 5 00 V TO 7 50 V TN2106 amp 4 U20A 14 NOTE PLUS BATTERY VOLTAGE p BY DESIGN To uP input ROVC1 af 15 cso gt gt VBATT_MON 11 0K UC3909DW 10Kx2 R102 4 R103 CHARGE STATUS LED s ANALOG lt CAO CA STATO STAT1 EN R107 MODULE_LOGIC GROUND GRN RED aioe 2 5 i 16 9K 3 3V_LOGIC oe ous ENG p Ted kn RIS POWER GROUND GROUND On OFF Bulk Charge 10047 E ALL GROUND SYMBOLS ARE PLANES OFF On Over Charge 470 pF AND JOINED POWER GROUND BY R112 H Float Charge Full Charge ell 23806 FOR SENSE 0 A TO 4 15 A 50 MIL MIN TRACE AT LOCATION SHOWN i AC POWER y ha SENSE ON 91410M001 DRAWING Defective or No Battery Connected _ 10 0K VIEW J 27 TP15 zcss00ES 73 U21 T
65. Section 2 Service Menus Press the MENU key to enter the Main Menu Use the arrow keys to highlight CONFIGURATION and press the MENU key to access it Use the arrow keys to move through the configuration submenu and highlight the setting you desire to change Press the MENU key to access the settings for the desired item When the setting is changed as desired press the MENU key to save the setting Sets the monitor time to 24 Hour or AM PM The hospital default is 24 Hour The alternate care default is AM PM Set the current hour Hour is always set in 24 hour format to establish the correct AM PM time Sets the current minute Sets the current day Sets the current month Sets the current year Adjusts the LCD display from 596 to 9596 in 596 increments The contrast changes as the adjustment is made The factory default value is 7096 Adjusts the LCD brightness from 596 to 95 in 596 increments The brightness changes as the adjustment is made The factory default value is 5096 The LCD display can be set to reverse video The factory default value is Off Turns the NIBP function On or Off This automatically resets to On when restarting the monitor Turns the SpO function On or Off This automatically resets to On when restarting the monitor The monitor can display units in English and Metric The factory default is English The monitor has language settings available in English and Spanish The monitor must be r
66. TLE PART NO REV RELEASED DOCUMENT 506DN DIST _ SHEET OF CSI 0385 Rev 0 REVISIONS REV DATE DESCRIPTION BY va L 5 i S EC 4 PL TE 5 IN LBS S 0 E 2 am dps x lt lt gt J v S 7 BN 2 1 d W Em N _ ME S PCB NIBP ASSEMBLY SEE SHT 1 VENDOR SHOULD COMPLY WITH THE FOLLOWING CSI QUALITY REQUIREMENTS Q1 Q2 04 Q5 Q6 97 010 Q11 AND 016 IN ADDITION THE QUALITY REQUIREMENTS Q9 Q13 AND Q17 APPLY SEE CSI WEB SITE www csiusa com pdf QA Requirements pdf SW FOR THE DEFINITION OF THE QUALITY REQUIREMENTS CST CRITICARE SYSTEMS INC ENG Fo SC EA APPR QA 4 04 08 DATE APPR MFG quy DO NOT SCALE PRINT APPR 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 PART NO REV DIST _ SHEET 2 OF 4 CSI 0385 Rev 0 3 PL 5 IN LBS CUT 2 LONG X 5 WIDE BLUE
67. V CUSP and Off The factory default value is Text Sets the baud rate of the monitor The choices are 2400 4800 9600 19200 and 38400 The factory default value is 19200 eQuality 506DN Service Manual Criticare Systems Inc Section 2 Service Menus Patient Data Press the MENU key to enter the Main Menu Use the arrow keys to highlight PATIENT DATA and press the MENU key to access it Use the arrow keys to move through the patient data submenu and highlight the setting you desire to change Press the MENU key to access the settings for the desired item When the setting is changed as desired press the MENU key to save the setting Weight Sets the patient s weight Height Sets the patient s height Respiration Sets the patient s respiration rate Pain Sets the patient s pain level Criticare Systems Inc eQuality 506DN Service Manual Page 2 17 Section 3 Theory of Operation System Architecture Criticare Systems Inc The 506DN monitor s circuitry consists of a Main Board LCD Module SpO Module and NIBP Module The Main Board SpOs Module and NIBP Module are considered the Main Module This module is located in the monitor s font bezel The LCD display mounts to the main board which in turn mounts to the front bezel Affixed to the front bezel is the membrane switch and overlay that connects directly to the main board The rear housing contains the 6 Volt lead acid battery and AC to DC Power Supply
68. able ferrites to coil on the main board Reassemble the monitor and perform the Completion of Service procedure at the end of this section Criticare Systems Inc eQuality 506DN Service Manual Page 7 3 Section 7 Disassembly Bezel Disassembly Replace Speaker 1 Follow the caution for static sensitive devices in Electrostatic Discharge Protection on page 7 2 2 Detach bezel assembly from housing assembly See Detach Bezel Assembly from Housing Assembly on page 7 3 3 On the bezel assembly disconnect the speaker cable J4 from on the main board 4 Remove the speaker from the rail on the bezel 5 Slide the new speaker P N 90929A001 under the NIBP assembly and into the rail of the bezel Rail gt Figure 7 1 Reinsert Speaker 6 Connect the speaker cable to the main board at J4 Reassemble the monitor and perform the Completion of Service procedure at the end of this section Page 7 4 eQuality 506DN Service Manual Criticare Systems Inc Section 7 Disassembly Replace LCD Display 1 Follow the caution for static sensitive devices in Electrostatic Discharge Protection on page 7 2 2 Detach bezel assembly from housing assembly See Detach Bezel Assembly from Housing Assembly on page 7 3 3 Detach the PCB NIBP assembly from the bezel by removing the two 2 screws PHMS SEMS 4 40 X 25 LG P N 40995B004 4 Disconnect all of the tubing and remove the connector f
69. aia vere wines a aos Serviceable Components ua 000 aaa uapa akui Casas aaa aa u 5 3 Battery Removal Replacement Fuse Removal Replacement 5 5 Annual Testing 2 5 6 Accessory re eren 5 6 Functional and Safety Testing seen 5 6 Equipment and Tools 6 7 Test EIXtUEF 85 7 PEU INA e 5 8 Electrical Safety Tests TER x 5 10 Withstanding Voltage Test 5 10 Equipment Needed reet entier or sees 5 10 Setup Hi pot Tester 5 recen Recette inerte eiie ees 5 10 Hi pot Performance Test U uuu u 5 11 Loakage T6stilig uu te prn rene pen 5 11 Setup Procedure Self Test sess 5 11 Leakage Progedure u incer tette ua td rh iR UR Enea ok cau 5 12 Functional Tests SyStem Check esso dace cette eee ee tee de te eda 5 14 Speaker Performance Alarms Verification 5 15 Power Supply Performancoe mene meenenneenenn 5 15 Monitoring Module 5 16 NIBP VerifiGation rrr Re 5 16 NIBP Seal 16S eet nett eet dca D e ett da 5 17 SpOs Verficatioh cron einen enne tena E neni 5 18 Functional and Saf
70. all the converter and software on the computer as directed by the converter manufacturer Digital manometer calibrated accuracy of 0 05 ESD Protected Work Bench Calibration Kit Cat No 454 G includes e Serial null modem cable DB9F DB9F 6 foot null modem cable pn 87016B002 Calibration fixture with 700cc reservoir and tee connector Service program software CD ROM pn 97082A003 revision 2 or higher Installing the PC The NIBP Service Program is provided on a self installing CD ROM Service Program disk If the CD ROM does not run automatically you may need to click on the CD ROM drive 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 Configuring the Ports The Service Program is designed to operate using a serial COM COMS or COMA port If your computer uses USB ports instead of a serial port an adapter will be required The following adapters are recommended USB to Serial PDA Converter Cable GUC232A e Keyspan USB Serial Adapter USA 19HS If COM1 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
71. amp Calibration Leak Test 1 Click on the Leak test button 72 CSI NIBP Service Support Program 50643 NIBP Module xl Connection View Help E 3200 a m 300 250 200 150 100 50 Signals 0 0 00 0 01 0 02 0 03 0 04 0 05 0 06 0 07 0 08 0 09 0 10 Host mode Service mode Mode Systolic mmHg Diastolic mmHg Calibrate Adult pes ean mmHg Infant Accuracy ean Adult xI m Safety Heart Rate bpm Pass Fail Unit Elapsed Time sec Speed Inflate Deflate x Reset F5 eset F5 Peak Pressure mmH 000 d Adk Disable FE Time Leak ime Infant lt 1 0 0 mmHg Elapsed Time 0 Infant 506N3 NIBP Module 26 Watchdog circuit fired 70 Fact idle 00 OK Figure 6 20 Select Leak 2 A Leak and High Time Test window appears Click Start Leak and High Time Test rLeakage Test rHigh Time Test Elapsed time 0 sec Elapsed time 0 sec Pass criterion Pass criterion Help No more than 4 mmHg min Time out within 110 and 160 seconds Pass Adult Pass Fail Fail Infant Pass Fail Approximate actual timing is done in the monitor Timer starts when cuff exceeds 15 mmHg Cuff 0 0 mmHg Infant high time test only Start 50643 NIBP Module 70 Fact
72. ants for the SpO clinical accuracy validation include a mix of adult males and females from 18 to 45 years of age 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 Clinical testing for neonatal participants was conducted per U S FDA recommended clinical protocols eQuality 506DN Service Manual Criticare Systems Inc Specifications 5 Range Resolution Accuracy Indications Method Modes Operation Sensor Wavelength Sensor Power ComfortCuff NIBP Technique Average Measurement Time Automatic Measurement Cycles Inflation Pressure Range Max Inflation NIBP Pulse Rate Range Resolution NIBP Pulse Rate Accuracy STAT Mode Clinical Accuracy Clinical Mean Error Clinical Standard Deviation Static Transducer Accuracy Heart Rate Source Accuracy Range Accuracy Criticare Systems Inc eQuality 506DN Service Manual Section 1 Introduction 1 99 1 70 to 99 2 50 to 69 3 lt 50 Unspecified Statistical represents one st dev 66 of clinical samples Plethysmographic Numerical Audible pulse tone pitch varies with SpO Dual wavelength LED Adult Pediatric Neonatal Continuous Use 660nm 905nm 80mW Oscillometric measure upon inflation 30 seconds 1 2 3 5 10 15 30 45 60 min 2 4 hrs Adult 30 to 300 mmHg Pediatric
73. ast 5 95 70 70 96 Brightness 5 95 50 96 50 NIBP Tone None Begin End Both None None Reverse Video ON OFF OFF OFF NIBP ON OFF ON t ON t SpOs ON OFF ON T ON T Units English Metric English English Language English Spanish N A N A T The monitor returns to this setting on power up N A This setting does not have a factory default value This setting is only available after a MENU power up Communication Menu Setting Options Factory Default Value Print on NIBP ON OFF ON Print on alarm ON OFF OFF Interval Spot BPT OFF 1 2 5 10 15 30 60 minutes 2 4 8 12 24 hours OFF Patient Data ON OFF OFF Print To Serial OFF Serial Serial Text CSV CUSP OFF Text Baud Rate 2400 4800 9600 19200 38400 19200 Page 2 10 eQuality 506DN Service Manual Criticare Systems Inc Patient Data Menu NIBP Cycle Menu Criticare Systems Inc Section 2 Service Menus Setting Options Factory Default Value Weight 2 500 16 100 16 Height 5 100 in 60 in Respiration 1 to 99 min 20 min Pain 1to 10 1 Setting Options Factory Default Value NIBP Cycle 1 2 3 5 10 15 30 45 60 minutes Off 2 or 4 hours Off NOTE The NIBP CYCLE menu is accessed using the NIBP CYCLE key located on the front panel other default settings are accessed using the MENU key with the UP DOWN keys eQuality 506DN Service Manual Page 2 11 Section 2 Service Menus Main Menu Page 2 12 Patient Size Alarm
74. by Criticare Systems Inc or the 506DN 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 Suite 100 Orders 800 458 4615 Waukesha WI 53186 Fax 262 798 8290 USA Internet www csiusa com eQuality 506DN Service Manual Page vii Service Return Policy Return Procedure In the event that it becomes necessary to return a unit to Criticare Systems Inc the following procedure should be followed 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 Obtain return authorization Contact the CSI Service Department 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 i
75. charge Protection 7 2 Tools Needed 7 2 Disconnect and Remove Battery 7 3 Detach Bezel Assembly from Housing Assembly 7 3 Bezel Disassembly sos m rere Replace Speaker Replace LCD 7 5 Replace u u u u u 7 6 Replace Main Board 2 rrr mener eere denn 7 7 Replace 7 9 Replace NIBP Module Housing Disassembly uu uuu terme rn nne Replace Power 7 11 Completion of Service nenne nennen nennen nnne nnt 7 12 Section 8 Troubleshooting Troubleshooting Guide sese 8 1 Section 9 Drawings and Schematics 62 5 9 1 Assembly P rts Lists ciet erre ni e ee ent 9 1 PCB Drawings List rene tnr eee riter retener 9 1 506DN Final Assembly NIBP MOdullg RD Fehr a s u u as 5OGDN MONITO Page vi eQuality 506DN Service Manual Criticare Systems Inc Warranty Workmanship amp Materials Exemptions Safety Reliability amp Performance In Case of Emergency Contact Criticare Systems Inc Criticare Sy
76. cond 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 is proportional to the pulse volume changes occurring in the tissue illuminated by the SpO sensor All Criticare oximeter s DOX compatible have SpO calibration tables which were originally generated by monitoring desaturated human patients or volunteers and matching their displayed SpO 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 or methemoglobin concentrations near zero This oximeter is a two wavelength device which is calibrated to measure functional gt 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 is a higher displayed SpO value than is actually present in the patient SpO clinical accuracy validation to CO oximeter SaO readings was performed for the sensors using a DOX compatible monitor The personal demographics of the study particip
77. d oscillometric waveform are beyond the detectable limits The monitor reports error messages if valid measurements cannot be obtained The monitor continues to look for valid SpOs based heart rate measurements and attempts a second NIBP measurement if the first attempt fails eQuality 506DN Service Manual Criticare Systems Inc Section 1 Introduction DOX Pulse Oximetry 506DN patient monitor comes with Digital Oximetry Measurement SpO technology to measure blood oxygen saturation SpO Definition Hemoglobin exists in the blood in several forms Oxygenated Oxyhemoglobin Reduced Deoxyhemoglobin Dsyhemoglobins Carboxyhemoglobin and Methemoglobin In the monitor SpO pulse arterial 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 percent oxygen saturation Dyshemoglobins such as carboxyhemoglobin and methemoglobin are not directly measured and therefore are not factored into the measurement DOX Digital Oximetry 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 fro
78. d membrane from the bezel Once removed clean the bezel with alcohol to remove any residue from the bezel surface 6 Obtain a new membrane P N 45214 001 Slide the membrane tail through the bezel and remove the paper backing from the membrane Place the membrane flush with the bezel and press firmly around the bezel to ensure that the membrane is flat and no air bubbles are apparent 9 Reassemble in reverse order Perform the Completion of Service procedure at the end of this section eQuality 506DN Service Manual Criticare Systems Inc Replace Board 1 Section 7 Disassembly Follow the caution for static sensitive devices in Electrostatic Discharge Protection on page 7 2 Detach bezel assembly from housing assembly See Detach Bezel Assembly from Housing Assembly on page 7 3 Detach the NIBP module from the main board by removing the two 2 screws PHMS SEMS 4 40 X 44 LG P N 40995B009 located in the lower middle of the main board Disconnect the NIBP module from the NIBP fitting P N 42014B001 on the side panel P N 45225B001 Disconnect the NIBP module s ribbon cable from P3 on the main board Disconnect the NIBP module s open tube from the SENS1 connector on the main board Remove SpO board by removing the four 4 screws NOTE Two different types of screws are used to attach the SpO board to the insulator board The two 2 screws PHMS
79. dre nra TALL RESISTORS ARE 1 1 10W UNLESS OTHERWISE NOTED BATSTAT1 AN4 P44 PG6 74AHCOB 1 ALL fo 118 AN3 P43 12 PGS 11 BLA31AG102SN4D t 114 AN2P42 PGSIBACK 130 4 9 2 ALL CAPACITORS ARE IN uF UNLESS OTHERWISE NOTED IBATT MON 114_ ANUPAT PGA BREQO pat _ t awu 10 3 LAST DESIGNATORS USED C163 D29 E16 F2 J6 JMP1 L7 R199 VANL 2 112 PHSIGSTATROTYOE CKE 38 REBO 4 8 L MTG3 P5 PWR5 Q24 R209 RN22 RT1 SENS1 S1 TP32 TVS2 U38 Y2 ne i 111 avec LLL PHACSS IRQS 3 3 6 PSS cte 21 c22 PH1 CSSIRASSISDRAM_clk NCAT P53 C23 C24 C25 C20 JCSAIRASAIWE 7545 BOOT DISABLE 1 PGS Ba 01 00 AN IT PGSICSS RASSICAS 109 R 2 Pee PGZ CSZIRASZIRAS sv 2 o3 o1 T T tas EXT RAI 3 did s2209 FRONT PANEL GND ANL gt 4 4 4 AVSS 60 50 RNA 91 MEMBRANE 4 pe IHIPRESS S D P50 TxD2 IROO MUR lt gt BUOLDIBABLE diio CONNECTOR AIRON 134 p51 RxD2IIRQT GND_PWR GROUND ITIMEOUTS 135 P52 SCK2 IRO2 _ P65 TMO1 DACKT IROTS 106 SAFETY CTRL 470 pF 33D RNIS a 88 PS3 ADTRG IRQS P64 TMOO DACKONRG12 104 BE GAIN GIRL PGS TMCH TENDT IRQTT GAIN Pe2 TMCIO TENDO IRQ1O 8 BAT54S 5 13 OE IDREQHIROS L 8 PVALVE1 R28 3 3D IL POSISCKUSCLONOEMCKE P61 TMRI1
80. e 71 Fact controlled inflation Figure 6 29 Pressure Accuracy Test 70 mmHg 4 Repeat for 140 and 280 mmHG Pressure Accuracy Test E Manometer reading should match display reading 2 or 3 mmHg _ Cancel Pass Fail Help Inflate to 70 mmHg v Inflate to 140 mmHg Inflate to 280 mmHg Indicate Pass or for this inflation level Cuff 133 0 mmHg 06 3 Module 70 Fact idle Figure 6 30 Pressure Accuracy Test 140 mmHg Manometer reading should match display reading 2 or 3 mmHg Lancet Pass Fail Help Inflate to 70 mmHg LI v Inflate to 140 mmHg v Inflate to 280 mmHg Indicate Pass Fail for this inflation level Cuff 273 0 mmHg 06 3 Module 70 Fact idle Figure 6 31 Pressure Accuracy Test 280 mmHg 5 Click Done if the test passes after the 280 mmHg test 6 Turn off power and remove serial cable and manometer fixture Criticare Systems Inc eQuality 506DN Service Manual Page 6 21 Section 7 Disassembly Before You Begin Service Safety Criticare Systems Inc Opening a monitor and breaking the quality seal can void the manufacturer warranty Contact the Criticare Service Department before breaking the seal on any monitor The following procedures are intended to be used by qualified biomedical engineering or field service personnel for replacement of PCB assemblies
81. e User settings DEFAULT SETUPS CONFIG DEF USER STORE USER NO CONFIRM NO AUDIO OFF YES LINE FREQ 60 Figure 2 7 Select STORE USER 5 Select YES and press the MENU key The CONFIRM submenu item now becomes active Use the arrow keys to select YES and press the MENU key to confirm the new User Default settings 6 The new User Default settings are now saved on the monitor Page 2 8 eQuality 506DN Service Manual Criticare Systems Inc Factory Defaults Main Menu Alarm Menu Criticare Systems Inc Section 2 Service Menus To recall factory defaults from memory hold the MENU key while you press the POWER key to turn on the monitor Settings affect the MAIN MENU ALARM CONFIGURATION COMMUNICATION PATIENT DATA and the NIBP CYCLE Menus NOTE The Main Menu and Alarm Configuration Communication and Patient Data submenus are all accessed through the MENU key on the front panel The NIBP Cycle Menu is entered through the NIBP CYCLE key on the front panel Setting Size Alarm Volume Pulse Volume Enable MAP Alarm Pulse Rate Pulse Rate 5 SpO NIBP Systolic NIBP Systolic NIBP Diastolic NIBP Diastolic NIBP Mean NIBP Mean Options Adult Pediatric Ped Neonate Neo 1to 10 OFF 1 to 10 OFF ON OFF Range 80 to 240 OFF Type High Low 2010150 OFF High 701098 OFF Low 1 to 98 OFF High 7510240 OFF Low 50 150 OFF High 5000 180 OFF L
82. e potential differences between connected equipment and touchable conducting parts found in medical rooms Connection Lead Equipotential T inal Socket ermina Equipotential Main Connector Body Earth Ground Defibrillation HF and monitor when used with its recommended accessories is Electronic Device protected against the effects of the discharge of a defibrillator and the Protection 5 of HF electrosurgical equipment The monitor presents no known adverse effects to pacemakers or other medical safety equipment Biocompatibility patient contact or user contact materials in this monitor and its accessories have passed ISO 10993 5 10 and 11 biocompatibility tests of have been in use in clinical environments in large numbers over an extended period of time predating these standards Latex Content All 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 and or tissue contact Criticare Systems Inc eQuality 506DN Service Manual Page 1 15 Section 2 Service Menus Introduction There is one primary service boot that uses the DOWN arrow at power up takes the monitor into Service Mode A seco
83. eQuality 506DN Vital Signs Monitor Service Manual C Cat No 1557 Part No 39184B101 Date 01 09 Revision 0 Copyright COPYRIGHT O CRITICARE SYSTEMS INC 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 Inc nor the
84. ect Open in Service Mode 7 CSI NIBP Service Support Program Open in Service Made Open in Host Glose Gonnection Exil Figure 6 4 Select Open in Service Mode 11 If communication has been established the following screen should appear When this message appears communication with the PC is established 506CN Integrated NIBP 70 Fact idle Page 6 8 00 OK 00 OK Figure 6 5 Communication Established eQuality 506DN Service Manual Criticare Systems Inc Section 6 Service Testing amp Calibration Calibrate 1 Select Calibrate from the service tool screen on the PC Connection View 350 300 Signals 250 On 200 150 100 Clear 50 12 10 58 0 0 00 0 01 0 02 0 03 0 04 0 05 0 06 0 07 0 08 0 09 0 10 Host mode Service mode Mode Systolic mmHg Service Bead Diastolic mmHg Calibrate Adult Pass Fail c Mean mrmH 3 Accuracy EZA Pass Fail Heart Rate bpm r Unit Elapsed Time sec Speed Inflate Deflate Reset lt F5 gt 00 00 Peak Pressure mmHg Adult Disable F5 Time Infant 7 Adult Infant Cuff 0 mmHg Elapsed Time 0 506 Module 70 Fact idle Figure 6 6 Select Calibrate 2 A box appears as shown Verify that the pressure at the cuff is OmmH
85. eed Test E Inflation Pass criterion Inflate at 5 mmHg sec Deflation Pass criterion Deflate at 17 mmHg sec Cancel Help 3 seconds 80 mmHg sec 1 seconds 130 mmHg sec Pass Fail Pass Fail Cuff 0 0 mmHg 6 NIBP Module 70 Fact idle CSI NIBP Service Support Program 506N3 NIBP Module Connection View Help Figure 6 18 Factory Speed Test Pass 4 If each Pass box has a checkmark click on the Done button 5 The main screen displays checkmarks indicating a Pass of the Speed tests 350 300 Signals 250 On 200 150 100 Clear 50 13 08 52 0 0 00 0 01 0 02 0 03 0 04 0 05 0 06 0 07 0 08 0 09 0 10 Host mode Service mode Mode Systolic mmHg Service j Diastolic mmHg Calibrate Adult Pass Fail ean mmH g Accuracy Infant H a eart Rate bpm PES si 7 Unit Elapsed Time sec Speed Inflate Dellate IV Li y Reset lt F5 gt 3 Peak Pressure mmHg Adi Disable FE m Time Leak me Infant _ Adult m m nii qawa Safety 0 0 mmHg Elapsed Time sec Infant v Li E Ie NIBP Module 26 Watchdog circuit Fired fra Fact idle 00 OK 00 Criticare Systems Inc Figure 6 19 Speed Test Pass eQuality 506DN Service Manual Page 6 15 Section 6 Service Testing
86. ennen 1 14 Leakage Current Voltage Fluctuations Equipotential Ground Defibrillation HF and Electronic Device Protection 1 15 Biocompatibility Latex Content DEHP Content Section 2 Service Menus Introductionis nei e tti ceu o oce tto dined a DE ev o ten 2 1 Service Mode irri eee vede e 2 1 Service Mode WihdOoW Tu eerie ete ted er een deduce 2 1 Service Menus Revisions Menu DG ise aa E EEA E I Default Setups Board Setups NIBP Calibration Menu Setting User Defaults essere nennen nnne Setting User Defaults sess 2 7 Power Up in Service 2 7 Criticare Systems Inc eQuality 506DN Service Manual Page iii Contents Page iv Factory Defaults nnne Main Menu Alarm Menus eet cerro ee e Ete adden Configuration Communication Menu Patient Data NIBP Cycle Menu Main Feb v eese 2 ne d Alarm Volume gt ATETEA AE EE LIL IL U Ua aaa als Enable
87. estarted before the language setting change activates NOTE This setting is only available after MENU power up eQuality 506DN Service Manual Page 2 15 Section 2 Service Menus Communication Menu Page 2 16 On NIBP On Alarm Interval Patient Data Print To Serial Baud Rate Press the MENU key to enter the Main Menu Use the arrow keys to highlight COMMUNICATION and press the MENU key to access it Use the arrow keys to move through the communication submenu and highlight the setting you desire to change Press the MENU key to access the settings for the desired item When the setting is changed as desired press the MENU key to save the setting The monitor prints data when an NIBP reading is taken Choices are On or Off The factory default setting is Off The monitor prints data during a medium or high level alarm limit violation Choices are On or Off The factory default value is Off This sets the time interval for automatic interval printing of vital signs data Choices are 10 20 or 30 seconds 1 2 5 10 15 30 or 60 minutes 2 4 8 12 or 24 hours and Off The factory default value is Off Selecting On causes the patient data to print when a demand print is requested Sets the output device of the monitor Choices are Serial and Off The factory default value is Serial Sets the data format for the external serial port for sending data to an external device The choices are Text CS
88. ety Testing Checklist u 5 19 Section 6 Service Testing amp Calibration Monitor Testing iier rne Prae a eerte Service Checks Field Service Testing esns oorr t pete Equipment and Tools u u u uu u 6 2 Communication Testing m Equipment Fieq lred 6 3 zio dert PED tates 6 3 Procedure 6 3 Nurse 6 4 SpO Performance Testing 6 5 Programming the SmartSat 2 a 6 5 Test Procedure tern terr tre tnnt eren cree Ee 6 5 Criticare Systems Inc eQuality 506DN Service Manual Page v Contents NIBP Calibration L rennen nre tene 6 6 Equipment Required 6 6 Installing the PC Service 6 6 Configuring the Ports uuu tp cta tt eee eite d te ea tee tette da 6 6 Setup E Calibrate n aa 6 9 Safety Test a aa deam REI e dete REST Seca EU ee 6 11 Speed T6614 oret EE 6 14 E 6 16 ioca thea rene Ur Hr P ETHER 6 20 Section 7 Disassembly Before You Begin 7 1 Service Safely aste LRL DERE 7 1 Electrostatic Dis
89. ey 2 The monitor begins its normal boot sequence but enters the Service Mode instead The LCD shows the message SERVICE DISPLAY 3 Press the DOWN arrow to scroll through the menu options to TEST MENU 4 Press the DOWN arrow to scroll through the test menu options to NIBP SEAL lt OFF 5 Press the MENU key The display should read NIBP SEAL gt OFF 6 Press the DOWN arrow once to turn the test to ON 7 Press the MENU key to start the test The monitor will then function as a plain pressure meter allowing the technician to manual test the pressure transducer with a manometer Pump up the manual squeeze bulb Verify that the manometer readings agree with the monitor readings The accuracy of the pressure transducer for static pressure measurements should be within 2 mmHg or 2 of reading whichever is greater The current pressure will be displayed in the LCD window Criticare Systems Inc eQuality 506DN Service Manual Page 5 17 Section 5 Preventative Maintenance Page 5 18 SpO Verification 1 Using a SpO finger sensor verify heart rate and plethysmograph operation displayed on the LED s within 15 seconds Verify no SpO error messages appear alarm violations may occur depending on individual readings and monitor set up Remove your finger from the sensor and verify SPO2 SENSOR message is displayed when the finger sensor is plugged in but with no finger inserted in the sensor Ver
90. g x2mmHg Unit Calibration Softwar Attach digital manometer and dummy cuff Cuff mmHg 0 5 506 Integrated NIBP 70 Fact idle Figure 6 7 Verify Cuff Pressure Criticare Systems Inc eQuality 506DN Service Manual Page 6 9 Section 6 Service Testing amp Calibration 3 Click Next and verify that the pressure at the cuff is mmHg 2 mmHg Unit Calibration gt x Software Cal Cancel It pressure is ott by more than 2 mmllg adjust ZERO POT if equipped Otherwise wail fur Mudule lu aulu zeru Cuff mmHg SO6CN Inley NIBP 70 FacL idle Figure 6 8 Verify Cuff Pressure 4 Connect a manometer to power Connect the open tube to the fitting on the back of the manometer Connect a 700cc block into on of the tubes Connect the fitting from the manometer onto the NIBP fitting on the unit Click Next again The pump should inflate to 250 mmHg and then settle Use the UP or DOWN buttons to adjust the gain to match the manometer pressure with the cuff pressure 5 When Manometer and cuff match select Finish Unit Calibration Software Cal Burn in file path Cancel C APROGRA 1NSCsAT oolsNNibpsvc ncalbum Browse Help Adjust up and down with arrows Click Finish to accept calibration Cuff mmHg 215 5 0 zl Gain adjust 506N3 NIBP Module 71 Fact controlled inflation
91. guration defaults are restored following a MENU power up Choices are USER HOSP hospital and ALT C alternate care STORE USER This allows the monitor s current configuration settings to be stored as the USER defaults The options for this setting are Yes and No Pressing the MENU key with Yes selected causes the CONFIRM setting to become available Select Yes for CONFIRM to store the current settings as the user defaults AUDIO OFF This selects the nature of the Alarm Volume setting of OFF in the ALARMS MENU Choosing Yes indicates true silencing of the audio alarm Choosing No causes the audio not to annunciate alarms but sounds a double beep every two minutes for verification that the audio circuit still functions LINE FREQUENCY The monitor has a 60 Hz setting for domestic U S use and a 50 Hz setting for international use The frequency must be set correctly to the local AC Mains power frequency for the monitor to function correctly Contact the local CSI distributor for more information about which setting to use Page 2 4 eQuality 506DN Service Manual Criticare Systems Inc Section 2 Service Menus Board Setups BOARD SETUPS menu provides settings for the monitoring Criticare Systems Inc modules installed on the monitor BOARD SETUPS SPO2 DOX NIBP 1020 DOWNLOAD NONE Figure 2 5 506DN Board Setups Menu SPO2 Selects which type of SpO module is installed in the monitor Choice
92. han what is described in this manual The following tests are designated for monitors that require service repairs Opening the monitor may void your warranty so it is important to contact Criticare customer service before you attempt any repair The pre assembly testing of printed circuit boards PCBs is not covered in this manual Disassembly of surface mounted components on PCBs in not recommended Tests provided here are only for the identification of damaged or degraded PCBs eQuality 506DN Service Manual Page 6 1 Section 6 Service Testing amp Calibration Equipment and Tools Page 6 2 Any time you open a monitor s case you should perform the electrical safety tests before you return the monitor to operation If you serviced the monitor you should also perform the associated functional tests Additional tests that are specific to modules and assemblies you should perform when you service adjust calibrate or otherwise disassemble any assemblies See the following table Field Service Testing Required Test Recommended Test D c c 9 Oo c 5 LL Battery NIBP Module Monitor roped Sofware Download je v v Annual e e viviv No Fault case opened ee SpO2 Performance Testing NIBP Module Calibration jel Power Supply Calibration lt lt lt lt lt lt lt Withstanding Voltage
93. he Completion of Service procedure at the end of this section Page 7 8 eQuality 506DN Service Manual Criticare Systems Inc Replace SpO Board 5 6 Section 7 Disassembly Follow the caution for static sensitive devices in Electrostatic Discharge Protection on page 7 2 Disconnect and remove the battery from the monitor See Disconnect and Remove Battery on page 7 3 Detach bezel assembly from housing assembly See Detach Bezel Assembly from Housing Assembly on page 7 3 Remove old SpO board by removing the four 4 screws holding it to the insulator board NOTE Two different types of screws are used to attach the SpO board to the insulator board The two 2 screws PHMS 4 40 X 25 LG NYLON P N 42744 001 on the left side of the board differ from the two 2 screws PHMS SEMS 3144 40 X 44 LG P N 409958011 on the right side of the board Obtain a new SpO board P N 913914002 Reassemble in reverse order NOTE When reassembling after the NIBP module and SpO board are mounted route the NIBP tube as shown below It must be around the sensor and valves 5 Figure 7 3 Tubing Perform the Completion of Service procedure at the end of this Criticare Systems Inc section eQuality 506DN Service Manual Page 7 9 Section 7 Disassembly Replace NIBP Module 1 Follow the caution for static sensitive devices in Electrostatic Discha
94. ice and an immersed monitor presents a danger to anyone who handles the device The action to be taken following accidental wetting of the equipment is as follows 1 2 Turn the power off Disconnect the AC power from the monitor If monitoring a patient transfer the patient to another monitor as quickly as possible Use a clean dry towel or cloth to remove the liquid from the monitor housing A service technician should inspect the monitor as soon as possible If the internal mechanism is saturated allow the liquid to drain out for 24 hours before shipping If liquid has entered the monitor it needs to be dried and cleaned internally Full testing is required before the monitor can be used Contact the Criticare 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 eQuality 506DN Service Manual Page 4 3 Section 5 Preventative Maintenance Incoming Inspection All new monitors should be inspected upon arrival for shipping damage before being placed into operation The monitor should be free from dents cracks or other physical damage The quality inspection seal of the monitor should be unbroken this indicates that the monitor has been tested according to the manufacturer s specifications If further incoming inspection or testing
95. ice tests can be found in Service Testing amp Calibration in Section 6 Some tests may require specialized equipment Check the patient cables monthly for damage loose wires connections loose connectors cracked housing etc Check the cuffs for leakage as part of the NIBP verification Annual testing should include electrical safety testing the withstanding voltage and electrical leakage tests Additional functional tests and verifications are provided that you may perform as designated by hospital protocols or as necessary A complete list of functional and safety tests are included here 1 Electrical Safety Tests a Withstanding Voltage Hi Pot b Electrical Leakage 2 Functional Tests a System Check b Speaker Performance and Alarm Verification c Power Supply Performance 3 Vital Sign Modules Verifications a NIBP b Oximeter SpO eQuality 506DN Service Manual Criticare Systems Inc Equipment and Tools Criticare Systems Inc Section 5 Preventative Maintenance The following procedures assume that the technician has an ESD safe workbench available a set of electronic hand tools and a digital multimeter with a 10 amp setting You need a withstanding voltage tester Hi Pot an oscilloscope and an electrical leakage tester for safety testing At the beginning of each test special equipment may be listed You may also need a variety of customized cables clips and test fixtures to complete all the
96. ify SPO2 HIGH AMBIENT message appears by introducing a higher than normal amount of ambient light on the SpO sensor detector Disconnect the SpO sensor from the unit after power Verify a SPO2 NO SENSOR displays on the LCD eQuality 506DN Service Manual Criticare Systems Inc Section 5 Preventative Maintenance Functional and Safety Use the checklist on the following pages to record the successful Testing Checklist completion of the annual safety tests and verification Functional and Safety Testing Checklist Page 1 of 2 Copy this checklist as needed to record results Model Unit serial number Software Rev Tested by Date Electrical Safety Tests Hi Pot Tests Hi Pot Hot Neutral to Ground 2500VDC Hi Pot Hot Neutral to Metal Case 9 2500VDC Hi Pot Hot Neutral to SpO Gnd 4242VDC Hi Pot SpO to DB 9 shell 2500VDC Hi Pot Neutral to Nurse Call 2500VDC Leakage Tests Perform Self Test on Leakage Tester Leakage GND CONDUCTOR Normal Polarity 50 100uA Leakage GND CONDUCTOR Normal Reverse 50 100uA Leakage Open GND and Normal Polarity 250 500uA Leakage Open GND and Reverse Polarity lt 250 lt 5000 Leakage Case Normal Polarity 50 100uA Leakage Case Reverse Polarity 50 100uA Leakage Case Normal Polarity Open Ground 250 500uA Leakage Case Reverse Polarity Open Ground 250 500uA SpO LEAKAGE Normal Polarity 5 10uA SpO LEAKAGE
97. inse thoroughly to remove any residual disinfectants Do not allow liquids to enter the neoprene bag You may sterilize the cloth cuff in an autoclave If the cuffs become grossly soiled with blood or other body fluids you should launder the cloth cuffs by hand or machine Remove the neoprene inflation bag before you launder or sterilize the dacron cloth cuff Feed the inflation tube back through the hole and then pull out the cloth flap Flap Figure 4 1 Remove the Inflation Bag Roll up the inflation bag and slide it out the open slot in the cloth cuff Be sure to observe the following laundering precautions do NOT launder disposable cuffs and neoprene inserts Remove the inflatable bag from the cuff before you launder or sterilize the cuff Strong bleach solutions will damage the cuff Temperatures over 275 F 135 C will damage the cuff Close the Velcro fastener before you launder 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 cleaning the cuff allow the cuff to air dry then insert the inflation bag in the cuff eQuality 506DN Service Manual Criticare Systems Inc Accidental Wetting Criticare Systems Inc A Section 4 Cleaning and Disinfecting A WARNING Shock Hazard The monitor is an AC powered dev
98. m the patient and environment due to the availability of the true unfiltered sensor signal for digital signal processing Method 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 source 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 Criticare Systems Inc eQuality 506DN Service Manual Page 1 5 Section 1 Introduction SpO Clinical Testing and Accuracy Page 1 6 The light from the LEDs shines into a pulsating vascular bed A photodetector located opposite of 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 average 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 se
99. mHg Cuff 0 mmHg Infant high time test only 50643 NIBP Module 10 Host disabled pz Figure 6 23 High Time Test Adult eQuality 506DN Service Manual Page 6 17 Section 6 Service Testing amp Calibration 5 Click on the nfant high time test only A checkmark appears in the box Click Start Leak and High Time Test rLeakage Test r High Time Test Elapsed time 59 sec Elapsed time 127 sec Cancel Pass criterion Pass criterion _ Help No more than 4 mmHg min Time out within 50 and 90 seconds 2 mmHg over 60 seconds Pass Adult Pass Fail mmHg min Fail Infant Pass Fail Approximate actual timing is done in the monitor Timer starts when cuff exceeds 5 mmHg 50643 NIBP Module 10 Host NIBP disabled Figure 6 24 Infant High Time Test Only 6 After approximately 60 seconds the box next to Pass should contain a checkmark in front of it Leak and High Time Test rLeakage Test r High Time Test Elapsed time 59 sec Elapsed time 63 sec Cancel Pass criterion Pass criterion Help No more than 4 mmHg min Time out within 50 and 90 seconds 2 mmHg over 60 seconds Pass Adult Pass Fail mmHg min Fail Infant Pass Fail Approximate actual timing is done in the monitor Timer starts when cuff exceeds 5 mmHg Cuff 0 mmHg Infant high time test only
100. measure how accurately a particular pulse oximeter monitor is reproducing that calibration curve eQuality 506DN Service Manual Page 1 13 Section 1 Introduction Software Error Related Hazard Mediation Potential Interference Leakage Current Page 1 14 Criticare Systems Inc has quality control practices and procedures in place to review potential hazards as they relate to software The monitor is Year 2000 Compliant and utilizes a 4 digit year for all date time and leap year calculations 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 506DN patient monitor is not intended for use in MRI environments RADIO FREQUENTLY INTERFERENCE The monitor conforms with IEC 61000 4 3 for radio frequency interference and will operate with negligible effects CONDUCTED TRANSIENTS The monitor conforms to IEC 61000 4 4 and IEC 61000 4 5 for conducted transients and will operate with negligible adverse effects X RAY The monitor will o
101. nal printer module There is a power supply section of the Main Board wherein regulated DC voltages are generated for various logic and analog functions as well as the battery charging function This module connects to the Main Board The upgraded NIBP algorithm firmware installed conforms to EN1060 This module is the Criticare Digital Oximetry circuit The DOX Module provides electrical isolation of 1500VAC minimum through power and serial interface connections The SpO sensor connector is mounted directly onto the Module eQuality 506DN Service Manual Criticare Systems Inc Block Diagram Criticare Systems Inc Section 3 Theory of Operation The following block diagram is provided for the general understanding of the 506DN monitoring system The diagram below shows the system module interconnections SpO2 Sensor J2 DOX SpO2 J1 NIBP Module 12V Input RS232 Battery Communication Figure 3 3 506DN Board Interconnect Block Diagram eQuality 506DN Service Manual Page 3 3 Section 4 Cleaning and Disinfecting Cleaning and Disinfecting A N Pulse Oximeter Sensors Criticare Systems Inc NWARNING N Shock Hazard Turn the power off and disconnect the AC power before cleaning the monitor and accessories e Shock Hazard Never immerse the monitor The monitor has an internal power source that is active when the unit is unplugged Do not use abrasive cleaners on the
102. nc Criticare Systems Inc Section 5 Preventative Maintenance 4 Connect the SpO leakage cable to the LA terminal on leakage tester Record the measurement on the check sheet or attach print out of the acceptable test result to the check sheet and test Configure the leakage tester to measure the patient connection to GND leakage Dynatech 232D MODE ECG LEADS ALL TO GND e Normal Polarity 5uA 10uA Normal Polarity Open Ground 25uA 50uA Remove the SpO cable NWARNING N Hazardous voltage are present on the test leads Do not touch these leads or the monitor while performing this test Connect the SpO leakage cable to the LA terminal on leakage tester Record the measurement on the check sheet or attach print out of the acceptable test result to the check sheet and test Configure the leakage tester to measure patient isolation Dynatech 232D MODE ECG LEADS ISOLATION TEST Normal Polarity 50uA Press the isolation button eQuality 506DN Service Manual Page 5 13 Section 5 Preventative Maintenance Functional Tests Page 5 14 System Check Confirm the proper start up of the monitor No cable should be attached to the external serial port during this test 1 Press the POWER key to start the monitor The alarm icon displays and the sensor is detected The monitor displays the following messages CRITICARE SYSTEMS INC 506DN SERIES REVISION x x C 200X
103. ndary service boot uses the NIBP START STAT STOP key at power up and takes the monitor into N BP Calibration Mode These service software tools allow downloading of software upgrades for the 506DN operating system and for calibration of the NIBP module in the field To exit the SERVICE MENU power cycle the monitor Service Mode Service Mode Window SERVICE DISPLAY REVISIONS TEST MENU DEFAULT SETUPS BOARD SETUPS Figure 2 1 506DN Service Mode Window NWARNING N Never service a monitor while it is attached to a patient Never enter the service menu while monitoring a patient Criticare Systems Inc eQuality 506DN Service Manual Page 2 1 Section 2 Service Menus Service Menus Revisions Menu Page 2 2 The Service Menu is displayed when the DOWN ARROW is held when during power up and no upgrade tool is attached the external serial port The Service Menu contains four submenus Revisions Test Menu Default Setups Board Setups These submenus are accessed by using the arrow keys and then pressing the MENU key when the desired menu is highlighted The revisions menu contains the revisions of the software and module components Exit the REVISIONS menu by pressing and holding the MENU key The monitor will return to the main service menu REVISIONS 506CN 506DN SERIES REVISION 1 0H APP 3TED AUG 21 2008 SN 999999999 SPO2 DOX 1 3A HW REV 00 Figure 2
104. nt 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 cuff s 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 mmHg Adult 50 280 30 225 35 245 Pediatric 50 280 30 225 35 245 Neonate 50 135 20 100 30 120 eQuality 506DN Service Manual Criticare Systems Inc Section 1 Introduction NIBP Clinical Testing This device was clinically tested per the requirements of EN 1060 and Accuracy and AAMI SP 10 The NIBP module as installed in the 506DN patient monitor has been tested to meet the performance specifications listed in this manual Cuff Inflation and maximum cuff inflation rate is 15 mmHg second The software Pressure Protection limits inflation to 300 mmHg adult 300 mmHg pediatric or 150 mmHg neonate A secondary circuit limits maximum possible cuff pressure to 330 mmHg in adult pediatric mode and 165 mmHg in neonatal
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106. om pdf QA Requirements pdf S W FOR THE DEFINITION OF THE QUALITY REQUIREMENTS CRITICAR TE SYSTEMS INC NIBP WITH DOX SQL SPO2 DRAWN CHECK ENG BY SC BY APPR Q A pa 04 10 08 DAE APPR MFG ScALE NTS DO NOT 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 DIST SHEET or CSI 0385 Rev 0 REMSIONS REV DATE DESCRIPTION BY
107. or xAmmHg whichever is greater from the calculated average Each reading shall not vary more than 8 mmHg from the simulator setting Leave the monitor connected to the NIBP analyzer Change the NIBP analyzer setting to the neonate configuration with a simulator setting of 80 50 62 mmHg Heart Rate 80 bpm A neonatal dummy cuff must be used during this test 1 Set the monitor to NEONATE Mode in the Main Menu 2 Press the NIBP START STAT STOP key and allow the monitor to take at least four 4 readings The systolic diastolic and mean readings should not vary by more than 4 or xAmmHg whichever is greater from the calculated average Each reading shall not vary more than 8 mmHg from the simulator setting 3 If the monitor continues to fail verification contact the Criticare Technical Support Department eQuality 506DN Service Manual Criticare Systems Inc Section 5 Preventative Maintenance NIBP Seal Test EQUIPMENT REQUIRED Digital manometer calibrated accuracy of 0 05 Manual squeeze bulb with valve Tee connector SETUP 1 Connect the manual squeeze bulb to the tee connector 2 Connect the digital manometer to the tee connector 3 Connect the tee connector to the NIBP connector on the monitor PROCEDURE The 506DN monitor has a simple test mode for checking the seal and pressure transducer The instructions are as follows 1 Press the POWER key while holding the DOWN arrow k
108. ow 15 to 50 OFF High 70 to 200 OFF Low 25 to 125 OFF Factory Default Values Hospital 150 Adult 150 Pediatric 180 Neonate 40 Adult 40 Pediatric 90 Neonate OFF Adult OFF Pediatric OFF Neonate 90 Adult 90 Pediatric 90 Neonate 200 Adult 200 Pediatric 140 Neonate 50 Adult 50 Pediatric 50 Neonate 100 Adult 100 Pediatric 80 Neonate 30 Adult 30 Pediatric 30 Neonate 150 Adult 150 Pediatric 100 Neonate 50 Adult 50 Pediatric 40 Neonate t The monitor returns a minimum low value of 85 on power up Mean values only appear if MAP is enabled in the main menu eQuality 506DN Service Manual Adult 4 OFF ON Alternate Care 150 Adult 150 Pediatric 180 Neonate 40 Adult 40 Pediatric 90 Neonate OFF Adult OFF Pediatric OFF Neonate 90 Adult 90 Pediatric 90 Neonate 200 Adult 200 Pediatric 140 Neonate 50 Adult 50 Pediatric 50 Neonate 100 Adult 100 Pediatric 80 Neonate 40 Adult 40 Pediatric 30 Neonate OFF Adult OFF Pediatric OFF Neonate OFF Adult OFF Pediatric OFF Neonate Page 2 9 Section 2 Service Menus Configuration Menu Hospital Default Alternate Care Setting Options Value Default Value Time 24 Hour AM PM 24 Hour AM PM Hour 0 23 N A N A Minute 0 59 N A N A Day 1 31 N A N A Month JAN DEC N A N A Year 00 99 N A N A Contr
109. perate with negligible adverse effects in an X ray environment However the 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 electrosurgery infrared energy pacemakers or defibrillation The monitor complies with leakage current limits required by medical safety standards for patient connected devices Standards include the International Electrotechnical Commission IEC 60601 1 2nd edition 1988 Part 1 A hazard caused by the summation of leakage currents is possible when several pieces of equipment are interconnected eQuality 506DN Service Manual Criticare Systems Inc Section 1 Introduction Voltage Fluctuations The monitor is suitable for connection to AC mains voltage as defined by EN 61000 3 3 and EN 61000 4 11 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 will cause damage to the charger circuits The monitor is designed with circuitry that will turn the unit off before spurious readings can be caused by a low battery connection Equipotential Ground Health care providers and patients are subject to dangerous uncontrollable compensating currents for electrical equipment These currents are due to th
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111. rcuit the battery terminals The resulting high current discharge can cause burns Charge the battery completely after extended battery use to ensure a fully charged battery is available for the next use Explosion hazard Keep lighted cigarettes sparks and flames away from the battery The battery contains sulfuric acid electrolyte which can cause severe burns and eye damage as well as illness from sulfur oxide fumes Do not crack cut burn or dissolve with solvents the battery case Damaging the battery case can cause the release of sulfuric acid If sulfuric acid is released from the battery wear eye protection and rubber gloves to handle the battery and use a solution of baking soda in water to neutralize the sulfuric acid The used battery is a potential environmental hazard and must be disposed of properly Dispose the old battery in accordance with local and federal laws Do not incinerate eQuality 506DN Service Manual Page 5 3 Section 5 Preventative Maintenance REMOVE THE BATTERY 1 Turn the monitor off and disconnect the monitor from the AC Mains power source 2 Remove the two 2 Phillips screws from the battery cover on the back of the monitor Remove the battery cover Remove screws Figure 5 1 Remove Screws 3 Remove the battery P N MISC10004 from the monitor Disconnect Battery Figure 5 2 Remove Battery 4 Label and remove the cables connected to the battery NOTE P
112. rge Protection on page 7 2 2 Detach bezel assembly from housing assembly See Detach Bezel Assembly from Housing Assembly on page 7 3 3 Detach the NIBP module from the main board by removing the two 2 screws PHMS SEMS 4 40 X 44 LG P N 40995B009 located in the lower middle of the main board 4 Disconnect the NIBP module s ribbon cable from P3 on the main board 5 Disconnect the NIBP module s open tube from the SENS1 connector on the main board 6 Disconnect the NIBP module from the NIBP fitting P N 42014B001 on the side panel P N 45225B001 7 Obtain a new NIBP module P N 95597A005 8 Reassemble in reverse order NOTE When reassembling after the NIBP module and SpO board are mounted route the NIBP tube as shown below It must be around the sensor and valves Figure 7 4 NIBP Tubing Perform the Completion of Service procedure at the end of this section Page 7 10 eQuality 506DN Service Manual Criticare Systems Inc Housing Disassembly Replace Power Supply Criticare Systems Inc 1 Section 7 Disassembly Follow the caution for static sensitive devices in Electrostatic Discharge Protection on page 7 2 Detach bezel assembly from housing assembly See Detach Bezel Assembly from Housing Assembly on page 7 3 Remove the three 3 screws PMHS SEMS 4 40 X 25 LG P N 40995B005 holding the insulator P N 42740B002 to the power supply bracket and chassis
113. rical Weight Size Battery Rating Battery Life Recharge Time Power Requirements Environmental Operating Temperature Storage Temperature Operating and Storage Humidity Medical Device Electrical Protection Degree of Protection Protection against ingress Section 1 Introduction 4 5 lbs 8 in H x 5 5 in W x 5 75 in D Rechargable Sealed lead acid battery 6V 7 2 Amp Hours 8 hours with NIBP every 5 minutes 6 hours 100 240 VAC 10 50 60 Hz 0 to 40 C 32 to 104 F 20 to 65 C 4 to 149 5 to 95 non condensing Class Equipment Class Equipment CF Defibrillator Proof IPX1 rating Drip Proof Equipment All specifications are subject to change without notice eQuality 506DN Service Manual Page 1 9 Section 1 Introduction Symbols Symbol Definition N Refer to Operator s Manual for Information Shock Hazard Equipotential Terminal 0413 European Community Mark of Approval Electrical Testing Laboratories ETL Mark IPX1 Identifies the degree of protection against fluid as drip proof CF Equipment defib proof Do not dispose of in municipal waste Wheeled bin symbol indicates separate collection for electrical and electronic equipment WEEE Directive 2002 96 EEC Alternating Current AC Fuse a Technical Support Phone Number Page 1 10 eQuality 506DN Service Manual Criticare Systems Inc
114. rier RN8 98 p82 3 IRD iT 87 PFS RD 3 3D gt a AN2 P42 PF6 AS noB RN9 AN1 P41 I 95 ANO P40 P67 CS7IIROS 28 TDXMIT 3 4 Ses E fa di P6G CSG IRQ2 24 1 ee 100 4 103 TOKKZ AvSS PGA IRQO 5 uz ft peo DRESS 62 P60 MODI 0 to pc IDREQO CS4 61 330 Converter VIN P61 TENDONCS5 I vour 8 i TREES 82 Pez us fisovouT VN 14 imi DREQT N EN Ps0 TxD2 IRQ4 Pes mENDT 63 S T pe 90 5 2 1 ao vec gig Tee hai aoe ee T 4 91 PSVRXD2 IROS to the other design Will 40 1 22 PSSIADTRG IRQT NATTIBREQO other design The main SI9435BDY RN12 330 E2PROM lt disadvantage with the module is 7 SE RN10 120 sc the cost at least 5 00 more DNI 10KX2 550 tig RSTSYS 3 E2PROM than the discretes it would 1 4 T eee 118 TEXTRAM vss SDA R27 replace a RX a ET RDISETUP 3 P RGATE 57 X24C04S8 DNI TP20 IRGATE 118 R29 2992992999 CASPGO INMI TPAD E 100K 2222222252 p74 M g EEPROM for Board ID Ti 10 1 75 F R31 Hitachi Emulator Connector QOP D1 1 e D9 for Development Only i a i R30 1 ONOFF 330 HD64F2328 29VTE 4444 50 PWR 10 NOMINAL UNREGULATED 7 100 100 Low Turns Module OFF cas i 31960R TP22 ij Serial Port Assignments ue 0 cis i 1 q ud SCIO DDC 101 interface utes T
115. rinting faces inward Page 5 4 eQuality 506DN Service Manual Criticare Systems Inc Section 5 Preventative Maintenance REPLACE THE BATTERY 1 Attach the battery cables to the new battery P N MISC10004 IMPORTANT Connect the red battery cable to the positive battery terminal and the black cable to the negative battery terminal Figure 5 3 Connecting the Battery 2 Slide battery into the battery bay 3 Reattach the battery cover with the two 2 screws removed earlier Torque to 5 in lbs Fuse Removal There are two AC power fuses located at the rear of the monitor Replacement directly below the AC power entry socket Use 250V time delay fuses FUSE T TIME LAG 5mA L 250V 5X20 P N 82013B002 1 With a flat blade screwdriver turn the fuse cover s out 2 Gently pull the fuse cover s with fuse s out of the fuse assembly 3 Gently pull the fuse s out of the fuse cover s 4 in reverse order Criticare Systems Inc eQuality 506DN Service Manual Page 5 5 Section 5 Preventative Maintenance Annual Testing Page 5 6 Accessory Testing Functional and Safety Testing You may perform the following tests as part of a periodic safety check The following safety tests are designed so that the monitor s quality warranty seal does not need to be broken If the monitor fails any portion of these tests contact Criticare Support for additional information Descriptions of serv
116. rom P3 5 On the bezel assembly disconnect the speaker cable from J4 on the main board 6 Remove speaker from the rail on the bezel 7 Remove the two 2 screws PHMS 4 40 X 312 SEMS P N 409958011 that secure the SpO board 8 Remove the two 2 plastic screws that secure the DOX PCB 9 Lift and remove the DOX board and insulator 10 Remove the four 4 screws PHMS 4 40 X 25 SEMS P N 40995B005 that secure the main board 11 Disconnect the LCD display s ribbon cable from J1 on the main board 12 Unlock the membrane tail from J2 on the main board 13 Lift and remove the main board 14 Detach LCD display and display shield from the bezel by removing the four 4 screws PHMS SEMS 4 40 X 25 LG P N 40995 005 15 Lift the display shield P N 83401B002 from the bezel 16 Remove and replace the LCD display 81521 001 17 Reassemble in reverse order See assembly drawings for torque instructions Perform the Completion of Service procedure at the end of this section Criticare Systems Inc eQuality 506DN Service Manual Page 7 5 Section 7 Disassembly Page 7 6 Replace Membrane 1 Follow the caution for static sensitive devices in Electrostatic Discharge Protection on page 7 2 Detach bezel assembly from housing assembly See Detach Bezel Assembly from Housing Assembly on page 7 3 Unlock the membrane tail from the connector at J2 on the main board Remove the ol
117. rvice Diastolic mmHg Calibrate Adult I Pass Mean mmHg Infant Accuracy E Heart Rate bpm Systolic mmHg IH Pass Fail Unit Elapsed Time sec Speed Inflate Deflate Reset F5 00 00 Peak Pressure mmHg Aaa v ult Disable lt F6 gt em Leak ET me Infant 4 Adut LI Jm Safet cut 0 Elapsed Time 0 sec Stv Infant M 506N3 NIBP Module 70 Fact idle 00 OK 100 OK Figure 6 27 Select Accuracy 2 A Pressure Accuracy Test window appears Click Start Manometer reading should match display reading 2 3 mmHg Cancel Pass Fail Help Inflate to 70 mmHg Inflate to 140 mmHg Inflate to 280 mmHg Cuff mmHg 506N3 NIBP Module 70 Fact idle Figure 6 28 Pressure Accuracy Test Window Page 6 20 eQuality 506DN Service Manual Criticare Systems Inc Section 6 Service Testing amp Calibration 3 Check the manometer and the cuff pressure Pressure will inflate to 70 mmHg Verify that the pressure is within 2 or 3 mmHg If OK click on the Pass box to place a checkmark in the box Click Next Pressure Accuracy Test Manometer reading should match display reading 2 or 3 mmHg Pass Fail v Inflate to 70 mmHg m v Inflate to 140 mmHg Li Inflate to 280 mmHg Cuff 1040 mmHg Next 06 3 NIBP Modul
118. s and present a hazard to the patient Risk of electrical shock Do not remove cover Refer servicing to qualified personnel U S Federal law restricts this device to sale by or on the order of a physician eQuality 506DN Service Manual Criticare Systems Inc Criticare Systems Inc Section 1 Introduction NCAUTION A 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 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 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 Setting alarm limits to extreme values may render the alarm System useless A functional tester cannot be used ti assess the accuracy of a pulse oximeter probe or pulse oximeter monitor If there is independent demonstration that a particular calibration curve is accurate for the combination of a pulse oximeter monitor and a pulse oximeter probe then a functional tester can measure the contribution of a monitor to the total error of a monitor probe system The functional tester can then
119. s are DOX and SEQL SEQUEL NIBP Selects which type of NIBP module is installed in the monitor Choices are 1020 ComfortCuff and None DOWNLOAD Use this menu item to download software Choices are None DOX 1020 ComfortCuff and Main Selecting a processor will cause the monitor to search for a software download tool Software downloads are sent to the monitor by opening the software file on an external computer and sending the application to the monitor via the COM1port eQuality 506DN Service Manual Page 2 5 Section 2 Service Menus NIBP Calibration Mode To enter the NIBP Calibration mode 1 Press the POWER key and the NIBP START STAT STOP key at the same time 2 The 506DN monitor attempts to connect to extended NIBP calibration tools through the external serial port identifying itself as a 506DN monitor 3 The message CHECKING FOR NIBP TOOLS should appear in the LCD message bar A service calibration application called NIBP SERVICE pn 97082A003 may be run on a connected PC See NIBP Calibration in Section 6 for testing details Page 2 6 eQuality 506DN Service Manual Criticare Systems Inc Section 2 Service Menus Setting User Defaults This is a default setting profile that can be set for a facility s special needs The user defaults are initially set to the same settings as the HOSP hospital defaults User defaults setup should be performed by qualified personnel Setting User Defaul
120. s in the bottom right corner of the display Set all desired alarm limits for adult monitoring conditions Change the patient size to pediatric and set all desired alarm limits for pediatric monitoring conditions Change the patient size to neonate and set all desired alarm limits for neonate monitoring conditions Select the high alarm limit for pulse rate Choices are 80 through 240 bpm and off Resolution is 2 bpm The factory default value is 40 for Adult and Pediatric modes and 180 for Neonate mode Select the low alarm limit for pulse rate Choices are 20 through 150 bpm and off Resolution is 2 bpm The factory default value is 40 for Adult and Pediatric modes and 90 for Neonate mode Select the high alarm limit for SpOs Choices 70 through 98 and off The resolution is 196 blood oxygen saturation The factory default is off for all patient size modes Select the low alarm limit for SpO s Choices 1 through 98 and off The factory default value is 90 for all patient size modes If Low SpOz is set to 98 the High SpO alarm may not be changed from the off setting The Low SpO setting returns to a minimum value of 85 after a power cycle eQuality 506DN Service Manual Page 2 13 Section 2 Service Menus Page 2 14 High Systolic Low Systolic High Diastolic Low Diastolic High MAP Low MAP Select the high alarm limit for systolic blood pressure Choices are 75 through 240 mmHg and off
121. s necessary to provide a loaner system CSI will ship a loaner by overnight courier The loaner system must be returned to CSI at the customer s expense within one week after 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 Incoming Inspection The following incoming inspection is required whether it is a first time arrival or a return from service Prior to clinical use the instrument should be inspected for the following 1 The quality inspection seal on the instrument should be unbroken This seal indicates that the instrument has been tested according to manufacturers specifications 2 No physical damage is observed 3 The instrument s battery is to be charged by connecting the instrument to a power outlet for a minimum of 6 hours prior to clinical use 4 When connecting the instrument to a power outlet and then turning the instrument on all displays appear to function correctly and no system errors occur If a discrepancy to these inspection items is observed do not use the instrument and immediately report the discrepancy to the CSI Service Department Page viii eQuality 506DN Service Manual Criticare Systems Inc EC Declaration of Conformity eQuality 506DN To view the Declaration of Conformity vi
122. sit the Criticare website at Patient Monitor www csiusa com 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 Representative in the Criticare Systems Limited European Union 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 Criticare Systems Inc eQuality 506DN Service Manual Page ix Section 1 Introduction Description Intended Use Criticare Systems Inc The 506DN patient monitor is a compact vital signs monitor that measures heart rate blood oxygen saturation 5 and non invasive blood pressure NIBP Heart rate is measured primarily by the plethysmographic waveform but when the oximeter is not is use heart rate is determined from the blood pressure data using an oscillometric method that measures during inflation The 506DN monitor is intended to monitor physiological parameters of patients within clinical care settings and can be used in transport It is intended that the user is a professional health care provider Physiological data systems 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
123. stems 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 940 Series Multi Site Sensor carries a six month warranty 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 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 506DN Patient Monitor if assembly operations extensions readjustments modifications or repairs are carried out by persons other than those authorized
124. t release pressure before peak pressure Cancel exceeds 160 mmHg Help HU iv Pass Adult Pressure released at 314 0 mmHg Fail Infant zd Pressure released at 132 0 mmHg Fail Test infant mode Cuff 131 0 mmHg Peak Pressure 155 0 mmHg 06 3 NIBP Module 71 Fact controlled inflation Figure 6 14 Test Infant Mode Pass 6 Click Done if a checkmark appears in the Pass box The main screen displays checkmarks indicating a Pass of the Safety tests 9 CSI NIBP Service Support Program 506N3 NIBP Module E ni x Connection View Help Signals On Clear 12 58 48 0 00 0 01 0 02 0 03 0 04 0 05 0 06 0 07 0 08 0 09 0 10 Host mode Service mode Service Bead Diastolic mmHg Calibrate Adult Pass Fail Mean mmHg Infant is LI Systolic mmHg Heart Rate bpm PEEL D Pass Fail Unit nil Elapsed Time sec Speed Inflate Deflate gl Reset F5 1 Peak Pressure mmHg mm Adk Disable FE m Time Leak m ne Infant Adut Safet 0 mmHg Elapsed Time 0 sec Sae Infant M 506 3 NIBP Module 26 Watchdog circuit Fired Fact idle 00 OK 00 Figure 6 15 Safety Test Pass Criticare Systems Inc eQuality 506DN Service Manual Page 6 13 Section 6 Service Testing amp Calibration
125. temperature module 1 and turn off the NIBP monitoring module The NIBP numerics should not display on the LCD main screen Restart the monitor to reset the NIBP module to ON Verify the green AC LED lights up the AC power symbol on the front membrane when the monitor is plugged into the AC inlet Verify the monitor powers up on AC only Verify the monitor powers up on DC only with a battery eQuality 506DN Service Manual Page 5 15 Section 5 Preventative Maintenance Monitoring Module Verification NIBP Verification Page 5 16 The NIBP verification requires Dynatech Nevada NIBP Analyzer Connect the 506DN monitor to a Dynatech Nevada NIBP Analyzer set for the following operation NIBP Analyzer Settings Adult 120 80 90 Heart Rate 120 bpm Pressure Adjustments Gain 10096 Shift 4 Use a tee connection with an adult dummy cuff Connect to the 0 300 mmHg port of the NIBP analyzer A neonatal dummy cuff is also required for complete testing It is recommended that the actual cuffs to be used with the monitor are setup as dummy cuffs for this verification Wrap the cuff snug with bubblewrap around a sturdy cylinder 1 Connect the monitor to an AC power source and turn on the monitor Set the monitor to the ADULT Mode Adult Patient 2 Press the NIBP START STAT STOP key and allow the monitor to take at least four 4 readings The systolic diastolic and mean readings should not vary by more than 4
126. tests The following tools are needed for these procedures Set of hand tools Digital multimeter 10A Oscilloscope Power supply Setra 350 1 or equivalent manometer with Dynatech 232D or equivalent leakage tester Dynatech cufflink NIBP simulator with neonatal and adult cuffs 7512DT Associated Research withstanding voltage tester or equivalent Smart Sat SS 100A pulse oximetry analyzer or equivalent Computer with CSI NIBP Service program P N 97082A003 and WFSDLOAD program P N 97134A002 e SpO2 Hi Pot Test Fixture see Test Fixtures in this section e SpO2 Leakage Test Fixture see Test Fixtures in this section Nurse Call Box see Test Fixtures in this section Screw in order to Hi Pot to case Serial cable with null modem P N 87016B002 AC Mains Power cord 700 cc factory test block Cat 51150 finger sensor or equivalent with optical load foam packing peanut eQuality 506DN Service Manual Page 5 7 Section 5 Preventative Maintenance Test Fixtures SPO2 HI POT TEST FIXTURE No Connect 5 9 Connect Connect 8 Pinna lt lt 7 6 Connect Point B SPO2 LEAKAGE TEST FIXTURE 9 8 PointA OJ j Connect 6 1 Point B NURSE CALL BOX Alligator clips to connect to battery 3 5 mm stereo plug D1 D2 D3 D4 J2 12 Batt Pos b gt b J11 pins 1 and 2 E 1 2 LED LED LED LED CON 12V Batt Neg J114
127. the lights on the Nurse Call fixture go on Press the Alarm Silence button and verify that the two minute alarm silence is indicated on the LCD display and that the lights on the Nurse Call fixture go off and remain so for two minutes while in the alarm state Press and hold the Alarm Silence button The Nurse Call fixture should go off and remain off regardless of changing alarm states NOTE Wile 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 eQuality 506DN Service Manual Criticare Systems Inc Performance Testing Programming the SmartSat Analyzer Test Procedure Criticare Systems Inc Section 6 Service Testing amp 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 DOX SpO module The SmartSat model SS 100A is available from Clinical Dynamics Corp of Wallingford CT The SmartSat comes standard with a Lemo style connection The Cat No 913A adapter that converts to DB 9 style SpOs connections is needed for the 506N3 Series monitor The analyzer also has a custom port designed for testing DOX SpO sensors The SmartSat can be used for spot checking SpO gt
128. the rear of the enclosure Attach the ground test lead of the Hi Pot tester to the screw and the red test lead to Hot Neutral Test at 2500VDC 3 Connect the DOX SpO Hi Pot cable to the ground test lead of the Hi Pot tester and connect to the gt connector on the monitor Attach the red test lead to Hot Neutral and test at 4242VDC 4 Connect the DOX SpO Hi Pot cable to the red lead of the Hi Pot tester and connect the ground test lead to the Hi Pot tester to the DB9 shell of the 506DN Test at 2500VDC 5 Connect red lead of the Hi Pot tester to Hot Neutral and the black lead to the Nurse Call cable Test at 2500VDC Leakage Testing This test requires a Dynatech 232D Safety Analyzer or equivalent leakage testing device Setup Procedure Perform a self test if applicable to ensure proper operation of the Self Test leakage tester If the self test fails don t proceed with this test For Dynatech 232D only 1 Perform a self test on the Dynatech 232D Set the MODE switch to SELF test The display should read 1000 20 and the CURRENT SOURCE ACTIVE lamp should be on NCAUTION A e f these conditions are not met do not continue with the leakage test 2 Set the MODE switch on the Dynatech to L1 L2 The display should read 220 to 240 VAC or 110 to 130 VAC if supply voltage is 120 VAC Set the MODE switch to L1 GND The display should read no more than 5 of the previous line voltage measurement Set
129. to Serial Adapter to 1 For laptops using a USB adapter select COM 4 or an alternate COM port as necessary Page 6 6 eQuality 506DN Service Manual Criticare Systems Inc Section 6 Service Testing amp Calibration Setup 1 Turn off the power and disconnect the AC Mains power 2 Place the monitor on a ESD protected workbench Observe all ESD protection procedures as described in Electrostatic Discharge Protection in Section 7 3 Connect the download cable to the DB 9 serial connection of the monitor s front bezel Connect the other end to the DB 9 serial port of the computer 4 Open the service tool on the computer Select Start Programs gt CSI NIBP Service gt NIBPSvc click the shortcut on the m PC desktop Close the disclaimer dialogue box 5 Select COM for the port For laptops using a USB adapter select COM 4 or an alternate COM port as necessary 6 Select 506CN in the drop down menu box e CSI NIBP Service Support Program Figure 6 3 Select the COM Port and Model 7 Plug the monitor back to the AC Mains source 8 Power up the unit while holding the NIBP START STAT STOP key 9 On the display of the unit verify that the message CHECKING FOR NIBP TOOLS appears Criticare Systems Inc eQuality 506DN Service Manual Page 6 7 Section 6 Service Testing amp Calibration 10 Select the Connection from the drop down menu Sel
130. ts facility can save setting in USER default setting Once the settings are made the settings can be saved under a USER setting profile on the monitor To set user defaults 1 Power up the monitor 2 Press the MENU key to access the MAIN MENU 3 Use the MENU and ARROW keys to access the different submenus and adjust the settings for each patient size NOTE It is not possible for to store USER defaults for LOW 5 2 below 85 NIBP ON OFF SPO2 ON OFF and LANGUAGE Each of the ignored user defaults is controlled independently of the USER default settings LOW SPO2 returns to a default value of 8526 if the current setting is below 85 4 Verify all settings are correct and power off the monitor Power Up in Service Mode The monitor needs to be powered up in the Service Mode to finish setting the user defaults To power up the monitor in Service Mode 1 While holding the DOWN arrow key press the ON OFF power key 2 Continue holding the DOWN arrow key until SERVICE DISPLAY menu appears on the LCD display Criticare Systems Inc eQuality 506DN Service Manual Page 2 7 Section 2 Service Menus 3 Use the arrow keys to highlight DEFAULT SETUPS and press the MENU key to enter the Default Setups Menu SERVICE DISPLAY REVISIONS TEST MENU DEFAULT SETUPS BOARD SETUPS Figure 2 6 Select Default Setups 4 Use the arrow keys to highlight STORE USER and press the MENU key to move the cursor to the Stor
131. ty 506DN Service Manual Criticare Systems Inc Section 9 Drawings and Schematics List of Drawings Assembly Parts Lists Title Drawing Number FINAL AY 506DN DOX 93987A001 NIBP MODULE 6 PIN CONN 955974005 506DN MONITOR CAT 506DN X PCB Drawing List AY DIG SPO2 913914002 AY DIG SPO2 SCHEMATIC 913915002 506CN MAIN BOARD 91410A001 506DN MAIN BOARD SCHEMATIC 914105001 Criticare Systems Inc eQuality 506DN Service Manual Page 9 1 Section 9 Drawings and Schematics 506DN Final Assembly 939874001 Item CSI Part 01 91410A001 02 42742B001 03 42743B001 04 42744B001 06 42740B002 07 42740B001 08 913914002 09 955974005 10 452258001 11 420148001 12 409958011 13 402848005 14 452118001 15 452148001 16 815218001 17 421278004 18 834018002 21 409958005 22 95257A003 23 909294001 24 452108001 25 872778001 26 402848001 27 834768001 28 820138001 29 420648003 30 909684005 31 411588001 32 411648001 33 909274003 34 PWRS10000 35 45213B001 36 83378B001 38 42435B002 39 MISC10004 40 45212B001 41 42745B001 43 40284B002 44 40067B001 45 40294B001 46 40132B001 47 41157B001 48 41891B004 49 40995B009 Page 9 2 eQuality 506DN Service Manual FINAL AY 506DN DOX Description PCB AY 506CN MAIN BOARD STANDOFF 4 40 X 375 LG NYLON HEX NUT 4 40 NYLON P H M S 44 40 X 25 LG NYLON INSULATOR CHASSIS INSULATOR DOX MAIN BRD PCB AY DIG SPO2 506DN NIBP MODULE 6 PIN CONN SIDE P
132. use s by the AC input Reposition ribbon cable into Main Board Replace keypad membrane Replace Main Board and software Monitor shuts off Automatic shutoff after 30min Drained battery Bad software Bad Main Board Press the ON OFF key Connect to AC power Update software Replace Main Board and reprogram Functions not Default settings wrong Return to factory default settings Bad LCD Board connection Bad LCD Board available Incorrect software Update software Degraded software Replace software LCD display blank Contrast is misadjusted Adjust CONTRAST in the CONFIGURATION menu Check pins and reconnect Replace LCD Board Leaks in NIBP system Defective cuff Defective hose Damaged loose NIBP fitting Stripped insulator Leaky pneumatics amp pump Replace cuff Replace hose Replace tighten Quick Connect fitting Replace nylon insulator and O ring Replace NIBP mechanical assembly Fails performance test NIBP not functioning Leaks in NIBP system Poor calibration Defective pump or valves Bad transducer NIBP module turned off Bad NIBP switch Pump not running Failed pump motor Bad Main Board Bad NIBP Board See above Recalibrate NIBP Replace NIBP mechanical assembly Replace NIBP mechanical assembly Turn on NIBP in the CONFIGURATION menu or ensure 1020 is selected for the NIBP setting in BOARD SETUPS in the service menu Check pump wires to NIBP Board Check pins on NIB
133. values using the manual settings The manufacturer recommends using a timed and programmed sequence to ensure that there is optimal performance Auto Seq Model 506DN Oximeter DOX Level SPO2 Limits Heart rate Limits 1 Verify the SpO module as described in 5 Verification in Section 5 2 Attach the monitor to the SmartSat 3 Start the SmartSat programmed sequence SmartSat Auto Sequence Verify that the monitor s reported SpO values within the limits specified Level Saturation Limits Heart Rate Limits 1 98 97 99 40 39 41 2 96 94 98 60 59 61 3 90 88 92 80 79 81 4 78 76 80 100 99 101 5 61 58 64 120 119 121 6 52 49 55 180 179 181 7 40 37 43 300 297 303 4 Even if the monitor fails only one level 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 eQuality 506DN Service Manual Page 6 5 Section 6 Service Testing amp Calibration NIBP Calibration The manufacturer recommends that NIBP calibration be performed only at authorized service facilities The NIBP calibration procedures require specialized equipment Cat No 454 G Calibration Kit necessary for proper calibration testing Equipment Required Windows compatible computer with DB 9 serial port USB ports a USB Serial converter with software is needed to complete this procedure Inst

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