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SIGMA 8000 Infusion Pump Service Manual

1. MAIN PROCESSOR MODEL 8000 PROCESSOR SILKSCREEN REV Q T gt Section 2 page 16 Item SIGMA MODEL 8000 8 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 6 2 PROCESSOR SENSOR PCB ASM BOM Quant P N Description Manufacturer 1 1 55003 BT1 BATTERY 3 6
2. 95044 d ys 35112 gt INLE 7 1 DULE e a XFORMER ER KEYBOARD H 5 878 1 LINE FILTER A 35113 i Mu p 5 FUSE HOLDER 22 iP H LBLU 2 3 24884 10463 TJI 1J5 POWER SPEAKER DISPLAY AUX BUS TEST PDRT 17087 ei Don peenp ANALOG SENSOR INTERFACE IO ROCESSUR Dr ley PCB CB 3 ass LEVER L 00 CLOSED D 7 RINGE WT 1 101 0 A aa LIEU 60010 1 60010 2 GUARD SENSOR INPUTS N Pals KEYBOARD 228665 050 SHAFT LEVER ROLLER INTERFACE SENSUR LOCK MOTOR CLAMP AlR USU PORT 143 ue 1 8 201 202 233 d 1P2 ep 3 35033 35045 D A m 8 s H SHAFT SENSOR 9 N 512 MP MOTOR M SENG FLOW SENSOR OR PCA SWITCH STAFF CALL zmr ov U C LEVER DPEN SENSOR PUMP VDTUR ASSMEBLY CHASSIS apalay i ROLLER 35038 CLAMP SENSORS DSO SENSOR 4 3 LEVER CLOSED SENSOR Section 2 page 4 SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 3 0 TRANSFORMER PCB SCHEMATIC DWG 60
3. XE Z A ee c a J S J ON 1G 4 2G 5 ey ON Er PE OFF 3 d CHARGE 1 gt I CHARGE 1 lt 3 CHARGE 7 4 ZA JA Z gt TT gt ITA S 7 5 RATE 4 WEITE RATE 7 JKL MNO O i 5 1 ML H Jf 30303 ML H nu D fF ei e er VOL Wry 1 n Q 2 voL PQR STU f vwx ur 600 LIMIT 8 9 J Z M f a Z ar da J AK n f YZ RUN Higiene 7 7 RUN j SILENCE STOP NY U Lomp JD ff A Wa ES ENTER CLEAR ENTER CLEAR YES NO 1 OPTIONS ps NO 5 IN 7 d IN IN J WU f TTA 916 OPEN TOTAL 222 d p DUE 1 CRAPHICS FILE NAME 8000 OPS MANUAL dwg FILE OPS MANUAL dwg Section 2 page 38 SIGMA MODEL 8000 8 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 15 1 PUMP BODY MOTOR ASSEMBLY DWG 35018 Rev l Section 2 page 39 SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 15 2PUMP BODY MOTOR ASSEMBLY BOM
4. J 00 0 O BONDING WIRE REAR PANEL m x FC gt AD M la 1 1 35044 BONDING WIRE IEC MODULE 9 REAL CA 2 Ro A ER C 4 1 IN FILTER O REAR CASE MOLDED ITEM Ore S N Section 2 page 30 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 12 1 FRONT CASE ASSEMBLY DWG 35002s1 Rev U N NN Y N N AN SV Section 2 page 31 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 12 1 FRONT CASE ASSEMBLY DWG 35002s2 Rev U Section 2 page 32 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 12 1 FRONT CASE ASSEMBLY DWG 35002s2 Rev U 95011 4 00 x 7 16 LG BH 3501 PO JO C 1 95018 INSTREAM SENSOR ASM 4 40 x 1 4 LG BH I o 0 2
5. E la b E a ENCODER SUPERVISD la z T H g KEYBOARD Section 2 page 14 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 6 0 SENSOR PCB SCHEMATIC DWG 60012s2 Rev R CONTACT SIGMA FOR FULL SCALE SCHEMATIC ANALOG FILTERS DROP SENSOR PCA DETEC
6. CD CAP Ayuf 1 20 TANT CA AP 1uf 5C 20 CER GS CAP 47 uf IC 20 TANT C2 CAP 1uf 5 20 GER e GAP ado 20 CER PCB PCB BLANK SST N DESCRIPTION BILL OF MATERIALS Section 2 page 13 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 6 0 PROCESSOR PCB SCHEMATIC DWG 60012s1 Rev R CONTACT SIGMA FOR FULL SCALE SCHEMATIC DOWER CONTROL AND MONITOR SHAFT SENSUR TEST PORT
7. Section 2 page 34 SIGMA MODEL 8000 amp 8000 As INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 13 1 FINAL ASSEMBLY DWG 35001s2 Rev T NN PN N ND R IN R 1 Section 2 page 35 SIGMA MODEL 8000 amp 8000 As INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 13 2 FINAL ASSEMBLY BOM 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 5 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 BUSHING SEF REF REF REF REF REF REF REF REF REF REF IN LINE FI 2 vA 2 2 yl ra 2 a 2 2 S 1 1 2 gt 1 3EF REF REF REF REF REF REF REF REF REF REF REF 11 11 11111 1 1 1 1 1 1 2 FA 2 REF REF REF REF CLAMP ASSEMBLY FRENCH 1 1 BLY A R A R AZ RIA R 1 LYLE 1 18 1 1 1 1 1 1 1 2 2 E 2 2 m 2 gt 2 gt 1 1 1 1 1 1 1 1 1 1 1 1 4 4 4 4 4 4 4 4 4 4 4 4 7
8. 20 85033 SCREW 6 32 x 1 4 PHIL TRUSS 19 1 50017 TOR MOUN 18 1 89204 HEX NUT 8 32 SMALL PATTERN 1 AK 90029 PRIMER LOCTITE 16 AR 85081 ADHESIVE 14 19 4 95019 STUD MOUNT STABILIZER ARM 13 AR 83608 ADHESIVE LOCTITE 222 le 86487 WIRE HOLD DOWN 1 1 95123 8 INTERNA IHSTAR LOCKWASHER J W ER 84 FLAT 4 ESNA NUT 5 BELT ASSEMBLY PUMP SUB ASSEMBLY QTY DESCRIPTION Section 2 page 40 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 16 1 ROLLER CLAMP PCB SCHEMATIC DWG 60018 Rev E RI vl 5 Kj gt dr N IR EMITTERS Re BE NC S NAM 5 SWITCH Toe 401 8 E IR DETECTORS Section 2 page 41 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 17 UPSTREAM PCB SCHEMATIC DWG 60019 Rev B SCHEMATIC XMITI 1 e e e xMIT2 3 1 10M E e RECI I 6 FC S RE 10M ZECE lt Cos 7 S m 8 9 1 u 10 THe Section 2 page 42 SERVICE MANUAL SIGMA INTERNATIONAL MODEL 8000 amp 8000 Aw INFUSION PUMPS
9. CELLS REF WRE HARNESS 212 REF POWER SUPPLY GABLE CBL REF 02 LED INDICATOR CABLE ALL CABLE amp IRE ASSEMBLIES TO BE INSTALLED AT SIGMA HEADER 2 PIN TRANSFORMER FUSE 4A SB PICO DIODE 1N4002 PCB 1 ITEM Gp TRANSFORMER PCB BLANK DESCRIPTION MATERIALS Replace T1 only with the transformer above Substitution violates the Certification of this product and may compromise product safety Section 2 page 7 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 4 0 REGULATOR PCB SCHEMATIC DWG 60003 Rev SIOGEH ASSY 931990 ce N 18 22 228032 22 1 3 wir m EIER ELSEN oji a 4JAVHO 02 8688SNI Sg 833 3001 DEAS 11 A08 DT 04 ater as Ant 5 2 we 6H 2 a
10. 8 N 8 1 ui in Ti SI RER y k 33 5 2 8 9 A 00 09 out 0 Fg EN ma IV iva OG e ND F S nai D lt mA O MMM st D ON Section 2 page 11 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 5 1 DISPLAY PCB LAYOUT DWG 60004 Rev D SIGMA INT 5 C3 3 EM zm N SJl ASSY 60004 RIE Section 2 page 12 SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 5 2 DISPLAY PCB ASM BOM 3 2 REF SOLD JSPLAY PCB BL REF 35021 LED INDICATOR E 542 FADE PIN 341 EADER 20 PIN 7AHC138 5 C 74HC574 4 C uf C245 5 C 74HC1 39 V at 4 2 DISPLAY GREEN 1 DISPLAY GREEN
11. E T gt um Qo SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M POL CLAM ENTIA REAR VIEW CSA CERTIFICATION LABEL LABE ENTIA 7 MN Z EN JIN ZAR JIN SE FAN ZATION Pp JIN fe FX Section 2 page 2 SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 1 0 BLOCK DIAGRAM ac INE VEN MODULE UWER REGULATOR BATTERY TRANSFORMER PCR ACK BATTERY 4 b LINE FILTER 0 ARGE VOLTAGE JIP 12v DISPLAY BJDISPLAY A F BUS PCB O SE U 5 MAINS FUSE HOLDER gt 12 15V DC PWR UUTPUT INI TO PROTECTIV GE SE INDICATOR SENSOR PCR D 2 SULLER INTER E a is CLAMP u FACE 4 JURIVE sensors 8 11 am MICRUPRUCESSUR
12. INFUSION PUMP SERVICE MANUAL REV M THEORY OF OPERATION 3 2 6 1 Microprocessor Central to the operation of the Model 8000 Infusion Pump is the Motorola MC68HC16Z1 Control Adapted Microprocessor see Figure 2 6 0 The internal makeup of the 68HC16 includes a 16 bit processing unit capable of clock rate as high as 16 MHz surrounded with an array of counters timers analog to digital converter general purpose input output multi priority interrupts and data bus interface The 68HC16 is housed in a 132 pin Plastic Surface Mount Package Designated UNN1 on the Assembly Drawing Figure 2 6 1 The 68HC16 is seen to occupy the center of sheet 1 on the Schematic surrounded with peripheral circuits providing the functions necessary for operation of the Model 8000 Infusion Pump Starting at pin 1 of the 68HC16 Processor and following the pin numbering counter clockwise operation of the processor may be discussed Detailed descriptions of the other parts on the Processor Board will follow Pin 3 is the output of a timer set to the frequency of the alarm tone The tone is a square wave and drives the alarm volume control IC U7 Pins 6 7 and 127 are I O pins used to increment and decrement the volume control U7 Pins 4 5 13 and 14 are outputs Pin 4 controls the Staff Call circuit pin 5 the DC On off function and pins 13 and 14 device selection for the Syringe and Roller Clamp Sensors Pins 10 11 12 15 and 16 are used to form the
13. SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M THEORY OF OPERATION A second switched mode regulator provides the logic power voltage from the intermediate supply voltage 3 2 4 DISPLAY PCB AUXILIARY BUS See Schematic Figure 2 5 0 Assembly Figure 2 5 1 and Bill of Material Table 2 5 2 3 2 4 1 DISPLAY PCB The Display is made up of two side by side four character alohanumeric Light Emitting Diode Data Display Circuits for a total of eight characters Each LED matrix is 6 9 mm high 0 27 inches and comprises a 5 horizontal by 7 vertical dot matrix LED color is green The display has the capability of 128 ASCII characters Details of the Display Board Assembly are found in Figure 2 5 1 and Table 2 5 2 All data reports alarm messages and user operating prompts instructions appear on the Display 3 2 4 2 DISPLAY AUX BUS INTERFACE The data is transmitted from the Processor Board to the Display Board via a 20 conductor 8 bit parallel data bus The bus contains four address bits and two device select lines allowing up to 32 read write data locations to be defined The Display Board utilizes nine locations one for each of the eight characters and the ninth for a bidirectional control register The data bus connects to 3J1 The Power Indicator LED is also housed on the Display Board connected to 3J2 The LED illuminates the power indicator on the Keyboard whenever the AC line cord is plugge
14. Fully open the levers Observe the back walls of the tubing channels shown as hatched Area A and Area B on the Fig 1 i e areas between roller clamp holders and lever assemblies using directional light Any evidence of cracks on these areas is reason to return the pump to the factory for service 6 4 KEYBOARD TEST The Model 8000 keyboard and displays may be checked for proper operation as follows 6 4 1 6 4 1 1 6 4 1 2 6 4 1 3 6 4 1 4 6 4 1 5 6 4 1 6 6 4 1 7 Aren A lt A d Im 185 sm P N OB ene EJ poa SAEI SOE lt 2 Fig 1 Press the ON OFF key to turn the unit on and observe that the displays indicate 8888 8888 Press the RATE ML H key followed by the 1 2 and 3 keys and observe the display to be RATE 123 Press the RATE ML H key followed by the 4 5 and 6 keys and observe the display to be RATE 456 Press the VOL LIMIT key followed by the 7 8 and 9 keys and observe the display to be VOL 789 Press the VOL LIMIT key followed by the 9 0 and keys and observe the display to be VOL 90 0 Press the
15. JOY U BB 0 WASHER 4 INT TOOTH STAR SS CABLE LEVER OPEN ASM 6 GASKET PUMP BODY MOTOR ASM 5 BOLT HOUSE ASSEMBLY 4 SOLENOID ASSEMBLY 33 2 1 SILICUNE RUBBER DAMPER 3e 67 9 1 4 FLAT 125 190 x 315 x 22 THK 31 2 153 NUT ESNA 4 40 NYLON INSERT SS 30 018 PUMP BODY MOTOR ASW 29 2 23 SCREW 4 40 x 1 3 8 FHMS 28 AR 90025 ACCELERATUR LOCTITE 712 27 45055 HALL EFFECT MOUNT 26 86484 WIRE HOLD DUM 25 40019 GASKET CASE 4 40 x 1 4 BHMS ADHESIVE LUCTITE 414 ALCOHOL LEVER CAP WAC WAS ER NYLON MAS NADSMEN SYRINGE HLD LEVER ID 6 LABEL P N LABEL P RUBBER FEET H HER 265 x 500 LABEL SYRINGE HOLDER 4 40 x 1 3 8 FHMS SYRINGE HOLDER 4 40 x 5 16 LNG WHT GASKET R C H ROLLER CLAMP HDLDER ASM LABEL LEVE DISPLAY PCB ASN A MEMBRANE SWITCH RIVET FASTENER 6 32 SNAP RING LEVER ASSEMBLY O Co AC FRONT CASE ITEM QTY DESCRIPTION Section 2 page 33 F MATERIALS SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 13 1 FINAL ASSEMBLY DWG 35001 Rev T
16. ND C lt T LJ V UGN3120 Section 2 page 22 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 9 1 POLE CLAMP ASSEMBLY DWG 35007 Rev K INSTALLED AT SIGMA PLAC VIEW B LABEL PLACEMENT REG LABEL Section 2 page 23 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 9 2 BACK PANEL POLE CLAMP ASSEMBLY BOM 38 AR 85245 LOCTITE 425 ASSURE 37 1 95036 SET SCREW 8 32 x 3 8 36 35 1 40012 LABEL EQUIPOTENTIALITY 34 1 86340 LABEL GROUND 33 2 85134 NUT 6MM 32 2 85206 WASHER STAR 6MM 31 1 86690 EXTERNAL GROUND STUD 30 2 85037 SCREW 8 32 x 1 2 29 1 50025 CORD RETAINER 28 AR 90023 HIGH VACUUM GREASE 27 AR T106 SANDPAPER 220 GRIT DETAIL A 26 1 SEE DETAIL A LABEL RS 232 ASSEMBLY RS 232 25 1 40016 LABEL CSA NUMBER LABEL P N 24 1 40038 LABEL INTERNAL FUSE SPEC 35007 40009 23 1 40037 LABEL BATTERY SPEC 35007F 40009F 22 AR 90019 LOCTITE 406 21 1 50072 ANTI TIP ADAPTER 20 19 18 AR 90012 ALCOHOL 17 1 40023 POLE CLAMP PAD 16 1 40032 SPACER BATTERY CO
17. 3 1 3 1 1 Upstream Air Occlusion Detection Upstream air and pressure are measured by two ultrasonic transmit receive transducer pairs The two pairs are spaced 0 5 inch apart along the length of the tube channel allowing the presence of a bubble of this length to be determined Air vs fluid in the tubing is determined by changes in sound transfer characteristics across the tube diameter indicated by changes in received signal phase and amplitude A pressure change within the tubing will be reflected by change in the amplitude of the received signal Multiple calibration values must be entered to allow for operation of the sensors There is a frequency setting provided for each of the two transducer pairs one for pair 1 upper and one for pair 2 lower Also an air trip threshold and fluid calibration value is provided for each pair There are calibration values representing relative sensor drive levels baseline signal levels and other parameters required for overall sensor operation The frequency selection is written into the Frequency Register Latch U31 or U59 from the Aux Bus The sensor control and drive level are written to U33 in similar fashion The frequency value is applied to the divide by n input of the respective phase locked loop PLL U34 or U57 and causes the voltage controlled oscillator VCO to shift until the PLL locks The VCO runs at twice the transmit frequency The phase reference stage U36 divides the VC
18. 13 1 1 1 1 1 1 1 ez 12 1 1 1 1 1 1 1 1 11 1 1 1 1 1 1 10 1 1 1 1 1 1 1 1 1 1 1 1 z tea 2 2 2 2 Z 2 lt 2 1 1 1 1 1 1 1 1 1 1 1 1 BB ENG 1 RENCH 6 1 1 1 1 1 1 I r alen 5 1 1 1 1 1 1 1 1 GEES 4 7 1 1 1 1 1 S 3 1 ABBOTT DIST PUMPS ONLY 2 1 1 1 1 1 1 1 FRONT FRENCH 1 FRONT ONT 1 SS ITEM E FRENCH BILL OF MATERIALS Section 2 page 36 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M KEYBOARD T 5 4 vA 5 RIN Y3 ON al x1 X4 X3 x1 x2 X3 X4 ON OFF u Kr lt CHARGE RATE br ML H 4 VOL Y3 LIMIT gt I RUN va SILENCE STOP J J SPARE OPTIONS ENTER CLEAR Y5 1 YES NO VE TOTAL 0 OPEN SPARE SPARE 2 vo SHIELD 0 Figure 2 14 0 ND TO BACKER PLATE FILE NAME 8000 OPS Section 2 page 37 SIGMA MODEL 8000 8 8000 A INFUSION PUMP SERVICE MANUAL REV M KEYBOARD
19. 6 13 4 6 13 5 6 13 6 The following alternate method may be used with an IV set in place the pump is started with RATE of 100 ml hr and VOL LIMIT of 500 ml selected to give a delivery time of 5 hours The time is noted or timer started and the line cord unplugged from the wall with the pump in operation 6 13 5 1 The pump will alarm when the battery capacity is nearly depleted LOW BATT and will turn off when the battery reaches exhaustion following PLUG IN 6 13 5 2 The battery voltage at shutdown is approximately 10 4 volts Elapsed time to pump shutdown should be at least 2 hours with a fully charged battery that includes 231 minutes between Low Batt and Plug In messages L gt P Time 6 13 6 1 Less battery capacity indicates a battery reaching end of life 6 13 6 2 See section 1 9 of the Model 8000 Service Manual for the Battery Replacement Procedure 6 14 BATTERY CAPACITY TEST MODEL 8002 ONLY 6 14 1 The storage capacity for the battery in the Model 8002 may be determined by running the Battery Capacity Test Section 1 page 13 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M 1 5 PREVENTATIVE MAINTENANCE ITP 35001PM Procedure revision level G 6 14 2 6 14 3 6 14 4 6 14 5 6 14 6 6 15 Setting The Model 8002 must be connected to the AC line for at least 24 hours prior to the test to allow the battery to attain full charge
20. When a FIX 04 message occurs enter Biomed Option 160 and confirm that the temperature compensation is properly configured for the pump The thermistor used for temperature compensation is located in the upstream sensor area of the tube channel and can be identified as a green block in the center rib on the left side of the sensor Ensure that COMP ON is set in Biomed Option 160 if the thermistor is present Ensure that COMP OFF is set in Biomed Option 160 if the thermistor is not present If your facility is using the Carevue monitoring system ensure that the feature is enabled in Biomed Option 270 Also if your facility is not using the Drug Error Prevention feature you must disable it in Biomed Option 600 When a FIX 05 message occurs the pump must be returned to the factory for service due to the possible corruption of calibration data When a FIX 24 message occurs it is essential that the pumping channel is carefully inspected to ensure that a fragment of tubing is not present Turn the pump on and load a closed roller clamp to unlock the lever open the lever fully and inspect the pumping channel Section 1 page 48 SIGMA MODEL 8000 8 8000 INFUSION PUMP SERVICE MANUAL REV M 1 9 SERVICE 1 9 1 RETURN AUTHORIZATION Contact SIGMA International LLC for all service information at Telephone 1 800 356 3454 or 585 798 3901 Or write SIGMA International Inc 711 Park Avenue
21. 6 14 2 1 The pump may be in use during this time With an IV set in place start both channels with a RATE of 100 ml hr and VOL LIMIT of 500 ml selected to give a delivery time of 5 hours The time is noted or timer started and the line cord unplugged from the wall with the pump in operation 6 14 4 1 The pump will alarm when the battery capacity is nearly depleted LOW BATT and will turn off when the battery reaches exhaustion following PLUG IN 6 14 4 2 The battery voltage at shutdown is approximately 10 4 volts Elapsed time to pump shutdown should be at least 1 5 hours with a fully charged battery that includes 231 minutes between Low Batt and Plug In messages L P Time 6 14 5 1 Less battery capacity indicates a battery reaching end of life See section 1 9 of the Model 8000 8002 Service Manual for the Battery Replacement Procedure PM Due Date 6 15 1 Biomed Option 210 available in 4meg V3 29 00 and later may be used to set up a PM Due 6 15 2 6 15 3 6 15 4 display and alarm 6 15 1 1 If the alarm is enabled on the display PM DUE and a short alarm will be given on power up of the pump once the set due date has been reached The alarm will be given on every power up until reset or disabled turned off To set up this feature enter Biomed Option 210 as indicated in the Service Manual Section 1 7 Follow the prompts and use the keypad to enter the year month and day for the
22. 6 17 6 18 V3 28 and earlier or V3 29 and later 2 MEG 6 16 1 New Battery verify 5 hours to the PLUG IN message 6 16 2 Used Battery verify gt 2 hours to the PLUG IN message 6 16 3 New or Used Battery verify gt 31 minutes from the start of BATT LOW to start of PLUG IN message V3 29 and later 4 MEG only 6 17 1 New Battery verify gt 5 hours for BATT TEST TOTL TIME 6 17 2 Used Battery verify gt 2 hours for BATT TEST TOTL TIME 6 17 3 New or Used Battery verify gt 31 minutes for L P TIME Model 8002 only 6 18 1 New Battery verify gt 3 0 hours for BATT TEST TOTL TIME 6 18 2 Used Battery verify gt 1 5 hours for BATT TEST TOTL TIME 6 18 3 New or Used Battery verify gt 31 minutes for LP TIME Section 1 page 46 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M 1 8 TROUBLESHOOTING GUIDE 1 8 TROUBLE SHOOTING GUIDE A comprehensive Trouble Shooting Guide is planned for the Model 8000 Following is a description of internally generated codes used to define failures 1 8 1 SIGMA MODEL 8000 FIX ME CODE DESCRIPTIONS A series of error codes are generated by the software of the SIGMA 8000 Infusion Pump then displayed on the pump The following error codes or FIX ME codes are intended to help the biomedical engineer to identify problems encountered during operation of the pump for assistance
23. DISPLAY PUMP SERIAL NUMBER CHANGE PUMP SERIAL NUMBER 4meg feature SET PM DUE DATE 4meg feature General access protection Press CLEAR to enable disable this feature Press ENTER to accept the setting Press OPTIONS to exit setup with no change Display Software Version Number and PROM size indicator Display pump Serial Number Provides one time access to the serial number Once the value has been entered this option is view only Protected option that allows the pump serial number to be entered corrected or reentered in the event of memory corruption Modification of this value requires entry of the restricted access password General access password provides read only rights Set date when Preventative Maintenance Due message will be displayed by typing in the year month and day values The user is then prompted to enable or disable the notification alarm Section 1 page 25 TEMP COMP PASS WORD COMP ON COMP OFF SOFT WARE V XXXX SUB xxxx 2MEG CON FIRM SN X XXxx PUSH ENTR once set SN X XXxx SET SN PASS WORD SN x XXXX SN y yyyy CON FIRM SN y yyyy PUSH ENTR once set SN y yyyy PM DUE YEAR Xxxx MON xx DAY xx ALRM ON or ALRM OFF SIGMA MODEL 8000 8 8000 A INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Opt Option Name Description of Option Pump Display 220 USER OPTIONS DISABLE ENABLE
24. M ITP 35001BAT Procedure revision level E 1 0 PURPOSE This procedure is an outline to verify that the batteries will provide the required capacity when used in the SIGMA International Model 8000 or Model 8002 Infusion pump 2 0 SCOPE This procedure is to ensure that the battery back up system in all SIGMA International Model 8000 and model 8002 I V pumps will meet the specifications for new and used batteries to maintain proper operation of the pump when ac power is disconnected 3 0 REFERENCES ICL 35001 Production ICL 8000 4 0 DEFINITIONS 4 1 New Battery From the stock room to 29 days after the sale and shipment of the unit 4 2 Used Battery 30 days or greater after the sale and shipment of the unit 5 0 PROCEDURE NOTES e Prior to this evaluation the 2 5 Ah batteries must be charged for a minimum of 18 hours e Prior to this evaluation the 3 2 Ah model 8000 or 4 5Ah model 8002 batteries must be charged for a minimum of 24 hours e If the 2 5 Ah batteries had been previously in plug in they must be charged for a minimum of 24 hours e Pump must remain plugged into the AC receptacle after completion of the battery test for a minimum of 18 hours 6 14 V3 28 and earlier or V3 29 and later 2 MEG 6 14 1 Verify that AC power is at the pump by the AC indicator being illuminated 6 14 2 Turn the pump on 6 14 3 Set the pump s rate to 100 ml hr and volume for a minimum of 900 ml 6 14 4 Unplug the pump
25. Polyester film providing resistance to all common hospital cleaners and disinfecting solutions Details of the Keyboard Assembly and functional key assignments may be found in Figure 2 14 0 Schematic Figure 2 14 1 8000 Keyboard Assembly Drawing and Figure 2 14 2 8000 Plus Keyboard Assembly 3 2 7 1 KEYBOARD INTERFACE A keyboard of up to 40 keys in a 4 by 10 key matrix may be accommodated by the keyboard encoder comprised of U10 and U12 The 74C923 U10 is the Keyboard Encoder proper and converts a single key closure in the x y switch matrix into a binary code which is presented to data buffer U11 Key bounce and multiple closures are eliminated by U10 Five additional y inputs are added to the switch matrix by U12 doubling the capacity of the Encoder from 20 keys to 40 keys When a key is pressed the Encoder U10 begins a time out to allow the key to stop bouncing At the end of the time out the key code appears at the outputs and the data available line U10 13 rises The rising data available line sets flip flop U18A entering an interrupt on the IRQ3 level When the Processor responds to the interrupt the acknowledge Section 3 page 13 SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M THEORY OF OPERATION line IACKS falls and clears the interrupt The processor then reads the keycode data by asserting DSEL2 strobing the data onto the system data bus via U11 3 2 8 TEST PORT SHAFT S
26. SECTION 3 SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M TABLE OF CONTENTS SECTION 3 THEORY OF OPERATION 3 1 MECHANICAL COMPONENTS WwW 1 1 1 N 3 1 4 CASE BACK PANEL POLE CLAMP ASSEMBLY TUBE CHANNEL 3 1 3 1 AIR UPSTREAM OCCLUSION SENSOR 3 1 3 1 1 UPSTREAM AIR OCCLUSION DETECTION 3 1 3 2 ROLLER CLAMP HOLDER 3 1 3 2 1 UNCONTROLLED FLOW PROTECTION 3 1 3 2 2 ROLLER CLAMP SENSING 3 1 3 8 PUMP ASSEMBLY 3 1 3 8 1 PERISTALTIC PUMP FINGERS AND PRESSURE PLATE 3 1 3 4 DOWNSTREAM OCCLUSION SENSOR 3 1 3 4 1 DOWNSTREAM OCCLUSION SENSING 3 1 3 5 PRESSURE PLATE RELEASE LEVER STEPPER MOTOR AND DRIVE BELT 3 1 4 1 MOTOR 3 1 4 2 MOTOR DRIVER 3 1 4 8 STEPPER MOTOR CONTROL 3 2 ELECTRONIC COMPONENTS 3 2 1 3 2 2 3 2 5 3 2 6 FUNCTIONAL BLOCKS 3 2 1 1 BLOCK DIAGRAM AND CABLE DIAGRAM TRANSFORMER PCB AC LINE CIRCUIT 3 2 2 1 LINE CORD 3 2 2 1 1 LINE CORD AND INPUT VOLTAGE SELECTOR 3 2 2 2 AC INLET MODULE FUSES 3 2 2 3 POWER TRANSFORMER 3 2 2 4 SECONDARY VOLTAGE AND POWER INDICATOR REGULATOR PCB BATTERY CIRCUIT 3 2 3 4 RECTIFIER FILTER REGULATOR 3 2 3 2 LOGIC VOLTAGE SUPPLY AND SWITCH 3 2 3 8 BATTERY CHARGER 3 2 3 4 BATTERY PACK 3 2 3 5 REGULATOR PCB DISPLAY PCB AUXILIARY BUS 3 2 4 1 DISPLAY PCB 3 2 4 2 DISPLAY AUXILIARY BUS INTERFACE 3 2 4 8 LED DISPLAYS SENSOR PCB PROCESSOR PCB 3 2 6 1 MICROPROCESSOR 3 2 6 2 POWER SWITCHING CONTROL 3 2 6 3 STATIC RAM AND PRO
27. cogged pulleys The Motor allows the camshaft to be rotated throughout the rate range by increments of 260 motor steps per pump revolution or multiples thereof Because the motor step rate is derived by the Processor from its crystal controlled clock the motor rotation rate is constant to near the error of the crystal Error is less than 0 196 for all sources of error 3 1 4 1 MOTOR The Motor is a two phase 1 8 degree stepper motor It is coupled to the pumping mechanism through a glass reinforced timing belt and cogged pulleys The pulley drive ratio is 1 3 1 thereby making the motor make 260 steps 1 3 revolutions per one revolution of the pump 3 1 4 2 MOTOR DRIVER The Driver Circuit for the Motor is located on the Processor Board Constant current phase drive for the motor coils is provided by a switched mode full bridge motor drive circuit 3 1 4 3 STEPPER MOTOR CONTROL The Stepper Motor Control consists of two functions contained in two IC packages U9 is a dual seven bit plus sign Digital to Analog converter which translates data from the system bus to two analog voltages The analog voltages determine the motor phase current produced by the pulse width modulated current limiters in the dual motor driver U8 Sign bits from the A D determine the polarity of the motor current Motor rotation and torque are determined solely by the sequence and amplitude of the voltages written by the Processor to the D A converter of the cont
28. will exit the user from this menu enable any changes made to the options and return the pump to the user operating mode NOTE An access password is required to enter into certain Biomed options Some of the options require service school certification for access Contact SIGMA International Service Department for details Section 1 page 23 SIGMA MODEL 8000 8 8000 A INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of Option Pump Display AIR SENSOR DISABLE Select Air Sensor Enabled Disabled with Flow AIR ENA Detector installed AIR ON Option will display Air Sensor status Push Clear or key to toggle status between On and Off Push AIR OFF Enter key to accept displayed status Push Options key to exit with no change from original status UPSTREAM Select Upstream Occlusion Sensor TOCC ENA OCCLUSION SENSOR Enabled Disabled with Flow Detector installed TOCC ON DISABLE Option will display US Occl Sensor status Push Or Clear key to toggle status between On and Off TOCC OFF Push Enter key to accept displayed status Push Options key to exit with no change from original status UPSTREAM Protected option to enable disable the RUN key TOCC OCCLUSION RUN lockout after consecutive upstream occlusions LOCK LOCKOUT ENABLE have occurred CLEAR to toggle ENTER to LOCK ON select OPTIONS to exit with no change made or Currently supported in Hospira calibration only LOCK OFF D
29. 7 6 8 and 6 11 of ITP 35001 PM may be omitted and section 6 6 may be abbreviated to just confirm the occurrence of the alarm rather than measure the alarm threshold if a full P M is not desired 4 3 4 Select OPTION 99 and ENTER Verify the display indicates ALL CLR 4 3 5 Reset all required hospital specific BioMed settings using the respective options 4 3 6 Upon the completion and passing of all the above steps complete forms and return a copy of each to SIGMA International Mail or Fax to SIGMA International ATTN Device Tracking Coordinator P O Box 0756 Medina NY 14103 Fax 585 798 3909 4 4 Additional Required Checks for Facility Upgrade Approvals En QA Fill in any additional checks required for this upgrade N A if none Required PASS FAIL 4 4 1 Replace case labels as required with the latest revision of respective labels Label 40005 Rev Label 40006 Rev Label 40007 Rev Label 40011 1 Rev _ 4 4 2 4 4 3 Mark here if continued on back of Sheet NOTE If the unit does not pass all the steps contact the SIGMA Service Department for repair instructions Signature Date Section 1 page 52 SIGMA MODEL 8000 amp 8000 Z INFUSION PUMP SERVICE MANUAL REV M TABLE OF CONTENTS SERVICE MANUAL SIGMA INTERNATIONAL MODEL 8000 amp 8000 Aw INFUSION PUMPS SECTION 2 SIGMA MODEL 8000 8 8000 As INFUSION PUMP SERVICE MANUAL REV M TABLE OF CONT
30. AS 0001 REN Section 2 page 9 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 4 1 REGULATOR PCB ASM BOM CBL2 EE 1 ERES CBL2 1 ME canes GELA EN CBL1 EM tex CBL1 CBL1 et NI 3 2 BRIDGE RECT SA REF ZA 1 TURN A T lt lt Z 2 0 000 TT BILL OF MATERIALS Section 2 page 10 SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 5 0 DISPLAY PCB SCHEMATIC DWG 60006s1 Rev C WIEN 111 CU CH 1 09 UV Ta 19 SAT 413 D lt 230i 133i b 10 lt
31. Allows user to disable or enable the User Options The user is prompted initially to enable and or disable all User Options and then given the choice to exit the mode The user is then prompted to enable and or disable all Dose Modes and once again given the choice to leave the mode If the user stays in the mode at this point he or she is prompted to enter the number of the option desired to be either disabled or enabled The choice to exit the option is presented again and if denied the prompt to enable or disable another option number is redisplayed The CLEAR key toggles the response selections YES NO or ON OFF the ENTER key accepts the selection and OPTIONS exits the mode with no changes saved If any changes are made and the pump was not in Primary Mode previous to entering this BioMed Option PRI MODE is displayed for 2 seconds and the pump will revert to Primary upon exit of the mode Section 1 page 26 OPT DISA ENA ALL ALL ON DONE NOW DISA ALL ALL OFF DONE NOW PRI MODE if settings were changed SET BIO OPT DOSE ON DOSE ON DONE NOW DOSE OFF DOSE OFF DONE NOW PRI MODE if settings were changed SET BIO OPT SET OPT CODE OPT nn OPT ON Or OPT OFF DONE NOW PRI MODE if settings were changed SET BIO OPT or SET OPT CODE SIGMA MODEL 8000 8 8000 A INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of O
32. DOWN 4meg feature Displays current dose value and infusate concentration in two values Press ENTER to accept value Press the numeric keys to change value SRS 0160 990 Displays current dose value infusate concentration in two values and patient mass Press ENTER to accept value Press the numeric keys to change value SRS 0160 991 Displays current dose value infusate concentration in two values and patient mass Press ENTER to accept value Press the numeric keys to change value SRS 0160 992 Displays current dose value and infusate concentration in two values Press ENTER to accept value Press the numeric keys to change value SRS 0160 993 Displays current dose value and infusate concentration in two values Press ENTER to accept value Press the numeric keys to change value SRS 0160 994 Calculates a 21 step program to deliver the selected volume VOL over the selected time hrs in which the first and last ten steps are done at increasingly higher and lower rates respectively Beginning at 50 of the main rate the ramp up increases at 596 per step until the main rate is reached at step 11 The ramp down is the same process in reverse The ramp steps are each 1 and the main infusion is 80 of the total time SRS 0160 999 Allowed only when an automatic program mode Option 60 or 62 is already set the step number is changed to the first step of the down ramp or taper which is step 12 in
33. FILTER CHIP SM LC4 LC5 22 1 60011 PCB PCB BLANK 23 3 25204 Q12 Q13 Q14 TRANS MOSfet p ch enh 60V 2 4A SM 24 1 25207 Q19 TRANSISTOR SM 25 8 25203 Q2 Q8 Q15 Q17 TRANS MOSfet n ch enh 60V 18A SM Q20 Q22 Q23 Q24 26 1 25202 021 SM TRANS 2N3904 Section 2 page 17 Item SIGMA MODEL 8000 8 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 6 2 PROCESSOR SENSOR PCB ASM BOM Quant P N Description Manufacturer 27 4 16003 R1 R9 R209 R210 RESISTOR 100 1 4W 5 CF SM 28 2 15028 R102 R184 RESISTOR 33 20 1 4W 196 MF SM 29 2 15029 R103 R185 RESISTOR 56 2KQ 1 4W 1 MF SM 30 4 16019 R105 R106 R107 RESISTOR 1002 1 4W 5 CF SM R108 31 2 16007 R11 R29 RESISTOR 150KQ 1 4W 5 CF SM 32 2 16010 R12 R195 RESISTOR 2 7KQ 1 4W 5 CF SM 33 4 15005 R124 R127 R216 RESISTOR 30 9KQ 1 4W 1 MF SM R217 34 5 15006 R125 R134 R135 RESISTOR 4759 1 4W 1 MF SM R136 R137 35 1 15009 R126 RESISTOR 49 9KQ 1 4W 1 MF SM 36 2 15032 R129 R130 RESISTOR 3 83KQ 1 4W 1 MF SM 37 4 16014 R13 R14 R15 R16 RESISTOR 0 479 1 4W 5 CF SM 38 7 15012 R132 R133 R143 RESISTOR 1 0MQ 1 4W 1 MF SM R148 R189 R193 R197 39 4 15008 R187 R188 R191 RESISTOR 4 99KQ 1 4W 1 MF SM R192 40 4 16006 R19 R100 R142 RESISTOR 15KQ 1 4W 5 CF SM R182 41 2 16013 R2 R49 RESISTOR 478 1 4W 5 CF SM 42 2 16025
34. HEADER 9 PIN Fem 2mm TH 119 3 30020 1J3 1J11 2J8 HEADER 3 P TH 120 3 30006 1 6 2 5 2 6 HEADER 4 P V 2mm pc pin hdr TH 121 4 30007 1J4 1J7 2J4 2J7 HEADER 20 P RA 2mm pc pin hd TH Section 2 page 20 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 7 1 MOTOR ASSEMBLY CABLE DWG 35032 Rev D AND FIGURE 2 7 2 MOTOR ASSEMBLY BOM amp WIRE COLORS FOR SCHEMATIC 30082 1 Connector 4 PIN 1 55013 1 Stepper Motor ITEM P N TY DESCRIPTION MANUF ACT B BCT MYCLIM RED BRN WHT YEL BRN BLU 25 e I C2 N pm 7 N L Puer EN 3 m lt 1 Co u OJ Ea d Section 2 page 21 SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 8 1 SHAFT SENSOR ASSEMBLY DWG 35033 Rev C AND FIGURE 2 8 2 SHAFT SENSOR ASSEMBLY BOM 6 AR SOLDER 4 SHRINK 81 16 x 3 4 5 WIRE 26 awg 1 2 1 Conn 3 PIN 1 J 1 Sensor Hall effect ITEM P N 017 DESCRIPTION 2 gt
35. INTER EN STREAM y FACE 5 P C DEN KEYBOARD T z Jr u C1 mn All Gil T Ji li Ji d A 12 4 AU SHAFT SENSOR INTERFACE DUCTED INTER THERMISTER z PUMP MOTOR LOCK SENSOR up mroo illis on LEVER CALL PCA DPEN SENSOR Section 2 page 3 SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 2 1 CABLE DIAGRAM UTENTI E0 COMMON LUG E SPEAKER P PCB BATTERY PACK GRN YEL BATTERY OWE 22 AWG N 69 yes POWER INDICATOR 2 IC OUTPUT 35021 818 AVG A PUMP MOTOR ASSY CHASSIS GND
36. MANUAL REV M 1 3 CLEANING AND MAINTENANCE 1 3 MODEL 8000 CLEANING AND MAINTENANCE 1 CAUTION Always press STOP then OFF and unplug the mains cord before cleaning CAUTION DO NOT sterilize by autoclaving ETO gas or spraying DO NOT immerse any part of the pump DO NOT use abrasive cleaners CAUTION Do not use phenolic based cleaners or disinfectants extended use may cause damage to the keyboard case and any other plastic component of the Model 8000 Clean exterior surfaces with pump in upright position Apply cleaners with a dampened cloth per manufacture s instruction and dilution ratios A lint free foam tipped swab Chemtronics Foamtip TM for example may be used in the Tube Channel Visually inspect the tubing channel and remove any foreign material Blocked tube channel could cause accidental free flow Cleaning FLOW SENSORS drop sensors Clean FLOW SENSOR and PUMP FLOW SENSOR CONNECTOR with a small amount of isopropyl alcohol and a cotton swab USE OF ELECTRICAL CONTACT CLEANERS WILL CAUSE DAMAGE TO THESE PARTS Subsequent disinfecting is recommended using the same application technique Disinfectants should remain on the pump surface in an even but not dripping film for the manufactures recommended contact time Wipe dry or air dry after completion of contact time period before pump reuse Dispose of all cleaning disinfectant materials per federal state and local regulations for infectious waste di
37. MANUAL REV M 1 4 PUMP SPECIFICATIONS Ground impedance 13 ohms per UL544 or CSA C22 2 No 4 Patient leakage 25 microamps normal condition lt 50 microamps single fault condition Electro magnetic compatibility immunity and emissions In compliance with IEC 601 1 2 and IEC 601 2 24 1 edition 1993 04 Operating conditions Relative humidity 30 9096 non condensing Temperature 65 85 F Atmospheric pressure 22 31 in Hg Battery Type 12 volt battery pack consisting of 6 2V 2 5 amp hr rechargeable sealed lead acid batteries Operation gt 4 5 hrs to LOW BATTERY indication gt 30 min from LOW BATTERY to PLUG IN alarm Recharge time gt 18 hrs NOTE Specification for batteries in as new condition Computer interface RS232 port on the back panel This connector is also used to connect the pump to staff call systems Since the systems pumps may be connected to vary widely users should consult with SIGMA s Service Department for specific instructions Users without sufficient electronic background and knowledge of both the SIGMA 8000 infusion pump and outside devices it may be connected to should never attempt such a connection To do so otherwise can result in severe damage to the pump Staff Call System Contact Closure Rated Load 0 50A at 125VAC 1A at 24VDC Flow Sensor Drop Sensor The Flow Sensor detects drop flow in the IV set s drip chamber The sensor fits on the drip chamber and its
38. OR MODEL IS FOR ILLUSTRATIVE PURPOSES ONLY AND SHALL NOT BE DEEMED TO CREATE AN EXPRESS WARRANTY THAT THE PUMP SHALL CONFORM TO SUCH SAMPLE OR MODEL AND NO AFFIRMATION PROMISE DESCRIPTION SAMPLE OR MODEL SHALL BE DEEMED TO BE PART OF THE PURCHASE OF THE PUMP THE PURCHASER EXPRESSLY ACKNOWLEDGES THAT THIS LIMITED WARRANTY CONSTITUTES THE PURCHASERS SOLE AND EXCLUSIVE REMEDY WITH RESPECT TO ANY CLAIM OF THE PURCHASER ARISING OR RESULTING DIRECTLY OR INDIRECTLY FROM THE USE OF THE PUMP IN NO EVENT SHALL SIGMA BE LIABLE HEREUNDER FOR AN AMOUNT THAT EXCEEDS THE PURCHASE PRICE OF THE PUMP NO PERSON FIRM OR CORPORATION IS AUTHORIZED TO ASSUME FOR SIGMA ANY LIABILITY IN CONNECTION WITH THE SALE OF THE PUMP Section 1 page 1 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M 1 2 CAUTIONS AND WARNINGS 1 2 MODEL 8000 INFUSION PUMP DANGERS WARNINGS AND CAUTIONS DANGER WARNING CAUTION ATTENTION CAUTION RISK OF EXPLOSION IF USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS RISQUE D EXPLOSION NE PAS EMPLOYER EN PRESENCE D ANESTHESQUES INFLAMMABLES ELECTRIC SHOCK HAZARD NO USER SERVICEABLE PARTS DO NOT OPEN DEVICE COVER REFER SERVICING TO QUALIFIED SERVICE PERSONNEL RISK OF FIRE REPLACE FUSES AS MARKED ANY PUMP THAT HAS BEEN DROPPED OR IS OTHERWISE VISIBLY DAMAGED MUST NOT BE USED Discontinue use immediately and r
39. Queued Serial Bus for the serial EEPROM and the RTC The Serial Receive Data and Transmit Data occupy pins 17 and 18 and drive the Serial Communication Interface U49 Pins 19 through 39 form the System Address Bus A18 A1 A18 is unused while AO originates on pin 90 The Analog Inputs with eight separate A D converter channels and reference voltage inputs occupy pins 42 through 53 Standby voltage from the lithium Backup Battery is applied to pin 54 This source also maintains the Real Time Clock when power is shut down The battery is protected from chance contact with other voltage sources by D1 and from short circuits by R3 Projected battery life for the Lithium Battery is at least four years of continuous backup probably nearer five or six years with normal use since the battery is not consumed while unit power is on The 32 768 Hz clock input is on pin 57 Decoupled power for the internal clock synthesizer is supplied through pin 56 The phase detector filter capacitor for the synthesizer is connected at pin 60 The internal clock frequency is set by the program by the values loaded into the synthesizer dividers The synthesized clock frequency may be monitored at pin 63 of the Processor or on 1J9 14 The External Debugging Port occupies pins 63 through 71 of the Processor and are available at the Test Port Connector 1J9 This port is intended to allow access to the processor for test and calibration purposes under the contro
40. REPEAT STEPS 6 2 THRU 6 10 FOR BOTH CHANNELS INDICATING THE CHANNEL INSPECTED ON ICL 35001PM NOTE The brand of IV sets being tested must be compatible with the pump under test The proper IV set calibration is listed on the label located on the top of the pump 6 1 PREVENTATIVE MAINTENANCE SCHEDULE 6 1 1 Preventative maintenance is recommended a minimum of once annually on all pumps in service 6 1 2 Preventative maintenance should be performed after any user facility maintenance 6 1 3 Preventative maintenance test should also be carried out whenever a pump is dropped or suspected of having been otherwise damaged 6 1 4 A PM DUE alarm may be set as indicated in section 6 15 of this procedure 6 2 VISUAL INSPECTION 6 2 1 Inspect the pump for visual evidence of damage and or defects to exterior components i e case membrane and lever 6 22 The IV set tube channel must be free of foreign materials and dry for both testing and use 6 2 2 1 Any evidence of damage to these parts is reason to run the preventative maintenance checks 6 2 3 Verify legibility of all labels Section 1 page 9 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M 1 5 PREVENTATIVE MAINTENANCE ITP 35001PM Procedure revision level G 6 2 3 1 Replace labels as necessary 6 3 VISUAL INSPECTION FOR MODEL 8002 ONLY 6 3 1 Inspect the both channels of the pump for visual evidence of pump body cracks 6 3 1 1 6 3 1 2
41. SERVICE MANUAL REV M 1 5 PREVENTATIVE MAINTENANCE ITP 35001PM Procedure revision level G 1 0 PURPOSE The purpose of this procedure is to provide a guideline for the Preventative Maintenance of the SIGMA 8000 and 8002 IV pumps This procedure may be used as an incoming check out procedure 2 0 SCOPE The guidelines are to ensure that the SIGMA 8000 8002 IV pumps are operating within the specified parameters set forth by SIGMA International Inc 3 0 REFERENCES ICL 35001PM Preventative maintenance check off sheet ICL 13000 Field Procedure for Onboard Flow Calibration Model 8000 IV Pump 4 0 EQUIPMENT 4 1 SIGMA 8000 or 8002 Infusion Pump 4 2 IV set of the brand specified on the pump label NOTE If the pump is being accuracy tested following a clinical problem it is essential to test with an IV set of the same catalog number and lot number as that in use when the problem occurred 4 3 IV container 250 500 or 1000 ml filled with water to be used as pumping source 4 4 Collection vessel to be class A 100 ml graduate any 100ml collection vessel may be used if scale is used for flow rate accuracy measurement 4 5 Pressure gauge 4 6 Line Safety Analyzer 4 7 Electronic balance with at least 0 01 gram precision 4 8 Collection cup 4 9 A cloth or paper towel 5 0 DOCUMENTATION 5 1 After each operation in this procedure record the findings on ICL 35001PM 6 0 PROCEDURE NOTE WHEN INSPECTING THE MODEL 8002
42. SET OPT CODE DLAY STRT mode IN STOP PUSH RUN RATE KVO KVO ALRM x x hrs lt mode gt INF COMP RATE KVO PUSH STOP CLEAR ALL Reset all Program Mode parameters to default PRGS CLRD PROGRAM MODE values Includes all Rate Volume Ramp Up VALUES Taper Down and Total Program time values The mode of the pump will revert to Primary if this option is used while the pump is in a Program Mode SRS 0160 096 Section 1 page 21 SIGMA MODEL 8000 amp amp 8000 AZ INFUSION PUMP SERVICE MANUAL Rev M 1 6 USER ACCESSIBLE OPTIONS Option Name Description of Option Pump Display NA Not Available CLEAR ALL USER Reset all possible user changeable variables to ALL CLR VALUES default values Primary Rate Volume and Time will be assigned their default values Variables cleared to zero are total volume current rate and volume running time and vol limit piggyback rate volume and time dose mode kg vol mg and ugkm values but not Program Mode variables SRS 0160 007 Section 1 page 22 SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS 1 7 BIOMEDICAL ACCESSIBLE OPTIONS 1 7 1 INSTRUCTIONS FOR BIOMEDICAL OPTIONS A series of selectable options are available to the biomedical technician for customizing certain aspects of pump operation Once the options are programmed the pump will operate according to the selected optio
43. VOL LIMIT key followed by the CLEAR key and observe the display to be VOL 0 Press the following keys and observe the associated displays 6 4 1 7 1 OPTIONS key display sequence is SET OPTION CODE 9 key display is OPT 9 6 4 1 7 2 9 key display is OPT 99 6 4 1 7 3 ENTER key display is ALL CLEAR the pump will return to normal operation 6 4 1 7 4 Prime a set and load the roller clamp closed into the pump 6 4 1 7 5 Press the OPEN key and finish loading the set into the pump 6 4 1 7 6 Setthe rate to 999 and the volume to 1 0 6 4 1 7 7 Press the RUN STOP key let the pump run to infusion complete Section 1 page 10 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M 1 5 PREVENTATIVE MAINTENANCE ITP 35001PM Procedure revision level G 6 4 1 7 8 Press the RUN STOP key to stop the pump 6 4 1 7 9 Press the TOTAL VOLUME key observe the display is TOTL 1 0 6 5 UPSTREAM PROXIMAL OCCLUSION SENSOR TEST 6 5 1 Setrate to 100 ml hr 6 5 2 Set volume to 1 ml 6 5 3 Occlude IV set 12 above the pump with a slide clamp or pair of hemostats 6 5 4 Push the RUN STOP key to start the pump 6 5 5 Verify the pump goes into CLR T OCC CLR AIR alarm prior to infusion complete message 6 6 AIR DETECTION TEST 6 6 1 Set volume limit to 50 ml 6 6 2 Push the RUN STOP key 6 6 3 Introduce a 1 1 8 air bubble upstream from the pump 6 6 4
44. Verify the pump goes into CLR AIR CLR OCC alarm 6 7 DOWNSTREAM DISTAL OCCLUSION SENSOR TEST 6 7 1 Enter option 70 by pressing the OPTION key and 70 and ENTER 6 7 1 1 Verify the downstream occlusion trip pressure setting if set to less than 15psi 50mmHg set equal to 15psi 750mmHg 6 7 2 Record pressure setting 6 7 3 Set volume limit to 1 ml 6 7 4 Connect a pressure gauge to the end of the IV set with a length of 4 to 5 of tubing between the pump and gauge 6 7 5 Push the RUN STOP key to start the pump 6 7 6 Verify the pump goes into CLR 4 OCC alarm at a pressure within 2 psi or 100 mmHg of the occlusion trip pressure setting 6 7 7 If occlusion trip pressure setting was changed in step 6 7 1 1 then reset to PSI changed from using option 70 6 8 MEMORY TEST 6 8 1 Turn the pump on 6 8 2 Seta parameter for RATE and VOL LIMIT 6 8 3 Turn the pump off 6 8 4 Turn the pump on and verify the parameters were saved 6 9 LOW FLOW RATE ACCURACY TEST FOR MODEL 8002 ONLY 6 9 1 Test should be done for both channels of the pump 6 9 2 Materials required See section 4 0 steps 4 1 4 4 4 7 4 9 6 9 3 Testdata Flow rate ml hr selected for test 10 ml hr Pump vol Limit ml length of test 10 1 hr Optimal actual volume pumped 10 ml Pass criteria acceptable volumes 9 5 10 5 ml 6 9 4 1 hour warm up period running with a tube installed is r
45. a nurse call output an RS 232 based serial data interface and planned future expansion options 3 2 9 4 FLOW SENSOR AND INTERFACE The Flow Sensor which connects to the SIGMA 8000 attaches to the drop chamber of the I V set It consists of a housing enclosing an IR LED emitter with two IR phototransistors located opposite across the drop chamber to register the drops and an integral interconnect cable The LED is pulsed at 2 kHz at a 12 5 per cent duty cycle The signals from the phototransistors are demodulated by U46 a quad analog switch which is used as a synchronous demodulator A sudden drop in the output level of either phototransistor causes a negative pulse at the input of differentiator U47B The pulse is inverted by 478 and the edges squared by 370 The DROP signal sets flip flop U5B which interrupts the processor on IRQ2 Installing a sensor pulls up the LED drive line above five volts switching comparator U47A to its high state The high Logic State is transferred to the Processor FLOWINStalled line through U37D 3 2 9 2 NURSE CALL The Nurse Call consists of a relay closure with an isolated output stage The relay output is bi directional to allow AC signals to be switched or DC signals of indifferent polarity The back panel connector contacts used for this function are pins 1 and 4 Section 3 page 14 SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M THEORY OF OPER
46. and dry the inside with a cloth or paper towel 6 9 12 4 Weigh the empty cup This value multiplied by negative one 1 is the weight of the fluid collected 6 9 13 If this weight is within the range 9 5 10 5 g the pump is properly calibrated Otherwise return the pump to SIGMA International Inc or perform the flow rate calibration procedure according to CTP 13000 when flow rate error is not greater than 896 and repeat the Low Flow Rate Accuracy Test 6 10 RECOMMENDED FLOW RATE ACCURACY TEST 6 10 1 Materials required See section 4 0 steps 4 1 4 4 6 10 2 Test data Flow rate ml hr selected for test 100 ml hr Collection vessel Class A Graduate 100 ml Pump vol Limit ml length of test 50 30 min Optimal actual volume pumped ml 50 ml Pass criteria acceptable volumes 47 5 52 5 ml 6 10 3 A 1 hour warm up period running with a tube installed is recommended for the pumps before flow rate testing Ref IEC601 2 24 6 10 4 Hang the IV container 24 above the pumping mechanism 6 10 5 Connect the IV set to the IV container and prime the set completely 6 10 5 1 Remove all air from the tubing being sure the drip chamber is at least half full 6 10 6 Load a new fresh section of the set into SIGMA 8000 pump and close the lever 6 10 6 1 Open the roller clamp 6 10 7 Connect the end of the IV set to the collection vessel 6 10 7 1 If the ve
47. in repair of the product FIX CODE DESCRIPTION OF PROBLEM ENCOUNTERED FIX 01 Software has detected a failure of the microprocessor during the self test CPU FIX 02 Software has detected a failure of the PROM checksum during the system PROM test PRM FIX 03 Software has detected a failure of the RAM during the read write system RAM test RAM FIX 04 Software has detected a failure of the non volatile RAM during the system RAM test NVRAM FIX 05 Software has detected a failure of the EEPROM checksum during the system EEPROM test EEPRF FIX 06 Software has detected a failure of the EEPROM checksum during the system EEPROM test EEPRV FIX 07 Software has detected a failure of the Real Time Clock during the system clock test RTC FIX 08 Software has detected a failure of the external clock in the system CLK FIX 14 Software has detected a data integrity failure while sorting the Drug Library The library will have to be copied back into this pump see Biomed Option 601 and 602 FIX 15 Software has detected a failure of the drug library check value during the diagnostic of this memory space Factory default drug library is restored once this alarm is cleard FIX 17 The Index mark was never detected while the pump was running INDEX FIX 18 The processor is running in limp mode system clock failure LIMP FIX 19 The software has detected that the upstrea
48. is similar to the regulator described for the 15 volt supply but all of the parts are contained in a single package The switching frequency is 650 kHz allowing a small inductor to be used Field effect transistor Q1 allows the logic supply to be turned on or shut off electronically from the processor board This action may originate from the keyboard the roller clamp or within the program The keyboard switch may turn the power on or signal the microprocessor to turn the power off The roller clamp may only turn power on upon installation while the program may only turn power off in the event of low battery voltage or an OFF key actuation A low level applied to the gate turns Q1 on 3 2 3 3 Battery Charger The Battery is a 12 volt lead acid storage battery with a 2 5 Amp hour capacity When a new battery is fully charged the battery will power the Model 8000 Infusion Pump for a minimum of 4 5 hours The Battery is considered to be exhausted when its loaded voltage drops to 10 volts at which time the system shuts down to prevent damage to the battery An exhausted battery begins to charge as soon as the line cord is plugged in Q3 is biased on by R9 and R10 and draws a collector current of 10 mA through D2 The voltage drop of GaAs LED D2 roughly constant at 1 5 volts forward biases the base of PNP transistor Q2 Because Q2 attempts to maintain a voltage of 0 9 volts 1 5 Vbe across the emitter resistor R6 the emitter current and th
49. s AC power cord from the supply 6 14 5 Verify that the AC indicator is not illuminated 6 14 6 Press RUN when prompted 6 14 7 While the pump is running the BATT ON message shall be added to the display scroll sequence 6 14 8 Verify that the time elapsed to BATT LOW and PLUG IN has met the Acceptance Criteria 6 14 9 Document proper test completion on ICL 35001 Battery Test line by initials and date 6 15 V3 29 and later 4 MEG only 6 15 1 Verify that AC power is at the pump by the AC indicator being illuminated 6 15 2 Turn the pump on 6 15 3 Unplug the pump s AC power cord from the supply 6 15 4 Verify that the AC indicator is not illuminated 6 15 5 Enter BMO 402 and press RUN when prompted When testing the 8002 enter BIO 402 and press RUN on both channels simultaneously Section 1 page 45 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL Rev M ITP 35001BAT Procedure revision level E 6 15 6 While the pump is running any numeric key may be pressed to display the battery strength gauge in the display 6 15 7 Pump powers itself off at test completion 6 15 8 Power the pump back on to view test results 6 15 9 Verify that the displayed times meet the Acceptance Criteria 6 15 10 Document proper test completion on ICL 35001 Battery Test line by initials and date 6 0 ACCEPTANCE CRITERIA NOTE restock units are 10 be tested at the new battery criteria 6 16
50. 009s1 Rev F LV 4 7 a3dWnr 1ND SAWN 533981 lt ASVINYLSI 583 0 3 E v NOILI414S 3991 ANI 831 1083 SO 35 4 1914 500847 51111111 35 4 MOTE AU IS dwNv v v HJIA G39v 1438 38 LSM IA 3 ASVWIS4 4 DNIINIA HIVI IND 9921 J1V ISLA 4 2208 dz 310NIS NI 28H aD OLS ASSY 37803 5 1 1 WASSHL D SNIVINEO TINO 30 1899 NE C 9 7 S E VI x 46 V ER 20 109331 ASWADASNVAL SM ILSIML ES a Ne Ken LIG AM 045 4 3 c 5 13y o e N OV M 0 106 8 SSY 118253 018 s 1S v 3 IS 0 Na f F d 1 9v bOOELY 47 1 1214 8S NIE gt 7 s gt 9 1 IL ve NHI12313S Us y 3991106 ANTI Ke V IndNI INIT Section 2 page 5 SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 3 1 TRANSFORMER PCB LAYOUT DWG 60007 Rev G Section 2 page 6 SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 3 2 TRANSFORMER PCB ASM BOM AR 85089 HUMIS EAL TRE 188
51. 10 2 Bill of Material Pump Assembly 2 11 Rear Case Figure 2 11 1 Assembly Rear Case Table 2 11 2 Bill of Material Rear Case 2 12 Front Case Figure 2 12 1 Assembly Front Case Table 2 12 2 Bill of Material Front Case SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL REV M TABLE OF CONTENTS 2 13 Final Assembly Labels Figure 2 13 1 Assembly Final Table 2 13 2 Bill of Material Final Assembly 2 14 Keyboard Figure 2 14 0 Schematic Figure 2 14 1 Assembly 8000 Keyboard Figure 2 14 2 Assembly 8000 Keyboard 2 15 Assembly Pump Body Motor Figure 2 15 1 Assembly Pump Body Motor Table 2 15 2 Bill of Material Pump Body Motor 2 16 Roller Clamp Figure 2 16 0 Schematic 2 17 Upstream Occlusion Sensor Figure 2 17 0 Schematic SECTION 3 THEORY OF OPERATION 3 1 Mechanical Components 3 1 1 Case 3 1 2 Back Panel Pole Clamp Assembly 3 1 3 Tube Channel 3 1 3 1 Air Upstream Occlusion Sensor 3 1 3 1 1 Upstream Air Occlusion Detection 3 1 3 2 Roller Clamp Holder 3 1 3 2 1 Uncontrolled Flow Protection 3 1 3 2 2 Roller Clamp Sensing 3 1 3 3 Pump Assembly 3 1 3 3 1 Peristaltic Pump Fingers and Pressure Plate 3 1 3 4 Downstream Occlusion Sensor 3 1 3 4 1 Downstream Occlusion Sensing 3 1 3 5 Pressure Plate Release Lever 3 1 4 Stepper Motor and Drive Belt 3 1 4 1 Motor 3 1 4 2 Motor Driver 3 1 4 3 Stepper Motor control 3 2 Electronic Components 3 2 1 Functional Blocks 3 2 1 1 Block Dia
52. 131 072 bytes 128k bytes in a 32 pin SOIC or 65 536 bytes 64k bytes in a smaller 28 pin SOIC Although the program may never need the storage capacity of either of these packages they are the industry standards and the migration path is provided so that the product life time of the Model 8000 is not dictated by the seemingly rapid component turnover in the IC industry 3 2 6 4 ELECTRICALLY ERASABLE PROM Electrically Erasable Programmable Read Only Memory or EEPROM provides the Model 8000 with a medium for the storage of data which must be changed on occasion but maintained most of the time This might include pump configuration data or the history buffer log EEPROM is read or written by the processor through the Queued Serial Bus Data to the EEPROM is applied to U15 3 the Data In line of the EEPROM from UNN1 11 the MOSI line of the Processor Returning data on the MISO line moves from U15 4 to UNN1 10 Section 3 page 11 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M THEORY OF OPERATION The Processor clocks the data transfer by pulsing UNN1 12 and U15 2 The EEPROM select is decoded by U22 10 from the states of UNN1 15 and 16 3 2 6 5 RTC Clock and Supervisor Circuit The Real Time Clock U4 provides the Model 8000 with a time of year timekeeping function so that the history log may be time stamped Time is maintained during unpowered storage by the lithium back up battery
53. 17 U18 IC DDFF 74HC74 SM U28 U36 90 1 20034 U51 U61 IC MC14093 SM 91 1 20035 U52 IC MAX709 SM 92 2 20033 U54 U55 IC LT1121CS8 5 SM LINEAR TECH LT1121CS8 5 93 1 20008 U6 IC PWRAMP LM386M 1 SM 94 2 20036 U62 U63 IC 4060 SM Section 2 page 19 SIGMA MODEL 8000 8 8000 A INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 6 2 PROCESSOR SENSOR PCB ASM BOM Quant P N Description Manufacturer 95 1 20038 IC SN75374 SM 96 1 20039 U67 IC LM317LM SM 97 1 20040 U68 IC 74HC4538 SM 98 1 20041 U69 IC LM34DM SM 99 1 20042 U70 IC LT1211 SM 100 1 20010 U8 IC MOTDRV PBL3772QN SM 101 1 20009 U7 IC EEPOT 10K X9C103 34SM 102 1 20011 U9 IC MOTCTRL PBM3960QN SM 103 1 30016 U2A SOCKET 44 PIN FOR U2 104 1 55072 LITHUM BATTERY REFERENCE U1 105 1 20029 U1 BATTERY BACKED RAM 106 1 20043 U2 IC EPROM 256x16 4 MEG 107 1 20029 UNN1 IC uCONTR 16MHz MC68HC16Z1 SM 108 2 25312 Y1 Y2 XTAL 32 768kHz SM 109 2 25313 Y3 YA CERAMIC RESONATOR 1 024MHz TH 110 1 30013 101 PLUG 5 PIN TH 111 1 30003 1910 HEADER 10 P 2mm pc pin hdr TH 112 5 30036 1J1P PIN PROCESS PCB TH 113 1 30011 1J2 HEADER 5 P V 2mm pc pin hdr TH 114 1 30017 105 HEADER 2 P V 2mm pc pin RT angle TH 115 1 30008 1J6 HEADER 16 P V 2mm pc pin hdr TH 116 1 30010 2J1 HEADER 8 P V 2mm pc pin hdr TH 117 1 30009 2 2 HEADER 10 P V 2mm pc pin hdr TH 118 1 30012 2J3
54. 4 6 26 97 Update sections 2 6 2 7 2 10 2 11 2 12 2 13 2 14 2 15 1 11 add ICL 35001 opt541 8 opt542 A 11 3 98 Initial release B 9 00 Updated to include information for newest software release V3 29 C 10 10 00 Updated to include information for newest software release V3 30 00 D 5 15 01 Updated to include information for newest software release V3 40 00 also updated description of Nursecall E 9 01 01 Updated to include information for the newest software release V3 41 00 F 4 16 02 Updated to include 8000 7 references SOP 11089 to Rev B G 5 16 03 Updated drawings and procedures added information related to Drug Error Prevention and updated user and biomed options tables G1 9 234 03 Preliminary changes related to DEP G2 10 14 03 Preliminary 2 updated graphics made corrections based on review of G1 G3 4 28 04 Preliminary Made changes per markups of G2 corrected grammer where indicated H 9 13 04 Incorporated changes 31 G3 J 5 13 05 Updated Dose Mode Displays changed Abbott to Hospira updated drawings for changes made since last Service Manual update added Biomed Option 291 NOTE Revision will not be used due to the similarity to the 1 K 11 2 05 Reformatted Table of Contents updated 6 6 of ITP 35001PM to run at high pressure fixed grammatical errors added R70 to figure 2 6 2 changed P N on figure 2 9 2 and updated Rev levels of drawings M 6 13 07 Added tests for 8002 pump steps 6 3 and 6 9 to chapter 1 5 Preventative Ma
55. 86 R89 R176 RESISTOR 953KQ 1 4W 1 MF SM R179 58 3 15004 R87 R90 R213 RESISTOR 249KQ 1 4W 1 MF SM 59 1 15031 R84 R88 R141 RESISTOR 14K 1 4W 1 SM 60 2 16020 R91 R93 RESISTOR 7509 1 4W 5 CF SM 61 1 16022 R92 RESISTOR 1809 1 4W 5 CF SM 62 11 16018 R95 R104 R111 RESISTOR 5 1KQ 1 4W 5 CF SM R112 R113 R114 R118 R119 R120 R121 R186 63 1 17002 R97 POTENTIOMETER 10KQ SM 64 1 16008 R98 RESISTOR 20KQ 1 4W 5 CF SM 65 1 25310 RT1 POLYSWITCH 03 A TH 66 1 25357 R70 FUSE 1 5 AMP 1206 pkg 67 1 25316 RU1 VARISTOR V360CH8 68 1 20012 U10 IC KYBDCTRL 740923 SM 69 3 20003 U11 U13 U14 IC OCTBUF 74HC245 SM 70 1 20013 U12 IC 8INNAND 74HC30 SM 71 1 20014 U15 IC SER EEPROM 2Kx8 SM 72 1 20016 U19 IC DDFF CD4013B SM 73 1 20002 U22 IC D2TO8ENG 74C139 SM 74 2 20019 U27 U66 IC QTRISTATE 74HC125 SM 75 1 20023 U29 IC TONEDETECT LMC568 SM 76 5 20032 U3 U20 U26 U45 IC QNAND 74HC00 SM U56 77 3 20004 U31 U33 U59 IC 8BLATCH 74HC574 SM 78 2 20024 U34 U57 IC PLL MC145151 SM 79 1 20021 U35 U58 IC VCO PLL 74HC4046 SM 80 2 20017 U37 U48 IC QXOR 74HC86 SM 81 2 20028 U38 U39 IC DIFFBUS SN75176 SM 82 1 20006 U4 IC RTC 68HC1621 SM 83 1 20026 U40 IC SWCAPAMP LTC1043 SM 84 4 20025 U41 U42 U47 U60 IC DOPAMP LT1013 SM 85 1 20005 U43 IC 74HC138 SM 86 1 20020 U44 IC 4BITUPDN 74HC191 SM 87 1 20022 U46 IC QSWITCH 74HC4066 SM 88 1 20027 U49 IC RS2321NT MAX232 SM 89 5 20007 U5 U
56. ATION Refer to Section 1 4 4 for Staff Call Contact Ratings Pump alarms that activate Nurse Call are Air In Line Upstream Proximal Occlusion Downstream Distal Occlusion Motor Speed Error Plug In Alarm Battery Dead Infusion Complete Flow Sensor Removed Empty Bottle Alarm 3 2 9 3 SERIAL COMMUNICATION INTERFACE The serial interface is compatible with EIA RS 232 Serial Communication Interface bus The serial interface allows Pump status to be monitored and history information access by an external host computer system Changes in the pump operating status can only be made from the Keypad not from the serial interface The Serial Transmit Data and Receive Data from the Processor are converted to EIA RS 232 levels for transmission by the Serial Communication Interface U49 The interface IC contains internal charge pumps to generate 12v and 12v for biasing the transmitter and receiver stages The transmit and receive lines exit through the Sensor Interface via J12 to the Serial Flow Connector J12A on the rear panel of the Model 8000 Section 3 page 15 P N 44000 Level Date Revision M REVISION HISTORY Description of revision PO1 2 28 96 Preliminary copy for trial distribution original 1st issue PO2 6 10 96 Updated section 1 10 1 FIX ME codes PO3 11 11 96 Update sections 1 2 1 3 1 4 1 6 1 7 1 11 and tech drawings PO
57. DEL XX DRIV X UQRF XXX UNRF XXX LQRF XXX LNRF XXX UTRP XXX LTRP XXX DSNT XX DSSF XX 11 5 XXX 10 4 XXX COMP DATA PASS WORD tube ID SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Opt Option Name Description of Option Pump Display 501 FLOW CALIBRATION Steps the user through the process of running a FLOW CAL series of canned infusions then prompts the user to type the delivered volume results of these PASS 4meg feature infusions into the pump Using these values the WORD software then calculates the proper amount of compensation to apply to the motor curve to WARM UP ensure accurate fluid deliveries when selected DCAY SMPL TEST 1 TEST 2 TEST 3 TEST 4 while running FLOW CAL or DCAY SMPL IN PROC PUSH ENTR ENTR VOLS CON FIRM COMP DATA values are shown STOR ING if set not loaded EXIT BIO TO LOAD SET Section 1 page 35 SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of Option Pump Display COMPENSATION HISTORY 4meg feature FLOW CALIBRATION PREPARATION MODE The 4 hour break in 4meg feature SET REAL TIME CLOCK SET TUBE TYPE SET KEYPAD TYPE Provides a visual record of the calibration history of the pump Maintains the compensation factors of the five m
58. E CLAMP ASSEMBLY The Back Panel Pole Clamp assembly is a one piece aluminum die casting providing the facility for mounting the Model 8000 Pump on a standard IV pole The Pole Clamp will accept round poles with diameters between 0 5 and 1 0 inches 12 7 25 4 mm and is secured to the pole by a screw mechanism and hand knob lt acts as a removable cover for access to the battery and is a heat dissipation surface allowing the internal case temperature to be kept below the 105 degree F temperature desirable for reliability It also provides means for mounting of the PCA syringe holder assembly The Back Panel Pole Clamp Assembly is described in Figure 2 9 1 and the accompanying Bill of Material Table 2 9 2 3 1 3 TUBE CHANNEL The Tube Channel is a slot in the front of the Model 8000 Volumetric Infusion Pump which holds and acts upon the tubing of the IV set Arrayed along the Tube Channel from top to bottom are all of the devices used to monitor and control fluid delivery through the tubing These include the peristaltic pump assembly and a variety of sensors and mechanical devices essential to operation The devices in the Tube Channel are described in the following sub sections in order from the top of the Tube Channel to the bottom which is the direction of fluid flow Section 3 page 1 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M THEORY OF OPERATION 3 1 3 1 AIR UPSTREAM OCCLUSION S
59. E FUSES The A C Power Entry Module provides a chassis receptacle to allow for easy replacement of a damaged AC line cordset houses the line fuses and provides a filter for control of line conducted interference into and out of the Pump chassis Both Line and Neutral conductors from the Line Cord are fused in accordance with IEC safety requirements Fuses may be replaced only with the following parts For 120 Volt operation Littelfuse 218 500 0 5A FB For 240 Volt operation Littelfuse 218 250 0 25A FB Substitution of other fuses violates the Medical Device Certification of this Product and may compromise Product Safety Section 3 page 6 SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M THEORY OF OPERATION 3 2 2 3 POWER TRANSFORMER AC Line power enters the Pump through a 50 60 Hz dual primary double bobbin wound Power Transformer The Power Transformer steps the line voltage down to a low AC voltage nominally 24 vrms for rectification filtering and subsequent regulation The Power Transformer is mounted on the Transformer Printed Circuit Board described further in Section The Power Transformer is wound on double bobbins to guarantee minimum risk leakage current maximize breakdown voltage and provide fault current creepage distance in accordance with the safety requirements of IEC Standard 601 2 CSA C22 2 125 and UL 544 The Transformer contains internal thermal cutouts to limit temperatur
60. E MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of Option Pump Display DECAY TEST MODE 4meg feature TEST FLOW MODE 4meg feature Allows the tester to run the decay test without having to type in running parameters the rate and volume values for each test already preprogrammed by the pump software Press RUN to start Pump runs the long term infusion then the 32 ml sample prompting user to continue after each iteration The tubeset must be loaded prior to entering this option A utility for the QA In Process Volume Accuracy test The parameters for each infusion are preprogrammed or canned by the software Pump stops after each volume has been delivered press RUN to begin the next infusion When all infusions have been run software will prompt the tester to indicate the status of the test results The tubeset must be loaded prior to entering this option Section 1 page 31 DCAY TEST PASS WORD IN PROC DCAY SMPL IN PROC CONT INUE YES NO if set not loaded EXIT BIO TO LOAD SET TEST FLOW PASS WORD WARM UP TEST 1 TEST 2 TEST 3 TEST 4 TEST 5 while running FLOW TEST IN PROC ALL PASS YES NO CON FIRM ALL PASS or TEST FAIL if set not loaded EXIT BIO TO LOAD SET SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of Opt
61. ENSOR FLOW SENSOR and LEVER LOCK CONTROL See Assembly Figure 2 8 1 and Bill of Material Table 2 8 2 The Test Port 1J9 contains all of the signals used by the MC68HC16Z1 Processor for its internal debugging mode The intention is to allow access to the processor via a PC terminal for automated test and calibration procedures The Shaft Sensor is a magnetically activated Hall effect device which produces one pulse for each rotation of the pump shaft The sensor pulse sets flip flop U5A entering an interrupt on IRQ1 The processor clears the interrupt by asserting IACK1 and enters any operation dictated by the interrupt service routine Monitoring pump rotation allows the processor to determine whether the pump has stalled due to a broken belt or other reason The flow sense signal produces a similar response on USB IRQ2 and IACK2 The Lever Release Solenoid is controlled from Processor output PF6 UNN1 73 which drives a high current switching FET Q12 Energizing the solenoid opens the Lever lock allowing the Lever to open The status of the Lever is monitored by two Hall effect devices through Processor inputs and PF7 pins and UNN1 72 respectively 3 2 9 BACK PANEL SERIAL INTERFACE CONNECTOR A 9 pin D subminiature connector located on the rear panel of the pump provides for connection of devices to access various input and output functions of the pump Accessories and options include an opto electronic flow detection device
62. ENSOR See Schematic Figure 2 17 0 Assembly The Air Upstream Occlusion Sensor is comprised of a molded plastic housing incorporating two 2 pairs of ultrasonic transducers The housing is designed to efficiently couple the signals from the transmitters through the I V set and its contents back to the receiving transducers The tubing in the Tube Channel passes through the Air Upstream Occlusion Sensor before it reaches the Pump Mechanism Air bubbles in the fluid are sensed and if of sufficient size pumping will stop an alarm will sound and a message will be displayed Air bubbles are sensed ultrasonically by measuring characteristics of the sound waves that travel across the diameter of the tubing Two sensors are spaced 0 5 inch apart along the length of the tubing and are used simultaneously to sense bubbles giving better freedom from false alarms An air bubble greater than 1 inch 25 4 mm long or approximately 100 to 150 microliters in volume stops the pump and results in an alarm and message display over the entire range of delivery rates An equivalent single volume of micro bubbles or foam in the fluid path is interpreted as a continuous air bubble Upstream Occlusions are detected by monitoring the loss in signal strength across both of the sensors A loss of signal results from the loss of contact pressure between the tube and the sensors due to the negative pressure build up internal to the tube during an upstream occlusion
63. ENTS SECTION 2 TECHNICAL DRAWINGS 2 0 External Features Case 2 1 Functional Blocks Block Diagram 2 2 Cables and Wiring 2 3 AC Line Circuit 2 4 Regulator PCB 2 5 Display PCB 2 6 Processor Sensor PCB 2 7 Motor Assembly 2 8 Shaft Sensor 2 9 Pole Clamp 2 10 Pump Mechanism 2 11 Rear Case Assembly 2 12 Front Case Assembly 2 13 Final Assembly Labels 2 14 Keyboard 2 15 Pump Motor Assembly 2 16 Roller Clamp Schematic 2 17 Upstream Occlusion Sensor Schematic SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M FRONT VIEW T HOOK wv N x E D 5 BM V AIR amp UPSTREAM d OCCLUSION SENSOR xe x ee e OPEN ROLLER SENSOR g 7 E p ROLLER CLAMP HOLDER LOSED ROLLER CLAMP SENSOR SHEE f Smo 4 3 SN 4145171819 OPTION Ion CLEAR ke YES NO 3 gt EN TOTAL VOL E LBVER LEVER LOCKING DIN FVER ARE LEVER LAGE OPTIONS KEY CentER KEY Section 2 page 1 a I gt S m
64. FORMATION 1 1 Limited Warranty 1 2 Cautions and Warnings 1 3 Cleaning and Maintenance 1 4 Specifications 1 5 Preventive Maintenance 1 6 User Accessible Options 1 7 Biomedical Accessible Options 1 8 Troubleshooting Guide 1 9 Service SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M 1 1 WARRANTY 1 1 MODEL 8000 INFUSION PUMP LIMITED WARRANTY SIGMA International warrants to the original purchaser the SIGMA 8000 Infusion Pump hereinafter Pump to be free from defects in material and workmanship under normal use and service for one year from the date of purchase SIGMA s obligation under this limited warranty shall be limited to repair or replacement of Pumps which upon SIGMA s examination are found defective in material or workmanship under normal use and service within one year from the date of purchase by the original purchaser The repair or replacement of any Pump under this limited warranty shall not extend the term of this limited warranty beyond the original term as set forth in this paragraph Qualified trained service personnel must perform all repairs qualifying under this limited warranty In the event that any Pump is found to be defective during the aforesaid warranty period the purchaser shall notify SIGMA in writing of any claimed defect within thirty days after such claimed defect is discovered The Pump claimed to be defective must then be promptly delivered to SIGMA or its designate
65. GRAM PROM 3 2 6 4 ELECTRICALLY ERASABLE PROM 3 2 6 5 RTC CLOCK AND SUPERVISOR CIRCUIT 3 2 6 6 ANALOG INPUT CHANNELS 3 2 6 7 PUMP TEMPERATURE MONITOR 3 2 6 8 SPEAKER DRIVER VOLUME CONTROL 3 2 6 8 1 SPEAKER 3 2 6 9 DISPLAY AUXILIARY INTERFACE SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M TABLE OF CONTENTS 3 2 7 KEYBOARD 3 2 7 1 KEYBOARD INTERFACE 3 248 TEST PORT SHAFT SENSOR FLOW SENSOR LEVER LOCK CONTROL 3 2 9 BACK PANEL SERIAL INTERFACE CONNECTOR 3 2 9 1 FLOW SENSOR AND INTERFACE 3 2 9 2 NURSE CALL 3 2 9 3 SERIAL COMMUNICATION INTERFACE SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M THEORY OF OPERATION 3 0 MODEL 8000 INFUSION PUMP THEORY OF OPERATION 3 1 MECHANICAL COMPONENTS 3 1 1 CASE The Model 8000 Case is a two piece plastic molding providing mounting and protection for all of the other components in the Pump The plastic material chosen for the case provides high strength and a UL Flame Spread Rating of 94V O Refer to Figure 2 0 1 and Figure 2 0 2 for the front and rear Views of the case respectively Case assembly details are contained in Figure 2 11 1 Assembly Drawing Rear Case Table 2 11 2 Bill of Material Rear Case Figure 2 12 1 Assembly Drawing Front Case Table 2 12 2 Bill of Material Front Case Figure 2 13 1 Assembly Drawing Final Labels Table 2 13 2 Bill of Material Final Labels 3 1 2 BACK PANEL POL
66. H RUN displays then repeat steps 2 4 Section 1 page 16 SIGMA MODEL 8000 amp amp 8000 ZQ INFUSION PUMP SERVICE MANUAL Rev M 1 6 USER ACCESSIBLE OPTIONS Option Name Description of Option Pump Display NA Not Available AUDIO ALARM Select Default level for Audio alarm tone Option TONE n DEFAULT TONE will display and sound i e demo the current LEVEL default Press integer from 1 quiet to 3 loud The new choice will be displayed and demo ed Press the ENTER key to accept the displayed value and demo the new tone Press Clear key to reset to system default 2 SRS 0160 001 KEY LOCK Option will display current status of Key Lock KEY LOCK ON OFF Toggle Key Lock on or off by selecting the option or Can only be de activated when the set is loaded LOCK OFF and the rate and volume parameters have been entered and may only be deactivated at KVO or during air occlusion alarms SRS 0160 002 RETURN TO Press Enter to return to Primary Mode from any OPT 12 PRIMARY MODE Option Mode The Option Mode s parameter PRI MODE values in permanent memory will be retained PUSH ENTR SRS 0160 998 PIGGYBACK Option will display current piggyback time value SET TIME VOLUME MODE and current piggyback volume value Press Enter PIG TIME to accept value and calculate the rate Press 0 mins numeric key to change value SRS 0160 980 SET PIG VOL VOL 0 then PIG RATE RATE xx PIGGYBACK Option will display current
67. INDX OFF SER PARM 19K2 BAUD or 9600 BAUD or 4800 BAUD or 2400 BAUD 7BIT CHAR or 8BIT CHAR NO PAR or ODD PAR or EVEN PAR CAL MODE COMM TEST TEST PASS TEST FAIL SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of Option Pump Display DUMP PUMP Sends all calibration values considered to be CALIBRATION DATA critical out the serial port where the maybe captured to a file and or printed 4meg feature Included in the list of values is pump serial number tube type the five motor calibration values all upstream sensor values the downstream notube and scale factor values and the low and dead battery values VIEW COMPENSATION Displays calibration tube information and pump DATA motor speed calibration values The left half of the display shows the rate and the right half detail to the right applies displays the calibration value The Decimal Point to 2meg version the key is used to enter a negative value All values 4meg version is view only are percents in the form xx 96 in the range 140 to 140 Modification of these values requires a 2meg PROM and the restricted access password General access password and or a 4meg PROM provides read only rights Section 1 page 34 DUMP DATA DUMP DONE Sent to terminal SN XXXX TUBE X 10 XX 40 XX 100 XX 400 XX 800 XX UFRQ XXX LFRQ XXX QDEL XX N
68. LE Piggyback infusion complete default is disabled INACTIVITY TIMEOUT Set the alarm timer at 2 or 5 minutes OPTIONS ALARM DELAY will exit the mode with no change CLEAR will toggle between 2 and 5 minutes ENTER sets the displayed value and exits the option Section 1 page 27 ALT DISP PRI TOTL TOTL ON Or TOTL OFF DOSE TOTL TOTL ON Or TOTL OFF PRI VOL VOL ON Or VOL OFF DOSE VOL VOL ON Or VOL OFF 4meg only BATT DISP DISP ON or DISP OFF PIG CLMP ALRT ON ALRT OFF KYBP ENA KYBP ON or KYBP OFF BEEP OFF or BEEP ON ALRM DLAY DLAY 2MIN or DLAY 5MIN SIGMA MODEL 8000 8 8000 A INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of Option Pump Display FOREIGN LANGUAGE DISPLAY 4meg feature ENABLE HP CAREVUE OUTPUT CLEAR HISTORY COUNTERS 4meg feature DOSE MODE TEXT ABBREVIATION 4meg feature Protected option to set the language used in all pump displays to be either English or French default to English CLEAR to toggle ENTER to select selected language updated as option is exited Modification of this value requires entry of the restricted access password General access password provides read only rights Either enable or disable the serial output of data relevant to the Hewlett Packard Device Link CareVue system CLEAR to toggle ENTER to select General access password required Al
69. MODE PUSH RUN PASS WORD while stopped TEST MODE RATE 100 while running with scrolling rate SIGMA MODEL 8000 amp 8000 Z INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of Option Pump Display SENSOR TEST MODE Sensor Test Mode for testing upstream and downstream sensors Press CLEAR key to toggle sensor configuration press ENTER key to accept sensor configuration press OPTIONS key to exit the option and ignore configuration changes Then press ENTER key to take a reading or OPTIONS key to exit the option BATTERY TEST MODE Test the life of the internal battery pack by running the pump at a rate of 100 ml h until the battery is depleted and the pump turns itself off 4meg feature All battery alarms are silenced during the test The pump will record the time of occurrence of the low battery and plug in alarms then turn itself off Upon power up the software calculates the total running time and the Low Batt to Plug In time and displays them to the operator in hours and minutes General access password required Section 1 page 30 SENS TEST SNS ON Or SNS OFF VSNS ON Or V SNS OFF PUSH ENTR FOR RDNG UP xxx LO xxx BATT TEST BATT TEST TOTL TIME UN PLUG PUMP BATT LOW NO TEST or BATT TEST PUSH RUN BATT TEST RATE 100 E E POWR OFF SIGMA MODEL 8000 amp 8000 Z INFUSION PUMP SERVIC
70. MP 15 2 86727 SIL PAD 14 2 95166 SHOULDER WASHER NYLON 13 5 95018 SCREW 4 40 x 1 4 BH 12 1 55022 KNOB POLE CLAMP 11 1 95109 SNAP RING 10 1 95102 WASHER 9 1 50007 SHAFT DOUBLE LEAD THD 8 1 95108 WASHER RED FIBER 7 1 45040 PLUNGER 6 4 95004 SCREW 2 56 x 3 16 5 1 50005 COVER PLATE 4 1 40025 GASKET COVER PLATE 3 4 95029 SCREW 8 32 x 9 16 CAPTIVE 2 1 60001 ASSEMBLY REGULATOR PCB 1 1 50026 BACK PANEL POLE CLAMP ITEM QTY P N DESCRIPTION BILL OF MATERIALS Section 2 page 24 SIGMA MODEL 8000 amp 8000 Z INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 10 1 PUMP ASSEMBLY DWG 35005 Rev H ZN 5 J EN ZA S E LS S E ZY ay SN ZSL gt N 4 AES TU 40 V Section 2 page 25 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 10 1 PUMP ASSEMBLY DWG 35005 1 Rev K 3 S 3 e x gt S SN S N _ gt S no Q i Tix SS amp N Q SS AY amp I p EN I II e D TR SA d Bn m un S Sr SN E DZ To Z 9 EG u Q N zz v lt 41705 OL LON v MATA VV
71. Medina N Y 14103 Email Service Coordinator at jallport sigmapumps com Please be prepared to provide the serial number and a description of the difficulty experienced including all pertinent information such as flow rate administration set used and the message displayed at the time of the difficulty Important Confirm pump failure as described in this manual before return Unconfirmed complaints are required to go through Production Testing and Quality Assurance Inspection and will be billed accordingly See Warranty If it is necessary to return the unit for service 1 Contact the SIGMA International service center above for authorization RA number 2 A purchase order number or other authorized form of payment will be required on non warranty repairs before a RA number is issued 3 If an estimate is required before work is performed state this when you call in for a RA number 4 Clearly reference on all applicable documents a RAnumber b Purchase order number c Written description of problem d Name telephone number e mail and mailing address of the following people in your hospital or organization Repair Service Manager Purchasing Manager Accounts Payable Manager Please note that the above information is required for both the independent biomedical service company and for the pump owner in cases where SIGMA is not dealing directly with the pump owner e Complete name and address 5 Package pump in the
72. N PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of Option Pump Display SELECT SERIAL Select the source of serial output data The first OUTPUT choice is between System Messages or Sensor Readings Push the Clear key to toggle between choices the Enter key to accept a choice or the Options key to exit with no changes If Sys Msgs is chosen all sensor reading output is disabled and the option exits If Read Snsr is chosen five sensor choices are presented in sequence Upstream sensor Downstream sensor Power Supply voltages Thermistor readings and Index mark Use Enter Clear and Options keys as described above SET SERIAL Set the serial communications parameters The PARAMETERS first choice is to set the Baud Rate Push the Clear key to sequence through the available choices the Enter key to accept a choice or the Options key to exit with no changes The second choice is to set the Character Size and the final choice is to set the Parity Use Enter Clear and Options keys as described above CALIBRATION MODE tbd COMMUNICATIONS Assembles a test message and employs an TEST MODE external loopback adapter to transmit it and read it back in Section 1 page 33 SER OUT SYS MSGS or READ SNSR TSNS ON or TSNS OFF if ON FULL MSG or PART MSG if FULL AIR MSG or OCCL MSG JSNS ON or SNS OFF PWR ON or PWR OFF TEMP ON or TEMP OFF INDX ON or
73. O frequency by two and produces a transmit phase reference whose phase is constant The reference stage also produces a demod phase reference which may be the same as the transmit phase 0 degrees or 90 degrees out of phase 90 degrees Section 3 page 2 SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M THEORY OF OPERATION The transmit phase signal excites whichever transmit transducer is selected by turning on its driver U38 or U39 The final drive stage U65 is powered from the adjustable drive level power supply and drives the transmitting transducer The demod phase is applied to the reference input of the synchronous demodulator U40 The level of either O degree or 90 degree output from the receive transducer may then be read at Analog input 0 for pair 1 or Analog input 4 for pair 2 3 1 3 2 ROLLER CLAMP HOLDER See Schematic Figure 2 16 0 The Roller Clamp Holder is a molded plastic housing designed to retain the roller clamp in the pump and house the sensors needed to monitor the presence of the roller clamp and the position of the clamp s roller wheel The holder is an interchangeable block allowing users the flexibility of using IV sets of various manufacturers whose roller clamps are of differing sizes 3 1 3 2 1 Uncontrolled Flow Protection To install an I V set into the Model 8000 Infusion Pump the roller clamp on the set must first be installed in the Roller Clamp Holder and th
74. OWNSTREAM Select Downstream Occlusion Sensor LOCC ENA OCCLUSION SENSOR Enabled Disabled Option will display DS Occl DISABLE Sensor status Push Clear key to toggle status PASS between On and Off Push Enter key to accept WORD displayed status Push Options key to exit with no change from original status Modification of JOCC ON this setting requires entry of the restricted access or password LOCC OFF 130 ROLLER CLAMP Select Roller Clamp Sensor Enabled Disabled RCLP ENA SENSOR DISABLE NA OPT N A 140 FLOW DETECTOR Set Flow Detector Required On or Off FLOW REQUIRED ENABLE SNSR FDET ON or FDET OFF DOWNSTREAM Select Downstream Occlusion Auto Restart DSAR ENA OCCLUSION AUTO Enabled Disabled Option will display DS Occl DSAR ON RESTART DISABLE Auto Restart status Push Clear key to toggle or status between On and Off Push Enter key to DSAR OFF accept displayed status Push Options key to exit with no change from original status DOWNSTREAM Press CLEAR to enable disable the feature DFLT OFF OCCLUSION DEFAULT Press ENTER to accept the setting Use the DFLT ON PRESSURE LIMIT numeric keys to enter a value Press OPTIONS to exit setup with no change SET DFLT XX psi Section 1 page 24 SIGMA MODEL 8000 8 8000 A INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of Option Pump Display TEMPERATURE COMPENSATION ENABLE DISPLAY SOFTWARE INFORMATION
75. Procedure revision level C 1 0 PURPOSE 1 1 The purpose of this procedure is to provide the necessary steps for field PROM upgrades and to provide the manufacturer a tool for upgrading the Device History File and Tracking Database 2 0 SCOPE 2 1 This procedure applies to all SIGMA Model 8000 units 3 0 REFERENCES 3 1 SOP 11088 PROM Installation Procedure SIGMA Model 8000 Infusion Pump 3 2 SOP 11070 DOC 11070 AAMI Safe Currents Test Procedure and Data Sheet 3 3 ITP 35001 PM Preventative Maintenance Procedure for Model 8000 IV Pump 3 4 DOC 11089 Software Version Case Labeling Matrix 4 0 PROCEDURE 4 1 Fill in the Facility Name Pump Serial Number and Software Version to be installed Facility Pump Serial Number Upgrade to Software Version 4 2 Update Check each step Pass or Fail to the right as it is completed PASS FAIL 4 2 1 Verify any hospital specific BioMed Option setting requirements before beginning 4 2 2 Replace software with latest version Reference SOP 11088 4 2 3 Press ON Record the software version Either during PROM update or via BMO 200 Ver 4 2 4 Check pump serial number BIO OPT 201 Verify with Serial Number above 4 3 Functional Checks 4 3 1 Plug unit into an AC outlet verify the AC indicator is illuminated 4 3 2 Perform Additional Required Checks for this Facility Upgrade Section 4 4 4 3 3 Perform ITP 35001 PM Preventative Maintenance Procedure Note sections 6 3 6
76. QN3 839NI4 ANNA QHVMOL 3903 1773 3015 AXdO amp 8 3 115 Lid MJAOO 44 85 GAYMOL 20 34 82 Section 2 page 26 SIGMA MODEL 8000 8 8000 Al INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 10 2 PUMP ASSEMBLY DWG 35005 amp 1 BOM gt FMBLY er BODY DESCRIPTION TERIALS Section 2 page 27 SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 11 1 REAR CASE ASSEMBLY DWG 35003s2 Rev N Section 2 page 28 SIGMA MODEL 8000 8 8000 Al INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 11 1 REAR CASE ASSEMBLY DWG 35003s1 Rev N LOCATE ON LEFT DIRECTLY UNDER THE B GEN LOCATE AS SHOWN tus LT BLUE N Section 2 page 29 SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 11 2 REAR CASE ASSEMBLY BOM HOLD V
77. R pressed the comp values are displayed as shown in BioMed Option 500 CAL PREP PASS WORD RATE 400 CAL PREP when the 4 hour infusion completes YEAR xxxx MON xx DAY xx HOUR xx MIN xx CLK SET TUBE TYPE PASS WORD TUBE xx VALU HIGH KYPD TYPE KYPD x VALU HIGH SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of Option Pump Display VIEW UPSTREAM SENSOR CALIBRATION DATA CALIBRATE UPSTREAM SENSOR 4meg feature ENTER DOWNSTREAM SENSOR CALIBRATION DATA View the upstream sensor calibration values upper and lower transducer frequencies quadrature and normal delay values transducer drive level upper and lower transducer quad and normal reference values upper and lower transducer air trip points Modification of these values requires the restricted access password General access password provides read only rights Calibrate the upstream sensor tester is initially prompted to use default calibration values or the current values stored then the tester is prompted to load and remove a water filled tube and an air filled tube Success places the tester in BMO 530 to view the calibration results failure will display a descriptive reason for the failure General access password required Enter Downstream sensor calibration values default no tube threshold value and scale factor v
78. R20 R115 RESISTOR 1 5KQ 1 4W 5 CF SM 43 1 15024 R204 RESISTOR 1 78KQ 1 4W 1 MF SM 44 2 15025 R205 R207 RESISTOR 8879 1 4W 1 MF SM 45 1 15026 R206 RESISTOR 3652 1 4W 1 MF SM 46 1 15033 R208 RESISTOR 3169 1 4W 1 MF SM 47 1 16016 R215 RESISTOR 47KQ 1 4W 5 CF SM 48 5 16017 R3 R17 R18 RESISTOR 1KQ 1 4W 5 CF SM R138 R139 49 1 15021 R30 RESISTOR 6 49KQ 1 4W 1 MF SM 50 6 16011 R4 R96 R99 RESISTOR 330KQ 1 4W 5 CF SM R159 R172 R181 51 1 15022 R40 RESISTOR 4 12KQ 1 4W 1 MF SM 52 1 15023 R48 RESISTOR 2940 1 4W 1 MF SM 53 2 16009 R5 R170 RESISTOR 22MQ 1 4W 5 CF SM 54 50 16004 R6 R8 R26 R27 RESISTOR 10KQ 1 4W 5 CF SM R28 R33 R34 R46 R5 1 R62 R63 R64 R65 R66 R67 R68 R69 R7 1 R72 R73 R74 R75 R76 R77 R79 R80 R81 R82 R8 3 R144 R145 R146 R147 R149 R150 R155 R156 R158 R166 R174 R177 R178 R190 R194 R196 R203 R211 R212 R218 99 27 16005 R7 R21 R22 R23 RESISTOR 100KQ 1 4W 5 CF SM R24 R25 R52 Section 2 page 18 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 6 2 PROCESSOR SENSOR PCB ASM BOM Item Quant P N Description Manufacturer R101 R109 R110 R116 R117 R122 R123 R154 R160 R161 R162 R164 R165 R167 R168 R169 R175 R180 R183 R214 56 1 15001 R78 RESISTOR 10KQ 1 4W 1 57 4 15011 R
79. SERVICE MANUAL SIGMA INTERNATIONAL MODEL 8000 amp 8000 Aw INFUSION PUMPS 44000 REVISION M June 2007 Additional copies of this Service Manual Are available from SIGMA International Inc 711 Park Avenue Medina NY USA 14103 0756 Latest revision will be sent unless otherwise specified SIGMA INTERN MODEL INFUS SER FILE NAME INTERNATIONAL MODEL Pins INFUSION PUMP SERVICE MANUAL FILE NAME 8000 OPS MANUAL SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M TABLE OF CONTENTS SECTION 1 GENERAL INFORMATION 1 4 Limited Warranty 1 2 Cautions and Warnings 1 3 Cleaning and Maintenance 1 4 Specifications 1 5 Preventive Maintenance 1 5 1 ITP 35001PM Preventative Maintenance Procedure 9 Visual Inspection Keyboard Test Upstream Proximal Occlusion Sensor Test Air Detection Test Downstream Distal Occlusion Sensor Test Memory Test Recommended Flow Rate Accuracy Test Line Safety Analysis Flow Sensor Operation Battery Capacity Test 1 6 User Accessible Options 1 7 BioMedical Accessible Options 1 7 1 Instructions for Biomedical Options e Battery Capacity Inspection Sheet ITP 35001BAT 1 8 Troubleshooting Guide 1 9 Service 1 9 1 Return A
80. TOR DOWNSTREAM OCCLUSION INTERFACE PORT g m Kin 5 p gen RATOR 2 TECH cias ze DROP SENSOR CLOCK GENERATO e T CIRCUIT ED DRIVERS STAFF CALL TRANSMIT DRIVE SUPPLY e 7 x m
81. TT CLR OCC approximately 10 seconds after the pump started Connect the flow sensor to the set s drip chamber and push RUN 6 12 6 1 Allow the pump to run for gt 40 seconds Verify that the pump runs without an EMPT BOTT CLR OCC alarm while the drops are correctly flowing While the pump is continuing to run disconnect the flow sensor from the RS 232 plug Verify that the pump stops and display indicates PUMP STOP PUSH RUN 6 13 BATTERY CAPACITY TEST 6 13 1 6 13 2 6 13 3 The storage capacity for the battery in the Model 8000 may be determined by running the Battery Capacity Test The Model 8000 must be connected to the AC line for at least 24 hours prior to the test to allow the battery to attain full charge 6 13 2 1 The Model 8000 may be in use during this time Biomed Option 402 available in 4meg pumps V3 29 00 and later may be used to perform automatic monitoring of the battery capacity test See alternate method step 6 13 4 for other pump configurations 6 13 3 1 Enter Biomed Option 402 as indicated in section 1 7 of the Service Manual 6 13 3 2 Follow the prompts using the ENTER key push the Run key to start the test 6 13 3 3 Allow the pump to run until it turns itself off 6 13 3 4 Plug the pump into AC Turn pump on and observe resulting test times displayed 6 13 3 5 Confirm capacity per step 6 13 6 Pump 4 meg and software version can be determined by accessing Biomed Option 200
82. The 32 768 kHz clock for the Processor is supplied by the RTC when the 5 volt logic power is turned on and the power up reset is asserted until the logic supply has been stable for about one second Time is read or set by the processor through the Queued Serial Bus Data to the RTC is applied to U4 5 the MOSI line of the RTC from UNN1 11 the MOSI line of the Processor Returning Data on the MISO line moves from U4 6 to UNN1 10 The Processor clocks the data transfer by pulsing UNN1 12 and U4 4 The RTC select is decoded by U22 11 from the states of UNN1 15 and 16 The processor must pulse the RTC select line every 200 ms 5 PPS to prevent the Supervisor Circuit from sounding an alarm and shutting off power to the micro processor This audio is an indication of processor failure produced by counter U16 which continuously counts the independent 32 kHz clock A pulse on the RTC select line is synchronized with the clock by the two flip flop stages U17B and U18A and applied to the counter reset Failing to reset the counter will start a pulse modulated 2 kHz tone at 2 bursts per second within 250 ms of the last reset pulse 3 2 6 6 Analog Input Channels Eight Analog to Digital Converter Inputs give the Processor access to the analog signals necessary to the operation of the Model 8000 Infusion Pump A 4 096 volt reference is established for the A D Converters by adjustable zener diode D14 This also serves as the excitation source for the
83. Thermistor TH1 Analog inputs are assigned as follows Analog 0 Air Upstream Occlusion Sensor 1 Analog 1 Temperature Thermistor TH2 Analog 2 Downstream Pressure Analog 3 DS Occlusion Supply 5Vex Analog 4 Air Upstream Occlusion Sensor 2 Analog 5 12V Battery Voltage 2VBAT Analog 6 Temperature Analog 7 Motor Supply Status AC Line Status 2SWVMOT 3 2 6 7 PUMP TEMPERATURE The pump temperature is monitored by U69 on the Processor PCB The alarms that may occur due to a temperature change are as follows LOW TEMP The pump s temperature sensor has detected that the pump temperature is below 40 F Allow the pump to reach a minimum of 68 F before subsequent operation This alarm will reset when temperature goes above 40 F HIGH TEMP The pump s temperature sensor has detected that the pump temperature is above 150 F Allow the pump to return to below 85 F before subsequent operation This alarm will reset when temperature goes below 150 F Section 3 page 12 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M THEORY OF OPERATION 3 2 6 8 SPEAKER DRIVER VOLUME CONTROL The alarm tone originates as a square wave output from UNN1 3 which is the output from one of the timer functions of the Processor The Tone is applied to the high end of U7 Pin 3 which is a CMOS electronic voltage divider 7 operates analogously to a manual volume control b
84. UMP SERVICE MANUAL Rev M 1 6 USER ACCESSIBLE OPTIONS 1 6 USER ACCESSIBLE OPTIONS 1 6 1 INSTRUCTIONS FOR USER OPTIONS A series of selectable options are available to the user for customizing pump operation Once the options are programmed the pump will operate according to the selected options until the user again changes them To access the options de Identify the desired option code number from the following list or the list on the side label of the pump Press the OPTIONS key Select the desired option code number using the numeric keys and then press the ENTER key Operator prompts indicate the information that must be entered using the numeric keys and or the ENTER YES key or the CLEAR NO key When all values are properly set in the option the pump will either indicate PUSH RUN for the optional operating mode just set or will return to the previous operating mode from options which do not affect the mode of operation of the pump Once an option has been entered to review all entries prior to starting the infusion repeatedly press the ENTER key To erase a mistaken entry press the CLEAR key when the mistake displays then enter the correct value and press the ENTER key To erase and leave an entire option mode press the CLEAR key while the option code number option name PUSH ENTR or PUSH RUN is displaying To access additional options before starting the pump wait until the PUS
85. V 0 75Ah 1 2AA Li TCI 2 3 11002 C1 C8 C83 CAP cer 22pf 100V C0G 596 SM 3 18 10003 C10 C27 C35 C36 CAP tant 1uf 50V 2096 SM C37 C38 C39 C60 C6 9 C70 C77 C90 C93 C122 C126 C127 C131 C133 4 1 11010 C12 CAP cer 33uf 50V 20 X7R Z5U SM 10005 C13 C17 CAP tant 47uf 10V 20 SM 6 10 11007 C14 058 059 0105 C CAP cer 1000pf 50V 10 COG SM 106 C108 C109 C110 C136 0138 T 4 11008 C19 C52 C71 C97 CAP cer 3300pf 50V 10 COG SM 8 1 12002 C2 CAP myl 0 1uf 100V 10 TH 9 1 10004 C21 CAP tant 10uf 35V 20 SM 10 1 10006 C24 CAP tant 4 7uf 35v 10 TH 11 3 11006 C29 C30 C44 CAP cer 820pf 100v 10 C0G SM 12 7 10001 C3 C9 C31 C46 CAP tant 10uf 20V 20 SM C72 C103 C128 13 53 11001 C4 C5 C6 C7 C11 C2 CAP cer 0 1uf 50V 20 X7R Z5U SM 0 C22 C23 C26 C40 C42 045 047 048 04 9 C55 C56 057 061 C62 C63 C64 C65 C6 6 C67 C68 C74 C75 C76 C78 C81 C82 C8 6 C87 C88 C89 C92 C94 C95 C96 C99 C1 04 C111 C112 C120 C123 C129 C130 C132 C134 C135 C121 14 5 11005 C41 C43 C73 C79 C8 CAP cer 01uf 100v 10 X7R TH 0 15 7 11003 C50 C51 053 098 C1 CAP cer 100pf 100V 596 C0G SM 01 C102 C124 16 2 11004 C54 C100 CAP cer 560pf 100V 596 C0G SM 17 8 25104 D1 D5 D6 D7 D8 DIODE ref schtky 1A 40V SM D21 D30 D 31 18 18 25102 D2 D9 D 10 D11 DIODE sig 1N4148 50D80 C SM D12 D13 D23 D24 D3 2 D33 D34 D35 D36 D37 D38 D39 D40 D4 1 19 3 25101 D4 D14 D22 DIODE ref adj TL431 SM 20 1 25319 K1 RELAY SM 21 5 25317 LC1 LC2 LC3 EMI
86. a VALU HIGH display then revert to the NDX xxx prompt where xxx is the previous value Press OPTIONS to exit the option with no changes Modification of this value requires the restricted access password General access password provides read only rights Enter calibration values for low battery and dead battery General access password required Section 1 page 38 DS CAL PASS WORD SET PRES TO 2PSI PUSH ENTR 2PSI xxxx SET PRES TO 1 8PSI PUSH ENTR 18P xxxx DSSF xxxx DSNT CAL PASS WORD NO TUBE PUSH ENTR DSNT xxxx INDX OFST PASS WORD NDX xxx VALU HIGH BATT CAL PASS WORD LBAT XXXX SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of Option Pump Display CALIBRATE BATTERY Calibrate the battery thresholds for low battery BATT CAL THRESHOLDS and dead battery Requires an adjustable power supply connected to the battery terminals PASS General access password required WORD SET BATT TO LBAT PUSH ENTR LBAT XXXX SET BATT TO DBAT PUSH ENTR DBAT XXXX DISPLAY BATTERY Displays the current voltage level of the battery in xx x Vdc LEVEL IN VDC Vdc Motor may be operated to check battery under typical load conditions General access flashing password required when motor is in operation DISPLAY THERMISTOR Displays the current temperature as it reads on TEMP xx9F TEMPERATURE VALUE
87. alue General access password required Section 1 page 37 US CAL PASS WORD UFRQ xxxx LFRQ xxxx QDEL xxxx NDEL xxxx UDRV x LDRV x UQRF xxxx UNRF xxxx LQRF xxxx LNRF xxxx UTRP xxxx LTRP xxxx TSNS CAL PASS WORD DFLT VALU YES NO WORK ING RMVE TUBE WATR TUBE AIR TUBE TCAL DONE BAD SNSR LOW RDNG HIGH RDNG HILO RDNG BAD REFS WIDE REFS WIDE DRIV DS CAL PASS WORD DSNT xxxx DSSF xxxx SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of Option Pump Display CALIBRATE DOWNSTREAM SENSOR CALIBRATE DOWNSTREAM NO TUBE VALUE ENTER MOTOR INDEX OFFSET VALUE ENTER BATTERY CALIBRATION VALUES Calibrate the Downstream sensor Scale Factor ADC counts per PSI Requires that a tube be already loaded into the pump and can be pressurized to 2 psi and 18 psi The pump takes sensor readings at the 2 psi and 18 psi pressures displays the readings and calculates and displays the Scale Factor General access password required Calibrate the Downstream sensor No Tube value Requires that no tube be loaded into the pump A reading of the sensor is taken displayed and saved General access password required Enter index offset in value of degrees Press CLEAR to revert to default value of 0 Press ENTER to accept the value 0 359 inclusive An out of range value will result in
88. am steps stored in permanent memory are made available to the user to select whatever rates and volumes are desired They are run as a continuous program until they are all finished SRS 0160 997 This provides another set of eleven program steps and works the same as Option 63 SRS 0160 996 Set pressure limit for downstream occlusion sensor in psi CLEAR key displays default value of 10psi Range of 2 15 psi SRS 0160 005 Set pressure limit for downstream occlusion sensor in mmHg CLEAR key displays default value of 500 mmHg Range of 100 750 mmHg SRS 0160 980 Enables or disables the Downstream Pressure Graphic Trend display that will be included in the running display sequence SRS 0160 979 Displays the downstream pressure graphic for 30 seconds whether the pump is running or not SRS 0160 978 Option will display current status of the Drug Label feature Toggle Drug Label on or off by selecting the option SRS 0160 300 Section 1 page 20 SET PROG VOL 0 SET PROG 0 hrs SET RAMP RAMP UP 0 hrs SET TAPR TAPR DOWN 0 hrs DISP ON or DISP OFF gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt LABL ON or LABL OFF SIGMA MODEL 8000 8 amp 8000 Z INFUSION PUMP SERVICE MANUAL Rev M 1 6 USER ACCESSIBLE OPTIONS Option Name Description of Option Pump Dis
89. chemical spill kit and rinsed away with water Skin or eyes contacted by sulfuric acid must be flushed with large amounts of water and receive immediate medical attention to prevent serious burns or blindness 1 Disconnect the Line Cord and lay the Model 8000 Pump on its front Use a protective surface such as plastic foam to prevent damage to the front panel 2 Loosen the four screws securing the pole clamp assembly and lift the assembly away from the case 3 Disconnect 6P2 the battery connector and lay the pole clamp over the side of the pump 4 Note the positions of any anti rattle pads around the batteries and remove them if necessary The batteries may now be lifted out On newer pumps the foam pads will be attached to the case and will not be on the batteries 5 Position new batteries in the battery compartment and replace the pads replace pads to case if not on replacement batteries 6P2 and pole clamp in their original positions Allow the new battery to charge for 18 24 hours with the Pump plugged in Section 1 page 50 SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M 1 9 SERVICE Figure 1 9 4 BATTERY REPLACEMENT SERVICE MANUAL FILE NAME BATTRPLA DWG Section 1 page 51 SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL REV M SOP 11089
90. cord plugs into the pump s RS232 connector back panel When the sensor detects no drop flow the EMPT BOTT CLR TOCC empty bottle upstream occlusion alarm occurs Eliminating the cause of the alarm and pushing RUN causes the infusion to resume Alarms Air Downstream Occlusion Upstream Occlusion Infusion Complete Program Complete Low Battery Plug In Malfunctions Empty Container with optional flow sensor Operator Errors Prompts PM Due Notification Section 1 page 7 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M 1 4 PUMP SPECIFICATIONS 1 4 5 PHYSICAL Dimensions 9 5 H x 6 5 W x 6 75 D 242 mm x 165 mm x 174 mm Weight 10 Ibs 4 5 Kg Case material High impact plastic UL listed CSA certified IV Pole Clamp Pole Size Requirement 0 5 to 1 0 diameter 1 4 6 LISTINGS amp CERTIFICATIONS NRTL C to CSA Standard C22 2 No 125 M1984 Electromedical Equipment and UL Standard No 544 Medical and Dental Equipment The NRTL C indicates that the product has been evaluated by CSA to the applicable ANSI UL and CSA Standards for use in the U S and Canada NRTL Nationally Recognized Testing Laboratory is a designation granted by the U S Occupational Safety and Health OSHA to laboratories which have been recognized to perform certification to the U S Standards Section 1 page 8 SIGMA MODEL 8000 amp 8000 A INFUSION PUMP
91. d in 3 2 4 3 LED Displays The Display Board holds two 4 character ASCII Alphanumeric LED Data Displays Each Character is made up of a 5x7 matrix of green light emitting diodes Characters are 0 27 inches high and spaced on 0 25 inch centers Any of 128 ASCII characters may be written to the display in any of the eight character positions in random order 3 2 5 SENSOR PCB See Schematic Figure 2 6 0 Assembly Figure 2 6 1 and Bill of Material Table 2 6 2 The Sensor Board provides additional printed circuit board area to house the interface circuits for the temperature air roller clamp drop flow and pressure occlusion sensors Each of these sensors operation depends upon a transducer element to change the physical quantity being measured into an electrical analog voltage along with circuitry to standardize the voltage for use by the processor Each of these is discussed in its respective sensor section elsewhere in this theory of operation 3 2 6 PROCESSOR PCB See Schematic Figure 2 6 0 Assembly Figure 2 6 1 and Bill of Material Table 2 6 2 The Processor Board contains the 68HC16 Microprocessor and the Random Access Memory RAM and Programmable Read Only Memory Program PROM necessary to run the control program of the Model 8000 Infusion Pump In addition the Keyboard Interface Display Interface Motor Controller and Speaker Driver occupy the Processor Board Section 3 page 9 SIGMA MODEL 8000 amp 8000
92. d option will allow operator to delete individual drugs from the drug library or delete all drugs at once All actions must be confirmed The default drug library is not affected Section 1 page 41 DUMP LIBR blinking while in progress SEND ING DUMP DONE PUSH ENTR LIBR INFO V XX yyy LIBR SIZE USED xxx FREE yyy DLET DRUG PASS WORD DLET ALL YES NO drug name YES OR Y DE LETE drug name YES NO DELE TED SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of Option Pump Display ADD DRUGS TO DRUG Password protected option to allow the operator ADD DRUG LIBRARY to add drugs to the drug library Character entry PASS is provided to spell the drug Drug Error WORD 4meg feature Prevention limits may be entered for the new Pla model feature drug from within this option see BMO 612 ENTR DRUG Software version 4 00 and later N New Drug ADD LMIT YES NO if YES see BMO 612 ADD DRUG YES NO Section 1 page 42 SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of Option Pump Display ASSIGN LIMITS TO DRUGS 4meg feature Pu model feature Software version 4 00 and later Password protected option to allow the operator to assign dose rate and drug concentration lim
93. d representative for inspection and repair or replacement if necessary Pumps returned to SIGMA must be properly packaged and sent to SIGMA with postage and handling prepaid Severe pump damage may result if SIGMA shipping cartons and inserts are not used Shipping cartons and inserts are available from SIGMA This limited warranty shall not apply to defective conditions or damage caused in whole or in part by negligence fluid spills dropped Pumps misuse abuse improper installation improper cleaning alteration or damage caused by improper shipment to SIGMA If after inspection SIGMA is unable to identify a problem SIGMA reserves the right to invoice the purchaser for such inspection Annual Preventative Maintenance Inspections are also excluded from this warranty THIS LIMITED WARRANTY IS THE SOLE AND ENTIRE WARRANTY PERTAINING TO THE PUMP AND IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES OF ANY NATURE WHATSOEVER WHETHER EXPRESS IMPLIED OR ARISING BY OPERATION OF LAW TRADE USAGE OR COURSE OF DEALING INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE ANY AFFIRMATION OF FACT OR PROMISE MADE BY SIGMA SHALL NOT BE DEEMED TO CREATE AN EXPRESS WARRANTY THAT THE PUMP SHALL CONFORM TO THE AFFIRMATION OR PROMISE ANY DESCRIPTION OF THE PUMP IS FOR THE SOLE PURPOSE OF IDENTIFYING IT AND SHALL NOT BE DEEMED TO CREATE AN EXPRESS WARRANTY THAT THE PUMP SHALL CONFORM TO SUCH DESCRIPTION ANY SAMPLE
94. e preventing removal of the line cord from the Pump except with a screwdriver to prevent accidental loss of the line cord 3 2 2 1 1 LINE CORD AND INPUT VOLTAGE SELECTOR Power from the AC line enters the Model 8000 Infusion Pump through the line cord and A C Power Entry Module as shown on Figure 2 2 1 the Cable Diagram The AC line connection to the Transformer Board is made through 7W1 the brown line wire and 7W2 the light blue neutral wire These connections are made with double insulated wire On entering the Transformer Board line power is applied to the Voltage Selection connectors as seen in the Schematic If no jumpers are installed fixed jumper traces are present it results in parallel excitation of the dual transformer primary for operation on 120 volts RMS nominal line voltage Operation on nominal 240 volts RMS lines is possible by removing the fixed jumper traces and installing a jumper as seen on the schematic which selects series connection of the dual primary Fuses in the A C Power Entry Module must be selected for compatibility with the line voltage operation selected Line fuses are as follows Fuses may be replaced only with the following parts For 120 Volt operation Littelfuse 218 500 0 5A Slo Blo For 240 Volt operation Littelfuse 218 250 0 25A Slo Blo Substitution of other fuses violates the Medical Device Certification of this Product and may compromise Product Safety 3 2 2 2 A C INLET MODUL
95. e rise in the case of a short circuit fault either within the transformer or in the associated circuitry Accordingly The Power Transformer may be replaced only with a CSA approved replacement transformer Sigma p n 55001 Substitution of another transformer is a violation of the Medical Device Certification of this Product and may compromise Product Safety 3 2 2 4 SECONDARY VOLTAGE AND POWER INDICATOR The secondary voltage of the Power Transformer is nominally 24 volts and powers the Model 8000 through 7W3 and 7W4 Presence of AC power is indicated by energizing a light emitting diode LED on the front panel The small current required for the LED is supplied by D1 R1 and R2 and is a half wave rectified pulsating DC of less than 10 mA average current or less than 20 mA peak Fuse F1 protects the transformer in the event of a catastrophic overcurrent drawn from the secondary This fuse will ordinarily never need to be replaced and in the event that it opens a serious failure elsewhere is indicated Return the equipment for factory service if F1 opens unless the reason for its failure is known for certain i e an accidental short circuit during maintenance 3 2 3 REGULATOR PCB BATTERY CIRCUIT See Schematic Figure 2 4 0 Assembly Figure 2 4 1 and Bill of Material Table 2 4 2 3 2 3 1 RECTIFIER FILTER REGULATOR Low voltage AC from the power transformer secondary enters the Regulator Board at 6P1 and is rectified by bridge r
96. e roller must be placed in the closed position This guarantees that no uncontrolled gravity flow can go undetected prior to the pump being started The roller must likewise be closed before the tubing is removed from the pump This assures that no uncontrolled flow is possible during I V set removal The Tube Channel is locked closed on an installed IV set until the roller clamp is placed in the closed position This system assures that either a pump finger or a closed roller clamp occludes the tubing to prevent uncontrolled gravity flow through the infusion set The pump is not allowed to start unless the roller clamp is in the open position assuring proper fluid delivery Three conditions must be met to allow the Tube Channel to be safely opened for unloading or re priming the IV set without danger of accidental uncontrolled gravity flow First the roller clamp wheel must be closed Second the lever locking mechanism must be unlocked Note in some instances the OPEN key on the Keypad must be pressed to do so Third the Pressure Plate Release Lever must be pulled open to release the tubing At this time the IV set may be safely removed from the Tube Channel or the roller clamp may be opened to re prime the tubing intentionally under operator supervision 3 1 3 2 2 Roller Clamp Sensing Sensors monitor the presence of the clamp and the position of the roller The presence of the Roller clamp is detected by a switch contact closure Roller p
97. ecommended for the pumps before flow rate testing Ref IEC601 2 24 6 9 5 Hang the IV container filled with water 24 above the pumping mechanism 6 9 6 Connect the IV set to the IV container and prime the set completely 6 9 6 1 Remove all air from the tubing being sure the drip chamber is at least half full 6 9 7 Load a new fresh section of the set into SIGMA 8002 pump and close the lever 6 9 7 1 Open the roller clamp 6 9 8 Place the open end of the IV set over a dry collection cup 6 9 8 1 Be sure fluid is at the end of the IV set but none has dripped into the collection cup before starting the test 6 9 9 Turn the pump on and set the flow rate 10 ml hr and set volume limit 10 ml 6 9 10 Begin the test by pressing the RUN key 6 9 11 Allow the SIGMA 8002 pump to run until it goes into infusion complete alarm 6 9 11 1 Press the STOP key to halt the KVO keep vein open rate once the pump goes into infusion complete 6 9 11 2 Iftest is interrupted by any alarms start this test again from the beginning Section 1 page 11 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M 1 5 PREVENTATIVE MAINTENANCE ITP 35001PM Procedure revision level G 6 9 12 When delivery is complete weigh the fluid using an electronic balance 6 9 12 1 Weigh the collection cup with fluid in it 6 9 12 2 Zero the electronic balance while fluid is in the cup 6 9 12 3 Remove the collection cup Empty the cup
98. ectifier D8 The raw DC is filtered by C16 The raw DC may vary between 22 to 39 Volts DC and contain up to 4 Volts p p of ripple depending upon line and load A switched mode buck topology regulator U1 steps down the raw DC voltage to a nominal value of 15 volts Due to component variations the actual value of the regulated voltage may be between 14 9 and 16 2 volts C10 C15 provide low impedance decoupling for the switching ripple current of U1 which switches at 100 kHz L1 is the filter inductor and D3 is the output catch diode for the regulator R4 and R5 are the feedback resistors which set the output voltage of the regulator Filter capacitors C4 C9 minimize ripple on the output voltage Details of the operation of U1 a Linear Technology LT1076 may be found in Linear Technology Application Note 44 The regulated 15 volts is summed with the battery voltage in diodes D4 and D6 to form the motor voltage supply labeled VMOT Diode summing allows the battery to take over Section 3 page 7 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M THEORY OF OPERATION instantly upon loss of AC line voltage and the battery to begin recharging immediately upon restoration of line voltage 3 2 3 2 LOGIC VOLTAGE SUPPLY AND SWITCH Supply voltage for the 5 volt logic in the Model 8000 Infusion Pump is regulated by a three lead switching regulator the Power Trends 78SR105 designated U2 The device
99. efer to a qualified Service Technician for inspection and repair prior to further use USE ONLY I V ADMINISTRATION SETS THAT ARE LISTED ON SIGMA COMPATIBLE SET LISTING contact SIGMA for listing NOTE Use of any other sets will result in malfunction or inaccurate delivery DO NOT USE IF ROOM OR PUMP TEMPERATURE IS BELOW 15 C 60 F OR ABOVE 40 C 104 F LITHIUM BATTERY SIGMA P N 55003 LOCATION BT1 ON PCBA P N 60010 DANGER OF EXPLOSION IF THE BATTERY IS INCORRECTLY REPLACED REPLACE ONLY WITH THE SAME OR EQUIVALENT TYPE RECOMMENDED BY SIGMA DISCARD USED BATTERIES ACCORDING TO THE MANUFACTURER S INSTRUCTIONS LITHIUM BATTERY SIGMA P N 55003 LOCATION BT1 ON PCBA P N 60010 IL Y A DANGER D EXPLOSION S IL Y A REMPLACEMENT INCORRECT DE LA BATTERIE REMPLACER UNIQUEMENT AVEC UNE BATTERIE DU MEME TYPE OU D UN TYPE RECOMMANDE PAR SIGMA METRE AU REBUT LES BATTERIES USAGEES CINFORMENT AUX INSTRUCTIONS DU FABRICANT Federal USA law restricts this device to sale by or on the order a physician or other licensed practitioner Operate only on the AC Line voltage for which the unit is marked Use only a Hospital Grade outlet for AC operation to assure proper grounding The pump should be plugged in during storage to maintain proper battery charge Section 1 page 2 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M 1 2 CAUTIONS AND WARNINGS CAUTION Remove AC pow
100. er and disconnect the battery connector prior to servicing this Pump Routine cleaning and periodic maintenance is needed to assure that the Pump remains safe and functional Refer to Section 1 3 Cleaning and Maintenance and Section 1 5 Preventative Maintenance Solution spills should be cleaned up as soon as possible using a damp cloth or sponge Dry thoroughly before use The upstream sensors tube channel must be kept clean and dry at all times during pump operation Do not use hard or sharp objects to clean sensor tube channel areas Failure to comply with this requirement may cause the pump to fail Refer to Section 1 3 Cleaning and Maintenance Static sensitive electronics used in SIGMA infusion pumps may be damaged by electrostatic discharge Service technicians must follow proper ESDS procedures when working on units Refer to MIL STD 1686 for protective handling procedures Do not use a pen or any other sharp object to actuate the keyboard switches Replace torn or punctured membranes immediately to assure solutions won t internally damage the membrane switch and prevent proper operation of the Model 8000 Replacement should only be performed by authorized personnel If using filter set use only filters which state specifically in the instructions that they may be used with pumps Read and follow instructions of the filter to be used Section 1 page 3 SIGMA MODEL 8000 amp 8000 Zs INFUSION PUMP SERVICE
101. erefore the collector current are constant Q2 thus acts as a constant current source charging the Battery at a current of around 250 mA or C 10 for the 2 5 Ah Battery Battery voltage is sensed by divider network R11 R12 and R13 D5 prevents discharge by the divider when line voltage is not connected When the wiper of R12 rises to 2 5 volts adjustable zener diode D7 draws anode current partially shutting off Q3 and Q2 terminating constant current charging The collector of Q2 then maintains a set voltage charging in constant voltage mode until full charge is obtained R12 allows the constant voltage of the charger to be adjusted between 13 8 and 15 1 volts accommodating the charging voltage needs of various batteries 3 2 3 4 BATTERY PACK Six 6 D Cell starved electrolyte sealed lead acid storage batteries provide 4 5 hours of pump operation when fully charged This can be used for either standby or portable operation 3 2 3 5 REGULATOR PCB Low voltage AC from the Power Transformer is rectified to DC filtered and voltage regulated by the Regulator Board Regulation occurs in two steps A switched mode pre regulator drops the voltage of the filtered DC to an intermediate level suitable for operating the pump motor and charging the battery The battery is charged by the current limited constant voltage technique at a rate of C 10 The motor is driven with a constant current switched mode motor driver Section 3 page 8
102. exit the option with no change to the old value Press ENTER to accept the new value SET MAXIMUM VOLUME Set maximum allowed value to be entered for primary Volume Enter the new value using the numeric and decimal keys Press CLEAR to reset to default value of 9999 Press OPTIONS to exit the option with no change to the old value Press ENTER to accept the new value Set maximum allowed value to be entered for VALUE primary Time NA SET MINIMUM RATE Set minimum allowed value to be entered for primary Rate Enter the new value using the numeric and decimal keys Press CLEAR to reset to default value of 0 Press OPTIONS to exit the option with no change to the old value Press ENTER to accept the new values SET MAXIMUM Set maximum allowed value to be entered for PIGGYBACK RATE piggyback Rate NA SET MAXIMUM Set maximum allowed value to be entered for PIGGYBACK VOLUME piggyback Volume NA SET MAXIMUM Set maximum allowed value to be entered for PIGGYBACK TIME piggyback Time NA ENTER TEST MODE Enter Test Mode for running pump to test it Press Run key to start pump at rate 100 volume 9999 press Run key again to stop pump press Options key to exit option and stop the pump if running General access password required Section 1 page 29 MAX RATE RATE xx curr value RATE yy new value MAX VOL VOL xx curr value VOL yy new value MIN RATE RATE xx curr value RATE yy new value TEST
103. flow rate error is not greater than 896 6 11 LINE SAFETY ANALYSIS 6 11 1 Verify ground impedance is 0 13 ohms 6 11 2 Verify chassis leakage current is 25 microamps Section 1 page 12 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M 1 5 PREVENTATIVE MAINTENANCE ITP 35001PM Procedure revision level G 6 11 3 6 11 4 The Line Cord is tested for chassis risk current 15 micro amps normal 50 microamps single fault and safety ground resistance 0 13 ohms using a Line Safety Analyzer 6 11 3 1 The AAMI Safe Currents Limits Test SIGMA SOP 11170 available from SIGMA International Inc is the recommended test procedure 6 11 3 2 Another procedure based on the AAMI IEC or CSA Line Safety tests may also be used if so dictated by the individual safety standards of the installation site Inspect the line cord retainer to be sure that the cord can not be removed accidentally 6 12 FLOW SENSOR OPERATION OPTIONAL 6 12 1 6 12 2 6 12 7 6 12 8 6 12 9 Set RATE to 125 and VOL LIMIT to 100 6 12 1 1 Push RUN and allow the fluid to flow Plug the appropriate tubing calibration flow sensor into the nine pin RS 232 connector on the rear of the pump Verify that the pump stops and displays PUMP STOP PUSH RUN Push RUN to start the pump with the flow sensor off of the set s drip chamber Verify that the pump goes into an audio alarm and displays EMPT BO
104. gative downstream pressure Plus 100 mmHg maximum positive downstream pressure With 72 hour usage of one section of an IV set while infusing a maximum of 9 liters i e 125 ml Rr With the solution 24 in above the pumping mechanism Using the single standard IV set brand specified for the pump approved Hospira Baxter or B Braun McGaw sets Minimum 60 minute sample volumes contact SIGMA for detailed trumpet curves Nominal temperature range from 68 F to 75 F Sets loaded taut with minimal stretch during loading excessive set stretching can cause 10 flow errors Note If these parameters are exceeded move to a fresh section of tubing to restore specified accuracy 0 1 999 ml hr delivery range RATE with 0 1 ml hr increments from 0 1 99 9 ml hr and 1 0 ml hr increments above 100 ml hr 0 1 9999 ml volume limit range Note IV bottle usage requires a vented IV set KVO keep vein open rate is 1 ml hr or the selected rate whichever is lower IV set based anti free flow protection Section 1 page 5 SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL REV M 1 4 PUMP SPECIFICATIONS Upstream occlusion time to alarm DISTANCE OCCLUSION ABOVE PUMP RATE 6 IN 24 IN 5 ml hr 4 min 8 min 100 ml hr 30 sec 40 sec 999 ml hr 10 sec 10 sec Note Upstream occlusion detection is only effective for occlusions present immediately after the start of the pu
105. gram and Cable Diagram 3 2 2 Transformer PCB AC Line Circuit 3 2 2 1 Line Cord 3 2 2 1 1 Line Cord and Input Voltage Selector 3 2 2 2 AC Inlet Module Fuses 3 2 2 3 Power Transformer 3 2 2 4 Secondary Voltage and Power Indicator 3 2 8 Regulator PCB Battery Circuit 3 2 3 1 Rectifier Filter Regulator 3 2 3 2 Logic Voltage Supply and Switch SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M TABLE OF CONTENTS 3 2 3 3 Battery Charger 3 2 3 4 Battery Pack 3 2 3 5 Regulator PCB 3 2 4 Display PCB Auxiliary Bus 3 2 4 1 Display PCB 3 2 4 2 Display Auxiliary Bus Interface 3 2 4 3 LED Displays 3 2 5 Sensor PCB 3 2 0 Processor PCB 3 2 6 1 Microprocessor 3 2 6 2 Power Switching Control 3 2 6 3 Static RAM and Program PROM 3 2 6 4 Electrically Erasable PROM 3 2 6 5 RTC Clock and Supervisor Circuit 3 2 6 6 Analog Input Channels 3 2 6 7 Pump Temperature Monitor 3 2 6 8 Speaker Driver Volume Control 3 2 6 8 1 Speaker 3 2 6 9 Display Auxiliary Interface 3 2 7 Keyboard 3 2 7 1 Keyboard lnterface 3 2 8 Text Port Shaft Sensor Flow Sensor Lever Lock Control 3 2 9 Back Panel Serial Interface Connector 3 2 9 1 Flow Sensor and Interface 3 2 9 2 Nurse Call 3 2 9 3 Serial Communication Interface SERVICE MANUAL SIGMA INTERNATIONAL MODEL 8000 amp 8000 Aw INFUSION PUMPS SECTION 1 SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M TABLE OF CONTENTS SECTION 1 GENERAL IN
106. intenance Updated Preventative Maintenance Check Off Sheet Section 3 page 16
107. ion Pump Display REINITIALIZE NVRAM Reinitializes NVRAM to default values updates checksum and then powers down the pump Press Yes key to perform action or press No or Options key to exit with no action taken DUMP HISTORY LOG Dump contents of History Log out the serial port Dump current values of history counters out the serial port DUMP SHORT HISTORY Dump Pump ID History Counters and System LOG Timestamp readings out the serial port 430 CLEAR FIX CODE Clear an existing fix code and then power down the pump 40 4 TEST FUNCTION Perform a series of tests of the pump hardware The display will indicate if the Drop Sensor is installed or not and will show the current drop count The count can be cleared by pushing the Clear key Push the Enter key to continue to the next test or the Options key to exit the Option The next test will display the status of four input port bits s syringe installed p pca input I pca lock and i spare i o 1 The Enter key continues to the next test and the Options key exits the option The last test is a thermistor reading The Enter or Options keys exit the option Section 1 page 32 INIT NVRM if YES pressed NVRM INIT POWR OFF DUMP HIST blinking while in progress DUMP DONE SHRT HIST DUMP DONE CLR FIX FIX 00 POWR OFF TEST HW FLOW SNSR IN xxxx or OUT xxxx INPT STAT SPLI spli TEMP RDNG TEMP xxxx SIGMA MODEL 8000 amp 8000 A INFUSIO
108. its as well as desired delivery mode to any drug in the drug library Limits may be entered as either soft limits or hard limits or both mode is represented by the delivery mode selected to deliver the drug in units of drug over a period of time considering patient weight when applicable Concentration values shall be entered based on the unit type of drug per mL of diluent If RATE mL h is selected operator may assign only minimum and maximum rate values no concentration value is allowed Section 1 page 43 DRUG LMIT PASS WORD drug name YES OR Y SET MODE DOSE mode or RATE mL h if DOSE mode selected above SET CONC 0 nnmL nn drug unit sMAX DOSE 0 mode sMIN DOSE hMIN DOSE 0 mode if RATE mL h selected above sMAX RATE 0 mL h sMIN RATE 0 mL h hMAX RATE 0 mL h hMIN RATE 0 mL h ANO THER YES NO SIGMA MODEL 8000 8 8000 A INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of Option Pump Display INITIALIZE DRUG Password protected option to allow the operator LIBRARY to initialize the drug library restoring it to the default library shipped from the factory 4meg feature Phu model feature Software version 4 00 and later Section 1 page 44 INIT LIBR PASS WORD CON FIRM LIBR INIT YES NO INIT DONE SIGMA MODEL 8000 amp 8000 7X INFUSION PUMP SERVICE MANUAL Rev
109. l 00 2 85 DA NIA T VST AS 3AS012S m 000 edm te l 0 778 SE 9 0658 ASSY 314735 k UJ oreasan 0001 E K 1 NIS Se DHIA 26011 S 2 8 50 20 9 gays 8 ca 14 209 2201 VIVIA 22 LAS va 228038 AG 959 228977 NIS T 435 1 f NIS GAS TNDd A02 02 432701 3001 4001 Ani anro 22818 Lt Lt pares Em REI 83 93 3 4 A02 34001 A001 06 06 AOS R 228225 2 d S FEI AN 411 u KOR snooze EHE i E Ep 63 va 719 2 913 N TY 08 A0S MOOST 0072 A d 4 0 i z Sa N DE d T ES YS gab u un H gy 213 He SK oveduan H I ea HSL IN Voy ASA d NIA Am 2 13920117 c 90730 LIA 61 Section 2 page 8 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 4 1 REGULATOR PCB LAYOUT DWG 60001 Rev E RAE 2 SLCSLCZLCRLC L1 i 14 MS W26 o ON N D8
110. l of a PC The Lever latch is controlled by pin 73 configured as an output while the status of the Lever is monitored by pins 72 and 79 configured as inputs System interrupts are applied to the processor on pins 75 through 78 Interrupt acknowledges return on pins 119 through 123 Section 3 page 10 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M THEORY OF OPERATION The Write line is on Processor pin 80 Pin 81 through pin 89 and 182 to 131 are used as miscellaneous Input Port lines for example monitoring the status of the PCA input and flow detector installation Most of the Input port is spare The balance of the Processor pins are devoted to Data Bus Pin 91 to pin 109 and Device Select Lines Pin 110 to pin 118 3 2 6 2 POWER SWITCHING CONTROL The power switching control allows the DC power to the Model 8000 Infusion Pump circuit boards to be turned on or off electronically U19 is powered from the standby supply VSTBY continuously Operating the On Off key on the keyboard or installing a roller clamp grounds one of the inputs to U51 A forcing the output high The clock input of U19 A rises and the flip flop toggles turning on Q2 Q13 Q14 on the Processor Board and Q1 on the Regulator Board Logic power and motor power are thus applied to the circuitry The output of U51 A is applied to the set input of U19 B which will turn off the alarm backup power U54 had it previo
111. lows the cumulative totals stored in EEPROM to be cleared when needed For example when the battery pack is replaced the user may clear from memory the total time that the pump ran on the old battery and reset it to zero for the new battery The user may select to either clear a specific value or all the values at once indicated in the column to the right Once a choice has been made the user must confirm the intent to Clear as the value is not recoverable once it has been zeroed Allows the user to select between showing dose mode displays in abbreviated or unabbreviated form Press CLEAR to toggle selection press ENTER to select press OPTIONS to exit with no change Selection is stored in permanent memory Section 1 page 28 LANG UAGE PASS WORD ENGL ISH YES NO FRAN CAIS OUI NON CARE VUE PASS WORD SYS ON SYS OFF CLR TOTS PASS WORD CLR ALL Or BATT TOTL Or REV TOTL Or RUN TOTL Or POWR TOTL Or LEV TOTL Or CLMP TOTL shown with YES NO CON FIRM choice CLEA RING DOSE ABBR ABBR OFF or ABBR ON SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of Option Pump Display SET MAXIMUM RATE Set maximum allowed value to be entered for VALUE primary Rate Enter the new value using the numeric and decimal keys Press CLEAR to reset to default value of 999 Press OPTIONS to
112. m 82 2 v a D i o 1 v 5 ka j 3 gt sy d sie m E 3 1 d al E s 6 3 EI u SE 5 A ae 2 38 123 H Li 3 g NES S gt u E x 4 lt 3 A E EE Section 2 page 15 SIGMA MODEL 8000 8 8000 Al INFUSION PUMP SERVICE MANUAL REV M FIGURE 2 6 1 PROCESSOR SENSOR PCB LAYOUT DWG 60010 Rev P SENSOR ASSY 5
113. m sensor has failed USSENSOR FIX 21 The Downstream Sensor is returning a no tube value beyond the acceptable level FIX 22 The battery charge circuit has failed FIX 23 Lever is not detected in closed position FIX 24 User has improperly unloaded the set lever has remained closed FIX 69 Illegal rate value detected at motor start FIX 97 Software detected that a timer was illegally in use TIMERERR FIX 98 Software has detected that a timer allocation has failed ALLOCFAIL Fix codes can be cleared by using the following method V3 28 and earlier Select BioMed options by pressing the OPTIONS key followed by 89 and the ENTER key Select BioMed option 430 by pressing 430 followed by the ENTER key Exit out of the BioMed options by pressing 0 followed by the ENTER key Turn the pump off then on by pressing the ON OFF key If the FIX code has been cleared the pump can be returned for use Fix codes can be cleared by using the following method V3 29 and later Select BioMed options by pressing the OPTION key followed by 89 and the ENTER key Select BioMed option 430 by pressing 430 followed by the ENTER key The pump will turn off at this point Previous versions of software prior to V3 29 require that the ON OFF key be pressed to turn off the pump at this time Section 1 page 47 SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M 1 8 TROUBLESHOOTING GUIDE 0 Ka
114. mp s run operation Downstream occlusion time to alarm With Occlusion 45 in below the pump and alarm set to RATE 2 PSI 10 PSI 15 PSI 1 ml hr 20 min 40 min 60 min 100 ml hr 15 sec 20 sec 30 sec Max Bolus 0 34 ml 0 6 ml 0 7 mil Downstream occlusion time to alarm for Securus AN tubing With Occlusion 45 in below the pump and alarm set to RATE 2 PSI 10 PSI 15 PSI 1 ml hr lt 20 min gt 80 min 110 min 100 ml hr lt 15 sec lt 30 sec lt 30 sec Max Bolus 0 34 ml 0 7 ml 0 8 mil Ocelusion pressure is adjustable from 2 15 PSI Specifications for downstream ocelusion are Pressure setting Trip pressure tolerance 2 psi 2 1 psi 3 to 4 psi 2 1 5 psi 5 to 15 psi t2 psi Mechanical occlusion pressure limit under fault conditions the maximum pumping pressure if the occlusion alarm is inoperative 55 PSI The air detector senses air bubbles 1 inch long in the IV set All safety related sensing systems are automatically checked for proper operation at power on and periodically thereafter Faults are identified by FIX code 1 4 4 TECHNICAL Type of pump Volumetric infusion pump Operating Principle Linear peristaltic Rated voltage and current 105 135 VAC 0 5A 50 60 Hz fused T500ma IEC 127 U S 220 240 VAC 0 25A 50 60 Hz fused T250ma IEC 127 European Section 1 page 6 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE
115. next PM Due Date Each entry must be followed by pressing the ENTER key Toggle the alarm setting ON or OFF using the CLEAR NO key as desired Press the ENTER key to save all settings and exit the option Pump 4 meg and software version can be determined by accessing Biomed Option 200 Section 1 page 14 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M ICL 35001PM Procedure revision level D SERIAL NUMBER DATE CHANNEL circle one A B N A CUSTOMER CONTROL NUMBER PREVENTATIVE MAINTENANCE CHECK OFF SHEET 6 2 VISUAL INSPECTION PASS FAIL 6 3 VISUAL INSPECTION FOR MODEL 8002 ONLY PASS FAIL 6 4 KEYBOARD TEST PASS FAIL 6 5 UPSTREAM PROXIMAL OCCLUSION SENSOR TEST PASS FAIL 6 6 AIR DETECTION TEST PASS FAIL 6 7 DOWNSTREAM DISTAL OCCLUSION SENSOR TEST PASS FAIL PSI OR MM HG 6 8 MEMORY TEST PASS FAIL 6 9 LOW FLOW RATE ACCURACY TEST FOR MODEL 8002 ONLY PASS FAIL VOLUME OUTPUT ML 6 10 FLOW RATE ACCURACY TEST PASS FAIL VOLUME OUTPUT ML VOLUME OUTPUT ML required for SOP 35002 9 only VOLUME OUTPUT ML required for SOP 35002 9 only VOLUME OUTPUT ML required for SOP 35002 9 only 6 11 LINE SAFETY ANALYSIS PASS FAIL 6 12 FLOW SENSOR OPERATION PASS FAIL 6 13 BATTERY CAPACITY TEST PASS FAIL TIME TO PLUG IN ALARM HRS 6 15 NEXT PM DUE DATE IF ENABLED PM DUE DATE TESTER DATE Section 1 page 15 SIGMA MODEL 8000 8 8000 INFUSION P
116. ns until the biomedical technician changes them They may be accessed as follows 1 Select the OPTIONS key from the main menu display sequence of the pump SET OPT CODE will display Using the numeric keys enter 89 as the option number and press the ENTER key The display will then show SET BIO OPT At this time an option code number for a specific option from the following list may be entered by use of the numeric keys followed by the ENTER key to go directly to any of the listed options see note If the user enters into an option in error pressing the OPTIONS key will exit the present option without change to any of the option settings Pressing the ENTER key while a particular option is displayed allows the biomedical technician to make changes to the set up for that option see note The option may be changed by use of the numeric keys the CLEAR key to clear an entry error or toggle between choices and the ENTER key to accept the currently displayed value or setting as indicated in each of the following sections While setting an option at any point before the final ENTER key is pressed within that option the OPTIONS key may be pressed to immediately exit that option and discard all of the changes made i e the settings that were in effect before entry into that option will remain unchanged Selecting OPT O then pressing the ENTER key from the SET BIO OPT display or any of the OPT displays
117. original shipping container replacement available upon request and affix the RA number on the outside of the package 6 Ship pump freight prepaid by traceable means to SIGMA International LLC 7 When a device is warranted or under a service agreement it is returned freight prepaid 8 SIGMA International Inc will not be responsible for unauthorized returns or units damaged in shipment due to improper packing 1 9 2 FIELD SERVICE Authorization Verbal authorization must be obtained in advance before field service can be performed Written documentation will also be required Section 1 page 49 SIGMA MODEL 8000 8 8000 INFUSION PUMP SERVICE MANUAL REV M 1 9 SERVICE Parts While under warranty SIGMA will supply factory trained authorized service technicians with no charge parts as needed All defective warranty parts must be returned to SIGMA 1 9 3 BATTERY REMOVAL AND REPLACEMENT Should removal of the battery become necessary for any reason the following procedure may be used Refer to Figure 1 9 4 on the next page for the location of parts Defective batteries should be returned to a local battery recycling center or to SIGMA International for recycling DO NOT dispose of sealed lead batteries in the garbage DO NOT short circuit or drop a battery CAUTION Spilled sulfuric acid from a broken battery case must be neutralized with baking soda household ammonia or a commercially available
118. osition is sensed with two Infrared Emitter Detector pairs one pair at both the open position and the closed position of the roller wheel The LED emitter current is chopped at 16 384 kHz to distinguish the infrared beam from room light The phototransistor IR detector drives a tone detection circuit tuned to the chopping frequency which changes the output state when the beam is broken The three IR LED emitters are driven singly by sections of U27 a high current tri state buffer whose signal inputs are connected to a 16 384 kHz signal divided from the processor clock The enable inputs for U27 are decoded from two Processor output lines by U22A The program selects one LED and then monitors the CLAMP 0 5 output of tone detector U29 Section 3 page 3 SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M THEORY OF OPERATION The roller closed state is determined reflectively so the CLAMP O S signal will be low to indicate the presence of the syringe or roller Roller open breaks the beam producing CLAMP O S high to indicate roller presence The tone detector is tuned to twice the chopping frequency or 32 768 kHz to allow its phase detector to work 3 1 3 8 PUMP ASSEMBLY The Model 8000 Volumetric Infusion Pump utilizes a linear peristaltic pumping mechanism Pumping action is effected by inserting the tubing of an IV set into the Tube Channel and closing the pressure plate on the tubing The pressure
119. ost recent calibration attempts and posts a date stamp at the top of each Upon entry the run number of the most recent calibration is displayed with the date on which it was performed Press CLEAR to scroll to the previous entry Press ENTER to view each compensation factor of the calibration number in view Runs the pump at a controlled rate for a 4 hour period to break in the pressure plate and pumping assembly mechanism in preparation for flow rate calibration Pump automatically titrates to 100 ml hr after the four hours have expired Set internal real time clock time and date The values displayed are the current settings Modification of these values requires the restricted access password General access password provides read only rights Set tube type to select motor compensation table CLEAR key clears the value to zero ENTER key accepts value and OPTIONS exits the BMO with no changes Entering a value greater than 9 displays VALU HIGH Modification of these values requires the restricted access password General access password provides read only rights Set the keypad type to select key mapping There are three 0 for Original Standard keypad 1 for Revised Standard keypad with the load key shifted over and 2 for the Braun keypad using the calculator style layout rather than the telephone style Entering a value greater than 9 displays VALU HIGH Section 1 page 36 CAL HIST CAL n mm d d yy if ENTE
120. piggyback rate value SET RATE VOLUME and current piggyback volume value Press Enter PIG RATE MODE to accept value Press numeric key to change RATE 0 value SRS 0160 003 SET PIG VOL VOL 0 30 PRIMARY Set up an infusion using time in hours and tbd TIME VOLUME MODE minutes and volume NA 40 DOSE MODE UN H Displays current dose value and infusate SET DOSE Unit hr concentration in two values Press ENTER to DOSE 0 accept value Press the numeric keys to change SET CONC value 0 unit SRS 0160 982 SET CONC 0 mL Section 1 page 17 1 6 USER ACCESSIBLE OPTIONS SIGMA MODEL 8000 8 amp 8000 ZQ INFUSION PUMP SERVICE MANUAL Rev M Option Name Description of Option NA Not Available Pump Display DOSE MODE UNKM Unit kg m DOSE MODE UNKH Unit kg h DOSE MODE MU M mUnit m DOSE MODE G H gram hr DOSE MODE UGKM mcg kg m DOSE MODE UGKH mcg kg h DOSE MODE UG M mcg min Displays current dose value infusate concentration in two values and patient mass Press ENTER to accept value Press the numeric keys to change value SRS 0160 983 Displays current dose value infusate concentration in two values and patient mass Press ENTER to accept value Press the numeric keys to change value SRS 0160 984 Displays current dose value and infusate concentration in two values Press ENTER to accept value Press the numeric keys to change val
121. plate maintains the tubing in close contact with the peristaltic pump fingers allowing the progressive tubing occlusion necessary to the pumping action The pumping mechanism assembly is described by figure 2 10 1 and Table 2 10 2 the accompanying Bill of Material 3 1 3 3 1 Peristaltic Pump Fingers and Pressure Plate When the tubing is loaded in the peristaltic pumping mechanism a pressure plate forces the tubing into contact with the tips of the pump fingers The fingers move sequentially toward the pressure plate progressively compressing the tubing into occlusion and forcing the trapped fluid downward As the last bottom finger finishes its compression cycle and begins to retract the first finger has reached occlusion trapping the next quantity of fluid and starting the next pumping cycle Flow is effectively continuous The sequential motion of the fingers is controlled by a camshaft comprised of seven eccentric cams each offset rotationally from its neighbors by 1 6 of a revolution 3 1 3 4 DOWNSTREAM OCCLUSION SENSOR Downstream occlusion is detected by measuring fluid pressure for a rising pressure trend during pumping indicating blockage below the pump If the pressure rises a downstream occlusion alarm message is displayed and pumping is suspended 3 1 3 4 1 Downstream Occlusion Sensing Internal tubing pressure is sensed below the pumping area of the Tube Channel If the pressure between the pump and the patient cathete
122. play NA Not Available DRUG LABEL Option allows the addition of a label if no infusion DRUG LABL Software Versions parameters are entered Drug Library is enabled YES NO 4 00 and higher in the Biomed Mode 4meg feature CLEAR DRUG Clear any assigned drug labels and remove them LABL CLRD LABELS from the running display Retains the current status of the Drug Label feature 4meg feature SRS 0160 301 FACTORY OPTIONS Select the Factory Option These options are SET restricted to in house personnel only FACT OPT SRS 0160 976 PASS WORD BIOMED OPTIONS Select BioMed option see the BioMed Options SET section of this document Press numeric keys to BIO OPT select option number Press Clear key to exit and mode OPT nn SRS 0160 006 lt title gt PUSH ENTR DELAYED START Enables the user to delay the start of an infusion SET with or without a KVO infusion during the start DLYD STRT currently not available delay period and after the infusion is complete 0 hrs in software later than Start delay and KVO alarm delay times are v3 28 entered If no infusion mode is set up Primary KVO ON Mode is then suggested but any Alternate Mode is YES NO 4meg feature allowed Once the desired mode is set up the RUN key is pressed to begin the delayed infusion DLAY END At the end of the infusion a KVO alarm delay will KVO ALRM begin if selected after which the KVO alarm will 0 hrs sound SRS 0160 977 PRI MODE YES NO
123. ption Pump Display TITRATION Allows user to disable or enable Titration DISABLE ENABLE OPTIONS exits the option with no change CLEAR toggles between on and off ENTER accepts the displayed status on or off and exits the option TITR DISA TITR ON or TITR OFF bd 230 SET INITIAL POWER ON Set initial prompt displayed at power on NA t PROMPT SET SPECIAL DISPLAY Allows custom setting of the Primary Total OPTIONS Volume Dose Total Volume Primary Volume Dose Volume and Battery Indicator running display prompts 4meg version only Press CLEAR to toggle status between On and Off Press ENTER to accept the value Press OPTIONS to exit the option with no changes DISABLE CHECK PIG Option will display the check pig clamp prompt CLAMP PROMPT status Push CLEAR to toggle ENTER to select OPTIONS to exit with no change from original status RASPBERRY ALARM Disable or enable the lever improperly positioned raspberry buzzer and or set its default volume Press 0 to disable it CLEAR to set it to the medium level 1 for low 2 for medium or 3 for loudest NVRAM Init will leave it on at medium KEY BEEP DISABLE Select Key Beep Enabled Disabled Option will display Key Beep status Push CLEAR key to toggle status between On and Off Push ENTER key to accept displayed status Push OPTIONS key to exit with no change from original status 242 PIGGYBACK COMPLETE Enable disable the four beeps sounded at BEEP ENAB
124. r is found to be rising an appropriate occlusion alarm message is displayed and an alarm sounded alerting the user to total obstruction of the fluid path The Pump stops and remains stopped until the cause of the occlusion is removed and the measured pressure is reduced allowing the delivery to resume automatically Downstream pressure is monitored by the Downstream Pressure Transducer which is a piezo resistive bridge transducer The transducer is excited with a DC reference of 4 0 volts U42A A differential amplifier with a gain of 260 U42B boosts the signal level of the transducer and feeds the signal to Analog input 2 of the Processor 3 1 3 5 PRESSURE PLATE RELEASE LEVER The Pressure Plate Release Lever is pulled open to move the pressure plate away from the pump fingers allowing tubing to be installed in or removed from the Tube Channel The roller clamp must be installed and in its closed position to allow the Lever to be opened for Section 3 page 4 SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M THEORY OF OPERATION removal of the tubing otherwise the Lever remains locked and closed at all times when the tubing is sensed in the pump 3 1 4 STEPPER MOTOR AND DRIVE BELT See Assembly Figure 2 7 1 Bill of Material Table 2 7 2 Assembly Figure 2 15 1 and Bill of Material Table 2 15 2 The pump assembly camshaft is rotated by a Stepper Motor through a cogged drive belt and
125. rol IC If the Processor fails the motor stops 3 2 ELECTRONIC COMPONENTS 3 2 1 FUNCTIONAL BLOCKS 3 2 1 0 BLOCK DIAGRAM AND CABLING DIAGRAM A Block Diagram showing a simplified interconnection of all of the Functional Blocks which make up the Model 8000 Volumetric Infusion Pump is found in Figure 2 1 0 A more detailed description of the actual Printed Circuit Boards Components and Interconnections is contained in Figure 2 2 1 Cable Diagram The two of these diagrams together describe the signal data flow within the Model 8000 as well as which cable connector and boards are associated with a certain function The Model 8000 circuitry is seen to reside on five printed circuit boards specifically the Transformer Board the Regulator Board the Display Board the Sensor Board and the Section 3 page 5 SIGMA MODEL 8000 amp 8000 INFUSION PUMP SERVICE MANUAL REV M THEORY OF OPERATION Processor Board Each of these is discussed in general in this section and in more detail in the associated sub sections 3 2 2 TRANSFORMER PCB AC LINE CIRCUIT See Schematic Figure 2 3 0 Assembly Figure 2 3 1 and Bill of Material Table 2 3 2 3 2 2 1 LINE CORD Power is supplied to the pump through a Hospital Grade plug and line cordset The cordset is terminated at the chassis in an A C input receptacle allowing the cordset to be replaced if damaged The pole clamp assembly is provided with a mechanical retention devic
126. sposal The following cleaners and disinfectants may be used 7096 to 9096 ethyl or isopropyl alcohol in water 1096 bleach in water produces 0 5596 Sodium Hypochlorite Sodium Hypochlorite cleaner disinfectant such as Dispatch TM by Caltech Industries Inc 1 800 234 7700 Alcohols are flammable and should be used in a well ventilated area The selection and use of disinfectants should be in accordance with hospital and user facility polices This listing is strictly provided to indicate pump material compatibility with cleaning and disinfectant agents Section 1 page 4 SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL REV M 1 4 PUMP SPECIFICATIONS 1 4 MODEL 8000 INFUSION PUMP SPECIFICATIONS 1 4 1 APPLICATIONS Large and small volume parenterals Neonatal Homecare Blood infusions and Epidural applications 1 4 2 ADMINISTRATION SET Compatible with standard gravity IV sets supplied by Hospira Baxter and B Braun McGaw all three are registered trademarks and several other companies consult SIGMA for a complete list of compatible standard IV sets and syringes 1 4 3 PERFORMANCE When using IV bags or bottles flow rate accuracy is nominal 5 from 2 999 ml hr and 10 from 0 1 1 9 ml hr Flow rate accuracy for Securus AN tubing is 596 Accuracy 2 100 mL hr 6 Accuracy gt 100 400 mL hr 8 Accuracy 2400 999 mL hr This is based upon Minus 100 mmHg maximum ne
127. ssel is a 100 ml graduate locate the end of the set around the 60ml level 6 10 7 2 Be sure fluid is at the end of the IV set but none has dripped into the graduate before starting the test 6 10 8 Turn the pump on and set the flow rate 100 ml hr and set volume limit 50 ml 6 10 9 Begin the test by pressing the RUN key 6 10 10 Allow the SIGMA 8000 pump to run until it goes into infusion complete alarm 6 10 10 1 Press the STOP key to halt the KVO keep vein open rate once the pump goes into infusion complete 6 10 10 2 If test is interrupted by any alarms except air the test can be continued as long as the pump was observed by the tester to have not been in STOP for more than ten minutes 6 10 11 Observe the actual volume collected either visually or weighed on the scale 6 10 11 1 When measuring fluid level visually in the graduate the level is read from the bottom of the fluid meniscus 6 10 11 2 When measuring with the scale gravimetric method 6 10 11 2 1 Weigh the collection vessel and water 6 10 11 2 2 Empty and dry the collection vessel 6 10 11 2 3 Weigh the collection vessel The difference between the two measured weights is equivalent to the volume delivered 6 10 11 3 If the collection volume is within the range 47 5 52 5 ml the pump is properly calibrated 6 10 11 4 If not return the pump to SIGMA International Inc for recalibration or perform the flow rate calibration procedure according to CTP 13000 when
128. the case of the Auto Program Mode SRS 0160 995 Section 1 page 19 SET DOSE DOSE 0 SET CONC 0 mg SET CONC 0 ml SET DOSE DOSE 0 SET CONC 0 mg SET CONC SET DOSE DOSE 0 SET CONC 0 mg SET CONC SET DOSE DOSE 0 SET CONC 0 mg SET CONC 0 ml SET DOSE DOSE 0 SET CONC 0 mg SET CONC 0 ml SET PROG VOL 0 SET PROG 0 hrs AUTO TAPR AUTO PROG SIGMA MODEL 8000 amp amp 8000 ZQ INFUSION PUMP SERVICE MANUAL Rev M 1 6 USER ACCESSIBLE OPTIONS Option Name Description of Option NA Not Available Pump Display PROGRAM MODE AUTOMATIC WITH CUSTOM RAMPS 4meg feature PROGRAM MODE MANUAL 4meg feature PROGRAM MODE MANUAL 4meg feature SET DS OCCLUSION PRESSURE psi SET DS OCCLUSION PRESSURE mm Hg ENABLE DOWNSTREAM PRESSURE DISPLAY DISPLAY DOWNSTREAM PRESSURE GRAPHIC DRUG LABEL ENABLE DISABLE Software Versions 3 5X XX 4meg feature Calculates a 21 step program to deliver the selected volume VOL over the selected time hrs in which the ramp time RAMP hrs climbing to main rate and the taper time TAPR hrs descending from main rate can be set by the user Beginning at 50 of the main rate the ramp up increases at 5 per step until the main rate is reached at step 11 The taper down is the same process in reverse The ramp steps are each 1 and the main infusion is 8096 of the total time SRS 0160 981 Up to eleven progr
129. the thermistor located in the upstream TEMP xx c air occlusion sensor CLEAR toggles between Fahrenheit and Celsius scales THERMISTOR DRUG LABEL Password protected option will display current DRUG LABL ENABLE DISABLE status of the Drug Error Prevention feature PASS Toggle the feature on or off by pressing the WORD Ameg feature CLEAR NO key press ENTER to select the Pla model feature displayed status press OPTIONS to exit with no LABL ENA change Default status is enabled Or Software Version 4 00 or LABL DIS later Section 1 page 39 SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of Option Pump Display DRUG LIBRARY TRANSMIT 4meg feature Pu model feature Software version 4 00 and later DRUG LIBRARY RECEIVE 4meg feature Pu model feature Software version 4 00 and later Password protected option will transmit the contents of the stored drug library in one Pes model pump to another 7 model pump using the RS 232 port and the SIGMA pump to pump serial cable Pump shall attempt to establish a communications link with the receiving pump Once the transmission has completed the pump shall prompt the technician to repeat the process if desired Password protected option will receive the contents of a drug library being transmitted Pump shall attempt to establish a communications link with
130. the transmitting pump Once the library has been successfully received the option is exited If the transmission fails the default drug library is restored see INITIALIZE DRUG LIBRARY below Section 1 page 40 DRUG XMIT PASS WORD WAIT ING blinking LINK ING NO LINK blinking while in progress SEND ING XMIT DONE ANOTHER YES NO DRUG RECV PASS WORD PUSH ENTR WHEN RDY blinking LINK ING NO LINK blinking while in progress RECV ING XMIT DONE if transmission fails BAD XFER LIBR INIT if transmission broken NO LINK LIBR INIT SIGMA MODEL 8000 amp 8000 A INFUSION PUMP SERVICE MANUAL Rev M 1 7 BIOMEDICAL ACCESSIBLE OPTIONS Option Name Description of Option Pump Display DRUG LIBRARY DUMP 4meg feature Pu model feature Software version 4 00 and later DRUG LIBRARY INFORMATION 4meg feature Pu model feature Software version 4 00 and later DELETE DRUGS FROM DRUG LIBRARY 4meg feature Pu model feature Software version 4 00 and later Send the contents of the stored drug library along with the host pump serial number installed software version current drug library revision number and date of configuration out the RS 232 port in a format suitable for viewing and storing on a PC Displays the current revision of the drug library along with the number of drugs in the library and the number of vacancies Password protecte
131. ue SRS 0160 985 Displays current dose value and infusate concentration in two values Press ENTER to accept value Press the numeric keys to change value SRS 0160 986 Displays current dose value infusate concentration in two values and patient mass Press Enter to accept value Press numeric key to change value SRS 0160 987 Displays current dose value infusate concentration in two values and patient mass Press ENTER to accept value Press the numeric keys to change value SRS 0160 988 Displays current dose value and infusate concentration in two values Press ENTER to accept value Press the numeric keys to change value SRS 0160 989 Section 1 page 18 SET DOSE DOSE 0 SET CONC 0 unit SET CONC SET DOSE DOSE 0 SET CONC 0 unit SET CONC SET DOSE DOSE 0 SET CONC 0 unit SET CONC 0 ml SET DOSE DOSE 0 SET CONC 0g SET CONC 0 ml SET DOSE DOSE 0 SET CONC 0 mg SET CONC SET DOSE DOSE 0 SET CONC 0 mg SET CONC SET DOSE DOSE 0 SET CONC 0 mg SET CONC 0 ml SIGMA MODEL 8000 8 amp 8000 ZQ INFUSION PUMP SERVICE MANUAL Rev M 1 6 USER ACCESSIBLE OPTIONS Option Name Description of Option NA Not Available Pump Display DOSE MODE UG H mog hr DOSE MODE MGKM mg kg m DOSE MODE MGKH mg kg h DOSE MODE MG M mg min DOSE MODE MG H mg hr PROGRAM MODE AUTOMATIC 4meg feature PROGRAM MODE IMMEDIATE RAMP
132. usly been turned on by the supervisor circuit Operating the On Off key again has no further effect upon U19 but signals the processor through the keyboard encoder that the power should be turned off The microprocessor will then apply a low level to U20 pin 5 and through 51 clears the output of U19 A turning Q2 off and shutting off the power to the circuitry The IPWROFF signal from the processor allows the processor to turn power off but logically can not turn power on when it has no power Q14 Switches current limited battery power to the voltage divider made up of R88 R89 and R90 The divider allows the processor to monitor the battery charge state at Analog Input 5 Shutting off the divider prevents discharging the battery during storage if the line cord is not plugged in 1J1 connects the Processor Board to the power harness 3 2 6 3 STATIC RAM AND PROGRAM PROM Program storage occupies U2 the Programmable Read Only Memory PROM The PROM is organized as 65 536 words 128k bytes of 16 bits and may be doubled to 131 072 words 256k bytes by installing a more dense memory package Because the processor reads program memory by word the byte control bit of the address AO is not used on the PROM PROM chip select IPCS is derived from the ICSBOOT line of the Processor Data storage is accomplished by U1 the Static Random Access Memory SRAM The SRAM is organized as bytes of 8 bits addressed as bytes by AO with a capacity of
133. ut the control rotation is replaced by an electronic counter turning field effect transistors on and off to change the resistance of a 100 step resistor divider The sign of the volume change increase or decrease and slope of the change how quickly it changes are controlled by three outputs from the Processor The alarm tone is amplified and applied to the speaker by power amplifier U8 as is the supervisor tone when active 3 2 6 8 1 SPEAKER A 1 inch plastic cone speaker allows the Model 8000 Infusion Pump to alert an operator to a malfunction via an auditory alarm The audible alarm tone accompanies all displayed alarm messages Tone volume is selectable by the user with a key sequence on the Keypad The tone may be silenced for a period of two minutes from the Keypad while the alarm message continues to be displayed 3 2 6 9 DISPLAY AUXILIARY INTERFACE The Display Auxiliary Bus is a general purpose eight bit extension of the system data bus Eight bi directional data lines are buffered by U14 allowing data to be written or read on the Aux Bus by the Processor Four address lines and two device selects are buffered by U13 allowing thirty two locations to be defined on the bus There is also an interrupt level IRQ4 assigned to the Aux Bus The Display Aux Bus is presently used for the Display Board and the Sensor Board 3 2 7 KEYBOARD The Keyboard is a 21 position membrane key switch matrix The surface of the Keypad is PET
134. uthorization 1 9 2 Field Service 1 9 3 Battery Removal and Replacement 1 9 4 PROM Upgrade Procedure SECTION 2 TECHNICAL DRAWINGS 2 0 External Features Figure 2 0 1 Front View Case Figure 2 0 2 Rear View Case 2 1 Functional Blocks Figure 2 1 1 Block Diagram 2 2 Cables and Wiring Figure 2 2 1 Cable Diagram 2 3 AC Line Circuit Figure 2 3 0 Schematic Transformer PCB Figure 2 3 1 Assembly Transformer PCB SIGMA MODEL 8000 amp 8000 Al INFUSION PUMP SERVICE MANUAL REV M TABLE OF CONTENTS Table 2 3 2 Bill of Material Transformer PCB 2 4 Regulator PCB Figure 2 4 0 Schematic Regulator PCB Figure 2 4 1 Assembly Regulator PCB Table 2 4 2 Bill of Material Regulator PCB 2 5 Display PCB Figure 2 5 0 Schematic Display PCB Figure 2 5 1 Assembly Display PCB Table 2 5 2 Bill of Material Display PCB 2 6 Processor Sensor PCB Figure 2 6 0 Schematic Processor Sensor PCB NOTE Contact Sigma International for a full size schematic Figure 2 6 1 Assembly Processor Sensor PCB Table 2 6 2 Bill of Material Processor Sensor PCB 2 7 Motor Assembly Figure 2 7 1 Assembly Motor Table 2 7 2 Bill of Material Motor Assembly 2 8 Shaft Sensor Figure 2 8 1 Assembly Shaft Sensor Table 2 8 2 Bill of Material Shaft Sensor 2 9 Pole Clamp Figure 2 9 1 Assembly Back Panel Table 2 9 2 Bill of Material Back Panel Assembly 2 10 Pump Mechanism Figure 2 10 1 Assembly Pump Table 2

SIGMA 8000 Infusion Pump Service Manual

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