Fresenius Optima PT,ST,VS - Frank`s Hospital Workshop
Contents
1. 2 3 2 5 4 Battery Output this connector goes to the CPU board Pin Description 1 VBAT Battery 2 Capteur Temp Temperature Sensor output 3 Masse GND Battery before thermal fuse fuse breakdown de 4 VBAT NP eaten 2 3 2 6 5 Battery Input this connector comes from the battery pack Pin Description 1 VBAT Battery Battery before thermal fuse fuse breakdown de 2 VBAT NP tection 3 Capteur Temp Temperature Sensor output 4 Capteur Temp Temperature Sensor GND 5 Masse Battery GND 2 3 3 Electronic drawings On request to Fresenius Vial After Sales Service department 2 3 4 Components layout On request to Fresenius Vial After Sales Service department 2 4 Air detector board The air sensor is based on an ultrasonic sensor 2 4 1 Electronic drawings and Components layout The air sensor is based on an ultrasonic sensor NT1789 R v AO page 19 3 Configuration calibration and check The configuration and calibration of the device are accessible using the serial link RS232 and the Fresenius Vial PC software to configure and calibrate the pump Using the keyboard of the pump through a special encoded menu For further information please contact our Maintenance Department See addresses atthe end of this docu ment Any change in the configuration leads to major changes in Module running Staff trained on the software and devices are the only people authorised to perf2. 102 1 Display board 159601 112 1 CPU board 159646 107 1 OCS motor 168402 110 1 PT VS OT air bubble board 168403 110 1 ST air bubble board 168938 111 1 Air sensor 174252 108 1 OCS foam ring 168442 104 1 Air sensor housing 159899 100 1 Drop detector NT1789 R v A0 page 41 6 1 4 Base Reference Dig Ref Quantity Component 159895 204 1 Base 168480 206 2 Pressure sensor 168428 2 Sensor clip 168439 208 2 Sensor membrane 651211 1 Mechanical bloc membrane 159621 205 1 Left hook 168437 209 1 Right hook 159604 200 1 Flat cable 159648 203 1 Motor 168479 211 1 Mechanical bloc 168482 1 Belt 168483 1 Pump side gear 168489 1 Motor side gear 168485 3 Silent bloc 40 shores 159618 207 2 Feet 199261 210 1 PT VS OT door kit 199262 210 1 ST door kit Page 42 NT1789 R v A0 159632 1 Switch clamp holder 6 1 5 Brace 302 305 306 Reference Dig Ref Quantity Component 159612 303 1 Brace Optima 159613 304 1 Shelf Optima 159603 302 1 Power supply board 159622 305 1 Battery pack 159642 301 1 Nut 182108 306 1 Screw cap 159643 307 1 M8 screw 159617 300 1 Handle NT1789 R v AO page 43 Page 44 NT1789 R v A0 7 Circuit diagram Cicuit daigrams are available nearby our service department please refer to useful addresses chapter NT1789 R v AO page 45 8 Addenda and information bu
3. Common Contact NT1789 R v AO page 13 8 Nurce Call Normally closed Contact 2 1 2 9 10 D C motor Pin Description 1 DC motor 2 DC motor 2 1 2 10 J2 Sensors Pin Description 1 GND 2 Pres Clamp Switch clamp output 3 CD Clamp Switch clamp power supply 4 Up Force Sensor Upstream force sensor output 5 Up Force Sensor Upstream force sensor input 6 Up Force Sensor Upstream force sensor output 7 Up Force Sensor Upstream force sensor input 8 GND 9 Hall effect sensor Hall effect power supply 10 Hall effect sensor GND 11 Hall effect sensor Hall effect output 12 Dw Force Sensor Downstream force sensor output 13 Dw Force Sensor Downstream force sensor input 14 Dw Force Sensor Downstream force sensor output 15 Dw Force Sensor Downstream force sensor input 16 GND 17 ET OPTO Outlet opto signal 18 CD LED LED driver 19 GND Opto ground 20 5V LED Power supply 2 1 3 Electronic drawings On request at Fresenius Vial After Sales Service department 2 1 4 Components layout On request at Fresenius Vial After Sales Service department Page 14 NT1789 R v AO 2 2 Display board 2 2 1 Functional description The display board is considered as a peripheral board ofthe CPU board e The keyboard matrix is connected to this board e Display description Function Display Flow rate m l 4 green
4. SAV2 setnumber configuration Display of configuration number on 7 segments display and coloured inverse on the LCD screen atthe same time 3 4 2 Preventive maintenance SAV1 CL oes EEEN are 1210611998 3333h 3335h 3345h HE 05 1998 12 0 1998 12105 EN SELECTION number of hours before maintenance or date of maintenance selection ENTER changes one field to another Confirm back to Service configuration menu with recording of new duration and date STOP erases the last changes and goes back to Service configuration menu Choice of number of hours before maintenance between 1 and 9999 hours 0 inhibits the request of preventive check with the working duration Choice of the date between 01 01 1990 and 31 12 2079 One of the three numbers 0 inhibits the request of preventive check with the date 3 4 3 Set number Configuration SA V2 coe 2 Jiu C MS pc ree Display of different sets available for the pump type A check mark shows the sets already calibrated SELECTION moves up or down in the set list Confirm or ENTER saves the set selection coloured inverse selection STOP cancel the last selection and return to calibration menu If a non calibrated set is selected at the next switching on the device is locked in occlusion and or upstream pressure alarm requiring calibration NT1789 R v AO page 31 3 5 Technical failures messages Any technical fail use initiates an error code as well
5. TST Sensor check 2 5V Power Supply 3 GND Ground 4 DETECT Air output signal 2 1 2 3 J1 CPU Display board interconnection Pin Description 1 5V Power Supply 2 VBAT Battery voltage 3 GND 4 MOSI AFF Serial output 5 GND 6 MISO AFF Serial Input 7 GND 8 CLK AFF Serial clock 9 GND 10 CSLCD Chip Select LCD 11 GND 12 CSAFCL Chip Select Display Page 12 NT1789 R v AO Pin Description 13 GND 14 AOAFF LCD Adress 15 GND 16 RESET 17 GND 18 TON OFF ON OFF signal 19 VBAT Battery Voltage 20 5V Power supply 2 1 2 4 Drip Sensor Pin Description 1 CDLED goutte Led command 5V 40mA 2 GND 3 GND 4 P ulse goutte O utput drop signal 2 125 4 Stepper motor Pin Description 1 Bobine A Coil A 2 Bobine A CoilA 3 Bobine B Coil B 4 Bobine B Coil B 2 1 2 0 J6 Power Supply Pin Description 1 ALIM EXT Not Used 2 GND 3 ALIM SECT Power Supply 9V 1 3A 2 1 2 7 J8 Battery Pin Description 1 VBATNC Battery 2 ANA CTN Temperature sensor output 3 GND 4 VBATNP Battery before thermal fuse fuse breakdown detection 2 1 2 8 J11 RS232 Nurse Call Pin Description 1 TxD PC Data Reception from PC 2 RTS PC Request to send from PC Should be positioned at high state 3 DTR PC Data Terminal Ready of PC Should be positioned at high state 4 RXD PC Data Transmission to PC 5 GND 6 Nurse Call Normally Opened Contact 7 Nurse Call
6. open Pam2 Upstream pressure 0 mmHg Pavi Downstream pressure door open Pav2 Downstream pressure 0 mmHg Pav3 Downstream pressure 750 mmHg The value between brackets gives the number of calibrations done Display of upstream and downstream pressure calibration values in accordance with active set number NT1789 R v AO page 29 3 3 13 Infusion motor Test TestF This test allows to setthe motor running without alarm management C Emi I Leow l 1 L SELECTION selection of infusion flow rate 0 1 ml h 1000 ml h ENTER flow rate validation STOP stops motor and return to test menu if motor already stopped If motor problem then LCD screen blank and Er01 Er11 or Er21 displayed on 7 segment display STOP to return to test menu 3 3 14 Display of last 10 alarms before a failure occurs TestJ LCL nl 7815 ea x SE 34 E Je U 41 Ok LC al Bion 7 1410 t Jt UT SED 3 F ail SELECTION scrolling number of switching on then error and codes Confirm or ENTER back to test menu Page 30 NT1789 R v AO 3 4 Maintenance Service Configuration 3 4 1 Service configuration Menu Display of configuration number on 7 segments display and coloured inverse on the LCD screen atthe same time SELECTION configuration selection Confirm or ENTER configuration execution STOP return to test menu E oO Service configurations list e SAVI preventive maintenance e
7. the flow rate The signal command is performed either by Ye step or 1 4 step according to the requested flow rate 2 1 1 3 Rotation control An optical sensor verifies the rotation of the came shaft This sensor generates an alarm for any difference higher than 5 with the programmed value 2 1 4 4 Door detector A Hall effect sensor placed in the Module and a magnet located in the door This sensor detects door opening and set missing when door is closed 2 1 1 5 Drip sensor optional on Optima MS and VS or MCM 440 OT The drip detection is performed by an optical sensor An infra red filter avoids interference due to external light This sensor generates an alarm for any flow rate difference higher than 40 of the programmed value 2 1 1 6 Downstream pressure sensor This sensor detects downstream occlusion on the infusion line It also detects the right positioning of the infusion set when the door is closed It generates an alarm in both cases 2 1 1 7 Up stream pressure sensor This sensor detects up stream occlusion on the infusion line when the drip sensor is absent This sensor detects the right positioning of the infusion set when the door is closed It generates an alarm in both cases 2 1 1 8 Buzzer The device is equipped with 2 buzzers triggered by the microprocessor 2 1 1 9 On Off function When the device is connected to the mains it is in stand by mode Switching ON is performed e Either by press
8. 11 2 1 2 Connectors description saneren ennen 12 2 1 3 Electronic drawings anno ennen eneen 14 2 1 4 Components layout 14 2 2 Display board 2 2 1 Functional description 2 2 2 Connector description 2 2 3 Electronic drawings 2 2 4 Components layout 2 3 POWER SUPPLY BOARD 2 3 1 Functional description 2 3 2 Connector description 2 3 3 Electronic drawings essi aa 2 3 4 Components layout 2 4 Air detector board 2 4 1 Electronic drawings and Components layout 19 3 Configuration calibration and check 20 3 1 Configuration 20 3 2 Calibration 22 3 2 1 Manual calibration menu 22 3 2 2 Door calibration Etall sse 22 3 2 3 Correcting coefficient adjustment Etal2 23 3 2 4 Up and Down stream pressure sensors calibration tal line rine tide edite renes 24 3 3 Tests Maintenance tests 26 3 3 1 Manual Service test menu 26 3 3 2 Maintenance tests list secsec 26 3 3 3 Working duration Test nennen oenen 26 3 3 4 LED s LCD screen 7 segments display and Buzzers T eStTest2 b nisse nt eden ntt 3 3 5 Keyboard test Test3 3 3 6 Battery voltage display Test4 nnee 27 3 3 7 Display of the last 10 alarms codes Test5 28 3 3 8 Total working duration Test6 nnen 28 3 3 9 Display analog values of senso
9. 7 segment LED display Alarm 1 red LED Pre alarm 1 orange LED Perfusion signal LED s 4 green LED Drop LED s 1 green LED Battery LED s 1 green LED Mains LED s 1 orange LED Perfusion start LED s 1 green LED LCD 33x100 points LCD display 2 2 2 Connector description 2 2 01 General J1 1 x 20 Pins CPU Display boards Interconnection J2 18 Pins LCD connector J3 10 Pins Keyboard connector NT1789 R v A0 page 15 2 2 2 2 J1 CPU Display Board interconnection Page 16 Pin Description 1 5V Power Supply 2 VBAT Battery voltage 3 GND 4 MOSI AFF Serial output 5 GND 6 MISO AFF Serial Input 7 GND 8 CLK AFF Serial clock 9 GND 10 CSLCD Chip Select LCD 11 GND 12 CSAFCL Chip Select Display 13 GND 14 AOAFF LCD Address 15 GND 16 RESET 17 GND 18 TON OFF ON OFF signal 19 VBAT Battery Voltage 20 5V Power supply NT1789 R v AO 2 2 03 2LCD Connector Pin Description 1 VBAT back light 2 led back light 3 5V 4 RESET 5 VSS Gnd 6 LDO Data Write 7 GND Write Select 8 LD6 Data Write 9 AOAFF LCD Address 10 LD5 Data Write 11 LD4 Data Write 12 LD3 Data Write 13 LD2 Data Write 14 LD1 Data Write 15 LDO Data Write 16 Enable 17 LCDCS2 Chip select 18 LCDCS1 Chip select 2 2 2 4 3 keyboard Connector Pin Descripti
10. BLIES 4 1 Module opening W hen opening the OPTIMA anti static precautions must be strictly applied The use of anti static carpet and grounded bracelets is highly recommended Disconnect battery as soon as the Module is opened 4 2 Replacing CPU board In case of CPU board replacement systematically perform configuration and calibration as described in chapter 3 4 3 Dismounting pumping mechanism Retractthe door axis and remove the door Remove the sticker up to the pumping mechanism to unscrew axis holder Unscrew the 4 fixing screws of the pumping mechanism 4 4 Replacement of pressure sensors In case of replacing pressure sensor systematically perform configurations and calibrations described in chapter 3 Be extremely careful within the direction of the sensor positioning lead output 4 5 Replacement of door or of Hall effect sensor In case of replacing these elements systematically perform configurations and calibrations described in chapter 3 Page 34 NT1789 R v A0 5 MAINTENANCE 5 1 Recommendations The qualified technicians in your establishment or our Maintenance Service should be notified of any abnormal opera tion ofthe device For further information concerning troubleshooting or usage procedure please contact our Maintenance Department or ourSales Representative see Useful Addresses chapter 9 If the device has to be returned to our Maintenance Service it must be disinfected and packed
11. Standard PVC Standard PVC Standard Silicone Drip Sensor Optional Standard Standard OCS Test Occlusivity Yes No No Control System Tube Clamping A mechanical clamp on the device assure the clamping of the tube when the door is opened A mechanical clamp on the device assure the clamping of the tube when the door is opened A mechanical clamp on the device assure the clamping of the tube when the door is opened Maximum Rate 1000 ml h 1000 ml h 1500 ml h OCS A dc motor assure the clamping of the tube during OCS NO OCS gt no DC motor Tube clamping during door opening A mechanical clamp on the device assure the clamping of the tube when the door is opened NT1789 R v A0 page 7 1 2 Bloc diagrams RS232 Nurse Call Key board Power supply board Display board AIR connectors Drip Sensor bubbles option sensor CPU i Motor Rotation detector Transmission ocs MS VS only Door Peristaltic Mecanism Openning detector LOOCK Counter Pressure flask downstream occlusion Up stream occlusion Detector Detector Clamp detector MS only PUMP Up stream extension Drip chamber Figure 1 General diagram of the OPTIMA Page 8 NT1789 R v A0 1 3 Precautions to be taken before use Please consultthe user guide 1 4 Internal safety features The pump has a continuous functions inspection system as soo
12. TECHNICAL MANUAL OPTIMA PT ST VS gt OES Cee ae OPTIMA PT A T PE ape ith CAR AR VY Fresenius Vial Infusion Technology Page 2 NT1789 R v A0 TABLE OF CHANGES The information contained in this document only concerns a OPTIMA PT ST VS type MCM 440 PT OT type MCM550 ST type Technical Manual reference NT 1789 Revision date oaeen 27 May 2003 Applicable from serial no 18180100 Date Revision no Pages concerned Changes 27 05 2003 A0 NT1789 R v AO page 3 Page 4 NT1789 R v A0 TABLE OF CONTENT 1 OVERVIEW eh erne baner 7 1 1 General 2 eere 7 1 2 Bloc diagrams eene 8 1 3 Precautions to be taken before use 9 1 4 Internal safety features 9 1 5 Technical characteristics 9 1 5 1 Biological characteristics 9 1 5 2 Mechanical characteristics ceecee 9 1 5 3 Dimensions Weight a 1 5 4 Electrical characteristics m 1 5 5 Electronic characteristics 12539 1 5 6 Operator s guide SR oe dn Katan 9 1 57 Registration Cards cene fnerit 9 1 5 8 Material used to build the OPTIMA MCM 9 1 5 9 Conformity and symbols annae ennen een 9 2 ELECTRONIC BOARDS 11 24 CPU boatd uae 11 2 1 1 Functional description neee eeen
13. able upon requestto our Maintenance Department 1 5 8 Material used to build the OPTIMA MCM Q Top and bottom housing Polycarbonate ABS aA Keyboard ie troie crt ve etg erige Polyester CPS TEK ONS PR Polyester EI Pump membrane tm e fm e oes Elastomer latex free EX Dip SONS Oris tee E nm Polycarbonate ABS or polyamide O Rear housing handle PC 4109 1 5 9 Conformity and symbols Q Conform EN60 601 1 and EN60 601 2 24 standards NT1789 R v AO page 9 Q CE0459 marking in compliance with EEC 93 42 Medical Device directive IP 31 Liquid projections protected L CF type device Battery CLASS I device Q Each symbol shows below is visible on the device or in this document A Refer to accompanied documents x Equipotentiality e Protective earth RS 232 RS232 Communication Interface 4000V insulation 5 f Nurse Call 4000V insulation 24Vdc 1A De eN E Permanent magnet allowing the fixing of drops sensor Page 10 NT1789 R v A0 2 ELECTRONIC BOARDS 2 1 CPU board 2 1 1 Functional description 2 1 1 1 CPU Main Microprocessor T80c5112 512 Ko of Flash 8Ko of RAM External RAM nnen 32 Ko EEPROM zeros tacite 16 Ko Secondary Microprocessor MSP430 Control frequency of the main microprocessor time keeper function ON OFF function and control the charge of the battery 2 1 1 2 Stepper motor control The motor is powered with 12 or 20 volts according to
14. as a continuous sound alarm An error code is displayed on the 7 segments display Error codes Err xx Description 10 Internal RAM problem 20 External RAM problem 30 IncoherentEPROM check sum 40 EEPROM problem 50 ADC problem 60 Incoherent infusion set parameter 70 Motor frequency incompatibility 80 Keyboard problem 01 Motor rotation error 11 Motor rotation error 21 Motor rotation error 31 DC Motor 41 Motor rotation error 03 Serial link transmission error 14 Error on motor period calculation parameters verification 24 Motor rotary direction incompatibility 44 Quartz frequency incompatibility 54 display board missing 74 No battery connection 84 Battery charge error 56 S oftware problem 28 Non compatible language file 55 clock failure 94 Battery temperature error 55 Secondary microprocessor error 85 Secondary microprocessor error 16 Date time check error Alarm codes A XX Description 10 Battery 12 End of infusion 16 Downstream Occlusion 17 Air detection 18 Air detection 19 Upstream Occlusion 20 No tubing set 21 No clamp Page 32 NT1789 R v A0 Alarm codes XX Description 22 Door 23 No drip sensor 24 Drip sensor low flowrate 25 Drip sensor high flowrate 26 Free flow 27 Occlusion control NT1789 R v A0 page 33 4 REPLACING SUB ASSEM
15. ave Preventive maintenance 58ug SAV2 Tubing Set configuration Etal1 Door calibration Etal2 Infusion correction coefficient configuration Calibration i Etal9 Up stream and down stream pressure sensors calibration Main menu 70 20 oft cz Lo u an en nmm TT User Setting W ard Setting Maintenance Access code type User Setting Code Maintenance Code W ard Setting Code Code selection with Selection keys or Proceed to sub menus with confirm key or ENTER keys Code back to 0 if incorrect code validation after 15 seconds non validation beep STOP back to main menu Maintenance sub menu Test Configuration Calibration NT1789 R v AO page 21 3 2 Calibration Calibration is possible on e Down stream pressure sensor e Up stream pressure sensor e Door Hall effect sensor Calibration is compulsory in the following cases e Down stream pressure sensor After change of sensor of its protective diaphragm of the door or CPU board e Up stream pressure sensor After change of sensor of its protective diaphragm of the door or CPU board e Door Hall effect sensor After change of sensor of the door or CPU board Q The CPU board is configured with specific parameters for each Device so itis forbidden to change CPU boards from a device to an other Q For the same reasons itis forbidden to change door from a device to another 3 2 1 Manual calibration m
16. cord to the Module Install an infusion set full of water Start infusion Check that the green indicator flashes when a drop is detected Disconnect the sensor Check that the drip sensor alarm goes ON Connect the drip detector set the infusion at 60 ml h remove the chamber from the drip detector Verify the alarm should set 40 sec lt lt 2 min 30 sec 10 Q Air bubbles sensor check see 5 4 6 When switching on without infusion set Check that the red indicator and the air sensor of LCD display flash Install an infusion set full of water Check that the red indicator and the air sensor of LCD display switch off Select a 60 ml h flow rate and start infusion Keep drip chamber up side down for at least 20 sec to generate a gt 0 25 ml air bubble for a device configured for a cumulated air detection of 0 25 in 15 min Check the alarm air bubble goes on when bubble passes in the sensor 11 Q Down stream pressure detector Install an infusion set full of water with a manometer at the end see 5 4 2 Select a pressure threshold of 750 mmHg Start infusion at 100 ml h Check that manometer indicates 750 mmHg 110 mmHg when alarm is triggered Do it again for a pressure threshold of 500 mmHg 75 mmHg 12 13 14 Average Flow rate check can also be perform with a scale amp ISDebit program test Place the infusion set in a 100ml test tube Select a 80ml h flow rate and infuse for 1 hour Not
17. e the infused volume The flow rate can be adjusted see 3 2 3 76 ml lt infused volume ml 84 ml Q Battery check Before checking charge the battery for at least 16 hours Start an infusion at 125 ml h mains disconnected Check working autonomy is 4h IMPORTANT if autonomy 3h30 CHANGE battery LJ Continuity test Neutral and Drip sensor connector any pin 10Mohms Phase and drip sensor connector any pin gt 10 Mohms Earth and equipotentiality 0 1 Ohms Earth and screw below the device 0 1 Ohms Checking result conform no conform Visa NT1789 R v AO page 39 6 ANNEXE 1 Illustrated parts lists 6 1 Subassemblies traceability table 6 1 1 Introduction The aim ofthis chapter is to help the technician to find spare parts so thatthe module can be serviced 6 1 2 Spare parts table The table below lists the mains modifications made to improve the product The module s serial number should be used when looking for components OPTIMA MCM 1 equivalence table From 18180100 Instrument serial no T 0 Display board 159602 CPU board 159601 Power Supply board 159603 Page 40 NT1789 R v AO 6 1 3 Upper housing 100 104 105 106 107 a9 108 109 110 111 112 Reference Dig ref Quantity Component 159611 101 1 Upper housing 159620 103 1 Keyboard 159602
18. eam pressure sensor at pressure zero 0 mmHg Door closed Page 24 NT1789 R v AO 1 Place a disposable infusion set as described here above and open the 3 ways tap between the pump and the manometer 2 To relax the infusion set press on the confirm key gt the pump run at 200 ml h 3 When the pressure reaches about 750 mmHg open the 3 way tap to release the pressure 4 Letinfuse atzero pressure for about 5 minutes 5 Stopthe device by pressing on STOP 6 Record the pressure by pressing ENTER l m Fave OmmHa 2456 x gt mm n1 mT Values down stream pressure sensor at pressure zero 0 mmHg Door closed 1499 X c 3696 mVolts 3 2 4 3 Calibration of the down stream pressure sensor at 750 mmHg Door closed 1 Close the tap between the pump and the manometer 2 Startthe pump by pressing confirm key 3 Open and close the tap until the manometer pressure reaches 750 mmHg 30 mmHg 4 Stop the pump by pressing on STOP key 5 Record the pressure by pressing on ENTER key CoL Col Pas 760 mmHs 1542 down stream pressure sensor at 760 mmHg Door closed 898 X 2998 mVolts Values 3 2 4 0 Calibration of the up stream pressure sensor at mmHg 1 Openthe tap between the pump the manometer and tank 2 Wait until the pressure set to zero 3 Infusion set still in place and door closed press ENTER key to record the value lPam2 OmmHa 2545 L LII A Values up stream pre
19. ent range allows a correction up to 20 10 Measure the flow rate for a flow rate of 100 ml h Install the tube full with non mineral water the container should be at 50cm above the device Place a weight balance 0 01 g resolution and accuracy at the same level as the device Place a needle at the end of the tubing set Collect on the balance the infused water Se lect the rate and infuse for around 15 min Press STOP on the device Reset the balance 000g Press START on the device the pump infused at 100 ml h Infused for at least 15 min Stop the infusion Note the infused volume and time Calculate the measured flow rate volume collected on the balance infusion time The Correcting coefficient adjustment is performed in Etal2 IL al Selected 100ml h LL ae EE Measured 100ml h CLO Selected 100mI h LL II Measured 105ml h C L Selected 100mI h GL IE Measured 125ml h Error SELECTION key Qo selects the programmed flowrate 100 increment 1 ml h and actual flow rate 80 120 ml h ENTER key to select a field value confirm key calculate record the new coefficient if included between 0 8 and 1 1 times the programmed one back to the configuration menu otherwise Error is displayed NT1789 R v AO page 23 STOP key back to the menu without calculation of the coefficient Note After flowrate adjustment a control of the flowrate should be done 3 2 4 Up and Down stream pressure sensors calibrati
20. enu SELECTION keys calibration choice CONFIRM or ENTER keys calibration procedure STOP key back to maintenance menu Values are not memorised Calibration number is displayed on 7 segments display and simultaneously displayed in inverse video on LCD screen clo al Etall Door Lee Etal2 Rate Etal9 Pressure Calibrations list Etall door Etal2 Infusion correcting coefficient configuration Etal9 Up and Down stream pressure sensor 3 2 2 Door calibration Etal1 Q 3 levels are calibrated Q Note Pressing STOP allows to escape from the menu without memorisation EAT Port 0 Close the door without set record the value by pressing on or ENTER G key Q Doorclosed without set gem gem Need Q Door open without set Page 22 NT1789 R v AO Pore 1237 LO I EEA Open the door without set record the value by pressing on 9 or GB ENTER key Q Door closed with set gem m L1 LI 1 L I n E Par 2456 LE Place a set with the clamp correctly positioned and close the door record the value by pressing on or E ENTER key Values Door closed without set 1196 X 3750 mVolts Door opened without set 2197 X 2695 mVolts Door closed with set 1699 X lt 3398 mVolts 3 2 3 Correcting coefficient adjustment Etal2 This function allows to adjustthe flow rate of the device according to the used set The adjustm
21. essure alarm at 500 mmHg Start infusion with bypass closed between manometer and pump After 5 minutes of infusion at 0 pressure open bypass between the manometer and the pump Mm B Ww N When alarm goes check the pressure P displayed by the manometer is correct P 500 mmHg 75 mmHg gt 0 65 0 1 bar 6 Do the test again with a programmed counter pressure of 750 mmHg P 750 mmHg 110 mmHg gt 1 0 15 bar Page 36 NT1789 R v A0 5 4 3 Battery autonomy test 1 The battery autonomy is minimum 4h for usual flow rates 125 ml h 2 The battery when properly charged pre alarm gives a warning to the user about 30 minutes before total stop of the device Q Note The battery charge duration is minimum 16 hours 100 9 of its capacity when the pump is ON Q Note The battery charge duration is minimum 5 hours 100 ofits capacity when the pump is off 5 4 4 Fix clamp checking VS PT and ST pumps 1 Make the following installation Manometer Device Infusion set Y CEE Syringe Drip chamber 2 Open the door of the device the in line mechanical clamp should clamp the infusion set 3 Apply a 0 5 bar pressure with the syringe and check no liquid goes in the drip chamber 5 4 5 Air detector check Note Do the test with the tubing set displayed on the device We recommend to do the test with the differents types of tubing sets used in the hosti
22. ing the ON OFF key Or by opening the door according to the software configuration Switching OFF is performed e Either manually by pressing the ON OFF key e Or automatically when battery is low The On off function is performed by the secondary microprocessor 2 1 1 10 Battery charge management NT1789 R v AO page 11 The battery charge is managed by both primary and secondary microprocessors 2 1 1 11 Air detector An ultra sound sensor allows to detect air bubbles in the infusion set It generates an alarm if air bubbles are larger than programmed value 2 1 1 12 Automatic OCS clamp The OPTIMA MS and VS or MCM MS and OT are equipped with a DC motor actuated clamp After each infu sion start or door closing the infusion set is clamped by this system and the device checks then pumping mechanism occlusivity 2 1 1 13 Nurse Call RS232 The RS232 and Nurse Call have both 4000 V dielectric strenght The Nurse call relay is rated 24 VDC 1A 2 1 2 Connectors description 21 21 General Connector Pin number Function J7 2x17 For development purpose J3 2x7 For manufacturing J9 1x4 Air Sensor J1 1x20 CPU Display interconnection J 12 1x4 Drip Sensor J4 1x4 Stepper Motor J6 1x3 Power Supply J8 1x4 Battery 5 1x6 Not Used J11 1x8 RS232 NURSE CALL J10 1x2 DC motor J2 1x20 Sensors 2 1 2 2 J9 Air Sensor Pin Description 1
23. lletins Page 46 NT1789 R v A0 NT1789 R v A0 page 47 9 Useful addresses All request for information or documentation technical file tubing catalogue or commercial documentation should be addressed to CUSTUMER SERVICE INTERNATIONAL Fresenius Vial Tel 33 0 4 76 67 10 14 or 10 03 Le Grand Chemin 38590 Br zins FRANCE or 1067 Fax 33 0 4 76 67 11 12 E mail commercial vial fresenius hemocare com MAINTENANCE SERVICES INTERNATIONAL Fresenius Vial Tel 33 0 4 76 67 10 76 Le Grand Chemin 38590 Br zins FRANCE Fax 38 0 4 76 67 11 22 BELGIUM Fresenius NV SA Belgique Tel 32 388 07307 DIVISION VIAL MEDICAL Fax 32 388 05007 Molenberglei 7 2627 Schelle BELGIUM GERMANY FRESENIUS MCM Tel 49 60 23 97 22 0 AM NEUNEN BERG 8 Fax 49 60 23 43 06 63749 ALZENAU GERMANY Itis possible that this document contains typing errors or mistakes Changes may occur at any time in subsequent editions COPYRIGHT 2002 Fresenius Vial This technical manual may not be reproduced in whole or in part without the written consent of Fresenius Vial Fresenius Vial SAS Head Office Le Grand Chemin 38590 Br zins FRANCE Capital 13 744 520 EUR SIREN Grenoble B 408 720 282 Page 48 NT1789 R v A0
24. n as the pump is ON Nevertheless the qualified per sonnel in your establishment or our Maintenance Department should always be notified of any abnormal functioning when no specific cause can be found See useful addresses chapter 9 For any mains failure the pump is powered automatically from its internal battery Opening the pump or the battery cover must only be carried out by qualified staff with all the necessary technical pre cautions Non compliance with these procedures may be dangerous for the staff and may damage the Module 1 5 Technical characteristics 1 5 1 Biological characteristics The infusion liquid is only in contact with the infusion set 1 5 2 Mechanical characteristics The OPTIMA Pump operates with a linear peristaltic system 1 5 3 Dimensions Weight S MP UN do MEE 135 x 175 x 145 mm a Weight scene a a PUR Dip 2 9 kg approximately 1 5 4 Electrical characteristics Q External power supply 100 240 Vac EIGPOWOTL ro E T A T 50 VA EJ Battery EEEN 6V 2 7 3 Ah NiMH ERE US Ea LR e heat eset tlh Lr mete en AX Se 2x 630 MAT IEC 127 1 5 5 Electronic characteristics The Device contains 4 PCB s CPU PCB Display keyboard PCB Power Supply PCB Air detection PCB 1 5 6 Operator s guide The operator s guide is available upon request to our Maintenance Department see useful addresses at the end of this document 1 5 7 Registration cards Registration information is avail
25. nfirm and ENTER saves changes and goes back to test menu STOP goes back to test menu with erasing of change of maintenance date If date of maintenance is changed then working duration is set to zero Page 26 NT1789 R v AO 3 3 4 LED s LCD screen 7 segments display and Buzzers Test Test2 Lighting of all the LED s display of amp plus decimal point on the 7 segments display LCD screen completely black wait for pressing on ON or ENTER bod Bog Scrolling of LED one by one scrolling of segments one by one on all the display then scrolling of 8 and decimal point on each display Scrolling of LCD screen image Back to test menu manual test STOP quick return to test menu manual test 3 3 5 Keyboard test Test3 Le leo O ON OO C D l DL COO X0 OO OOo ol OOO CO S mT UM NI Display of pressed keys in inverse video Confirm or ENTER back to test menu 3 3 6 Battery voltage display Test4 LEL FIY E 2c 4 HE L CL ul B r E JC 1 IE Confirm or ENTER back to test menu NT1789 R v AO page 27 3 3 7 Display of the last 10 alarms codes Test5 Dr CE C 7A 10 CC Si S ges 10 Dr lh orca c 1410 It Jt J 3 Fail 4 Oif SELECTION Codes scrolling Confirm or ENTER back to test menu 3 3 8 Total working duration Test6 Display the Total pump working duration independent of Test 1 The Display duration can t be set to zero 3 3 9 Display analog values of sens
26. nical check procedure 38 6 ANNEXE 1 Illustrated parts lists 40 6 1 Subassemblies traceability table 40 6 1 T Introduction trat ae ce 40 6 1 2 Spare parts table 40 6 1 3 Upper housiig sc ttt et tee 41 6 1 4 BaSe iiid e EROR RR E EUER PECURE E NR se 42 6 1 5 Brace sirena bete og ia inci dnas 43 7 Circuit diagram eene 45 8 Addenda and information bulletins 46 9 Useful addresses 48 page 5 Page 6 NT1789 R v A0 1 OVERVIEW 1 1 General The OPTIMA Pump is a new volumetric pump based on the same mechanical pumping mechanism as the MVP pump The battery is automatically recharged when the pump is connected to the mains A choice of easily accessible configurations ensures optimum use of functions according to the needs of each depart ment 3 types of OPTIMA exist VS PT ST e OPTIMA VS MCM 440 OT PVC Type Volumetric pump with standard PVC Set The Drip sensors is optional An automatic control of the occlusivity of the pump OCS Occlusivity Control System is implemented e OPTIMA PT MOM 440 PT PVC Type Volumetric with standard PVC Set The Drip sensors is compulsory e OPTIMA ST MCM 550 ST Silicone Type Volumetric with standard Silicone Set The Drip sensors is compulsory e Mains differences between the types Description VS OT PT ST Functional differences Tube
27. on 1 COL2 Keyboard Column 2 COLI Keyboard Column 3 COLO Keyboard Column 4 Ligne 3 Keyboard Line 5 Ligne 2 Keyboard Line 6 Ligne 1 Keyboard Line 7 Ligne 0 Keyboard Line 8 TON OFF On Off 9 CONTR LE Keyboard Control line 10 GND 2 2 3 Electronic drawings On request to Fresenius Vial After Sales Service department 2 2 4 Components layout On request to Fresenius Vial After Sales service department NT1789 R v A0 page 17 2 3 POWER SUPPLY BOARD 2 3 1 Functional description An AC DC 12W Module convertor switching mode power supply convert the mains input voltage 100 240 Vac to 9Vdc 1 3A This voltage is used to charge the battery and power the device ECG EEG noise rejection filter 2 Class X2 Capacitor and a 10Kohms resistance connected to a functional earth garanteed the EEG EEG noise rejection 2 3 2 Connector description 2 3 2 1 General Connector Pin Function Ji 1x1 Functional Earth J2 1x2 Main supply connector J3 1x3 Output power supply J4 1x4 Battery Output J5 2x5 Battery Input 2 3 2 2 1 Functional Earth Pin Description 1 z Functional Earth Page 18 NT1789 R v A0 2 3 2 3 J2 Main Supply Connector Pin Description 1 PH Phase 100 240 Vac 2 N Neutral 100 240 Vac 2 3 2 4 3 Output Power supply Pin Description 1 9V Sect 9V Output from AC DC converter 2 GND 3 9V Ext 9V From external power Supply not used
28. on Etal9 This calibration should be done with the set selected on the pump in SAV2 sea 3 4 3 Set number Configuration SAV2 The set has a relaxation time when the door is closed so follow precisely the following procedure to guaran tee the occlusion alarm level 1m PUMP lt gt Manometer 3 ways tap Di tank 50 cm Test set The manometer and the device should be placed at the same level RAZ Presure Q Calibration calibration NO Complete calibration choice YES or NO through the selection key If Yes the force sensor calibration values are set to zero for all the tubes YES choice is mandatory for any replacement of the force sensor door or CPU board NO choice does not set to zero the force sensor calibration value for the other tubes only the one selected on the pump is set to zero See 3 4 3 Set number Configuration SAV2 The following procedure allows to carry out the calibration of the active tube 3 2 4 1 Dooropen 1 Open the door of the device without disposable set 2 Record the values door open down stream pressure and door open up stream pressure by pressing on ENTER 4221 Leno NE 3854 door open down stream pressure threshold 1997 lt X lt 4453 mVolts Values door open up stream pressure threshold 1997 X lt 4297 mVolts 3 2 4 2 Calibration of the down str
29. ormed theses operations 3 1 Configuration This mode is actived by pressing MODE key when switching ON the pump The main menu display User setting Ward setting Maintenance Each menu is composed with some sub menu press confirm key or enter to get through Some menu need a code to access to the sub menu The access code of user setting can be defined or disabled in the ward setting Once the access code is typed it is not necessary to type it again as long as the device is not switched off The 7 segments displays are off during the display of the main menu and codes typing Code Main menu T voi Sub menu Sub menu nn This code will be given at the end of the maintenance staff training Test Maintenance test menu Maintenance configura tion Maintenance configuration menu Calibration Maintenance calibration menu User setting see operator s guide Code XXXX User configuration menu Ward setting see operator s guide Code 0200 Service configuration menu Page 20 NT1789 R v AO Test ESEI Test Work duration displa t5te2e Test2 LED s LCD screen 7 segment displays and buzzers test t5t3 Test3 ESEY Test4 t5t5 Tests Last 10 alarms display E5t6 Test z t5tg Test9 3 ESEA Testa g ESEC Test 2 ESEE Teste d ESEF Test t5tJ TestJ Before failure last 10 alarms codes display m saul le
30. ors Test9 UPstream Pressure LEL 152 fi 1 i 1 Downstream Press 2360 E Dorr hall 2100 ly C Pp Ol Upstream Pressure 152 Loe d Dorr hall 2100 Display of analog input values in form 0 5000 for 0 1024 Lsb No display for up stream sensor if not used Confirm or ENTER back to test menu 3 3 10 Display of software version number TestA Ic SEA Cod QE idis Jt ht Sri agg ERE LCL A i LL J ugs Confirm or ENTER proceeds to language version then back to test menu SELECTION language scrolling Page 28 NT1789 R v AO 3 3 11 Motor clamp Test TestC Clame SELECTION function choice Confirm or ENTER Runclamp or unclamp STOP stops motor and return to test menu if motor already stopped Clamp the dc motor turns forward to clamp Unclamp the dc motor turns backward to unclamp If problem on clamp motor driver then LCD screen black and Er31 displayed on 7 segment display STOP to return to test menu 3 3 12 Calibration values display TestE Fori 1440 Leet Pere 1275 L JL L Pari 2944 Bat db24 SELECTION scrolling of calibration values Confirm or ENTER back to test menu Display of calibration values in form 0 5000 for 0 1024 Lsb The calibration values list is as following Port Hall effect sensor door closed without set Por2 Hall effect sensor door opened Por3 Hall effect sensor maximum value door closed with set Pami Upstream pressure door
31. pal 1 Place an infusion set full of water in the device For an air bubbles volume programmed at 0 20 ml Program a 60 ml h flow rate Get drip chamber upside down for about 20 seconds to infuse about 0 5 ml air bubble Mm RB W N Check the air alarm goes when air bubbles pass through the air detector The length passing through before alarm should approximately correspond to the size selected 1 3cm 0 1ml 5 4 6 Continuity test 1 Using a Ohmmeter verify the presence of the electrical resistor higher than 10 M ohms between Neutral and drip sensor plug any pin Phase and drip sensor any pin NT1789 R v AO page 37 5 5 Technical check procedure In order to ensure follow up within the framework of a preventive maintenance a routine inspection is recommended It is recommended to use the technical manual as a complement for correct run of the procedure A checking software allows to automatically perform the following tests IMPORTANT recharge battery 16 hours prior to the check procedure Device OPTIMA MCM Type Code Device serial N Check date PEE fine Depart Technician Check Con YES NA N Description form NO FUNCTIONAL CHECK see 3 3 Q Check general outside casing appearance mains power cord and stickers and pumping membrane 2 Q Display of working duration test H D M 3 Q Last maintenance date
32. rs Test9 28 NT1789 R v A0 3 3 10 Display of software version number TestA 28 3 3 11 Motor clamp Test TestC nanne eneen 3 3 12 Calibration values display TestE 3 3 13 Infusion motor Test TestF 3 3 14 Display of last 10 alarms before a failure occurs Tester Ai ae ede un 30 3 4 Maintenance Service Configuration 31 3 4 1 Service configuration Menu 31 3 4 2 Preventive maintenance SAV1 31 3 4 3 Set number Configuration SAV2 31 3 5 Technical failures messages 32 4 REPLACING SUB ASSEMBLIEG 34 4 1 Module opening 34 4 2 Replacing CPU board 34 4 3 Dismounting pumping mechanism 34 4 4 Replacement of pressure sensors 34 4 5 Replacement of door or of Hall effect SONS O boicssdevsecsciedesndsestecescicdecss a anea daaa Naina iiaa 34 5 MAINTENANCE eene nnn 35 5 1 Recommendations 35 5 2 Cleaning and disinfecting 35 5 3 Storag8 uie 35 5 4 Routine inspections nnn anneer enn 36 5 4 1 Checking before use 36 5 4 2 Occlusion alarm checking neee oenen 36 5 4 3 Battery autonomy test 37 5 4 4 Fix clamp checking VS PT and ST pumps 37 5 4 5 Air detector check 5 4 6 Continuity lest tipa ede aa ee pps 5 5 Tech
33. s contact the service in charge of cleaning and disinfecting products of your estab lishment gt gt gt gt 5 3 Storage The device should be stored in a dry and cool place In case of prolonged storage time disconnect the battery through the battery door located on the rear panel This operation should be made by qualified technician W hen storage a full recharge of the battery is recommended before restarting the pump in order to avoid any risk caused by micro mains supply cuts and to insure maximum autonomy Storage place should be Temperature between 10 c and 60 Maximum relative humidity 9096 no condensation NT1789 R v AO page 35 5 4 Routine inspections 5 4 1 Checking before use Refer to operating instructions In order to ensure optimal work of the device regular servicing inspections and tests are recommended A servicing check procedure should include the points listed below These service checks are not covered by any con tract or agreement with FRESENIUS VIAL INFUSION SYSTEMS and are the responsibility of the Users technical Staff For further information please contact our Maintenance Service Q Note Failure to comply with these maintenance procedures could damage the device and lead to a functional failure 5 4 2 Occlusion alarm checking 1 Make the following installation 1m 50cm i PUMP nn Manometer bypass Program a 125 ml h flow rate and a counter pr
34. ssure sensor at 0 mmHg 1499 X 3696 mVolts NT1789 R v AO page 25 3 3 Tests Maintenance tests 3 3 1 Manual Service test menu Choice with SELECTION keys Proceed with confirm or ENTER keys Back to maintenance menu with STOP no parameter stored Test number is displayed on 7 segments display and simultaneously on LCD screen 3 3 2 Maintenance tests list Test aj Test Testl Display of working duration and number of switching on Test2 LED s LCD screen 7 segments display and buzzers test Test3 Keyboard test Test4 Battery voltage display Test5 Last 10 alarms codes display Test6 Total working duration and total number of switching on Test9 Analog sensor value display TestA Software version number display TestC Clamp dc motor test TestE Calibration values display Test F Infusion motor test TestJ Last 10 alarms before fail codes display 3 3 3 Working duration Test1 Display the cumulated pump working time in hours 72 hours in days 120 days or in months and the maintenance date Flashing display Er 1 if pump working time is gt time before maintenance see SAV1 or if actual date gt maintenance date SAV1 ri EEn C daro5r1998 Cri Oh ENTER selects date SELECTION changes maintenance date in actual date or restores configured maintenance date if maintenance date actual date then display 0 h and Ctrl erasing Co
35. test D M Y I Total working duration test6 H D M 5 M Lights buzzers and displays check test2 6 M Keyboard check test 3 7 Q Door check Put on the pump without infusion set door closed connect drip sensor Check the message on the alarm screen Insert Tube Place an infusion set full of water in the device and closed the door Check the absence of alarm Open the door Check the message Door opened 8 OCS Test forpump OPTIMA MS and VS or MCM MS and OT Install a tubing set and put on the device Check that the OCS test passes correctly Clamp Check all pumps Install a tubing set full of water roller clamp opened and bottle place at least 50 cm above the pump Close the door and then open the door Check the effective clamping of the tube by the device for VS PT ST or by the clamp on the MS sets for the MS pump no drips at the end of the infusion sets Detection of the clamp of the MS sets for MS type pumps Install the MS sets properly in the pump Turn on the MS pump Check that there is no alarm display Open the door and move the clamp on the MS set outside the device Close the door Check that no clamp Page 38 NT1789 R v AO Check Description Con form YES NO NA Q Drip sensor check if present Check sensor integrity chock marks cleanliness of the detection zone drip chamber maintaining spring good condition of the cord Connect the
36. very carefully if possible in its original packaging FRESENIUS VIAL INFUSION SYSTEMS is not liable for loss or damage to the device during transport to our Mainte nance Service 5 2 Cleaning and disinfecting The Module DPS and the FRESENIUS VIAL Infusion Station form part of the patients immediate environment It is advisable to clean and disinfect the devices external surfaces on a daily basis in order to protect patient and staff Q Disconnect the FRESENIUS VIAL OPTIMA Pump from the mains supply before starting to clean Q Do not place in an AUTOCLAVE nor IMMERSE the device Do not let liquids enter the devices casing Q Use a cloth soaked in DETERGENT DISINFECTANT previously diluted with water if required Avoid abrasive scrubbing which could scratch the casing Do not rinse or wipe surfaces Q If the device is placed in a high contamination risk unit it is advisable to leave it in the room during fu migation disinfecting after having disinfected it with a moist cloth Q Do not use gt TRICHLOROETHYLENE DICHLOROETHYLENE AMMONIA AMMONIUM CHLORIDE CHLORINE and AROMATIC HYDROCARBON ETHYLENE DICHLORIDE METHYLENE CHLORIDE gt CETONE These aggressive agents could damage the plastic parts and cause device malfunction Q Take care also with ALCOHOL BASED SPRAYS 20 40 alcohol They lead to tarnishing and small cracks in the plastic and do not provide the necessary cleaning prior to disinfecting Q For further detail
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