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Service Manual Maintenance

1. edet trt etin iiie itle ibt Heu 8 49 8 5 T2 PATIENNTASEINSQR TT 8 50 8 5 132A CONDUCTIVITY EE 8 51 8 5 14 DIASCAN COND ee eit parade heeded 8 54 8 5 T5 B CONDJUGTIVITY hotel trei e Qin e RR EROS 8 56 8 5 IG DI FLOW 8 60 ON 8 62 EN d Tue 8 64 8 5 A D BAVA seu EROR ERREUR RSEN RR ERN EU 8 67 6 5 20 Temperature i i eb ten ee EEN eed 8 69 8 5 2 TOUCH SC REENERT 8 71 8 5 22 HDBPM PRESSURE SENSOR ee 8 72 8 5 23 HDBPM SAFETY SWITGCEI eoe ettet tee t dei e een Ee d 8 74 8 6 Other Calibrations and Tests 8 76 8 6 1 ABD SENSOR 555 ares E RISE UR PON RENE ERROR UR S RA ARS UT e Rude 8 76 8 6 2 BED SENSOR ise dete ene e da HA o Be editis tease ie e eed 8 76 8 6 3 HDBPM on board accuracy Test 8 76 8 7 SAFETY VALVE TEST PROCEDURE nennen tentent nennen entrent etn 8 80 8 8 Autocalibration for PA pump PB pump UF pump Ne 8 81 8 8 1 Autocalibration Procedure for the Peristaltic Pumps During Dialysate Preparatlonmzc cute ed Re d ee 8 81 8 8 2 Autocalibration Procedure for the PA PB Peristaltic Pumps during a Dialysis Treatment n nete ee ER HG ERE EE OE p HR e HERR 8 84 8 8 3 Autocalibration of the UF Pump tenente tette tnter 8 85 9 7 TT General aeia E AOR 9 1 9 2 PHOENIX Doors Opening Closing Instructions eese 9 1 92 1 Opening IHSECUCEODS ER on a en ee b E
2. INI AIT UEPIXYO VIMITOD 7 7 1 1 Machine Ov rviE 1 1 1 1 1 Therapies Description we 1 1 1 1 2 Structure of the machine iiec cecinere eh ese a HEU He Rea RE 1 2 13 21 Master Module tie d te toe tette Do ere ee 1 2 1 1 2 2 Hydraulic Module 1 2 1 1 2 3 Blood Module rcr ei d be E reet e 1 3 1 1 2 3 1 CONTROL SYSTEM nennt nentes 1 3 1 1 2 4 Protection eee nia ri pei i ERE PUERO RH Tea dais 1 3 1 1 2 5 BIO WT 1 3 1 2 Description Of the machine ertet iret dy rii erre ven ertet 1 4 IO 1 4 1 2 2 Front Panel Machine Components sese tete 1 5 1 2 3 1 7 1 2 4 Rear Machine Components ee 1 8 1 3 Operator Interfaces aeter d neret aedi eie pepe euer e e ee e eins 1 10 1 3 1 Patient Card Reader 1 10 123 2 Screen D SCIIptlOrni i a e ede EES 1 10 1 3 3 Icons shown in Icon Area tnnt tentent nne 1 12 IP dan iD T 1 14 1 3 3 dc M 1 15 1 3 5 1 Background shape sees tette 1 15 1 3 5 2 List of Pietograms retener nte ette tentent tete nnn ennt 1 16 1 3 6 Help messages Idle mode 1 21 1 25 1 5 Blood Circuit Description 1 27 1 5 1 Venous and arterial pressure SenSOTS retener tenens 1 27 1 5 2 Blood age cete eren ti Pa RR pU e F
3. Indicates that the equipment conforms to the rules related to the Safety of Medical Electrical Equipment for U S and Canada The and US indicator adjacent to the CSA mark signifies that the product has been evaluated to the applicable ANSI UL and CSA Standards for use in the U S and Canada This page is left intentionally blank INTRODUCTION INTRODUCTION IEC Symbols WARNING Consult accompanying documents TYPE B APPLIED PART This apparatus provides an adequate degree of protection against electric shock particularly regarding allowable LEAKAGE CURRENTS and reliability of the protective EARTH connection OFF Mains power disconnected ON Mains power connected Alternating current Protective earth ground This symbol indicates that the equipment may not be disposed of together with other municipal waste the equipment was placed on the market after 13 August 2005 Rev A Il PHOENIX SERVICE MANUAL MAINTENANCE Rev A Keep dry Year of Manufacturing Name and address of the Manufacturer Serial Number from IEC 601 1 Very important information related to the patient or operator safety or given to avoid the machine breaking down Read carefully before operating the machine Important information related to the correct operation of the machine Read carefully before operating the machine INTRODUCTION INTENDED USE gt gt Thi
4. sse 3 280 3 5 29 Heat Citric Disinfection phase 28 Deflating ohase sss 3 282 4 BLOOD CIRCUIT DESCRIPTION eege 4 1 44 Introd ctione re SON dL MEET 4 1 4 2 Blood Cartridge Set nace rere ee dde er n EINE 4 1 4 2 1 Blood Module Double Needle sss 4 2 4 2 2 Blood Circuit Diagram Double Needle sees 4 3 4 2 3 Dialyzer amp Connections EEN 4 4 43 5 EE 4 4 4 4 EE 4 4 4 5 Venous Access Oort au diei tiani i aed P ted e inai aiiis aia 4 4 4 6 Venous and Arterial Pressure Sensors terere nte tenter 4 5 4 7 Blood eto ate eret eet a Rer TRES 4 5 4 8 Blood Pump Door with door Sensor tentent tenente tentent tte tente 4 6 4 9 Blood Pump Rotor Raceway amp Rotor Position Hall Sensors 4 6 4A OAIF bubble detector 5 5 pee mera eaae de qute RI D exa 4 6 4 10 1 Ultrasonic Oscillator and Transmitter Output essere 4 7 4 10 2 Ultrasonic Receiver Output 4 7 NUMINI LAE 4 7 4 12 Venous tubing presence switch in Air Bubble Detector 4 8 4 1 3 VENOUS Clamp T 4 8 4 14 Venous tubing presence switch in venous camp 4 8 4 15 Heparin Pump iei ten s de a de RU Gp ge Reg ida 4 9 4 16 Additional Blood Circuit Intomaton ee 4 10 4 16 1 Blood Pump Control Panel 4 10 4 16 2 Blood Pump flow and Ulpraftltratton sse 4 10 4 17 Single Needle Clamp Assembly 3 4 11 4 17 1 Blood Module
5. 5 11 5 44 Heater Flow Switch DEP atre ade re de at dd 5 11 5 4 5 Dialysate How Swtteh iiit aeter dae nente ete cereis dtes 5 11 5 4 6 Drain Pressure Switch SWP1 4 5 11 5 4 7 Deaeration Pump irt ern he e hte 5 12 Pump Encoder FRG tectae ce re ce Ro 5 12 54 8 How Pup W PT o t ee RE EHI IER NER C ERREUR Yen Hd 5 12 5 12 5 4 9 Flow Pumyp P2 aiedeiaei i e d i dei HO etie died 5 12 5 12 5 12 5 45 T D2 Flowmeter ED2 eddies ee ele ae egen 5 13 5 4 12 PD Drain Pressure ette eed eege 5 13 5 413 PO Pressure Sensoren nn esteem nappe rep pd t edis 5 13 5 4 14 PI Pressure Sensor E tette sensn teens 5 13 54 15 PES Pr sS reSensOF sert eee e eee dr eei degit dae rit 5 13 5 4 16 Ultrafiltration Pump PUE 5 13 5 4 16 1 UF Burette Level Sensors HLUF LLUEI eere 5 14 5 4 17 Concentrate Pumps PB and DA 5 14 5 4 18 Conductivity Cells CCA PCA PCB ttt 5 14 5 4 19 Sterilant Pump PS Level Sensors HLS LLS HLUF LLUF ce seen 5 15 5 4 20 Level Sensors LP LDT LD2 eese eene ener tnter 5 15 5 4 21 Heater HB Temperature Sensors TP TPS Thermocouple Temperature Sensor STA aceite ditata emendis a eaaet tdi 5 15 5 5 Protective Slave Board 5 25 5 5 1 Air Bubble Deiector 5 25 5 5 2 Venous Clamp Line S
6. Single Needle sse 4 12 4 17 2 Blood Circuit Diagram Single Needle serene 4 13 5 FLECTRONIC DESCRIPTION 5 1 Bal 5 1 Ka GER 5 2 5 1 2 Liquid Crystal Display and Touch Screen sees 5 2 bzT 32Patient EE 5 2 EE 5 2 5 T 5 RS485 ta pe o b ae RP rera 5 3 5 T 6 Ethernet Connection oie ied EAS E RR RETRAITE AN VHS ERR EE 5 3 5b TZ BPM Module tta enn aad qa dede qat tiae ris 5 3 5 2 Control Protective St 5 3 XIV PHOENIX sERVICE MANUAL MAINTENANCE Al SP Communication Besseres 5 3 5 3 Blood Slave Board di rated t ac de 5 5 5 3 1 SPI Commo nication BUS prre eter eee aeta E i 5 5 5 32 Blood Pump eredi ea te etos e npe HIR 5 5 5 3 3 Blood Pump Encoder is aite eran d Meet i reds 5 5 5 3 4 Blood Pump Door Sensor dette ded ie dte doe a s re uds 5 5 5 3 5 Blood Pump Rotor and Direction Hall Sensors 5 5 5 3 6 VENOUS Clamp tie der rg 5 6 5 3 7 Arterial and Venous Pressure Transducers sse nettes 5 6 5 3 8 Renate edet Pr t dens 5 6 5 3 9 Heparin Pump ECOG GF ater tte ide detti de e d endis 5 6 5 3 10 Heparin Pump Limit Switches ee 5 6 5 3 11 Blood Pressure Monitor BDMI tn ens 5 6 5 4 Hydraulic Slave Board EEN 5 11 5 4 1 SPI Communication Bus 4 5 11 5 4 2 Water Inlet Pressure Switch SW 5 11 5 43 Inlet Water Valve EVEIDQ a de eite e
7. Acid Temperature Control and Protective essent 1 35 1 9 9 Acid Conductivity Control and Drotechve sse 1 35 1 9 10 Acetate Concentrate Preparation ee 1 35 1 10 Disinfection and Rinse ee 1 36 1 10 1 List of ADR Parameters and their meanings sese 1 37 2 HYDRAULIC 2 1 2 4 Elydra licCireuitDescrptiOm soo OO AGO aan Nd eU ds 2 1 2 2 Water Supply Connection and Filtering E 2 1 2 3 Inlet Water Pressure Control ue itte treten 2 2 2 4 Heating and deaeration ee 2 2 244 Heat Exchangetzs nee tert rro dete e dece e et nin Phau deena 2 3 2 4 2 Restrictor Bypass Re 2 3 2 4 3 Heater HB Thermocouple Temperature sensor STH 2 3 2 4 3 1 Heater Temperature Sensor TP 2 3 SE DRETT 2 4 2 4 5 Degassing restrictor IOR2 a ep i E asar Ei 2 4 2 5 Concentrate mixing and conductivity Control 2 5 2 5 1 Bicarbonate Concentrate Mixing eret 2 5 2 5 1 1 Bicarbonate Temperature Control Sensor Tc and Protective Sensor Tp EE 2 6 2 5 1 2 Bicarbonate Conductivity Control Sensor and Protective Sensor R EE 2 6 25 13 BiCart EIDEN Rea S re OR t er RA d 2 6 2 5 2 Acid Concentrate Preparation iint tue ENEE asc 2 7 2 5 2 1 Acid Concentrate Mixing eese eterne tnter 2 7 2 5 2 2 Acid Temperature Control and Protective 5 2 7 2 5 2 3 Acid Conductivity Control and Protective Sensors ss
8. BPRLY lt gt BLOOD PUMP BOARD 6 51 6 52 6 7 1 TERMINAL BLOCKS lt gt MAIN SWITCHH eese nennen nennen nnns 6 52 6 7 2 HEATER RELAY lt gt TERMINAL BLOCKS ps 6 52 6 7 3 OPTOTRIAC lt gt TERMINAL BLOCKS 4 6 52 6 7 4 Connector JZ OVERTEMP eine uer rte ds ri a ee a or s 6 52 6 7 5 TRANSFORMER lt gt TERMINAL BOCK 6 53 6 7 6 J3 OVTEMP lt gt TERMINAL BLOCK 6 53 67 7 J9 POWER SUPPLY lt gt BATTERY eege eege Ee Beis 6 53 6 7 8 Ja POWER SUPPLY lt gt MAIN SWITCH AUXIL CONTACT 6 53 6 8 Power rack wiring 6973432 tci nene tereti e E ini tie ett leere ete 6 54 XVI PHOENIX sERVICE MANUAL MAINTENANCE 6 8 Phoenix TNS 6 54 6 8 1 1 TERMINAL BLOCKS lt gt MAIN SWITCH sese 6 54 6 8 1 2 TERMINAL BLOCKS lt gt HEATER RELAN 6 54 6 8 1 3 TERMINAL BLOCKS lt gt J3 ntes 6 54 6 8 1 4 OPTOTRIAC lt gt TERMINAL BLOCKS and HEATER 6 54 6 8 1 5 J1 POWER SUPPLY lt gt TERMINAL BLOCKS sss 6 55 6 8 1 6 Ja POWER SUPPLY lt gt MAIN SWITCH AUXIL CONTACT se 6 55 6 8 1 7 9 POWER SUPPLY lt gt BATTERY eese tenente tenentes 6 8 1 8 Connector J2 ONERTEMP nennen etre ntes tente nern 6 8 1 9 POWER RACK GROUND CONNECTIONS 6 82 Phoenix 230WV x derer eae t a eee Re e t a des 6 8 2 1 TERMINAL BLOCKS lt gt MAIN SWITCH sese 6 8 2 2 TERMINAL BLOCKS lt gt HEATER RELAY esses 6 8 2 3 HEATER RELAY lt gt
9. Hemodialyzer Connechon sss 3 28 phase 11bis BYPASS due to an alarm 3 30 phase 12 HD Connection annaa 3 32 phiase 12B Calibration aii aee diee dee eee qase ea 3 34 phase 13 Filling and Rinsing the Hemodialyzer Hydraulic p 3 36 phase 14 Hydr Priming end and Wait for Dattent sss 3 38 phase 15 Wait for Patient when the machine is in 3 40 phase 16 Patient Connection 3 42 phase 17 Start Dialysis REENEN 3 44 phase 18 Flow meters Calibration seen 3 46 phase 19 DialySsigs tette nnne 3 48 phase 20 BY PASS UF ONLY Operator eee 3 50 phase 21 Flow meter Calibration es 3 52 phase 22 UF ONLY set by the Protective System 3 54 phase 23 Filling and rinsing the hemodialyzer in case of filter uring the treatment entente 3 56 phase 24 Hydraulic Priming end in case of filter replacement during the treatment sess tentent tette tnter tinte tente 3 58 3 1 30 Dialysis 3 1 31 Dialysis 3 1 32 Dialysis 3 1 33 Dialysis 3 1 34 Dialysis 3 1 35 Dialysis 3 1 36 Dialysis 3 1 37 Dialysis 3 1 38 Dialysis 3 1 39 Dialysis 3 1 40 Dialysis phase 25 Ultrafilter tangential rinsing sse 3 6
10. OE UI ERN CIS IRR ERIS TRUE 13 1 T4 INSTALLATION eebe ee 14 1 T4 1 Required Equlpient terrre ee re e e A e HAIR Rs 14 1 14 2 Unpackagirg insttUCtioHs acra Rn 14 1 14 3 Setup For Checkout ee 14 1 E Filling procedure ih erret ere iur I ien e ri ertet 14 3 T4 5 R1 R2 and PG darsi deed ate eb dete 14 4 14 6 Warming psthe machiligz 5 tre e e alae a b i 14 7 14 7 test Proced ut es qu n nei TA tie Mni pte ari ters 14 8 Re ele Ip Een HAH EE 14 8 14 7 2 A CONDUGTIVIDY 5er ertet e et ed dere et 14 9 14 7 3 Diascan Cond ee te rd ite e 14 10 TAZA Ierdeul d P 14 10 147 5 Venous Pr ssure 5 ep e e de s 14 11 14 7 6 Arterial Pressure Sensor 14 12 UE WEE EE 14 13 4 78 PH probes eee e e eR RR RR ER RU eS 14 14 14 8 Parameters ConflguratlOn siu demie atte uat IM 14 15 AM 14 15 14 8 2 Configuring Multiple Machines ee 14 15 14 9 Preparing for a treatment ee 14 16 14 10 Simulated Dialysis freatmenmt tnnt tenete tentent tenete tentent 14 16 1441 Electrical Safety Verification 2 RR 14 19 14 12 DISITMe CIO C eR ae ea oa E 14 20 TS SPECIFICATIONS E 15 1 15 1 General specifications eet ni cere iae a tees e a n cente diee i eta 15 1 15 2 Hydraulic d resin n qui Un UU RU rU RS 15 9 15 2 T Water SUDply ii n
11. OPTOTRIAC sese 6 8 2 4 OPTOTRIAC lt gt OPTOTRIAC tette tenete nettes 6 8 2 5 TERMINAL BLOCKS lt gt SWITCHING eese 6 8 2 6 HEATER RELAY lt gt HEATER AS9EMBLY 6 8 2 7 OPTOTRIAC lt gt HEATER ASSEMBLY ee 6 8 2 8 J1 POWER SUPPLY lt gt TERMINAL BLOCKS 6 8 2 9 J1 POWER SUPPLY lt gt MAIN SWITCH AUXIL CONTACT ss 6 59 6 8 2 10 Connector J1 OVTEMP3 lt gt OPTOTRIAC 6 59 6 8 2 11 J9 POWER SUPPLY lt gt BATTERY se 6 59 6 8 2 12 Connector J2 OVERTEMP3 lt gt RELAY 6 59 6 8 2 13 POWER RACK GROUND CONNECTION 6 60 6 9 Power Rack 6957377 Cabling sese 6 61 6 10 Power Rack 6973432 Cabling tentent teniente trennt 6 61 6 65 6 10 2 Phoenix EE 6 69 Ze SOFTWARE DESCRIPTION Tt 7 7 EE 7 1 7 3 7 2 1 Power up memory test ettet e I Red e I Her eet 7 3 OCT 7 3 7 3 1 Data lee EE 7 3 7 332 Redundant data structures inet Eeer 7 4 7 3 3 Redundant parameter modtftcatton sese 7 4 7 3 4 Messages BENETAUOMN p 7 4 7 5 74 1 T1 Test Description ere rie d e e Ede eet 7 8 6 CALIBRATION 2 55 522216220222 2 2 03522 09 002 tos do dios oc actes toc Dod doc testen tes 8 1 8 1 CALIBRATION INTRODUCTION Qu tes 8 1 8 2 SOFTWARE C
12. WARNING Before moving the machine check that the brake is released and remove infusion bags or hanging objects from the IV pole WARNING It is recommended to use concentrates which conform to the requirements of the local standards or of the AAMI RD61 Concentrates for hemodialysis standard or of the European Pharmaceutical standards The control of alarm thresholds and dialysate conductivity precision is of major medical importance in ensuring a safe dialysis treatment WARNING It is the responsibility of the user to determine the correspondence between the dialysate conductivity displayed by the machine and the dialysate solute content verified by clinical laboratory results for each dialysate concentrate used for dialysis treatment This can be done by taking dialysate samples at different conductivity values e g 13 14 15 mS cm and sending them to a laboratory for analysis WARNING Carefully read the BiCart Instructions for Use before using the device BiCart may only be used by staff who are specially trained for hemodialysis treatments using the Operator Manual see BiCart paragraph WARNING Only in the event of the CONCENTRATE TYPE ERROR A PUMP or B PUMP or A amp B PUMPS alarm is when it possible to perform the Autocalibration of PA or PB pump in dialysis see Maintenance Section when the operator accesses the appropriate page by pressing the MACHINE Tab Rev A VI PHOENIX SERVICE MA
13. 0 phase 27 Blood Restitution sse teretes 3 62 phase 28 Emptying the HemodialyZet sse 3 64 phase 29 End of session and Rinsing 3 66 phase 30 Descalilig irte tete ie ee tine Re 3 68 phase 30A Descaling with AUTOEMPTYING ps 3 70 phase 31A PI gt 500 mmHg Restart condton 3 72 phase 31 lt 450 mmHg Restart 3 74 phase 31B Hemodialyzer connectors in bad 3 76 OA 3 78 phase 33 BY PASS due to alarm during priming 3 80 INTRODUCTION REM Mure c 3 2 1 Rinsing phase 2 Tangential Ultrafilter rinsing seen 3 2 2 Rinsing phase 3 Rinsing main circuit test air HLS LLS HLUF LLUF 3 2 3 Rinsing phase 4 Test air on LP LD 1 Listener tenentes 3 2 4 Rinsing phase 5 Test water on LP UD 3 2 5 Rinsing phase 6 Rinsing main circuit test water on 3 2 6 Rinsing phase 7 Emptying DH tank only on failure of phase 6 3 2 7 Rinsing phase 8 Rinsing external bypass ee 3 2 8 Rinsing phase 9 Rinsing EVD2 zU 3 2 9 Rinsing phase 10 Rinsing EVR1 EVWV 2 3 2 10 Rinsing phase 11 Rinsing EVR1 3 2 11 Rinsing phase 12 Ri
14. 7 Heat Disinfection phase 7 Rinsing EV2 line and UF burette external line 3 196 3 4 8 Heat Disinfection phase 8 Heating water 3 198 3 4 9 Heat Disinfection phase 9 Disinfecting the line EVR1 3 200 3 4 10 Heat Disinfection phase 10 Disinfecting the line above BT1 3 202 3 4 11 Heat Disinfection phase 11 Disinfecting the EVW2 line sss 3 204 3 4 12 Heat Disinfection phase 12 Disinfection the EVW T1 3 206 3 4 13 Heat Disinfection phase 13 Disinfecting bypass UE 3 208 3 4 14 Heat Disinfection phase 14 Tangential disinfection of the Ultrafilter 3 210 3 4 15 Heat Disinfection phase 15 Disinfecting the line above BT2 Ultrafilter 3 212 3 4 16 Heat Disinfection phase 16 Disinfecting P2 3 214 3 4 17 Heat Disinfection phase 17 Cooling the main circuit sss 3 216 3 4 18 Heat Disinfection phase 18 Heating phase in case of temperature 3 218 3 4 19 Heat Disinfection phase 19 End of process Ne 3 220 3 4 20 Heat Disinfection phase 20 Deflating phase seen 3 222 3 5 Heat Citric ette rd ter ite er te det tents 3 224 3 5 1 Heat Citric Disinfection phase 1 Rinsing Loop PC Loop EVR1 Loop PO Bypass PA and ER PUMPS er te qu eH ENG UR ve ER Dnus 3 226 3 5 2 Heat Citric Disinfection phase 2 Rinsing Loop PC Loop EVR1 Loop PO Bypass PA and P
15. ALIBRATION General Description 8 3 8 3 0 2 2 CAL HOME pages e oe aie e el i eque agn 8 4 8 2 3 INFORMATION Action key 8 5 9 2 4 TEST A GOD GV tae eee DRE o p NU epa s A asia 8 6 82 5 CALIBRATION ActionKey Ree E 8 8 82 6 AUTOCAL EhvirOnmient secrete ita ie ede e e i EINE 8 10 8 2 7 OPERATIONS Environment eene tnnt tnnt nennen tenete 8 12 8 2 7 1 SW UPGRADE Action Key 8 12 8 2 7 2 CONFIG TRANSF Action Key u ccccsssssssssseeeeseseseseseseeesnscsnseseeeseseseeseaeseaeaees 8 14 8 2 7 3 MAIN SETTING Action Key c ccccccessssssseeseeeseeseseseseceseecseeeeeeeeeeeseseseseseeeseanaees 8 16 8 2 7 4 DEFAULT COEFF Action Key 8 20 8 2 7 5 RESTORING Action Key 8 21 8 2 7 6 ACC TESTING Action key 8 22 Rev A INTRODUCTION XVII 8 3 Power Supply Verifications ee 8 24 8 4 R1 and R2 Pressure Regulators Calibration es 8 26 8 5 CALIBRATION Procedures secs de eR e e RET 8 28 015 PE PUMP zie er E GP ER ra Pide cus d e CERES 8 28 8 5 2 IN HD PRESSURE SENSOR DI 8 31 8 5 3 OUT HD PRESSURE SENSOR POL 8 33 8 5 4 PES PRESSURE SENSOR Eesen 8 35 8 5 5 DRAINCPRESSURE SENSORX PD ines Eegeregie 8 37 8 56 DLL VE 8 39 8 5 7 VEN PRESSURE SENSOR ehe tede ed ede er de 8 41 8 5 8 ART PRESSURE SENSOR ee re eret eet ede eee ree ede 8 43 8 5 9 EET VEN PRESSURE 8 45 8 5 10 TET eR ete eee eee etes er eaae reete dae 8 47 8 5 TE BATIENTSSENSOR EED
16. B HERE RENI E PUR dE eekleg 3 228 3 5 3 Heat Citric Disinfection phase 3 Rinsing EV2 line external line UF ele 3 230 3 5 4 Heat Citric Disinfection phase 4 Rinsing EVBP line UF burette 3 232 3 5 5 Heat Citric Disinfection phase 5 Rinsing EVP EV2 ee 3 234 3 5 6 Heat Citric Disinfection phase 6 Rinsing Loop PC EVD2 line EVD1 line erp 3 236 3 5 7 Heat Citric Disinfection phase 7 Rinsing EV1 EVW1 EVW2 lines 3 238 3 5 8 Heat Citric Disinfection phase 8A Filling the disinfectant tank IFLIQUID FROM SREAR T eed ca EE ee OE NS 3 240 3 5 9 Heat Citric Disinfection phase 8B Filling the disinfectant tank If LIQUID FROM REAR 2 3 242 3 5 10 Heat Citric Disinfection phase 9 Heating and filling the disinfectant tank if IQUID FROM FRONTE ecce eda red a dre id d aire 3 244 3 5 11 Heat Citric Disinfection phase 10 Disinfecting EVP Loop EVR1 PA and PB EE 3 246 3 5 12 Heat Citric Disinfection phase 11 Disinfecting EVD1 and Loop EVR1 3 248 3 5 13 Heat Citric Disinfection phase 12 Disinfecting EVW2 Loop EVR1 UF burette PA and PB cccccccccsccsscsssssccsssssscesssscesssssssecssessescscssssecessessenccssasscacssstesceesssenecsstsancessenseasoss 3 250 3 5 14 Heat Citric Disinfection phase 13 Disinfecting EVW1 Loop EVR1 UF e UR 3 252 3 5 15 Heat Citric Disinfection phase 14 Disinfecting Byp
17. IC PHASE DESCRIPTION ussscssssssosssssssssssssssesssssssssssssssssscssvssscsssssssscsssssssscssvssssssssussasssvesssasesvesseases 3 1 3 1 Dialysis DFOGess d divae estesa dtd 3 1 3 1 1 Dialysis Ph ses ardet EUR decree ee ente es 3 2 Rev A 3 1 2 Dialysis 3 1 3 Dialysis 3 1 4 Dialysis 3 1 5 Dialysis 3 1 6 Dialysis 3 1 7 Dialysis 3 1 8 Dialysis 3 1 9 Dialysis 3 1 10 Dialysis 3 1 11 Dialysis 3 1 12 Dialysis 3 1 13 Dialysis 3 1 14 Dialysis 3 1 15 Dialysis 3 1 16 Dialysis 3 1 17 Dialysis 3 1 18 Dialysis 3 1 19 Dialysis 3 1 20 Dialysis 3 1 21 Dialysis 3 1 22 Dialysis 3 1 23 Dialysis 3 1 24 Dialysis 3 1 25 Dialysis 3 1 26 Dialysis 3 1 27 Dialysis 3 1 28 Dialysis replacement d 3 1 29 Dialysis phase 32 End of Process UDLEI tnter 3 4 phase 7 Filling the Circuit for Pi and Po test 3 6 phase 1 Emptying of residual water from Disinfectant 3 8 phase 2 Rinsing The Main Hydraulic CirCuit sss 3 10 phase 3 Rinsing the Main Hydraulic CirCuit esses 3 12 phase 4 Emptying the Circuit ee 3 14 phase 5 Filling the circuit with water essere 3 16 phase 6 Dialysate preparation Temp And Cond Regulation 3 18 phase 8 Dialysate preparation es 3 20 phase 9A P2 Pump checking sese 3 22 phase 9B UF Pump checkmg 3 24 phase 10 Flow meter Calibration es 3 26 phase 11 Wait for
18. NUAL MAINTENANCE gt WARNING In the case of Autocalibration of the Acetate or Bicarbonate pump the user must verify that the concentrate at the machine concentrate inlet is correct and confirm this by pressing the Confirm button on the main keyboard The process will only proceed after this confirmation The use of incorrect concentrates can lead to an incorrect dialysate conductivity not detectable by the Protective System WARNING If a bicarbonate dialysis was performed do not turn off the machine with bicarbonate dialysate fluid inside An acetic acid rinse must be performed at least twice a week to remove the calcium and residues which may be deposited in the system during dialysis treatments WARNING The use of the Cartridge Blood Tubing s Set designed for the machine is recommended to guarantee safe and proper functioning of the system WARNING Never insert fingers in the automatic clamp When the cover of the blood pump is open verify that the pump is off WARNING The Heparin Syringe diameters have been taken from samples from many countries and are correct at the time of going to press However the manufacturer cannot be held responsible for changes in syringe dimensions that may occur The user should periodically check the correlation between the stated and the actual diameters WARNING For the BPM installation carefully follow the instructions supplied with the BPM kit WARNING The BPM mu
19. Phoenix Service Manual Maintenance C e 6 dE US service code 6990576 revision A from SW rev 3 36 date March 2009 Manufactured by GAMBRO DASCO S p A Via Modenese 66 41036 MEDOLLA MO Italy Questions or comments about this publication can be directed to your Local Representative 2009 GAMBRO LUNDIA AB All rights reserved PHOENIX is trademark of GAMBRO HOSPAL Schweiz AG and registered in Australia Austria Benelux Denmark Estonia France Georgia Germany Italy Latvia Lithuania Norway Poland Portugal Republic of Moldova Romania Russian Federation Slovakia Slovenia Sweden Turkey United Kingdom United States and in the European Community PHOENIX is a trademark of GAMBRO LUNDIA AB registered in Canada The logo Phoenix is a trademark of GAMBRO HOSPAL Schweiz AG registered in the United States is a registered trademark of GAMBRO LUNDIA AB HOSPAL is a trademark of GAMBRO HOSPAL Schweiz AG and is registered in Algeria Austria Belarus Benelux Bosnia Herzegovina Brazil Bulgaria Canada China Croatia Czech Republic Denmark Egypt Finland France Germany Greece Hungary Italy Japan Liechtenstein Macedonia Monaco Morocco Norway North Korea Poland Portugal Romania Russian Federation San Marino Slovak Republic Slovenia Spain Sweden Switzerland Ukraine United Kingdom United States Vietnam Yugoslavia Phoenix amp machine is protected by one or more
20. RE 9 1 9 2 2 Closing IpstruCtiOnDs EE 9 1 9 UII RET 9 2 9 3 1 Blood pump rotor cleaning sese tentent netten 9 3 9 3 2 Removing the iron oxide deposits within the hydraulic flowpath with Oxalic H T 9 4 miro mri D MR 9 6 9 4 1 Sealed Lead Battery storage Ne 9 6 9 5 Periodic Safety Inspection EE 9 7 9 6 Preventive malntenarice 52e a HE De P Ee n e Ree Ped 9 8 9 Z Emptying thiezmachlfe e OR OE US 9 9 9 7 1 Disinfectant solution preparation ee 9 9 9 7 2 Chemical deintechon essent treten tentent eterne 9 9 9 7 3 Emptying the Phoenix by using a vacuum pump Ne 9 10 9 7 4 Emptying the Phoenix without devices to drain water 9 12 9 7 5 Restarting the machine after storage or shipment ee 9 13 XVIII PHOENIX SERVICE MANUAL MAINTENANCE 70 SERVICE SCREEN amp TROUBLESHOOTING sscsscsssssssssssssssssssssssssssssssssssssssssssssssssscssssssssssssssssssssssssssssases 10 1 10 1 Service Screen ACCESS VIEW sessi eee eeepc Licet dese Ree 10 1 TO 2 Status Screens First Haeren eege Rete e AEN 10 4 10 2 1 First Page Parameters description ee 10 5 10 3 Status Screen Second Page 10 8 10 3 1 Second Page Parameter description 10 9 10 4 Status Screen Third Pages scsi cc rr e bte i te e HR AR et bre eet qund 10 13 10 4 1 Third Page Parameter d
21. ass external line UE e cuc MJ 3 254 Rev A INTRODUCTION XIN 3 5 16 Heat Citric Disinfection phase 15 Disinfecting EVBP Ultrafilter external line F brenge ear Ree 3 256 3 5 17 Heat Citric Disinfection phase 16 Disinfecting EVD2 Ultrafilter 2 3 258 3 5 18 Heat Citric Disinfection phase 17 Disinfecting the main circuit 3 260 3 5 19 Heat Citric Disinfection phase 18 Rinsing EVP EV1 PA and 3 262 3 5 20 Heat Citric Disinfection phase 19 Rinsing EVD1 EVR1 PA and 3 264 3 5 21 Heat Citric Disinfection phase 20 Rinsing EVBP PA and 3 266 3 5 22 Heat Citric Disinfection phase 21 Rinsing the external Bypass line UE PA ana Pests IN Ee LARA 3 268 3 5 23 Heat Citric Disinfection phase 22 Rinsing main circuit P2 UF external line EVD2 EVHE PA and PR 3 270 3 5 24 Heat Citric Disinfection phase 23 Rinsing Loop EVR1 EVW2 PA and PB 3 272 3 5 25 Heat Citric Disinfection phase 24 Rinsing Loop EVR1 EVW1 PA and PB 3 274 3 5 26 Heat Citric Disinfection phase 25 Rinsing main circuit P2 3 276 3 5 27 Heat Citric Disinfection phase 26 Heating phase in case of temperature ld M 3 278 3 5 28 Heat Citric Disinfection phase 27 End of process
22. ee 1 27 1 5 3 Blood Pump Door with door semsor tette 1 27 15A Air e TEE 1 27 1 5 5 Patient SENSO EE 1 28 1 5 6 Venous patient tubing presence sensor in Air Bubble 1 28 1 5 7 Venous patient line clamp sss 1 28 1 5 8 Arterial line clamp optional essere nennen 1 28 1 5 9 Venous patient tubing presence sensor in venous clamp ee 1 28 T5 EO Bleparin PUM Pisses iin retro die ie ner tene erri d nd HERPES 1 28 1 5 11 Saline Tineelarip aeter ame ettet ete stie dran adest d tesi 1 28 1 5 12 Blood Cartridge ee 1 29 1 5 12 1 Blood circuit front view 1 29 1 55 2 2 C EE 1 30 1 5 12 3 Blood Pressure Transducers essent 1 31 1 6 Automatic or Manual Priming tete 1 32 INTRODUCTION IX 1 7 Ultrafiltration Control Mass Balance 1 33 1 8 Temperature Control and Monitoring essent ntes 1 33 1 9 Conductivity Control and Monitoring 1 34 1 9 1 Bicarbonate Concentrate Preparation essent 1 34 1 9 2 Bicarbonate Concentrate Mixing eterne tentent 1334 1 9 3 Bicarbonate Temperature Control and Protective seen 1 34 1 9 4 Bicarbonate Conductivity Control and Protective Ne 1 34 1 9 5 BiGart OPUN zt er e re d de eR t e E Ca Ride 1 35 1 9 6 Acid Concentrate Preparation sess tenente tentent 1 35 1 97 Acid Corcehtr te tee derniere o eder e e die eres 1 35 1 9 8
23. ensor 5 25 5 5 3 Venous Line Presence Sensor 5 25 5 5 4 Blood Leak Detector ith tette ha ct a iere 5 25 bbb FWP ROW Gis i due RE RUSSE GHI RYDER 5 26 5 5 6 Patient SensoOt EE 5 26 RE E D Ee BEE 5 31 5 7sBIGOG PUMP Board eeschter Ee 5 31 5 31 6 SIGNALS amp CONNECTIONS DESCRIPTION oooeeeeeeeeeeeeeeeoeooooosooossososonssronononrnronononsnronononsorooonooroooooooorooooon 6 1 6 1 MOTHER BOARD LAY OUT from Rev A0 6 1 6 2 MOTHER BOARD SIGNAL LIST from Rev A0 6 5 6 241 Rev AO uh rtt de e etit dr e a e 6 5 6 212 Revi BOSOM Create us hh ab det ttd eq dtl ete rt e dedans 6 7 6 335lgnals DescriptioHs o smt Vemm tst 6 17 INTRODUCTION XV 6 4 Circuit Boards Description tentent tenete tete treten teret tte treten enne 6 25 6 4 1 Protective Board EMC 69691441 6 25 6 4 2 Hydraulic Slave Board 6969125 unien ea eene tette tenens 6 26 6 4 3 Blood Slave Board 6969109 4 6 28 6 4 4 Bioslave Board code 6970362 and Ggo z10pb tnt 6 30 6 4 5 CARRIER 1 6967772 6 32 6 4 6 DTY MONITOR board 6973028 4 6 33 6 4 7 PC TOAPenturm EE 6 34 6 4 8 HDBPM Board 6963839 6 35 6 4 9 SMD Board 6965545 tee ied 6 36 6 5 Mother Board Connectors Descrtptton tenente nennen 6 37 6 5 1 Connector J1 Mother Board 6 37 6 5 2 Connector J2 Mother Board 6 37 6 5 3 Connecto
24. entent tenente tenens 11 5 11 3 General Safe state after communication alarms or after a bad Touchscreen De 11 9 11 4 Frozen Main Control Panel 11 14 11 5 BPM troubleshooting reo ettet er cte re e ese 11 15 12 SPECIAL CHECKOUT PROCEDURES ssssessssssssssscssesscssessssscsscsscsssssssscssssssssssssssssssessssssssssssssssssssssssssesssees 12 1 12 1 Blood Circuit Leakage Test 12 1 12 2 Venous Clamp Occlusion TeSt cccecsssesssssesessessssessesesseseesecnesesacsuesececsessessesesececaesesaesneaeeasanseceeeetens 12 2 12 3 Blood Pump Rotor Occlusion Test sss eterne tete 12 3 12 4 ABD Alarm Verifications ee 12 4 12 5 Blood Pump Cover position fest 12 5 12 6 Venous Line Presence Sensor tests ee 12 6 12 7 Blood Pump Rotor positioning fest 12 6 12 6 12 9 Ground Integrity TGS 12 7 12 10 Power Failure amp Battery Test 12 7 12 1 T Water Leakage Checked e eire e d e e RR RUE 12 9 12 12 WHO door sensor test eter dit e ar ie eis 12 10 12 13 Total Ultrafiltration Accuracy Test ceseesessesessesecsessesesseseesecseseesecscsesecesssesnssessecesaecnsaeeassnsaeeceaeeseees 12 10 12714 Mass Balance 12 12 12 15 SWP Inlet Water Pressure Sensor Test tenete tenente tenete nnne 12 13 Rev A INTRODUCTION XIX VERI AN I AAN A RI D A AE E 13 1 AST ue ipee PRSE
25. escription 10 14 10 5 Status Screen Coding aee tte dateien a Hetruria 10 17 DJ 10 17 10 5 2 Vismode ONOFF teneret tete tette tent 10 17 NE 10 17 10 5 4 Vismode LEVE Da 10 17 10 5 5 Vismode DOOR tenerent tet tette A A 10 17 1 0 5 6 Mismod REV DER 10 17 10 5 7 Vismode SET PUMPS trennen treten tenente tete tete tentent teen nnns 10 17 10 18 10 5 9 Vismode REVYESN O ee G 10 18 10 5 10 Vismode FIEXADEG c t Detectors ada Bete 10 18 10 5 T i Vismode DEGIM A Iss 5 e eh t Pte e 10 33 10 6 Alarms and Signal 10 34 10 6 1 Classification and modes of Intervention 10 34 10 6 2 Operator Guidelines for responding to Alarms on the Phoenix machine 10 39 10 6 2 1 OVERRIDING Arterial and Venous Pressure Alarms ss 10 40 10 6 2 2 Operator Actions required after pressing the OVERRIDE Button for Arterial and Venous Pressure Alarms sse 10 40 10 6 3 Alphabetic List of Alarms essent 10 41 10 6 4 Alarm description sere dete inte e tee ed ten reete teg 10 53 10 6 5 Numerical List of Alarms and Troubleshootng see 10 54 11 ADDITIONAL TROUBLESHOOTING TABLES eee sees sees sanno naa a nasa ansa 11 1 11 1 Pi and Po Pressure sensor Test sse teret nte nennen tentent tenentes 11 2 11 2 Mass Balance troubleshooting sansen ion a G t
26. esponsibility or liability for use of accessories or disposable other than those specified in this manual It is the responsibility of the user to validate that other accessories or disposables provide safe and effective performance SPARE PARTS 7 5 J Note The Manufacturer will maintain spare parts availability for ten years after the end of production of PHOENIX At the end of that time the involved product is considered obsolete and therefore it must be disposed of according to local applicable regulations The final user will be informed that spare parts are no longer available through the technical service or the sales representative For additional information contact your local technical service representative Rev A IV PHOENIX SERVICE MANUAL MAINTENANCE WARNINGS Pee dp op gt WARNING Do not assemble install or use the machine before having read the Operator and Service manuals WARNING This operation must be carried out by authorized personnel if not the Manufacturer cannot accept any responsibility for damage which may occur and such damage is not covered by the warranty WARNING Check the continuity and the reliability of the ground connection WARNING Verify the quality of the protective earth ground at installation WARNING Do not perform any technical intervention on the machine from the dialysis preparation phase until patient disconnection Before per
27. forming any technical intervention on the machine are sure that it has been properly disinfected WARNING Do not use this machine near flammable gas or flammable anaesthetic mixtures with air with oxygen or with nitrous oxide WARNING Storage under 0 C is only possible if the hydraulic circuit has been drained see Maintenance section of this Manual WARNING This equipment conforms to IEC 60601 1 2 standard on Electromagnetic Compatibility thus it has an adequate degree of protection against electromagnetic disturbances However to prevent any problem it is recommended not to use cellular phones hand held in the dialysis room or at least to keep a minimum distance of 10 m from the equipment Refer to local standards and guidelines WARNING Possible hazards may arise from other equipment different from the accessories listed in the Operator Manual being connected to the hemodialysis machine which may cause the maximum leakage current to be exceeded gt E gt INTRODUCTION V WARNING The correct installation of a MEDICAL ELECTRICAL SYSTEM requires that each SYSTEM component be individually connected to the main power It is strongly recommended NOT TO USE MULTIPLE PORTABLE SOCKET OUTLETS However if using multiple portable socket outlets they must comply with the IEC 60601 1 1 Standard and must NOT BE PLACED ON THE FLOOR WARNING Wait at least 5 seconds between power off and power on cycles
28. iit tiii t a Oe eO e aed egede 15 9 15 10 15 2 3 Materials in contact with dialysate concentrates and 15 24 15 24 ios eese edades e e aer dtt 15 24 15 2 5 DIsinfectiOn s ii e e ipod dal dete aaa 15 25 15 2 6 Ultrafiltration System tentent tette tentent nennen 15 27 15 2 7 Detection of Extracorporeal Blood Loss 15 28 15 2 8 Operating Modes i se ettet ipe ee 15 30 15 3 Extracorporeal Circulation 15 33 15 3 1 Operating Modes x etate dU eI RI Re nas 15 33 15 32 Blood Pumps is er RO RU OPER ODER GRUB HI DR iR 15 35 15 3 3 Heparin PUMP ci ne e e RD E SEE I EA 15 37 15 3 4 enee Ile ele EE 15 38 15 3 5 Main Surveillance Devices pde ee 15 39 15 336 Safety system actllatoEs sees edet t n oe t E 15 40 q5 4 Protection System enee EEN 15 41 15 5 General Safety Control 15 42 15 6 Estimate consumptions of the machine ee 15 44 WARRANTY E A Appendix Guidelines and Manufacturer s Declaration Electromagnetic Emissions and aero I RE 7 XX PHOENIX SERVICE MANUAL MAINTENANCE This page is left intentionally blank Rev A
29. infectant in order not to damage the DiaClear ultrafilter WARNING For the disinfection of the ultrafilter it is mandatory to use only the chemical agents recommended in the DiaClear Instructions for Use compatible with the equipment The maximum concentration allowed for the disinfectant used is 6 Sodium Hypochlorite 4 Peracetic acid 40 Formaldehyde 100 Instrunet 100 Steridial Refer to the DiaClear Instructions for Use Some solvents or other chemical products used for cleaning can damage the DiaClear ultrafilter Refer to the DiaClear Instructions for Use for the list of non validated products WARNING The user must take precautions against the hazard of cross infection between patients by disinfecting the accessible surfaces of the equipment WARNING Do not use chemicals which might damage the plastic parts of the machine Avoid chemicals containing benzene toluene xylene acetone or similar solvents WARNING Any fluid spilled on the machine must immediately be cleaned to prevent it from getting into the machine Rev A PHOENIX SERVICE MANUAL MAINTENANCE Tables of Contents INTRODUCTION EEVEE VEG WO User s P Il INTENDED EE SPARE PARTO EE WARNINGS EE IV Tables e EE VIII SERVICE INFORMATION
30. n phase 6 Disinfecting the lines above and BT1 3 3 9 Chemical Disinfection phase 7 Disinfecting the lines above 2 3 3 10 Chemical Disinfection phase 8 Disinfecting Ultrafilter es 3 3 11 Chemical Disinfection phase 9 Disinfecting the bypass 3 3 12 Chemical Disinfection phase 10 Disinfecting the main 3 3 13 Chemical Disinfection phase 11 Preparing the Bacteriostatic solution in BAS EE 3 3 14 Chemical Disinfection phase 12 Filling of water the DT Tank 3 3 15 Chemical Disinfection phase 13 Empting the DT tank through the EVR1 hp A 3 3 16 Chemical Disinfection phase 14 Final Emptying the _ 3 3 17 Chemical Disinfection phase 15 Emergency phase in case of heater protection falling i c tete etie ete to i adi inre yet iere n deis 3 3 18 Chemical Disinfection phase 16 End of process sse 3 3 19 Chemical Disinfection phase 17 Deflating 3 3 20 Integrated Chemical Disinfection phase 1 Disinfecting the EVR1 line Un ETE e RU HT E IT OI tado 3 3 21 Integrated Chemical Disinfection phase 2 Disinfecting the EVW1 EVR1 lies E S entes E EE 3 3 22 Integrated Chemical Disinfection phase 3 Disinfecting the EVW2 EVR1 lines ET 3 3 23 Integrated Chemical Disinfec
31. nsing EVR1 EVD isset 3 2 12 Rinsing phase 13 Rinsing EVR1 DNR 3 2 13 Rinsing phase 14A Rinsing Ultrafilter emptying DT tank only if last PASE EE 3 2 14 Rinsing phase 14B Rinsing Ultrafilter emptying DT tank only if last PASE E 3 2 15 Rinsing phase 15 End phase EE 3 2 16 Rinsing phase 16 Deflating phase only on operator STOP or if parameter AUTO SWITCH OFFRES 3 2 17 CCK Rinsing phase 1 Rinsing the Central Bicarbonate Line and the Central Acid Line A1 or Ai 3 2 18 CCK Rinsing phase 2 End of process tenete 3 2 19 CCK Rinsing phase 3 Deflating phase only on operator 3 3 Chemical disinfection esee 3 3 1 Chemical Disinfection phase 1 Empting tank rinsing main circuit 3 3 2 Chemical Disinfection phase 2A Filling DT tank through SWD rinsing c 3 3 3 Chemical Disinfection phase 2B Filling DT tank through jug 1 rinsing UE ale S 3 3 4 Chemical Disinfection phase 2C Filling DT tank through jug 2 rinsing MAIN elle EE 3 3 5 Chemical Disinfection phase 3 Disinfecting the EVR1 line sss 3 3 6 Chemical Disinfection phase 4 Disinfecting the EVW1 3 3 7 Chemical Disinfection phase 5 Disinfecting the EVW2 3 3 8 Chemical Disinfectio
32. of the following patents US4889635 US5276611 US5111683 US5590237 US5228889 US5567320 US5895578 US4784495 US5024756 US4798090 US5041215 US5928177 US5609770 US5394732 US5641144 US6811707 US6881344 US6794194 US5647984 US5733457 US5650071 US5776091 US5624572 US5618441 US5629871 US5685835 US5948251 US6003556 055620608 US6468427 056949214 154740755 EP0243284 403401 428676 418171 465381 467805 501894 EP0658352 813880 EP0900093 EP0330892 54702 EP0643301 830155 EP0830156 EP0831945 0836486 EP0830153 EP0835493 CA1327022 CA2032156 CA2208931 CA1286284 CA1282012 CA1308569 CA1265403 CA2016863 CA1253919 JP2059115 JP3129326 JP3001235 JP2753242 JP3095223 JP3200594 JP1777042 JP2542728 JP2823513 171241624 1701267416 1701256865 1701320264 1701320247 AU595423 BR PI8800439 2 KR094404 SE467142 SE465404 TWO0O32116 DE P3620743 8 35 DE4031613 FR9014523 GB2239820 MX5077 Phoenix amp machine is protected by one or more of the following design registrations US D446861 US D446860 US D464060 US D462698 US D462362 US D462696 DM 051905 DM 055087 IT80564 Certifications Indicates that the equipment conforms to Council Directive 93 42 EEC of 14 June 1993 relating to Medical Devices Also indicates that the notified body which has approved the manufacture s quality system is the British Standards Institution BSI
33. r J3 Mother Board 6 38 6 5 4 Connector J4 Mother Board 6 38 6 5 5 Connector J5 Mother Board 6 38 6 5 6 Connector J6 Mother Board 6 39 6 5 7 Connector J7 Mother Board 6 39 6 5 8 Connector J8 Mother Board 6 39 6 5 9 Connector J9 Mother Board 6 40 6 5 10 Connector J10 Mother Board 6 40 6 5 11 Connector J12 Mother Board 6 40 6 5 12 Connector J13 Mother Board 6 40 6 5 13 Connector J14 Mother Board 6 41 6 5 14 Connector J15 Mother Board 6 41 6 5 15 Connector J18 Mother Board 6 42 6 5 16 Connector J19 Mother Board 6 42 6 5 17 Connector J20 Mother Board 6 43 6 5 18 Connector J21 Mother Board 6 43 6 5 19 Connector J32 Mother Board 6 44 6 5 20 Connector J34 Mother Board 6 44 6 5 21 Connector J35 Mother Board 6 45 6 5 22 Connector J36 Mother Board 6 46 6 5 23 Connector J36 2 Mother Board 6 47 6 5 24 Connector J36 3 Mother Board 6 47 6 5 25 Connector J37 Mother Board 6 48 6 5 26 Connector J38 Mother Board 6 48 6 5 27 Connector J39 Mother Board 6 48 6 5 28 Connector J41 Mother Board 6 48 6 5 29 Connector J42 Mother Board 6 49 6 5 30 Connector J43 Mother Board 6 49 6 5 31 Connector J45 Mother Board 6 50 6 5 32 Connector J46 Mother Board 6 50 6 6 Other Connectors wiring eese entente tnnt tnter tentent tentent eterne ttes 6 51 6 6 1 PIB lt gt ARTERIAL PRESSURE SENSOR ee 6 51 6 6 2 P4 PIB lt gt VENOUS PRESSURE SENSOR 6 51 6 6 3 lt gt SYRINGE LEVEL KEN 6 51 6 6 4
34. s 2 7 2 5 2 4 Acetate Concentrate Preparation tenen 2 7 2 8 2 5 4 Final Temperature Monitor 2 8 2 8 2 6 WF and FLOW eio rote E ee elen E ee AE 2 9 2 6 Clean Dialysate eseou eene X ER e e e Re X EUR e e eee 2 10 SN RE 2 10 25623 Dial ZO I 2 10 2 6 4 Dialyzer Bypass Block essent tenete tnnt nennen 2 11 2 6 5 P2 Pump and Pd pressure sengt 2 11 2 6 6 EE EE 2 11 2 6 7 Post Dialyzer Bubble Trap BT2 sess treten 2 11 2 6 8 Blood Leak Detector BUD ae 2 12 2 6 9 Ultrafiltration Control 2 12 2 6 10 Effluent REMOVAL ee 2 12 ZF MINAS CAN DE 2 13 2 8 Waste Handling Option WHO 2 14 pp 2 15 X PHOENIX SERVICE MANUAL MAINTENANCE 2 9 1 Chemica 2 9 2 Heat Dis 2 9 3 Disinfect Disinfection from front port 4 2 15 infection with Citric 2 16 ion with Permanent Connected Containers Ne 2 16 2 10 Phoenix Hydraulic circuit essent tentent tenente tnnt ttt tenentes 2 17 QI Component legend ER aO Ve Ee Ee 2 21 2 12 Phoenix Pr ss re map is aceto cte te ete dee ee en OR td S ANREISE seers eee 2 25 213 Hydraulic Location eo S enr Det enee 2 29 2 431 Real VIEW oi ient eae edet e at oed de HAS 2 29 2 13 2 Front Valves Group 2 30 2 13 3 Pumps and Conductivity Cells sse 2 31 2 13 4 UF Circuit and Sterilant Lime sese 2 32 2 13 5 Heat System and D1 Flow Meter 2 33 3 HYDRAUL
35. s Phoenix amp Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more The Phoenix system is to be used with either high or low permeability dialyzers This device is intended to be used by trained operators when prescribed by a physician in a chronic care dialysis facility or acute care unit WARNING Fluid balance deviations even if within the specified Phoenix accuracy can exceed a level that can be tolerated by low weight patients WARNING The use of procedures not recommended by the manufacturer may result in patient injury or death The Manufacturer does not assume responsibility for patient safety if the procedures described in this manual are not followed carefully and if staf who perform the procedures have not been appropriately trained and are not qualified WARNING It is responsibility of the physician to ensure that the appropriate dialyzer and Cartridge Blood Set is selected for the weight of the patient being treated WARNING This manual contains a number of references to accessories and disposables for use with the Phoenix machine The Phoenix machine has been tested and validated for use with the accessories and disposables listed in this manual The Manufacturer has not validated the use of accessories or disposables other than those specified in this manual The Manufacturer does not assume r
36. st only be used for adult patients with a body weight greater than 15 Kg and using a BPM cuff of the appropriate size Avoid squeezing or kinking of pressure tubes The BPM should be tested at least once every 4000 hours or any time irregular performance is suspected or observed Insulating material protects the BPM Applied Part Type BF against the effects of a defibrillator discharge If the cuff or the pneumatic connections gets wet wipe immediately to prevent moisture entering the machine gt gt gt gt INTRODUCTION WARNING In order to fully comply with the indications of the European Medical Device Directive 93 42 the user is notified that the information originating from the BPM cannot be used alone as a unique source of information to induce any therapeutical or pharmacological actions WARNING To prevent damaging the machine do not leave disinfectant solution in the machine during the ADR CHEMICAL DISINFECTION procedure for periods over the following limits 4 hrs for Amuchina Instrunet HD and Sodium Hypochlorite at Disinfectant strength 1 25 dilution 24 hrs for Dialox Acetoper Peresal Actril amp and Renalin 48 hrs for formaldehyde solution and Steridial One week for Sodium Hypochlorite at Bacteriostatic strength 1 750 dilution WARNING When the DiaClear ultrafilter is installed the CHEMICAL DISINFECTION must only be performed with an approved dis
37. tion phase 4 Disinfecting the EVP EVD1 rcf PHOENIX SERVICE MANUAL MAINTENANCE 3 3 24 Integrated Chemical Disinfection phase 5 Disinfecting the EVD2 In e 3 170 3 3 25 Integrated Chemical Disinfection phase 6 Disinfecting the EVBP line 3 172 3 3 26 Integrated Chemical Disinfection phase 7 Disinfecting the Bypass line 3 174 3 3 27 Integrated Chemical Disinfection phase 8 Disinfecting the main circuit 3 176 3 3 28 Integrated Chemical Disinfection phase 9 Last phase sss 3 178 3 3 29 Integrated Chemical Disinfection phase 10 Deflating 3 180 3 4 a einzeln 3 182 3 4 1 Heat Disinfection phase 1 Rinsing EVP EV2 Ines 3 184 3 4 2 Heat Disinfection phase 2 Loop PC Loop PO EVD1 EVD2 lines Bypass 3 186 3 4 3 Heat Disinfection phase 3 Rinsing EV1 EVW1 EVW2 lines sees 3 188 3 4 4 Heat Disinfection phase 4 Rinsing EVBP and UF burette 3 190 3 4 5 Heat Disinfection phase 5 Rinsing Loop PC Loop EVR1 Loop PO BypD sS iiieiaituemgui oeil i i rd aui op e ei a io add 3 192 3 4 6 Heat Disinfection phase 6 Rinsing Loop PC Loop EVR1 Loop PO M 3 194 3 4

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