TECHNICAL MANUAL OPTIMA PT/ST/VS

TECHNICAL MANUAL OPTIMA PT/ST/VS

Page 2 NT1789 Rév.A0

TABLE OF CHANGES The information contained in this document only concerns : OPTIMA PT/ST/VS type, MCM 440 PT/OT type, MCM550 ST type. Technical Manual reference :...: NT 1789 Revision date :......: 27 May 2003 Applicable from serial no :...: 18180100 Date Revision no. Pages concerned Changes 27/05/2003 A0 All First release NT1789 Rév.A0 page : 3

Page 4 NT1789 Rév.A0

T A B L E O F C O N T E N T 1. O V E R V IE W... 7 1.1. G e n e r a l...7 1.2. B lo c d ia g r a m s...8 1.3. P r e c a u tio n s to b e ta k e n b e fo r e u s e...9 1.4. In te r n a l s a fe ty fe a tu r e s...9 1.5. T e c h n ic a l c h a r a c te r is tic s...9 1.5.1. B io lo g ic a l c h a ra c te ris tic s... 9 1.5.2. M e c h a n ic a l c h a ra c te ris tic s... 9 1.5.3. D im e n s io n s / W e ig h t... 9 1.5.4. E le c tric a l c h a ra c te ris tic s... 9 1.5.5. E le c tro n ic c h a ra c te ris tic s... 9 1.5.6. Operator s guide... 9 1.5.7. Registration cards... 9 1.5.8. Material used to build the OPTIMA / MCM... 9 1.5.9. Conformity and -symbols... 9 2. E L E C T R O N IC B O A R D S... 1 1 2.1. C P U b o a r d...1 1 2.1.1. Functional description.... 11 2.1.2. Connectors description... 12 2.1.3. Electronic drawings... 14 2.1.4. Components layout... 14 2.2. D is p la y b o a r d...1 5 2.2.1. Functional description... 15 2.2.2. Connector description... 15 2.2.3. Electronic drawings... 17 2.2.4. Components layout... 17 2.3. P O W E R S U P P L Y B O A R D...1 8 2.3.1. Functional description... 18 2.3.2. Connector description... 18 2.3.3. Electronic drawings... 19 2.3.4. Components layout... 19 2.4. A ir d e te c to r b o a r d...1 9 2.4.1. Electronic drawings and Components layout... 19 3. C o n fig u r a tio n, c a lib r a tio n a n d c h e c k... 2 0 3.1. C o n fig u r a tio n...2 0 3.2. C a lib r a tio n...2 2 3.2.1. Manual calibration menu... 22 3.2.2. Door calibration (Etal1)... 22 3.2.3. Correcting coefficient adjustment (Etal2)... 23 3.2.4. Up and Down stream pressure sensors calibration (Etal9)... 24 3.3. T e s ts : M a in te n a n c e te s ts...2 6 3.3.1. Manual Service test menu... 26 3.3.2. Maintenance tests list :... 26 3.3.3. Working duration (Test1)... 26 3.3.4. LED s, LCD screen, 7 segments display and Buzzers Test (Test2)... 27 3.3.5. Keyboard test (Test3)... 27 3.3.6. Battery voltage display (Test4)... 27 3.3.7. Display of the last 10 alarms codes (Test5)... 28 3.3.8. Total working duration (Test6)... 28 3.3.9. Display analog values of sensors (Test9)... 28 3.3.10. Display of software version number (TestA)... 28 3.3.11. Motor clamp Test (TestC)... 29 3.3.12. Calibration values display (TestE)... 29 3.3.13. Infusion motor Test (TestF)... 30 3.3.14. Display of last 10 alarms before a failure occurs (TestJ)... 30 3.4. M a in te n a n c e S e r v ic e C o n fig u r a tio n.... 3 1 3.4.1. Service configuration Menu... 31 3.4.2. Preventive maintenance (SAV1)... 31 3.4.3. Set number Configuration (SAV2)... 31 3.5. T e c h n ic a l fa ilu r e s m e s s a g e s.... 3 2 4. R E P L A C IN G S U B -A S S E M B L IE S...3 4 4.1. M o d u le o p e n in g.... 3 4 4.2. R e p la c in g C P U b o a r d.... 3 4 4.3. D is m o u n tin g p u m p in g m e c h a n is m... 3 4 4.4. R e p la c e m e n t o f p r e s s u r e s e n s o r s.... 3 4 4.5. R e p la c e m e n t o f d o o r o r o f H a ll e ffe c t s e n s o r... 3 4 5. M A IN T E N A N C E...3 5 5.1. R e c o m m e n d a tio n s... 3 5 5.2. C le a n in g a n d d is in fe c tin g... 3 5 5.3. S to r a g e... 3 5 5.4. R o u tin e in s p e c tio n s... 3 6 5.4.1. Checking before use... 36 5.4.2. Occlusion alarm checking... 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... 37 5.4.6. Continuity test... 37 5.5. T e c h n ic a l c h e c k p r o c e d u r e... 3 8 6. A N N E X E 1 : Illu s tr a te d p a r ts lis ts...4 0 6.1. S u b a s s e m b lie s tr a c e a b ility ta b le... 4 0 6.1.1. Introduction... 40 6.1.2. Spare parts table... 40 6.1.3. Upper housing... 41 6.1.4. Base... 42 6.1.5. Brace... 43 7. C ir c u it d ia g r a m...4 5 8. A d d e n d a a n d in fo r m a tio n b u lle tin s...4 6 9. U s e fu l a d d r e s s e s...4 8 NT1789 Rév.A0 page : 5

P a g e 6 NT1789 Rév.A0

1. O V E R V IE W 1.1. G e n e r a l T h e O P T IM A P u m p is a n e w v o lu m e tric p u m p b a s e d o n th e s a m e m e c h a n ic a l p u m p in g m e c h a n is m a s th e M V P p u m p. T h e b a tte ry is a u to m a tic a lly re c h a rg e d w h e n th e p u m p is c o n n e c te d to th e m a in s.. A c h o ic e o f e a s ily a c c e s s ib le c o n fig u ra tio n s e n s u re s o p tim u m u s e o f fu n c tio n s a c c o rd in g to th e n e e d s o f e a c h d e p a rtm e n t. 3 ty p e s o f O P T IM A e x is t : V S / P T / S T O P T IM A V S / M C M 4 4 0 O T : P V C T y p e V o lu m e tric p u m p w ith s ta n d a rd P V C S e t. T h e D rip s e n s o rs is o p tio n a l. A n a u to m a tic c o n tro l o f th e occlusivity of the pump ( OCS Occlusivity Control System) is implemented. OPTIMA PT / MCM 440 PT :PVC Type Volumetric with standard PVC Set. The Drip sensors is compulsory. OPTIMA ST / MCM 550 ST Silicone Type Volumetric with standard Silicone Set. The Drip sensors is compulsory Mains differences between the types : Description VS / OT PT ST F u n c tio n a l d iffe re n c e s Tube Standard PVC Standard PVC Standard Silicone Drip Sensor Optional Standard Standard OCS Test (Occlusivity Control System) Tube Clamping Yes No No 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 Tube clamping during door opening A dc motor assure the clamping of the tube during OCS NO OCS -> no DC motor 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. NT1789 Rév.A0 page : 7

1.2. B lo c d ia g r a m s B a tte ry A IR K e y b o a rd D is p la y b o a rd P o w e r s u p p ly b o a rd R S 2 3 2 N u rs e C a ll c o n n e c to rs b u b b le s s e n s o r K e y b o a rd /d is p la y in te rfa c e C P U D rip S e n s o r (o p tio n ) P ro c e s s o r fu n c tio n O C S (M S /V S o n ly ) D C M o to r S e n s o r in te rfa c e M o to r d riv e r R o ta tio n d e te c to r M o to r D o o r O p e n n in g d e te c to r P e ris ta ltic M e c a n is m D O O R T ra n s m is s io n L 0 O C K C o u n te r P re s s u re fla s k d o w n s tre a m o c c lu s io n D e te c to r C la m p d e te c to r (M S o n ly ) U p -s tre a m o c c lu s io n D e te c to r L u e r d e riv a tio n D o w n s tre a m e x te n s io n P U M P c la m p U p -s tre a m e x te n s io n D rip c h a m b e r P e rfu s io n s e t F ig u re 1. G e n e ra l d ia g ra m o f th e O P T IM A P a g e 8 NT1789 Rév.A0

1.3. P r e c a u tio n s to b e ta k e n b e fo r e u s e P le a s e c o n s u lt th e u s e r g u id e. 1.4. In te r n a l s a fe ty fe a tu r e s T h e p u m p h a s a c o n tin u o u s fu n c tio n s in s p e c tio n s y s te m a s s o o n a s th e p u m p is O N.. N e v e rth e le s s, th e q u a lifie d p e r- s o n n e l in y o u r e s ta b lis h m e n t o r o u r M a in te n a n c e D e p a rtm e n t s h o u ld a lw a y s b e n o tifie d o f a n y a b n o rm a l fu n c tio n in g w h e n n o s p e c ific c a u s e c a n b e fo u n d. (S e e u s e fu l a d d re s s e s, c h a p te r 9 ) F o r a n y m a in s fa ilu re th e p u m p is p o w e re d a u to m a tic a lly fro m its in te rn a l b a tte ry. O p e n in g th e p u m p o r th e b a tte ry c o v e r m u s t o n ly b e c a rrie d o u t b y q u a lifie d s ta ff w ith a ll th e n e c e s s a ry te c h n ic a l p re - c a u tio n s. N o n -c o m p lia n c e w ith th e s e p ro c e d u re s m a y b e d a n g e ro u s fo r th e s ta ff a n d m a y d a m a g e th e M o d u le. 1.5. T e c h n ic a l c h a r a c te r is tic s 1.5.1. Biological characteristics T h e in fu s io n liq u id is o n ly in c o n ta c t w ith th e in fu s io n s e t. 1.5.2. Mechanical characteristics T h e O P T IM A P u m p o p e ra te s w ith a lin e a r p e ris ta ltic s y s te m. 1.5.3. Dimensions / Weight q H x L x D... 1 3 5 x 1 7 5 x 1 4 5 m m q W e ig h t... 2.9 k g a p p ro x im a te ly 1.5.4. Electrical characteristics q E x te rn a l p o w e r s u p p ly... 100 240 Vac q Power... 50 VA q Battery... 6V 2.7/ 3 Ah NiMH. q Fuse... 2 x 630 ma T IEC 127 1.5.5. Electronic characteristics The Device contains 4 PCB s: C P U P C B. D is p la y / k e y b o a rd P C B. P o w e r S u p p ly P C B. A ir d e te c tio n P C B 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 R e g is tra tio n in fo rm a tio n is a v a ila b le u p o n re q u e s t to o u r M a in te n a n c e D e p a rtm e n t. 1.5.8. Material used to build the OPTIMA / MCM q T o p a n d b o tto m h o u s in g... P o ly c a rb o n a te / A B S q K e y b o a rd... P o ly e s te r q S tic k e rs... P o ly e s te r q P u m p m e m b ra n e... E la s to m e r (la te x fre e ) q D rip s e n s o r... P o ly c a rb o n a te / A B S o r p o ly a m id e q R e a r h o u s in g h a n d le... P C + 1 0 % 1.5.9. Conformity and -symbols q C o n fo rm E N 6 0 6 0 1-1 a n d E N 6 0 6 0 1-2 -2 4.s ta n d a rd s NT1789 Rév.A0 page : 9

C E 0 4 5 9 m a rk in g in c o m p lia n c e w ith E E C 9 3 /4 2 M e d ic a l D e v ic e d ire c tiv e. IP 3 1 L iq u id p ro je c tio n s p ro te c te d. C F ty p e d e v ic e B a tte ry. C L A S S I d e v ic e q E a c h s y m b o l s h o w s b e lo w is v is ib le o n th e d e v ic e o r in th is d o c u m e n t. R e fe r to a c c o m p a n ie d d o c u m e n ts. E q u ip o te n tia lity P ro te c tiv e e a rth 56 R S 2 3 2 C o m m u n ic a tio n In te rfa c e 4 0 0 0 V in s u la tio n N u rs e C a ll 4 0 0 0 V in s u la tio n / 2 4 V d c -1 A P e rm a n e n t m a g n e t a llo w in g th e fix in g o f d ro p s s e n s o r P a g e 1 0 NT1789 Rév.A0

2. E L E C T R O N IC B O A R D S 2.1. C P U b o a r d 2.1.1. Functional description. 2.1.1.1 C P U M a in M ic ro p ro c e s s o r... T 8 0 c 5 1 1 2 E x te rn a l R A M... 3 2 K o / 5 1 2 K o o f F la s h / 8 K o o f R A M E E P R O M... 1 6 K o S e c o n d a ry M ic ro p ro c e s s o r... M S P 4 3 0 C o n tro l fre q u e n c y o f th e m a in m ic ro p ro c e s s o r, tim e k e e p e r fu n c tio n, O N /O F F fu n c tio n a n d c o n tro l th e c h a rg e o f th e b a tte ry. 2.1.1.2 S te p p e r m o to r c o n tro l T h e m o to r is p o w e re d w ith 1 2 o r 2 0 v o lts a c c o rd in g to th e flo w ra te. The signal command is performed either by ½ step or ¼ step according to the requested flow rate. 2.1.1.3 R o ta tio n c o n tro l 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 2.1.1.4 D o o r d e te c to r 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 D rip s e n s o r (o p tio n a l o n O p tim a M S a n d V S o r M C M 4 4 0 O T ) 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 D o w n s tre a m p re s s u re s e n s o r 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 U p -s tre a m p re s s u re s e n s o r 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 B u z z e r The device is equipped with 2 buzzers triggered by the microprocessor. 2.1.1.9 O n /O ff fu n c tio n When the device is connected to the mains, it is in stand by m o d e. S w itc h in g O N is p e rfo rm e d E ith e r b y p re s s in g th e O N /O F F k e y O r b y o p e n in g th e d o o r, a c c o rd in g to th e s o ftw a re c o n fig u ra tio n. S w itc h in g O F F is p e rfo rm e d : E ith e r m a n u a lly b y p re s s in g th e O N /O F F k e y O r a u to m a tic a lly w h e n b a tte ry is lo w. T h e O n /o ff fu n c tio n is p e rfo rm e d b y th e s e c o n d a ry m ic ro p ro c e s s o r 2.1.1.1 0 B a tte ry c h a rg e m a n a g e m e n t NT1789 Rév.A0 page : 11

T h e b a tte ry c h a rg e is m a n a g e d b y b o th p rim a ry a n d s e c o n d a ry m ic ro p ro c e s s o rs. 2.1.1.1 1 A ir d e te c to r A n u ltra - s o u n d s e n s o r a llo w s to d e te c t a ir b u b b le s in th e in fu s io n s e t. It g e n e ra te s a n a la rm if a ir b u b b le s a re la rg e r th a n p ro g ra m m e d v a lu e. 2.1.1.1 2 A u to m a tic O C S c la m p T h e O P T IM A M S a n d V S o r M C M M S a n d O T a re e q u ip p e d w ith a D C m o to r a c tu a te d c la m p. A fte r e a c h in fu - s io n s ta rt o r d o o r c lo s in g, th e in fu s io n s e t is c la m p e d b y th is s y s te m a n d th e d e v ic e c h e c k s th e n p u m p in g m e c h a n is m o c c lu s iv ity. 2.1.1.1 3 N u rs e C a ll / R S 2 3 2 T h e R S 2 3 2 a n d N u rs e C a ll h a v e b o th 4 0 0 0 V d ie le c tric s tre n g h t. T h e N u rs e c a ll re la y is ra te d 2 4 V D C /1 A. 2.1.2. Connectors description 2.1.2.1 G e n e ra l C o n n e c to r P in n u m b e r F u n c tio n 2.1.2.2 J9 Air Sensor P in J 7 2 x 1 7 F o r d e v e lo p m e n t p u rp o s e J 3 2 x 7 F o r m a n u fa c tu rin g J 9 1 x 4 A ir S e n s o r J 1 1 x 2 0 C P U /D is p la y in te rc o n n e c tio n J 1 2 1 x 4 D rip S e n s o r J 4 1 x 4 S te p p e r M o to r J 6 1 x 3 P o w e r S u p p ly J 8 1 x 4 B a tte ry J 5 1 x 6 N o t U s e d J 1 1 1 x 8 R S 2 3 2 / N U R S E C A L L J 1 0 1 x 2 D C m o to r J 2 1 x 2 0 S e n s o rs D e s c r ip tio n 1 /T S T S e n s o r c h e c k 2 5 V P o w e r S u p p ly 3 G N D G ro u n d 4 /D E T E C T A ir o u tp u t s ig n a l 2.1.2.3 J1 CPU/Display board interconnection P in D e s c r ip tio n 1 5 V P o w e r S u p p ly 2 V B A T B a tte ry v o lta g e 3 G N D 4 M O S I-A F F S e ria l o u tp u t 5 G N D 6 M IS O _ A F F S e ria l In p u t 7 G N D 8 C L K -A F F S e ria l c lo c k 9 G N D 1 0 C S L C D C h ip S e le c t L C D 1 1 G N D 1 2 C S A F C L C h ip S e le c t D is p la y P a g e 1 2 NT1789 Rév.A0

P in D e s c r ip tio n 1 3 G N D 1 4 A 0 A F F L C D A d re s s 1 5 G N D 1 6 R E S E T / 1 7 G N D 1 8 T O N /O F F O N /O F F s ig n a l 1 9 V B A T B a tte ry V o lta g e 2 0 5 V P o w e r s u p p ly 2.1.2.4 D rip S e n s o r P in D e s c r ip tio n 1 C D L E D -g o u tte L e d c o m m a n d 5 V / 4 0 m A 2 G N D 3 G N D 4 P u ls e -g o u tte O u tp u t d ro p s ig n a l 2.1.2.5 J 4 - S te p p e r m o to r P in D e s c r ip tio n 1 + B o b in e A + C o il A 2 - B o b in e A - C o il A 3 + B o b in e B + C o il B 4 - B o b in e B - C o il B 2.1.2.6 J6 Power Supply P in D e s c r ip tio n 1 A L IM E X T N o t U s e d 2 G N D 3 A L IM S E C T P o w e r S u p p ly 9 V / 1.3 A 2.1.2.7 J8 Battery P in D e s c r ip tio n 1 V B A T N C + B a tte ry 2 A N A -C T N T e m p e ra tu re s e n s o r o u tp u t 3 G N D 4 V B A T N P + B a tte ry b e fo re th e rm a l fu s e (fu s e b re a k d o w n d e te c tio n ) 2.1.2.8 J11 RS232/Nurse Call P in D e s c r ip tio n 1 T x D -P C D a ta R e c e p tio n fro m P C 2 R T S -P C R e q u e s t to s e n d fro m P C (S h o u ld b e p o s itio n e d a t h ig h s ta te ) 3 D T R -P C D a ta T e rm in a l R e a d y o f P C (S h o u ld b e p o s itio n e d a t h ig h s ta te ) 4 R X D -P C D a ta T ra n s m is s io n to P C 5 G N D 6 N u rs e C a ll N o rm a lly O p e n e d C o n ta c t 7 N u rs e C a ll C o m m o n C o n ta c t NT1789 Rév.A0 page : 13

8 N u rc e C a ll N o rm a lly c lo s e d C o n ta c t 2.1.2.9 J 1 0 - D.C. m o to r P in D e s c r ip tio n 1 + D C m o to r. 2 - D C m o to r. 2.1.2.1 0 J2 Sensors P in D e s c r ip tio n 1 G N D 2 P re s -C la m p S w itc h c la m p o u tp u t 3 C D -C la m p S w itc h c la m p p o w e r s u p p ly 4 U p -F o rc e S e n s o r U p s tre a m fo rc e s e n s o r o u tp u t 5 U p -F o rc e S e n s o r 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 P a g e 1 4 NT1789 Rév.A0

2.2. D is p la y b o a r d 2.2.1. Functional description T h e d is p la y b o a rd is c o n s id e re d a s a p e rip h e ra l b o a rd o f th e C P U b o a rd. T h e k e y b o a rd m a trix is c o n n e c te d to th is b o a rd. D is p la y d e s c rip tio n F u n c tio n F lo w ra te m /l A la rm P re -a la rm Perfusion signal LED s Drop LED s Battery LED s Mains LED s Perfusion start LED s LCD D is p la y 4 g re e n 7 -s e g m e n t L E D d is p la y 1 re d L E D 1 o ra n g e L E D 4 green LED 1 green LED 1 green LED 1 orange LED 1 green LED 33x100 points LCD display 2.2.2. Connector description 2.2.2.1 G e n e ra l J1 1 x 20 Pins CPU/Display boards Interconnection J2 18 Pins LCD connector J3 10 Pins Keyboard connector NT1789 Rév.A0 page : 15

2.2.2.2 J 1 - C P U /D is p la y B o a rd in te rc o n n e c tio n P in D e s c r ip tio n 1 5 V P o w e r S u p p ly 2 V B A T B a tte ry v o lta g e 3 G N D 4 M O S I-A F F S e ria l o u tp u t 5 G N D 6 M IS O _ A F F S e ria l In p u t 7 G N D 8 C L K -A F F S e ria l c lo c k 9 G N D 1 0 C S L C D C h ip S e le c t L C D 1 1 G N D 1 2 C S A F C L C h ip S e le c t D is p la y 1 3 G N D 1 4 A 0 A F F L C D A d d re s s 1 5 G N D 1 6 R E S E T / 1 7 G N D 1 8 T O N /O F F O N /O F F s ig n a l 1 9 V B A T B a tte ry V o lta g e 2 0 5 V P o w e r s u p p ly P a g e 1 6 NT1789 Rév.A0

2.2.2.3 J 2 L C D C o n n e c to r P in D e s c r ip tio n 1 V B A T + b a c k lig h t 2 -le d - b a c k lig h t 3 + 5 V 4 /R E S E T 5 V S S G n d 6 L D 0 D a ta W rite 7 G N D W rite S e le c t 8 L D 6 D a ta W rite 9 A 0 A F F L C D A d d re s s 1 0 L D 5 D a ta W rite 1 1 L D 4 D a ta W rite 1 2 L D 3 D a ta W rite 1 3 L D 2 D a ta W rite 1 4 L D 1 D a ta W rite 1 5 L D 0 D a ta W rite 1 6 - E n a b le 1 7 L C D C S 2 C h ip s e le c t 1 8 L C D C S 1 C h ip s e le c t 2.2.2.4 J 3 k e y b o a rd C o n n e c to r P in D e s c r ip tio n 1 C O L 2 K e y b o a rd C o lu m n 2 C O L 1 K e y b o a rd C o lu m n 3 C O L 0 K e y b o a rd C o lu m n 4 L ig n e 3 K e y b o a rd L in e 5 L ig n e 2 K e y b o a rd L in e 6 L ig n e 1 K e y b o a rd L in e 7 L ig n e 0 K e y b o a rd L in e 8 T O N /O F F O n / O ff 9 CONTRÔLE 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 Rév.A0 page : 17

2.3. P O W E R S U P P L Y B O A R D 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 G e n e ra l C o n n e c to r P in F u n c tio n J1 1 x 1 Functional Earth J2 1 x 2 Main supply connector J3 1 x 3 Output power supply J4 1 x 4 Battery Output J5 2 x 5 Battery Input 2.3.2.2 J 1 F u n c tio n a l E a rth P in D e s c r ip tio n 1 - Functional Earth P a g e 1 8 NT1789 Rév.A0

2.3.2.3 J 2 M a in S u p p ly C o n n e c to r P in D e s c r ip tio n 1 P H Phase (100 240 Vac) 2 N Neutral (100 240 Vac) 2.3.2.4 J 3 O u tp u t P o w e r s u p p ly P in D e s c r ip tio n 1 9V Sect 9V Output from AC/DC converter 2 GND 3 9V Ext 9V From external power Supply (not used) 2.3.2.5 J 4 B a tte ry O u tp u t ( th is c o n n e c to r g o e s to th e C P U b o a rd ) P in D e s c r ip tio n 1 VBAT + Battery 2 + Capteur Temp Temperature Sensor output 3 Masse GND + Battery before thermal fuse (fuse breakdown detection) 4 VBAT NP 2.3.2.6 J 5 B a tte ry In p u t ( th is c o n n e c to r c o m e s fro m th e b a tte ry p a c k ) P in D e s c r ip tio n 1 VBAT + Battery + Battery before thermal fuse (fuse breakdown detection) 2 VBAT NP 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. A ir d e te c to r b o a r d 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 Rév.A0 page : 19

3. C o n fig u r a tio n, c a lib r a tio n a n d c h e c k T h e c o n fig u ra tio n a n d c a lib ra tio n o f th e d e v ic e a re a c c e s s ib le : u s in g th e s e ria l lin k (R S 2 3 2 ) a n d th e F re s e n iu s V ia l P C s o ftw a re to c o n fig u re a n d c a lib ra te th e p u m p. U s in g th e k e y b o a rd o f th e p u m p th ro u g h a s p e c ia l e n c o d e d m e n u. F o r fu rth e r in fo rm a tio n, p le a s e c o n ta c t o u r M a in te n a n c e D e p a rtm e n t (S e e a d d re s s e s a t th e e n d o f th is d o c u - m e n t) A n y c h a n g e, in th e c o n fig u ra tio n le a d s to m a jo r c h a n g e s in M o d u le ru n n in g, S ta ff tra in e d o n th e s o ftw a re a n d d e v ic e s a re th e o n ly p e o p le a u th o ris e d to p e rfo rm e d th e s e s o p e ra tio n s. 3.1. C o n fig u r a tio n T h is m o d e is a c tiv e d b y p re s s in g M O D E k e y w h e n s w itc h in g O N th e p u m p / T h e m a in m e n u d is p la y : - U s e r s e ttin g - W a rd s e ttin g - M a in te n a n c e 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. C o d e M a in m e n u S u b -m e n u S u b -m e n u T y p in g M a in te n a n c e T h is c o d e w ill b e g iv e n a t th e e n d o f th e m a in te n a n c e s ta ff tra in in g T e s t M a in te n a n c e te s t m e n u M a in te n a n c e c o n fig u r a - tio n M a in te n a n c e c o n fig u ra tio n m e n u C a lib r a tio n M a in te n a n c e c a lib ra tio n m e n u U s e r s e ttin g ( see operator s guide) Code XXXX User configuration menu W a r d s e ttin g ( see operator s guide) Code 0200 Service configuration menu P a g e 2 0 NT1789 Rév.A0

M a in te n a n c e Test 7VW Test1 Work duration display 7VW Test2 LED s, LCD screen, 7- segment displays and buzzers test. 7VW Test3 Keyboard test. 7VW Test4 Battery tension voltage display 7VW Test5 Last 10 alarms display. 7VW Test6 Total work duration display. 7VW Test9 Analog sensors value display. 7VW$ TestA Software version number display. 7VW& TestC Clamp motor DC motor test. test. 7VW( TestE Calibration values display. 7VW) TestF Infusion stepper motor test. 7VW- TestJ Before failure last 10 alarms codes display Configuration 6$9 SAV1 Preventive maintenance 6$9 SAV2 Tubing Set configuration Etalonnage Calibration (7$ Etal1 Door calibration. (7$ (7$ Etal2 Etal9 Infusion correction coefficient configuration. Battery Up-stream and down-stream pressure sensors calibration. M a in m e n u U s e r S e ttin g W a rd S e ttin g M a in te n a n c e A c c e s s c o d e ty p e U s e r S e ttin g C o d e 0 0 0 0 M a in te n a n c e C o d e 0 0 0 0 W a rd S e ttin g C o d e 0 0 0 0 C o d e s e le c tio n w ith S e le c tio n k e y s ( o r ) P ro c e e d to s u b -m e n u s w ith c o n fir m k e y o r E N T E R k e y s. C o d e b a c k to 0 if in c o rre c t c o d e v a lid a tio n, a fte r 1 5 s e c o n d s n o n v a lid a tio n = b e e p. S T O P = b a c k to m a in m e n u. M a in te n a n c e s u b -m e n u T e s t C o n fig u ra tio n C a lib ra tio n NT1789 Rév.A0 page : 21

3.2. C a lib r a tio n C a lib r a tio n is p o s s ib le o n : D o w n -s tre a m p re s s u re s e n s o r. U p -s tre a m p re s s u re s e n s o r. D o o r H a ll e ffe c t s e n s o r.. C a lib r a tio n is c o m p u ls o r y in th e fo llo w in g c a s e s D o w n -s tre a m p re s s u re s e n s o r : A fte r c h a n g e o f s e n s o r, o f its p ro te c tiv e d ia p h ra g m, o f th e d o o r o r C P U b o a rd U p -s tre a m p re s s u re s e n s o r : A fte r c h a n g e o f s e n s o r, o f its p ro te c tiv e d ia p h ra g m, o f th e d o o r o r C P U b o a rd D o o r H a ll e ffe c t s e n s o r : A fte r c h a n g e o f s e n s o r, o f th e d o o r o r C P U b o a rd q T h e C P U b o a rd is c o n fig u re d w ith s p e c ific p a ra m e te rs fo r e a c h D e v ic e, s o it is fo rb id d e n to c h a n g e C P U b o a rd s fro m a d e v ic e to a n o th e r. q F o r th e s a m e re a s o n s, it is fo rb id d e n to c h a n g e d o o r fro m a d e v ic e to a n o th e r 3.2.1. Manual calibration menu S E L E C T IO N k e y s = c a lib ra tio n c h o ic e C O N F IR M o r E N T E R k e y s = c a lib ra tio n p ro c e d u re S T O P k e y = b a c k to m a in te n a n c e m e n u. V a lu e s a re n o t m e m o ris e d. C a lib ra tio n n u m b e r is d is p la y e d o n 7 s e g m e n ts d is p la y a n d s im u lta n e o u s ly d is p la y e d in in v e rs e v id e o o n L C D s c re e n. C a lib ra tio n s lis t : E ta l1 : d o o r. (W$ E ta l2 : In fu s io n c o rre c tin g c o e ffic ie n t c o n fig u ra tio n. E ta l9 : U p a n d D o w n -s tre a m p re s s u re s e n s o r. E ta l1 -D o o r E ta l2 -R a te E ta l9 -P re s s u re 3.2.2. Door calibration (Etal1) q 3 le v e ls a re c a lib ra te d q N o te : P re s s in g S T O P a llo w s to e s c a p e fro m th e m e n u w ith o u t m e m o ris a tio n. q D o o r c lo s e d w ith o u t s e t : (W$ C lo s e th e d o o r w ith o u t s e t, re c o rd th e v a lu e b y p re s s in g o n o r E N T E R k e y. q D o o r o p e n w ith o u t s e t : P a g e 2 2 NT1789 Rév.A0

(W$ O p e n th e d o o r w ith o u t s e t, re c o rd th e v a lu e b y p re s s in g o n o r E N T E R k e y. q D o o r c lo s e d w ith s e t : (W$ P la c e a s e t w ith th e c la m p c o rre c tly p o s itio n e d a n d c lo s e th e d o o r, re c o rd th e v a lu e b y p re s s in g o r E N T E R k e y. o n V a lu e s : D o o r c lo s e d w ith o u t s e t : 1 1 9 6 < X < 3 7 5 0 m V o lts D o o r o p e n e d w ith o u t s e t : 2 1 9 7 < X < 2 6 9 5 m V o lts D o o r c lo s e d w ith s e t : 1 6 9 9 < X < 3 3 9 8 m V o lts 3.2.3. Correcting coefficient adjustment (Etal2) T h is fu n c tio n a llo w s to a d ju s t th e flo w ra te o f th e d e v ic e a c c o rd in g to th e u s e d s e t. The adjustment 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. Select 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. (7$ Selected 100ml/h Measured..100ml/h (7$ (7$ Selected 100ml/h Measured..105ml/h Selected 100ml/h Measured..125ml/h Error S E L E C T IO N key ( or ) : selects the programmed flowrate(100, increment 1 ml/h) and actual flow rate (80 à 120 ml/h). E N T E R key : to select a field value. c o n fir m k e y : c a lc u la te re c o rd th e n e w c o e ffic ie n t if included between 0.8 and 1.1 times the programmed one, back to the configuration menu otherwise Error is displayed. NT1789 Rév.A0 page : 23

S T O P k e y : b a c k to th e m e n u w ith o u t c a lc u la tio n o f th e c o e ffic ie n t. N o te : A fte r flo w ra te a d ju s tm e n t a c o n tro l o f th e flo w ra te s h o u ld b e d o n e 3.2.4. Up and Down stream pressure sensors calibration (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 guarantee the occlusion alarm level. B a g 1 m P U M P M a n o m e te r 3 w a y s ta p 5 0 c m ta n k T e s t s e t The manometer and the device should be placed at the same level q C a lib r a tio n RAZ Presure 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 D o o r o p e n 1. Open the door of the device w ith o u t disposable set. 2. Record the values door open down-stream pressure and door open up-stream pressure by pressing on E N T E R (W$ Values : door open down-stream pressure threshold : 1997 < X < 4453 mvolts door open up-stream pressure threshold : 1997 < X < 4297 mvolts 3.2.4.2 C a lib ra tio n o f th e d o w n -s tre a m p re s s u re s e n s o r a t p re s s u re z e ro (0 m m H g ), D o o r c lo s e d. P a g e 2 4 NT1789 Rév.A0

1. P la c e a d is p o s a b le in fu s io n s e t a s d e s c rib e d h e re a b o v e a n d o p e n th e 3 w a y s ta p b e tw e e n th e p u m p a n d th e m a n o m e te r. 2. T o re la x th e in fu s io n s e t, p re s s o n th e c o n firm k e y -> th e p u m p ru n a t 2 0 0 m l/h. 3. W h e n th e p re s s u re re a c h e s a b o u t 7 5 0 m m H g, o p e n th e 3 w a y ta p to re le a s e th e p re s s u re. 4. L e t in fu s e a t z e ro p re s s u re fo r a b o u t 5 m in u te s. 5. S to p th e d e v ic e b y p re s s in g o n S T O P. 6. R e c o rd th e p re s s u re b y p re s s in g E N T E R ; (W$ V a lu e s : d o w n -s tre a m p re s s u re s e n s o r a t p re s s u re z e ro (0 m m H g ), D o o r c lo s e d : 1 4 9 9 < X < 3 6 9 6 m V o lts 3.2.4.3 C a lib ra tio n o f th e d o w n s tre a m p re s s u re s e n s o r a t 7 5 0 m m H g, D o o r c lo s e d ; 1. C lo s e th e ta p b e tw e e n th e p u m p a n d th e m a n o m e te r. 2. S ta rt th e p u m p b y p re s s in g c o n fir m k e y. 3. O p e n a n d c lo s e th e ta p u n til th e m a n o m e te r p re s s u re re a c h e s 7 5 0 mmhg ± 30 mmhg 4. Stop the pump by pressing on S T O P key. 5. Record the pressure by pressing on E N T E R key. (W$ Values : down stream pressure sensor at 760 mmhg, Door closed 898 < X < 2998 mvolts 3.2.4.4 C a lib ra tio n o f th e u p s tre a m p re s s u re s e n s o r a t 0 m m H g 1. Open the 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 E N T E R key to record the value. Values : (W$ up stream pressure sensor at 0 mmhg 1499 < X < 3696 mvolts NT1789 Rév.A0 page : 25

3.3. T e s ts : M a in te n a n c e te s ts 3.3.1. Manual Service test menu C h o ic e w ith S E L E C T IO N k e y s P ro c e e d w ith c o n fir m o r E N T E R k e y s. B a c k to m a in te n a n c e m e n u w ith S T O P. (n o p a ra m e te r s to re d ) T e s t n u m b e r is d is p la y e d o n 7 s e g m e n ts d is p la y a n d s im u lta n e o u s ly o n L C D s c re e n. 3.3.2. Maintenance tests list : T e s t1 : D is p la y o f w o rk in g d u ra tio n a n d n u m b e r o f s w itc h in g o n. T e s t2 : 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) D is p la y th e c u m u la te d p u m p w o rk in g tim e in h o u rs (< 7 2 h o u rs ) in d a y s (< 1 2 0 d a y s ) o r in m o n th s a n d th e m a in te n a n c e d a te. F la s h in g d is p la y &WUO, if p u m p w o rk in g tim e is tim e b e fo re m a in te n a n c e (s e e S A V 1 ) o r if a c tu a l d a te m a in te n a n c e d a te (S A V 1 ). W6W E N T E R : selects date S E L E C T IO N : changes maintenance date in actual date or restores configured maintenance date. (if maintenance date = actual date then display = 0 h and Ctrl = erasing) C o n fir m and E N T E R : saves changes and goes back to test menu. S T O P : 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. P a g e 2 6 NT1789 Rév.A0

3.3.4. LED s, LCD screen, 7 segments display and Buzzers Test (Test2) Lighting of all the LED s, display of plus decimal point on the 7 segments display, LCD screen completely black; wait for pressing on O N or E N T E R. Scrolling of LED, one by one, scrolling of segments one by one on all the display then scrolling of and decimal point on each display. Scrolling of LCD screen image. Back to test menu (manual test). S T O P : quick return to test menu (manual test). 3.3.5. Keyboard test (Test3) W6W Display of pressed keys in inverse video. C o n fir m or E N T E R : back to test menu. 3.3.6. Battery voltage display (Test4) W6W W6W C o n fir m o r E N T E R : back to test menu. NT1789 Rév.A0 page : 27

3.3.7. Display of the last 10 alarms codes (Test5) W6W W6W S E L E C T IO N : C o d e s s c ro llin g. C o n fir m o r E N T E R : b a c k to te s t m e n u. 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 sensors (Test9) W6W W6W Display of analog input values in form 0-5000 for 0-1024 Lsb. No display for up-stream sensor if not used. C o n fir m or E N T E R : back to test menu 3.3.10. Display of software version number (TestA) W6W$ W6W$ C o n fir m or E N T E R : proceeds to language version then back to test menu. S E L E C T IO N : language scrolling. P a g e 2 8 NT1789 Rév.A0

3.3.11. Motor clamp Test (TestC) W6W& S E L E C T IO N : fu n c tio n c h o ic e. C o n fir m o r E N T E R : R u n c la m p o r u n c la m p. S T O P : s to p s m o to r a n d re tu rn to te s t m e n u if m o to r a lre a d y s to p p e d. C la m p : th e d c m o to r tu rn s fo rw a rd to c la m p. U n c la m p : th e d c m o to r tu rn s b a c k w a rd to u n c la m p. If problem on clamp motor driver then LCD screen black and Er31 displayed on 7 segment display. S T O P : to return to test menu. 3.3.12. Calibration values display (TestE) W6W( S E L E C T IO N : scrolling of calibration values. C o n fir m or E N T E R : back to test menu Display of calibration values in form 0-5000 for 0-1024 Lsb. The calibration values list is as following: Por1 : Hall effect sensor, door closed, without set. Por2 : Hall effect sensor, door opened. Por3 : Hall effect sensor maximum value, door closed, with set. Pam1 : Upstream pressure, door open. Pam2 : Upstream pressure, 0 mmhg. Pav1 : 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 Rév.A0 page : 29

3.3.13. Infusion motor Test (TestF) T h is te s t a llo w s to s e t th e m o to r ru n n in g w ith o u t a la rm m a n a g e m e n t. W6W) S E L E C T IO N : selection of infusion flow rate (0.1 ml/h à 1000 ml/h). E N T E R : flow rate validation. S T O P : 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. S T O P : to return to test menu. 3.3.14. Display of last 10 alarms before a failure occurs (TestJ) W6W- W6W- S E L E C T IO N : scrolling number of switching on then error and codes. C o n fir m or E N T E R : back to test menu. P a g e 3 0 NT1789 Rév.A0

3.4. M a in te n a n c e S e r v ic e C o n fig u r a tio n. 3.4.1. Service configuration Menu. D is p la y o f c o n fig u ra tio n n u m b e r o n 7 s e g m e n ts d is p la y a n d c o lo u re d in v e rs e o n th e L C D s c re e n a t th e s a m e tim e. S E L E C T IO N : c o n fig u ra tio n s e le c tio n. C o n fir m o r E N T E R : c o n fig u ra tio n e x e c u tio n. S T O P : re tu rn to te s t m e n u. 6$9 S e rv ic e c o n fig u ra tio n s lis t : S A V 1 : p re v e n tiv e m a in te n a n c e. S A V 2 : s e t n u m b e r c o n fig u ra tio n. D is p la y o f c o n fig u ra tio n n u m b e r o n 7 s e g m e n ts d is p la y a n d c o lo u re d in v e rs e o n th e L C D s c re e n a t th e s a m e tim e. 3.4.2. Preventive maintenance (SAV1) 6$9 S E L E C T IO N : n u m b e r o f h o u rs b e fo re m a in te n a n c e o r d a te o f m a in te n a n c e s e le c tio n. E N T E R : c h a n g e s o n e fie ld to a n o th e r. C o n fir m : b a c k to S e rv ic e c o n fig u ra tio n m e n u w ith re c o rd in g o f n e w d u ra tio n a n d d a te. S T O P : e ra s e s th e la s t c h a n g e s a n d g o e s b a c k to S e rv ic e c o n fig u ra tio n m e n u. C h o ic e o f n u m b e r o f h o u rs b e fo re m a in te n a n c e b e tw e e n 1 a n d 9 9 9 9 h o u rs. 0 in h ib its th e re q u e s t o f p re v e n tiv e c h e c k w ith th e w o rk in g d u ra tio n. C h o ic e o f th e d a te b e tw e e n 0 1 /0 1 /1 9 9 0 a n d 3 1 /1 2 /2 0 7 9. O n e o f th e th re e n u m b e rs = 0, in h ib its th e re q u e s t o f p re v e n tiv e c h e c k w ith th e d a te. 3.4.3. Set number Configuration (SAV2) 6$9 D is p la y o f d iffe re n t s e ts a v a ila b le fo r th e p u m p ty p e. A c h e c k m a rk s h o w s th e s e ts a lre a d y c a lib ra te d. S E L E C T IO N : m o v e s u p o r d o w n in th e s e t lis t. C o n fir m o r E N T E R : s a v e s th e s e t s e le c tio n (c o lo u re d in v e rs e s e le c tio n ) S T O P : c a n c e l th e la s t s e le c tio n a n d re tu rn to c a lib ra tio n m e n u. If a n o n -c a lib ra te d s e t is s e le c te d, a t th e n e x t s w itc h in g o n, th e d e v ic e is lo c k e d in o c c lu s io n a n d /o r u p s tre a m p re s s u re a la rm, re q u irin g c a lib ra tio n. NT1789 Rév.A0 page : 31

3.5. T e c h n ic a l fa ilu r e s m e s s a g e s. A n y te c h n ic a l fa il u s e in itia te s a n e rro r c o d e a s w e ll a s a c o n tin u o u s s o u n d a la rm. A n e rro r c o d e is d is p la y e d o n th e 7 s e g m e n ts d is p la y. E r r o r c o d e s E r r x x D e s c r ip tio n 1 0 In te rn a l R A M p ro b le m 2 0 E x te rn a l R A M p ro b le m 3 0 In c o h e re n t E P R O M c h e c k s u m 4 0 E E P R O M p ro b le m 5 0 A D C p ro b le m 6 0 In c o h e re n t in fu s io n s e t p a ra m e te r 7 0 M o to r fre q u e n c y in c o m p a tib ility. 8 0 K e y b o a rd p ro b le m. 0 1 M o to r ro ta tio n e rro r. 1 1 M o to r ro ta tio n e rro r. 2 1 M o to r ro ta tio n e rro r. 3 1 D C M o to r. 4 1 M o to r ro ta tio n e rro r. 0 3 S e ria l lin k tra n s m is s io n e rro r 1 4 E rro r o n m o to r p e rio d c a lc u la tio n p a ra m e te rs v e rific a tio n 2 4 M o to r ro ta ry d ire c tio n in c o m p a tib ility. 4 4 Q u a rtz fre q u e n c y in c o m p a tib ility. 5 4 d is p la y b o a rd m is s in g. 7 4 N o b a tte ry c o n n e c tio n. 8 4 B a tte ry c h a rg e e rro r 5 6 S o ftw a re p ro b le m. 2 8 N o n c o m p a tib le la n g u a g e file. 5 5 c lo c k fa ilu re 9 4 B a tte ry te m p e ra tu re e rro r 5 5 S e c o n d a ry m ic ro p ro c e s s o r e rro r 8 5 S e c o n d a ry m ic ro p ro c e s s o r e rro r 1 6 D a te / tim e c h e c k e rro r A la r m c o d e s A x x 1 0 B a tte ry 1 2 E n d o f in fu s io n 1 6 D o w n s tre a m O c c lu s io n 1 7 A ir d e te c tio n 1 8 A ir d e te c tio n 1 9 U p s tre a m O c c lu s io n 2 0 N o tu b in g s e t 2 1 N o c la m p D e s c r ip tio n P a g e 3 2 NT1789 Rév.A0

A la r m c o d e s A x x 2 2 D o o r 2 3 N o d rip s e n s o r 2 4 D rip s e n s o r : lo w flo w ra te 2 5 D rip s e n s o r : h ig h flo w ra te 2 6 F re e flo w 2 7 O c c lu s io n c o n tro l D e s c r ip tio n NT1789 Rév.A0 page : 33

4. R E P L A C IN G S U B -A S S E M B L IE S 4.1. M o d u le o p e n in g. W h e n o p e n in g th e O P T IM A, a n ti-s ta tic p re c a u tio n s m u s t b e s tric tly a p p lie d. T h e u s e o f a n ti-s ta tic c a rp e t a n d g ro u n d e d b ra c e le ts is h ig h ly re c o m m e n d e d. D is c o n n e c t b a tte ry a s s o o n a s th e M o d u le is o p e n e d. 4.2. R e p la c in g C P U b o a r d. In c a s e o f C P U b o a rd re p la c e m e n t, s y s te m a tic a lly p e rfo rm c o n fig u ra tio n a n d c a lib ra tio n a s d e s c rib e d in c h a p te r 3. 4.3. D is m o u n tin g p u m p in g m e c h a n is m. R e tra c t th e d o o r a x is a n d re m o v e th e d o o r. R e m o v e th e s tic k e r u p to th e p u m p in g m e c h a n is m to u n s c re w a x is h o ld e r. U n s c re w th e 4 fix in g s c re w s o f th e p u m p in g m e c h a n is m. 4.4. R e p la c e m e n t o f p r e s s u r e s e n s o r s. In c a s e o f re p la c in g p re s s u re s e n s o r, s y s te m a tic a lly p e rfo rm c o n fig u ra tio n s a n d c a lib ra tio n s d e s c rib e d in c h a p te r 3. B e e x tre m e ly c a re fu l w ith in th e d ire c tio n o f th e s e n s o r p o s itio n in g (le a d o u tp u t). 4.5. R e p la c e m e n t o f d o o r o r o f H a ll e ffe c t s e n s o r In c a s e o f re p la c in g th e s e e le m e n ts, s y s te m a tic a lly p e rfo rm c o n fig u ra tio n s a n d c a lib ra tio n s d e s c rib e d in c h a p te r 3 P a g e 3 4 NT1789 Rév.A0

5. M A IN T E N A N C E 5.1. R e c o m m e n d a tio n s T h e q u a lifie d te c h n ic ia n s in y o u r e s ta b lis h m e n t o r o u r M a in te n a n c e S e rv ic e s h o u ld b e n o tifie d o f a n y a b n o rm a l o p e ra - tio n o f th e d e v ic e. F o r fu rth e r in fo rm a tio n c o n c e rn in g tro u b le s h o o tin g o r u s a g e p ro c e d u re, p le a s e c o n ta c t o u r M a in te n a n c e D e p a rtm e n t o r o u r S a le s R e p re s e n ta tiv e. (s e e U s e fu l A d d re s s e s, c h a p te r 9 ) If th e d e v ic e h a s to b e re tu rn e d to o u r M a in te n a n c e S e rv ic e, it m u s t b e d is in fe c te d a n d p a c k e d v e ry c a re fu lly, if p o s s ib le in its o rig in a l p a c k a g in g. F R E S E N IU S V IA L IN F U S IO N S Y S T E M S is n o t lia b le fo r lo s s o r d a m a g e to th e d e v ic e d u rin g tra n s p o rt to o u r M a in te - n a n c e S e rv ic e. 5.2. C le a n in g a n d d is in fe c tin g T h e M o d u le D P S a n d th e F R E S E N IU S V IA L In fu s io n S ta tio n fo rm p a rt o f th e p a tie n t s im m e d ia te e n v iro n m e n t. It is a d v is a b le to c le a n a n d d is in fe c t th e d e v ic e s e x te rn a l s u rfa c e s o n a d a ily b a s is in o rd e r to p ro te c t p a tie n t a n d s ta ff. q D is c o n n e c t th e F R E S E N IU S V IA L O P T IM A P u m p fro m th e m a in s s u p p ly b e fo re s ta rtin g to c le a n. q D o n o t p la c e in a n A U T O C L A V E n o r IM M E R S E th e d e v ic e. D o n o t le t liq u id s e n te r th e d e v ic e s c a s in g. q U s e a c lo th s o a k e d in D E T E R G E N T -D IS IN F E C T A N T, p re v io u s ly d ilu te d w ith w a te r if re q u ire d. A v o id a b ra s iv e s c ru b b in g w h ic h c o u ld s c ra tc h th e c a s in g D o n o t rin s e o r w ip e s u rfa c e s. q If th e d e v ic e is p la c e d in a h ig h c o n ta m in a tio n ris k u n it, it is a d v is a b le to le a v e it in th e ro o m d u rin g fu - m ig a tio n d is in fe c tin g, a fte r h a v in g d is in fe c te d it w ith a m o is t c lo th. q D o n o t u s e : À T R IC H L O R O E T H Y L E N E -D IC H L O R O E T H Y L E N E, À A M M O N IA, À A M M O N IU M C H L O R ID E, À C H L O R IN E a n d A R O M A T IC H Y D R O C A R B O N, À E T H Y L E N E D IC H L O R ID E -M E T H Y L E N E C H L O R ID E, À C E T O N E T h e s e a g g re s s iv e a g e n ts c o u ld d a m a g e th e p la s tic p a rts a n d c a u s e d e v ic e m a lfu n c tio n. q T a k e c a re a ls o w ith A L C O H O L B A S E D S P R A Y S (2 0 % - 4 0 % a lc o h o l). T h e y le a d to ta rn is h in g a n d s m a ll c ra c k s in th e p la s tic, a n d d o n o t p ro v id e th e n e c e s s a ry c le a n in g p rio r to d is in fe c tin g. q F o r fu rth e r d e ta ils, c o n ta c t th e s e rv ic e in c h a rg e o f c le a n in g a n d d is in fe c tin g p ro d u c ts o f y o u r e s ta b - lis h m e n t. 5.3. S to r a g e T h e d e v ic e s h o u ld b e s to re d in a d ry a n d c o o l p la c e. In c a s e o f p ro lo n g e d s to ra g e tim e, d is c o n n e c t th e b a tte ry th ro u g h th e b a tte ry d o o r lo c a te d o n th e re a r p a n e l. T h is o p e ra tio n s h o u ld b e m a d e b y q u a lifie d te c h n ic ia n. W h e n s to ra g e a fu ll re c h a rg e o f th e b a tte ry is re c o m m e n d e d b e fo re re s ta rtin g th e p u m p, in o rd e r to a v o id a n y ris k c a u s e d b y m ic ro m a in s s u p p ly c u ts a n d to in s u re m a x im u m a u to n o m y. S to ra g e p la c e s h o u ld b e : Temperature between -10 c and 60 c Maximum relative humidity 90% no condensation. NT1789 Rév.A0 page : 35

5.4. R o u tin e in s p e c tio n s 5.4.1. Checking before use (R e fe r to o p e ra tin g in s tru c tio n s ) In o rd e r to e n s u re o p tim a l w o rk o f th e d e v ic e, re g u la r s e rv ic in g in s p e c tio n s a n d te s ts a re re c o m m e n d e d. A s e rv ic in g c h e c k p ro c e d u re s h o u ld in c lu d e th e p o in ts lis te d b e lo w. T h e s e s e rv ic e c h e c k s a re n o t c o v e re d b y a n y c o n - tra c t o r a g re e m e n t w ith F R E S E N IU S V IA L IN F U S IO N S Y S T E M S a n d a re th e re s p o n s ib ility o f th e U s e r s te c h n ic a l s ta ff. F o r fu rth e r in fo rm a tio n, p le a s e c o n ta c t o u r M a in te n a n c e S e rv ic e. q N o te : F a ilu re to c o m p ly w ith th e s e m a in te n a n c e p ro c e d u re s c o u ld d a m a g e th e d e v ic e a n d le a d to a fu n c tio n a l fa ilu re. 5.4.2. Occlusion alarm checking 1. M a k e th e fo llo w in g in s ta lla tio n. 1 m P U M P 5 0 c m M a n o m e te r b y p a s s 2. P ro g ra m a 1 2 5 m l/h flo w ra te a n d a c o u n te r p re s s u re a la rm a t 5 0 0 m m H g. 3. S ta rt in fu s io n w ith b y p a s s c lo s e d b e tw e e n m a n o m e te r a n d p u m p 4. A fte r 5 m in u te s o f in fu s io n a t 0 p re s s u re, o p e n b y p a s s b e tw e e n th e m a n o m e te r a n d th e p u m p. 5. W h e n a la rm g o e s, c h e c k th e p re s s u re P d is p la y e d b y th e m a n o m e te r is c o rre c t : P = 5 0 0 m m H g ± 7 5 m m H g -> 0.6 5 + 0.1 b a r 6. D o th e te s t a g a in w ith a p ro g ra m m e d c o u n te r p re s s u re o f 7 5 0 m m H g. P = 7 5 0 m m H g ± 1 1 0 m m H g -> 1 + 0.1 5 b a r P a g e 3 6 NT1789 Rév.A0

5.4.3. Battery autonomy test 1. T h e b a tte ry a u to n o m y is m in im u m 4 h fo r u s u a l flo w ra te s (< 1 2 5 m l/h ). 2. T h e b a tte ry (w h e n p ro p e rly c h a rg e d ) p re a la rm g iv e s a w a rn in g to th e u s e r a b o u t 3 0 m in u te s b e fo re to ta l s to p o f th e d e v ic e. q N o te : T h e b a tte ry c h a rg e d u ra tio n is m in im u m 1 6 h o u rs ( 1 0 0 % o f its c a p a c ity ) w h e n th e p u m p is O N. q N o te : T h e b a tte ry c h a rg e d u ra tio n is m in im u m 5 h o u rs ( 1 0 0 % o f its c a p a c ity ) w h e n th e p u m p is o ff. 5.4.4. Fix clamp checking ( VS/PT and ST pumps) 1. M a k e th e fo llo w in g in s ta lla tio n. M a n o m e te r D e v ic e In fu s io n s e t P S y rin g e D rip c h a m b e r 2. O p e n th e d o o r o f th e d e v ic e, th e in lin e m e c h a n ic a l c la m p s h o u ld c la m p th e in fu s io n s e t. 3. A p p ly a 0.5 b a r p re s s u re w ith th e s y rin g e a n d c h e c k n o liq u id g o e s in th e d rip c h a m b e r. 5.4.5. Air detector check N o te : D o th e te s t w ith th e tu b in g s e t d is p la y e d o n th e d e v ic e. W e re c o m m e n d to d o th e te s t w ith th e d iffe re n ts ty p e s o f tu b in g s e ts u s e d in th e h o s tip a l. 1. P la c e a n in fu s io n s e t fu ll o f w a te r in th e d e v ic e. 2. F o r a n a ir b u b b le s v o lu m e p ro g ra m m e d a t 0.2 0 m l. 3. P ro g ra m a 6 0 m l/h flo w ra te. 4. G e t d rip c h a m b e r u p s id e d o w n fo r a b o u t 2 0 s e c o n d s ( to in fu s e a b o u t 0.5 m l a ir b u b b le ) 5. C h e c k th e a ir a la rm g o e s w h e n a ir b u b b le s p a s s th ro u g h th e a ir d e te c to r. T h e le n g th p a s s in g th ro u g h b e fo re a la rm s h o u ld a p p ro x im a te ly c o rre s p o n d to th e s iz e s e le c te d (1.3 c m / 0.1 m l). 5.4.6. Continuity test 1 U s in g a O h m m e te r, v e rify th e p re s e n c e o f th e e le c tric a l re s is to r h ig h e r th a n 1 0 M o h m s b e tw e e n N e u tra l a n d d rip s e n s o r p lu g (a n y p in ) P h a s e a n d d rip s e n s o r (a n y p in ) NT1789 Rév.A0 page : 37

5.5. T e c h n ic a l c h e c k p r o c e d u r e In o rd e r to e n s u re fo llo w -u p w ith in th e fra m e w o rk o f a p re v e n tiv e m a in te n a n c e, a ro u tin e in s p e c tio n is re c o m m e n d e d. It is re c o m m e n d e d to u s e th e te c h n ic a l m a n u a l a s a c o m p le m e n t, fo r c o rre c t ru n o f th e p ro c e d u re. A c h e c k in g s o ftw a re a llo w s to a u to m a tic a lly p e rfo rm th e fo llo w in g te s ts. IM P O R T A N T : re c h a rg e b a tte ry ( 1 6 h o u rs ) p rio r to th e c h e c k p ro c e d u re D e v ic e : O P T IM A / M C M T y p e : C o d e : Device serial N : Check date :... /... /... Depart : Technician : C h e c k N Description FUNCTIONAL CHECK ( see 3.3.) 1 q C h e c k g e n e ra l o u ts id e c a s in g a p p e a ra n c e, m a in s p o w e r c o rd a n d s tic k e rs. a n d p u m p in g m e m b ra n e C o n - fo r m Y E S N O N A 2 q D is p la y of working duration (test1) H/D/M 3 q Last maintenance date (test1)..d/m/y 4 q Total working duration ( test 6) H/D/M 5 q Lights, buzzers and displays check (test2) 6 q 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 O C S T e s t ( fo r p u m p O P T IM A M S a n d V S o r M C M M S a n d O T ) In s ta ll a tu b in g s e t a n d p u t o n th e d e v ic e 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. D e te c tio n o f th e c la m p o f th e M S s e ts ( fo r M S ty p e p u m p s ) In s ta ll th e M S s e ts p ro p e rly in th e p u m p. T u rn o n th e M S p u m p C h e c k th a t th e re is n o a la rm d is p la y O p e n th e d o o r a n d m o v e th e c la m p o n th e M S s e t o u ts id e th e d e v ic e. C lo s e th e d o o r. Check that no clamp. P a g e 3 8 NT1789 Rév.A0

C h e c k N Description C o n - fo r m Y E S N O N A 9 q D rip s e n s o r c h e c k (if p re s e n t) 1 0 C h e c k s e n s o r in te g rity (c h o c k m a rk s, c le a n lin e s s o f th e d e te c tio n z o n e, d rip c h a m b e r m a in ta in in g s p rin g, g o o d c o n d itio n o f th e c o rd ) C o n n e c t th e c o rd to th e M o d u le In s ta ll a n in fu s io n s e t fu ll o f w a te r S ta rt in fu s io n C h e c k th a t th e g re e n in d ic a to r fla s h e s w h e n a d ro p is d e te c te d. D is c o n n e c t th e s e n s o r: 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 < <2 min 30 sec 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 > 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 g o e s o n w h e n b u b b le p a s s e s in th e s e n s o r. 1 1 q D o w n -s tre a m p re s s u re d e te c to r. 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) 1 2 A v e ra g e F lo w ra te c h e c k (c a n a ls o b e p e rfo rm w ith a s c a le & IS D e b it p ro g ra m te s t) P la c e th e in fu s io n s e t in a 1 0 0 m l te s t tu b e. S e le c t a 8 0 m l/h flo w ra te a n d in fu s e fo r 1 h o u r N o te th e in fu s e d v o lu m e T h e flo w ra te c a n b e a d ju s te d ( s e e 3.2.3 ) 76 ml < infused volume :.ml< 84 ml 1 3 q B a tte ry c h e c k Before checking, charge the battery for at least 16 hours Start an infusion at 125 ml/h, m a in s d is c o n n e c te d Check working autonomy is > 4h IM P O R T A N T : if autonomy < 3h30, CHANGE battery. 1 4 q C o n tin u ity te s t Neutral and Drip sensor connector (any pin) > 10Mohms Phase and drip sensor connector (any pin) > 10 Mohms Earth and equipotentiality < 0.1 Ohms Earth and screw below the device < 0.1 Ohms Checking result conform no conform Visa : NT1789 Rév.A0 page : 39

6. A N N E X E 1 : Illu s tr a te d p a r ts lis ts 6.1. S u b a s s e m b lie s tr a c e a b ility ta b le 6.1.1. Introduction T h e a im o f th is c h a p te r is to h e lp th e te c h n ic ia n to fin d s p a re p a rts s o th a t th e m o d u le c a n b e s e rv ic e d. 6.1.2. Spare parts table T h e ta b le b e lo w lis ts th e m a in s m o d ific a tio n s m a d e to im p ro v e th e p ro d u c t. T h e m o d u le s s e ria l n u m b e r s h o u ld b e u s e d w h e n lo o k in g fo r c o m p o n e n ts. O P T IM A / M C M e q u iv a le n c e ta b le In s tru m e n t s e ria l n o. F ro m :1 8 1 8 0 1 0 0 T o : 1 D is p la y b o a rd 1 5 9 6 0 2 C P U b o a rd 1 5 9 6 0 1 P o w e r S u p p ly b o a rd 1 5 9 6 0 3 P a g e 4 0 NT1789 Rév.A0

6.1.3. Upper housing 100 101 104 105 106 107 102 103 108 109 110 111 112 R e fe r e n c e D ig. r e f Q u a n tity C o m p o n e n t 1 5 9 6 1 1 1 0 1 1 U p p e r h o u s in g 1 5 9 6 2 0 1 0 3 1 K e y b o a rd 1 5 9 6 0 2 1 0 2 1 D is p la y b o a rd 1 5 9 6 0 1 1 1 2 1 C P U b o a rd 1 5 9 6 4 6 1 0 7 1 O C S m o to r 1 6 8 4 0 2 1 1 0 1 P T / V S / O T a ir b u b b le b o a rd 1 6 8 4 0 3 1 1 0 1 S T a ir b u b b le b o a rd 1 6 8 9 3 8 1 1 1 1 A ir s e n s o r 1 7 4 2 5 2 1 0 8 1 O C S fo a m rin g 1 6 8 4 4 2 1 0 4 1 A ir s e n s o r h o u s in g 1 5 9 8 9 9 1 0 0 1 D ro p d e te c to r NT1789 Rév.A0 page : 41

6.1.4. Base 211 200 201 203 205 204 206 207 208 209 210 R e fe r e n c e D ig. R e f. Q u a n tity C o m p o n e n t 1 5 9 8 9 5 2 0 4 1 B a s e 1 6 8 4 8 0 2 0 6 2 P re s s u re s e n s o r 1 6 8 4 2 8 2 S e n s o r c lip 1 6 8 4 3 9 2 0 8 2 S e n s o r m e m b ra n e 6 5 1 2 1 1 1 M e c h a n ic a l b lo c m e m b ra n e 1 5 9 6 2 1 2 0 5 1 L e ft h o o k 1 6 8 4 3 7 2 0 9 1 R ig h t h o o k 1 5 9 6 0 4 2 0 0 1 F la t c a b le 1 5 9 6 4 8 2 0 3 1 M o to r 1 6 8 4 7 9 2 1 1 1 M e c h a n ic a l b lo c 1 6 8 4 8 2 1 B e lt 1 6 8 4 8 3 1 P u m p s id e g e a r 1 6 8 4 8 9 1 M o to r s id e g e a r 1 6 8 4 8 5 3 S ile n t b lo c 4 0 s h o re s 1 5 9 6 1 8 2 0 7 2 F e e t 1 9 9 2 6 1 2 1 0 1 P T / V S / O T d o o r k it 1 9 9 2 6 2 2 1 0 1 S T d o o r k it P a g e 4 2 NT1789 Rév.A0