Maintenance Manual AK 200 S / AK 200 ULTRA ULTRA S 0 5 . 2006
GAMBRO
Maintenance Manual
Preventive maintenance procedures for AK 200 S / AK 200 ULTRA S Gener eneral al ........ ................ ............... ............... ................ ............... ............... ............. ..... 2:2 T est equi equipmen pmentt ....... ............... ................ ................ ............... .............. ....... 2:3 Preve eventi ntive ve Mai Maintenanc ntenance: e:Base ase-ki -kitt ... ..... ..... ...... ..... 2:4 P a rts ........ ............... ............... ................ ................ ................ ................ ................ .......... 2: 2:4 4 How t o exc excha ha nge the par ts included in the B a sese-kit kit ........ ................ ................ ................ ................ ............... ......... .. 2: 2:5 5 Actio ctions ns to ca ca rry out a fter the part s ha ve been exc excha ha nged ........ ............... ............... ............... ............... ........ 2: 2:8 8 Preventive Mai Maintenance: ntenance:A-kit A-ki t .. .... .... .... .... .... .... .... 2:23 P a rts ....... ............... ................ ............... ............... ................ ............... ............... .......... 2: 2:23 23 How t o exc excha ha nge the exterior exterior pa rts included in th e A-kit A-kit ....... ............... ............... .............. ............... .......... 2: 2:24 24 Actio ctions ns to ca ca rry out a fter the part s have been exc excha ha nged ........ ............... ............... ................ ................ .............. ...... 2: 2:25 25 Preventive Mai Maintenance: ntenance:B-kit B-ki t .. .... .... .... .... .... .... .... 2:26 P a rts ....... ............... ................ ............... ............... ................ ............... ............... .......... 2: 2:26 26 How t o exc excha ha nge the par ts included in the B -kit ....... ............... ............... ............... ................ ................ .............. ...... 2: 2:27 27 Actio ctions ns to ca ca rry out a fter the part s have been exc excha ha nged ........ ............... ............... ................ ................ .............. ...... 2: 2:29 29
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Maintenance Manual
Preventive maintenance procedures for AK 200 S / AK 200 ULTRA S Gener eneral al ........ ................ ............... ............... ................ ............... ............... ............. ..... 2:2 T est equi equipmen pmentt ....... ............... ................ ................ ............... .............. ....... 2:3 Preve eventi ntive ve Mai Maintenanc ntenance: e:Base ase-ki -kitt ... ..... ..... ...... ..... 2:4 P a rts ........ ............... ............... ................ ................ ................ ................ ................ .......... 2: 2:4 4 How t o exc excha ha nge the par ts included in the B a sese-kit kit ........ ................ ................ ................ ................ ............... ......... .. 2: 2:5 5 Actio ctions ns to ca ca rry out a fter the part s ha ve been exc excha ha nged ........ ............... ............... ............... ............... ........ 2: 2:8 8 Preventive Mai Maintenance: ntenance:A-kit A-ki t .. .... .... .... .... .... .... .... 2:23 P a rts ....... ............... ................ ............... ............... ................ ............... ............... .......... 2: 2:23 23 How t o exc excha ha nge the exterior exterior pa rts included in th e A-kit A-kit ....... ............... ............... .............. ............... .......... 2: 2:24 24 Actio ctions ns to ca ca rry out a fter the part s have been exc excha ha nged ........ ............... ............... ................ ................ .............. ...... 2: 2:25 25 Preventive Mai Maintenance: ntenance:B-kit B-ki t .. .... .... .... .... .... .... .... 2:26 P a rts ....... ............... ................ ............... ............... ................ ............... ............... .......... 2: 2:26 26 How t o exc excha ha nge the par ts included in the B -kit ....... ............... ............... ............... ................ ................ .............. ...... 2: 2:27 27 Actio ctions ns to ca ca rry out a fter the part s have been exc excha ha nged ........ ............... ............... ................ ................ .............. ...... 2: 2:29 29
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Maintenance Manual
General To ensure proper opera opera tion of th e AK AK 20 200 0S / AK 200 ULTRA S, a qua lifie lified d service technician must perform a complete series of preventive ma intena nce pro proce cedures dures at regular int ervals. The ma intena nce a nd calibra tion informat informat io ion n tha t you need to use is provi provided ded in this ma nua l. The preventive maintenance procedures have been bee n devised to require a minimum of time w hile ensuring ensuri ng tha t t he machine is is ma intained in optimum opera opera tion condit condit ion. Included in th e preventive preventive ma intena nce proce proce-dures a re check checkss to verify normal m a chine operat op erat io ion. n. Should the ma chine fail to pass a ny of these tests, repair or ca ca librat io ion n might be needed, neede d, then r ep epeat eat the t ests unt il the speci specific ficaa tions tio ns a re met.
To fulfill fulfill the prevent ive ma inten a nce procedures procedures for AK AK 200 S /AK /AK 200 UL TRA S some pa rt s mu st be excha excha nged. The The necessa necessa ry pa rt s to be exexchanged a re available in in a B asease-kit kit and tw o comple co mplementa menta ry kits: •
Ba se se--ki kitt (K40 K401 165001)
•
A-kit (K401 (K40166 6600 001) 1):: Includes Includes exterior exterior pa rts
•
B -kit (K401 (K40167 6700 001) 1):: Overha Overha uling service service--kit
When pe performing rforming preventive ma intena nce procedures or calibrations, which require access to the interior of of the ma chine chine,, you you must ha ve properr electr prope electr osta tic sa fety devices (i.e. (i.e. w rist grounding stra ps or or grounding ma ts) in in place to prevent preve nt da ma ge to electrosta electrosta tic sensitive compo compo-nents within the ma chine hine..
It is ma ndat ory to perfo perform rm a t least a pre preventiv ventivee ma intena nce eve every ry second second yea r. A yea yea rly ma intena nce is is recommended. recommended. The The ra te of preventive preventive maint enan ce might be different different due to var iat io ions ns of the operat operat ing environment. environment. The AK 200 S /AK /AK 200 U LTRA S w ill perform a s designed designe d only only if it is used used a nd ma inta ined in in a cc ccordance ordance with G a mbro’ mbro’ss instructions. Any w ar ran ties made by by G a mbro with respec respect t o th e AK AK 20 200 0 S /AK /AK 200 UL TRA S a re void if th e equipment is not used in accorda accorda nce with t he instructions provided. provided. G a mbro will not a cc ccept ept responsibil respo nsibility ity for a ny da ma ge or or injury resulting from improper improper use or or ma intena nce or or una uthorized repa repa ir.
2:2
During r ep epaa ir of of an y of the part s in the flow flow pat h, special special car e should should be taken a nd a goo good d hyg iene should be kept. After fter ma intena nce a disinfection disinfection progra progra m Note! A must be perfo performed rmed before before a trea tment is perperformed. Checklists a re provide Checklists provided d in the Spare P a rt s Inst ructio ruction n tha t is include included d in the ma intena nce nce-kits. The purpose of th ese checklists checklists is t o record record the w ork done. done.
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Test equipment Test equipment needed t o perform ma intena nce Test equipment:
Tolerance:
Manufacturer:
Conductivity measurement Pressure measurement
± 0.1 mS/cm ± 2mmHg to ± 200mmHg ± 1% beyond ± 200mmHg If BPM is installed: ± 0.8mmHg ± 0.2ºC ± 0.5% ± 5 ml N/A
MESA, IBP MESA, IBP, Druck
Temperature measurement: Digital Voltmeter Measuring glass Blood leak Calibration Cover Gauge pin kit for blood pump rollers (including three different pins)
Gambro Order number:
MESA, IBP Fluke Gambro
K40169001
Gambro
K40158001
Gambro
K40158002 K40158003 K40158004
N/A N/A N/A
Gambro
K13983002
According to IEC 60601-1 N/A N/A ± 0.07 pH units
Rigel, Biotec, Metron Gambro Gambro
T = 1.1 (Stop pin = 1.1*2*0.7 = 1.5mm) T = 1.6 (Stop pin = 1.6*2*0.7 = 2.2mm) T = 2.0 (Stop pin = 2.0*2*0.7 = 2.8mm) T = wall thickness of the blood tubing
Gauge pin kit for blood pump rollers (to be ordered separately)
T = 1.1 (Stop pin = 1.1*2*0.7 = 1.5mm) T = 1.6 (Stop pin = 1.6*2*0.7 = 2.2mm) T = 2.0 (Stop pin = 2.0*2*0.7 = 2.8mm) T = wall thickness of the blood tubing
Calibration tube kit Drip chamber Tube for calibration of priming detector Safety tester *BPM test equipment *BPM Cuff *pH buffers BVS test tool Magnet for blood pump cover
Gambro Gambro
K22151001 100900141 pH 7 – 100810001 pH 9 – 100810002 K22281001 K19049001
* If installed
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Maintenance Manual
Base-kit
Preventive Maintenance: Base-kit Parts The B a se-kit (K40165001) includes a ll pa rt s necessary t o fulfill the man da tory preventive ma int ena nce procedur es for AK 200 S / AK 200 UL TRA S. Step 2, 3 4
Monitor BM/FM AC/DC
5, 6
FM
7 7 8 9 10 11 12 13 14 15 16 16 17 18
FM FM FM FM FM FM FM FM FM FM FM FM FM FM
Denomination Air filter Air filter O-ring for BiCart- and SelectCart holder, upper and lower. O-ring for ultrafilter holders Square-ring for ultrafilter holders Filter BiCart holder, upper and lower (50µm) Filter SelectCart holder, lower (50µm) Filter after the SelectBag holder (50µm) Filter heating vessel (250µm) V-ring heating vessel Membrane for internal pressure regulator Membrane for non-return valve Sample port for 6 mm tube Sealing ring (Inlet unit - heating vessel) Ring (Inlet unit - heating vessel) Sealing for infusion port Label
Part no. K11503001 K18891001
Qty 3 1
100319008
4
100319029 K14920001 K16538C K16538C K16538C K14944001 100318086 K40153001 K17989001 K20219002 K07994001 K08227001
4 2 2 1 1 1 2 1 1 1 1 1
K18184001 K24092001
1 1
Note! As a complement t o the Ba se-kit, tw o additional kits a re a vaila ble; A- a nd B -kit.
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Base-kit
How to exchange the parts included in the Base-kit
1. Firs t perform a combined heat disinfection program with CleanC ar t C or liquid citric acid. Then perform a heat disinfection progra m in combination w ith CleanCa rt A or a Chemical disinfection progra m wit h sodium hypochlorit e. Refer to th e AK 200 S or AK 200 U LTRA S Opera tor’s Man ua l.
4. Ch a nge a ir filters in the AC/DC unit .
OK Kommentare
OK Kommentare
2. Cha nge a ir filters in the Blood Monitor.
5. Cha nge the upper a nd lower O-rings in the B iCart holder. 2 3 1
o-ring
OK Kommentare
3. Cha nge a ir filter in the Fluid Monitor.
OK Kommentare
6. Chan ge the upper a nd lower O-rings in t he SelectC a rt holder. 2 3 1
o-ring
OK Kommentare
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7. Cha nge the O-rings a nd squa re-rings in the ultr a filter holders. (Only for AK 200 S w ith U FD -kit a nd AK 200 ULTRA S)
10. Cha nge the part icle filter after t he SelectB a g hold er (50 µm).
o-ring
o-ring squarering
OK Kommentare
8. Cha nge the upper a nd lower filters on the B iCa rt holder (50 µm).
OK Kommentare
9. Chan ge the lower filter on the SelectC a rt hold er (50 µm).
OK Kommentare
11. Cha nge the filter for the heat ing vessel (250 µm).
OK Kommentare
12. Cha nge th e V-rings in the h eat ing vessel.
A
OK Kommentare
2:6
B
OK Kommentare
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OK Kommentare
13. If ULTRA: Cha nge the membrane for t he interna l pressure regulat or.
16. Cha nge the sea ling ring and th e ring on the inlet un it inside the hea ting vessel.
Note! It is importa nt t ha t th e sea ling ring is re-a ssembled w ith its flat side according to this illustra tion.
OK Kommentare
14. If ULTRA: Cha nge the membrane for t he non-return valve.
OK Kommentare
15. Cha nge the sa mple ports.
17. If ULTRA: Cha nge the sea ling for the infusion port on t he FM front.
OK Kommentare
18. Mar k month a nd yea r for the next scheduled preventive ma intena nce. Att a ch the label to the rea r cover of the ma chine.
05
10 06
07 08
09
OK Kommentare
OK Kommentare
10
05 06
09 07
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Actions to carry out after the parts have been exchanged 1. Check tha t the screws for t he blood pump(s) ar e tightened.
OK Kommentare
2. Check tha t t he screws for t he hose cla mps on the wa ter inlet and dr ain tube are tightened.
3. Check tha t th e wheels ar e tightened.
OK Kommentare
4. Check tha t t he screw for the infusion sta nd is tightened.
OK Kommentare
5. P erform the P rotective Ea rth Test (P ET) a ccording t o instructions a vaila ble in HC E N12190, Electrical sa fety inspections for AK-machines. OK Kommentare
OK Kommentare
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Maintenance Manual
6. Check the protective eart h resista nce in B M. Mea sure betw een TP 8 (Z0VL) on the B MCP U board a nd the earth point on the bottom plat e. Measure in M Ω, should be > 1 M Ω. The ma chine must be empty a nd sw itched off during measurement. Note! The B M must be connected to the F M. TP4 TP5 TP7
8. Era se the error code buffers. E nter service menu > Diagnose > System > Errors > Era se OK Kommentare
TP9 TP10 TP11
TP14
TP12
TP17 TP18 TP22
TP13 TP6 TP8 TP15 TP16 TP21
TP3
TP19 TP20
TP2
E01342007
4 7 0 1
OK Kommentare
7. Check the protective eart h resista nce in FM. Mea sure betw een TP 7 (Z0VL) on the P ower distribution boa rd a nd the eart h point on the ba ck plate. Measure in M Ω, should be > 1 M Ω . The ma chine must be empty a nd swit ched off during measur ement.
TP4 TP3
TP1 TP2
TP7 TP8
TP5 TP6
E01345009
OK Kommentare
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9.3 Ch eck of a ir leaka ge
9. BPM-test
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B y entering this test mode the a ir leaka ge for t he B P M module, cuff hose a nd cuff will be tested au tomat ica lly. B efore entering t he test mode cuff an d cuff hose to be connected t o the AK 200 S / AK 200 UL TRA S. Cuff to be wra pped tight to the BP M test equipment.
9.1 Test method: - Att a ch B P M cuff, 100900141, tight to th e B P M t est equ ipment, K22151001. - St a rt th e AK 200 S /AK 200 ULTRA S w ith the ma in swit ch and the ON/OFF but ton. - E nt er Serv ice mode. - En ter D iagn ostics mode. - Select B M, Others, BP M 9.2 B P M sub-tests In t he B P M service menu the following subtests are included: - Air leaka ge test: measur es tha t t he equipment is airtight. - Inflat ion speed test: mea sures t he time t o fill the cuff with air. - St a tic pressure: Check of pressure tra nsducer calibrat ion Ea ch of the tests can be ca rried out separa tely but t he above order for ca rrying out t he subtests is recommended.
B P M test equipment is used to simulat e the pa tient a rm circumference. The a ir leaka ge is only t ested for 90 sec but the va lue is reca lculat ed for 3 minut es. If th e displa yed va lue is a bove 18 mm H g / 3 minutes, this indica tes tha t th ere is a possible a ir leaka ge in the syst em. It is of course a lso possible to perform th is test wit hout th e cuff and cuff hose connected but then t he test will only check for a ir leaka ge within the AK 200 S /AK 200 U LTRA S. I n t his ca se repla ce the cuff and cuff hose by a tube, w hich is closed. 9.4 Check of infla tion speed
Check tha t t he results from the sub-tests n ot exceed following limits: - Air lea ka ge: ma ximum 18 mmH g/3 min - In fla t ion speed: 2 -11 s - St a tic pressure: Ma ximum deviat ion from reference to be wit hin ± 3 mm Hg. 50 ± 3 mmHg 150 ± 3 mmHg 250 ± 3 mmHg OK Kommentare - 9.1
B y entering this test mode the ca pacity for the pump w ithin t he module will be tested a utoma tically. Before entering the test mode cuff an d cuff hose to be connected t o t he AK 200 S /AK 200 U LTRA S. Cuff to be wra pped tight to the BP M test equipment. I f the displayed t ime is above 11 seconds, this t est indica tes tha t t he pump is w orn-out. OK Kommentare - 9.3
OK Kommentare - 9.2 OK Kommentare - 9.4
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9.5 Check of pressure tra nsducer ca librat ion a nd measu red pressure B y entering t his test m ode it w ill be possible to check the a ctua l pressure value for th e BP M pressure on t he AK 200 S / AK 200 UL TRA S displa y. B efore entering the test m ode, pressure tra nsducer calibra tion t ube kit K 13983002 to be connected to the B P M connector on t he rear of t he AK 200 S /AK 200 U LTRA S . No cuff a nd cuff hose to be connected.
10. Ca librat e the P riming detector (B M 6). 10.1 En ter Serv ice/Ca libr/B M a nd set t he AK 200 S /AK 200 UL TRA S displa y t o: PRIMING DETECTOR BM 6
10.2 P ress
to sta rt calibrat ion routine.
10.3 INSERT EMPTY REFERENCE TUBE Press SET key when ready
Note! The pressure tra nsducer ca librat ion t ube kit must be drained before being connected, to ma ke sure tha t no fluids or par ticles enters the B P M connector or t ubing’s. This might otherwise da ma ge or destroy the sensitive BP M sensors. When “Measur ed pressure” is displa yed it is possible to sta rt a pplying t he external r eference pressure.
Note! P ressures sha ll be a pplied very car efully so that no overpressures occur. To check the actual pressure value, external pressure reference instrument to be connected a nd exter na l pressure of 250, 150, 50 mm H g to be applied. Check deviat ion from reference pressure instr ument for displa yed va lue. OK Kommentare
10.4 The calibra tion is now performed a utoma tica lly a nd t he calibration factor is w ritten into t h e E E P R O M. 10.5 The ca libra tion va lue is now show n on the informa tion displa y: R A E DY BLOOD
LEVEL
XX
10.6 P ress th e lit
Confirm
to confirm .
OK Kommentare
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12. Measure the power on ba tt ery B1 on the B M-CP U boa rd, excha nge if the va lue is below 2,6 V (Note! The ma chine mus t be
11. Ca librat e the Level detector (Air det ector) (B M 5). 11.1 E n t e r S erv ice/Ca libr /B M a n d s e t t h e AK 200 S /AK 200 UL TRA S displa y t o:
swit ched on when mea suring).
LEVEL DETECTOR BM 5
11.2 P ress
to sta rt calibrat ion routine.
11.3 Insert a filled drip cham ber. It is recommended tha t both the wa ter and th e drip chamber ha ve a temperat ure of approx. 37 ºC. Ma ke sure tha t t he level detector a nd drip cha mber a re dry a nd clea n. If possible, the drip cha mber sha ll be from the sam e ty pe of bloodline as w ill be used dur ing treatment.
OK Kommentare - 11
Level = Transmit =
OK Kommentare - 12
Batt =
11.4 P ress the lit
.
11.5 The calibra tion is now performed a utoma tically a nd t he calibrat ion fa ctor is w ritten into the EEP ROM. 11.6 The calibra tion va lue is now s hown on t he information display: R A E DY
LEVEL XX
T A R NSMIT YYY
Confirm
The value under LEVEL is the new a lar m limit, it is recommended tha t t his value is betw een 30 and 40 for best performa nce. The va lue under TRANSMIT is th e tra nsmission level, which is norma lly 255 but can a lso be 160, if th e air detector t ra nsducers a re exceptionally g ood.
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13. Cont rol of the blood pump occlusion Check surface on the roller a t the pump rotor, if it is da ma ged exchange t he unit. The roller unit should eas ily go back to upper end position wh en it ha s been pressed dow n to end position, exchange unit if it gets st uck in a ny position.
Note! If t he blood lines/infu sion lines h a ve a different w a ll thickness, the occlusion of th e blood pump must be a djusted to the right size. U se th e ga uge pins (stop/go) a va ilable in t he kit K40158001. The kit in cludes following t hr ee different ga uge pins: T = 1.1 (St op pin = 1.1*2*0.7 = 1.5mm) T = 1.6 (St op pin = 1.6*2*0.7 = 2.2mm) T = 2.0 (St op pin = 2.0*2*0.7 = 2.8mm)
The G O pin should bar ely pass w ithin t he ca librating area. The S TOP pin is NOT a llowed to pass in a ny point w ithin the calibrat ing area.
Note! P ut grease on the GO a nd STOP pins wh en not used and st ore ga ge in plastic bag to prevent it from corroding. Note! The ga uge pins can a lso be ordered separately: T= 1.1 (w hit e) K40158002 T= 1.6 mm (red) K 40158003 T= 2.0 mm (blue) K40158004
OK Kommentare - 13
T = wa ll thickness of the blood t ubing
U se following formula to calcula te w hich gage pin to use: 2 * wa ll thickness * 0,7 (mm) Check the r a nge betw een t he blood pump rollers a nd t he pat h a ccording to the picture below. Adjust ra nge betw een t he blood pump rollers a nd the pat h if it is necessary .
= Measuring
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14. En t er S ervice/Ca libr/B M a n d s et t h e AK 200 S /AK 200 UL TRA S displa y t o: PRESSURE SYSTEM
15. E nt er S ervice/Ca libr/B M a n d s e t t h e AK 200 S /AK 200 U LTRA S displa y t o: PRESSURE ARTERIAL
BM 1
14.1 P ress
BM 2
to sta rt calibrat ion routine. 15.1 P ress
14.2 Make sure tha t n othing is connected to the tra nsducer (zero pressure) 14.3 Check zero level of the System Pressure Transducer. Toleran ce: ± 5 mmHg. Ca librat e if necessary (see chapter calibra tion for deta ils).
OK Kommentare - 12
zero leve =
2:14
to sta rt calibrat ion routine.
15.2 Make sure tha t n othing is connected to the tra nsducer (zero pressure) 15.3 Check zero level of the Arteria l P ressur e Transducer. Toleran ce: ± 5 mmHg. Ca librat e if necessary (see cha pter calibrat ion for deta ils).
OK Kommentare - 15
zero level =
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16. E nt er Ser vice/Ca libr/B M a n d s e t t h e AK 200 S /AK 200 UL TRA S dis pla y t o:
17. E nt er Dia gnose/B M/P umps a nd check th a t th e blood pump(s) stops wh en t he cover is opened.
PRESSURE VENOUS BM 3
16.1 P ress
to sta rt calibrat ion routine.
16.2 Make sure tha t n othing is connected to the tr a nsdu cer (zero pressur e). 16.3 Check zero level of th e Venous P ressur e Transducer. Toleran ce: ± 5 mmHg. Ca librat e if necessary (see chapter calibra tion for deta ils).
18. St a rt t he blood pump(s) a nd let it run a t low est possible speed. Open th e blood pump cover a nd pla ce a ma gnet (1) on the sensor for the cover. S top th e blood pump rotor by ma nua lly grabbing th e hand le (2). Check tha t t he power t o the blood pump motor is swit ched off wit hin 2 seconds. 1
2
OK Kommentare - 16
zero level =
OK Kommentare - 17
OK Kommentare - 18
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19. E nt er S ervice/Ca libr/FM a n d s e t t h e AK 200 S /AK 200 UL TRA S displa y t o: DEGASSING
PRESSURE
20. E nt er S ervice/Ca libr/FM a n d s e t t h e AK 200 S /AK 200 U LTRA S displa y t o: FLOW OUTPUT PRESSURE
FM 7
19.1 P ress
to sta rt calibrat ion routine.
FM 8
20.1 P ress
to sta rt calibrat ion routine.
19.2 Disconnect a tu be to achieve zero pressur e (see pict ur e).
20.2 Disconnect a tu be to achieve zero pressure (see pict ur e).
19.3 Check zero level of the D ega ssing P ressur e Transducer. Toleran ce: ± 5 mmHg. Ca librat e if necessary (see chapter calibra tion for deta ils).
20.3 Check zero level of the Flow Out put P ressure Transducer. Toleran ce: ± 5 mmHg. Ca librat e if necessary (see cha pter calibrat ion for deta ils).
OK Kommentare - 19
Zero level =
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OK Kommentare - 23
Zero level =
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21. E nt er S ervice/Ca libr/FM a n d s e t t h e AK 200 S /AK 200 UL TRA S dis pla y t o:
22. E nt er S ervice/Ca libr/FM a n d s e t t h e AK 200 S /AK 200 UL TRA S displa y t o: HIGH PRESSURE GUARD
FLOW INPUT PRESSURE
FM 10
FM 9
21.1 P ress
to sta rt calibrat ion routine. 22.1 P ress
21.2 Disconnect a tu be to achieve zero pressure (see pictur e). 21.3 Check zero level of the Flow I nput P ressur e Transducer. Toleran ce: ± 5 mmHg. Ca librat e if necessary (see chapter calibra tion for deta ils).
OK Kommentare - 21
Zero level =
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to sta rt calibrat ion routine.
22.2 Disconnect a tu be to achieve zero pressur e (see pict ur e). 22.3 Check zero level of the High P ressur e G ua rd Tra nsducer. Toleran ce: ± 5 mmHg. Ca librat e if necessary (see chapter calibra tion for deta ils).
OK Kommentare - 22
Zero level =
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Base-kit
23. E nt er S ervice/Ca libr/FM a n d s e t t h e AK 200 S /AK 200 UL TRA S displa y t o:
24. E nt er S ervice/Ca libr/FM a n d s e t t h e AK 200 S /AK 200 U LTRA S displa y t o: SAFETY
DIALYSIS FLUID PRESSURE
GUARD
PRESSURE
FM 11
23.1 P ress
to sta rt calibrat ion routine.
FM 12
24.1 P ress
to sta rt calibrat ion routine.
23.2 Disconnect a tu be to achieve zero pressur e (see pict ur e).
24.2 Disconnect a tu be to achieve zero pressure (see pict ur e).
23.3 Check zero level of the Dia lysis F luid P ressure Transducer. Toleran ce: ± 5 mmHg. Ca librat e if necessary (see chapter calibra tion for deta ils).
24.3 Check zero level of the Sa fety G ua rd P ressure Transducer. Toleran ce: ± 5 mmHg. Ca librat e if necessary (see cha pter calibrat ion for deta ils).
OR
OK Kommentare - 23
Zero level =
2:18
OK Kommentare - 24
Zero level =
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25. If installed: Ca librat e the pH-sensor (FM 13) w ith a buffer solution. 26. Remove the blood leak detector cover and clean th e inside of th e blood lea k housing. Mount a blood lea k calibra tion cover. Make sure tha t t he filter is in horisont a l position, st a rt th e AK 200 S /AK 200 ULTRA S. En ter t he Service menu, select ca librat ion, FM, intern a nd B lood Lea k Detector (FM24). P lace A-pickup tu be in concentra te conta iner a nd let it sta bilise for 15 minut es.
Note! Let th e AK 200 S /AK 200 U LTRA S sta bilize a t 37° C
P ress
to enter the blood leak calibra -
tion routine. Ch eck th e blood leak det ector limit s 0 a nd 100 ± 10. Ca librat e if necessa ry (see cha pter calibrat ion for deta ils). 27. Check the wa ter level in the heat ing vessel, should be approximat ely 1cm a bove the centerline, adjust if necessary . OK Kommentare - 25
OK Kommentare - 26
OK Kommentare - 27
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28. Check the conductivity indicat ions, a t a pproxima t ely 14 mS /cm. Us e GXL – fluid monitor screen a nd a reference instrum ent connected t o the dia lysis fluid tubes. The indicated conductivity va lues in G XL should corr espond t o th e indica tion on the reference instrument. The ma ximum deviation is ± 0.1 mS/cm. 29. Check the temperat ure indicat ions, at a pproximat ely 37 °C . Us e GXL – fluid monitor screen a nd a reference instrum ent connected t o the dia lysis fluid tubes. The indica ted temperat ure value (a t t he conduct ivity cell 2, gua rd) should correspond to th e indica tion on the r eference instr ument. The maximum deviat ion is ± 1.5 °C. If the deviat ion is more than the sta ted tolera nce; the affected temperat ure tra nsducer m ust be exchanged. 30. P lace the B -pickup tube in t he concentr a te container. P erform a n FRN calibrat ion. Ent er service me nu /C a lib r/F M/Ot he r/U F /Res t r.
OK Kommentare - 28
OK Kommentare - 29
OK Kommentare - 30
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31. Let th e machine pass Fch. Check the DC leaka ge betw een TP 7 (Z0VL) on t he P ower distribution boa rd a nd the eart h point on the back plat e. Mea sure in DC Volta ge, should be < 1 V. 32. Ch eck th e DC lea ka ge betw een TP 7 (Z0VL) on t he P ower distribution board a nd t he cover on the D egass pump motor. Measur e in DC Volta ge, should be < 1 V. 33. Ch eck th e DC lea ka ge betw een TP 7 (Z0VL) on t he P ower distribution board a nd t he Degass pump hea d. Mea sure in DC Volta ge, should be < 1 V. 34. Ch eck th e DC lea ka ge betw een TP 7 (Z0VL) on t he P ower distribution board a nd t he cover on the Flow Out pump motor. Measur e in DC Volta ge, should be < 1 V.
Base-kit
38. If ULTRA: Ca librat ion of interna l pressure regulator.
38.1 P ress
a nd set the ma in flow to
500 m l/m in .
38.2 Ch oose
38.3 P ress
or
.
a nd sw itch to
.
38.4 Connect t he dia lyzer coupling t o the condu ctivity cell on t he reference instrument . 38.5 Adjust venous pressure to + 100 mmH g a nd TMP to + 400 mmHg.
35. Ch eck th e DC lea ka ge betw een TP 7 (Z0VL) on the P ower distribution board a nd the Flow Out pump head. Measur e in DC Volta ge, should be < 1 V.
38.6 Connect a tub e betw een the infusion port a nd a n external pressure reference instr ument.
36. Ch eck th e DC lea ka ge betw een TP 7 (Z0VL) on t he P ower distribution board a nd t he cover on the Flow I n pump motor. Measure in DC Volta ge, should be < 1 V.
38.7 P ress
37. Ch eck th e DC lea ka ge betw een TP 7 (Z0VL) on the P ower distribution board a nd the Flow In pump head. Measu re in DC Volta ge, should be < 1 V. OK Kommentare - 31
OK Kommentare - 32
OK Kommentare - 33
to obta in ma in flow thr ough the
pressure regula tor. 38.8 Adjust t he pressure regula tor to + 55 m m H g ± 5 m m H g .
38.9 P ress
a nd remove th e reference
instrument and t ube.
OK Kommentare - 37
OK Kommentare 38
OK Kommentare - 34
OK Kommentare - 35
OK Kommentare - 36
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39. Perform a simulat ed treat ment a ccording to follow ing instr uction:
· If the B VS is insta lled, switch it on. · The ma chine must be in volume cont rol. · Insert a filled venous drip cha mber in the level detector. · When th e priming butt on is flash ing, simulate a venous pressure of approximat ely 50 mmH g. · (Ins ert th e B VS t est tool, K22281001). · Set t he UF -volume to 0.9 and trea tment TIME t o 1:00h. · Connect a T-piece to the dia lysis t ubings. P ut the end of the tube in a m easuring gla ss filled wit h more tha n 1 liter of wa ter, approx. 37 °C . · P ress fluid bypass. Check tha t t he tube to the meassuring glass is filled with wa ter a nd a ll a ir bubbles a re evacua ted. · S et t he blood pump s peed to 200 ml/min , press the priming button a nd sta rt t he blood pump. · P ress UF -rat e and set priming UF r at e and minimu m U F-ra te t o 0.0 l/h. · Ma ke sure the mea suring gla ss is filled t o 1.00 liter a djust if necessa ry.
· Check the residual volume at TIME = 0:00 · Approved r esidua l volume: 100 ml ± 50 ml. · Approved difference betw een actu a l U F volume and U F Supervision volume is 120 ml. · The B VS test t ool simula tes a hemoglobin va lue wit hin t he ra nge 60 – 160 g/l. When inserted into t he B VS unit it is possible to check the switch, tha t a reference va lue is ta ken a nd tha t a graph is shown on the informa tion display w hen the B VS key is pressed. The va lue for relat ive blood volume w ill be a pprox. 0 %with some deviat ions. Do note tha t t he blood flow must be more tha n 180 ml/ min for 5 minut es before a reference value is taken.
OK Kommentare - 39
Note! It is very importa nt to do the following things (A,B a nd C ) more or less simultan eously i.e. within seconds. A: Simula te blood in th e priming detector. B : Make sure (aga in) tha t t he mea suring glass is filled t o 1.0 liter. C: P ress
.
D: P ress TMP when U F ra te is approxima tely at set va lue (check bar gra ph).
Note! Ma ke sure tha t t he blood pump is not stopped by a ny a lar m during this test since this ma y affect the a ccumula ted UF volume. All kind of fluid ala rms (conduct ivity et c.) ha ve to be avoided.
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OK Kommentare - 25
40. Check tha t the overloa d protection on the heparin pump is w orking. 41. Check the a rterial clam p by at ta ching the calibrat ion tube set into the a rteria l clam p. En ter priming mode a nd create a level detector a la rm t o get t he cla mp closed. Apply a pressure of 600 mmHg. Ch eck tha t t he pressure does not fall more tha n 30 mmHg in 15 second s. 42. Check the venous clamp by a tt a ching the calibrat ion tu be set int o the venous clamp. En ter priming mode a nd creat e a level detector alarm, by lowering the level in the drip cha mber, to get t he clamp closed. Apply a pressur e of 600 mmH g. Check tha t t he pressure does not fall more tha n 30 mmHg in 15 seconds. 43. If installed: Check the batt ery backup by disconnecting the ma ins plug. Let t he ma chine run for at least 1 minute.
Note! This is not a capa city test of the backup bat teries. Instructions how t o perform a capacity t est of the backup-ba tt eries, refer t o cha pter Ca librat ion in AK 200 S / AK 200 ULTRA S Ser vice Ma nua l.
OK Kommentare - 41
OK Kommentare - 42
OK Kommentare - 43
OK Kommentare - 44
44. Reconnect t he ma ins plug to th e out let supply of an electrica l sa fety t ester. P erform t he Ea rth Leaka ge Test (EL T) a nd the P a tient Ea rth L eaka ge Test (P LT) a ccording t o instr uctions a va ilable in HC E N12190, Electrical sa fety inspections for AK-machines.
OK Kommentare - 45
45. P erform h eat /chemical d isinfection.
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A-kit
Maintenance Manual
Preventive Maintenance: Supplementary A-kit Parts The A-kit is designed t o be used a s a complementa ry a ddition to the B a se-kit for the preventive ma intena nce procedures of AK 200 S a nd AK 200 UL TRA S. The A-kit (K40166001) includes follow ing exter ior parts: Step 1 2 3 3,4 4 4 4 4 5 6
Monitor FM FM FM FM FM FM FM FM FM FM
Denomination Pick-up tube (red) Pick-up tube (blue-white) Dialyser connector set (blue) Locking ring (Dialyser connector) Dialyser connector set (red) Conical filter O-ring for conical filter Nipple Non-return valve Washer, blood pump rotor
Part no. K13467002 K13467001 K14082002 K22591001 K14081002 L50824001 100319046 K13736001 K17978001
Qty 1 1 1 2 1 1 1 1 1
K07316001
4
Note! All par ts in th e A-kit a re possible to excha nge wit hout opening the dialysis ma chine.
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A-kit
How to exchange the exterior parts included in the A-kit 1. Ch a nge the pick-up tube A (red).
4. Cha nge the dialyser connector set red, locking rin g, nipple, conica l filter a nd O-ring.
5 mm
OK Kommentare - 1
2. Ch a nge the pick-up tube B (blue-w hite).
OK Kommentare - 2
3. Cha nge the dialyser connector set blue a nd the locking ring.
OK Kommentare - 4
5. Cha nge the non-return valve on the wa ter inlet tube.
OK Kommentare - 5
6. Add/cha nge t he w a shers for th e blood pump rotors.
5 mm
OK Kommentare - 3
2:24
OK Kommentare - 6
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Actions to carry out after the parts have been exchanged 1. First perform a heat disinfection program. Refer t o th e AK 200 S or AK 200 ULTRA S Opera tor’s Ma nua l.
U se following formula to calcula te w hich gage pin to use: 2 * wa ll thickness * 0,7 (mm)
2. After the heat disinfection; re-tight en the nuts of the dialyser connector set to the ma chine.
Check the range between the blood pump rollers a nd th e pa th a ccording to the picture below.
ut
5 mm
= Measuring
3. L e t t h e m a c h in e pa s s F C H . A leaka ge test of th e dialyser connector set is peformed in st a te 24.
Adjust ra nge between t he blood pump rollers a nd the pat h if it is necessary . The G O pin should bar ely pass w ithin t he ca librating area.
4. Cont rol of the blood pump occlusion Check surface on the roller a t the pump rotor, if it is da ma ged exchange t he unit. The roller unit should ea sily go back to upper end position w hen it ha s been pressed dow n t o end position, exchange unit if it gets st uck in a ny position.
Note! If th e blood lines/infu sion lines h a ve a different w a ll thickness, the occlusion of th e blood pump must be a djusted to the right size. U se th e ga uge pins (stop/go) a va ilable in t he kit K40158001. The kit in cludes following t hr ee different ga uge pins: T = 1.1 (St op pin = 1.1*2*0.7 = 1.5mm) T = 1.6 (St op pin = 1.6*2*0.7 = 2.2mm) T = 2.0 (St op pin = 2.0*2*0.7 = 2.8mm)
The S TOP pin is NOT allowed to pass in a ny point w ithin the calibrat ing area.
Note! P ut grease on the GO a nd STOP pins wh en not used and st ore ga ge in plastic bag to prevent it from corroding. Note! The ga uge pins can a lso be ordered separately: T= 1.1 (w hit e) K 40158002 T= 1.6 mm (red) K 40158003 T= 2.0 mm (blue) K40158004 OK Kommentare
OK Kommentare - 2
T = wa ll thickness of th e blood tubing OK Kommentare - 3
OK Kommentare - 4
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B-kit
Preventive Maintenance: Supplementary B-kit Parts The B -kit is design ed to be used a s a complementa ry a ddition to the B a se-kit for the preventive ma int ena nce procedur es of AK 200 S a nd AK 200 UL TRA S. The B -kit (K40167001) includ es followin g overhaul part s: Step
Monitor
1
FM
2
FM
3 4 4 5 6 7 8 9
FM FM FM FM BM BM BM BM BM
9
2:26
Denomination Spike kit BiCart- and SelectCart holder (PEEK lower) Complete valves: FOVA, DIVA, TAVA, BYVA, DRVA BCVA, TPVA, PBVA Recirculation valve (complete) Silicon tube (3x2mm) Silicone tube 2x1,5 Santoprene tube Venous pressure line (complete) Arterial pressure line (complete) System pressure line (complete) Pump tube (air pumps) Strap (air pumps)
Part no.
Qty
K21557006
2
K15235A
8
K15514002 100312032 100312166 100312141 K21353A K15145001 K21358A K22114001 100314015
1 7m 1m 2m 1 1 1 3 3
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Maintenance Manual
How to exchange the parts included in the B-kit 1. Cha nge th e low er complete spike house an d O-rings in the BiCa rt a nd SelectC a rt holder. Assemble according t o ma chine configura tion.
OK Kommentare
OK Kommentare
2. Cha nge following complete va lves: F OVA, D I VA, TAVA, B YVA, D RVA, B C VA,TP VA a nd P B VA.
3. Ch a nge complete Recircula tion va lve.
OK Kommentare
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5. Cha nge all the Sa ntoprene tubes in the fluid monitor.
OK Kommentare
OK Kommentare
AK 200 S /AK 200 ULTRA S H
4. Cha nge all the Silicone tubes in the fluid monitor.
6. Cha nge t he (complete) venous press ure line.
OK Kommentare
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B-kit
7. Ch a nge the (complete) a rt eria l pressure line.
OK Kommentare
8. Cha nge th e (complete) syst em pressure line.
OK Kommentare
9. Cha nge the pump tubes for the a ir pumps. Clea n t he rollers w ith etha nol (70 %).
OK Kommentare
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B-kit
Actions to carry out after the parts have been exchanged 1. First perform a heat disinfection progra m. Refer t o th e AK 200 S or AK 200 ULTRA S Opera tor’s Ma nua l.
OK Kommentare
OK Kommentare
2. L et t h e m a c h in e pa s s F C H . 3. P erform a BiCa rt /SelectCart priming a ccording to the Operat or’s Ma nua l.
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OK Kommentare
2:29