2008 Spare Parts Manual Rev E

2008®Series Hemodialysis Spare Parts Manual This document contains proprietary information of Fresenius USA, Inc. d/b/a Fresenius Medical Care North America and its affiliates (“Fresenius Medical Care”). The contents of this manual may not be disclosed to third parties, copied, or duplicated in any form, in whole or in part, without the prior written permission of Fresenius USA, Inc. Fresenius Medical Care, the triangle logo, 2008, bibag and Diasafe are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies. All other trademarks are the property of their respective owners. The 2008K, 2008K2, 2008K@home™, & 2008T machines constitute the 2008® Series Hemodialysis Machines. In this manual the 2008K, 2008K2 & 2008K@home™ hemodialysis machines may be referred to as “2008K Series”. Caution: US Federal Law restricts this device to sale by or on the order of a physician. As part of the Conditions for Coverage, it is the medical director’s responsibility that the operators of the Fresenius Medical Care 2008® Series hemodialysis machines, bibag and Diasafe® must be trained in its operation and thoroughly familiar, being able to distinguish between normal and abnormal operation. Assembly, installation, adjustment, or repair is to be performed only by persons authorized by the facility medical director or by Fresenius USA, Inc. Field Service Bulletins, and other documentation is located on the Internet at http://www.fmcna.com.

For further information regarding the operation, repair, parts, or maintenance of the Fresenius Medical Care 2008® Series hemodialysis machines, please contact: Fresenius USA, Inc. 4040 Nelson Avenue Concord, CA 94520

(800) 227-2572

General Warnings Warning! Never perform maintenance when a patient is connected to the machine. If possible, remove the machine from the treatment area when it is being serviced. Label the machine to ensure it is not accidentally returned to clinical use before the service work is completed. Always fully test the machine when maintenance is completed. Confirm dialysate conductivity and pH level before returning the machine to clinical use. Shock Hazard: Refer servicing to qualified personnel. The electrical source must be 120 volts, 60 Hz, single phase. The outlet must be a three-conductor type with a hospital-grade receptacle and a ground fault interrupter. Test the polarity and ground integrity before installation and ensure it is maintained thereafter. Failure to do so may result in electrical shock to the operator or patient Warning! Only Original Equipment Manufacturer (OEM) Fresenius Medical Care parts should be used in the repair or upgrade of the Fresenius Medical Care 2008 Series Hemodialysis System. Although, parts may look similar to parts in various vendor catalogs or brick and mortar stores the 2008 Series Hemodialysis System uses parts that have been specified and tested in accordance to ANSI/AAMI/ISO guidelines. The use of nonOEM parts will void your warranty and may cause patient harm.

Helpful Info

To order a spare part: If the part number is known call: 800-227-2572 – Option 3 – Spare Parts Department to place the order. If the part number is not known, first look in this manual. If unable to find call: 800-227-2572 – Option 4, then Option 1 – Technical Support to obtain the desired part number. Technical documentation update notifications are available via email. To subscribe go to: http://www.fmcna.com

TABLE OF CONTENTS (continued) 5.0.0 5.1.0 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 6.0.0 6.1.0 6.1.1 6.2.0 6.2.1 6.3.0 6.4.0 6.5.0 7.0.0 7.1.0 7.1.1 7.1.2 7.2.0 7.2.1 7.3.0 7.4.0 7.5.0 7.6.0 7.7.0 7.8.0 7.9.0 7.10.0 7.11.0 7.12.0 7.13.0 7.14.0 7.15.0 7.16.0 7.17.0 8.0.0 8.1.0 8.2.0 8.3.0 8.4.0 8.5.0 8.6.0

ii

POWER SUPPLY ...61 POWER SUPPLY ASSEMBLY ...63 POWER SUPPLY, DETAIL A ...65 POWER SUPPLY, DETAIL B ...67 POWER SUPPLY, DETAIL C ...69 POWER SUPPLY, DETAIL D ...71 POWER SUPPLY, DETAILS E & F ...73 MODULES ...75 LEVEL DETECTOR MODULE - FRONT VIEW ...77 LEVEL DETECTOR MODULE - REAR VIEW ...79 ARTERIAL BLOOD PUMP - FRONT VIEW ...81 ARTERIAL BLOOD PUMP - REAR VIEW ...83 DIGITAL HEPARIN PUMP ...85 BLOOD TEMPERATURE MODULE (BTM) & BLOOD VOLUME MODULE (BVM) ...87 BLOOD PRESSURE MODULE ...89 HYDRAULIC ASSEMBLY ...91 HYDRAULIC ASSEMBLY - FRONT VIEW ...93 HYDRAULIC ASSEMBLY - REAR VIEW ...95 HYDRAULIC ASSEMBLY - TOP VIEW ...97 HYDRAULIC FRONT PANEL ASSEMBLY ...99 HYDRAULICS REAR PANEL ASSEMBLY ...101 DISTRIBUTION BOX ASSEMBLY ...103 HYDROCHAMBER ASSEMBLY ...105 BALANCING CHAMBER ASSEMBLY ...107 AIR SEPARATOR ASSEMBLY...109 FLOW/DEAERATION PUMP ASSEMBLY ...111 CONCENTRATE (ACID) CONNECTOR ...113 BICARBONATE CONNECTOR ...115 CONCENTRATE PUMP ASSEMBLY...117 BICARBONATE PUMP ASSEMBLY ...119 ULTRAFILTRATION PUMP ASSEMBLY ...121 DIASAFE® PLUS FILTER ASSEMBLY ...123 O-RINGS ...125 CLAMPS AND FITTINGS ...127 TUBING ...129 ONLINE CLEARANCE (OLC) ...130 BIBAG ...131 BIBAG CONNECTOR ...132 BIBAG HYDRAULICS...133 BIBAG HYDRAULICS – DISTRIBUTION BOX ...134 BIBAG – VALVE 108 ...135 BIBAG – TUBING ...136 BIBAG – INTERFACE BOARD & MISCELLANEOUS ITEMS ...137

2008 Series Hemodialysis Machine Spare Parts Manual P/N 490124 Rev. E

TABLE OF CONTENTS (continued) 9.0.0

WETNESS DETECTOR ...138

9.1.0

WETNESS DETECTOR ...139

10.0.0

CONCENTRATE FEED SYSTEM ...141

10.1.0 10.1.1 10.1.2 10.1.3 11.0.0 11.1.0 11.2.0 11.2.1 11.3.0 11.3.1 11.4.0 11.5.0

CONCENTRATE CANISTERS & WANDS...143 ACETIC ACID (VINEGAR) KIT ...145 DISINFECTION KIT ...145 MISCELLANEOUS ...147 TEST EQUIPMENT & KITS ...149 CALIBRATION & TEST EQUIPMENT ...151 FRESENIUS MEDICAL CARE TEST KIT, DETAIL A ...153 FRESENIUS MEDICAL CARE TEST KIT, DETAIL B...155 PREVENTIVE MAINTENANCE KIT - 2008K SERIES...156 PREVENTIVE MAINTENANCE KIT – 2008T ...157 INTEGRATED AUTO DISINFECT (IAD) KIT ...158 ELECTROSTATIC DISCHARGE KIT (ESD) KIT ...158

2008 Series Hemodialysis Machine Spare Parts Manual P/N 490124 Rev. E

iii

STATEMENT: MINIMUM TESTABLE ASSEMBLIES Some assemblies in the 2008 Series machine can only be sold complete. These assemblies are 100% tested and are assigned an identification number by Fresenius Medical Care Quality Control. These "Minimum Testable Assemblies" are: FOR THE 2008K MACHINE PART NUMBER DESCRIPTION 675142 GEAR PUMP HEAD M39184 BLOOD LEAK DETECTOR 190163 FRONT PANEL INTERFACE BOARD 190164 MUTE/RESET BOARD 190165 POWER LED BOARD 190332 SENSOR BOARD 190232 MOTHER BOARD 190193-339 FUNCTIONAL BOARD 190205-04 COLOR LCD 669983-Q TEST BOARD 190246 POWER LOGIC BOARD (W/ -12V) 190234-227 ACTUATOR-TEST BOARD Note: • Reworked circuit board part numbers are the above numbers with an ‘R’ prefix. e.g. a reworked 190246 is R190246. FOR THE 2008K2 MACHINE PART NUMBER DESCRIPTION 675142 GEAR PUMP HEAD M39184 BLOOD LEAK DETECTOR 190605 FRONT PANEL INTERFACE BOARD 190164 MUTE/RESET BOARD 190165 POWER LED BOARD 190332 SENSOR BOARD 190232 MOTHER BOARD 190642-526 FUNCTIONAL BOARD 190642-540 FUNCTIONAL BOARD 190205-04 COLOR LCD 190246 POWER LOGIC BOARD 190234-227 ACTUATOR-TEST BOARD 190234-231 ACTUATOR-TEST BOARD Note: • Reworked circuit board part numbers are the above numbers with an ‘R’ prefix. e.g. a reworked 190246 is R190246.

iv

2008 Series Hemodialysis Machine Spare Parts Manual P/N 490124 Rev. E

STATEMENT: MINIMUM TESTABLE ASSEMBLIES-CONTINUED FOR THE 2008T MACHINE PART NUMBER DESCRIPTION 675142 GEAR PUMP HEAD M39184 BLOOD LEAK DETECTOR 190246 POWER LOGIC BOARD 190234-227 ACTUATOR-TEST BOARD 190681 UI/MICS BOARD 190681-01 UI/MICS BOARD W/PC 190332 SENSOR BOARD 190500 MOTHER BOARD 190654-261 FUNCTIONAL BOARD 190856 KEYBOARD ASSEMBLY 190561 TOUCHPAD ASSEMBLY Note: • Reworked circuit board part numbers are the above numbers with an ‘R’ prefix. e.g. a reworked 190246 is R190246. FOR THE 2008K@HOME MACHINE PART NUMBER DESCRIPTION 675142 GEAR PUMP HEAD M39184 BLOOD LEAK DETECTOR 190389 FRONT PANEL INTERFACE BOARD 190387 MUTE/RESET BOARD 190332 SENSOR BOARD 190232 MOTHER BOARD 190818-436 FUNCTIONAL BOARD 190205-04 COLOR LCD 669983-Q TEST BOARD 190246 POWER LOGIC BOARD (w/ -12V) 190234-227 ACTUATOR-TEST BOARD Note: • Reworked circuit board part numbers are the above numbers with an ‘R’ prefix. e.g. a reworked 190246 is R190246.

2008 Series Hemodialysis Machine Spare Parts Manual P/N 490124 Rev. E

v

22

1

12

70

3 13

2

TYP. 4 PLCS

5

20

30

24 9

7 4

73 TYP 2 PLCS.

74

13 29 TYP 2 PLCS. 20

75

76

See Section 1.4.0

CABINET WITH ACCESSORIES 2

2008 Series Hemodialysis Machine Spare Parts Manual P/N 490124 Rev. E

1.2.0

CABINET, REAR, WITH ACCESSORIES

SEQ.

PART NUMBER

2 3 4 4A 7 9 14 20 21 22 23 26 27 28 29 31 32 33 36 37 40 43 43A 44 44A 45 46 47 48 51 52 53

190011 190247 190380 290170 190047 290056 450113 190124 539148-Q 670658-Q 552234 642697 552339 552345 553693 330606-03-01 330606-05-01 330937-04-01 572604 579066 642925 M31268 M31175 M30656 M31355 677971 M30340 553315 644091 290069 330904-01 562296

DESCRIPTION ASSEMBLY, POWER SUPPLY ASSEMBLY, CABINET, (w/Wheels, w/o: Shunt, IV Pole Support) (2008K & 2008K2) ASSEMBLY, CABINET, 2008K@HOME (w/Wheels, w/o Shunt, w/o IV Pole Support) CABINET PAINTED, NO WHEELS (2008K@HOME) MAIN POWER CABLE (24V) – POWER SUPPLY to MOTHER BOARD CLAMP, RETAINING STRAP LABEL, FLAMMABLE ANESTHETICS CABLE, DIGITAL HEPARIN PUMP CABLE, 20 PIN RIBBON, 28" – PWR SUPPLY TO PWR LOGIC BRD. CABLE 10 PIN (BLOOD PUMP TO FUNCTION BOARD – P10) SCREW, SHCS M8X45, S.S. SCREW, FHD PHIL, M5X16, S.S. SCREW, PNHD PHIL, M6X20, S.S. SCREW, PNHD PHIL, M6X35, S.S. WASHER, FLAT, 4.3mm, S.S. WASHER, #8 SPLIT LOCK WASHER, 1/4" SPLIT LOCK LOCKWASHER, SPLIT 5/16" SS BUSHING, GREY FRONT HYD. SCREW O-RING, 24-1 (IV POLE) WASHER, FLAT OVERSIZED, 6.4mm, S.S. ARTERIAL PLATE, TUBING ORGANIZER BLANK MODULE PLATE ARTERIAL BLOOD PUMP MODULE DRIP CHAMBER CLIP, ROSE GREY* DIGITAL HEPARIN PUMP MODULE LEVEL DETECTOR MODULE SCREW, SHCS, M6X16, S.S. SCREW, SELF-LOCKING PHIL, M4X8, S.S. HYDRAULIC HOOK BRACKET THREADED INSERT, M-5 THREADED INSERT M4X0.7

*ITEM NOT ILLUSTRATED.

2008 Series Hemodialysis Machine Spare Parts Manual P/N 490124 Rev. E

5

2.0.0

CABINET 2008T

NOTE: Many cabinet components are the same between the 2008K Series machines and the 2008T machine, however, there are differences. If you do not find the desired 2008T cabinet component in this section, refer to the corresponding 2008K Series section.

2008 Series Hemodialysis Machine Spare Parts Manual P/N 490124 Rev. E

23

3.6.0

MONITOR ASSEMBLY & CIRCUIT BOARDS (2008K, 2008K2, 2008K@HOME)

SEQ.

PART NUMBER

DESCRIPTION

POWER LOGIC BOARD 1

190246

ASSEMBLY, POWER LOGIC BOARD (W/-12 VOLTS)

1A

641566

FUSE 2.5A – USED ON ITEM 1

1B

539148-Q

POWER LOGIC CABLE (X2) – GOES TO POWER CONTROL BOARD*

2 2A

190234-227 190234-231

ASSEMBLY, ACTUATOR-TEST BOARD – (VER. 2.27 FOR 2008K, 2008K2 & 2008K@HOME) ASSEMBLY, ACTUATOR-TEST BOARD – (VER. 2.31 FOR 2008K2)

3 3A 3B 3C 3D

190193-339 190642-526 190642-540 190818-436 362637-07

FUNCTIONAL BOARD – 2008K - (VER. 3.39) FUNCTIONAL BOARD – 2008K2 - (VER. 5.26) FUNCTIONAL BOARD – 2008K2 - (VER. 5.40) FUNCTIONAL BOARD – 2008K @HOME - (VER. 4.36) BATT PACK, SRAM – USED ON ITEMS 3, 3A,3B, &3C*

3E

190244-01

EEPROM, PROGRAMMED, NON OLC*

3F

190244-02

EEPROM, PROGRAMMED, OLC*

4

190332

ASSEMBLY, SENSOR BOARD

5

190232

ASSEMBLY, MOTHERBOARD

6

190005

ACTUATOR CABLE

7

190006

SENSOR CABLE

ACTUATOR/TEST BOARD

FUNCTIONAL BOARD

SOFTWARE COMPATIBLILTY Function Act/Test 2008K** 3.39 2.27 2008K2 5.26 2.27 2008K2 5.40 5.31 2008K@Home** 4.36 2.27

Act 5.35 N/A N/A 5.35

** Will have either Act/Test board or Actuator board, but not both

TEST BOARD 8

669983-Q

ASSEMBLY, LP545, TEST BOARD*

8A

190276

TEST BOARD SOFTWARE* - 2008K (SPECIFY VER. 1.17)

8B

190276-01

2008K@HOME – TEST BOARD SOFTWARE* (NO NEED TO SPECIFY VER)

9

190099

ASSEMBLY, -12 DC/DC CONVERTER BOARD* (PLUGS INTO TEST CONN., NO CABLE REQ'D)

11

640268

PCB GUIDE W/SCREWS

11A

552243

SCREW, M3 X 6 SS PAN HD PHIL, PCB GUIDE*

12

190047

MAIN POWER CABLE (FROM POWER SUPPLY)*

13

368208-03

CONNECTOR, 20-PIN DUMMY PLUG *

NOTE: Reworked circuit board part numbers are the above circuit board numbers with an ‘R’ prefix. e.g. 190246 reworked would be R190246. Potential Calibration Loss: Replacement Functional boards do not ship with an IC20 (EEPROM) installed. IC20 stores all machine calibrations. Before returning the old Functional board to Fresenius Medical Care, IC20 must be removed. Failure to remove IC20 will result in the loss of all calibrations and the need to purchase a new IC20. Full calibration of machine will then be required.

*ITEM NOT ILLUSTRATED.

2008 Series Hemodialysis Machine Spare Parts Manual P/N 490124 Rev. E

45

MANUFACTURED BY: FRESENIUS USA CONCORD, CA 94520 USA

WARNING! DO NOT CONNECT TO AN A.C. POWERED USB DEVICE

SPARE 1

RS 232

PEM

HOUR METER

HOURS

ETHERNET

SPARE 2

BATTERY

6 SPARE 3

SPARE 4

WITH RESPECT TO ELECTRICAL SHOCK,

MEDICAL ELECTRICAL EQUIPMENT

FIRE AND MECHANICAL HAZARDS ONLY

IN ACCORDANCE WITH:

PRESSURE

BLOOD

UL60601-1, 1st Edition, 2006-04-26 CAN/CSA-C22.2 No. 601.1-M90 (2005) IEC 60601-2-16

MFG. Date:

ARTERIAL

15 24V POWER

PEM

PEM

7

BLOOD PUMPS VENOUS

LIFT TO WITHDRAW

2 4 5 HEPARIN

12

8 14

Contains Wireless Module FCC ID: RYK-WUBR507N IC: 6158A-WUBR507N

10 TIMS

13

P/N 490194 REV

LEVEL DETECTOR

2008 Series Hemodialysis Machine Spare Parts Manual P/N 490124 Rev. E

52

~

SHUNT

9

1

11

3

2008T MONITOR CHASSIS, REAR PANEL, REAR VIEW (OUTSIDE)

PEM PEM

PEM

4.4.0

MONITOR ASSEMBLY & CIRCUIT BOARDS (2008T)

SEQ.

PART NUMBER

DESCRIPTION

1

190246

POWER LOGIC BOARD W/-12V

1A

641566

FUSE, 2.5 AMP* – USED ON ITEM 1

2

190234-227

ACTUATOR-TEST (VER. 2.27)

3

190654-261

FUNCTIONAL BOARD (VER. 2.61)

3A

362637-07

BATT PACK, SRAM*

3B

190244-08

EEPROM, PROGRAMMED – (WITH TOUCHSCREEN)*

3C

190244-07

EEPROM, PROGRAMMED, 2008T, OLC, NO CDX*

4

190681-01

UI/MICS BOARD WITH PC

4A

190681

UI/MICS BOARD W/O CDX

4B

190731

COMPACT FLASH CARD W/OS*

4C

360001-07

LITHIUM 3V BATTERY*

4E

190859

CDX UPGRADE KIT*

5

190332

SENSOR BOARD

6

190500

MOTHERBOARD

7

190005

ACTUATOR CABLE

8

190006

SENSOR CABLE

9

190070

CABLE, FUNCT. FDS08 (P6 TO RS232)

10

670658-Q

CABLE, SERIAL COMMUNICATION (FUNCT. – P10 TO BLOOD PUMP)*

11

190861-01

BIBAG INTERFACE BOARD WITH SOFTWARE*

12

190600

2008T VOLTAGE EXTENDER BOARD*

NOTE: • Reworked circuit board part numbers are the above circuit board part numbers with an ‘R’ prefix. e.g 190654-258 reworked would be R190654-258. • *ITEM NOT ILLUSTRATED. Potential Calibration Loss: Replacement Functional boards do not ship with an IC20 (EEPROM) installed. IC20 stores all machine calibrations. Before returning the old Functional board to Fresenius Medical Care, IC20 must be removed. Failure to remove IC20 will result in the loss of all calibrations and the need to purchase a new IC20. Full calibration of machine will then be required.

2008 Series Hemodialysis Machine Spare Parts Manual P/N 490124 Rev. E

57

5.0.0

POWER SUPPLY

NOTE: Power Supply is the same for all the 2008 Series machines.

2008 Series Hemodialysis Machine Spare Parts Manual P/N 490124 Rev. E

61

37 43

MONITOR CHASSIS GROUND (ADDED UPON INSTALLATION INTO MACHINE).

37 43

HEATER CABLE GROUND LUG

37 43

38

CAPACITOR GROUND LUG 42

37

43 TRANSFORMER

POWER CORD GROUND LUG CHASSIS

37 43

CHASSIS

36

Detail E Transformer Mounting Detail

Detail F Ground Lug Detail

POWER SUPPLY

72

2008 Series Hemodialysis Machine Spare Parts Manual P/N 490124 Rev. E

To vent

Vent

27 28

16

16 A

19 19A

Glass Deaeration Orifice located inside this tube

NOTE: The hydrochamber complete (tested) (P/N: M33974) includes everything except the hydrochamber mounting bracket (P/N: M46428) and mounting screws (P/N: 644091). If replacing an older style hydroblock, these items must be ordered separately. 104

2008 Series Hemodialysis Machine Spare Parts Manual P/N 490124 Rev. E

1

2

3

4

641362* 3.5mm I.D. 1.5mm WALL

579070* 3.5mm I.D. 1.5mm WALL

641759 4.47mm I.D. 1.78mm WALL

579072 6mm I.D. 1.5mm WALL

6

7

579058 9mm I.D. 1.5mm WALL

671079 12.42mm I.D. 1.78mm WALL

5

8

640919 8mm I.D. 2mm WALL

8A

579097 M42674 12.5mm I.D. 12.37mm I.D. 2.75mm WALL 2.62mm WALL

9

10

11

12

13

579092 13mm I.D. 1.5mm WALL

M34924 15.6mm I.D. 1.78mm WALL

579075 17.17mm I.D. 1.78mm WALL

M34925 20.35mm I.D. 1.78mm WALL

579066 24mm I.D. 1mm WALL

14

M34990 32mm I.D. 2mm WALL

15

16

640123 36mm I.D. 4mm WALL

646835 38mm I.D. 2.5mm WALL

* Items 1 & 2 have the same dimensions, but not the same durometer (hardness). NOTE: Not to scale.

O-RINGS

124

2008 Series Hemodialysis Machine Spare Parts Manual P/N 490124 Rev. E

1

3

2 YS6

674649 6 X 4 X 6mm T

332024-02 HOSE CONNECTOR WITH SEAL

674650 6-7mm Y

4

6

5

332145-01 3/16 X 1/4

332141-01 3/16 X 3/16

674648 6 mm T

SNP

SN

P2

8

7

670911 4mm x 4mm

M38033 1/4 x 3/16

9

10

336015-03 SNP-G2

670574 SNP-G4

4

SN

P6

11 670780 SNP-G6

13

12

641640 6.6mm I.D.

14

15

572727 8.7mm I.D.

M42892

642428

Wire Clamps

16

17

673013 - Black 11.9mm ID 673132 - Silver 12.8mm ID M05717 - Black 14.0mm ID

338016-01 7/32" X 5/8" Note: Not to Scale

CLAMPS AND FITTINGS 126

2008 Series Hemodialysis Machine Spare Parts Manual P/N 490124 Rev. E

8.0.0

2

1

BIBAG

3

5

4

†NOTE: The bibag feature and related spare parts are for use on 2008T/2008K@home machines only. 2008 Series Hemodialysis Machine Spare Parts Manual P/N 490124 Rev. E

131