Fresenius Medical Care 5008 Service Manual
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Fresenius Medical Care 5008 Service Manual

Hemodialysis system
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Service Manual
Hemodialysis System
5008
Edition: 1/08.04
Part number: M35 179 1
0123
Fresenius Medical Care

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Summary of Contents for Fresenius Medical Care 5008

  • Page 1 Service Manual Hemodialysis System 5008 Edition: 1/08.04 Part number: M35 179 1 0123 Fresenius Medical Care...

  • Page 3: Table Of Contents

    TSC / TMC / Maintenance Important Information ....................... 6-1 Test Report – Technical Safety Checks, Technical Measurements Checks and Maintenance Procedures6-3 Explanations on Technical Safety Checks, Technical Measurement Checks and Maintenance Procedures6-11 TSC / TMC Report ........................6-27 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 4 11.3 Monitor............................11-4 11.4 EBM (Extracorporeal Blood Module) ..................11-6 11.5 Hydraulics Unit ........................11-8 11.6 Power Supply Unit ......................... 11-10 11.7 Pneumatic Unit........................11-12 11.8 Hydraulics Unit ........................11-14 12 Service Program (Option) Fresenius Medical Care 5008 SM 1/08.04...
  • Page 5 Alarm processing AutoFlow Temperature Blood pump 5-10 Ultrafiltration 5-11 User interface Concentrates DIASAFE®plus EcoFlow Emergency External connections 11-14 Flow diagram Heparin pump 3-9, 5-9 ONLINEplus™ Operating programs Operator Setup Optical detector Override conditions Patient card Fresenius Medical Care 5008 SM 1/08.04...
  • Page 6 Kapitel 1: Index Fresenius Medical Care 5008 SM 1/08.04...

  • Page 7: Important Information

    Caution Advises the operator against certain procedures or actions that could cause damage to the equipment or may have adverse effects on operators and patients. Fresenius Medical Care 5008 SM 1/08.04...

  • Page 8: Precautions For Working On The System

    ESC precautions (e.g. EN 100 015-1). Monitor support arm If the 5008 hemodialysis system is to be placed in a horizontal position for servicing, the monitor support arm must be protected with the transport protection to prevent it from flipping over.
  • Page 9 Phone: +49 6172 609-7100 Fax: +49 6172 609-7102 E-mail: ServicecenterD@fmc-ag.com Service Fresenius Medical Care International Deutschland GmbH Service Support International Hafenstraße 9 97424 Schweinfurt Germany Phone: +49 9721 678-333 (hotline) Fax: +49 9721 678-130 Local Service Fresenius Medical Care 5008 SM 1/08.04...
  • Page 10 Chapter 2: Important Information Fresenius Medical Care 5008 SM 1/08.04...

  • Page 11: Specifications

    Degree of protection against electric shock: Type B CE mark Electrical safety (classification according to EN 60601-1, IEC 601-1) Type of protection against Safety class I electric shock Degree of protection Type B, symbol: against electric shock Fresenius Medical Care 5008 SM 1/08.04...
  • Page 12 Water inlet pressure 1.5 to 6.0 bar Water inlet temperature 5 °C to 30 °C with "Integrated hot rinse": 85 °C to 95 °C Water inlet rate 1.5 l/min; at an inlet pressure of 1.5 bar Fresenius Medical Care 5008 SM 1/08.04...

  • Page 13: External Connections

    Interface for the exchange of data. Electrically isolated by transformer. Port: RJ 45 RS232 Interface for the exchange of data. Electrically isolated by optocoupler. Port: DSUB 9-pin Fresenius Medical Care 5008 SM 1/08.04...

  • Page 14: Operating Programs

    Automatic raising of the fluid level during the rinse phase. Reinfusion Reinfusion volume adjustable in the SETUP. Return to dialysis still possible. Dialysis Bicarbonate dialysis ISO-UF Ultrafiltration without dialysate flow (Bergström method) Fresenius Medical Care 5008 SM 1/08.04...
  • Page 15 Pump volume accuracy: ±1 % (at P > –500 mbar) The UF rate/effective blood flow ratio is being monitored during the treatment. If an incongruity occurs a warning will be displayed after approx. 10 seconds. Pressure holding test Event-controlled Fresenius Medical Care 5008 SM 1/08.04...

  • Page 16: Autoflow

    EcoFlow: dialysate flow automatically reduced to 100 ml/min in Preparation Rinse and chemical Desired temperature: 37 °C disinfection temperature Resolution: 0.5 °C Measuring accuracy: ±0.2 °C Rinse and chemical Desired value: 600 ml/min disinfection flow Fresenius Medical Care 5008 SM 1/08.04...

  • Page 17: Optical Detector

    20 to 500 mmHg (adjustable from -100 to 500 mmHg via SETUP.) Fill level detector Method: Capacitive measurement Switching point 13 mm, ±4 mm from upper edge Optical detector Method: Infrared transmission Fresenius Medical Care 5008 SM 1/08.04...

  • Page 18: Diasafe®Plus

    Setting range of the loudness of the audible alarm: Factory setting ≥ 65 db (adjustable) Minimum setting: ≥ 65 db ® DIASAFE plus (option) Filter life: maximum 12 weeks. Monitored by the dialysis system and a warning (Filter change) is displayed. Fresenius Medical Care 5008 SM 1/08.04...
  • Page 19 Blood pump During Single Needle operation 180 seconds. stop alarm Single Needle pump Stroke volume 10 to 50 ml in increments of 5 ml External compliance 50 ml or 60 ml stroke volume chamber Fresenius Medical Care 5008 SM 1/08.04...
  • Page 20 Body temperature control Allowed range of desired values for body temperature change rate: – 0.5 °C/h to + 0.5 °C/h Maximum dialysate temperature range used by the BTM: 33.5 °C to 39.5 °C 3-10 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 21 The responsible organization of the network is responsible for the protection of the not encrypted, transferred data. The data transfer of alarm states via the network must not be used as an external alarm alert (nurse call). Fresenius Medical Care 5008 SM 1/08.04 3-11...
  • Page 22 Chapter 3: Specifications 3-12 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 23: Installation

    The initial start-up must be performed by the Technical Service of Fresenius Medical Care or a person authorized by them! Any information on initial start-up and the specifications in the Operating Instructions must be observed.

  • Page 24: Initial Start-Up Report

    Chapter 4: Installation Initial Start-Up Report 5008 Initial Start-Up Report Fresenius Medical Care Technician's name: Service report number: Customer/Customer no.: Inventory no.: Device no. Operating hours: Device type including option(s): Fresenius Medical Care 5008 SM 1/08.04...
  • Page 25 Check – water inlet flow / adjustment – degassing Check MaxWaterFlow. ________ Corr.: Desired value: 1300 ml/min to 1550 ml/min Perform the degassing adjustment. Check – dialysate flow Check flow at 800 ml/min. ________ Desired value: 770 ml/min to 830 ml/min Fresenius Medical Care 5008 SM 1/08.04...
  • Page 26 Desired value – difference: ±0.2 mS/cm Check – blood leak detector Check the blood leak: ________ Corr.: Desired value: 4.8 V to 5.2 V Check the dimness: ________ Desired value: 4.8 V to 5.2 V Fresenius Medical Care 5008 SM 1/08.04...
  • Page 27 ________ Desired value: S03 = Display of reference measuring instrument + (+16 mbar to +76 mbar) Check S07. ________ Desired value: S07 = Display of reference measuring instrument + (+16 mbar to +76 mbar) Fresenius Medical Care 5008 SM 1/08.04...
  • Page 28 Check – venous clamp: A pressure change within 3 minutes must not exceed the following values: Arterial pressure display Maximum pressure change: ±5 mmHg Reference measuring instrument for pressure display Maximum pressure drop: –0.1 bar Fresenius Medical Care 5008 SM 1/08.04...
  • Page 29 Check absence of disinfectant by means of test strips (not with Citrosteril). 11.7 Record entries in the medical device register and on the machine card. 11.8 Operating Instructions and accessories package complete and appropriate for the system. Fresenius Medical Care 5008 SM 1/08.04...
  • Page 30 The system has been released for the intended use. Test equipment used: Temperature, conductivity, pressure ________________________ (type, serial number): ________________________ Protective earth resistance, leakage current ________________________ (type, serial number): ________________________ Comments: Date: Signature: Stamp: Fresenius Medical Care 5008 SM 1/08.04...

  • Page 31: Explanations On The Initial Start-Up Report

    Tubing dimensions, adjusted: Length _____ m, internal diameter_____ mm Connect the CDS tubings and protect them from slipping out. Apply a shrink tube marking for the CDS tubings. CDS 1 CDS 2 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 32 (If it is not possible to set a water inlet flow ≥ 1300ml/min, it will not always be possible to achieve the dialysate flow of 1000ml/min.) In the service mode, select CALIBRATE. Basic requirements: Flow on. Perform the degassing adjustment. Touch the Degassing (A01/P01) button. 4-10 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 33 The hemodialysis system must be closed. (Avoid external light.) Temperature of approx. 37 °C achieved, flow on, flow 500 ml/min, Check the blood leak: Desired value: 4.8 V to 5.2 V Check the dimness: Desired value: 4.8 V to 5.2 V Fresenius Medical Care 5008 SM 1/08.04 4-11...
  • Page 34 Check S03. Desired value: S03 = Display of reference measuring instrument + (+16 mbar to +76 mbar) Check S07. Desired value: S07 = Display of reference measuring instrument + (+16 mbar to +76 mbar) 4-12 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 35: Check - Electrical Safety

    Protective earth resistance maximum 0.3 ohms (with power cord) The protective earth resistance must be checked on the following four measurement points. 1. Measurement point: power supply unit (power supply unit housing) 2. Measurement point: shunt door Fresenius Medical Care 5008 SM 1/08.04 4-13...
  • Page 36 Chapter 4: Installation Description 3. Measurement point: potential equalization 4. Measurement point: heater rod chamber 4-14 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 37: Leakage Current Measurement (Device Leakage Current)

    Chapter 4: Installation Description Leakage current measurement (device leakage current) Differential current measurement according to figure C.6 L(N) N(L) Direct measurement according to figure Fresenius Medical Care 5008 SM 1/08.04 4-15...

  • Page 38: Nominal Voltage Of Power Supply: 230 V

    Check – zero point arterial/venous pressure display and venous clamp 10.1 Zero point arterial pressure display Basic requirements: Blood lines inserted, pressure domes coupled, standby operation. Check the arterial pressure display. Desired value: –5 mmHg to +5 mmHg 4-16 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 39 Maximum pressure change within 3 minutes on the arterial pressure display of the hemodialysis system ±5 mmHg. Maximum pressure drop within 3 minutes on the display of the reference measuring instrument –0.1 bar. Fresenius Medical Care 5008 SM 1/08.04 4-17...
  • Page 40 Check absence of disinfectant by means of test strips (not with Citrosteril). 11.7 Record entries in the medical device register and on the machine card. 11.8 Operating Instructions and accessories package complete and appropriate for the system. 4-18 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 41: Setup

    – – (4.4 mm) (6.4 mm) 8.0 mm Delivery rates Prime 100 ml/min 30–600 ml/min 10 ml/min – Precirculation 100 ml/min 30–600 ml/min 10 ml/min – Reinfusion 100 ml/min 30–300 ml/min 10 ml/min – Fresenius Medical Care 5008 SM 1/08.04...

  • Page 42: Reinfusion

    Stop time 0:30 0:00–2:00 0:01 – Syringe Fresenius 30 ml – – Depending on Technician's Setup (define syringe types) Bolus 5.0 ml/h 1.0–20.0 ml/h 0.1 ml/h – 1000 I.U./h 0–15 000 I.U./h 10 I.U./h – Fresenius Medical Care 5008 SM 1/08.04...
  • Page 43 Automatic – – Automatic Manual UF goal 0 ml 0–9990 ml 10 ml – UF time 0 hrs 0 min 0–24 hrs. 1 min – UF rate 0 ml/min 0–4000 ml/min 10 ml/min – Fresenius Medical Care 5008 SM 1/08.04...

  • Page 44: Alarm Processing

    100 mmHg 40–200 mmHg 10 mmHg – Ven. alarm limit Asymmetric – – Asymmetric Centered Ven. window width 100 mmHg 40–200 mmHg 10 mmHg – Ven. window position Unlimited – – Unlimited ≥ 20 mmHg Fresenius Medical Care 5008 SM 1/08.04...
  • Page 45 (If the BPM option is available, a maximum of 3 options may be created.) Options can be added only if the particular option is available. Option HEPARIN – – HEPARIN ONLINE EMERGENCY CIRCULATE SINGLE NEEDLE ONLINE Defining controls – – – – – Fresenius Medical Care 5008 SM 1/08.04...
  • Page 46 Chapter 5: Setup Cleaning Submenu Default value Value range Resolution Selectable options Mand. cleaning pgm. – – after treatment Fresenius Medical Care 5008 SM 1/08.04...
  • Page 47 – ® The bibag may be installed after completion of the last disinfection of the 5008 hemodialysis system (72 hours maximum before the treatment). For profiting from this possibility, observe the following notes. Requirements: – Pre-program the T1 test under Auto On.

  • Page 48: Emergency

    – Message: Saving data to card. Leave card inserted! – Remove the patient card after the message disappeared. First name – – – – Surname – – – – Finesse ID – – – – Date of birth – – – – Fresenius Medical Care 5008 SM 1/08.04...
  • Page 49 – – OCM (Can only be selected if the device option exists.) Submenu Default value Value range Resolution Selectable options OCM start Automatic – – Automatic Manual Kt/V warning – – (see OCM description) Fresenius Medical Care 5008 SM 1/08.04...
  • Page 50 Default value Value range Resolution Selectable options Installation place Installation place of the 5008 hemodialysis system may be entered here (e.g. name of the clinic). BPM (Can only be selected if the device option exists.) Submenu Default value Value range...
  • Page 51 Manual Body temperature Temp. control Automatic – – Automatic Manual Temperature change 0.0 °C –0.5 to +0.5 °C/h 0.1 °C/h – Room temperature Room temperature 20.0 °C 15.0–35.0 °C 1.0 °C – Fresenius Medical Care 5008 SM 1/08.04 5-11...
  • Page 52 Chapter 5: Setup 5-12 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 53: Technician's Setup

    1.0–5.0 m 0.1 m – Internal diameter 6 mm 3–20 mm 1 mm – EBM settings Submenu Default value Value range Resolution Selectable options Machine options Motor type Premotec – – Premotec Papst others Fresenius Medical Care 5008 SM 1/08.04 5-13...
  • Page 54 32.0 mmol/l 0–40.0 mmol/l 1 mmol/l – Flow 500 ml/min 100–1000 ml/min 100 ml/min – Auto flow – – Auto flow factor 1.0–2.0 – Temperature 36.5 °C 34 °C–39 °C 0.5 °C – 5-14 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 55 AC-F 313/3 SK-F 313/2 AC-F 318/1 SK-F 301 AC-F 216 SK-F 309 AC-F 411 SK-F 311 AC-F 413 SK-F 312/1 AC-F 419 SK-F 316 AC-F 412/1 SK-F 313/1 AC-F 413/1 SK-F 318 AC-F 016 Fresenius Medical Care 5008 SM 1/08.04 5-15...
  • Page 56 Disinfection port 1 Diasteril (6 l) – – Diasteril (6000 ml) ® Citrosteril (5000 ml) ® Puristeril (4400 ml) ® ® Disinfection port 2 Sporotal 100 (4. – – Sporotal 3 l) (4300 ml) 5-16 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 57 06:00 Disinfection with/without 08:40 08:40 ® DIASAFE plus ONLINEplus™ 10:15 10:15 Heat disinfection with/without 13:40 13:40 ® DIASAFE plus ONLINEplus™ 15:40 15:40 Mandatory rinse with/without 16:10 13:35 ® DIASAFE plus ONLINEplus™ 18:10 15:05 Fresenius Medical Care 5008 SM 1/08.04 5-17...
  • Page 58 (not adjustable) Disinfection note – – – (not adjustable) Define options (cannot be set yet) Define screen pages (cannot be set yet) Novram Submenu Selectable options Novram Delete mandatory disinfection Delete mandatory rinse 5-18 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 59 Sound check – – Audible alarm Audible warning Audible info Start-up sound Skip T1 test – – Records – – Flash Flash 1 – – Flash 1 Flash 2 Recording rate – – High Fresenius Medical Care 5008 SM 1/08.04 5-19...
  • Page 60 Chapter 5: Setup 5-20 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 61: Information Regarding The Setting Of Concentrates In The Technician's Setup

    Proportion of the acidic concentrate of the composition, is the reference quantity of the mixing ratio, constant = 1 Bic components Proportion of the bicarbonate concentrate of the composition. In case of acetate dialysis the value is 0. Fresenius Medical Care 5008 SM 1/08.04 5-21...
  • Page 62 1/100 mmol/L 80.00 HCO3 1/10 mmol/L bicarbonate 30.00 40.00 acetate Glucose gm/L Acid proportion non- 1 ( = constant) (here = acetate dimensional concentrate proportion) Bic components non- dimensional non- components dimensional All others 5-22 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 63 The allowed concentrate setting limits specified above also affect the limits which can be set by the operator. Some of the expected operator adjustments may then no longer be possible: Operator setting limits: Fresenius Medical Care 5008 SM 1/08.04 5-23...
  • Page 64 Prescribed bicarbonate Concentration of the prescription ± 8 mmol/L and: 20 mmol/L ≤ prescribed bicarbonate ≤ 40 mmol/L and: 12.8 mS/cm ≤ expected conductivity ≤15.7 mS/cm Whichever condition is the most stringent applies. 5-24 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 65: Tsc / Tmc / Maintenance

    Protect the components against ingress of fluids. Do not touch live parts (e.g. connectors of the power cord or heater). When repairing and when replacing spare parts, observe the applicable ESD precautions (e.g. EN 100 015-1). Fresenius Medical Care 5008 SM 1/08.04...
  • Page 66 Chapter 6: TSC / TMC / Maintenance Fresenius Medical Care 5008 SM 1/08.04...

  • Page 67: Test Report - Technical Safety Checks, Technical Measurements Checks And Maintenance Procedures6-3

    Technician's name: Service report number: Customer/Customer no.: Inventory no.: Serial no.: Operating hours: Machine type: including option(s): Fresenius Medical Care 5008 SM 1/08.04...
  • Page 68 Torque setting of monitor arm checked in all 3 axes. Every 4 years only: Battery replaced. Hydraulics unit Loading pressure of balancing chamber checked. ________ Level sensor (S17, S19) checked. (Not applicable to bibag.) Leakage sensors (S14, S35) inspected. Fresenius Medical Care 5008 SM 1/08.04...
  • Page 69 ________ Desired value: S03 = Display of reference measuring instrument + (+16 mbar to +76 mbar) Check S07. ________ Desired value: S07 = Display of reference measuring instrument + (+16 mbar to +76 mbar) Fresenius Medical Care 5008 SM 1/08.04...
  • Page 70 A pressure change within 3 minutes must not exceed the following values: Arterial pressure display, maximum pressure change: ±5 mmHg Pressure display of reference measuring instrument, desired maximum pressure drop: –0.1 bar Leakage sensor (EBM) cleaned. Fresenius Medical Care 5008 SM 1/08.04...
  • Page 71 150 mmHg / ±3 mmHg System / ref. ____/____ 100 mmHg / ±3 mmHg System / ref. ____/____ 50 mmHg / ±3 mmHg System / ref. ____/____ Single Needle 6.3.1 Rotor position (Single Needle) checked. Rotor cleaned. Fresenius Medical Care 5008 SM 1/08.04...

  • Page 72: Device Leakage Current Mains Polarity 2

    Device leakage current mains polarity 2 with line voltage __________ V scaled to nominal voltage (maximum 500 µA, see Additional _____ µA requirements) Test equipment used: ________________________ Final inspection and testing T1 test performed with all options. Disinfection performed. Fresenius Medical Care 5008 SM 1/08.04...
  • Page 73 Chapter 6: TSC / TMC / Maintenance Date: Signature: Stamp: The system has been released for further use. Comments: Date: Signature: Stamp: Fresenius Medical Care 5008 SM 1/08.04...
  • Page 74 Chapter 6: TSC / TMC / Maintenance 6-10 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 75: Explanations On Technical Safety Checks, Technical Measurement Checks And Maintenance Procedures6-11

    Upper door area; warning of tilting risk and type label. Disinfection connectors; warning of cauterizing risk. Hydraulics connector Potential equalization label ZKV/CDS 1, ZKV/CDS 2 and BIC labels Warning of scalding and cauterizing risks. Accumulator label Fresenius Medical Care 5008 SM 1/08.04 6-11...
  • Page 76 If its brakes are not locked, the carriage can be moved as desired. Check the brake. Check EBM, concentrate connectors, filter chamber, and complete hydraulics (e.g. leaks, corrosion, broken parts, loose parts). No signs of damage on the power cord. 6-12 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 77 The following and other checks must be performed: Dialyzer supply and drain line Only applicable to CDS: Bicarbonate and concentrate flaps checked for proper functioning. Check engagement and microswitch. Seal of rinse chamber replaced. Replace seal and iron ring. Fresenius Medical Care 5008 SM 1/08.04 6-13...
  • Page 78 To the right: Filter, disinfectant 2 Change filter including O- ring. Grease O-rings before installing them. After installation, the mark must be at the top. Suction rod with acetate filter Suction rod with bicarbonate filter 6-14 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 79 1.12 O-rings in dialyzer couplings replaced. (Grease O-rings before installing them.) 1.13 Disinfectant suction valves (V20, V34) replaced. To the left: Disinfection valve 1 To the right: Disinfection valve 2 Fresenius Medical Care 5008 SM 1/08.04 6-15...
  • Page 80 Place the battery connection cable in the appropriate guides. Hydraulics unit Loading pressure of balancing chamber checked. This pressure should be measured in the course of maintenance procedures. Is done in the 5008 service program 6-16 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 81 CD7 (conductivity) checked. Desired value: approx. 13.5 mS/cm to approx. 14.5 mS/cm Measure the reference conductivity with an external measuring instrument. Difference = Reference conductivity minus CD7 Desired value – difference: ±0.2 mS/cm Fresenius Medical Care 5008 SM 1/08.04 6-17...
  • Page 82 Extracorporeal components Zero point of arterial pressure display checked (standby operation) Desired value: –5 mmHg to +5 mmHg Zero point of venous pressure display checked (standby operation) Desired value: –5 mmHg to +5 mmHg 6-18 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 83 Maximum pressure change within 3 minutes on the arterial pressure display of the hemodialysis system ±5 mmHg. Maximum pressure drop within 3 minutes on the display of the reference measuring instrument –0.1 bar. Fresenius Medical Care 5008 SM 1/08.04 6-19...
  • Page 84 The blood pressure cuff must be placed on an artificial limb. Pressure preselection 250 mmHg Touch the Leakage test I/O button. (Test time approx. 4 minutes) Read off the leakage rate from Info BPM. The maximum pressure leakage rate must be ≤6 mmHg/min. 6-20 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 85 250 mmHg/ ±3 mmHg 200 mmHg / ±3 mmHg 150 mmHg / ±3 mmHg 100 mmHg / ±3 mmHg 50 mmHg / ±3 mmHg Single Needle 6.5.1 Rotor position (Single Needle) checked. Rotor cleaned. Fresenius Medical Care 5008 SM 1/08.04 6-21...
  • Page 86 Protective earth resistance measured. No more than 0.3 ohms (with power cord) The protective earth resistance must be checked on the following four measurement points. 1. Measurement point: power supply unit 2. Measurement point: shunt door 6-22 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 87 Chapter 6: TSC / TMC / Maintenance Description 3. Measurement point: potential equalization 4. Measurement point: heater Fresenius Medical Care 5008 SM 1/08.04 6-23...
  • Page 88 Maximum value of both mains polarities: 180 µA Nominal voltage of power supply: 230 V Scaled to nominal voltage: 184 µA (180 µA: 225 V x 230 V = 184 µA Device leakage current < 500 µA: OK 6-24 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 89 Device leakage current: 470 µA Last measured value: 390 µA 470 + (470 – 390) = 470 + 80 = 550; not passed Final inspection and testing T1 test performed with all options. Disinfection performed. Fresenius Medical Care 5008 SM 1/08.04 6-25...
  • Page 90 Chapter 6: TSC / TMC / Maintenance 6-26 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 91: Tsc / Tmc Report

    Leakage sensors checked visually. Leakage sensors cleaned. Check valve for heat exchanger (A05) checked for proper function. Rotor position (blood pump) checked. Rotor cleaned. General checks Power failure alarm – continuous sound – display message: Emergency operation Fresenius Medical Care 5008 SM 1/08.04 6-27...
  • Page 92 System / ref. ____/____ 6.4.6 Safety valve tested. System emptied at 320 mmHg ±10 mmHg ________ 6.4.7 Blood pressure measurement performed. Measured values are plausible. Single Needle 6.5.1 Rotor position (Single Needle) checked. Rotor cleaned. 6-28 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 93 __________ V scaled to nominal voltage (maximum 500 µA, see Additional requirements) _____ µA Test equipment used: ________________________ Final inspection and testing T1 test performed with all options. Disinfection performed. Fresenius Medical Care 5008 SM 1/08.04 6-29...
  • Page 94 Chapter 6: TSC / TMC / Maintenance Date: Signature: Stamp: The system has been released for further use. Comments: Date: Signature: Stamp: 6-30 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 95: Error Messages

    Help can be displayed directly by touching the ? button in the window. The associated Information window will be opened automatically. Power failure and depleted battery Screen failure Fresenius Medical Care 5008 SM 1/08.04...
  • Page 96 Chapter 7: Error Messages Fresenius Medical Care 5008 SM 1/08.04...
  • Page 97 We recommend using the measuring device UMED (part no. M32 403 1) available from Fresenius Medical Care. HMED pressure measuring device with case (set) Part number: M30 770 1 UMED pressure measuring device with case (set) (conductivity, pressure, temperature) Part number: M32 403 1 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 98 (without printer module) Part number: 631 064 1 Printer module (without illustration) Part number: 630 652 1 Carrying bag (without illustration) Part number: 630 648 1 PC Service Software Part number: M35 016 1 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 99 Chapter 8: Tools (Service Equipment) Graduated cylinder 100 ml Part number: 510 085 1 ESD Service Kit Part number: 630 387 1 ESD Workshop Kit Part number: 630 388 1 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 100 Chapter 8: Tools (Service Equipment) Toolcase 5008 Part number: M35 463 1 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 101 Automatic adjustment of the zero of the pressure transducers S03, S07 and S16. When the pressure transducers have been calibrated, the following message will be displayed: Please check or recalibrate degassing (A01/P01) and loading pressure (A02/P02).Touch the Confirm button. Fresenius Medical Care 5008 SM 1/08.04...
  • Page 102 Confirm button. When the degassing (A01/P01) has been calibrated, the CALIBRATE SCREEN will be displayed. If the pressure limitation is not within the desired range, it must be adjusted using A01. Fresenius Medical Care 5008 SM 1/08.04...
  • Page 103 Confirm button. When the loading pump (A02/P02) has been calibrated, the CALIBRATE SCREEN will be displayed. If the pressure limitation is not within the desired range, it must be adjusted using A02. Fresenius Medical Care 5008 SM 1/08.04...
  • Page 104 Flow on, response time approx. 10 minutes Select the Ref. temp. field. Enter the reference temperature. Touch the OK button to confirm the value entered. Touch the Accept value button. The CALIBRATE SCREEN will be displayed. Fresenius Medical Care 5008 SM 1/08.04...
  • Page 105 Calibration will then be performed automatically! – Confirm – Abort. Touch the Confirm button. When the blood leak detector has been calibrated, the CALIBRATE SCREEN will be displayed. OCM (option) Before calibrating the OCM, the temperature must have been calibrated. Fresenius Medical Care 5008 SM 1/08.04...
  • Page 106 Chapter 9: Calibration / Adjustment Select the OCM field. Touch the Start calibration button. Automatic OCM adjustment. When the OCM detector has been calibrated, the CALIBRATE SCREEN will be displayed. Fresenius Medical Care 5008 SM 1/08.04...

  • Page 107: Repair

    Chapter 10: Repair 10 Repair (no contents yet) Fresenius Medical Care 5008 SM 1/08.04 10-1...
  • Page 108 Chapter 10: Repair 10-2 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 109: Functional Description

    Chapter 11: Functional Description 11 Functional Description 11.1 Overall System MONITOR RS 232 CAN_OS CAN_SS RS 232 HYDRAULICS RS 232 Extensions Fresenius Medical Care 5008 SM 1/08.04 11-1...
  • Page 110 Chapter 11: Functional Description 11-2 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 111: Overview Of P.c.b.s

    Valves Valves LP 1125 LP 1123 LP 1113 LP 1113 LP 1113 Valves Valves LP 1113 LP 1113 Hydraulics Distributor, front LP 952 LP 952 LP 1124 LP 952 LP 952 LP 952 Fresenius Medical Care 5008 SM 1/08.04 11-3...

  • Page 112: Monitor

    LP 1106 OS, SS, CAN On/Off LP 1106 LP 1104 LP 1102 Interface LP 1103 Service/Diagnostics 24 V Alarm output RS 232 RJ 45 DSUB Flanged socket Diode socket DSUB 15-pin 4-pin 5-pin 9-pin 11-4 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 113 It has a LAN interface (Ethernet) and an opto-decoupled serial interface (RS 232). A Service/Diagnostics plug and a plug with 24 V connection (1 V) is available for the technician. An alarm output for the nurse call is also present. Fresenius Medical Care 5008 SM 1/08.04 11-5...

  • Page 114: Ebm (Extracorporeal Blood Module)

    +12 V linear +12 V_PWR +24 V_SW +5 V +12 V linear LP 1106 +18 V LP 1106 +24 V LP 1107 CAN SS LP 1106 LP 1106 CAN OS RS 232 LP 1102 LP 1102 11-6 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 115 LP 1107. P.C.B. LP 1107 is connected to the OS (LP 1102) via the plug connector X1_OS, X2_OS and to the SS (LP1102) via the plug connector X1_SS, X2_SS. The serial connection between the OS and the SS is also established via P.C.B. LP 1107. Fresenius Medical Care 5008 SM 1/08.04 11-7...

  • Page 116: Hydraulics Unit

    LP 1109 --------------------Sensors-------------------- PT6, CD6, S17, S18, S23, S24, S25 --------------------Sensors-------------------- CD9, PT2, PT8, PT9, S01, S09, S15 --------------------Sensors-------------------- CD5, PT5, S19, S20, S21, S22 LP 1123 LP 1102 (Hydraulics front, left door) 11-8 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 117 P.C.B. LP 1125 is used to distribute the electrical connections to the components installed on the front in the right door of the hydraulic unit. P.C.B. LP 1125 is connected with P.C.B. LP 1109 and the valve drivers LP 1113. Fresenius Medical Care 5008 SM 1/08.04 11-9...

  • Page 118: Power Supply Unit

    (Rating output 1+2 480W) 90 - 264V/ AC Output 2 (18V/14A) LP 1106 LP 1106 Battery (24V/7Ah) LP 1106 Push-button Heater 0-100 % control On/Off LP 1106 Heater relay LP 1106 Heater (of hydraulics) LP 1105 11-10 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 119 On/Off logic for the entire system. A control chip with pulse-duration modulation controls the heater rod via two triacs. The data required for the control is sent via the CAN bus to the processors. Fresenius Medical Care 5008 SM 1/08.04 11-11...

  • Page 120: Pneumatic Unit

    Chapter 11: Functional Description 11.7 Pneumatic Unit Block diagram Arterial pressure Compressor unit measurement unit Venous pressure measurement unit Deaeration/ventilation Hydraulics 11-12 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 121 The pneumatic unit is located in the EBM. In the EBM it is used to control the arterial and the venous pressure measurement unit. In the hydraulics unit, the pneumatic unit is required for the membrane integrity test and for the filter change program. Fresenius Medical Care 5008 SM 1/08.04 11-13...

  • Page 122: Hydraulics Unit

    Chapter 11: Functional Description 11.8 Hydraulics Unit Flow diagram 11-14 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 123 Rinse chamber, bicarbonate Sensor 1, substituate port ® Connector, bibag Sensor 2, substituate port Male connector, CDS bicarbonate Sensor 1, rinse port Male connector, CDS concentrate 1 Sensor 2, rinse port (continued next page) Fresenius Medical Care 5008 SM 1/08.04 11-15...
  • Page 124 CDS valve, concentrate 1 in VS7s CDS valve, concentrate 2 shutoff valve OS VS8s CDS valve, concentrate 2 shutoff valve SS VS9s CDS valve, concentrate 2 test VS10s CDS valve, concentrate 2 in 11-16 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 125 The balancing chambers (H14) are operated at inverse sequences to ensure that the volume of dialysate which enters the dialyzer equals the volume which flows back across the balancing chambers. An impermeable elastic membrane separates the used from the fresh dialysate. Fresenius Medical Care 5008 SM 1/08.04 11-17...
  • Page 126 The dialyzer valve (V24) closes, the bypass valve (V26) opens, which prevents the improper dialysate from being fed to the dialyzer. The pressure transducer (S07) and the blood leak detector (S08) are further safety elements. 11-18 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 127: Service Program (Option)

    Chapter 12: Service Program (Option) 12 Service Program (Option) Quick Guide PC Service-Software 5008 4/29.04 Fresenius Medical Care 5008 SM 1/08.04 12-1...
  • Page 128 Chapter 12: Service Program (Option) 12-2 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 129 NOVRAM / Calibration data .................. 27 Setup Data ......................29 Error Memory ......................31 Service Data Recorder..................33 Software Update ....................35 Print Preview......................37 Modification ......................39 Quick Guide ......................39 Index......................... 41 Fresenius Medical Care 5008 SM 1/08.04 12-3...
  • Page 130 Chapter 12: Service Program (Option) 12-4 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 131: General Information

    This Service program is intended for service purposes only. During patient treatment neither the interface cable to the PC nor the modem must be connected to a dialysis system. 4/29.04 Page 5 from 41 Fresenius Medical Care 5008 SM 1/08.04 12-5...
  • Page 132 Chapter 12: Service Program (Option) 12-6 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 133: Preparation

    1 CD-ROM drive 1 free USB port (for Service Card Reader) 1 free RS232 interface or 1 network card or 1 TAPI compatible modem (for communication with the 5008) 4/29.04 Page 7 from 41 Fresenius Medical Care 5008 SM 1/08.04 12-7...

  • Page 134: Software Installation

    These will be installed when the PC Service Software 5008 is installed. Caution: If a previous version of the PC Service Software 5008 is already installed on the computer, this version must be uninstalled. Make sure this version is completely uninstalled before installing the new software.
  • Page 135 When the setup is complete, the installation routine for the Service Card Reader driver will be started automatically. Click Start to install the driver. The software installation is complete. 4/29.04 Page 9 from 41 Fresenius Medical Care 5008 SM 1/08.04 12-9...

  • Page 136: Hardware Installation

    Chapter 12: Service Program (Option) PC Service-Software 5008 Preparation Hardware Installation Use the enclosed interface cable to connect the PC to the 5008 dialysis system. Caution: The interface cable for the RS232 connection is not a standard cable. It is therefore imperative to use the enclosed interface cable (M35111).

  • Page 137: Description Of The Service Card

    Description of the Service Card The use of the PC Service Software 5008 requires an appropriate authorization. This is checked by the PC Service Software 5008 and the associated Service card. The Service card is read out via: 1. the Service Card Reader on the PC.

  • Page 138: Starting The Software

    Chapter 12: Service Program (Option) PC Service-Software 5008 Preparation Starting the Software After the hardware has been properly connected, the 5008 dialysis system can be turned on. Caution: For establishing a network connection with the 5008 via a Cross- Over patch cable, the following requirements must be met: •...

  • Page 139: Changing The Ip Address

    Properties pop-up menu. The following dialog will be displayed: Step 3: Select Internet Protocol (TCP/IP) and click the Properties button. The following dialog will be displayed: 4/29.04 Page 13 from 41 Fresenius Medical Care 5008 SM 1/08.04 12-13...
  • Page 140 Chapter 12: Service Program (Option) PC Service-Software 5008 Step 4: Adjust the settings as shown in the illustration above, then confirm the dialog with Step 5: Restart the PC. Page 14 from 41 4/29.04 12-14 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 141: Menu/Toolbar

    Chapter 12: Service Program (Option) Menu/Toolbar Menu Options/Toolbar: Overview Brief explanation of the menu option/toolbar functions: Connection Diagnosis Extras Settings View Help/About 4/29.04 Page 15 from 41 Fresenius Medical Care 5008 SM 1/08.04 12-15...

  • Page 142: Connection

    The operator here can select the desired connection: RS232 connection, e.g. via COM1 modem connection, via a modem installed under Windows network connection (see chapter Starting the Software) Page 16 from 41 4/29.04 12-16 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 143 The PC Service Software 5008 establishes communications with the 5008 and synchronizes with the 5008. • Offline (disconnecting communications): After clicking this menu option, communications with the 5008 will be disconnected. 4/29.04 Page 17 from 41 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 144: Diagnosis

    Setup Data view will be displayed. Here the operator can • read, partly display and save the setup data of the 5008. • edit the setup data for the network settings. • read and partly display the setup data from a file in order to upload them to the 5008.

  • Page 145: Extras

    • select if files on the CompactFlash and/or modules are to be updated. • upload the selected files to the 5008 and update the selected modules. 4/29.04 Page 19 from 41 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 146: Settings

    For a direct connection via RS232 the serial interface cable (M35111) is required. Modem Connection: Selection of the modem. The modem must be configured in the Window Control Panel. Page 20 from 41 4/29.04 12-20 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 147 Chapter 12: Service Program (Option) Menu/Toolbar Network Connection: Entry/selection of the 5008 IP address. If the 5008 (network setup) is in the PC Service mode, IP address 192.168.0.5. must be set. Caution: For a direct connection via a network a Cross- Over patch cable (M36433) is required.

  • Page 148: View

    When clicking this menu option all open windows will be displayed one above the other. Open views: In this field, the currently open views are listed. The active view is checked. Page 22 from 41 4/29.04 12-22 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 149: Help/About

    This dialog informs the operator of • the software version • the expiration date of the Service card • his Service card ID • his name • his authorization. 4/29.04 Page 23 from 41 Fresenius Medical Care 5008 SM 1/08.04 12-23...
  • Page 150 Chapter 12: Service Program (Option) 12-24 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 151: Views

    View Machine Info Downloads machine information from the 5008. Downloads machine information from the 5008 and saves them to a file. Uploads the selected operating hours (example above: complete system and monitor OS) to the 5008. Deletes the selected operating hours (example above: complete system and monitor OS) of the 5008.
  • Page 152 Clicking the button will upload the machine number to the 5008. Clicking the button will upload the time set by the operator to the 5008. Clicking the button will upload the current time of the PC to the 5008. Informs the operator of...

  • Page 153: Novram / Calibration Data

    NOVRAM variables to the 5008. Opens a file and uploads, depending on the selection of the operator, the entire NOVRAM data or only the calibration data to the 5008. Deletes the NOVRAM data of the selected assembly. 4/29.04 Page 27 from 41 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 154 5008. Shows general information (machine number, file name, software version of the 5008, download time and date) on the NOVRAM data saved to the file. Checkboxes where the operator can select for which assemblies the NOVRAM data are to be downloaded, to be deleted, to be displayed or which data are to be uploaded to the 5008.

  • Page 155: Setup Data

    If the text inside the column is not shown completely, this will be indicated by "...". The operator can undo the selection of the NOVRAM variables or select all NOVRAM variables. View Setup Data 4/29.04 Page 29 from 41 Fresenius Medical Care 5008 SM 1/08.04 12-29...
  • Page 156 - Download date on the error memory data downloaded from the 5008. Service-PC active must be selected if the PC Service Software 5008 is to be used for network communication with the 5008. The operator can view, edit and save the network settings of the 5008 and upload them with all other setup data to the 5008.

  • Page 157: Error Memory

    - File name - Software version of the 5008 - Download time - Download date on the error memory data downloaded from the 5008. Checkboxes where the operator can select for which assemblies the error 4/29.04 Page 31 from 41 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 158 Chapter 12: Service Program (Option) PC Service-Software 5008 memory data are to be downloaded, displayed or to be deleted. Dimmed assemblies have been reported by the 5008 as not present. Shows the error memory data. - Error Code: error code of the 5008...

  • Page 159: Service Data Recorder

    Chapter 12: Service Program (Option) Views View Service Data Recorder Downloads service data recorder file information from the 5008. Caution: The service data recorder files have not yet been downloaded from the 5008. Deletes the service data recorder files selected under from the Compact- Flash.
  • Page 160 Number of the selected and total number of service data recorder files. Current file size of the selected service data recorder files. Deselects the selected service data recorder files or selects all. Page 34 from 41 4/29.04 12-34 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 161: Software Update

    Chapter 12: Service Program (Option) Views View Software Update Downloads the service report from the 5008. This report includes the software versions, revisions, the CRC, the creation date of the individual modules and information on missing files. 4/29.04 Page 35 from 41 Fresenius Medical Care 5008 SM 1/08.04...
  • Page 162 Chapter 12: Service Program (Option) PC Service-Software 5008 Starts the software update of the 5008 in accordance with the operator's selection Opens the software update file. Saves the software status to a file (*.5008sws). Prints the software status. Displays the Print Preview.

  • Page 163: Print Preview

    Chapter 12: Service Program (Option) Views View Print Preview Click the Print Preview button to view the print preview. Selects individual pages Zooms in Prints the pages 4/29.04 Page 37 from 41 Fresenius Medical Care 5008 SM 1/08.04 12-37...
  • Page 164 Chapter 12: Service Program (Option) 12-38 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 165: Modification

    View: Error Memory Error memory view description extended • View: Setup Data Note: Operator/Technician's setup added Description for Service-PC active added • View: Software Update Release number omitted 4/29.04 Page 39 from 41 Fresenius Medical Care 5008 SM 1/08.04 12-39...
  • Page 166 Chapter 12: Service Program (Option) 12-40 Fresenius Medical Care 5008 SM 1/08.04...

  • Page 167: Index

    Setup Data ........29 Connection........16 Software Update ......35 Diagnosis ........18 Software Installation ......8 Extras..........19 Starting the Software ....... 12 Help/About ........23 System Requirements ....... 7 Overview ........15 4/29.04 Page 41 from 41 Fresenius Medical Care 5008 SM 1/08.04 12-41...
  • Page 168 Chapter 12: Service Program (Option) 12-42 Fresenius Medical Care 5008 SM 1/08.04...

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