DialogAd Sm Chapter 5-4-2002

Di al og / Di al og A dva nc ed

5. Technica ical Safety Inspection and Preventive Maintenance 4 / 2 0 0 2

5- 1

Copyright

This technical documentation contains confidential inf nform ormati ation on of B. Braun Medizi Medizintechnol ntechnologie ogie GmbH and may not be copied, partl partly or whole, nor made accessibl sible e to thi third rd parties parti es wit without hout our wri rittten consent and remai ains ns with all rights ri ghts the propert rty y of B. Braun Medizi zintechnol ntechnologie ogie GmbH.

Service

Only competent individuals that are trained in the repair, maint ainten enance and software ins instal talllati ation on of the Dialog/ alog/D Dialog Advanced should attem attempt to to servi rvice ce the the machi achine! ne! The servi rvici cing ng of the Dial alog/ og/D Dial alog og Advanced in accordance with wit h this this servic ervice e manual should never be carr carriied out in in the absence of proper tool tools, s, cali calibrati bration on equi uipm pment and the most recent editi tion on of thi this s servi rvice ce manual al,, which must be clea clearl rly y and thoroughl horoughly y underst rstood! ood!

Prevent Electrical Shock Hazard

Swit itch ch off the Dialog/Dialog Advanced and disconnect unit from mai ains ns bef efore ore openi ning ng the machi achine! ne! Do not touch touch any exposed wiri ring ng or conduct ctiive surf urfaces aces while the Dial alog/ og/D Dial alog og Advanced is open. The vol oltages tages present when elect electri rical cal power is is connected to the the Dial alog/ og/D Dial alog og Advanced can cause seri rious ous inj njury ury or death! If necessary open the machi achine ne for mai aint ntenan enance and repai repairr

ESD Recommendations

Pay att tte ention to ESD requir ire ements, because electr tro onic components are sensit sitiive to electr electros ostati atic c discha discharges (see appendix)!

Fuses

If fuses are replaced they must exactly match the type and ratiing speci rat eciffied by the manufact acturer. urer. Where appli plicable: cable: Fuses must be approved by UL/CSA! UL/CSA!

Calibration

Only perform a calibration after the Dialog/Dialog Advanced has reached worki orking ng temperat rature! ure!

MT-MD MT-MD- DE08C M.KAY

DialogAd_sm_Chapter DialogAd_sm_Chapter 5_4- 2002.doc/pdf <280602>ddmmyy

B. Braun Medizi Medizintechnol ntechnologie ogie GmbH


5. Technical Safety Inspection and Preventive Maintenance 4 / 2 0 0 2

5- 2

Seite

MT-MD-DE08C M.KAY

5.

Technical Safety Inspection and PreventiveMaintenance

5-3

5.1

Inspection Protocol for Automatic Blood Pressure Measurement ABPM

5-7

DialogAd_sm_Chapter 5_4- 2002.doc/pdf <280602>ddmmyy

B. Braun Medizintechnologie GmbH



5- 3

The technical safety inspection, according to the specified check list, must be performed and documented every 12 months, with reference to the service manual and operating instructions, which are subject to technical amendments. The preventive maintenance with the exchange of wear and tear parts, is recommended every 12 months and should be documented, according to the specified check list, with reference to the service manual and operating instructions, which are subject to technical amendments.

Art. No.: ....................................... Machine No.: ............................................. Year of Purchase: ........................ User: ............................................................ ................................................................................................................................. Operating Hours: ..................... h InventoryNo.: ............................................ SWVersion: ................................. HW Version: ............................................... Manufacturer:


Check List

Note:

Only calibrated measurement equipment must be used! ESD recommendations must be applied!

Technical Safety Inspection ..................................................................................................................................................................................................................................... Technical Safety Inspection with Preventive Maintenance............................................................................................................................................................. S M S = Technical Safety Inspection Points; M = PreventiveMaintenance Points

No Yes OK 

M Disinfection/decalcification wasperformed S

1.



 

Heat Exchanger (option) without leakages (TSM, LLC Manual Test)

2. 2.1

Visual Inspection with Maintenance Procedures Machine: clean/complete; no damages/moisture influences; unit rollers are moveable; machine record S book present; no special incidents; type plates and inscriptions legible, options present M 2.1.1 Clean interior space and exterior surfaces S 2.2 Check mains supply (power supply line and connectors)

 



 

M 2.3

Suction tubing for disinfection and concentrate exchanged 







M 2.4

O-rings in suction rod exchanged 







M 2.5

Tight seat of the tubing connectors, clamps and couplings







M 2.6

Dialyser coupling membranes, o-rings and tubings exchanged 







M 2.7

Tight seat of tubings, clamps and couplings of inlet and outlet tubings







M 2.8

Tight seat of boards and connectors







M 2.9 Fan in power supply clean (if necessary clean) 2.9.1 Exchange dust filter of fan (rear door) 































M 2.10 PC motherboard: 2.10.1 CPU fan exchanged (depends on hardware status) (CPU fan not i ncluded in t he maint enance kit , if necessary order separat ely.)

2.10.2 Battery or rechargeable battery on PC motherboard exchanged (after operating period of 4 years) (Batt ery or rechargeable bat tery are not i ncluded in t he maintenance kit , if necessary order separately.)

M 2.11 Monitor: no restriction of motion of rotation (and fan); tight seat touch membrane/keyboard membrane S 2.11.1 Function of the keys, display illumination and touch 2.11.2 Image display, geometry 2.11.3 Alarmactivation

  

M 2.12 No cracks in covers (rear door cover, front cover and mains suppression cover) M 2.13 Tight seat of groundterminals in frame,front door, rear door andsub-racks(if necessary order separat ely for sub-racks)













M 2.14 Check/set pressure reducer (DMV) to 1.3 bar 2.14.1 Check pressure non-return valves (RVDA, DDE, RVFPE, RVFPA)

























M 2.15 Conductivity Sensors 2.15.1 ENDLF sensor: Visual inspection 2.15.2 BICLF sensor: Visual inspection

MT-MD-DE08C M.KAY





S M S = Technical Safety Inspection Points; M = PreventiveMaintenance Points

5- 4

No Yes OK

M 2.16 Piston Pumps 2.16.1 BIC piston pump 2.16.1.1 Visual inspection







2.16.1.2 Check tight seat of driving elbow on motor axis (if necessary tighten screw)







2.16.2.1 Visual inspection














2.16.3.1 Visual inspection














2.16.3.3Check one-way bearing (if present)











































M 2.16.2 KP piston pump

M 2.16.3 UF piston pump (TSM, LLCManual Calibr ation, 2.8 Flow UF Pump)

M 2.17 Check temperature sensors (TSBIC, TSD/TSD- S -

TSM, LLC Manual Test) : difference ≤ 0.5

o

C

M 2.18 No visible leakages of balance chamber 2.18.1 Valves (VEBK1/2, VDEBK1/2, VABK1/ 2, VDABK1/2, VDE, VBP, VLA): Pressure test passed M 2.19 Disinfection valvel (VD) : if necessary exchangeparts and calibrate (Part s not i ncluded in t he maint enance kit , if necessary order separat ely.)

M 2.20 Blood leak detector (BLD) test passed 2.20.1 Blood leak detector calibrated  M 2.21 Pressure sensors water side (PE/PDA): Pressure test passed (TSM, LLC Manual Test)

2.21.1 PE (permissable tolerance ±50 [mmHg])

2.21.2 PDA (permissable tolerance ±50 [mmHg])

Comparison measurement at:

Comparison measurement at:

- 400 =.................. [mmHg]



- 100 =.................. [mmHg]



- 400 =.................. [mmHg]



0 =.................. [mmHg]



M 2.22 Heparin Pump 2.22.1 Heparin Pump Comfort: Syringe recognition passed







(TSM, LLC Manual Test, 1.4 Heparin Pump, wit h 20 ml and 50 ml template)

2.22.2 Heparin Pump Compact: Check display position (80 mm± 15 mm)

....................... [mm]



(Drive fast forw ard t o end posit ion wi t h 30 ml syringe. Check display posit ion i n mm.)

M 2.23 Filter (FVD, FB, FK, FBK1/2, FBIC) exchanged 







M 2.24 O-rings in BIC cartridge holder (option) exchanged







M 2.25 Summer/Winter Time Setting













(TSM, Treatment Support , System Configuration)

M 2.26 HDF Online: Filter (HFB) exchanged (Fil t er not included in maint enance kit , if necessary order separat ely.)

S

S

2.27 SAKV Curentless Closed (Option) 2.27.1 O-ring for magnetic plate exchanged (O- ring not included in mai ntenance kit , if necessary order separately.)



2.27.2 Gap for magnetic plate 1.6 (± 0.05 mm)



3. Function Inspection (Document Measurement Values) 3.1 Blood Pump: - Check function, moveability, drive belt, noise rating 3.1.1 Check roller; if necessary lubricate bearings



3.1.2 Alarmcover switch



3.1.3 One-way bearing



MT-MD-DE08C M.KAY







S M T = Technical Safety Inspection Points; P =PreventiveMaintenance Points S

S

3.2

Single Needle Pump (Option):

5- 5

No Yes OK

- Check function, moveability, drive belt, noise rating



3.2.1 Check roller; if necessary lubricate bearings



3.2.2 Alarmcover switch



3.2.3 One-way bearing



3.3

Venous Tubing Clamp:

- Function and moveability



3.3.1 Gap 1.4 (+0.1 mm) S

3.4



Arterial Tubing Clamp (Option):

- Function and moveability



3.4.1 Gap 1.4 (+0.1 mm) S

3.5



Arterial Pressure PA

- Comparison measurement at:

- 400 =.................. [mmHg]



0 =.................. [mmHg]



0 =.................. [mmHg]



+400 =.................. [mmHg]



0 =.................. [mmHg]



+400 =.................. [mmHg]



0 =.................. [mmHg]



+400 =.................. [mmHg]



(permissable tolerance ±12 [mmHg])

S

3.6

Inlet Pressure PBE



S

3.7

Inlet Pressure PBS (Option):



S

3.8

Venous Pressure PV:



S S

3.9 Mains Failure Interruption: 3.10 Staff Call (Option):

- Check function and alarmtone - Function or contact continuity passed



S

3.11 BIC Cartridge Holder (Option):

- Check reed sensors (BKUS and if present BKOS)





(TSM, LLC Manual Test)

S S

3.12 Automatic Blood Pressure Measurement ABPM (Option) - Check ABPM option, see 5.1) 3.13 Balance SystemHDF Bag (Option) (Switch to therapy, document applied reference weight and controller value from service overview) 3.13.1 Load cell comparison measurement (with reference weight) at: (permissable tolerance ±50 g)

+____.______

(permissable tolerance ±50 g)

M 3.14 DF Filter/Pyrogen Filter (Option):

g =........................... [g]

Difference between Reference/Actual Value =____________

3.13.2 Load cell comparison measurement (without reference weight) at:



[g]



0 g =........................... [g] Differencebetween Set/Actual Value =____________

- Visual inspection passed



[g]







4.

Electrical Safety Check Accordingto EN 60601-1/IEC 601-1

S

4.1

Measure mains voltage:

........................ [V~]



S

4.2

Protectiveearth conductor resistance <0.2 [Ω] - Potential equalization bolt

.......................... [Ω]



- Screw connection heater body

.......................... [Ω]



- Rinsing bridge (dialyser inlet and outlet)

.......................... [Ω]

Staff Call (Option)

- Rear door socket

.......................... [Ω]



Substitution/HDF (Option)

- Bag holder

.......................... [Ω]



(Machine incl. power supply line)



S

4.3

Earth leakage current ≤ 0.5 [mA]

- During heat-up phase

....................... [mA]



S

4.4

Patient leakage current <0.1 [mA]

- Under normal conditions

....................... [mA]



(Conductivity at 14 mS/cm)

MT-MD-DE08C M.KAY





S M T = Technical Safety Inspection Points; P =PreventiveMaintenance Points

5- 6

No Yes OK

5.

Setting into Service Accordingto Operating Instructions

S

5.1

Switch on Machine:

- Self-test passed

S

5.2

Temperature

- Comparison measurement at 37 oC (-1.5; +0.5)

......................... [oC]



S

5.3

Conductivity

- Comparison measurement at dialyser coupling, e.g. 14.3 mS/cm (±0.2) .................. [mS/cm]





S

5.4

Saferty Air Detector (SAD):

- Test alarmfunction passed



S

5.5

Ultrafiltration

- Comparison measurement at UF rate 500 (±15) ...................... [ml/h]



A disinfection was performed by:

- User - Service technician

M 5.6

CHECK RESULTS: Defects were detected, which could endanger patients, users or third parties. Applied Accessories/Disposables:

The technical safetyinspection or technical safety inspection with preventive maintenance was performed correctly.













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

................................................................................................................................. .................................................................................................................................

Must actions be taken with reference to maintenance Note next appointment:









................................................................................................................................. Name of Service Technician:

Name of Company:

...................................................................... ...................................................................... .......................................................

Date / Signature

User: ......................................................................

Date / Signature

 Maintenance Kit Dialog A maintenance kit can be ordered for the Dialog technical safety inspection with preventive maintenance. All parts are included which are recommended for exchange during preventive maintenance.

MT-MD-DE08C M.KAY


Art. No. Description 3451 893A Maintenance kit Dialog


Di al og / Di al og A dva nc ed 5.1


5- 7

Inspection Protocol for Automatic Blood Pressure Measurement ABPM The measurement inspection is recommended every 12 months onths and should be documented. The measuring methods are described in the execution procedures.

Measurement Inspection

Dialysis Machine Dialog/DialogAdvanced Automatic BloodPressureMeasurement ABPM Manufacturer User

Environmental Conditions

Serial No.: ............................................ Art. No.: ............................................ Serial No.: ............................................ B. Braun Medizintechnologie GmbH Anschrift: ................................................................................................................ ................................................................................................................................. ................................................................................................................................. ................................................................................................................................. The environmental conditions must be from 15 °C to 25 °C, the relative humidity must be between 20 % and 85 % (normal room condition).

1. Visual Inspection

- tight seat of all connectors - no damages which could affect the function or the safety (incl. tubing and cuff)

2. Limits of Error of the Pressure Indication

Admit a static pressure to the unit. The permissable tolerance is ± 5 mmHg for each measurement. Pressure [mmHg]

Measurement Value Dialog Reference

OK  OK 

Deviation [mmHg]

300 250 200 150 100 50 0

3. Air Leakage

The pressure drop must not exceed 18 mmHg.

(including tubing and cuff) Initial Pressure [mmHg]

Final Pressure [mmHg]

Air Leakage [mmHg/min]

4. Rapid Exhaust

Time for pressure reduction from>260 mmHg to <15 mmHg max. 10 s

........ s

5. Function Inspection

The results of a measurement on a test person are plausible ----- ----- - OK 

6. Result of Inspection

The blood pressure measurement module has passed the measurement inspection

no  yes  Comments: ............................................................................................................. ................................................................................................................................. The measurement inspection was performed correctly.

Name of Service Technician: .................................................................................. ..................................................................................

Date / Signature

MT-MD-DE08C M.KAY





5- 8

Execution Procedure for Measurement Inspection • • • • • •

Reference pressure instrument (accuracy ≤ 0.8 mmHg) Measurement chamber with 500 ml volume (rigid metal vessel, e.g. art. no. 770 3090) Syringe 50 ml (for pressure build-up) Stopcock system(e.g. art. no. 770 2035) Luer-lock connector (e.g. art. no. 3477 0739) Connection tubing

To Point 2: Limits of Error of thePressureIndication Measurement according to DIN EN 1060-1:1995 and DIN EN 1060-3:1997. ReferenceInstrument Referenzmeßgerät

1. Connect all components acc. to figure (stopcock systemacc. fig.). 2. Switch on Dialog in TSM service program. Measurement Chamber Meßkammer 3. Select in TSM Manual Test and Calibration , TTL Dialog ABPM and then ABPM Manual Test and Calibration Maintenance . 500 ml 4. Press P Test button. Wait until a pressure build-up of approx. 170 mmHg (start of pressure retention phase). Pressure Tube 5. Open/close valve 4 and set a test pressure of 300 Druckschlauch mmHg with the syringe (in ABPM Maintenance 3 1 4 2 menu) respectively. Enter displayed value from reference instrument in table. 50 ml Syringe Stopcock System Mehrwegehahnsystem 50 ml Spritze 6. Decrease pressure in increments of 50 mmHg and enter values in table. Fig.: Inspection Set- up for Compliance of Error Limits of the Measurement Display 7. Enter deviations in table. 50ml

To Point 3: Air Leakage Dialog ABPM

PressureTube Druckschlauch

Cuff Manschette

Measurement Chamber Meßkammer

Fig.: Inspection Set-Up for Inspection of Air Leakage

MT-MD-DE08C M.KAY


1. Set-up and connect ABPM and cuff according to figure. 2. Press Test 4 button. A test pressure of approx. 300 mmHg is automatically built up (test duration approx. 4 minutes, i.e. 1 minute stabilisation, 3 minutes test). 3. Enter values in table after test is expired. The values are displayed after the time has elapsed: The Initial Pressure , Final Pressure and Leakage are displayed in the ABPM Maintenance menu point 4. Pressure drop (leakage) must not be >18 mmHg (6 mmHg/min).




5- 9

To Point 4: Rapid Exhaust 1. Press P Test button. Wait until a pressure build-up of approx. 170 mmHg (start of pressure retention phase).

Dialog ABPM

2. Increase slowly pressure to >300 mmHg with the syringe until valve opens for rapid exhaust. 3. The valve for rapid exhaust must open between 300 and 330 mmHg. The indicated time for the pressure drop must not be exceeded.

Pressure Tube Druckschlauch

1 50ml

Stopcock System Mehrwegehahnsystem

MT-MD-DE08C M.KAY

50 ml Syringe 50 ml Spritze



DialogAd Sm Chapter 5-4-2002

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