MARK III Manometric Perfusion Pump Ve rtical Deck

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1 MARK III Manometric Perfusion Pump Ve rtical Deck Dentsleeve International Ltd. Manufactured by Mui Scientific 45 Traders Blvd. East, Unit Mississauga, Ontario, CANADA L4Z 3L3 Tel: (905) Fax: (905) Toll Free: Website: Handbook November, 004

2 In Index Section In Section A A - A - A 3 Section B Section C C C - C - 3 C - 4 C - 5 C - 6 C - 7 C - 8 C - 9 C - 0 C - C - C - 3 Section D D - D - D - 3 Section E E - E - E - 3 E - 4 E - 5 E - 6 E - 7 Index Overview Schematic of pump Major pump components Air Water System Precautions & Warnings Normal Use Assembly & filling of perfusate reservoir Check, connect & set air supply Connection & flushing of water manifold Check flow values of each hydraulic resistor Turn on water perfusion to fill each transducer Transducer calibration (if required) Connect catheter to transducers Water injection procedure - each channel Check flow value for air perfusion manometry Observation & refilling of perfusate reservoir C Maintain correct perfusate reservoir pressure Prevention, recognition and correction of hydraulic resistor blockage Compressor Steps on completion of measurements Perfusate reservoir Water manifold Air supply Set Up Procedures & Connection of Components Air supply/compressor Perfusate reservoir prior to first use Installation of pressure transducers Water perfusion manifold removal Standard hydraulic resistors Compact resistors Air perfusion circuit

3 Index In Section F F F - F - 3 F - 4 F - 5 Section G G - G - G - 3 G - 4 Section H H - H - Section I I - I - I - 3 I - 4 Cleaning & Disinfection Cleaning of plastic parts Sterilization of perfusate reservoir Sterilization of manifolds Hydraulic resistors Cleaning of compressor Regular Maintenance Every 3 months (or as needed): perfusate water filter Every year (or as needed): gas filters Service of control box by Dentsleeve Compressor dessicant Problem Solving Diagnosis of abnormal Air consumption Abnormal Air consumption - perfusate reservoir leakage Specifications, Support, Spart Parts & Accessories Specifications Support Spare parts Regulatory information Notes on the use of this manual References within the manual are shown in brackets eg (C 4.) = section C, part 4, instruction Part numbers (#) given in the text are unique for Dentsleeve The technical information and illustrations in this manual reflect specifications and operating procedures at the time of drafting. Some specifications and operating procedures differ from earlier manuals for Mark II perfusion pump models. Dentsleeve reserves the right to vary specifications and operating procedures as part of its continuous product improvement process. 3

4 Overview A Schematic of pump A 00 kpa or 5 psi Regulated air supply to perfusate reservoir Water perfusate Air supply Pump control box Catheter Catheter connector tubes Pressure transducers 3 Way stop cocks Hydraulic resistors Manifold side-arm pinch valves Manifold purge Perfusate manifold Note: Schematic diagram of water perfusion circuit. Only critical components are shown. 4

5 A Overview A Major pump components Reservoir pressurization line Perfusate reservoir Pump control box Reservoir outflow control device Compressor connection plug Pressure transducer rack Air inlet Air perfusion line Standard hydraulic resistors Manifold flush valve Calibration bowl Main perfusate manifold Pinch valves Note: Pump length, channel numbers and spacings vary according to individual specifications. Standard deck version shown. Transducer types vary: Abbott Transpac transducers shown. 5

6 A Overview A 3 MKIII Pump Air Water System 6

7 ! Precautions & Warnings B B!! Never drop. Do not use if visible damage. Only pressurise reservoir with this line (C 3.).! Water level never less than cm (C 0).! Air pressures never more than 300 kpa (45psi).! Air perfusion channel. Only use for pharyngeal swallow monitoring (C 9). 7

8 Normal Use C Assembly & filling of perfusate reservoir C Note: See E for Dentsleeve part # s Fill with particle free, degassed, distilled H 0 Add water, then place perfusion float barrier on top Blow-off valve Perfusate outlet hole O ring Reservoir outflow control device! Always use diffusion float barrier! Always use water filter Part #: APFIL/WA/ 3 Tighten firmly to seal May 003 8

9 C Normal Use For set-up and first use see E to E 7 C Check, connect & set air supply Click! Air Air Set to 00 kpa - 5 psi To gas supply 9 May 003

10 Normal Use C Connection & flushing of water manifold C 3 Connect to water manifold Part # ZPFIT/SW/B-QM-B-00 Air line from control box Filter 3 Open 4 Open, vent and close May 003 0

11 C Normal Use C 4 Check flow values of each hydraulic resistor Standard resistor shown : flow is colour coded Flow ml/min Tube Colour Screw Colour Part # Alternative: Compact hydraulic resistor 0.0 Black White R0HRE/ST/(3) 0.0 Black Black R0HRE/ST/(3) 0.04 Red Red R0HRE/ST/4(3) 0.08 Red White R0HRE/ST/8(3) 0.5 Red Black R0HRE/ST/5(3) 0.3 Green White R0HRE/ST/30(3) 0.45 Green Red R0HRE/ST/45(3) 0.6 Green Black R0HRE/ST/60(3) Water flow on case The flow value is... Correct, go to Changed, go to C 5 E 5 or 6 May 003

12 Normal Use C Turn on water perfusion to fill each transducer C 5 Open pinch valve or clamp Fill transducers Fill transducers Prefered position for 3 way stopcock - other than PVB DPT-600 Note: PVB DPT-600 Transducer shown Note: Abbott Transpac Transducer Shown

13 C Normal Use C 6 Transducer calibration (if required) Turn perfusion off - (C 5) 3 or use gravity calibration Set tranducer gain by applying standard external pressure Shows APCMA/TR/ 68cm H O, 50mm Hg Connect to transducers Pressurise with syringe Note: Shows Dentsleeve calibration manifold; made according to channel numbers and spacings Part # s APCMA/TR/to5 Note: Catheter must be attached to transducers (C 7) C 7 Connect catheter to transducers Select correct channel Twist & push on firmly Note: Catheter detail is for Dentsleeve product 3

14 Normal Use C Water injection procedure - each channel C 8 H O - no bubbles Open side-port 3 Inject 5ml of H O 4

15 C Normal Use C 8 Water injection procedure - each channel (continued) 4 Close side-port then remove syringe Note: Arrangement for PVB DPT-600 transducer shown 5

16 Normal Use C Check flow value for air perfusion manometry C 9 Identify air perfusion channel pinch valve! Only use air perfusion for detection of swallowing in pharynx Ensure resistor for air perfusion channel is correct! Air flow rate through hydraulic resistor is x00 water flow rate. Air flow ml/min Part # Black Black R0HRE/ST/(3) 4 Red Red R0HRE/ST/4(3) 8 Red White R0HRE/ST/8(3)! Must be installed between manifold and transducer to limit air flow into manometric catheter to less than 0ml/min May 003 Suitable compact resistors give airflow on case Air flow ml/min Water Flow Part # ml/min 0.0 R0HRE/CO/ R0HRE/CO/ R0HRE/CO/8 6

17 C Normal Use C 0 Observation & refilling of perfusate reservoir! If perfusate exhausted, large volumes of gas may be perfused down catheter Refill when at cm Release pressure Pull Back 3 Refill 4 Restart perfusion Particle free, degassed, distilled H 0 Tighten Repressurise 7

18 Normal Use C Maintain correct perfusate reservoir pressure C Monitor air pressure. Maintain at 00kPa/5psi psi kpa Check if air pressure drops 3 Check that air supply is adequate At least 30 kpa/ 0psi 0 psi kpa 600 OR open At least 000 kpa/ 50psi 8

19 C Normal Use C Prevention, recognition and correction of hydraulic resistor blockage Prevention of blockages - Always use perfusate filter Minimise perfusate particle load Double-distilled or de-ionised water No particles in reservoir (E-) Perfusate filter Part # APFIL/WA/ 3 Replace water perfusate filter regularly - (G-) 4 Check perfusate flow rates - assemble ml syringe barrel on transducer ml syringe 5 Start perfusion - (C -) Female/Female adapter Part # ZPFIT/VP/FTLLC-9 Transducer on rack 6 Measure time to deliver water Note: for resistor flow rates < 0.5ml/min use ml syringe barrels 9

20 Normal Use C Prevention, recognition and correction of hydraulic resistor blockage C 7 Flushing of blocked resistors - remove resistor from circuit Transducer end 8 Backflush forcibly 9 Observe water flow 0 Re-install - (E 5) OR Remove resistor from circuit Insert flush support tool - (E 6) 3 Same steps as C.7 to.0 above 0

21 C Normal Use C 3 Compressor Always ground Turn on power switch. Power is on when switch is illuminated 3 Connect compressor air outlet to pump 4 Plug in compressor to pump control 5 Press compressor on/off switch. Functioning normally when switch is illuminated

22 Steps On Completion of Measurements D Perfusate reservoir D Depressurise 3 Remove lid Close and disconnect from manifold 4 Drain Reservoir 5 Remove float & air dry Lint & particle free surface! Do not transfer particles to internal surfaces of reservoir

23 D Steps On Completion of Measurements D Water manifold Close D 3 Air supply Turn off compressor OR Close cylinder valve 3

24 Set Up Procedures & Connection of Components E Air supply E! Installation only by an approved, qualified biomedical engineer Use air Note: Air chosen as:. Air dissolution in perfusate prevented by perfusate float barrier.. More suitable for gas perfusion manometry than N. 3. Usually more available and cheaper than N. 4. Available from wall supply and simple compressors. Set up for compressor, wall or air bottle supply Compressor Wall Air bottle E.3 E.4 E.6 or.9 4

25 WARNINGS! E Set Up Procedures & Connection of Components E Air supply (continued) 3 Install next to pump deck or place on bottom shelf of trolley OR 4 Identify air line Black Part # ZPTUB/NS/ Part # ZPFIT/SW/SS Connects to pump Air inlet (C.) Part # ZPFIT/SW/B-QC4-B-400KI 5 Ensure air source is suitable: kpa or 0-35 psi no oil or moisture filtered to 0.5 micron 6 Make appropriate connection to supply 5

26 Set Up Procedures & Connection of Components E Air supply (continued) E 7 Identify air line with Dentsleeve supplied regulator Factory set by Dentsleeve to deliver 300 kpa or 45 psi Part # ZPREG/HP/ Connect to pump air inlet (C.) Cylinder pressure gauge Medical international air pin index (Size C cylinders only) 8 Identify air line if no high pressure regulator supplied Black! 9 Connect to suitable locally sourced high pressure regulator with lockable outlet pressure control! 0 Adjust regulator to deliver outlet pressure of 300 kpa or 45 psi 6

27 E Set Up Procedures & Connection of Components E Perfusate reservoir prior to first use Check correct assembly of perfusate reservoir Blow-off valve Part # ZPFIT/SW/SS-4CPA-3 Closure Knob Part # FAS/PR/ O ring Part # ZPSEA/OR/ Reservoir outflow control device Gasket under lid Part # ZPSEA/GA/ Part # ZPFIT/SW/SS-QM-S-PM Always use water filter (C.) Part # APFIL/WA/!! Always use diffusion float barrier Part # FLO/PR/ Gasket in channel Part # ZPSEA/GA/ Outlet O ring Part # ZPSEA/OR/ Flush reservoir with water to remove any particles 7

28 Set Up Procedures & Connection of Components E Installation of pressure transducers E 3 PVB DPT-600 Abbott Transpac Mount bar removable 8

29 E Set Up Procedures & Connection of Components E 3 Installation of pressure transducers (continued) 3 4 9

30 Set Up Procedures & Connection of Components E Installation of pressure transducers (continued) E

31 E Set Up Procedures & Connection of Components E 4 Water perfusion manifold removal Water perfusion manifold! Air perfusion (C 9 and E 7) 3

32 Set Up Procedures & Connection of Components E Water perfusion manifold removal (continued) E 4 Pinch valve 3 3

33 E Set Up Procedures & Connection of Components E 5 Standard hydraulic resistors Identify standard resistor with correct flow value. (C 4) Prime resistor with water. Use ml syringe for ml/min resistors 0.5ml syringe for lower flow rates Particle-free water 3 Inject till water flows from other end 4 Fill resistor connector as syringe withdrawn No bubbles trapped in luer 33

34 Set Up Procedures & Connection of Components E Standard hydraulic resistors (continued) E 5 5 Connect resistor to manifold side arm luer Ensure resistor connector remains water filled Manifold clamp Part # ZPFAS/RI/ 6 Push and rotate resistor firmly onto manifold luer 7 Open 34

35 E Set Up Procedures & Connection of Components E 5 Standard hydraulic resistors (continued) 8 Debubble downstream resistor luer Inject particle-free water into bottom of luer 9 Ensure no bubbles are trapped 0 Connect to pressure transducer Preferred position for 3 way stopcock Use special high pressure stopcock Push and rotate resistor firmly onto 3 way stopcock Abbott transpac shown Part # ZPSTO/HP/ Water filled Note PVB DPT-600 transducer has integral stop-cock at transducer outlet 3 Final setup: Follow instructions from (C 7.) 35

36 Set Up Procedures & Connection of Components E Compact resistors E 6 Check flow values for each hydraulic resistor Prime resistor with water - Use flush tool Flush tool - Part # APFTO/CR/ Adhesive tape Flush tool holder on top of control box 3 Place flush tool on silicone rubber connector 4 Use ml syringe for ml/min resistors syringe for lower flow rates 5 Inject until water flows from other end 6 Fill resistor connector as syringe withdrawn 7 Remove flush tool 36

37 E Set Up Procedures & Connection of Components E 6 Compact resistors (continued) 8 Connect as shown Water Only 0.60mL/min To water manifold Note: Connectors are self-debubbling. PVB DPT-600 transducer shown. 37

38 Set Up Procedures & Connection of Components E Compact resistors (continued) E 6 9 Connect resistor to manifold sidearm Manifold clamp Part # ZPFAS/RI/ 0 Open Final set-up - follow from (C 5.). 38

39 E Set Up Procedures & Connection of Components E 7 Air perfusion circuit! N perfusion into pharynx may dilute inspired oxygen - use only air for perfusate reservoir pressurisation in small children, as this gas is also used for gas perfusion circuit Identify circuit Locate air manifold and check correctly connected 3 Resistor must always be installed To transducer 39

40 Air Set Up Procedures & Connection of Components E Air perfusion circuit (continued) E 7 4 Select resistor that controls airflow to less than 0ml/min! 5 Airflow is x00 waterflow Air flow Waterflow ml/min ml/min Part # 0.0 Black Black R0HRE/ST/(3) Red Red R0HRE/ST/4(3) R0HRE/ST/8(3) Red White Appropriate compact resistors show airflow on case ml/min WATER 0.0mL/min Air 4mL/min WATER 0.04mL/min Air = ml/min Air = 4ml/min Air = 8ml/min 6 Install air flow resistor between air manifold luer and transducer No 3 way stopcock 7 No water prime required! Air perfusion to be used only for pharyngeal manometry To manifold luer 40

41 Cleaning & Disinfection F Cleaning of plastic parts F Clean with cloth and mild detergent Wipe with isopropyl alcohol Sterilization of perfusate reservoir F Gas sterilize only Sterilization of manifolds F 3 Water manifold Air manifold Autoclavable Hydraulic resistors F 4! Not autoclavable Autoclavable Cleaning of compressor F 5 Wipe with a dry cloth 4

42 G Regular Maintenance G Every 3 months (or as needed): perfusate water filter Replace Part # APFIL/WA/ 4

43 Regular Maintenance G Every year or as needed: gas filters G! To be done only by an approved, qualified biomedical engineer Disconnect gas supply then open control box (G 3.) Use correct filter Part # APFIL/GA/ Gas (Black) 3 Replace filter 4 Check for air-tightness Note: Gas filter life depends on quality of air always use medical grade 43

44 G Regular Maintenance G 3 Service of control box by Dentsleeve Undo screw that holds control box Send control box to Dentsleeve 44

45 Regular Maintenance G Compressor G 4 Check dessicant is orange. When it becomes colourless, replace. Orange White OR Spread granules evenly onto tray, one granule deep. Heat granules for approximately 5 mins. (or until it turns back to its original orange color) at 00oC (00oF) in a conventional oven. Cool dessicant before replacing back into canister. 45

46 Problem Solving H Diagnosis of abnormal air consumption H Check compressor connection For compressor malfunction, please contact Dentsleeve OR Air Check regulator/cylinder connection Not connected Tighten Pressurise air circuit - Turn on Air Adjust air pressure psi kpa Turn off Air 46

47 H Problem Solving H Diagnosis of abnormal air consumption (continued) 5 Recognise leakage - Wait hour either or 6 Drop less than 33 kpa/5psi No significant leak 7 Drop more than 33 kpa/5psi Significant leak 8 Follow (H-.9) below 47

48 Problem Solving H Diagnosis of abnormal air consumption (continued) H 9 Check for leakage outside control box If there are bubbles, replace fitting - Part # ZPFIT/SW/B-QM-B-00ZN psi kpa 50 00! Consult approved, qualified biomedical engineer to do check (H-. to H-.7) below Air Leakage? 3 Open pump control box. 4 Remove control box lid/back 48

49 H Problem Solving H H Diagnosis of abnormal air consumption (continued) 5? Filter leakage - tighten or replace 6 Check rest of air circuit 49

50 H Problem Solving H Abnormal air consumption - perfusate reservoir leakage H First exclude air circuit leakage - (H ) Set pressure psi kpa Tighten 3 Set up reservoir. Remove blow-off valve cap 4 No water 5 Pressurise 6 Locate site of leakage - observe underwater Still pressurised 7 Locate site of bubbling 50

51 H Problem Solving H H Abnormal Air consumption - perfusate reservoir leakage (cont.) ZPFIT/SW/B-QM-B-00ZN 8 If leak elsewhere, dismantle reservoir 9 Identify cause of leakage at base 0 Gasket clean and intact? Identify cause of leakage at top Underside Flip Check O ring Part # ZPSEA/OR/ Gasket underneath clean and intact? Part # ZPSEA/GA/ 5

52 Specifications, Support, Spare Parts & Accessories I Specifications I Air High pressure regulators Recommended first stage regulators (*if supplied) Medical grade only CONCOA Medical Air (Air pin index) Inlet pressure Pump inlet pressure (from gas supply first stage regulator) Air kPa (5-45 psi) Compressor 30-40kpa (0-35 psi) Supply lines (from gas bottles) Air (black) line Supplied with Swagelok female quick connects Air Male Inlet Swagelok Code ZPFIT/SW/B-QC4-DI-400KI Dentsleeve part # Air female connector to perfusate reservoir Swagelok Code ZPFIT/SW/B-QM-B-00ZN Dentsleeve part # Air supply on pump Driving air supply (pump) Air flow rate ± 0% Adjustable 0-50 kpa (0-36psi) Flow restricted to 30ml/min at 00kPa (5psi) Pressure relief valves Perfusate reservoir relief valve Control box inlet overpressure relief valve Preset to 00 kpa (9psi) Preset to 300 kpa (45psi) Filtration Air 0.5 micron male/female luer connection disposable disc filter Contact Dentsleeve for advice See contact details on front cover Technical Support I 5

53 Specifications, Support, Spare Parts & Accessories I H Spare Parts I 4 Spare Parts Kit x 5x x APFIL/GA/ Gas filters, for installation within pump control box. APFIL/WA/ Water filters, for filtration of water perfusate APSSA/PR/ Reservoir outflow control device, for perfusate outflow. Regulatory Information I 5 Authorised European Representative SOLAL Rue Du Travail Strasbiurg FRANCE FDA Approved CE Marked IS03488:996 Certified 53

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